iDesign Treatment Planning Software Operators Manual Rev E Feb 2012

iDesign Treatment Planning Software Operator’s Manual

This manual contains information for the iDesign Advanced WaveScan Studio Treatment Planning Software. 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. CustomVue, PreVue, STAR S4 IR, the iDesign Advanced WaveScan Studio logo, and iDesign are trademarks owned by or licensed to Abbott Laboratories, its subsidaries or affiliates. Windows XP is a trademark of Microsoft 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 European Representative: AMO Ireland Block B Liffey Valley Office Campus Quarryvale, Co. Dublin, Ireland Order Placement of Accessories and Replacement Parts Call 1-800-511-0911 (USA only) Call +800-511-09111 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 +800-511-09111 outside USA or contact your local representative. Rx Only © Copyright 2012 AMO Manufacturing USA, LLC

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Revision History Section Affected

Part Number

Rev.

Revision Date

All

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XA

3-25-2010

Development Release

All

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XB

3-25-2010

Development Release

All

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C

6-30-2011

Production Release

Chapters 2,3, and 7

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D

10-01-2011

Production Release

Chapters 2 and 3

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E

02-29-2012

Added Indications and Corrected Start-up Procedure

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Description

iDesign Treatment Planning Software Operator’s Manual

General Warnings and Precautions... 1-1 Manual Conventions... 1-1 General Warnings and Precautions... 1-1

Indications for Use and Contraindications... 2-1 Product Description... 2-1 Indications for Use... 2-1 Contraindications... 2-1

System Functional Overview... 3-1 System Startup... 3-1 Enabling/Disabling the HIPAA Privacy Screen... 3-2 Software Description... 3-2 Software Hierarchy... 3-3 Review Tab... 3-4 Treat Tab... 3-5 Utilities Tab... 3-9 Software Navigation... 3-13 Software Help System... 3-14 Using USB Flash Drives... 3-15 Removing a USB Drive from the iDesign Computer... 3-15

Setting User Defaults... 4-1 Using the Utilities Options... 4-1 Setting/Modifying Default Clinic Settings... 4-1 Enabling/Disabling the HIPAA Privacy Screen... 4-3 Enabling/Disabling the HIPAA Password Option... 4-3 Setting/Modifying Default View Options... 4-5 Setting/Modifying Default Treatment Settings... 4-6 Determining Refracting Lane Length... 4-9 Lane Length Graphical Examples... 4-9 Setting/Modifying Default Treatment Adjustments... 4-10 Configuring the Promotional Printout Information Screen... 4-12

Managing Patient Data... 5-1 Using the Database Maintenance Utilities... 5-1 Backing up and Restoring the iDesign System Database... 5-2 Importing Data from an iDesign System... 5-3 Exporting Patient Data... 5-6 Archiving Patient Data... 5-9 Restoring the Archive... 5-10 Merging Patient Records... 5-11 Deleting Patients and Exams... 5-12

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Reviewing Patient Data... 6-1 Using the Review Tab... 6-1 Review Tab Functions... 6-2 Exam List Icons... 6-2 Printing Data... 6-3 Printing Maps and other Views from the Review Tab... 6-3 Overriding Default Viewing Options for Data and Maps... 6-3 Eye Image... 6-4 Hartmann-Shack Image... 6-4 Wavefront Error and Refractive Correction Maps... 6-4 Wavefront Error and Refractive Correction Maps Difference... 6-4 Point Spread Function... 6-5 Zernike Coefficients Tables... 6-5 Corneal Topography Maps... 6-5 Corneal Topography Difference Maps... 6-6 Custom View... 6-6 Components of the 3D Plots... 6-6 Reviewing Data... 6-8 Selecting Custom Views and Viewing Options... 6-9 Custom View... 6-9 Custom View Options... 6-10 Wavefront Error Maps... 6-11 Wavefront Error Map View Options... 6-12 Wavefront Error Map ANSI Compliance... 6-13 Wavefront Error/Refractive Correction Difference Maps... 6-14 Exam Selection Order... 6-14 Wavefront Error/Refractive Correction Difference Map View Options... 6-15 Reading Wavefront Error Maps... 6-16 Selecting Pupil Size for Calculating Wavefront-based Refractions... 6-17 Point Spread Function Image... 6-17 Point Spread Functions Image View Options... 6-18 Zernike Coefficients Table... 6-20 Zernike Coefficients Table View Options... 6-20 Zernike Coefficients Difference Table... 6-21 Zernike Coefficients Difference Table View Options... 6-22 Hartmann-Shack (HS) Images... 6-23 Hartmann-Shack Image View Options... 6-25 Eye Image View... 6-25 Eye Image View Options... 6-27 Corneal Topography Image... 6-28 Corneal Topography Elevation Map... 6-28 Corneal Topography Elevation Map View Options... 6-29 Corneal Topography Axial Power Map... 6-31 Corneal Topography Axial Power Map View Options... 6-31 0110-0006 Rev. E 0212

iDesign Treatment Planning Software Operator’s Manual

Corneal Topography BFS (Best-Fit Sphere) Elevation Map... 6-33 Corneal Topography BFS Map View Options... 6-33 Corneal Topography Difference Maps... 6-34 Corneal Topography Difference Maps View Options... 6-36

Designing CustomVue Treatments... 7-1 Introduction... 7-1 Treatment Mode Features from the Acquire Tab... 7-1 Selecting the Appropriate iDesign Exam for CustomVue Treatments... 7-1 How the Software Selects iDesign Exams for Treatment... 7-2 Selecting iDesign Exams for Treatment... 7-2 Selecting One iDesign Exam for Treatment... 7-3 PreOp Sub-Tab Options... 7-5 Treatment Mode Sequence... 7-6 Troubleshooting during Treatment Mode Acquisition... 7-11 Treatment Adjustments for the iDesign System... 7-12 Using the Percentage Nomogram Adjustment... 7-12 Using the Physician Adjustment... 7-12 Using Expert and Express Modes... 7-13 Entering Treatment Design Parameters... 7-16 Calculating the CustomVue Treatment... 7-19 Saving a CustomVue Treatment... 7-22 Copying a CustomVue Treatment to the STAR S4 IR Excimer Laser System... 7-23 Printing Surgical Planning Forms and Treatment Reports... 7-24 Surgical Planning Form... 7-25 Surgical Treatment Plan Report... 7-26

Troubleshooting... 8-1 Warning Messages During Treatment Calculation... 8-1

Index... Index-i

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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 Measurement 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.

IMPORTANT: Identifies instructions important to the proper operation of the software.

NOTE: Provides background information to clarify a particular step or procedure.

General Warnings and Precautions WARNING! Always follow these instructions to help guard against patient injury and/or possible data loss.

• Carefully read all instructions prior to use. Retain all safety and operating instructions for future use. • 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. • The iDesign Measurement System is comprised of two separate medical devices: the measurement device (class IIa device) (MDD 93/42/EEC) and the treatment planning software (class IIb device) (MDD 93/42/EEC). The iDesign Measurement System is a Class I laser system with an 840 nm wavelength output. The instrument covers should be removed only by trained service personnel. • To avoid inadvertent exposure to laser radiation, never operate the system with the covers opened or removed. Doing so may expose the user or others to stray laser radiation. • 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.

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iDesign Treatment Planning Software Operator’s Manual • Operate the iDesign Measurement 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. • Do not tilt loaded motorized table more than 5°. • Do not use this product near water or a heat source such as a radiator. • 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. • Portable and mobile RF (Radio Frequency) communications equipment can affect medical electrical equipment and should not be operated in the vicinity of the system.

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Section 2 - Indications for Use and Contraindications Product Description The iDesign Treatment Planning Software (TPS) is used to calculate the desired laser vision correction treatment (CustomVue treatment) from the iDesign Measurement System. The software generates two sets of laser instructions, one for PreVue plastic lenses and the other for the patient procedure.

Indications for Use The iDesign Treatment Planning Software (TPS) is indicated for the calculation of desired laser vision correction treatment (CustomVue treatment) based on measurements obtained from the iDesign system. Refer to the iDesign Measurement System user manual for instructions on obtaining measurements. The treatment plan can be used on the STAR S4 IR Excimer Laser System for wavefront-guided laser assisted in situ keratomileusis (LASIK). Wavefront-guided LASIK (CustomVue) treatment using the iDesign Advanced WaveScan Studio System and the STAR S4 IR Excimer Laser System is intended for the reduction or elimination of

Myopia

Cylinder: Up to -8.00 D SE: Up to -12.00 D

Hyperopia

Cylinder: Up to +8.00 D SE: Up to +8.00 D

Mixed Astigmatism

The magnitude of cylinder (up to 8.00 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs

Contraindications The licensed eye care practitioner should not rely upon results obtained from patients with refractive errors that exceed the range defined in the iDesign Measurement System Operator’s Manual. CAUTION: Patients must discontinue the use of soft contact lenses at least two weeks prior to examination and treatment. Hard (PMMA) or RGP lenses must be discontinued at least three weeks prior to examination and treatment, with stable keratometry and refraction. Both soft and rigid contact lenses can cause reversible aberrations in the patient’s optical system due to alterations in corneal contour. Therefore, contact lenses must be discontinued prior to evaluation and treatment so the cornea can return to its baseline shape. If contact lens-related abnormalities are not allowed to resolve prior to the CustomVue treatment, they will be permanently ablated onto the corneal surface.

Refer to Chapter 1 in the STAR S4 IR Operator’s Manual, sections 1.2, and 1.42, for applicable wavefront-guided LASIK treatment contraindications, warnings, and precautions.

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Section 3-System Functional Overview System Startup To start the system, press the Main Power Switch (Figure 3.1), then press the System Power Switch (Figure 3.2). When power is applied to the system, all the system components will begin their warm-up procedures. NOTE: Before switching off the Main Power switch, be sure to perform a safe computer shut down by first selecting the System Shut Down option located under the System Tab. CAUTION: Allow the system to warm up for 15 minutes to allow the power to stabilize before taking patient measurements and performing daily verification.

1

1. Main Power Switch

Figure 3.1 – Main Power Switch

1

1. System Power Switch

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Enabling/Disabling the HIPAA Privacy Screen A privacy screen is displayed (Figure 3.3), which hides the current iDesign screen after ten minutes of no activity (U.S. HIPAA [Health Insurance Portability and Accountability Act]). If password protection is inactive, click OK to remove the privacy screen and return to the prior state of the application. If password protection is active, the application is locked when the privacy screen is displayed. Enter the password and click OK to unlock the application and return to the state of the application prior to lockout. In addition, if password protection is enabled, when the application starts, the privacy screen is displayed in locked mode.

Figure 3.3 – System Privacy Screen

Software Description The iDesign software is designed specifically for the iDesign system. The software runs using the Windows XP operating system. The software includes a Help System. To access the Help System, select the Help button on the bottom right side of screens or press F1 on the keyboard. NOTE: The operator does not need a detailed knowledge of computers or software to operate the iDesign System. CAUTION: The iDesign system computer is programmed to run specially designed software to produce iDesign results. Do not use the computer control station for general computer activity or for personal use. Do not attempt to plug in any devices other than USB flash drives in the USB ports. CAUTION: The iDesign Treatment Planning Software (TPS) is only to be run on iDesign devices.

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Software Hierarchy The iDesign system software program features six main tabs at the top of the screen: About, Acquire, Review, Treat, Utilities, and System. • About – available on the measurement portion of the iDesign system software. Refer to the iDesign Measurement System User Manual for a detailed description. • Acquire – available on the measurement portion of the iDesign system software. Refer to the iDesign Measurement System User Manual for a detailed description. • Review – used to review and print patient data (see Section 6 – Reviewing Patient Data). • Treat – used to design a CustomVue patient treatment based upon a selected iDesign exam (see Section 7 – Designing CustomVue Treatments). • Utilities – used to customize basic system, treatment, and maintenance settings and preferences (see Section 4 – Setting User Defaults and Section 5 – Managing Patient Data). • System – available on the measurement portion of the iDesign system software. Refer to the iDesign Measurement System User Manual for a detailed description.

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Review Tab The Review tab (Figure 3.4) allows you to search/view existing patients and exams stored in the database.

Figure 3.4 – Review Tab

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Treat Tab The Treat tab (Figure 3.5) contains the PreOp, OD/OS Design, and OD/OS Calc sub-tabs used for entering refractive and surgical data, calculating treatments, and saving treatments for use on the STAR S4 IR laser system. The Patient sub-tab allows you to select a patient for designing a CustomVue treatment.

Figure 3.5 – Treat Tab

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iDesign Treatment Planning Software Operator’s Manual The PreOp sub-tab (Figure 3.6) allows you to enter and view selected treatment parameters for OD and OS treatment plans.

Figure 3.6 – PreOp Sub-Tab

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iDesign Treatment Planning Software Operator’s Manual The OD/OS Design sub-tabs (Figure 3.7) show the CustomVue treatment parameters from the selected wavefront measurement and allow you to enter Physician Adjustments, treatment dimensions and treatment parameters for each eye while displaying a graphic of the planned ablation shape.

Figure 3.7 – OD Design Tab

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iDesign Treatment Planning Software Operator’s Manual The OD/OS Calc sub-tabs (Figure 3.8) allow you to initiate the treatment calculation process and then view the results.

Figure 3.8 – OD Calc Sub-Tab

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Utilities Tab The Utilities tab contains the Clinic Settings, Treat Settings, Treat Adjustments, and Database Maintenance sub-tabs used for setting personnel defaults, password options, refraction defaults, treatment types, acuity format, treatment adjustment defaults, and backing up and retrieving patient data from the database. The Clinic Settings sub-tab (Figure 3.9) allows you to add, edit and delete physician and operator names, set personnel defaults, set default slide export format, enable/disable the HIPAA password option, set defaults for refractions, set view options for the graphical maps and images, and set defaults for report printing (refer to Section 4 – Setting User Defaults, for more details).

Figure 3.9 – Clinic Setting Sub-Tab

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iDesign Treatment Planning Software Operator’s Manual The Treat Settings sub-tab (Figure 3.10) allows you to enter/select defaults for treatment type, acuity format, corneal thickness, lane length, and CV myopic/hyperopic zone dimensions, treatment card for limit testing, treat/patient tab options, LASIK flap parameters, and select/deselect to include a PreVue Lens in Expert Mode.

Figure 3.10 – Treat Settings Sub-Tab

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iDesign Treatment Planning Software Operator’s Manual The Treat Adjustments sub-tab (Figure 3.11) allows you to enter/select treatment adjustment defaults, including nomogram and physician adjustments.

Figure 3.11 – Treat Adjustments Sub-Tab

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