ORA SYSTEM VerifEye+ 2.0 Technology User Manual rev A

ORA SYSTEM™ with VerifEye™ + Technology User Guide Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099, USA Made in the USA with global materials

EC

REP

US Pat.: www.alconpatents.com

Telephone: (949) 753-1393 (800) 832-7827

www.ifu.alcon.com

8065000228 Rev. A 905-1912-001 Rev. A © 2021 Alcon Inc.

Catalog number Text number Issue Date: 27 May 2021

Revision

Date

A

May 2021

Description Initial release.

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.

ii | 

8065000228 Rev. A

Contents System Information

1

Intended Use... 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 and Acronyms... 5 Labels... 6 Aberrometer Label Locations... 6 Field Verification Tool Label Location... 6 Cart Label Locations... 7 Symbols... 9 Limited Warranty... 10 Description

11

ORA SYSTEM™ with VerifEye™ + Technology... 11 AnalyzOR™ Technology... 12 Components... 13 Aberrometer... 13 Carts... 14 Device Compatibility... 17 Mounting... 17 Sizes...17 Focal Length... 17

8065000228 Rev. A

Contents | iii

Performance Capabilities... 17 Intraoperative Refraction Readings... 17 Pupil Size... 17 Lens Opacity... 17 Results... 17 Software Version... 17 Cybersecurity... 17 Safety

19

General Safety Considerations... 19 Device Safety Features... 20 General Safety Precautions... 21 Specific User Responsibilities... 22 Protective Eyewear... 22 Protective Clothing... 22 Electrical Hazards... 22 Electromagnetic Compatibility (EMC) Compliance... 23 Guidance and Manufacturer Declarations... 23 Equipment Contains Wireless Transmitters... 25 USA - Federal Communications Commission (FCC)... 26 Canada - Industry of Canada (IC)... 26 Canada - Industrie du Canada (IC)... 26 Europe - RED Directive 2014/53/EU... 27 Summary of Wi-Fi Module Certifications... 27 Installation

29

Examine Shipping Contents... 29 Set-up Requirements... 30 Electrical Requirement... 30 Environmental Requirement... 30 Setup... 30 Customer Removal, Storage, and Transportation... 33 Configuration

35

Options... 35 SLED Mode... 35 Axis Value to Display... 36 Login Attempts... 36 Pre-Op Data... 36

iv | Contents

8065000228 Rev. A

Dynamic Reticle Doctor Configuration... 37 Refractive... 38 Toric Placement... 38 Toric Rotation...39 LRI... 39 Operating Instructions

41

Basic Operating Steps... 41 Setup the Device...41 System Verification... 43 Select Practice (If Required)... 44 Main Screen Icons... 45 Procedures Field Icons... 46 Search Field... 47 Create a New Patient... 48 Patient Information Tab... 49 Notes Tab... 50 Lens List Tab... 50 Surgery Field... 52 Measurements Field... 54 Select a Patient... 55 Begin Surgery... 58 Viewing Pre-Op Data during Surgery...59 Using the Static Reticle... 59 Performing the Procedure... 62 Before Acquiring Measurement... 62 State of the Eye Options... 63 Preview Acquisition Screen... 64 Cancel Button... 65 Alignment... 65 Image Acquisition... 67 Red Images... 68 Measurement Caution... 69 Power Calculation Measurement... 71 Add Lens to Lens List... 73 Power Calculation for Long Eyes... 74 Toric IOL Case... 75 Taking a Measurement... 82 Aphakic... 83 Pseudophakic... 84

8065000228 Rev. A

Contents | v

Taking an LRI Measurement... 84 Intraoperative Data Tags... 86 After Implant Tag... 86 After LRI – After LRI Enhancement Tag... 86 Entering Measurement Notes... 87 Selecting the Lens Used for a Surgery... 88 Search Lens Field... 89 Active Lens List Option... 89 Lens Manufacturer Field... 90 Lens Model and Power Fields... 90 Viewing Captured Images... 92 Ending a Surgery... 93 Powering Down the Device... 94 Remove and Store Device Components... 95 Viewing Completed Surgeries on the ORA SYSTEM™ Cart... 95 Care and Maintenance

97

Routine Maintenance... 97 ORA SYSTEM™ Verification... 97 Visual Inspection... 97 Aberrometer Cleaning... 98 Cleaning Central Camera Window, Focus Camera Window, and Led Windows... 98 Autoclavable Cover... 98 Microscope Repair Affecting the Aberrometer... 99 Cart Cleaning... 99 Cleaning Display screens... 99 Troubleshooting

101

Before Calling for Service... 101 System Messages... 102 Specifications

107

Mechanical Dimensions... 108 Aberrometer Dimensions... 108 Original Cart Dimensions... 109 Current Cart Dimensions... 109

vi | Contents

8065000228 Rev. A

System Information Intended Use The ORA SYSTEM™ with VerifEye™ + 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™ + 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) touch-screen.

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.

8065000228 Rev. A

System Information | 1

User Training Training is provided to the user(s) - on-line, Didactic, and Hands-on with training materials. The training is in phases.

Phase 1 – On-line Training: z

Clinical department will setup surgeon for on line Phase 1 training, which provides an overview of the ORA SYSTEM™ with features, benefits, work flow and important factors for operation.

z

Surgeon will complete Phase 1 training on-line prior to hands-on training and case support.

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

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

z

Surgeon should have completed the on-line training module prior to going into didactic and hands-on training.

z

Each surgeon should complete artificial eye test procedures and navigate the software for each surgery application.

AnalyzOR™ Technology: z

Each trainee should be setup with their own login and password, and practice 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, supervising the set-up, operation and breakdown of equipment.

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

2 | System Information

8065000228 Rev. A

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.

8065000228 Rev. A

System Information | 3

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

Patient’s 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, that will 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, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. The following terms are used throughout the manual: z

Aberrometer – A component that attaches to the surgical microscope. Its function is data acquisition and emission monitoring

z

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

z

SLED – 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.

4 | System Information

8065000228 Rev. A

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 and Acronyms Abbreviation

Description

Abbreviation

Description

ANSI

American National Standards Institute

LED

Light emitting diode

CAS

Alcon clinical application specialist

LRI

Limbal relaxing incision

CFR

Code of Federal Regulations

NIST

National Institute of Standards and Technology

EMC

Electromagnetic compatibility

NOHD

Nominal ocular hazard distance

Hz

Hertz

V

Volts

IEC

International Electrotechnical Commission

VAC

Volts alternating current

LCD

Liquid crystal display

SLED

Superluminescent light-emiting diode

8065000228 Rev. A

System Information | 5

Labels Aberrometer Label Locations The ORA SYSTEM™ is labeled as required by IEC and EN standards and 21 CFR §1040.10/11and WEEE and RED.

1 2 3

Aberrometer Product Label Locations 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

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

6 | System Information

8065000228 Rev. A

Cart Label Locations Note: Within this manual there will be reference to two styles of carts, the Original manufactured cart, and the Current manufactured cart. Both carts perform the same functions.

Original Cart Label Locations

4 5

1 2 3 Cart Label Locations 1

Product label – Includes cart identification information.

2

ESD awareness label – Identifies ESD warning.

3

Ground label – Identifies ground point.

4

Processor label – Includes system information and serial number.

5

High voltage warning label – Includes a high voltage warning.

8065000228 Rev. A

System Information | 7

Current Cart Label Locations

1 2

ETHERNET L-com

SERVICE ONLY A L-com

3 4

HDMI

OH I/O

Current Cart label Locations 1

Pinch warning label – Identifies location of possible pinch hazard.

2

Product label – Includes cart identification information.

3

FCC ID label – Includes information about FCC compliance.

4

ORA SYSTEM™ Client label – Identifies system software, CE mark, and medical device.

8 | System Information

8065000228 Rev. A

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 Magnetic resonance environment unsafe

REF

Catalog number

SN

Serial number

Mass

Medical device

Safe load

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

Laser beam

8065000228 Rev. A

MR

System Information | 9

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.

10 | System Information

8065000228 Rev. A

Description ORA SYSTEM™ with VerifEye™ + 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.

ORA SYSTEM™ with VerifEye™ + Technology

8065000228 Rev. A

Description | 11

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. 12 | Description

8065000228 Rev. A

Components Aberrometer The intra-operative Wavefront aberrometer is a system that, as an attachment to a surgical microscope, shall deliver two separate diagnostic beams. The infrared SLED produces light used to generate the refraction wavefront image. Four (4) LEDs shall provide the alignment and focus illumination. The Intraoperative Wavefront aberrometer shall be used as an intra-operative refractometer.

1

Aberrometer 1

ORA SYSTEM™ aberrometer – The ORA SYSTEM™ aberrometer is an intra-operative system mounted under a compatible ophthalmic surgical microscope and may be easily removed and replaced. It is designed to improve refractive outcomes in cataract surgery through real-time intra-operative refractive measurements and calculations.

8065000228 Rev. A

Description | 13