AMO iDesign G300 User manual

iDesign Advanced WaveScan Studio System
Operator s Manual
0110-0624 Rev. D 0217
iDesign Advanced WaveScan Studio
Operator’s Manual
USA Edition
Model: iDesign/G300

iDesign Advanced WaveScan Studio System
Operator s Manual
0110-0624 Rev. D 0217
This manual contains information for the iDesign Advanced WaveScan Studio System,
hereafter called the iDesign System. The information contained in this document is the
confidential and proprietary property of AMO Manufacturing USA, LLC (AMO). 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 AMO Manufacturing USA, LLC.
Advanced CustomVue, PreVue, STAR S4 IR, iDesign Advanced WaveScan Studio, and
iDesign are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or
affiliates.
Pentium is a registered trademark of Intel Corporation. Please note that while every effort has
been made to ensure that 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:
AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 USA
1-800-511-0911 (USA only)
www.amo-inc.com
Product of USA
Order Placement of Accessories and Replacement Parts
Call 1-800-511-0911 (USA only)
Call [phone] outside USA or contact your local representative.
Returns or Technical Service
Call 1-800-511-0911 (USA only)
All returns must be accompanied by an RGA# (Returned Goods Authorization).
Call [phone] outside USA or contact your local representative.
Rx Only
© Copyright 2017 Abbott Medical Optics Inc.

iDesign Advanced WaveScan Studio System
Operator s Manual
0110-0624 Rev. D 0217
Revision History
Section Affected Part Number Rev. Description
All 0110-0624 A Merged Measurement Manual and Treatment Planning
Software Manual into System Manual.
1,2,4,5,6, 10 and
11
0110-0624 B Changes made to Sections: 1,2,4,5,6,10, and 11.
6.8 and 10.9 and 10.10 screenshots were replaced.
page ii, sections 5
and 7
0110-0624 C Removed references to the Windows XP operating system.
section 4 0110-0624 D Deleted Symbol Explanation Table and added Symbol
Glossary Table.

iDesign Advanced WaveScan Studio System
Operator s Manual
Table of Contents
0110-0624 Rev. D 0217 1
Table of Contents
General Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Environmental and Chemical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Storage and Installation Requirements, and Routine Maintenance . . . . . . . . . . . . . . . 3-1
Storage Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Installation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Room Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Cleaning and Disinfection Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Service Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Safety Notices and System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Safety Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Uninterruptible Power Supply Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
iDesign System Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Symbol Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
iDesign System Product Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Label Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Electromagnetic Guidance and Avoidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
System Functional Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Hardware Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
iDesign System Model Eyes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Isolation Transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Motorized Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Glide Pad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Joystick Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Joystick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Table Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Retractable Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Principle of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

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The iDesign System Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Enabling/Disabling the HIPAA Privacy Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Software Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Software Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Software Help System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Software Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
About Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Acquire Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Review Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Treat Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Utilities Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
System Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Using USB Flash Drives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Removing a USB Drive from the iDesign System Computer . . . . . . . . . . . . . . . . . . . . . 5-15
Setting User Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Using the Utilities Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Setting/Modifying Default Clinic Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Enabling/Disabling the HIPAA Privacy Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Enabling/Disabling the HIPAA Password Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Setting/Modifying Default View Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Setting/Modifying Default Treatment Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Determining Refracting Lane Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Lane Length Graphical Examples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Setting/Modifying Default Treatment Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Configuring the Promotional Printout Information Screen . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Managing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Specifications for the External USB Hard Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Using the Database Maintenance Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Backing up and Restoring the iDesign System Database. . . . . . . . . . . . . . . . . . . . . . . . 7-2
Importing Data from an iDesign System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Exporting Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Archiving Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Restoring the Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Merging Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Deleting Patients and Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Acquiring Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Entering Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Adding a New Patient’s Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Editing Existing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Preparing the Examination Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

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Preparing the Patient for the Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Positioning the Patient for Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Eye Alignment and Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Automatic Refraction (Precompensation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Saving the Results of a Failed Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Eye Images Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Screening Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Treatment Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Troubleshooting during Treatment Mode Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Suggestions to Improve Capture Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Reviewing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Data Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Review Tab Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Exam List Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Printing Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Printing Maps and other Views from the Review Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Overriding Default Viewing Options for Data and Maps . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Custom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Wavefront Error and Refractive Correction Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Wavefront Error and Refractive Correction Maps Difference . . . . . . . . . . . . . . . . . . . . 9-6
Point Spread Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Zernike Coefficients Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Corneal Topography Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Corneal Topography Difference Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Eye Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Hartmann-Shack Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Components of the 3D Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Custom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Custom View Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Wavefront Error Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Wavefront Error Map View Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Wavefront Error Map ANSI Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Wavefront Error/Refractive Correction Difference Maps . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Exam Selection Order. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Wavefront Error/Refractive Correction Difference Map View Options . . . . . . . . . . . 9-15
Reading Wavefront Error Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Selecting Pupil Diameter for Calculating Wavefront-based Refractions . . . . . . . . . . . 9-17
Point Spread Function Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Point Spread Functions Image View Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Zernike Coefficients Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Zernike Coefficients Table View Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Zernike Coefficients Difference Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21

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Zernike Coefficients Difference Table View Options . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Corneal Topography Elevation Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Corneal Topography Elevation Map View Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Corneal Topography Axial Power Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Corneal Topography Axial Power Map View Options . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Corneal Topography Difference Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27
Corneal Topography Difference Maps View Options . . . . . . . . . . . . . . . . . . . . . . . . . 9-28
Eye Image View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Eye Image View Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Hartmann-Shack (HS) Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
Hartmann-Shack Image View Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-33
Corneal Topography Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-34
Designing Advanced CustomVue Treatments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Treatment Mode Features from the Acquire Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Selecting the Appropriate iDesign System Exam for
Advanced CustomVue Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Selecting iDesign System Exams for Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Selecting One iDesign System Exam for Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
PreOp Sub-Tab Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Treatment Adjustments for the iDesign System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Using the Percentage Nomogram Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Using the Physician Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Using Expert and Express Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Entering Treatment Design Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Calculating the Advanced CustomVue Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Saving an Advanced CustomVue Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Printing Surgical Planning Forms and Treatment Reports . . . . . . . . . . . . . . . . . . . . . . . 10-20
Surgical Planning Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Surgical Treatment Plan Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
Copying an Advanced CustomVue Treatment to the
STAR S4 IR Excimer Laser System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Self Test and Daily Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Self Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Running the Self Test Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Daily Verification Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Warning Messages During Treatment Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Error Messages During Treatment Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Warning Messages Displayed After Treatment Calculation . . . . . . . . . . . . . . . . . . . . . . . 12-2
Tolerance Range Between Manifest and Wavefront Refraction for Treatment . . . . . . . . 12-2

iDesign Advanced WaveScan Studio System
Operator s Manual
General Warnings and Precautions
0110-0624 Rev. D 0217 1-1
Section 1 — General Warnings and Precautions
Manual 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 iDesign
Advanced WaveScan Studio System.
NOTE: Provides background information to clarify a particular step or procedure.
General Warnings
• Carefully read all instructions prior to use. Retain all safety and operating instructions for future
use. Only trained operators may perform measurements on the iDesign Advanced WaveScan
Studio System.
• Performance of procedures, use of controls, or any other adjustments other than those specified
herein may result in a hazardous condition.
• Observe all contraindications, warnings, and precautions noted in this manual. Failure to do so may
result in patient and/or user complications.
• When lowering table height, take extra care and ensure that patients legs, arms or chair parts do not
interfere with table travel.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
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.
IMPORTANT: Identifies instructions important to the proper operation of the software.
WARNING!
Always follow these instructions to help guard against patient injury.
CAUTION: Failure to abide by the following recommendations could result in damage to equipment or
data loss.

iDesign Advanced WaveScan Studio System
Operator s Manual
General Warnings and Precautions
0110-0624 Rev. D 0217 1-2
• Power down the iDesign System before placing the dust cover over the system.
• Do not place food or liquids on or near the system.
• Portable and mobile RF (Radio Frequency) communications equipment can affect medical
electrical equipment and should not be operated in the vicinity of the system.
• Medical equipment needs special precautions regarding EMC (Electromagnetic Compatibility) and
needs to be installed and put into service according to the EMC information provided in the
accompanying documents and installation instructions. Use of accessories, transducers, and cables
other than those specified, with the exception of replacement parts sold by AMO Manufacturing
USA, LLC, may result in increased emissions or decreased immunity of the system.
• Suggested operating conditions are 62°F to 81°F with relative humidity between 35 and 65%,
non-condensing.
• Any service requiring access to the interior of the system should be performed only by AMO
service personnel or by qualified service technicians who have received specific system training.
• Operate the iDesign System only from the type of power source indicated on the product rating
label.
• All power cords must be connected to the medical grade isolation transformer in the system.
• Do not run the motorized table continuously for longer than 1 minute. The table motor duty cycle is
1 minute on, 15 minutes off.
Environmental and Chemical Safety
No hazardous gases or chemicals are used in the iDesign System. The iDesign System does not emit or
purge any chemical gas or ozone.
This symbol is located on AMO systems and indicates that the equipment consists of
electronic assemblies and other components that may be subject to Directives 2002/96/
EC, 2003/108/EC, and 2002/95/EC of the European parliament, which advises that
electrical and electronic devices must not be disposed of as normal domestic refuse. To
prevent environmental risks or endangerments by non-professional disposal, the
disposal of this product, including any accessories, must comply with valid practices as
outlined in Directives 2002/96/EC, 2003/108/EC, and 2002/95/EC, and local
regulations. All electronic components and systems should be returned to AMO for
disposal.

iDesign Advanced WaveScan Studio System
Operator s Manual
Indications for Use and Contraindications
0110-0624 Rev. D 0217 2-1
Section 2 — Indications for Use and Contraindications
Indications for Use
The iDesign System is indicated for the automatic measurement of wavefront aberrations (coma,
spherical aberration, trefoil, and other higher order aberrations), corneal topography, pupilometry, and
recording the refractive error of the eye; including myopia, hyperopia, astigmatism and keratometry.
Refer to Chapter 1 in the STAR S4 IR Operator’s Manual for applicable wavefront-guided LASIK
treatment indications.
Contraindications
The licensed eye care practitioner should not rely upon results obtained from patients with refractive
errors that exceed the specified range below:
Refer to Chapter 1 in the STAR S4 IR Operator’s Manual for applicable wavefront-guided LASIK
treatment contraindications.
Warnings and Precautions
Refractive errors represent only one component of the complex human visual system. Before
prescribing any type of optical correction based on this device’s output, a licensed eye care practitioner
should always do the following:
• Confirm this device’s output with measurements obtained from other vision measurement sources.
• Be cautious of measurements from patients who have difficulty remaining still or focusing on the
fixation target.
The safety and effectiveness of the iDesign System is not established in patients with a known opacity
of the lens or cornea, including patients with cataracts, corneal scars, or dry eye syndrome (Sicca).
Refer to Chapter 1 in the STAR S4 IR Operator’s Manual for applicable wavefront-guided LASIK
warnings, and precautions.
Measurable
Range made in
0.01D
increments
Spherical equivalent range (6 mm pupil) -16 to +12 D Cylinder
range (6 mm pupil) 8 D.

iDesign Advanced WaveScan Studio System
Operator s Manual
Storage and Installation Requirements, and Routine Maintenance
0110-0624 Rev. D 0217 3-1
Section 3 — Storage and Installation Requirements, and
Routine Maintenance
Storage Requirements
Store the iDesign Advanced WaveScan Studio System according to temperature and humidity
requirements explained in this chapter. Only qualified AMO personnel should install this system. Place
the system in a room that can be sufficiently darkened for measurements. The only maintenance
required by the operator or physician is routine cleaning between patients.
When storing the iDesign System before installation, adhere to the following site requirements:
• Storage temperature must be between 41 to 104°F (5 to 40°C).
• Relative humidity must be in the range 35 to 65% (non-condensing).
Installation Requirements
Only qualified AMO personnel should install the iDesign System. Do not open or unpack the system or
any accessories. Upon system delivery, contact the AMO Service Department to schedule a system
installation appointment.
NOTE: An electrical plug used for connecting the iDesign System to supply mains is provided with the iDesign
System. In specific cases the plug may be subject to the following requirements:
Room Requirements
• Do not place the unit near windows or in a room that cannot be sufficiently darkened to allow the
patient’s eyes to dilate naturally.
• Ambient operational temperature range: 60°F – 80°F (15°C – 27°C).
• Humidity: Relative humidity no less than 35% and no greater than 65% (non-condensing).
• Barometric pressure range: 11 – 16 psi (76 – 110 kPa).
CAUTION: Do not block access to the power outlet connecting the iDesign System to the supply mains. If
an emergency situation arises, disconnect the iDesign System power cord from the power outlet.
CAUTION: The iDesign System is not intended for installation in an oxygen-rich environment.

iDesign Advanced WaveScan Studio System
Operator s Manual
Storage and Installation Requirements, and Routine Maintenance
0110-0624 Rev. D 0217 3-2
Routine Maintenance
Aside from routine cleaning of the iDesign System between patients as described below, routine system
maintenance is performed by an authorized AMO service representative.
Cleaning and Disinfection Instructions
• After each patient, wipe down the chin and forehead rests with isopropyl alcohol.
• Use only a soft rag with mild soap and warm water to wipe the system exterior. Never apply water
directly to the system.
• The iDesign System is not intended to be sterilized and does not require sterilization.
All other system maintenance must be completed by an AMO service representative. Only AMO service
representatives may open the instrument’s covers.
Service Interval
Routine maintenance should be performed by a qualified service technician every two years. The
technician will inspect, check the calibration, perform any routine maintenance such as dust removal,
cleaning, lubrication and testing, and verify proper function of all components.
CAUTION: Do not put cleaning fluids or other material into the optical head aperture.

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-1
Section 4 — Safety Notices and System Specifications
Safety Notices
The iDesign Advanced WaveScan Studio System complies with electrical and laser safety standards.
Always follow the warnings in this manual to guard against personal injury and system damage. The
system’s safety is not established in patients with a known opacity of the lens or cornea, including
patients with cataracts, corneal scars, or dry eye syndrome (Sicca). The licensed eye care practitioner
should always confirm this device’s output with other measurement sources. The iDesign System has
been designed and tested to comply with the standards for electrical and laser safety listed below:
• International Standards IEC 60601-1:2005/01/01 and IEC 60601-1-2:2007/03/01.
Warnings
The iDesign System has been designed to minimize harmful conditions. Always follow these
instructions to help guard against personal injury and damage to your iDesign System.
• Only trained service personnel should remove the instrument covers.
• Only AMO service personnel or qualified service technicians who have received specific system
training should perform any service requiring access to the interior of the system.
• Operate the iDesign System only from the type of power source indicated on the product rating
label.
• Connect all power cords to the medical grade isolation transformer in the system.
• Carefully read all instructions prior to use. Retain all safety and operating instructions for future
use.
• Do not run the motorized table continuously for longer than 1 minute. The table motor duty cycle is
1 minute on, 15 minutes off.
System Specifications
• Isolation Transformer
!Input: 100/120/220/240 VAC at 50/60 Hz
!Power: 750 VA
• Physical Dimensions of the optical head (L, W, H): 20”, 18”, 27”, (50.8 cm, 45.7 cm, 68.6 cm),
including base
• Weight of the optical head: 80 lbs (36 kg)
WARNING!
Observe all contraindications, warnings, and precautions noted in this manual.

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-2
• Physical Dimensions of the motorized table (L, W, H) 52.5”, 28.3”, 31.9” -46.7” (min-max),
(133.4 cm, 71.8 cm, 81.0 -118.6 cm)
• Weight of motorized table 149 lbs (68 kg)
• Electrical ratings for the motorized table are 120 V ~, 50/60 Hz, 6 A
• Optical Head Enclosure Construction: Aluminum and plastic
• Special Packaging Provisions: Delicate optical instrument; avoid condensation
• Measurable Range: Sphere and Cylinder measurements in 0.01 D increments. Spherical equivalent
range (6 mm pupil) -16 to +12 D. Cylinder range (6 mm pupil) 8 D.
• Axis in 1° increments
• Pupil measurements 2.0 to 9.5 mm, with 0.1 mm resolution.
• Maximum wavefront diameter 8.5 mm.
• Zernike Terms displayed through the sixth order
• Measurement spatial resolution 0.177 mm (approximately 1250 measurement points for a 7 mm
pupil)
• Integrated corneal topographer 37 x 37 spot measurement grid.
• Topographer grid extent (X and Y) +4.1 mm for eye with 8 mm radius of curvature.
• Illumination ranging from 535 to 940 nm
• Model Number -G300

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-3
Uninterruptible Power Supply Specifications
In the event that it is desired to use an uninterruptible power supply with the iDesign System, use the
specifications shown in the table below to select an appropriate unit. Several commercial vendors
manufacture UPS systems that meet these specifications.
UPS Output
Voltage Match user country line voltage
Regulation (normal mode) -10% to +6%
Regulation (battery mode) +/-5%
Frequency Match user country frequency range
Power Rating 1000 VA
Load Power Factor Greater than or equal to 0.6
Transfer Time < 10 milliseconds
Maximum Current 5 Amp minimum at 120 VAC; 2.5 Amp minimum at 240 VAC
Waveform Sine Wave
Receptacles Match user country standards at rated output current
UPS Input
Voltage Match user country line voltage
Frequency Match user country frequency range
Maximum Current 6.5 Amp minimum at 120 VAC, 3.25 Amp minimum at 240 VAC
Connections 10 A IEC-320 connector
UPS Battery
Type No specific requirement. Comply with local regulations.
Diagnostics Periodic automatic test recommended but not required.
Autonomy Time > 10 minutes at full load
Recharge Time No specific requirement. User needs will determine.
Environmental Considerations
Audible Noise < 50 dBA or as required by the user
Operating Temperature 10 °C to 40 °C as a minimum requirement
Storage Temperature -15 °C to 45 °C or as required by user
Relative Humidity 5% to 80% non-condensing
Altitude As required by the user site
Safety EN60601-1 and must comply with site requirements
EMC Emissions and Immunity EN60601-1-2 and applicable local standards

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-4
iDesign System Labeling
The iDesign System is labeled appropriately in compliance with required directives.
Symbol Glossary
Symbol Description Reference
Follow instructions for use. IEC 60601-1:2005/(R)2012 Medical
electrical equipment – Part 1: General
requirements for basic safety and essential
performance
Symbol reference Table D.2 #10
Type B Applied Part. IEC 60601-1:2005/(R)2012 Medical
electrical equipment – Part 1: General
requirements for basic safety and essential
performance
Symbol reference Table D.1 #19
Indicates the medical device manufacturer, as
defined in EU Directives 90/385/EEC, 93/42/EEC
and 98/79/EC.
ISO 15223-1:2012 Medical devices –
Symbols to be used with medical device
labels, labeling and information to be
supplied – Part 1: General requirements
Symbol reference # 5.1.1
The ETL Mark is proof of product compliance to
North American safety standards. The product
conforms to ANSI/AAMI STD ES60601-1, and is
certified to CSA STD. C22.2 #60601-1.
Intertek’s ETL Listed Mark.
Do not dispose with household waste. All electronic
components and systems should be returned to AMO
for disposal.
EU Directive 2012/19/EU on waste
electrical and electronic equipment
(WEEE).
Symbol reference Annex IX

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-5
iDesign System Product Labels
Note that all label images are for reference only.
Label 1: iDesign System Measurement Abberrometer Product Identification Label
Label 2: iDesign System Measurement System Product Identification Label
Label 3: iDesign System Table Intermittent Operation Only (English Language)

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-6
Label 5: Manufacturer Contact Label

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-7
Label Locations
Figure 4.1 – iDesign Advanced WaveScan Studio System Label Placement (Back)
Figure 4.2 – iDesign Advanced WaveScan Studio System Label Placement (Side)
1. iDesign System Table Intermittent Operation Only (English Language)
2. iDesign System Table Intermittent Operation Only (French Language)
1. Patent Label
2. iDesign System Table Product Identification Label

iDesign Advanced WaveScan Studio System
Operator s Manual
Safety Notices and System Specifications
0110-0624 Rev. D 0217 4-8
Electromagnetic Guidance and Avoidance
The iDesign System is intended for use in the electromagnetic environment specified below. The
customer or user of the iDesign System should make sure that the System is used in such an
environment.
The iDesign System is intended for use in the electromagnetic environment specified below. The
customer or the user of the iDesign System should make sure that the System is used in such an
environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.
Guidance and Manufacturer s Declaration – Electromagnetic Emissions
Immunity Test Compliance Electromagnetic Environment - Guidance
RF Emissions CISPR 11 Group 1 The iDesign System uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11 Group 2 The iDesign System is suitable for use in all establishments
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Harmonic Current Emissions Complies
Voltage Fluctuations and
Flicker
Complies
Guidance and Manufacturer s Declaration – Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -
Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-4
+/- 1 kV differential mode
+/- 2 kV common mode
+/- 1 kV differential mode
+/- 2 kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply lines
IEC 61000-4-11
< 5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
< 5% UT
(>95% dip in UT) for 5 sec
< 5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
< 5% UT
(>95% dip in UT) for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the iDesign
System requires continued operation
during power main interruptions, it is
recommended that the iDesign System be
powered from an uninterruptible power
supply or a battery.
Power frequency (50/
60 Hz)
3 A/m 3 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Magnetic field
IEC 61000-4-8