ORA SYSTEM VerifEye Lynk Technology User Manual Rev A

with VerifEye™ Lynk Technology

Revision

Date

Description

A

13 AUG 2021

CN106734ECN – Initial release of ORA software instructions for VLynk v3.08 ORClient software.

Printed in the United States of America. All rights reserved. No portion of this reference manual may be used or reproduced in any manner without the written permission of Alcon Laboratories, Inc. Making copies of any part of this manual for any purpose other than personal use is a violation of United States copyright laws. Permitted copies must carry the same copyright notices as the original. Though every effort has been made to ensure the accuracy of the information provided in this manual, the contents of this manual are subject to change without notice. U.S. Federal law restricts this device to sale by or on the order of a physician or ophthalmologist.

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Contents System Information

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Intended Use(s)... 1 Indications For Use... 1 Intended Users... 1 Intended Patient Population... 1 Contraindications... 1 Clinical Benefits... 1 User Training... 2 Phase 1 – On-line Training:... 2 Phase 2 – Didactic and Hands-on Training:... 2 Phase 3 – Surgery Support... 2 Post Installation... 2 Product Service... 3 Serious Incident Reporting... 3 Potential Complications... 4 Operator’s Manual... 4 Warning, Precaution, Caution, and Note Examples... 5 Abbreviations, Acronyms, and Definitions... 5 Labels... 6 Field Verification Tool Label Location... 6 Cart Label Locations... 7 Symbols... 8 Limited Warranty... 9 Description

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ORA SYSTEM™ with VerifEye™ Lynk Technology ... 11 AnalyzOR™ Technology... 12 ORA SYSTEMTM Cart...14 Device Compatibility... 15 Mounting... 15 Sizes... 15 Focal Length... 15 Performance Capabilities... 16 Intraoperative Refraction Readings... 16 Pupil Size... 16 Results... 16 Software Version... 16 Cybersecurity... 16 8065000229 Rev. A

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Safety

17

General Safety Considerations... 17 Device Safety Features ... 18 General Safety Precautions... 19 Specific User Responsibilities... 20 Protective Eyewear ... 20 Protective Clothing ... 20 Electrical Hazards... 20 Electromagnetic Compatibility (EMC) Compliance... 21 Guidance and Manufacturer Declarations... 21 Equipment Contains Wireless Transmitters ... 23 USA - Federal Communications Commission (FCC)... 24 FCC Radiation Exposure Statement:... 24 Canada - Industry of Canada (IC)... 24 Canada - Industrie du Canada (IC)... 24 Europe - RED Directive 2014/53/EU... 25 Summary of Wi-Fi Module Certifications ... 25 Installation

27

Examine Shipping Contents... 27 Set-up Requirements... 28 Electrical Requirement... 28 Environmental Requirement... 28 System Setup... 28 Customer Removal, Storage and Transportation... 31 Transport... 31 Configuration

33

Options... 33 SLED Mode... 33 Axis Value to Display ... 34 Login Attempts... 34 Pre-Op Data... 34 Dynamic Reticle Doctor Configuration for MID Display... 35 Refractive... 36 Toric Placement ... 36 Toric Rotation ... 37 LRI... 37

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Operating Instructions

39

Basic Operating Steps... 39 Setup the Device... 39 Select Practice... 41 Create a New Patient on the ORA SYSTEM™... 41 Select a Patient (Existing or Imported from the Planner)... 43 Begin Surgery... 46 State of the Eye Options ... 49 Achieving Good Alignment... 51 Image Acquisition... 53 Red Images... 54 Measurement Caution ... 55 Aphakic Spherical Equivalent ... 56 Add Lens to Lens List... 59 Power Calculation for Long Eyes ... 60 Toric IOL Case... 60 After Toric Implant Measurement... 66 Pseudophakic Toric Results Screen ... 67 Taking an LRI Measurement... 70 LRI Circle Graphic... 71 Intra-Operative Data Tags ... 72 After Implant Tag... 73 After LRI – After Enh. Enhancement Tag ... 73 Entering Measurement Notes... 73 Selecting the Lens Used for a Surgery ... 74 Turn off the ORA SYSTEM™... 76 VERION™ Overview... 77 VERION™ Instrument Description... 77 Directing the User by Graying Out Screens... 78 Login to the VERION™ DMM... 79 Calibration and Calibration Check... 81 Digital Marker Calibration... 82 ORA SYSTEM™ Verification... 85 VerifEye™ Lynk Calibration... 86 Calibration Check... 91 ORA SYSTEM™ Verification... 93 VerifEye™ Lynk Calibration Check... 95 MID Verification... 96

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GUI overview... 98 Digital Marker M Planning Screen... 98 Digital Marker M Surgery screen... 99 ORA SYSTEM™ Cart Screen – Specific VLynk Features...100 Surgery Workflow...101 VerifEye™ Lynk Surgery Preparation...101 Surgery Preparation...101 Start Surgery Workflow with Reference Image...103 Start Surgery Workflow without Reference Image...104 Incision and Capsulorhexis Steps...105 ORA SYSTEM™ Aphakic Measurement and Lens Selection...106 IOL Centration...109 Toric Alignment...110 ORA SYSTEM™ Pseudophakic Measurement...111 Lens Axis Marker (LAM) - Optional Step...115 Finalizing Surgery...117 Exit Surgery...117 Alternative Measurements: LRI and LRI Enhancement...118 Patient Handling in the Operating Room...122 New Patient...123 ORA SYSTEM™ Cart Synchronization...125 Editing Existing Verion™ Plan Patient Data...126 Shutting Down the ORA VerifEye™ Lynk System...128

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Care and Maintenance

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Routine Maintenance...129 System Verification / Calibration Check...130 Visual Inspection ...130 Aberrometer Cleaning...131 Microscope Repair Affecting the Aberrometer...132 Cart Cleaning...132 Cleaning Display Screens...132 Troubleshooting

133

Before Calling for Service...133 System Messages...134 Network Messages...135 Unable to Log In...136 Other Issues...136 Touchscreen Not Centered...139 VERION™ Digital Marker M Error Messages...140 Specifications

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Mechanical Dimensions...148 Aberrometer Dimensions...148 ORA SYSTEM™ Cart Dimensions...149

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System Information Intended Use(s) The ORA SYSTEM™ with VerifEye™ Lynk is intended for use in the measurement and analysis of the refractive power of the eye (for instance, sphere, cylinder, and axis measurements).

Indications For Use The ORA SYSTEM™ with VerifEye™ Lynk is indicated for use during ophthalmic surgery. Wavefront data is obtained, analyzed, and presented to the user via a cart mounted liquid crystal display (LCD) touchscreen.

Intended Users The intended users are licensed ophthalmic surgeons and their surgical teams.

Intended Patient Population The intended population includes patients having refractive and/or cataract surgery and IOL Implantation during opthalmic surgery.

Contraindications There are no known contraindications for this device.

Clinical Benefits The ORA SYSTEM™ is designed to provide intraoperative measurement of the refractive power of the eye (sphere, cylinder, and axis measurements) during cataract removal and IOL implantation. It provides real-time confirmation to ophthalmic surgeons with respect to the correctness of IOL selection for the patient during the surgical procedure. In addition, it helps in judging the axis placement of the toric IOL.

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User Training Training is provided to the user(s) via online, didactic, and hands-on with training materials. The training is set up in the following phases.

Phase 1 – On-line Training: z

Clinical department sets up the surgeon for on-line phase 1 training that provides an overview of the ORA SYSTEM™ Technology with features, benefits, work flow, and important factors for operation.

z

The surgeon completes phase 1 training on-line prior to hands-on training and case support.

Phase 2 – Didactic and Hands-on Training: Aberrometer/Cart: z

Prerequisite: The surgeon must complete the on-line training module prior to didactic and hands-on training.

z

Each trainee practices setup of aberrometer, operation of cart, and shutdown of cart, including inspection of cables, aperture glass, and breakdown of aberrometer.

z

Each surgeon performs artificial eye test procedures and navigates the software for each surgery application.

AnalyzOR™ Technology: z

Each trainee sets up their own login and password, and practices patient entry and adding an IOL.

z

Pre-program cases for their first surgery day, if possible.

Phase 3 – Surgery Support z

Discuss procedure systematically and step by step, pointing out when to address surgical variables (i.e., perform routine phaco procedure, paying attention to incision size and wound creation, following implantation of IOL, pay attention to IOL centration and tilt, check IOP prior to image capture, etc.).

z

Work directly with staff in supervising the set-up, operation, and breakdown of equipment.

Post Installation CAS informs user of Lens Optimization data requirements and recommends continuous post-op data updates.

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Product Service

CLINICAL AND TECHNICAL

SERVICES SUPPORT LIKE NO OTHER

TM

For product service, contact Alcon Technical Services or an authorized local service representative. For optimal performance, schedule preventive maintenance for the system and relevant accessories at least once a year. However, systems may require additional service depending on use or other circumstances. Also, verify safety performance at least once a year and ensure ground resistance, leakage current, and dielectric withstand voltage meets appropriate international, national, and local standards. Before returning systems or accessories, contact Alcon Technical Services or an authorized local service representative. If necessary, follow any provided shipping instructions. Alcon Technical Services and Clinical Support (US) Phone: +1 (949) 238-8254 US toll free: +1 (800) 832-7827

Serious Incident Reporting Any serious incident related to the use of this medical device should be reported to Alcon Laboratories, Inc.: By phone:

In USA – (800) 757-9780 In EU/International – Contact the local country office or your Alcon distributor.

Website:

http://www.alcon.com/contact-us/

EU Email:

[email protected]

These serious incidents should also be reported to the competent authority for medical devices of your State.

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Potential Complications z

Potential errors in measuring refractions and/or IOL power calculations may occur when the cylinder, axis, or spherical equivalent are displayed in red on the ORA SYSTEM™ screen.

z

Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements.

z

Post RK eyes might yield inaccurate refractive measurement.

CAUTION It will be difficult to obtain accurate, consistent, and reliable measurements if any of the following conditions or situations exists: z

Patients having progressive retinal pathology such as diabetic retinopathy, macular degeneration, or any other pathology that the physician deems would interfere with patient fixation.

z

Patients having corneal pathology such as Fuchs’, EBMD, keratoconus, advanced pterygium impairing the cornea, or any other pathology that the physician deems would interfere with the measurement process.

z

Patients for which the preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics.

z

Visually significant media opacity, such as prominent floaters or asteroid hyalosis, that will limit or prohibit measurement process. Image quality indicator, and/or error message will indicate when this is an issue.

z

Patients having received retro or peribulbar block, or any other treatment that impairs their ability to visualize the fixation light.

z

Utilization of iris hooks during an ORA SYSTEM™ image capture, may yield inaccurate measurements.

Operator’s Manual This manual provides information on the operation of Alcon ORA SYSTEM™ (Optiwave Refractive Analysis) Intraoperative Wavefront Aberrometer and ORA SYSTEM™ Cart. While every effort has been made to ensure that the information provided within this document is accurate, the information contained herein are subject to change without notice.

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Warning, Precaution, Caution, and Note Examples Pay close attention to warnings, precautions, cautions, and notes in this manual. z

A warning statement is written to protect individuals from bodily harm.

z

A precautionary statement is action taken in advance to protect against possible danger, failure, or injury; a safeguard.

z

A caution statement is written to protect the instrument from damage.

z

A note is written to bring attention to highlighted information.

Abbreviations, Acronyms, and Definitions Abbreviation ANSI Aberrometer

Description American National Standards Institute A component that attaches to the surgical microscope. Its function is data acquisition and emission monitoring.

CAS

Alcon clinical application specialist

CFR

Code of Federal Regulations

DMM

Digital Marker Microscope

EMC

Electromagnetic compatibility

Hz

Hertz

IEC

International Electrotechnical Commission

LCD

Liquid crystal display

LED

Light emitting diode

LRI

Limbal relaxing incision

NIST

National Institute of Standards and Technology

MID

Microscope integrated display

NOHD

Nominal ocular hazard distance

SLED

Superluminescent light-emiting diode: An edge-emitting semiconductor light source based on super luminescence. It combines the high power and brightness of laser diodes with the low coherence of conventional light-emitting diodes. For safety purposes, the SLED can be considered equivalent to a laser of equivalent power. The terms SLED and laser are used interchangeably for the purpose of this document.

V

Volts

VAC

Volts alternating current

Vlynk

VerifEye™ Lynk

Wavefront

An imaginary surface joining all points in space that are reached at the same time by a lightwave propagating through a medium.

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Labels The ORA System™ is labeled as required by IEC and EN standards abd 21 CFR §1040.1/11 and WEEE and RED.

1 2 3

Aberrometer Product Label Locator 1

Compliance label – Includes 21 CFR information.

2

Aberrometer product label – Includes product identification information.

3

Laser label – Includes laser classification.

Field Verification Tool Label Location

1 ORA SYSTEM™ Field Verification Tool (FVT) Label 1

Field verification tool label – Includes model, serial number, and date of manufacture.

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Cart Label Locations

1

2

3 4

Cart Label Locations 1

Pinch warning label (quantity 3) - Identifies location of possible pinch hazard.

2

Product Identification and Certification Label - Includes model, serial number, date of manufacture, GTIN number, EC REP, CE mark, ETL, manufacturer, weight, FCC ID, IC, trademark, wireless symbol and read and understand symbol, voltage requirements.

3

FCC ID Label - Includes information about FCC compliance.

4

ORA SYSTEM™ Technology Client Label - Identifies system software, CE mark and Medical Device.

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Symbols Symbol

Description

Symbol

Description

Alternating current

European conformity mark

Direct current

Consult instructions for use or consult electronic instructions for use

Power button

Manufacturer

Earth terminal to ground

Date of manufacture

General warning

WEEE symbol Pb

Electrical warning

EC

REP

Authorized representative in the European community

Hand pinching warning

Fuse

Consult instructions for use

Equipotentiality

REF

Catalog number

SN

Serial number

MR

Magnetic resonance environment unsafe Mass of the system

XX Kg Medical device

Max load for various parts of the system (bin, tray, hook)

Caution: US federal law restricts this device to sale by or on the order of a physician

Laser beam

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Limited Warranty Alcon Laboratories, LLC. warrants that the ORA SYSTEM™ and accessories (collectively, the “Equipment”) and software and other related software will conform to the published product specifications of Alcon Laboratories and be free from material defects in materials and workmanship and will perform to Alcon Laboratories specifications during the time a contractually obligated warranty period is in place and during the time any continuous service and support agreement is in place and payment is current. Alcon Laboratories does not warrant that the operation of the Equipment will be uninterrupted or error free. Alcon Laboratories is not responsible and will charge the user for repair, replacement, or maintenance caused by user-induced damage, neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, or any Act of God, and unauthorized equipment attached to Alcon Laboratories Equipment, or unauthorized modification of Alcon Laboratories Equipment or Software. The foregoing Warranty applies only to the Equipment and does not extend to any equipment or software not provided by Alcon Laboratories. Except for this limited warranty, Alcon Laboratories makes no other warranty, express or implied, as to the Equipment and specifically disclaims all implied warranties including, without limitation, any implied warranties of merchantability or fitness for a particular purpose. The manufacturer accepts no liability for damage caused by unauthorized access to the interior of the instrument. Such actions will render any warranty claims invalid.

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Description ORA SYSTEM™ with VerifEye™ Lynk Technology The ORA SYSTEM™ with VerifEye™+ uses wavefront aberrometry data to measure and analyze the refractive power of the eye, taking real-time refractive measurements during cataract surgery. The ORA SYSTEM™ is designed to be used during ophthalmic surgery. Wavefront data is obtained, analyzed, and presented to the user via a cart mounted liquid crystal display (LCD) touchscreen and in the surgeon’s ocular of the microscope, within a period of time that does not impede the surgical procedure. The safety and effectiveness of using the data from the ORA SYSTEM™ have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations. The ORA SYSTEM™ is comprised of two major sub-systems, the aberrometer and surgical cart. The ORA SYSTEM™ with VerifEye™ Lynk integrates the registration, tracking and image guidance capabilities of the VERION™ Image Guided System, and incorporates the VERION™ Digital Marker Microscope (DMM) and Microscope Integrated Display (MID) to complete the system. Note: The ORA SYSTEM™ with VerifEye™ Lynk and VERION™ Image Guided System have their own respective manuals. Each manual describes the components and features of the specific product. The surgical procedure contained in this manual and the VERION™ manual is the same in each manual because the ORA SYSTEM™ with VerifEye™ Lynk and the VERION™ system share functions and screens during surgery, guiding the user to perform steps on both products.

ORA SYSTEM™ with VerifEye™ + Technology

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AnalyzOR™ Technology This technology collects and analyzes PreOp, IntraOp and PostOp data for dynamic variable optimization and robust reporting. Personalized lens-specific surgeon factors are optimized based on personal post-op results.

ORA SYSTEM™ AnalyzOR™ Technology Screen Patients can be created on the AnalyzOR™ technology database so that their information can be later accessed on the ORA SYSTEM™ cart. To create a patient, access the following URL using Microsoft1 Internet Explorer1 versions 8, 9, and 10 (in compatibility mode), Mozilla2 Firefox2 , or Google1 Chrome.1 https://home.wavetecvision.com. Refer to the AnalyzOR™ operator’s manual Text: 905-1910-001 Catalog number: 8056753051

1 Trademarks are property of their respective owners 2 Firefox and Mozilla are trademarks of the Mozilla Foundation.

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