Operator’s Manual

Alcon Laboratories, Inc.

6201 South Freeway
Fort Worth, TX 76134-2099, USA Alcon Laboratories Belgium BVBA
Made in USA with Global Materials Rijksweg 14
2870 Puurs, Belgium

Distributed By:

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.

*a trademark of Novartis
† a trademark of TUV
© 2018 Novartis

90086 Rev. B Text Only

90086 Rev. B ï Issued Issued June 13, 2018 1

 ORA SYSTEM* with VerifEye + Technology
90086

MANUAL REVISION RECORD

DATE REVISION ECN NUMBER AND DESCRIPTION

Jan. 25, 2018 A 20180096 Initial release

CN078720 Update to meet MDR requirements, CE mark
update, add MD label, address change for EC Rep, add read
June 13, 2018 B
symbol, update product labels, update warnings and cautions,
update specifications.

90086 Rev. B ï Issued Issued June 13, 2018 2

Table of Contents

1 - Introduction .................................................................................. 10
Intended Use ............................................................................................................................ 10
User Training ............................................................................................................................ 11
Phase 1 – On-line Training: ........................................................................................... 11
Phase 2 – Didactic and Hands-on Training:................................................................... 11
Phase 3 – Surgery Support ........................................................................................... 11
Post Installation ............................................................................................................. 11
Adverse Event Reporting .......................................................................................................... 12
Potential Complications....................................................................................................... 12
Operator’s Manual .................................................................................................................... 12
Notes, Cautions, Warnings ....................................................................................................... 13
Abbreviations, Acronyms and Definitions .................................................................................. 14
Labels ....................................................................................................................................... 15
Label Locations......................................................................................................................... 17
ORA SYSTEM* with VerifEye*+ Aberrometer Label Locations ............................................ 17
ORA SYSTEM* with VerifEye*+ Cart Label Locations ......................................................... 18
ORA SYSTEM* with VerifEye* + 2.0 Cart Label Locations........................................................ 19
ORA SYSTEM* Field Verification Tool Label Location ........................................................ 19
International Symbol Notation / Definitions .......................................................................... 21
Warranty ................................................................................................................................... 22
Warranty Period .................................................................................................................. 22

2 - ORA SYSTEM* Technology Description ................................ 23

ORA SYSTEM* with VerifEye*+ Technology............................................................................. 23
Components ............................................................................................................................. 24
ORA SYSTEM* Aberrometer .............................................................................................. 24
ORA SYSTEM* VerifEye+ and VerifEye + 2.0 Cart ............................................................. 25
LCD Touchscreen Display................................................................................................... 25
Protective Housing .............................................................................................................. 26
Device Switches.................................................................................................................. 26
AC Power Main Switch .................................................................................................. 26
Push Button Power Switch ............................................................................................ 26
Monitor Power Switch .................................................................................................... 26
VerifEye + Cart ......................................................................................................................... 27
VerifEye + 2.0 Cart ................................................................................................................... 28
Device Compatibility............................................................................................................ 29
Mounting ....................................................................................................................... 29
Sizes ............................................................................................................................. 29
Focal Length ................................................................................................................. 29
Performance Capabilities .................................................................................................... 29
Intraoperative Refraction Readings ............................................................................... 29
Pupil Size ...................................................................................................................... 29
Lens Opacity ................................................................................................................. 29
Results .......................................................................................................................... 29

3 - Safety ............................................................................................. 30
General Safety Considerations ................................................................................................. 30
Warning Labels ................................................................................................................... 30
Device Safety Features............................................................................................................. 31
General Safety Precautions ...................................................................................................... 32

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Table of Contents

Specific User Responsibilities ................................................................................................... 33

Protective Eyewear ............................................................................................................. 33
Protective Clothing .............................................................................................................. 33
Electrical Hazards ............................................................................................................... 33
EMC Statements ................................................................................................................. 34
Equipment Contains Wireless Transmitters ......................................................................... 38
Summary of Wi-Fi Module Certifications ................................................................................... 39

4 - Installation .................................................................................... 40
Shipping Contents .................................................................................................................... 40
Requirements ........................................................................................................................... 40
Electrical Requirement ........................................................................................................ 40
Environmental Requirement ................................................................................................ 41
Setup ........................................................................................................................................ 41
Initial Setup ......................................................................................................................... 41
Customer Setup .................................................................................................................. 41
Use of Peripheral Monitor via HDMI .................................................................................... 42
Customer Removal, Storage and Transportation ................................................................ 43
Transport....................................................................................................................... 43

5 - Configuration ............................................................................... 44
AnalyzOR* Technology Configuration ....................................................................................... 44
Creating a New User ........................................................................................................... 45
Surgeon LRI Configuration .................................................................................................. 46
ORA SYSTEM* Cart Configuration ........................................................................................... 48
ORA SYSTEM* Technology Settings .................................................................................. 48
ORA SYSTEM* Technology .......................................................................................... 48
Log ................................................................................................................................ 48
Email ............................................................................................................................. 49
Options.......................................................................................................................... 50

6 - Using the ORA SYSTEM* AnalyzOR* Technology .............. 52

Introduction ............................................................................................................................... 52
Login to the ORA SYSTEM* AnalyzOR* Technology ................................................................. 52
AnalyzOR* Technology Main Screen ........................................................................................ 53
Patient Pre-Op Screen ........................................................................................................ 54
Batch Print Surgical Results ................................................................................................ 55
Surgeries Screen ................................................................................................................ 55
Post Op Screen ................................................................................................................... 56
Overdue Post-Op Screen .................................................................................................... 57
Reports Screen ................................................................................................................... 58
Creating a New Patient ............................................................................................................. 59
Patient Information Field ..................................................................................................... 60
Pre-Operative Data Field..................................................................................................... 61
Eye Data Field............................................................................................................... 62
Required Data Field ...................................................................................................... 65
Surgeon Optional Data Field ......................................................................................... 67
Lens List Field ............................................................................................................... 68
Save .............................................................................................................................. 68
Cancel ........................................................................................................................... 68
Editing Patient Information ........................................................................................................ 69

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Table of Contents

Searching for Patients............................................................................................................... 71

Primary Search Options ...................................................................................................... 71
Additional Search Criteria.................................................................................................... 72
Search - Show Inactive Patients .................................................................................... 72
Search - All.................................................................................................................... 72
Search - Surgeries ........................................................................................................ 72
Search - Post-Op........................................................................................................... 72
Search - Follow Up ........................................................................................................ 72
Starting the Search ............................................................................................................. 73
Printing a Patient List ................................................................................................................ 74
Printing Selected Patients ................................................................................................... 74
Print All Patients.................................................................................................................. 75
Exporting Patient Information to an Excel File ........................................................................... 76
Approving Surgeon Specific Optimized Surgeon Factors (SF) .................................................. 77

7 – ORA SYSTEM* Cart Operating Instructions ......................... 80

Basic Operating Steps .............................................................................................................. 80
Setup the Device ...................................................................................................................... 80
Power up the Device ................................................................................................................. 81
Login to the ORA SYSTEM* Technology .................................................................................. 81
ORA SYSTEM* Technology Verification ................................................................................... 82
Select Practice, if required .................................................................................................. 84
Main Screen.............................................................................................................................. 85
Icons ................................................................................................................................... 86
Procedures Field ................................................................................................................. 87
Search Field ........................................................................................................................ 88
Create a New Patient ................................................................................................................ 89
Patient Information Tab ....................................................................................................... 91
Co-Managed Field ......................................................................................................... 91
Notes Tab ........................................................................................................................... 92
Lens List Tab ...................................................................................................................... 92
Add a Lens .................................................................................................................... 93
Surgery Field....................................................................................................................... 94
Eye ................................................................................................................................ 94
Surgery Code ................................................................................................................ 94
Post-Refractive .............................................................................................................. 95
Orientation..................................................................................................................... 95
Femto ............................................................................................................................ 95
Has Ocular Disease ...................................................................................................... 96
Measurements Field............................................................................................................ 96
Keratometry................................................................................................................... 97
Flat K............................................................................................................................. 97
Steep K ......................................................................................................................... 97
Steep axis ..................................................................................................................... 97
Target Refr. ................................................................................................................... 97
White-to-White .............................................................................................................. 97
Axial Length .................................................................................................................. 97
Lens Manuf ................................................................................................................... 97
Lens Model.................................................................................................................... 97
IOL Power Calc. Formula .............................................................................................. 97
Power (D) ...................................................................................................................... 97

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Table of Contents

REF (D) ......................................................................................................................... 97

Dynamic Reticle Doctor Configuration....................................................................................... 98
Refractive ...................................................................................................................... 99
LRI .............................................................................................................................. 100
Toric Placement .......................................................................................................... 100
Toric Rotation .............................................................................................................. 101
Select a Patient....................................................................................................................... 102
Before Acquiring Measurement............................................................................................... 105
Begin Surgery ......................................................................................................................... 106
Viewing Pre-Op Data during Surgery ................................................................................ 107
Using the Static Reticle ..................................................................................................... 107
Using the Dynamic Reticle ...................................................................................................... 107
Performing the Procedure ....................................................................................................... 109
State of the Eye Options ................................................................................................... 110
Phakic Measurement................................................................................................... 110
Aphakic Measurement................................................................................................. 110
Pseudophakic Measurement ....................................................................................... 110
ORA SYSTEM* with VerifEye*+ Technology Preview ............................................................. 111
ORA SYSTEM* Technology Preview Acquisition Screen .................................................. 111
Cancel Button.............................................................................................................. 112
Capture Button ............................................................................................................ 112
Alignment .......................................................................................................................... 112
Incorrect Alignment ..................................................................................................... 113
Correct Alignment........................................................................................................ 114
Capture Button ............................................................................................................ 115
Image Acquisition .............................................................................................................. 116
Red Images....................................................................................................................... 117
Measurement Caution ....................................................................................................... 118
Aphakic Measurement SE - Astigmatism..................................................................... 119
Repeat Button ............................................................................................................. 119
Ignore Caution............................................................................................................. 120
Do not show this message again ................................................................................. 120
Power Calculation Measurement ............................................................................................ 121
Gold Bar ...................................................................................................................... 122
Platinum Bar................................................................................................................ 122
No Bar ......................................................................................................................... 122
Add Lens to Lens List........................................................................................................ 123
Power Calculation for Long Eyes ...................................................................................... 124
Toric IOL Case .................................................................................................................. 125
Aphakic Toric results prior to spherical power selection............................................... 125
Aphakic Toric screen after spherical power and cylinder power have been selected ... 126
Keratometry option – Phaco Incision Axis.................................................................... 127
Keratometry option – User-Defined Values.................................................................. 128
Toric Lens Selection .................................................................................................... 128
ORA SYSTEM* with VerifEye*+Technology After Toric Implant .................................. 130
Pseudophakic Toric Results Screen ............................................................................ 131
Taking an LRI Measurement with VerifEye*+ Technology....................................................... 133
Aphakic ............................................................................................................................. 134
Pseudophakic ................................................................................................................... 135
Taking an LRI Measurement ................................................................................................... 136
LRI Circle Graphic ............................................................................................................. 138

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Table of Contents

Intraoperative Data Tags......................................................................................................... 139

After Implant Tag............................................................................................................... 140
After LRI – After LRI Enhancement Tag ............................................................................ 140
Entering Measurement Notes ................................................................................................. 140
Selecting the Lens Used for a Surgery .................................................................................... 141
Search Lens Field ............................................................................................................. 142
Active Lens List Option ..................................................................................................... 142
Lens Manufacturer Field.................................................................................................... 143
Lens Model and Power Fields ........................................................................................... 143
Lens List...................................................................................................................... 143
Other ........................................................................................................................... 143
OK Button.................................................................................................................... 143
OK and Add to Active List............................................................................................ 144
Viewing Captured Images ....................................................................................................... 145
Ending a Surgery .................................................................................................................... 146
Powering Down the Device ..................................................................................................... 147
Remove and Store Device Components ................................................................................. 148

8 - Completed Surgeries and Reports .......................................... 149

Viewing Surgical Results – AnalyzOR* Technology ................................................................ 149
Viewing Measurements - AnalyzOR* Technology ............................................................. 149
Results by Measurement Time .................................................................................... 150
Results by Measurement Type .................................................................................... 150
Print Surgical Results .................................................................................................. 151
Enter Post-Operative Data on the AnalyzOR* Technology ................................................ 152
Select Patient Name Link ............................................................................................ 152
Select Add Data Button ............................................................................................... 153
Post-Op Patient Data Screen ...................................................................................... 153
Overdue Post-Op Tab - AnalyzOR* Technology ............................................................... 154
Viewing Completed Surgeries on the ORA SYSTEM* Cart ..................................................... 155
Predefined Reports ................................................................................................................. 158
Outcome Analysis Report.................................................................................................. 158
Surgery Completion Date Field.................................................................................... 159
Practice Field .............................................................................................................. 159
IOL Used Field ............................................................................................................ 160
Femtosecond Laser Surgeries Field ............................................................................ 160
Femtosecond Laser Options Field ............................................................................... 160
Generate Outcome Analysis Report ............................................................................ 160
Astigmatism Management Report ..................................................................................... 161
New Astig Mgt Report ................................................................................................. 162
Define Patient Group Report ............................................................................................. 163
Custom Patient Group Report ..................................................................................... 163
Graphical Reports ............................................................................................................. 164
Outcomes Analysis Reports ........................................................................................ 164
Astigmatism Management Reports.............................................................................. 165
Print Button ................................................................................................................. 166
Save as Bitmap Button ................................................................................................ 166
Export All Data to Excel ............................................................................................... 166
Create a New Custom Report ........................................................................................... 167
New Outcome Analysis Report .................................................................................... 167
New Custom Patient Group ......................................................................................... 168

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Table of Contents

Case Study Report ............................................................................................................ 170

Print Button ................................................................................................................. 172
Save as Bitmap Button ................................................................................................ 172

9 - Maintenance and Service.......................................................... 173

Routine Maintenance .............................................................................................................. 173
ORA SYSTEM* Technology Verification ........................................................................... 173
Visual Inspection ..................................................................................................................... 173
Aberrometer Cleaning ............................................................................................................. 174
Central Focus Camera & LED Windows ...................................................................... 174
Aberrometer Cover ...................................................................................................... 174
Autoclavable Cover ..................................................................................................... 174
Microscope Repair affecting the Aberrometer.............................................................. 174
Cart Cleaning .......................................................................................................................... 175
Cleaning Display screens........................................................................................................ 175
Troubleshooting ...................................................................................................................... 176
Before Calling for Service.................................................................................................. 176
Telephone ................................................................................................................... 176
Fax .............................................................................................................................. 176
Email ........................................................................................................................... 176
Error Messages................................................................................................................. 177
Optical Head is offline ................................................................................................. 177
Laser safety circuit has tripped .................................................................................... 177
Checksum Error .......................................................................................................... 177
Spatial aperture Failure ............................................................................................... 177
ORA has encountered a problem while communicating with your optical head ........... 178
Check Focus LEDs...................................................................................................... 178
Laser Initialization Failed. Reboot Machine ................................................................. 178
Network Messages ...................................................................................................... 178
Connected ................................................................................................................... 178
The cart is connected to the network and operating normally ...................................... 178
Server Unavailable ...................................................................................................... 178
Network Unavailable ................................................................................................... 179
Unable to Log In .......................................................................................................... 179
Login icon grayed out .................................................................................................. 179
Symptoms ................................................................................................................... 180
Sputnik is in the Lower Left Corner of the Display during Image Capture .................... 180
Focus Ball frozen at the top of the screen ................................................................... 180
Touchscreen Does Not Line Up with Icons .................................................................. 180
Reticle misalignment or out of focus with the microscope or ORA SYSTEM*
misalignment or out of focus with the microscope........................................................ 181
Touchscreen Not Centered ......................................................................................... 181
Screen is Blank ........................................................................................................... 181
ORA SYSTEM* Technology Does Not Power On ........................................................ 182
Out of Focus................................................................................................................ 182
Shadows in Surgeon’s Oculars.................................................................................... 182
Multiple systems in the surgery center......................................................................... 182
Fails Verification .......................................................................................................... 182

10 - Appendix ................................................................................... 184

Measurement Specifications ................................................................................................... 184

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Table of Contents

Capabilities.................................................................................................................. 184
Specification ................................................................................................................ 184
Specifications.......................................................................................................................... 184
General Specifications ................................................................................................ 184
Console and Aberromter Dimensions .......................................................................... 184
Environmental Limitations - Operating VerifEye*+ Cart ............................................... 185
Environmental Limitations - Operating VerifEye*+ 2.0 Cart.......................................... 185
Refraction Laser Specifications............................................................................................... 185
LED Alignment Laser Specifications ....................................................................................... 185
User Interface Specifications .................................................................................................. 185
Aberrometer Mechanical Dimensions...................................................................................... 186
ORA SYSTEM* with VerifEye* + Cart Dimensions .................................................................. 187
ORA SYSTEM* with VerifEye* + 2.0 Cart Dimensions ............................................................ 188

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 1- Introduction

1 - Introduction
Intended Use
• The ORA SYSTEM* Technology is designed to be used during ophthalmic
surgery. Wavefront data is obtained, analyzed, and presented to the user via
a cart mounted LCD touchscreen, within a period that does not impede the
surgical procedure
• The ORA SYSTEM* Technology is intended for use in the measurement and
analysis of the refractive power of the eye (i.e. sphere, cylinder, and axis
measurements).
• The safety and effectiveness of using the data from the ORA SYSTEM*
Technology have not been established for determining treatments involving
higher order aberrations of the eye such as coma and spherical aberrations.
• U.S. Federal law restricts this device to sale by or on the order of a physician
or ophthalmologist.

Cautions:

It will be difficult to obtain accurate, consistent, and reliable measurements if any

of the following conditions or situations exists:
• Patients having progressive retinal pathology such as diabetic retinopathy,
macular degeneration, or any other pathology that the physician deems
would interfere with patient fixation.
• 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.
• Patient’s for which the preoperative regimen includes residual viscous
substances left on the corneal surface such as lidocaine gel or viscoelastics.
• Visually significant media opacity, such as prominent floaters or asteroid
hyalosis, will limit or prohibit measurement process. Image quality indicator
will indicate when this is an issue.
• Patients having received retro or peribulbar block, or any other treatment that
impairs their ability to visualize the fixation light.
• Utilization of Iris hooks during an ORA SYSTEM* Technology image capture
will yield inaccurate measurements.

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 1- Introduction

User Training
Training is provided to the user(s) on-line and Didactic and Hands-on with
training materials. The training is in phases.
Phase 1 – On-line Training:
• Clinical department will setup surgeon for on line Phase 1 training, which
provides an overview of the ORA SYSTEM* Technology with features,
benefits, work flow and important factors for operation.
• 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:

• Each trainee should practice setup of Aberrometer, operation of cart and

shutdown of cart, including inspection of cables, aperture glass and
breakdown of Aberrometer.
• Surgeon should have completed the on-line training module prior to going
into live surgery.
• Each surgeon should complete artificial eye test procedures and navigate
the software for each surgery application.

AnalyzOR* Technology:

• Each trainee should be setup with their own login, password and practice
patient entry and adding an IOL.
• Pre-program cases for their first surgery day if possible.
Phase 3 – Surgery Support
• 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 centration and tilt, minimally hydrate wound and check IOP
prior to image capture etc)
• 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.

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 1- Introduction

Adverse Event Reporting

Events that reasonably suggest the ORA SYSTEM* Technology may have caused or
contributed to serious injury or death, including events occurring as a result of failure of
the medical device to meet its performance specifications or otherwise perform as
intended, must be reported to Alcon Laboratories, Inc.

For product complaint or adverse event reporting in the United States:

800-757-9780
Alcon.com (contact us).
Outside the United States, please contact your local Alcon office or distributor.

Potential Complications
• Potential errors in measuring refractions may occur when the cylinder, axis,
or spherical equivalent are displayed in red on the ORA SYSTEM* VerifEye*+
screen.
• Significant central corneal irregularities resulting in higher order aberrations
might yield inaccurate refractive measurements.
• Post RK eyes might yield inaccurate refractive measurement.

Operator’s Manual
This manual provides information on the operation of Alcon Laboratories Inc.
ORA SYSTEM* (Optiwave Refractive Analysis) Intraoperative Wavefront
Aberrometer and ORA SYSTEM* Cart.

ORA SYSTEM* Technology is intended for use by qualified health care

personnel only.

All ORA SYSTEM* Technology operators must read and understand the
information in this manual before operating the device or performing any routine
maintenance. In addition, it is recommended that this manual must be readily
available for reference during device operation.

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.

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 1- Introduction

Notes, Cautions, Warnings

NOTE: Highlights important facts, gives helpful information and tips, and clarifies
procedures.

CAUTION:

Important information on the proper operation of the ORA SYSTEM* intraoperative

Wavefront Aberrometer. This information is crucial in preventing instrument damage and
maintaining the ORA SYSTEM* Technology.

ELECTRICAL WARNING:

Electrical caution! Unplug before handling.

LASER WARNING:

Laser radiation when open. Do not stare into the beam or view directly with
optical instrument. Class 1 laser product.

WARNING:

Identifies potentially hazardous situations that could result in serious injury to the
institution personnel.

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 1- Introduction

Abbreviations, Acronyms and Definitions

Aberrometer A component that attaches to the surgical microscope. Its function is data
acquisition and emission monitoring.
ANSI American National Standards Institute
CFR Code of Federal Regulations
EMC Electromagnetic Compatibility
Hz Hertz
IEC International Electrotechnical Commission
LCD Liquid Crystal Display
LED Light Emitting Diode
NIST National Institute of Standards and Technology
NOHD Nominal Ocular Hazard Distance
V Volts
VAC Volts Alternating Current
Wavefront An imaginary surface joining all points in space that are reached at the same
time by a lightwave propagating through a medium
SLED Superluminescent Light-Emitting 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.

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 1- Introduction

Labels
The ORA SYSTEM* is labeled as required by IEC and EN standards and 21 CFR
§1040.10/11and WEEE and RED. The table below provides a reproduction and a
description of each of the labels.

NOTE: “The labels shown are for reference only and may not be the same revision
as the actual labels on your ORA SYSTEM* Technology. Refer to the labels on
your actual system for applicable information.”

Label Label Description

Product Identification and Certification

Label
(for reference only)

Aberrometer Identification and

Certification Label
(for reference only)

Processor / Field Verification Tool

Identification and Certification Label
(for reference only)

FCC ID Label
(for reference only)

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 1- Introduction

Label Label Description

EC Importer Address Label

(for reference only)

Class 1 Laser Product Label

(for reference only)

Protective Housing Label – Class 3B

WARNING
(for reference only)

Label, Warning, Pinch SNGL

(for reference only)

High Voltage Warning Label

(for reference only)

Ground Label

(for reference only)

Electrostatic Sensitive Device (ESD)

Awareness Label

(for reference only)

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 1- Introduction

Label Locations
ORA SYSTEM* with VerifEye*+ Aberrometer Label Locations
NOTE: “The labels shown are for reference only and may not be the same revision
as the actual labels on your ORA SYSTEM* Technology. Refer to the labels on
your actual system for applicable information.”

Class 1 Laser
Aberrometer ID and Label
Certification Label

ORA SYSTEM* with VerifEye*+ Aberrometer Product Label Locator

Class 3B Warning Label

ORA SYSTEM* with VerifEye*+ Aberrometer Caution Label Locator

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 1- Introduction

ORA SYSTEM* with VerifEye*+ Cart Label Locations

NOTE: “The labels shown are for reference only and may not be the same revision as the
actual labels on your ORA SYSTEM* Technology. Refer to the labels on your actual system
for applicable information.”

EC Importer Label

Product ID and
Certification Label

ORA SYSTEM* with VerifEye*+ Cart Product Label’s

Ground Label
ESD Awareness
Label

High Voltage
Processor ID and Warning
Certification Label
Label

ORA SYSTEM* with VerifEye*+ Cart Label Locator (Rear, Internal)

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 1- Introduction

ORA SYSTEM* with VerifEye* + 2.0 Cart Label Locations

NOTE: “The labels shown are for reference only and may not be the same revision as the
actual labels on your ORA SYSTEM* Technology. Refer to the labels on your actual
system for applicable information.”

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 1- Introduction

ORA SYSTEM* Field Verification Tool Label Location

FVT ID and
Certification Label

ORA SYSTEM* with VerifEye*+ Field Verification Tool Label

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 1- Introduction

International Symbol Notation / Definitions

Label Meaning
Alternating current

Direct current

General Warning

“ON” / “OFF” (push-push)

Consult Operating Instructions

Laser Light Warning

Catalog Number

Serial Number

Manufacturer

Date of manufacture

Authorized representative in the

European Community

WEEE-Symbol. Placed onto the EU market

after the 13th August 2005

Medical Device

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 1- Introduction

Warranty
Warranty Period
Alcon Laboratories, Inc. 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.

90086 Rev. B ï Issued Issued June 13, 2018 22

 2 – System Description

2 - ORA SYSTEM* Technology Description

ORA SYSTEM* with VerifEye*+ Technology
The Intraoperative 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.

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 2 – System Description

Components
ORA SYSTEM* Aberrometer
The ORA SYSTEM* Aberrometer provides the means for generating and
capturing a wavefront of the human eye. It is mounted on a compatible surgical
microscope.

The ORA SYSTEM* Aberrometer mounts under the ophthalmic surgical

microscope and may be easily removed and replaced.

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 2 – System Description

ORA SYSTEM* VerifEye+ and VerifEye + 2.0 Cart

The portable cart sub-system provides control and power to, and receives and
processes data from, the ORA SYSTEM* Aberrometer. The portable cart is
tethered to the ORA SYSTEM* via a cable.

The cart is used for supporting all electronics and the display. The cart provides
organization and storage of the ORA SYSTEM* Aberrometer and cables. The
cart is equipped with casters and handles to allow movement of the cart. Two of
the casters are lockable to prevent inadvertent rolling.

The ORA SYSTEM* is available with a variant of the cart, the original VerifEye +
Cart pictured below on the left and the VerifEye + 2.0 cart pictured below on the
right. Both carts perform the same functions. All new systems will be equipped
with the VerifEye + 2.0 cart.

VerifEye*+ Cart and VerifEye*+ 2.0 Cart

LCD Touchscreen Display

The LCD is a touchscreen device that displays operating screens for user input,
option selections, and data output. It can also display wavefront analyses. The
touchscreen display is mounted on the cart, tilts 15°, and rotates 130° with
respect to the rest of the cart structure.

90086 Rev. B ï Issued Issued June 13, 2018 25

 2 – System Description

Protective Housing
The ORA SYSTEM* has a protective housing that prevents unintentional access
to laser-like radiation. This housing is to be opened only by a qualified Alcon
Laboratories Inc. service representative.

Device Switches
Ports (SIP/SOPS) provided on the equipment are intended to be connected to
equipment/accessories certified to national standards only.
AC Power Main Switch
It is located under the bottom of the cart platform on the rear of the cart.
Push Button Power Switch
Push the button switch to startup or shutdown the computer, without loss of data.
Monitor Power Switch
Turns the monitor power ON or OFF.

90086 Rev. B ï Issued Issued June 13, 2018 26

 2 – System Description

VerifEye + Cart
In the VerifEye + Cart (pictured below), the Power Switch is located at the top of cart column,
beneath the monitor. A green light will indicate power is on.

LCD
Touchscreen
Monitor Monitor
Switches

Push Button
Power Switch
(top of the
tower)

AC Power
Cord
AC Power Ethernet, USB,
Main Switch
(bottom rear) HDMI Ports
(processor rear)

Interconnect Port
WiFi to ORA SYSTEM*
Antenna Aberrometer

90086 Rev. B ï Issued Issued June 13, 2018 27

 2 – System Description

VerifEye + 2.0 Cart

In the VerifEye + 2.0 Cart (pictured below), the Power Switch is located at the top right of cart
column, beneath the monitor. A green light will indicate power is on.

90086 Rev. B ï Issued Issued June 13, 2018 28

 2 – System Description

Device Compatibility
Mounting
The ORA SYSTEM* Technology can be securely mounted to various
microscopes. Contact your Alcon Laboratories representative for specific
microscope list.
Sizes
The ORA SYSTEM* Technology is compatible with surgical scopes equipped
with an objective lens diameter ranging in size from 48mm to 85mm.
Focal Length
The ORA SYSTEM* Technology is designed to function with a 200 mm focal
length microscope objective lens.

Performance Capabilities
Intraoperative Refraction Readings
Able to measure sphere, cylinder, and axis.
Pupil Size
Able to measure eyes with pupils ranging from 4 mm to 10 mm diameter.
Lens Opacity
Able to measure eyes with lens opacities of 2+ or less, if being used in the
phakic setting.
Results
Provides user with intraoperative data.

90086 Rev. B ï Issued Issued June 13, 2018 29

3 – Safety

3 - Safety
General Safety Considerations
The safety considerations described in this manual apply during the operation of
the ORA SYSTEM*.

CAUTIONS:

• Only qualified Alcon WaveTec service personnel should access the interior of
the device, as there are no user-serviceable parts inside.

• Do not modify the device in any way. Modification of the device may result in
damage to the device.

WARNINGS:

• Personnel operating the device must be thoroughly familiar with all safety
requirements and operating procedures. Follow all safety precautions and
adhere to all warnings to ensure safe operation of the device.

• Improper use of this device or adjustments other than those specified in this
manual may result in exposure to dangerous voltage.

• Use of controls or adjustments or performance of procedures other than those

specified herein may result in hazardous laser-like radiation exposure. Laser-like
power up to 7 mW at 780 nm (peak) could be accessible in the interior.

Warning Labels
Appropriate warning labels are installed in appropriate locations on the ORA
SYSTEM* Technology to indicate conditions under which the user could be
subjected to laser-like radiation, see Labels page 15.

90086 Rev. B ï Issued Issued June 13, 2018 30

3 – Safety

Device Safety Features

The ORA SYSTEM* Technology is designed to properly ensure the safety of patient and
operating staff.
• SLED Power Monitor: The circuit connects to an optoelectronic sensor that is
positioned at a point in the ORA SYSTEM* Technology where reference SLED
light is available for detection of emitted light.
• SLED Power: If SLED power exceeds the maximum set point power of 415
microwatts to the cornea, the SLED light is extinguished in less than 50
milliseconds and an error flag sent to the controller.
• Optoelectronic Circuit: This circuit performs a self-check at each start-up
sequence.
• SLED Energy: The light energy emitted by this device is designed in accordance
with ANSI Z136.1 and IEC/EN 60825-1 to be eye safe and creates no laser
plume hazard, radiation hazard, or risk of explosion or fire.
• Calibration Verification: The Field Verification Tool must be used a minimum of
once per 24 hours to verify the instrument refraction calibration. If the Field
Verification Tool refraction does not match the initial calibrated value within
allowed tolerances, usage of the instrument is prevented.
• Insulation: Double insulation on power supply requires two failures in the
transformer to pass 120 VAC to the lines heading to the ORA SYSTEM*. Circuit
in the ORA SYSTEM* Technology shorts to ground. Triple failure has to occur.

90086 Rev. B ï Issued Issued June 13, 2018 31

3 – Safety

General Safety Precautions

It is important that the following safety precautions be strictly observed:
• Correct operation of the instrument is imperative for its safe function. Get
thoroughly familiar with the contents of this operator’s manual before using the
device.
• Ensure that the device is connected to a well-grounded power source that meets
the device power specifications, see Electrical Requirement on page 40.
• If the unit power cord is frayed or otherwise damaged, do not use the unit until
the cord has been replaced.
• A tripping hazard exists if the AC power cord is not protected from foot traffic.
• Ensure that the ORA SYSTEM* Technology is properly and securely connected
to the surgical microscope.
• Ensure that the specified routine maintenance has been performed.

Do not operate the device:

• In locations subject to explosion hazard.
• In the presence of flammable anesthetics or volatile solvents, such as alcohol,
benzene or similar.

The device may not be stored or operated in environmental conditions other than those
prescribed, see Environmental Requirement on page 41.

Disposable sterile barriers, that do not block the optical components of the head and do
not interfere with the operation of the touch screen monitor, may be used with the
ORA SYSTEM* Technology device. Reference the manufacturer’s instructions for the
application, use, and expiration of these items. Dispose of all materials in accordance
with local and federal regulations.

The Alcon Laboratories Inc. sterile covers should be sterilized according to the
component's instructions for use.

To ensure the ORA SYSTEM* Technology stays aligned with the surgical microscope,
the microscope should not be moved or adjusted by holding onto the ORA SYSTEM*
Technology.

The ORA SYSTEM* Technology has a protective cover that prevents unintentional
access to SLED radiation. This cover may only be opened by a qualified Alcon
Laboratories Inc. authorized service representative.

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.

Only personnel authorized by Alcon Laboratories Inc. staff may operate the device.

90086 Rev. B ï Issued Issued June 13, 2018 32

3 – Safety

Specific User Responsibilities

Any user of the ORA SYSTEM* Technology is responsible for ensuring the
following:

• The device is used in accordance with the instructions provided in this

manual.
• The user manual content must be readily available to the users of the
ORA SYSTEM* Technology.
• None of the labeling on the device is removed or rendered illegible.
• Before any patient measurements are taken, the device must be inspected
according to, see Visual Inspection on page 173.

Protective Eyewear
No protective eyewear is required. The SLED is a Class I medical device with an
IEC 60825-1 Class I (eye safe) laser emission rating.

Protective Clothing
No laser specific protective clothing is required.

Electrical Hazards
The ORA SYSTEM* Technology must be powered by a properly protected and
grounded electrical supply in accordance with the technical specifications listed
Section 10 – Appendix Specifications.

90086 Rev. B ï Issued Issued June 13, 2018 33

3 – Safety

EMC Statements
EMC Requirements for Alcon Laboratories Inc. ORA SYSTEM*:

The Alcon Laboratories Inc. ORA SYSTEM* product requires special precautions
regarding EMC and needs to be installed and put into service according to the EMC
information provided in the Tables 1-2.

The ORA SYSTEM* is a medical device designated for Indoor Use Only. The system
incorporates a short-range frequency radio transmitter that meets the EU and AFTA
countries requirements. They are also FCC; IC; RED 2014/53/EU compliant

WARNING:

Use of this ORA System* adjacent to or stacked with other equipment should be
avoided, because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.

The following is a list of the Alcon Laboratories Inc. product cables and other
accessories that are used as part of the ORA SYSTEM* that comply with EMC standard
IEC60601-1-2:
• Aberrometer Interface (15 ft.)
• Power Cord (12 ft.)

WARNING:

Use of cables or accessories other than those specified, with the exception of cables
and accessories sold by the manufacturer of the Alcon Laboratories Inc. product as
replacement parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the ORA SYSTEM*.

90086 Rev. B ï Issued Issued June 13, 2018 34

3 – Safety

Table 1 – Guidance and manufacturer’s declaration – electromagnetic emissions –For the

ORA SYSTEM*.
Guidance and manufacturer’s declaration – electromagnetic emissions

The Alcon Laboratories Inc. product is intended for use in the electromagnetic environment
specified below. The customer or the user of the Alcon Laboratories Inc. product should
assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment – guidance

The ORA SYSTEM* uses RF energy only for its

RF emissions
internal function. Therefore, its RF emissions are very
Group 1
low and are not likely to cause any interference in
CISPR 11
nearby electronic environment.

RF emissions
Class A The EMISSIONS characteristics of ORA SYSTEM*
CISPR 11 make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a
Harmonic residential environment (for which CISPR 11 class B
emissions Compliance is normally required) ORA SYSTEM* might not offer
IEC 61000-3-2 adequate protection to radiofrequency communication
services. The user might need to take mitigation
Voltage measures, such as relocating or re-orienting the
fluctuations/ equipment.
Compliance
flicker emissions
IEC 61000-3-3

90086 Rev. B ï Issued Issued June 13, 2018 35

3 – Safety

Table 2 – Guidance and manufacturer’s declaration – electromagnetic immunity –For the ORA
SYSTEM*.
Guidance and manufacturer’s declaration – electromagnetic immunity
The ORA SYSTEM* is intended for use in the electromagnetic environment specified below. The customer
or the user of the ORA SYSTEM* should assure that it is used in such an environment.

Immunity test IEC 60601 Compliance level Electromagnetic

test level environment – guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile. If
IEC 61000- 4-2 ±15 kV air ±15 kV air floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should
transient/ burst supply lines supply lines be that of a typical
IEC 61000- 4-4 commercial or hospital
±1 kV for input/ output lines ±1 kV for input/ output environment.
lines
Surge ±1 kV differential ±1 kV differential Mains power quality should
IEC 61000- 4-5 mode mode be that of a typical
commercial or hospital
±2 kV common mode ±2 kV common mode environment.
Voltage dips, 0% Ut for 0.5 cycle at 8 Φ 0% Ut for 0.5 cycle at 8 Φ Mains power quality should
short angles angles be that of a typical
interruptions and commercial or hospital
voltage 0% 1 cycle 0% 1 cycle environment. If the user of
variations the ORA SYSTEM* requires
on power supply 70 % UT 70 % UT continued operation during
input lines for 25/30 cycles for 25/30 cycles power mains interruptions, it
IEC 61000- 4-11 is recommended that the
0% for 250/300 cycles 0% for 250/300 cycles ORA SYSTEM* be powered
from an uninterruptible
power supply or a battery.
Power frequency 30 A/m, 50/60 Hz 30 A/m, 50/60 Hz Power frequency magnetic
(50/60 Hz) fields
magnetic field Should be at levels
IEC 61000- 4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.

Conducted RF 3 Vrms 3 Vrms The ISM (industrial,

IEC 61000-4-6 150KHz to 80MHz 150KHz to 80MHz scientific and medical)
bands between 150 kHz and
6 Vrms at ISM 6 Vrms at ISM 80 MHz are 6,765 MHz to
Frequencies Frequencies 6,795 MHz; 13,553 MHz to
13,567 MHz; 26,957 MHz to
27,283 MHz; and 40,66 MHz
to 40,70 MHz.

90086 Rev. B ï Issued Issued June 13, 2018 36

3 – Safety

Radiated RF 3 V/m 3V/m Since IEC 60601-1-2 Edition

IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz 2.1 and Edition 3 were
developed, new digital
IEC 61000-4-3 Frequency Level Frequency Level wireless
Proximity Fields (MHz) (V/m) (MHz) (V/m) technologies have been
from RF wireless introduced not only to
communication 385 27 385 27 hospitals, but are also in
equipment widespread use by
450 28 450 28 the general public. In
addition, existing
710,745,780 9 710,745,780 9 technologies are being used
in ways that they were not
810,870,930 28 810,870,930 28 used before.

1720,1845,1970 28 1720,1845,1970 28 The IMMUNITY TEST

LEVELS specified in the
2450 28 2450 28 table were calculated using
the following equation:
5240,5500,5785 9 5240,5500,5785 9 E=(6√P)/d
Where P is the maximum
power in W, d is the
minimum separation
distance in m, and E is the
Immunity Test Level in V/m.
The factor of 6 is a
compromise for a range of
antenna factors, to simplify
the test
WARNING!
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the ORA SYSTEM* including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.

90086 Rev. B ï Issued Issued June 13, 2018 37

3 – Safety

Equipment Contains Wireless Transmitters

ORA SYSTEM* Technology is a medical device designed for indoor use only that incorporates
short-range Wi-Fi radio transmitter for communication with Local Area Network (LAN). This
short-range frequency radio transmitter meets the EU and AFTA countries requirements. They
are also FCC; IC; RED and Japanese Radio Law compliant.

2.4 GHz:

2412 - 2472 MHz

5.0 GHz:
Frequency or frequency band of
transmission:
5180 - 5240 MHz

5260 - 5320 MHz

5500 - 5700 MHz

CCK, DQPSK, DBPSK for DSSS

Type and frequency
characteristics of the modulation:
64QAM, 16QAM, QPSK, BPSK for OFDM

WLAN 2.4 GHz frequency band: 19.24 dBm (84.56 mW)

The Effective Isotropic Radiated
Power (EIRP):
WLAN 5 GHz frequency band: 20.88 dBm (122.42 mW)

USA – Federal Communications Commission (FCC)

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
CAUTION

Change or modifications made to this equipment (including antenna) not expressly approved by Alcon
may void the FCC authorization to operate this equipment.

FCC Radiation Exposure Statement:

CAUTION

To ensure that the radio transmitter complies with current FCC regulations limiting both maximum output
RF power and human exposure to radio frequency radiation, a separate distance of at least 20 cm must
be maintained between the unit’s antenna and the body of the user and any nearby persons at all times,
and unit’s antenna must not be co-located or operating in conjunction with any other antenna or
transmitter.

Canada – Industry of Canada (IC)

90086 Rev. B ï Issued Issued June 13, 2018 38

3 – Safety

This device complies with Industry Canada license-exempt RSS standards. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2) this device must
accept any interference, including interference that may cause undesired operation of the device.

Cet appareil est conforme aux normes d’Industrie Canada RSS exemptes de licence. Son
fonctionnement est soumis aux deux conditions suivantes: (1) Cet appareil ne doit pas provoquer
d’interférences nuisibles, et (2) cet appareil doit accepter toute interférence, y compris les interférences
pouvant provoquer un fonctionnement indésirable de l’appareil.

Transmitter Antenna:
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type
and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio
interference to other users, the antenna type and its gain should be so chosen that the equivalent
isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.

Conformément à la réglementation de l’industrie du Canada, cet émetteur de radio ne peut être utilisé
qu’avec un type d’antenne approuvé pour l’émetteur par Industrie Canada et seulement avec une valeur
de gain inferieur ou égale au gain maximum approuvé par Industrie Canada. Pour réduire les risques
potentiels d’interférence à autrui, le type d’antenne et son gain doivent être choisis de sorte que la
puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas la valeur qui est nécessaire pour une
communication réussi.
Exposure of Humans to RF Fields:
This device complies with the RF exposure limits for humans as called out in RSS-102.

Cet appareil est conforme aux limites d’exposition RF pour les êtres humains comme elles le sont
notifiées dans la norme RSS-102.
Europe – RED Directive 2014/53/EU
This device complies with the requirements of the Council Directive 2014/53/EU (RED).

This device is a 2.4 and 5 GHz wireless LAN transceiver, intended for indoor use in all EU and EFTA
member states.
Summary of Wi-Fi Module Certifications
United States Contains FCC ID: N6C-SXPCEAN2
Canada Contains IC: 4908A-SXPCEAN2

This equipment contains specified radio equipment that has been

certified to the Technical Regulation Conformity Certification under
Japan
the Radio Law.
R 007-AC0271

Australia

Europe

90086 Rev. B ï Issued Issued June 13, 2018 39

4 - Installation

4 - Installation
CAUTION:

Do not attempt to operate the device before reading and understanding Chapter
3, Safety.

The ORA SYSTEM* Technology will be installed by a factory-trained

representative from Alcon Laboratories Inc. or an authorized Distributor.

Shipping Contents
Immediately document and report any damage to the carrier and to Alcon
Customer Service. Failure to correctly report damage invalidates the warranty.

If damage has occurred:

• Document observed damage on the way-bill at the time of delivery and
have the carrier examine and estimate the value of the damage.
• Since the insurance company is responsible for payment of any damage,
complete all insurance forms promptly.
• If functional damage has been incurred, but no exterior damage is
present, contact the carrier and have the device inspected immediately by
Alcon WaveTec Vision trained service personnel.
• Retain all packing and shipping material until problems have been
resolved with the carrier and/or insurance company.
• Reference the Alcon WaveTec Vision device serial number in all
communications.

Check the contents of the boxes with the shipping list:

• ORA SYSTEM* Intraoperative Wavefront Aberrometer
• ORA SYSTEM* Cart
• ORA SYSTEM* Operator’s Manual

Requirements
Electrical Requirement
The ORA SYSTEM* Technology requires a 100 - 240 VAC input, through the
provided power cable plugged into a properly grounded outlet.

90086 Rev. B ï Issued Issued June 13, 2018 40

4 - Installation

Environmental Requirement
Ambient temperature in the room containing the ORA SYSTEM* Technology and
ORA SYSTEM* Cart should remain between 10° C and 30° C (50° F and 86° F).
Humidity should be between 20% and 80% non-condensing. Store in a secure
temperature controlled area. Avoid exposure to freezing temperatures.

Ambient temperature in the room containing the ORA SYSTEM* Technology and
ORA SYSTEM* 2.0 Cart should remain between 10° C and 35° C (50° F and 95° F).
Humidity should be between 10% and 90% non-condensing. Store in a secure
temperature controlled area. Avoid exposure to freezing temperatures.

The ORA SYSTEM* Technology requires the use of natural resources for its production
and operation. This equipment may also contain hazardous substances which could
have a potential effect on the environment and human health if disposed of improperly.

The cross-bin symbol located on the equipment is a reminder to use the take-back
ORA SYSTEM* Technology, while also emphasizing the requirement to collect waste
equipment separately, and not dispose of it as unsorted municipal waste.

Setup
Initial Setup
At installation, the initial setup of the device must be performed by an Alcon
Laboratories Inc. representative that will perform the following:
• Inspect the entire ORA SYSTEM* Technology
• Verify proper operation of the ORA SYSTEM* Technology and ORA SYSTEM*
Cart
• Verify Calibration with the Field Verification Tool
• Explain the instrument operating controls and indicators to appropriate staff
members

Customer Setup
• Roll the cart into the room that the ORA SYSTEM* Technology will be used.
• Ensure that the correct microscope objective lens is in place
• Locate the aberrometer in the black case and slide the unit into the female
dovetail on the microscope all the way until it hits the stops. Secure the
aberrometer in place. Align the red dots on the signal cable connectors and plug
the aberrometer into the cable installed on the microscope arm.
• Rotate the microscope head from lock to lock to check for signal cable strain and
signal cable interference.
• Locate the second signal cable and plug the cable into the bottom of the cart.
Plug the other end of the cable into the cable installed on the microscope.
• If the facility has Wi-Fi, a wireless connection will be established on start-up.

90086 Rev. B ï Issued Issued June 13, 2018 41

4 - Installation

• Locate the power cord mounted on the pedestal of the cart, and plug the power
cable into the wall outlet. Check the end of the power cord going into the cart,
ensuring it is firmly seated and the wire securing bracket is in place and is
holding the plug firmly in place. The aberrometer head must be connected before
turning on the cart.
• Locate the power switch at the top of the pedestal and depress the switch. Hold
the switch for 2 to 3 seconds until the switch indicator turns green.
• Allow the cart to boot up and wait until the ORA SYSTEM* Technology Client
login screen is displayed.
• The switch on the VerifEye*+ Cart is on the top right and illuminates when on.

NOTE: Check in the upper left corner of the screen to see if the ORA SYSTEM*
Technology logo glows for a short time. A percentage number counts up and SUCCESS!
appears and then fades. If this does not occur, look at the top left of the screen, to the
right of the ORA SYSTEM* Technology logo, and note the status: connected or
disconnected. If the status is connected, the cart is communicating with the network.
Touch the curved arrows icon located on the top right of the screen to restart a ORA
SYSTEM* Technology synchronization; the logo on the left should begin glowing. If
SUCCESS! is displayed, the cart is communicating with the ORA SYSTEM* Technology
server.

NOTE: The ORA SYSTEM* Intraoperative Aberrometer and Cart have been designed to
allow the user to disconnect and reconnect the aberrometer while the cart is running and
the ORA display is up. This allows the aberrometer to be temporarily removed (if the
surgeon needed to perform a retina case, for example) and reconnected without rebooting
the ORA SYSTEM* Technology. To perform this operation, simply connect or disconnect
the single cable attached to the aberrometer at any time, except when the cart is in
Surgery Mode.

While the aberrometer is disconnected from the Cart, a message will appear on
the bottom left corner of the ORA SYSTEM* Technology screen displaying
“Reading Optical Head Offline”. When the aberrometer is reconnected, a popup
window will show the ORA SYSTEM* Technology status until the ORA SYSTEM*
Technology completes its automatic re-initialization. Do not disconnect the
aberrometer during the re-initialization process

Use of Peripheral Monitor via HDMI

The ORA SYSTEM* Cart can support a customer’s peripheral video monitor via
the HDMI port on the processor face panel. Contact Alcon Customer Service to
schedule assistance in connecting this equipment.

90086 Rev. B ï Issued Issued June 13, 2018 42

4 - Installation

Customer Removal, Storage and Transportation

• Remove the aberrometer from the microscope. Place the aberrometer into
the plastic bag provided and return it to the Pelican case.

NOTE: If the 200 mm objective lens needs to be removed from the microscope and
another lens needs to be installed, place the 200 mm lens into the pocket provided in the
Pelican case.

• Unplug the signal cable from the microscope and wrap the cable on the
storage posts located on the pedestal of the cart.

• Stow the black case on the cart, along with the network cable.

• Power off the microscope, and then replace the dust cover on the scope
head.

WARNING:

Do not modify the device in any way. Modification of the device or any accessory
may result in damage to the device or the accessory, and/or serious injury to the
patient or medical personnel.
Transport
If transported to another location, the device must be functionally checked by
authorized personnel.

90086 Rev. B ï Issued Issued June 13, 2018 43

5 - Configuration

5 - Configuration

AnalyzOR* Technology Configuration

NOTE: Only a user with Administrator privileges can modify the Settings. Primary Account
Manager and Surgeons can ONLY be added by Alcon Laboratories Inc.

From any website screen, click the Administration link located on the top right side of
the screen. The User List screen is displayed.

90086 Rev. B ï Issued Issued June 13, 2018 44

5 - Configuration

Creating a New User

NOTE: Primary Account Manager and Surgeons can ONLY be added by Alcon WaveTec.

From the User List, click the Create a new user link. The Create User screen is
displayed.

90086 Rev. B ï Issued Issued June 13, 2018 45

5 - Configuration

Surgeon LRI Configuration

Click the Surgeons tab, and click on the surgeons name link.

From the Surgeon Profile screen, select the LRI Incision Configuration button.

90086 Rev. B ï Issued Issued June 13, 2018 46

5 - Configuration

Select LRI Type Refraction or Keratometry and enter the surgeon preferred parameters.
The surgeon may override their preferred parameters during surgery by manually
entering LRI values. For Type, the surgeon may select:

Refraction- The LRI template will be based on the Aphakic refraction cylinder magnitude
from which they have selected their lens and will be centered about the Aphakic
refraction cylinder axis.

Keratometry- The LRI template will be based on the preoperative keratometric cylinder
magnitude (Steep-Flat) and will be centered about the steep axis.

User Defined- The LRI template will be manually input for each patient.

For the diameter, the surgeon has the following options:

Limbus (LIM)- The arcuates will be drawn at the value input for the White to White value
entered for each patient.

Fixed Value- The arcuates will be drawn at the diameter entered (in mm)

For Arc Length, the surgeon has the following options:

Cylinder magnitude- Arc lengths will be defined by the cylinder magnitude, refractive or
keratometric based on the surgeon's preferences. The table represents the surgeon's
defined nomogram with the arclength defined in each row for any value between the low-
high columns. All arcs are matched pairs.

Fixed length- All arcs (match pairs) are of the same length, independent of cylinder
magnitude.

90086 Rev. B ï Issued Issued June 13, 2018 47

5 - Configuration

ORA SYSTEM* Cart Configuration

ORA SYSTEM* Technology Settings
The ORA SYSTEM* Technology Settings can be accessed by touching the
Settings icon (see below).

ORA SYSTEM* Technology Settings: Touch to display the following

options:
• System settings
• Maintenance
• Log
• Email
• Options
• Hardware
• About
• DR Config

ORA SYSTEM* Technology

This option is used to perform an ORA SYSTEM* Technology Verification before
using the system. See ORA SYSTEM* Technology Verification page 82
.
Log
This option is reserved for Alcon Laboratories Inc. Personnel.

90086 Rev. B ï Issued Issued June 13, 2018 48

5 - Configuration

Email
This option can be used to send email to Alcon Laboratories Inc. Use the
keyboard to fill the fields, and then touch Hide Keyboard. Touch the Send
button to send the email.

90086 Rev. B ï Issued Issued June 13, 2018 49

5 - Configuration

Options
This option allows the user to define specific parameters and to select the order
and which preoperative data ports will be displayed during surgery.

90086 Rev. B ï Issued Issued June 13, 2018 50

5 - Configuration

SLED Mode

This option is used by Alcon Laboratories Inc. personnel to perform training,

using an artificial eye instead of a real human eye.

WARNING:

The "Artificial Eye" checkbox will be unchecked automatically when the ORA
SYSTEM* Technology boots up. If the user previously checks this checkbox, and
does not reboot the ORA SYSTEM* Technology, this option must be unchecked
before performing surgery on a real human eye.

Synch Interval

Select the Synchronisation interval time between the ORA SYSTEM* Technology
and the Alcon Laboratories Inc. Central Server. Options are every 5 minutes or
every 15 minutes, the default is 5 minutes.

Axis Value to Display

Select the Axis value to display. Options are Preop Ks or Last ORA Aphakic.

By default, the setting is Last ORA Aphakic. Selecting “Preop Ks” will cause the
ORA SYSTEM* Technology to use the patient's pre-op Ks as the point of
reference.

Pre-Op Data

This option allows the user to select the options that will be displayed in the Pre-
Op Data screen.

The interpretations of each value are:

• Manual Ks -- Cylinder (Ksteep-Kflat) and steep axis
• IOL Power Formula – Formula Used, Selected Power, Predicted Postop
Spherical equivalent
• IOL Master Ks -- Cylinder (Ksteep-Kflat) and steep axis
• Orbscan Ks -- Cylinder (Ksteep-Kflat) and steep axis
• Pentacam Ks -- Cylinder (Ksteep-Kflat) and steep axis
• Auto Refraction Ks -- Cylinder (Ksteep-Kflat) and steep axis
• Verion Ks?b
• Target Refraction – The desired postoperative spherical equivalent for the
patient
• LenStar 2.5mm Ks
• Peripheral Corneal Thickness – The Pachymetry, and Meridian
• Show Other Devices Ks -- Cylinder (Ksteep-Kflat) and steep axis
• Axial Length
• Post Refractive Type

When the options have been selected, click the Save button.

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6 - Using the ORA SYSTEM* AnalyzOR* Technology

Introduction
Patients can be created on the ORA SYSTEM* AnalyzOR* Technology so that their
information can be later accessed on the ORA SYSTEM* Cart. To create a patient,
access the following URL using Internet Explorer versions 8 or 9, and 10 (in
Compatibility Mode), Firefox version 21 or Safari version 5.1.7:

On the ORA SYSTEM* , the date and time format is displayed according to the regional
settings of the country in use.

Login to the ORA SYSTEM* AnalyzOR* Technology

The secure website requires a login user name and password, which will be provided by
Alcon’s Customer Service department. When accessing the website, the Login screen is
displayed.

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AnalyzOR* Technology Main Screen

After logging in, the Active Patient List screen is displayed.

The website Main screen displays five (5) tabs:

• Patients/Pre-Op
• Surgeries
• Post Op
• Overdue Post Op
• Reports

The Search option located on the top right of the screen is available on all sub-screens,
except the Reports screen.

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Patient Pre-Op Screen

This screen allows the user to:
• Create a New Patient
• Delete an Existing Patient
• Print Selected Patient Data
• Print All Patient Data
• Access Batch Print Surgical Results page

This screen displays the following information:

• Patient – ID, First and Last Name
• Eye - Right (OD), Left (OS) or Both (OU)
• Surgery/Post-Op
• Surgeon
• Pre-Op Date
• Surgery Type

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Batch Print Surgical Results

This screen allows the user to print a lot of surgical reports by;
• Today
• Yesterday
• This Week
• Date Range
• Surgeon specific

Surgeries Screen
This screen displays all upcoming surgeries with a scheduled date. Patients who do not
have a surgery scheduled for a date in the future will not be displayed on this list. The list
is ordered by the scheduled surgery date with the most recent dates first. The Upcoming
Surgery List displays surgeries, not patients. If a particular patient has two scheduled
surgeries, then two rows will display for that patient in the Upcoming Surgery List, with
one row for each date.

This screen displays the following information:

• Patient – ID, First and Last Name
• Eye - Right (OD), Left (OS) or Both (OU)
• Surgery
• Surgeon
• Pre-Op Date

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Post Op Screen
This screen displays the Post-Op Exam List of completed surgeries within the last 180
days.

The list is ordered so that patients who have had the greatest amount of elapsed time
since their last post-op exam will be displayed at the top of the list.

This screen is recommended to find patients in order to enter post-op examination

information.

If no postop data has been entered previously for the patient, a warning icon is
displayed next to the patient.

If the patient has had surgery on one eye (OD or OS), a single, “Add Data” button will be
displayed. If the patient has had surgery on both eyes (OU), two “Add Data” buttons will
be displayed, one for each eye (OD and OS).

This screen displays the following information:

• Patient – ID, First and Last Name
• Eye - Right (OD), Left (OS) or Both (OU)
• Post-Op Exam
• Surgery Date

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Overdue Post-Op Screen

This screen displays patients that have no postoperative data entered into the
ORA SYSTEM* AnalyzOR* Technology for surgeries completed greater than 10 days.

This screen displays the following information:

• Patient – ID, First and Last Name, greater than ten (10) days from surgery
• Eye - Right (OD), Left (OS) or Both (OU)
• Surgeon
• Surgery Date
• Axial Length
• IOL Lens Type
• Post-Refractive State
• Co-Managed
• Add Exam

Each screen contains selective options to export or print data.

Select the check box to the left and the appropriate button to manage the data as listed:
• Print Selected
• Print All
• Export Selected Data to Excel
• Export all Data To Excel
• Set No Post-Op

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Reports Screen
This screen is used to access outcome analysis reports, Astigmatism Management
reports, and to Define Patient Groups.

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Creating a New Patient

From the Patients/Pre-Op tab, click the Create a New Patient link.

The Patient Information screen is displayed.

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Patient Information Field

The Tab key can be used to move to the next available entry field.

Using the keyboard, enter the following patient information:

• First Name (required)
• Middle Initial (if available)
• Last Name (required)
• Patient ID
• Date of Birth (use the calendar or enter the date in the country format-required)
• Notes - enter any necessary note related to the patient or the surgery.
• Gender – (required) using the dropdown list
• Co-Manage - This option gives access to a dropdown list where a referring site
can be selected. Select this option to allow the co-management users from the
referring site to later enter post-operative results for the patient. Selecting this
option to indicate that the patient has been referred by another doctor (M.D. or
O.D.) and that the patient will be followed by that referring doctor.

Required fields are indicated with *. The patient information will not be saved if a
required field has not been filled.

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Pre-Operative Data Field

The fields are identical for the Right Eye (OD) the or Left Eye (OS). Required fields are
indicated with *. The patient information will not be saved if a required field has not been filled.

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Eye Data Field

Surgery Code

This field is required.

Code Use for

IOL A typical cataract surgery where the patient’s natural lens is

removed and replaced with an intraocular lens (IOL). This code is
pre-selected by default.
Non-Implant No IOL will be implanted, such as an LRI “touchup” or a
repositioning of a previously implanted toric IOL. Select this code
will remove the aphakic measurement types, no lens is selected.
ICL Implantation of a phakic IOL. Select this surgical code will disable
all the aphakic measurement types on the ORA SYSTEM* Cart at
the time of surgery. Only the phakic IOL lenses will be available
for selection.
IOL-LRI A typical cataract surgery where the patient’s natural lens is
removed and replaced with an intraocular lens (IOL). Limbal
Relaxing Incisions will be performed during surgery.

Surgery Date

Use the calendar or enter the surgery date in the country format.

Facility

This field is required. Use the dropdown list to make a selection.

Surgeon

This field is required. Use the dropdown list to make a selection.

Post-Refractive

This field is required. Use this option if the patient had previous refractive surgery, and
select the type of surgery. The available options are:
• No-Post Refractive
• Post-Myopic PRK\LASIK
• Post-Hyperopic PRK\LASIK
• Post-Myopic ALK
• Post-Hyperopic ALK
• Post RK
• Post-RK 4 Cuts
• Post-RK 8 Cuts
• Post-RK >8 Cuts

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Note: An algorithm for Post RK >8 cuts has not been developed and the below warning will be
displayed on the ORA cart when selected.

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Femtosecond Laser

Check this option if a Femtosecond laser will be used during the procedure. A popup
dialog displays the available options. Make the appropriate selection(s) and then click
the Save and Close button.

Ocular Disease

Check this option if the patient has an ocular disease in the eye undergoing surgery.
Touch the ? button to display examples of ocular diseases recognized for this option.

Non ORA SYSTEM* Technology Surgery

Check this option to indicate that ORA either was not or will not be used on that eye, but
the surgeon would like to have the post-op data to compare to either the other eye or to
the rest of the ORA patients in the database.

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Required Data Field

By default, this field is displayed. If the surgeon preferences have been defined, see
Surgeon Optional Data page 67.

Keratometry (K) Type

This field is required. The Keratometry Type is the source for the keratometry data. Use
the dropdown list to select the values:
• IOL Master Ks
• LenStar 2.5mm Ks
• Verion Ks
• Manual Ks
• Orbscan Sim Ks
• Pentacam Sim Ks
• AutoRefraction Ks
• Other Device for Ks

Flat K

This field is required. Enter the patient’s Flat K value.

Steep K

This field is required. Enter the patient’s Steep K value.

Steep axis

This field is required. Enter the patient’s Steep K axis measurement.

Target Refraction

This field is required. Enter the patient’s Target Refraction (Spherical Equivalent) value.

White-to-White

This field is required. Enter the patient’s White-to-White measurement.

Axial Length

This field is required. Enter the patient Axial Length measurement.

Lens Manufacturer

Use the dropdown list to select the Lens Manufacturer. The field has been pre-
populated.

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Lens Model

Use the dropdown list to select the Lens Model. The field has been pre-populated. The
lens information entered at this time is used to specify one or more lens models that are
candidates for implantation during surgery, as well as the predicted power needed for
each lens model. The data on the “Lens List” tab is used by the IOL Power Calculation
functionality in the Operating Room (OR); therefore, entering this data on the website will
save time in the OR.

Show all lens

Select this option to display all lenses. If not checked, surgeon preferred lenses will be
displayed.

IOL Power Calculation Formula

Use the dropdown list to select the Power Calculation Formula. The available options
are:
• Holladay1
• Holladay 2
• SRK/T
• Hoffer Q
• Haigis
• Olsen
• Barrett?
• Other

IOL Power (D)

Enter the pre-calculated IOL Power value (in diopters) to be used during surgery. This
information can be determined during the pre-exam surgery procedure. It is the IOL
power selected by the surgeon prior to surgery

(Pred. Refr. (D))

Enter the predicted postoperative spherical equivalent associated with the selected IOL
power.

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Surgeon Optional Data Field

This field can be used if the surgeon preferences have been defined.

Keratometry Types

If Keratometry procedures have been defined for the surgeon, select the appropriate
option from the prepopulated list, and then click the Add button. Otherwise, select the
procedure from the dropdown list.

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Peripheral Corneal Thickness

Enter the patient's lowest Pachymetry measurement and the meridian along which it is
located. Also, enter the planned depth of the LRI in terms of percentage of corneal
thickness.

Manifest Refraction Data

Enter the patient's pre-op refraction (sphere, cylinder, and axis).

Visual Acuity

Enter the patient’s UCVA (Uncorrected Visual Acuity), and BCVA (Best Corrected Visual
Acuity). These values will be expressed according to the surgeon’s preferences.

Others

Enter the planned phaco incision axis.

Lens List Field
Add Active Lens List

Click the Add Single Lens and select the Manufacturer, Model and Power from the drop
down.

Save
When all patient information has been entered, click the Save button. If any required
field is missing, the screen displayed the mandatory information in red.

NOTE: After the ORA SYSTEM* Cart synchronizes, the patient information will
appear on the cart and the surgery can be started on the patient.

Cancel
Click this button to suppress the Patient. Data entered in all fields will be removed.

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Editing Patient Information

Patient information can be edited by clicking the patient’s name hyperlink; the patient
profile will be displayed. All editable data are identical to the data entered while creating
a patient; see Creating a New Patient page 59.

NOTE: When saved, all edits will overwrite the previously entered information.

Click the Edit button located on the right of a specific field. The selected field is
displayed allowing the user to edit any data.

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When edits are completed, click the Save button. Edits will be saved and the previous
screen will be displayed and updated, overwriting the previous entry/entries.

NOTE: After the ORA SYSTEM* Cart synchronizes, the patient information will
appear on the cart and the surgery can be started on the patient.

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Searching for Patients

A search can be performed for patients from the following screens:
• Active Patients Pre-Op
• Surgeries
• Post-Op
• Overdue Post-Op screens

Primary Search Options

A patient can be searched by selecting the one of the following options from the
dropdown list:
• Any Data
• Patient ID
• Patient Last Name
• Patient First Name
• WaveTec Patient Number
• WaveTec Surgery Number
• Referring Site

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Additional Search Criteria

Search - Show Inactive Patients
This will display patients for which surgeries are closed.

Selection from the dropdown list:

• All
• Surgeries
• Post-Op
• Follow Up
Search - All
All active patients in the ORA SYSTEM* Technology.
Search - Surgeries
All active patients with a “Pending” surgery (no scheduled date) or “Scheduled”
surgery.
Search - Post-Op
All active patients with a surgery completed within the last 180 days.
Search - Follow Up
All active patients who were created or updated within the last 90 days, or with a
surgery not scheduled.

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Starting the Search

After selecting all the Search criteria, click the Search button. The screen displays a
patient list matching the search criteria.

The ORA SYSTEM* Technology will display only patients assigned to the surgeons
assigned to the logged in user.

The list can be sorted in ascending or descending order by clicking on the column
header and then clicking p or q. For the Eye column, patients are sorted by Right or
Left Eye.

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Printing a Patient List

A patient list can be printed from the Patients/Pre-op, Upcoming Surgeries, Post-Op and
Overdue Post-Op Data screens.

Printing Selected Patients

Click the checkbox next to the patient’s name from the list, and then click the Print
Selected button. The following window is displayed:

Click the printer’s icon located on the top right of the screen to print the list to
the user selected printer.

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Print All Patients

Click the Print All button. The following window is displayed:

Click the printer’s icon located on the top right of the screen to print the list to
the user selected printer.

The following information is included on the printed lists, depending upon which list is
being pulled:
1. Name (Last, First, ID)
2. Eye (OD, OS, OU)
3. Surgery Scheduled Date
4. Surgeon
5. The date of the patient’s last postop exam
6. Measurement Type

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Exporting Patient Information to an Excel File

From the Active Patient and Overdue Post-Op Data screens, an option to
export the information into an Excel spreadsheet is available. Clicking the
icon next to the printer icon gives the option to Open or to Save the created
file.

The Excel file will be created and will open in Excel.

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Approving Surgeon Specific Optimized Surgeon Factors (SF)

Surgeons, or other admin practice users who are assigned to surgeon’s approver list, must
manually review and approve new optimized SF on AnalyzOR* Technology before it can be
used for surgeries on the Cart. This process must be performed every time new optimized SFs
are calculated.

Surgeon optimized SF Approver list

Surgeon approver lists can only be updated by Alcon (WaveTec) users. Please
contact your Customer Support representative to add or modify users in these lists.

Notification for pending surgeon-specific optimized SF

After successful AnalyzOR* Technology login, an admin practice user who is a
member of a surgeon’s approver list will be notified if there are pending surgeon-
specific optimized SFs. This user will have the option to review it now or later. If the
user chooses to review it now, the application will automatically redirect the user to
the surgeon optimized SF Approval list.

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Optimized SF Approval List Description

On the practice user Administrator screen, the tab “Optimized SF” is used to view
optimized SF approval list.

Access to the list

• It is accessible for members of the authorized practice user list to view and update.
• It is accessible for read-only view by WaveTec users with Clinical Level 1, Clinical
Level 2, or Administrator role.

Search by Surgeon
• The surgeon drop-down is populated based on the practice user’s assigned surgeon,
listed in alphabetical order by Last, First names.
• By default, the surgeon drop-down is set to a surgeon with a pending approval list. If
there are multiple surgeons with pending approval list, the 1st surgeon in alphabetical
order by Last, First names is selected.

Search by Approval Status

• By default, the list shows current pending optimized SF update.
• Users are able to search by approved, skipped or pending review status.

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Approve or Skip
• Users are able to approve or skip pending approval item by clicking the “Approve” or
“Skip” button.
• Users are able to select multiple pending items to approve or skip.
• If a selected item is part of a lens family, then all lenses on the list that are part of the
same family will be automatically selected.
• Selected check box is disabled for items with approved or skipped status.
• When the user clicks the “Approve” button, a pop-up message is displayed to notify
the user that once it is successfully submitted the selected items cannot be changed
and will be immediately available for the selected surgeon’s new surgeries on his/her
assigned practice(s).

• When the user clicks the “Skip” button, a pop-up message is displayed to notify the
user that once they are successfully submitted the selected items will be skipped and
previous optimized SF or lens SF will be used for surgeries.

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7 – ORA SYSTEM* Cart Operating Instructions

Basic Operating Steps
CAUTION:

Before using the ORA SYSTEM* Technology, inspect the power cable, and plugs
for wear or damage including cuts, gouges, or other signs of physical damage. If
the power cable is damaged, do not use the device. Call Alcon Laboratories Inc.
for service or repair.

Ensure that all of the requirements for installation have been performed before
using the ORA SYSTEM* Technology. Follow the maintenance procedures as
described in instruction manual.

The normal sequence of steps to be followed is indicated below:

1. Setup the Device

2. Power Up the Device

3. Log In

4. ORA SYSTEM* Technology Verification

5. Select the Patient

6. Perform the Procedure

7. Next Patient or Logout

8. Power Down the Device

9. Remove and Store the Device Components

Setup the Device

1. Ensure the proper objective lens is on the microscope.

2. Attach and secure the ORA SYSTEM* Aberrometer to the surgical microscope.

3. Connect the ORA SYSTEM* Aberrometer to the cart.

4. Connect the cart power cord to a proper AC power source.

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Power up the Device

1. Aberrometer head must be connected to the cart before powering up the
ORA SYSTEM* Technology.

2. Turn ON the AC Power Main Switch located under the bottom of the cart
platform.

3. Press and hold the Push-Button Power Switch for approximate 2 seconds to
turn ON the unit. A green light will indicate power is on.

Login to the ORA SYSTEM* Technology

After powering up and a short boot up sequence the Login screen is displayed.

Enter User Name and Password, and then touch the Login button.
If the user forgot the password, see the practice’s administrator that supports
Alcon Laboratories Inc. to reset the password.

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ORA SYSTEM* Technology Verification

If the calibration of the ORA SYSTEM* Technology has not been verified within the last
24 hours, the ORA SYSTEM* Technology will require that verification be performed.

Attach the ORA SYSTEM* Technology Verification Tool and touch the OK button to start
the verification process. Adjust the angle of the scope so that the aberrometer is parallel
with the floor.

When the ORA SYSTEM* Technology is verified, remove the ORA SYSTEM*
Technology Verification Tool. After the ORA SYSTEM* Technology verification, adjust
the angle of the scope back to surgeon’s angle preference.

To perform a ORA SYSTEM* Technology verification without being prompted, perform

the following steps:

From the Main Screen, select the ORA SYSTEM* Technology Settings icon.
The ORA SYSTEM* Technology Settings screen is displayed.

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Follow the on-screen commands:

• Attach the Field Verification Tool
• Activate the touch screen to start the ORA SYSTEM* Technology verification
process.

If the ORA SYSTEM* Technology verification is unsuccessful, contact Alcon Customer

Service at: 800-832-7827

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Select Practice, if required

If the user login in is associated with multiple practices, the Select Practice screen will be
displayed. Select a practice and then touch the Continue button.

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Main Screen
Connection Status and Current Date and Time
currently logged in user

Search
Patient icon

Surgery icon

ORA
SYSTEM*
Technology
Settings
icon

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Icons
Patient: Touch to display the Patient information screen

Surgery: Touch to display the surgery screen and use the

ORA SYSTEM* Technology to perform measurements.

ORA SYSTEM* Technology Settings: Touch to display the

following options:
• System
• Maintenance
• Log
• Email
• Options
• Hardware
• About
• DR Config
Reticle: touch to turn ON

Reticle: touch to turn OFF

Use the arrows to adjust the brightness

Synchronization: Touch to synchronize the ORA SYSTEM*

Technology with the WaveTec server if a connection failed.

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Procedures Field

From the Procedures field, the following options can be selected:

• Today to display today’s procedures
• No Date to display unscheduled procedures
• Completed to display completed procedures

The right and left arrows t ucan be used to select the previous day or the next day.

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Search Field

The database can be searched using the dropdown list and selecting the following
criteria:
• Patient ID
• Patient First Name
• Patient Last Name
• Surgeon Last Name
• WaveTec ID
• Date

Select the criteria from the dropdown list, enter the information in the next field, and then
click the Search button.

Double-click on the patient line to display the Patient Information.

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Create a New Patient

From the Main Screen, touch the Add Patient button.

The Patient Information screen is displayed.

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The numerical keypad and common keystrokes are displayed on the right side of the
screen. When a field is selected requiring alpha entry, an alpha-numerical keyboard is
displayed.

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Patient Information Tab

The Tab key can be used to move to the next available entry field.

Using the keyboard, enter the following patient information:

• First Name
• Middle Initial (if available)
• Last Name
• Patient ID -optional field, it is suggested to use the patient's medical chart ID
number
• Gender – using the dropdown list
• Date of Birth (in the country format)
• Surgery Date (if available)

The WT ID (WaveTec Identification) is automatically generated.

Co-Managed Field
This option gives access to a dropdown list where a referring site can be selected.
Select this option to allow the co-management users from the referring site to later enter
post-operative results for the patient.

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Notes Tab

Use the keyboard to enter any necessary note related to the patient or the surgery.

Lens List Tab

The Lens List tab is used to specify one or more lens models that are candidates for
implantation during surgery, as well as the predicted power needed for each lens model.
The data on the “Lens List” tab is used by the IOL calculation logic in the Operating
Room (OR), therefore entering this data on the web will save time in the OR.

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Add a Lens
1. Touch the Add Lens button to select the lens to be used during the surgery.

2. Use the dropdown list to select the Lens Manufacturer, the Lens Model, and the Lens
Power. These fields have been pre-populated.

3. When all the Lens information has been selected, click Proceed to save the Lens
data.
4. Add or Delete a lens, as needed.

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Surgery Field

Make the appropriate selection from the dropdown list.

Eye
OD – Right eye or OS – Left eye
Surgery Code
Code Use for

IOL A typical cataract surgery where the patient’s natural lens is

removed and replaced with an intraocular lens (IOL). This code
is pre-selected by default.
Non-Implant No IOL will be implanted, such as an LRI “touchup” or a
repositioning of a previously implanted toric IOL. Select this code
will remove the aphakic measurement types, no lens is selected.
ICL Implantation of a phakic IOL. Select this surgical code will
disable all the aphakic measurement types on the ORA
SYSTEM* Cart at the time of surgery. Only the phakic IOL lenses
will be available for selection.
IOL-LRI A typical cataract surgery where the patient’s natural lens is
removed and replaced with an intraocular lens (IOL). Limbal
Relaxing Incisions will be performed during surgery.

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Post-Refractive
Use this option if the patient had previous refractive surgery, and select the type of
surgery.

Orientation
Temporal or Overbrow.
Femto
Check this option if a Femtosecond laser will be used during the procedure, and then
select the appropriate procedure(s).

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Has Ocular Disease

Check this option if the patient has an ocular disease in the eye undergoing surgery.
Touch the ? button to display examples of ocular diseases for this option.

Measurements Field
The measurement field displays the values of measurements obtained during the
preoperative exam, as well as the preoperative lens choice.

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Keratometry
The Keratometry Type is the source for the keratometry data. Use the dropdown
list to select the values:
• IOL Master Ks
• LenStar 2.5mm Ks
• Verion Ks
• Manual Ks
• Orbscan Sim Ks
• Pentacam Sim Ks
• AutoRefraction Ks
• Other Device for Ks
Flat K
Enter the patient Flat K value.
Steep K
Enter the patient Steep K value.
Steep axis
Enter the patient Steep K axis measurement.
Target Refr.
Enter the patient Target Refraction (Spherical Equivalent) value.
White-to-White
Enter the patient White-to-White measurement.
Axial Length
Enter the patient Axial Length measurement.
Lens Manuf
Select the manufacturer of the lens.
Lens Model
Use the drop-down list to select the lens model.
IOL Power Calc. Formula
Use the drop-down list to select the IOL power calculation formula used.
Power (D)
Use the drop-down list to select the lens Diopter power.
REF (D)
Displays the predicted postoperative spherical equivalent

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Dynamic Reticle Doctor Configuration

The DR Config tab is used to set the users preferences for the dynamic reticle.
Select the Surgeon name. Select the appropriate reticle graphic feature
checkbox then using the up/down arrows adjust the intensity of the selected
feature. Setting the intensity to zero will turn off that feature for the selected
display type.

Use the radio buttons to select each display types. Select Save when all features
have been set to the desired intensity.

Display Types

Graphic
Features

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Refractive
The refractive display type is designed to provide the surgeon with streaming
refractive information through the oculars, overlaid onto the patient's eye. The
refractive reticle features are displayed in this example.

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LRI
The LRI reticle template is designed to display an overlay in the surgeon's
oculars of the desired arcuate incisions for guidance in making Limbal Relaxing
Incisions or Astigmatic Keratotomy. The LRI template will be based on surgeon
defined preferences (See section 5 - Surgeon LRI Configuration). The LRI reticle
features are displayed in this example.

Toric Placement
The toric placement display type is designed to provide the surgeon a fixed line
to align the lens to assist in implanting a toric lens. The toric placement reticle
features are displayed in this example.

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Toric Rotation
The toric rotation reticle is designed to provide the surgeon guidance in the
rotation of the lens based on refractive information, the selected lens, and the
Aphakic measurement. The toric rotation reticle features are displayed in this
example.

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Select a Patient
The scheduled procedures screen displays patients for the selected date. The
left and right triangles are used to move the day/date back or ahead. When a
patient’s schedule date is reached, the patient’s name and information will be
displayed.

1. The screen contains a list of surgeries scheduled for the selected day.
2. Locate the name of the next patient scheduled for surgery.
3. The list displays the following information:
• Last Name
• First Name
• Patient ID (optional patient ID from the practice’s main information
ORA SYSTEM* Technology)
• WaveTec Patient ID
• OD or OS (the eye that will be operated on)
• The Surgical Code
• The Surgeon’s Name

NOTE: If the patient information has not been previously entered through the website,
patient information can be entered directly on the ORA SYSTEM* Cart by clicking the
Add Patient button. See Creating a New Patient, page 59.

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Double-click the patient’s line to display the patient’s information. Similar to the
ORA SYSTEM* AnalyzOR* Technology, only patients assigned to the surgeon
are available to the logged in user.

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Touch the Notes tab to display the field where notes about the patient can be
entered, see Notes Tab, page 92.

If any data needs to be modified, touch the Edit Information button and make
necessary changes.

Touch the LRI tab to display the limbal relaxing incision settings. Only access
this tab if the surgeon wants to specify the LRI parameters for a specific case. If
any information is input, the surgeon preferences will be overridden and the
patient's LRI template will be User Defined.

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Before Acquiring Measurement

Prepare the eye to ensure a good measurement:

• Ensure the capsule and anterior chamber are free of cortex and debris
• Clear the anterior chamber of air bubbles
• Seal incisions without excessive edema
• Ensure the lid speculum and lid are out of the way, well beyond the
limbus
• Make sure the eye is properly pressurized
• Ensure good tear film
• Focus the microscope on the anterior surface of the cornea
• Turn off the microscope light
• Instruct the patient to look directly at the red light

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Begin Surgery
When the patient’s information has been verified, touch the Begin Surgery
button.

The Surgery in Progress screen is displayed.

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Viewing Pre-Op Data during Surgery

Pre-Op Data field, located on the left side of the Surgery in Progress screen,
is displayed to view the patient’s preoperative data while in surgical mode.

The screen slides in and out from the left side of the screen. Touch the left
arrow (circled in yellow), the Pre-Op Data window will slide away, and the main
navigation icons will be displayed. Touch the right arrow, the Pre-op Data field
will be displayed.

The keratometry data are displayed by default. Additional information in this

field can be selected, see Options pag 50.

Using the Static Reticle

When not in preview or capturing the Static Reticle can be turned ON or
OFF by pressing the “Reticle” button located in the lower left corner below
the navigation icons.

The graphical image of the button will change to indicate when the Reticle is
ON.

When the reticle is on, the brightness intensity of the Reticle can be adjusted
by touching the up/down arrows next to the reticle button.
The ORA SYSTEM* Technology will memorize each user’s setting until it is
adjusted again.

The Reticle will automatically turn from on to off when a refraction capture begins.

Using the Dynamic Reticle

The Reticle can be turned ON or OFF by pressing the “Reticle” button located in the
lower left corner when in preview or during a capture. The left arrow displays
the Reticle configuration and the right the intensity adjustment. The intensity
is not adjustable for the Refractive Display Type or Toric Rotation Display
type and the microscope light needs to be off in order for the patient to fixate
and for the surgeon to see the information. The ORA SYSTEM* Technology
will memorize each user’s setting until it is adjusted again.

The dynamic reticle is displayed in the right ocular. Displayed data varies on
the measurement type and the preferences set in the DR Config. Data
includes;
Refraction data
Degree gauge
Centroid
Focus bar
Measured axes

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Lens power
Measured Axes Magnitude gauge
Capture zone
Acquisition zone
Keratometric axis
LRI template
Toric rotational arrows

The display type can be selected with the left split button next to the reticle button.

Refractive Data will be available for the Phakic-Before Incision, all LRI or LRI
Enhancement measurements, Power Calculation, and After IOL Implant (Non-Toric).

The LRI Template will be available for all LRI or LRI Enhancement Measurements.

The Toric Placement Template will be available for Power Calculation (provided an
aphakic measurement has been taken and a lens has been selected), and After Toric
Implant.

The Toric Rotation Template will only be available for after After Toric Implant
measurement types.

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Performing the Procedure

While in surgical mode, the following options regarding the State of the Eye can
be selected:
• Phakic
• Aphakic
• Pseudophakic

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State of the Eye Options

Phakic Measurement
In the Phakic eye state, the options are:
• Before Incision
• LRI
• LRI Enhancement

NOTE: The difference between the two LRI types is that the measurement will be stored
with a different intraoperative data tag.

Aphakic Measurement
In the Aphakic eye state, the options are:
• Power Calculation
• LRI
• LRI Enhancement
Pseudophakic Measurement
In the Pseudophakic eye state, the options are:
• After IOL Implant –Non-Toric
• LRI
• LRI Enhancement
• After Toric Implant

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ORA SYSTEM* with VerifEye*+ Technology Preview

ORA SYSTEM* Technology Preview Acquisition Screen
From the Surgery in Progress screen, select the appropriate option; see State of the
Eye Options Page 110.

Images from three cameras will be displayed:

• Wide field of view camera allows the surgeon to monitor surgical variables and
provides the primary feedback for alignment along the x and y axis.
• Refraction camera provides a view of the fringe pattern.
• Focus camera provides the primary feedback about alignment along the z axis,
secondary feedback about x and y alignment feedback about X, Y and Z
alignment position, and the integrity of the LED reflections. The ORA SYSTEM*
Technology must see four, full, LED reflections in order to capture.

Information displayed:
• Planned IOL
• Post refractive type
• Refraction and spherical equivalent
• Target post op spherical equivalent
• VerifEye*+ lens power
• Bull’s eye – indicates the magnitude and orientation of astigmatism

Touch the appropriate button to display the Preview Acquisition screen. The preview
screen should be used to align the eye, make note of the refractive information and
preliminary IOL power information, and to ensure that the eye is ready for measurement.

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Planned IOL
Post Refractive Type Target Post Op SE
Refraction and Spherical
Equivalent VerifEye*+ Lens
Power

Bull’s Eye
Refraction camera

Wide Field of View

Focus camera
camera

Cancel Button
Press this button to cancel the procedure and return to the previous screen.
Capture Button
Touch this button to initiate the measurement process. When the measurements
are activated, the screen displays image(s) streamed from the camera(s).

Alignment
• Focus the microscope on the apex of the cornea
• Adjust alignment on the Z axis using the focus pedal on the microscope in
order to position the focus ball in the green zone
• Adjust initial X and Y alignment using the microscope joystick in order to
position the dot in the green circle of the wide field of view camera image
• Fine adjustment in x and y position should be achieved my controlling the
patient head position

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Incorrect Alignment
The next screen displays an incorrect alignment.

If the target is red, the user must bring the target into the green circle, while
keeping the focus ball in the green zone.

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Correct Alignment
The next screen displays a correct alignment.

Achieve good alignment:

• Focus the microscope on the apex of the cornea
• Adjust alignment on the Z axis using the focus pedal on the microscope in order
to position the focus ball in the green zone
• Adjust initial X and Y alignment using the microscope joystick in order to position
the target in the green circle of the wide field of view camera image
• Fine adjustment in x and y position should be achieved my controlling the patient
head position

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Capture Button
Touch this button to initiate the measurement process. When the measurements are
activated, the screen displays image(s) streamed from the camera(s).

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Image Acquisition
After the ORA SYSTEM* Technology completes the measurement process, the results
are displayed. The image below shows the IOL power calculation page. The patient's
pre-op data is displayed to the left. The center section displays the astigmatism
measured by ORA, at the top, and the ORA IOL and predicted post-op SE information
power information below. The complete refractive findings are displayed on the right side
of the screen.

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Red Images
A red image is a safety mechanism that will not allow ORA to display a quality
measurement

• A red image can be caused by the following:

• A large range in refractions between the 40 images
• Dry corneal surface
• Central air bubble
• Chamber debris
• Cortex fragments
• PVD, retinopathy issues, etc.
• Also, patients with high order aberrations, keratoconus, or any eye diseases that
can obstruct the light path to the retina can result in a red image

Re-check the variables that can affect the quality of the image and touch Repeat to take
another capture

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Measurement Caution
The ORA SYSTEM* Technology will provide a warning if an aphakic measurement (of
any type) is outside the expected range given the preoperative biometry of the patient.
There are two conditions for the warning to appear: one is based on the spherical
equivalent, and the other is based on the astigmatism. In each case, the value measured
by the ORA SYSTEM* Technology is compared to a theoretical value calculated from
the patient’s preoperative biometry.

Aphakic Spherical Equivalent

The aphakic spherical equivalent measured by the ORA SYSTEM* Technology may be
different than the expected or calculated value, but statistical analysis has shown that it
is unusual for the difference between the predicted and measured aphakic spherical
equivalent to be greater than 2.0 D. If the ORA SYSTEM* Technology measures an
aphakic spherical equivalent that differs from the predicted value by more than 2.0
diopters, the ORA SYSTEM* Technology will display the message above.

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Aphakic Measurement SE - Astigmatism

Similarly, the ORA SYSTEM* Technology tests the measured astigmatism (cylinder and
axis) against the preoperative keratometry. The measured cylinder and axis are broken
down into their astigmatic decomposition as follows:
• J0=Cylinder* COS (2* Axis)
• J45=Cylinder* SIN(2* Axis)

The measured J0 and J45 are then compared to the J0 and J45 values calculated from
keratometry where Axis=Axissteep and Cylinder=Ksteep – Kflat. If the difference between the
J0 values calculated from the measurement and calculated from keratometry is greater
than 2.00 or the difference between the J45 values is greater than 1.75, the
ORA SYSTEM* Technology will display the message above.

Repeat Button
Touch the Repeat button on any of the Measurement Caution screens to take another
measurement of the same type. Before proceeding, check the surgical variables and the
pre-op biometry entered in ORA SYSTEM* Technology.

If the user elects to take another measurement after seeing one of the measurement
cautions, the ORA SYSTEM* Technology will compare the spherical equivalent and the
astigmatism of the second measurement with the first measurement.

If the two measurements agree within 0.5 diopters, a measurement caution is not
displayed even if the values for the spherical equivalent or cylinder of the second
measurement when compared to preoperative biometry would otherwise trigger a
caution.

If the two measurements do not agree within 0.5 diopters then another measurement
caution will be displayed if the thresholds compared to preoperative data are exceeded.

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Ignore Caution
Touch this button, a second measurement will not be taken, but the user can elect to
take another measurement later.
NOTE: It is recommended to not press the Ignore Caution button.

Do not show this message again

Selecting this checkbox will suppress all caution messages for the current surgery only.
The measurement that triggered the measurement caution will be displayed in the
measurement field with a yellow bar, see picture below.

NOTE: It is recommended to not press the Do not show this message again
button.

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Power Calculation Measurement

1. Select the patient from the Patient List.
2. From the Patient Information screen, touch the Begin Surgery button, the State of
the Eye screen is displayed.

3. From the Aphakic option, touch the Power Calculation button, the Preview
Acquisition screen is displayed.
4. Touch the Capture button.
5. When the measurements are completed, the results are displayed.
6. If multiple lenses have been selected, the ORA SYSTEM* Technology uses the
Surgical Factor (SF) of each lens in the lens list and a proprietary algorithm to
calculate the predicted spherical equivalent value for each available lens power for
each lens in the lens list. When the lens selection is made or if a lens list for the
patient was defined when the patient data was created, the ORA SYSTEM*
Technology will display the IOL Power Results screen, see picture next page.

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Select a lens from the Lens List, the ORA SYSTEM* Technology displays in the next
field the predicted spherical equivalent value for the patient for each available power
of the lens. The lens power that will yield a spherical equivalent closest to the target
refraction will be displayed in bold font. In the example above, the best option for the
SN60WF Lens is 22.00 Power and -0.28 Spherical Equivalent.

To measure the pseudophakic spherical equivalent after the IOL is implanted, from
the State of the Eye screen, under Pseudophakic measurements, touch the After
IOL Implant Non-Toric button as long as the user is not seeking to adjust the
angular positioning of a toric IOL.
Gold Bar
The gold bar above the lens indicates that this lens model is “ORA optimized”,
meaning that WaveTec has calculated a lens constant for this lens model based on
an analysis of postoperative results.
Platinum Bar
If the lens has been optimized with a surgeon-specific lens constant, the bar will be
platinum.
No Bar
There will be no bar if the manufacturer’s lens constant is being used.

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Add Lens to Lens List

When the alignment processes end, if the user has not added candidate lenses to the
lens list for this surgery, the following screen will be display allowing the user to add a
lens to the surgeries lens list.

The user can select the manufacturer and model of the lens that they wish to implant
into the patient. Lenses can be selected when creating the Patient Data, see Lens List
Tab page 92.

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Power Calculation for Long Eyes

The ORA SYSTEM* Technology is optimized to take power calculation measurements
on eyes that will yield an aphakic spherical equivalent of approximately 12.5 diopters (a
typical aphakic spherical equivalence for an average eye).

Some patients present with long axial lengths (> 28 mm) that produce aphakic spherical
equivalents less than 3 diopters. For these cases, the ORA SYSTEM* has logic to
optimize itself for a lower spherical equivalent. If, based on the preoperative biometry,
the ORA SYSTEM* Technology predicts that the aphakic spherical equivalent will be
less than 3 diopters, it will automatically adjust itself to take such a measurement.

If after taking the measurement the ORA SYSTEM* Technology measures an aphakic
spherical equivalent greater than 5 diopters, it will display the message below, and
adjust itself back to its normal settings. The optimization logic for long eyes is used for all
aphakic measurements, not just Power Calculation measurements.

NOTE: It will be necessary to take another measurement after this warning is

presented.

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Toric IOL Case

The ORA SYSTEM* Technology toric application provides tools to help a surgeon select
and optimally position a toric IOL. If the surgery lens is a toric lens the power calculation
will default to the toric screen. Prior to the implant of the toric IOL, the toric application
allows the user to assess the amount of astigmatism to be treated. After the implant of
the toric IOL, the application provides rotation recommendations that allow the surgeon
to position the IOL to achieve the maximum amount of astigmatic correction.

1. Select the patient from the Patient List, and then touch the Surgical icon.
2. From the Patient Information screen, touch the Begin Surgery button, the State of
the Eye screen is displayed.

3. From the Aphakic option, touch the Power Calculation button, the Preview
Acquisition screen is displayed.
4. Touch the Capture button.
5. When the measurements are completed, the results are displayed.

In order to access the Aphakic Toric Screen, a toric IOL model must be selected as the
type of lens to be implanted. Once the toric screen is displayed, select the spherical
power from the drop-down menu, then select the cylinder power from cylinder power
display.
Aphakic Toric results prior to spherical power selection
The picture below displays Aphakic Toric results prior to spherical power selection.
Select the appropriate spherical power from the drop down, and then select the cylinder
power that will provide the maximum amount of astigmatic correction.

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Aphakic Toric screen after spherical power and cylinder power have
been selected
The picture below displays the Aphakic Toric screen after lens power selection.

On the screen above, the bottom portion of the screen shows a graphical display of the
patient's astigmatism. The measurements are as follow:
• The orientation of the green line shows the axis of the aphakic measurement of
astigmatism.
• The length of the green line is proportional to the magnitude of astigmatism of the
aphakic measurement.
• The orientation of the blue line represents the axis of the patient’s keratometry
(the steep axis)
• The length of the line is proportional to the magnitude of the keratometric
Astigmatism.
• The scaling of the two lines will be such that the largest of either the aphakic
refraction cylinder or the keratometric cylinder will correspond to the diameter of
the circle that is labeled “Astigmatism”.

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Keratometry option – Phaco Incision Axis

After taking one or more aphakic measurements, if
the keratometry data is more representative of the
patient’s astigmatism, touch the button located next to
”Keratometry”, located on the left of the corneal
astigmatism graph. The ORA SYSTEM* Technology
will prompt the user to enter the phaco incision axis,
see picture below.

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Keratometry option – User-Defined Values

If the corneal astigmatism is a value other than that given by the
aphakic refraction or keratometry, the user can enter user-defined
values for the corneal astigmatism and axis by touching the arrow
right next to ”Keratometry”. The keypad will be displayed to enter
user-defined corneal astigmatism; see picture below.

Toric Lens Selection

The list of Toric lens models displays all the Toric lens models belonging to the selected
Toric lens manufacturer family that the surgeon has entered in the Lens List. If there is a
second Toric lens family in the pre-op Lens List, its family of lens members will also be
displayed on the upper right side of the screen.

NOTE: A lens family is composed of all the Toric lenses from the same manufacturer
that have common characteristics but vary in their cylinder value. Only the 2 Toric
lens families are displayed on the Toric page.

The screen on the next page displays a comparison of two Toric lens families side by
side, allowing the surgeon to decide which family and lens to choose for the patient.

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The Toric lens model that will yield the lowest possible residual astigmatism will be
indicated in bold in the list of Toric lens models in the lower left portion of the screen.
The user can review the predicted residual astigmatism for each of the lenses in the list
by selecting one Toric lens model from the list.

The predicted residual astigmatism will be displayed as a red bar in the “Astigmatism”
graphic in the lower portion of the screen; see picture below.

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ORA SYSTEM* with VerifEye*+Technology After Toric Implant

After the Toric IOL is implanted, touch Take Measurement button and then under the
State of the Eye screen, Pseudophakic option, touch the After Toric Implant button.

Model implanted Spherical Power

Post Refractive Type Implanted
Refraction and Spherical Astigmatism
Equivalent Reference
Rotation
Recommendation
Recommended IOL
Rotation Direction

Bull’s Eye

A lens model and a power must be selected before entering the alignment screen.
The preview screen will display:
• IOL model implanted
• Post Refractive Type
• Refraction and spherical equivalent
• Spherical power implanted
• Astigmatism reference (aphakic refraction or keratometry)
• Rotation recommendation – visual and written
o Clockwise (CW), indicating that the surgeon should rotate the lens
clockwise by no greater than 5 degree increments
o Counter-Clockwise (CCW), indicating that the surgeon should rotate
the lens counterclockwise by no greater than 5 degree increments.
o No-Rotation Recommended (NRR), indicating that the lens is located
close to the optimum position.
• Bull’s eye

Once the eye is aligned and the measurement is stable touch the Capture button.

The pseudophakic toric measurement with this option will be tagged with “After
Implant”.

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Pseudophakic Toric Results Screen

Clockwise Recommendation

The screen below indicates to the user that a clockwise rotation is recommended.

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No Rotation Recommendation

No Rotation Recommended will be displayed when one or both of the following

conditions are met:
• The measured residual astigmatism is less than 0.50 D
• The axis of the measured residual astigmatism is within 5 degrees of the
anticipated residual cylinder axis
The following screen will be displayed indicating that no further rotation of the toric lens
is recommended.

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Taking an LRI Measurement with VerifEye*+ Technology

1. Select the patient from the Patient List, and then touch the Surgical icon.
2. From the Patient Information screen, touch the Begin Surgery button, the State of
the Eye screen is displayed.

3. Select the appropriate option corresponding to the patient.

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Aphakic
1 If the eye is aphakic and no relaxing incision has been made, from the Aphakic
option, touch the Power Calculation button.
2 After the initial LRI treatment, touch the LRI button.
3 After additional treatments, touch the LRI Enhancement button.
4 The Preview Acquisition screen is displayed after each procedure selection.

The Aphakic VerifEye*+ Technology preview screen will display:

• Planned IOL
• Post refractive type
• Refraction and spherical equivalent
• Target post op spherical equivalent
• VerifEye*+ lens power
• Bull’s eye – indicates the magnitude and orientation of astigmatism

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Pseudophakic
If the eye is pseudophakic and no relaxing incision has been made, from the
Pseudophakic option, touch the After IOL Implant Non Toric button.
After the initial LRI treatment, touch the LRI button.
After additional treatments, touch the LRI Enhancement button.
The Preview Acquisition screen is displayed after each procedure selection.

The pseudophakic VerifEye*+ Technology preview screen will display:

• IOL model implanted

• Post Refractive Type
• Refraction and spherical equivalent
• Spherical power implanted
• Astigmatism reference (aphakic refraction or keratometry)
• Bull’s eye – indicates the magnitude and orientation of astigmatism

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Taking an LRI Measurement

1. Select the patient from the Patient List, and then touch the Surgical icon.
2. From the Patient Information screen, touch the Begin Surgery button, the State of
the Eye screen is displayed.

3. Select the appropriate option corresponding to the patient.

4. Touch the Capture button.
5. When the measurements are completed, the results are displayed; see picture next
page.

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The screen will display the sphere, cylinder, axis, and Spherical Equivalent (SE) of
the last two LRI measurements in the central portion of the screen. The most
recently taken LRI measurement is displayed in the shaded line in the central portion
of the screen. The top line of the central portion of the screen will display either the
preoperative Keratometry (K’s) or a third LRI measurement.

By default, the preoperative K’s will be displayed, but if the user touch an LRI
measurement other than one of the last two, then that measurement will be
displayed on the first line. Touch the Pre-Op Data on the left side of the screen to
display the preoperative K’s.

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LRI Circle Graphic

A circle graphic is displayed on the bottom of the screen. The circle graphic displays
both the keratometric steep axis (the solid blue line on the graphic) and the axis of the
last LRI cylinder measurement (the dotted purple line on the graphic).

The user can select which measurement is used for the corneal axis; either an aphakic
measurement or the preoperative K’s based on the surgeon’s preference.

To enlarge the graphic and display more detail, double-touch it; see picture below.

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Intraoperative Data Tags

Each measurement taken during a surgery will be displayed in the Measurement field
located on the right of the screen. Each entry displays the following information:
• the time the measurement was performed,
• the type of measurement (Power Calculation, LRI, or Toric),
• the refraction reading (sphere, cylinder, and axis),
• the phakic state of the eye (pseudophakic or aphakic), as well as the intra-
operative data tag in the case of Toric and LRI measurements.

If several measurements of the same type are

performed, the last measurement will display the tag in
black. The earlier measurement will display the tag is in
grey. The last measurement will be the one that is
returned if the user later queries for a measurement in
the ORA SYSTEM* AnalyzOR* Technology using the
data tag.

If an earlier measurement presents a more accurate

value, double-touch the measurement tagged in grey.
The tag will be displayed in black, and the tag previously
displayed in black will change to grey

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After Implant Tag

If the user takes several pseudophakic toric measurements, each of these
measurements will have the “After Toric Implant” data tag.

After LRI – After LRI Enhancement Tag

If the user takes several LRI measurements, each will have the “After LRI” or “LRI
Enhancement” tag.
Entering Measurement Notes
Comments can be entered for any of the measurements displayed on the Measurements
field. These comments can be retrieved for review at any time, either during or after the
surgery.

To enter a comment, first select the desired measurement. Touch the Notes button
located inside the graphic field to open the Notes panel.

Enter new note or edit any existing, then touch the Continue button to save the notes
and return to the previous screen. An asterisk inside the Notes* button indicates that
one or more comments have been created for this surgery. An asterisk will be displayed
next to the measurements that have comments.

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Selecting the Lens Used for a Surgery

The model and the spherical power of the intraocular lens (IOL) to be implanted must me
entered prior to ending the surgery. If the lens model and/or the lens power are not
selected prior to ending the surgery, the ORA SYSTEM* Technology will prompt to
select the lens model and power when ending the surgery.

The Surgery in Progress screen displays the lenses pre-selected for the surgery, see
picture below.

Use dropdown list to select a specific lens and power to take the measurement.

Touch the “Lens” or “Power” dropdowns list to display more options; see picture next
page.

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Search Lens field

Manufacturer field Power

field

Lens Model field

The lens selection contains four fields for information display and input:
1. Search at the top of the screen.
2. The manufacturer selection list on the left of the screen.
3. The lens model number list in the middle of the screen.
4. The available lens power list on the right side of the screen.

Search Lens Field

The Search field allows the user to search for a specific lens model number. Enter a
complete or partial model number into the Model # field and then touch the Search
button. The ORA SYSTEM* Technology will display a list matching the search criteria.

Active Lens List Option

Initially, the lens selection dialog displays only the lenses defined in the surgeon’s active
lens list. The active lens list for a surgeon is configured on the
ORA SYSTEM* AnalyzOR* Technology at the time that the surgeon’s profile is created
and it should contain the lens models used most often in their practice.

To select a lens that is not in the active lens list, uncheck the Active Lens List
checkbox. The lens model number and the manufacturers’ lists will display all of the
manufacturers and lens models.

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Lens Manufacturer Field

The manufacturer selection on the left side of the screen is a filter. The list initially
defaults to All meaning that the lens model number list displays all model numbers
regardless of the manufacturer.

Select a manufacturer from the list to display the lenses available from the selected
manufacturer.

Lens Model and Power Fields

Lens List
Select a lens model from the list. The ORA SYSTEM* Technology will display the
available lens powers for the selected lens.
Other
The manufacturers list, model number list, and power selection list display Other
option; see picture below. Select the Other option if the implanted lens is not
listed.

OK Button
After selecting a lens model and power, touch the OK button, to close the fields
and to populate the Surgery in Progress screen with the “Lens” and “Power”
selected values.

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After selecting Other from any of these lists and touching the OK button, the
ORA SYSTEM* Technology displays a screen where the user can enter the
manufacturer, lens model, and power of the implanted lens; see picture next
page.

After the Unlisted Lens Manufacturer, Model and Power has been filled, the
information will be sent to WaveTec via email and will be evaluated for future
inclusion into the lens catalog.
OK and Add to Active List
If the user selects a lens that is not in their active lens list, touch the OK and Add
to Active List button to add the selected lens to their active lens list.

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Viewing Captured Images

The images captured while taking measurements are available on the ORA SYSTEM*
Cart for review either immediately after the measurement was performed, or at any time
later while viewing post-surgery patient’s data; the images are only available on the cart
for up to 90 days. The Image Viewer feature of the ORA SYSTEM* Cart enables the
surgeon to review the patient’s eye condition, fixation, alignment, etc. either during the
procedure or soon after as desired.

Images can be accessed by touching the Images button displayed on the measurement
screen. The ORA SYSTEM* Technology loads all 40 frames for the selected
measurement, and then displays the Image Viewer screen. Buttons can be used to view
the images in a consecutive sequence until the last frame is displayed, or to stop the
sequence at any time and move forward or backward. Touch a number button to display
the corresponding frame.

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Ending a Surgery
After the patient’s surgery is complete, touch the End Surgery button located on the top
right of the Surgery in Progress screen.

The End Surgery screen will be displayed for 10 seconds before ending the surgery.
While the screen is displayed, the user has the option to end the surgery immediately or
return to the surgery.

However, if the highlighted lenses on the IOL page are different from the displayed lens
model the user will be prompted to select the implanted lens.

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When ending the surgery is confirmed, the ORA SYSTEM* Technology will automatically
initiate data synchronization, upload the patient’s surgical data to the WaveTec Central
Server, and then return to the Scheduled Procedures screen.

Powering Down the Device

From the Scheduled Procedure Screen, touch the Logout button.

The Login screen will be displayed.

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Touch the Turn Off button to switch off the ORA SYSTEM* Technology.

Remove and Store Device Components

1. Disconnect the ORA SYSTEM* Technology and place it into the ORA SYSTEM*
Technology storage case provided.
2. Unplug the device from the AC mains.

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8 - Completed Surgeries and Reports

Viewing Surgical Results – AnalyzOR* Technology

Viewing Measurements - AnalyzOR* Technology
To review measurements taken during patient’s surgery, from the Main screen, select
the Patients/Pre-Op Tab.

Click on the patient name to display the patient information. The Surgical Results are
displayed in the bottom part of the screen.

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Click the link for a measurement to display the stored information. For each
measurement, the screen displays the following information:
• type of measurement,
• time at which the measurement was taken
• rotation
• sphere
• cylinder
• axis value of the measurement
• chosen power
• predicted refraction
• suggested power
• predicted refraction
• quality measure
• eye phakic state
• if the measurement was forced or not

For Toric IOL Positioning measurements, the screen displays the rotation direction
recommended to the surgeon.
Results by Measurement Time
If the measurement time option was selected, the measurements are displayed by time
taken with the earliest measurements displayed first; see picture below.

Results by Measurement Type

If the measurement type option was selected, the measurements are grouped by type;
see picture below. The LRI and Toric IOL Positioning measurements will be grouped
together in their own sections.

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Print Surgical Results

Select the Print Surgical Results link. This will open a printable web page and
select the printer icon for a hard copy of the surgical results.

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Enter Post-Operative Data on the AnalyzOR* Technology

Post-operative data can be entered after the patient’s surgery is complete.
From the Main screen, click the Post-Op tab.
Select Patient Name Link
From the list, click the patient name link. Click the Add Exam button for the right or left
eye depending on the surgery.

Click No Post-Op if the Patient will not be returning for a post op exam. The patient will
not appear in the overdue post-op list.

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Select Add Data Button

From the pre-op list, click the Add Data button located on the patient row.

Post-Op Patient Data Screen

For each eye, the user can select the surgical date and the exam date.

Exam Date

The Exam Date field defaults to the current day, but if the post-op exam information was
entered on a different day, the user can change the Exam Date to the day that the post-
op exam was taken.

Exam List

The Exam List field displays the dates of prior post-op exams. Select one date to edit
the previous post-op exams.

Manifest Refraction – Visual Acuity – Near Visual Acuity – Keratometry

Data

The user has the option to enter manifest refraction, keratometry, or visual acuity data.
Data must be entered into each required field in order to save the post-op exam. The
software enforces the completeness of each data set.

For Manifest Refraction, the sphere, cylinder, and axis are required.

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For Visual Acuity, the UCVA and the BCVA are required:
Visual Acuity:
• Snellen in feet
• Snellen in meters
• Decimal
• LogMar

Near Visual Acuity:

• Snellen in feet
• Snellen in meters
• Jaegar
• Decimal
• LogMar

For Keratometry, the flat K, the steep K, and the steep axis can be entered, but are not
required.
Comments related to the post-op exam for each eye can be entered.
CAUTION:

Events that reasonably suggest the ORA SYSTEM* Technology may have caused or
contributed to serious injury or death, including events occurring as a result of failure of
the medical device to meet its performance specifications or otherwise perform as
intended, must be reported to Alcon Laboratories, Inc.

For product complaint or adverse event reporting in the United States:

800-757-9780
Alcon.com (contact us).
Outside the United States, please contact your local Alcon office or distributor.

Overdue Post-Op Tab - AnalyzOR* Technology

The Overdue Post-Op tab can be used to access patient information. This tab displays
patients that do not have postoperative data entered into the ORA SYSTEM*
AnalyzOR*.

If postoperative manifest refraction data is not entered for the patient, or if the manifest
refraction data is less than 10 days after surgery, the patient will be displayed under the
tab.

NOTE: A patient that does not have at least one good quality measurement with ORA
during surgery will not display under the Overdue Post-Op tab.

Select the “Print All” button to print the list of patients (by using the printer icon) or to
populate a more detailed Excel spreadsheet with the list of patients (by using the Excel
icon). The user may also select individual patients by clicking on checkboxes to the left
of the patient names, and only print those selected patients, in the same way.

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Viewing Completed Surgeries on the ORA SYSTEM* Cart

A surgery can be viewed on the ORA SYSTEM* Cart after it is completed.

From the Scheduled Procedures screen, touch the Today button, and then select
Completed from the drop-down. Select the Search option (see picture below) and ten
touch the Search button. The following screen will be displayed.

Double touch a patient’s name to display the Patient Information screen; see picture
next page.

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Touch the View Surgery button, the ORA SYSTEM* Technology will display the View
Surgery screen; see picture below.

Since the surgery is completed, the Take Measurement and End Surgery buttons are
disabled.

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Images of the measurement can be displayed by touching the Images button. See
Viewing Captured Images page 145.

To exit the View Surgery screen, touch the left arrow t located above the Pre-Op Data
field on the left part of the screen. Touch the Patient icon to return to the Completed
Surgeries screen.

Surgeries Reports
The ORA SYSTEM* AnalyzOR* Technology allows the user to report on patient’s pre,
post, and intraoperative data. From the website Main screen, click the Reports tab. The
following screen is displayed:

The following reports are available for selection by clicking on the link:
• Outcome Analysis Reports
• Astigmatism Management Reports
• Define Patient Groups

Two types of reports are available in ORA SYSTEM* AnalyzOR* Technology:

• Predefined Reports
• Custom Reports.

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Predefined Reports
Predefined reports are preconfigured with ready to use filters to generate a set of reports
providing specific information.

Outcome Analysis Report

From the Reports screen, click the Outcome Analysis Report link. The screen displays
the following options:
• Outcome Analysis – Standard
• Outcome Analysis – Post RK
• Outcome Analysis – Post Myopic LASIK
• Outcome Analysis – Post Hyperopic LASIK

From the Outcome Analysis Report List screen, click the desired link. All fields
included inside a predefined Outcome Analysis report are identical.

The following screen is displayed:

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The Name for the Report and the Description fields are pre-populated and can be edited.
Surgery Completion Date Field
This field can be specified by date with a start and end date, or by periods of time:
• Last 3 months
• Last 6 months
• Last 9 months
• Last 1 year
• Last 15 months
• Last 18 months

If no date field is selected the reports will include all ORA data for the selected
surgeon(s). The global data and graphics are only from the last 12 months from the
current date.
Practice Field
This field displays the practice to which the user has selected during the login.

NOTE: Only the practices and surgeons assigned to the currently logged in user will be
displayed.

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To add another practice, select it from the list displayed in the available practice, and
then click the Add button. If multiple practices were selected and only one will be used
to generate the report, select the practice to remove, and then click the Remove button.

To generate a report for all surgeons from the selected practice(s), click the Select All
checkbox. Individual or multiple surgeons can be selected by checking their name from
the list.
IOL Used Field
This field is used to select lenses used during surgeries. If no lenses are specified, all
lenses will be included.

Select a lens Manufacturer; the available lens models will be displayed.

• To select all models to assign to the report, click the Add All >> button.
• To select individual model to assign to the report, select the lens from the list,
and the click the Add > button.
• To remove all models assigned to the report, click the << Remove All button.
• To remove individual model assigned to the report, select the lens from the list,
and the click the < Remove button.
Femtosecond Laser Surgeries Field
• Select Exclude Femtosecond Laser Surgeries, to exclude these surgeries
from the report.
• Select Include Femtosecond Laser Surgeries, to include these surgeries to the
report. Other types of surgeries will be included.
• Select Only Femtosecond Laser Surgeries, to include only these surgeries to
the report. Other types of surgeries will be excluded.
Femtosecond Laser Options Field
If Include or Only Femtosecond Laser Surgeries have been selected in the Femtosecond
Laser Surgeries, click the checkbox (es) to select specific Laser options.

Generate Outcome Analysis Report

After entering the information, click the Generate Outcome Analysis button.

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Astigmatism Management Report

From the Reports screen, click the Astigmatism Management Report link. The screen
displays the following options:
• Astigmatism Management – Toric and LRI
• Astigmatism Management – Toric
• Astigmatism Management – LRI

From the Astigmatism Management Report List screen, click the desired link. All
fields included inside a predefined Astigmatism Analysis report are identical to the
Outcome Analysis Report. See Outcome Analysis Report page 158.

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New Astig Mgt Report

From the Reports screen, click the Astigmatism Management Report link.

From the Astigmatism Management Report List screen, click the Create a New
Custom Astigmatism Management Report link. The following screen is displayed:

Select the appropriate options to be used to generate the new Astigmatism Analysis
Report.

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Define Patient Group Report

NOTE: This option is used to define a new custom report template. It is
recommended to use it under Alcon Laboratories Inc. personnel’s guidance.

From the Reports screen, click the Define Patient Group link; the following screen is
displayed:

Custom Patient Group Report

Click this option; the following screens are examples of Patient Groups reports available
to the currently logged in user. Custom Patient Groups are specific to a user and/or
a practice.

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Graphical Reports
After clicking the Generate Outcome Analysis button or Generate
Astigmatism Management Report button, the ORA SYSTEM* Technology
displays the report according to the user selected criteria. The first column
represents the data for the selected surgeon(s) and the second column
represents the global Alcon WaveTec data.
Outcomes Analysis Reports
The following are examples only.

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Astigmatism Management Reports

The following are examples only.

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Print Button
Click this button; the Print Screen window is displayed. Click the printer button, located
on the top right of the window, to print the report using the practice printer.

Save as Bitmap Button

Click this button. The ORA SYSTEM* Technology prompts to Open, or Save the report
in Bitmap format to be open with a graphic viewer or editor software.

Export All Data to Excel

Click this button. The ORA SYSTEM* Technology prompts to Open, or Save the report
in Excel spreadsheet format. The excel file provides preop, intra op and post op data for
each patient included in the report.

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Create a New Custom Report

NOTE: This option is used to define a new custom report template. It is
recommended to use it under Alcon Laboratories Inc. personnel’s guidance.

New Outcome Analysis Report

From the Reports screen, click the Outcome Analysis Report link.

From the Outcome Analysis Report List screen, click the Create a New Custom
Outcome Analysis Report link. The following screen is displayed:

Select the appropriate options to be used to generate the new Outcome Analysis Report.

NOTE: Report Name and Description are required fields.

Generate Outcome Analysis Report

Click this button to generate the report.

Save

Click this button to save the new named report, and return to the Custom report screen.
Only custom data can be saved.

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Save and Close Report

Click this button to save and close the new named report. A report can be generated
later. Only custom data can be saved.
New Custom Patient Group
NOTE: This option is used to define a new custom patient group by selecting
the preferred filter options. It is recommended to use it under Alcon
Laboratories Inc. personnel’s guidance.

From the Reports screen, click the Define Patient Group link.

From the Patient Group List screen, click the Create Custom Patient Group link. The
following screen is displayed:

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Case Study Report

The ORA SYSTEM* AnalyzOR* Technology allows the user to create a Case Study
report.

From the Patient /Pre-Op, Surgeries, Post Op, and/or Overdue Post Op Tab, click on
a patient’s name to display the Patient Information screen.

The Case Study Report link is located at the bottom of the screen.

Click the Case Study Report link. The ORA SYSTEM* Technology displays the
Case Study Report for the selected patient.

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The first plot, labeled “From Refraction” displays all of the refraction readings for the
patient, preop, intraop, and postop. The second plot displays the pre-and post op
kertometric data, if data has been entered.

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Print Button
Click this button; the Print Screen window is displayed. Click the printer button, located
on the top right of the window, to print the report using the practice printer.

Save as Bitmap Button

Click this button. The ORA SYSTEM* Technology prompts to Open, or Save the report
in Bitmap format to be open with a graphic viewer or editor software.

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 9 – Maintenance and Service

9 - Maintenance and Service

This section of the manual is designed to inform the operator of basic care and
maintenance of the instrument. If a problem occurs on the instrument, contact
Alcon Technical Support or your local Alcon representative and give details of the
breakdown circumstances and effects.

For optimum performance, it is the user’s responsibility to schedule preventive

maintenance service on the system and its accessories at least one time each
year. Alcon’s Field Service Engineers are trained and equipped to provide the
highest quality of workmanship.

Routine Maintenance
Routine maintenance is required for the Cart LCD/display/monitor, the
Aberrometer windows, Focus camera LED’s.

CAUTIONS:

• Any maintenance or service other than routine maintenance, performed

by personnel other than those qualified by Alcon Laboratories, Inc., voids
any existing warranty. Possession of this manual or other maintenance or
service information does not imply qualified training. Service can only be
performed by Alcon Laboratories Inc. qualified personnel.

• Alcohol-based cleaners may damage the LCD transparent window

surface of the display screen. Avoid products containing ammonia. Do not
spray the cleaner directly onto the screen. Do not clean the display
screen immediately before starting the system.

ELECTRICAL CAUTION:

• Main AC line must be unplugged from ORA SYSTEM* Technology prior

to any service to the unit.

ORA SYSTEM* Technology Verification

ORA SYSTEM* Technology verification must be verified by using the Field
Verification Tool at a minimum of once every 24 hours. See ORA SYSTEM*
Technology Verification page 82.

Visual Inspection
Perform a visual inspection of the ORA SYSTEM* Technology periodically, check
for loose or damaged parts, perform a system verification and contact Alcon
Technical Support or your local Alcon representative and give details of the
breakdown circumstances and effects.
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Aberrometer Cleaning
The focus camera and focus LED’s are used to determine whether the
aberrometer is focused to the apex of the cornea. If the windows that cover the
focus camera or the LED’s get dirty from BSS or other debris, the software is
unable to determine focus. This causes the focus ball to either bounce or, in
extreme cases, peg to the top of the screen.
Routinely clean the optical windows covering the focus camera and LED’s to prevent focus
issues.
Central Focus Camera & LED Windows
Using a lint free cloth or low lint cloth soaked in Isopropyl alcohol (IPA), gently
wipe the window surfaces. After wiping the surface, the surface should be blown
off with clean dry air (canned air). Repeat as necessary to remove all dirt and
streaks.
NOTE: Do not wipe optical surfaces with dry cloth or wipes.

Focus Camera Central

Window Window

LED Window
(1 of 4)

Contact Customer Support if dirt or debris appears on any of the internal optical
surfaces.
Aberrometer Cover
As required, clean the cover and other outer surfaces using standard non-alcohol
based cleaning materials to keep it free of debris.
Autoclavable Cover
As required clean the autoclavable cover according to the directions for use,
allowing the cover to cool before using.
Microscope Repair affecting the Aberrometer
If the microscope is removed or repaired, notify Alcon Laboratories Inc. service
personnel to check alignment of the Aberrometer to the microscope.

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Cart Cleaning
As required, clean the covers and other outside surfaces of the cart, using standard non-
alcohol based cleaning materials to keep it free of debris.

Cleaning Display screens

The performance of the display screen is not affected by fingerprints or dust, but can be
cleaned.
As required, clean the Display screens using a standard glass cleaner that is free of
alcohol or ammonia, apply the glass cleaner to a soft lint free or low lint cloth and wipe
the screen to remove finger prints or dust.

NOTE: Always spray the glass cleaner on a cloth or towel and then clean the display
screen. Glass cleaner sprayed directly on the monitor cold possible leak inside and cause
damage

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Troubleshooting
Before Calling for Service
• Refer to the troubleshooting section at the end of this chapter. If unable to
clear the error or malfunction, call Alcon Customer Service.

NOTE: Before calling for Service, please make a note of any error messages displayed.

After completing the above, contact Alcon Customer Service for assistance.

Telephone
From U.S. and Canada locations (800) 832-7827
Fax
From U.S. and Canada locations 1-949-505-6614
Email
Use the email option provided with the software. See Email page 49.

Stay close to the ORA SYSTEM* Technology and be prepared to explain the
nature of the problem.

Provide:
• Your name
• Account name
• Telephone number with area code

Describe:
• Error messages
• Operation in process
• Problem being experienced

CAUTION:

Only qualified Alcon Laboratories Inc. service personnel should access the
interior of the device, there are no user-serviceable parts inside.

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Error Messages

Optical Head is offline

Causes Solutions
The interface cable is not Connect the interface cable to the aberrometer. Wait for a
connected to the screen pop-up that says “ORA has detected an optical head
aberrometer. reconnect. A re-initialization process will be performed”. A
status bar will appear and when the pop-up disappears the
error message should disappear.
The interface cable is not Connect the interface cable to the cart. Wait for a screen
connected to the cart pop-up that says “ORA has detected an optical head
reconnect. A re-initialization process will be performed”. A
status bar will appear and when the pop-up disappears the
error message should disappear.
The interface cable is Power down the ORA SYSTEM* Technology. Disconnect
improperly seated and reconnect the interface cable from the cart and
aberrometer. Turn the power back on.
If the problem persists, contact Alcon Customer Service.

Laser safety circuit has tripped

Stray Light Into the Reboot the ORA SYSTEM* Technology with the microscope
Aberrometer light turned off.

Poor connection Power down the ORA SYSTEM* Technology. Disconnect

and reconnect the interface cable from the cart and
aberrometer. Turn the power back on.

If the problem persists, contact Alcon Customer service.

Checksum Error
Optical head calibration data Confirm optical head is connected and reboot the ORA
mismatch SYSTEM* Technology to allow the calibration data to restore
If the problem persists, contact Alcon Customer service.

Spatial aperture Failure

Poor connection Power down the ORA SYSTEM* Technology. Disconnect
and reconnect the interface cable from the cart and
aberrometer. Turn the power back on.
If the problem persists, contact Alcon Customer Service.

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 9 – Maintenance and Service

ORA has encountered a problem while communicating with your

optical head
Communication issues ORA will reinitialize itself. There is no action required by
between the ORA SYSTEM* the user.
components
If the problem persists, contact Alcon Customer Service.

Check Focus LEDs

One of the focus LEDs is Ensure there is nothing blocking any of the four LEDs (i.e.
obscured sterile drape)
ORA SYSTEM* Technology Ensure the surgeon is focused on the corneal apex prior to
is not focused on the eye capturing an image
ORA SYSTEM* Technology Ensure the sputnik is in the center of the target
is not centered on the pupil
Wrong objective lens is Check to make sure the 200mm lens is installed on the
installed on the microscope microscope
If the problem persists, contact Alcon Customer Service.

Laser Initialization Failed. Reboot Machine

Communication error Power down the ORA SYSTEM* Technology. Disconnect
between the optical head and reconnect the interface cable from the cart and
and aberrometer. aberrometer. Turn the power back on.
If the problem persists, contact Alcon Customer Service.

Network Messages
Connected
The cart is connected to the network and operating normally

Server Unavailable

Network Firewall is Contact your network administrator to ensure ORA

preventing communication to SYSTEM* Technology has access to the internet.
the internet.

WaveTec server is From another computer, use your internet browser to

unavailable. navigate to https://home.wavetecvision.com. If
unsuccessful, contact your local Alcon customer service
immediately.
If the problem persists, contact Alcon Customer service.

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 9 – Maintenance and Service

Network Unavailable
Network cable is Check to make sure a Cat5 cable with network connectivity
disconnected is connected to the LAN port on the back of the Cart.

Internal Network is down Contact your network administrator to verify the status
of the network.

The ORA SYSTEM* It can take several minutes to establish a network

Technology is establishing connection.
a connection
Wait five minutes to see if network connectivity is
established.

Press the circular icon with two arrows in the

upper right-hand corner to check the connection

If the problem persists, contact Alcon Customer

Service.

Unable to Log In
Login icon grayed out
Network cable is Check to make sure a Cat5 cable with network connectivity
disconnected is connected to the LAN port in the the back of the Cart

Internal Network is down Contact your network administrator to verify the status of the
network.
The ORA SYSTEM* It can take several minutes to establish a network
Technology is establishing a connection.
connection Wait five minutes to see if network connectivity is
established.
Press the circular icon with two arrows in the upper
right hand corner to check the connection
If the problem persists, contact your IT specialist to test the
local network or contact Alcon Customer Service.
New user not registered Contact Alcon Customer Service

Incorrect password
Contact Alcon Customer Service.
Incorrect login ID Contact Alcon Customer Service.

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 9 – Maintenance and Service

Symptoms

Sputnik is in the Lower Left Corner of the Display during Image

Capture
No image on cameras Ensure the ORA SYSTEM* Technology is centered
and focused on a measurable subject (i.e. human
eye)
No SLED power Reboot the ORA SYSTEM* Technology

If the problem persists, contact Alcon Customer

service.

Focus Ball frozen at the top of the screen

One of the focus LEDs is obscured Ensure there is nothing blocking any of the four LEDs
(i.e. sterile drape)
ORA SYSTEM* Technology is not Ensure the surgeon is focused on the corneal apex
focused on the eye prior to capturing an image
ORA SYSTEM* Technology is not Ensure the sputnik is in the center of the target
centered on the pupil
Wrong objective lens is installed on Check to make sure the 200mm lens is installed on
the microscope the microscope
If the problem persists, contact Alcon Customer
service.
Cornea is dry Moisten the cornea with BSS

Touchscreen Does Not Line Up with Icons

The touchscreen is out of alignment. Touch the tools icon.
Touch the Hardware tab.
Touch the Calibrate Touch Screen button. Follow the
on screen instructions, touching the screen where
instructed.
Touch the green check mark to save the new
configuration.
If the problem persists, contact Alcon Customer
service.

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 9 – Maintenance and Service

Reticle misalignment or out of focus with the microscope or

ORA SYSTEM* misalignment or out of focus with the microscope
Wrong aberrometer installed on the If multiple ORA SYSTEM* Technology s are installed
microscope. in one surgical center the aberrometers are typically
labeled with numbers identifying with which
microscope they are associated. Ensure the number
on the aberrometer matches the number on the
microscope.
If the problem persists, contact Alcon Customer
service.

Touchscreen Not Centered

The touchscreen is out of alignment. Locate the menu button on the right side of the
screen.
Using the direction buttons, highlight the icon shown
below and press Enter. The display will automatically
center itself.

Screen is Blank
The touchscreen is not powered on. (VeirfEYE+ only) On the right side of the touchscreen
locate the “Power On” button. Press the button, and
observe if an image is displayed on the screen.
If no image appears, power down the cart, then
power up the cart, and observe the middle of the
screen.
A blue box should display “no signal detected.”
If this message appears, the touch screen is
operating normally.
If no further images are visible on the screen after
this message disappears, contact Alcon Customer
Service.

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 9 – Maintenance and Service

ORA SYSTEM* Technology Does Not Power On

Power switch may be turned off. Locate the power switch and hold it down for 3
seconds. Note if the switch turns green.
Circuit breaker turned off If the switch is dark, locate the circuit breaker at
bottom rear of the cart. Cycle the breaker down, then
up, and hold the power switch down for 3 seconds to
see if the light in the power switch turns green.
Power outlet is faulty If the switch is still dark, plug the cart into a different
AC outlet. If the cart still does not power up, contact
Alcon Customer Service.

Out of Focus
The microscope is focused on the Remove the aberrometer from the microscope.
apex of the cornea. Locate the focal length on the objective lens of the
When in alignment the four microscope, it should be 200mm.
alignment lights appear extremely If it is not, locate the 200mm lens normally stored in
out of focus. the Pelican case where the aberrometer is stored.

Shadows in Surgeon’s Oculars

When the aberrometer is mounted When looking through the surgeon’s oculars, if an
on the microscope, shadows may be obstruction is observed such as a shadow, remove
seen if the microscope is zoomed out the aberrometer from the microscope and observe if
too far; this is normal. the shadow disappears.
If it disappears, remount the aberrometer and
ensure it is mounted all the way forward.
If the shadow reappears, zoom in until the shadow
disappears.
If the shadow disappears, determine where it
disappears.
Is the view normally where the doctor sets the zoom
when performing surgery? If yes, then the ORA
SYSTEM* Technology is performing correctly.

Multiple systems in the surgery center

In the case of a multiple systems, the Make sure the correct aberrometer is paired with the
aberrometers are identified by correct microscope.
numbering the microscope to the
aberrometer.

Fails Verification
Make sure the microscope head is level to the floor.
Microscope head is not level
Rerun the test.

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 9 – Maintenance and Service

Remove the Verification Tool, and make sure the

The window on the aberrometer is artificial eye on the tool is clean. Remove the
dirty, aberrometer and turn it over. Clean the window using
an alcohol swab. Rerun the test.
Mount the aberrometer on the microscope and
mount the tool.
The verification tool is not installed Make sure that the pegs on the tool are inserted into
properly on the Aberrometer. the holes on the aberrometer, and the two side
latches are completely in the mounting holes. Rerun
the test.
Power down the cart, and then unplug the signal
cable from the aberrometer.
ORA SYSTEM* Technology needs Wait 10 seconds, and then plug in the aberrometer.
to reboot. Power up the cart and rerun the test.
If the test passes, the ORA SYSTEM* Technology is
ready for use.
If the test keeps failing, contact Alcon Customer
The problem persists.
Service.
Make sure the serial number on the FVT tool
Incorrect verification tool used
matches the serial number of the aberrometer.

• The ORA SYSTEM* Technology requires a verification test every 24 hours.

• The ORA SYSTEM* Technology will request that a verification test be performed
before the ORA SYSTEM* Technology is allowed to continue to operate.
• The verification test ensures the aberrometer is operating within normal parameters.

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 10 – Appendix

10 - Appendix
Measurement Specifications
Capabilities Specification
Measurement Range -5D to +20D

Accuracy (sphere) ±0.25D

Repeatability (sphere) ±0.13D

Accuracy (cylinder) ±0.2D from 0.5-5.0D

Accuracy (cylinder axis) ±4” if >0.5D (axis less relevant <0.5D)

Capture time <2 sec average

Specifications
General Specifications
Main voltage Configurable 100-240 VAC, 50/60Hz
Current draw (maximum) 5 A @ 100V

Power cord Length 15 ft (4.6 m) (Japan 7.9 ft/2.4 m)

Optical laser power to the cornea < 445 microwatts

Console and Aberromter Dimensions

Intraoperative Wavefront Approximately 14.25” L x 5.25”W x 3”H (36 x 13 x
Aberrometer Dimensions (LxWxH) 7.6 cm)

VerifEye*+ Cart Dimensions Approximately 28” L x 28”W x 64”H (71 x 71 x 163

(LxWxH) cm)
VerifEye*+ Cart Weight Approximately 100 lbs. (46 kg)

Weight of Intraoperative Wavefront Approximately 7 lbs. (3.2 kg)

Aberrometer

VerifEye + 2.0 Cart Dimensions Approximately 30”L x 32”W x 67”H (76 x 81 x 170
(LxWxH) cm)

VerifEye + 2.0 Cart Weight Approximately 130 lbs. (59 kg)

Power cord 15 ft (4.6 m) (Japan 7.9 ft/2.4 m)

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 10 – Appendix

Environmental Limitations - Operating VerifEye*+ Cart

Ambient temperature operating 50° to 86° F (10° C to 30° C)
range
Non-condensing relative humidity 20% to 80%.
Altitude requirements From 500 feet (150 m) below sea level to 10,000
feet (3000 m) above sea level
Environmental Limitations - Operating VerifEye*+ 2.0 Cart
Ambient temperature operating 50° to 95° F (10° C to 35° C)
range
Non-condensing relative humidity 10% to 90%.

Altitude requirements From 500 feet (150 m) below sea level to 10,000
feet (3000 m) above sea level

Refraction Laser Specifications

Wavelength 780 nm

ORA SYSTEM* Intraoperative

Wavefront Aberrometer laser axis co- To within 1 mm.
alignment to microscope ocular axes
Between 0.3 mm and 1.0 mm diameter, measured at
Optical beam diameter at the cornea
the 1/e^2 points

Class 1

LED Alignment Laser Specifications

Wavelength 880 nm

Quantity 4 ea.

Class 1

User Interface Specifications

17-inch (43 cm) touchscreen
User interface
1024 x 768 resolution

Input device On-screen keyboard

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 10 – Appendix

Aberrometer Mechanical Dimensions

NOTE: All dimensions are approximations are subject to change without notice.

ORA SYSTEM* Aberrometer Mechanical Dimensions

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 10 – Appendix

ORA SYSTEM* with VerifEye* + Cart Dimensions

NOTE: All dimensions are approximate and subject to change without notice.

ORA SYSTEM* Technology MSS Cart Mechanical Dimensions

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 10 – Appendix

ORA SYSTEM* with VerifEye* + 2.0 Cart Dimensions

NOTE: All dimensions are approximate and subject to change without notice.

ORA SYSTEM* Technology MSS 2.0 Cart Mechanical Dimensions

90086 Rev. B ï Issued Issued June 13, 2018 188

11- Index

Compatibility .................................................. 29
A
Complications ................................................ 12
Abbreviations ................................................. 14 Components................................................... 24
Aberrometer .................................................. 24 Configuration
Label Locations ................................................. 17 ORA Cart ...........................................................48
AC Power Main Switch .................................. 26 Connected ................................................... 178
Acronyms ...................................................... 14 Contraindications ........................................... 10
Active Lens List Option ................................ 142 Correct Alignment ........................................ 114
Add a Lens Create a New Custom Report ....................... 167
ORA cart ......................................................... 93 Create a New Patient
Add Active Lens List ...................................... 68 ORA cart ........................................................ 89
Add Lens to Lens List .................................. 123 Creating a New Patient
Additional Search Criteria .............................. 72 AnalyzOR...........................................................59
After Implant Tag ......................................... 140 Creating a New User ................................ 45, 46
After LRI – After LRI Enhancement Tag ....... 140 Customer Setup ............................................. 41
After Toric Implant with VerifEye .................. 130
D
Alignment
Correct ..........................................................114 Define Patient Group Report ........................ 163
Incorrect ........................................................113 Definitions ...................................................... 14
Alignment .................................................... 112 Device Compatibility ....................................... 29
All and Custom Patient Group Report .......... 163 Device Safety Features .................................. 31
AnalyzOR Configuration ................................ 44 Device Switches ............................................. 26
AnalyzOR Main Screen.................................. 53 Do not show this message again .................. 120
Aphakic ....................................................... 134
Aphakic Measurement ................................. 110 E
Aphakic Toric results prior to spherical power Editing Patient Information
selection .................................................. 125 AnalyzOR...........................................................69
Aphakic Toric screen after spherical power and Electrical Hazards .......................................... 33
cylinder power have been selected .......... 126 Electrical Requirement ................................... 40
Astigmatism Management Report ................ 161 Email...................................................... 49, 176
Astigmatism Management Reports .............. 165 EMC Requirements ........................................ 34
Axial Length..............................................65, 97 Ending a Surgery ......................................... 146
Axis Value to Display ..................................... 51 Enter Post-Operative Data
B AnalyzOR......................................................... 152
Environmental Requirement ........................... 41
Basic Operating Steps Error Messages............................................ 177
Operating Instructions ...................................... 80 Exam Date ................................................... 153
Batch Print Exam List ..................................................... 153
AnalyzOR .......................................................... 55 Excel
Before Acquiring Measurement .................... 104 Export all data .............................................. 166
Before Calling for Service ............................ 176 Excel File
Begin Surgery .............................................. 106 Exporting patient information ...........................76
C Export All Data to Excel ................................ 166
Exporting Patient Information to an Excel File . 76
Cancel Button .............................................. 112 Eye ................................................................ 94
Capture Button ..................................... 112, 115 Eye Data Field ............................................... 62
Cart
F
Label Locations ................................................. 18
Case Study Report ...................................... 170 Facility ........................................................... 62
Cautions ........................................................ 13 Fax .............................................................. 176
Check Focus LEDs ...................................... 178 Femto ............................................................ 95
Circle Graphic Femtosecond Laser........................................ 64
LRI .................................................................. 138 Femtosecond Laser Options Field ................ 160
Co-Managed Field Femtosecond Laser Surgeries Field ............. 160
ORA cart ......................................................... 91 Field Verification Tool ..................................... 20
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11- Index

Flat K............................................................. 97 Lens List Tab

Focal Length.................................................. 29 ORA cart............................................................92
Focus Ball frozen at the top of the screen .... 180 Lens Manufacturer ......................................... 65
Lens Manufacturer Field ............................... 142
G
Lens Model .................................................... 66
General Safety Precautions ........................... 32 Lens Model Field .......................................... 143
Generate Outcome Analysis Report ...... 160, 167 Lens Opacity .................................................. 29
Gold Bar ...................................................... 122 Lens Used for a Surgery............................... 141
Graphical Reports ........................................ 164 Log ................................................................ 48
Login icon grayed out ................................... 179
H Login to the ORA System ............................... 81
Has Ocular Disease ....................................... 96 Login to the ORA System AnalyzOR .............. 52
Long Eyes
I Power calculation ............................................ 124
Icons LRI Circle Graphic ........................................ 138
ORA cart ........................................................... 86 LRI Measurement with VerifEye ................... 133
Ignore Caution ............................................. 120 LRI Measurement without VerifEye............... 136
Image Acquisition ........................................ 116 M
Images
Viewing captured............................................ 145 Main Screen
Incorrect Alignment ...................................... 113 ORA cart............................................................85
Incorrect login ID ......................................... 179 Manifest Refraction ...................................... 153
Incorrect password ...................................... 179 Manifest Refraction Data ................................ 68
Initial Setup.................................................... 41 Measurement
Intended Use ................................................. 10 Aphakic ......................................................... 110
International Symbol Notation / Definitions ..... 21 Phakic ........................................................... 110
Intraoperative Data Tags ............................. 139 Power calculation ............................................ 121
Intraoperative Refraction Readings ................ 29 Pseudophakic .............................................. 110
Introduction Measurement Caution for Aphakic Measurement
ORA System AnalyzOR ...................................... 52 SE ............................................................ 119
IOL Power (D)................................................ 66 Measurement Cautions ................................ 118
IOL Power Calc. Formula ............................... 66 Measurement Notes ..................................... 140
IOL Used Field............................................. 160 Measurements Field ....................................... 96
Mechanical Dimensions................................ 186
K Monitor Power Switch..................................... 26
Keratometry ................................................... 97 Mounting ........................................................ 29
Keratometry (K) Type..................................... 65 Multiple ORA Systems in the surgery center . 182
Keratometry Data......................................... 153 N
Keratometry option – Phaco Incision Axis .... 127
Keratometry option – User-Defined Values .. 128 Near Visual Acuity ........................................ 153
Keratometry Types ........................................ 67 Near Visual Acuity:..................................... 154
Network Messages....................................... 178
L Network Unavailable .................................... 179
Label New Astigmatism Management Report ......... 162
Aberrometer..................................................... 17 New Custom Patient Group .......................... 168
Cart .................................................................. 18 New Outcome Analysis Report ..................... 167
Labels ......................................................15, 17 New Patient
Laser Initialization Failed. Reboot Machine .. 178 create from ORA cart.........................................89
Laser safety circuit has tripped..................... 177 New user not registered ............................... 179
LCD Touchscreen Display ............................. 25 No Bar ......................................................... 122
LED Alignment Laser Specifications ........ 185 Non-ORA System Surgery.............................. 64
Lens Notes ............................................................. 13
Add lens ......................................................... 123 Notes Tab
Lens List ...................................................... 143 ORA cart............................................................92
Lens List Field
AnalyzOR........................................................ 68
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11- Index

O Power Field .................................................. 143

Power up the Device ...................................... 81
Ocular Disease .............................................. 64 Powering Down the Device........................... 147
Ocular Reticle Practice Field ............................................... 159
Using .............................................................. 107 Pred. Refr. (D)................................................ 66
Operator’s Manual ......................................... 12 Predefined Reports ...................................... 158
Optical Head is offline .................................. 177 Pre-Op Data................................................... 51
Options Pre-Operative Data Field
configuration ................................................... 50 AnalyzOR...........................................................61
ORA Cart Configuration ................................. 48 Preview Acquisition Screen .......................... 111
ORA has encountered a problem while Primary Search Options ................................. 71
communicating with your optical head ...... 178 Print All Patients
ORA System.................................................. 23 AnalyzOR...........................................................75
ORA System AnalyzOR
Print Button .......................................... 166, 172
Introduction ..................................................... 52
Printing a Patient List ..................................... 74
ORA System with VerifEye Preview ............. 111
AnalyzOR...........................................................74
Orientation ..................................................... 95
Printing Selected Patients
Other ........................................................... 143
AnalyzOR...........................................................74
Others ........................................................... 68
Procedure
Out of focus ................................................. 181
Perform........................................................... 109
Out of Focus ................................................ 182
Outcome Analysis Report ............................ 158 Procedures Field
Outcomes Analysis Reports ......................... 164 ORA cart............................................................87
Overdue Post-Op Screen Protective Clothing ......................................... 33
AnalyzOR .......................................................... 57 Protective Eyewear ........................................ 33
Overdue Post-Op Tab Protective Housing ......................................... 26
AnalyzOR ........................................................ 154 Pseudophakic .............................................. 135
Pseudophakic Measurement ........................ 110
P Pseudophakic Toric Results Screen – Counter-
Clockwise Recommendation..................... 131
Patient Information Pseudophakic Toric Results Screen – No
Editing .............................................................. 69 Recommendation ..................................... 132
Patient Information Field Pseudophakic Toric Results Screen without
AnalyzOR .......................................................... 60 VerifEye ................................................... 131
Patient Information Tab Pupil Size ....................................................... 29
ORA cart ........................................................... 91 Push Button Power Switch ............................. 26
Patient List
Print ................................................................. 74 R
Patient Pre-Op Screen Red Images ................................................. 117
AnalyzOR .......................................................... 54 Refraction Laser Specifications ................ 185
Patients Removal......................................................... 43
Search AnalyzOR ......................................... 71, 77 Remove and Store Device Components ....... 148
Performance Capabilities ............................... 29 Repeat Button .............................................. 119
Performing the Procedure ............................ 109 Report
Peripheral Corneal Thickness ........................ 68 Astigmatism Management............................... 161
Phaco Incision Axis...................................... 127 Case Study ...................................................... 170
Phakic Measurement ................................... 110 Create a new custom....................................... 167
Platinum Bar ................................................ 122 Define Patient Group....................................... 163
Post Op Screen Outcome analysis ............................................ 158
AnalyzOR .......................................................... 56
Reports
Post-Op Patient Data Screen Astigmatism Management .......................... 165
AnalyzOR......................................................153 Graphical......................................................... 164
Post-Refractive .............................................. 62
Outcomes analysis ...................................... 164
ORA cart ......................................................... 95
Predefined ...................................................... 158
Potential Complications ................................. 12
surgeries ......................................................... 157
Power Calculation for Long Eyes ................. 124
Power Calculation Measurement.................. 121 Reports Screen
AnalyzOR..................................................... 57, 58
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11- Index

Required Data Field Surgeries Reports ........................................ 157

AnalyzOR........................................................ 65 Surgeries Screen
Requirement AnalyzOR...........................................................55
Electrical ........................................................... 40 Surgery
Environmental .................................................. 41 Ending............................................................. 146
Requirements ................................................ 40 Surgery Code ................................................. 62
Results .......................................................... 29 ORA cart......................................................... 94
Results by Measurement Time..................... 150 Surgery Completion Date Field ..................... 159
Results by Measurement Type.............. 150, 151 Surgery Date .................................................. 62
Reticle misalignment .................................... 181 Surgery Field
Routine Maintenance ................................... 173 ORA cart............................................................94
Surgical Results
S
AnalyzOR...........................................................55
Safety ............................................................ 30 Symbol........................................................... 21
Save as Bitmap Button ......................... 166, 172 Symptoms .................................................... 180
Screen is Blank............................................ 181 Synch Interval ................................................ 51
Search System
starting ............................................................. 73 Configuration .................................................. 48
Search – All ................................................... 72 System Does Not Power On ......................... 182
Search – Follow Up ....................................... 72 System Settings ............................................. 48
Search - Post-Op ........................................... 72 System Verification ................................ 82, 173
Search - Show Inactive Patients..................... 72
T
Search - Surgeries ......................................... 72
Search Field Tag
ORA cart ........................................................... 88 after implant ................................................... 140
Search Lens Field ........................................ 142 after LRI .......................................................... 140
Searching for Patients Tags
AnalyzOR .................................................... 71, 77 Intraoperative data ......................................... 139
Select a Patient Target Refr. .................................................... 97
ORA cart ......................................................... 102 Target Refraction ........................................... 65
Select Add Data Button................................ 153 Telephone .................................................... 176
Select Patient Name Link ............................. 152 Toric
Select Practice, if required lens selection ............................................... 128
ORA cart ........................................................... 84 Toric Lens Selection ..................................... 128
Selecting the Lens Used for a Surgery ......... 141 Toric Measurement
Service, Before calling for ............................ 176 taking.............................................................. 125
Setup............................................................. 41 Touchscreen Does Not Line Up with Icons ... 180
Setup the Device ........................................... 80 Touchscreen Not Centered........................... 181
Shadows in Surgeon’s Oculars .................... 182 Transport ....................................................... 43
Shipping Contents ......................................... 40 Transportation ................................................ 43
Show all lens ................................................. 66 Troubleshooting ........................................... 176
Sizes ............................................................. 29
SLED Mode ................................................... 51 U
Spatial aperture Failure................................ 177 Unable to Log In ........................................... 179
Specific User Responsibilities ........................ 33 Use of Peripheral Monitor via S-Video or HDMI
Specifications .............................................. 184 .................................................................. 42
Sputnik is in the Lower Left Corner of the User
Display during Image Capture .................. 180 Creating a New............................................ 45, 46
Starting the Search ........................................ 73 User Interface Specifications..................... 185
State of the Eye Options .............................. 110 Using the Ocular Reticle ............................... 107
Steep axis ................................................65, 97
Steep K ....................................................65, 97 V
Storage.......................................................... 43 Viewing Captured Images ............................ 145
Surgeon......................................................... 62 Viewing Completed Surgeries
Surgeon Optional Data Field ORA cart.......................................................... 155
AnalyzOR........................................................ 67 Viewing Measurements
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11- Index

AnalyzOR ........................................................ 149 W

Viewing Pre-Op Data during Surgery ........... 107
Warning Labels .............................................. 30
Viewing Surgical Results
Warnings........................................................ 13
AnalyzOR ........................................................ 149
Warranty ........................................................ 22
Visual Acuity ........................................... 68, 153
Warranty Period ............................................. 22
White-to-White ......................................... 65, 97

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