OPTOPOL REVO nx, REVO nx 130, REVO 60, REVO 80, REVO FC User Manual

SOCT User Manual Version 10.0 rev. A

Manufacturer:

OPTOPOL Technology Sp. z o. o.

ul. Żabia 42

42-400 Zawiercie

POLAND

www.optopol.com

[e-mail]

User Manual

REVO nx

REVO nx 130

SOCT Copernicus REVO

SOCT Copernicus

REVO 60
REVO 80

REVO FC

Software Version 10.0

User Manual Rev. A

0197

Make sure you read this manual before using
the instrument. Keep this manual in a safe
place so that you can use it in the future.

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SOCT User Manual Version 10.0 rev. A

Copyright

© 2021 OPTOPOL Technology Sp. z o. o. All rights reserved. No part of this publication may be stored

in a retrieval system, transmitted or reproduced in any way, including but not limited to photocopy,
photograph, magnetic or other record, without the prior agreement and written consent of OPTOPOL
Technology Sp. z o. o.

User Manual Version 10.0 rev. A

Date of issue of manual: February 2021
Date of review: February 2021

For Customer Service or Technical Service contact your authorized dealer of OPTOPOL Technology
Sp. z o. o. Contact details are available on www.optopol.com.

Note: The SOCT Copernicus REVO/SOCT Copernicus/REVO 60/REVO 80/REVO nx

REVO nx 130/REVO FC is hereinafter referred to as the “SOCT”.

The name of application which controls the scanning device is SOCT.

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a
physician. Proper procedures and techniques are the responsibility of the medical professional.

License and use of the SOCT is intended only for trained medical personnel in accordance with the
license agreement – all other usage is prohibited – warranty restrictions and possible claim
limitations apply.

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SOCT User Manual Version 10.0 rev. A

1 DESCRIPTION OF THE DEVICE ............................................................................................. 13

INTENDED USE ...................................................................................................................... 13

INTENDED USER .................................................................................................................... 14

THE MINIMUM KNOWLEDGE ............................................................................................ 14

EDUCATION NEEDED FOR OPERATING THE TOMOGRAPH.......................................................... 14

OPERATING SKILLS ......................................................................................................... 14

OCCUPATIONAL SKILLS ..................................................................................................... 15

JOB REQUIREMENTS FOR THE USER .................................................................................... 15

PLACES OF USE ..................................................................................................................... 15

PATIENT POPULATION ............................................................................................................. 15

PROPER INSTRUMENT USE ....................................................................................................... 15

CONTRAINDICATION ............................................................................................................... 16

INSTRUCTION MANUAL AVAILABILITY ................................................................................. 16

INSTRUCTION MANUAL APPLICABILITY ............................................................................... 16

DISPOSAL ..................................................................................................................... 17

PROTECTIVE MEASURES FOR IT SYSTEMS ................................................................................... 17

CYBERSECURITY FUNCTIONS .................................................................................................... 17

SYSTEM OVERVIEW ........................................................................................................ 17

AUTHENTICATION OF USERS ............................................................................................. 18

AUTO-LOGOFF .............................................................................................................. 18

ENSURE TRUSTED CONTENT ............................................................................................. 18

CYBERSECURITY EVENT .................................................................................................... 18

RECOVER ...................................................................................................................... 18

OTHER IMPLEMENTED MECHANISMS .................................................................................. 19

2 TECHNICAL DATA ................................................................................................................ 20

TECHNICAL DATA REVO NX 130 / REVO NX ............................................................................. 20

SOCT COPERNICUS REVO/ SOCT COPERNICUS / REVO 60/REVO 80 ........................................ 21

TECHNICAL DATA REVO FC .................................................................................................... 22

DEVICE CLASSIFICATION .......................................................................................................... 23

MINIMUM COMPUTER SYSTEM REQUIREMENTS ........................................................................... 23

CAPTURE STATION .......................................................................................................... 23

REVIEW STATION ............................................................................................................ 24

3 SAFETY .............................................................................................................................. 25

SAFETY INFORMATION ............................................................................................................ 25

PRODUCT LABEL ................................................................................................................... 26

SAFETY STANDARDS ............................................................................................................... 28

WARNINGS .......................................................................................................................... 30

CAUTIONS ........................................................................................................................... 34

GENERAL NOTES ................................................................................................................... 36

NOTES ON USE ..................................................................................................................... 38

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BEFORE USE .................................................................................................................. 38

AFTER USE .................................................................................................................... 38

4 UNPACKING AND INSTALLATION ........................................................................................ 39

UNPACKING ......................................................................................................................... 39

CONNECTING CABLES ............................................................................................................. 40

DEVICE CONNECTION ............................................................................................................. 42

FACTORY DEFAULT CALIBRATION AND CONFIGURATION .................................................................. 44

5 SOCT SOFTWARE ............................................................................................................... 45

RUNNING SOCT APPLICATION ................................................................................................. 45

SOCT APPLICATION STRUCTURE ............................................................................................... 45

6 PATIENT WINDOW ............................................................................................................. 46

PATIENT LIST VIEW ................................................................................................................. 46

CUSTOMIZATION OF THE PATIENT LIST VIEW. ........................................................................ 47

REGISTERING NEW PATIENTS .................................................................................................... 47

EDITING PERSONAL DATA ......................................................................................................... 49

UNREGISTERING PATIENTS ....................................................................................................... 49

EXAMINATION LIST ................................................................................................................ 49

DELETING EXAM/S ................................................................................................................ 50

CONNECTING SCANS CONNECTED TO THE WRONG PATIENT ............................................................. 51

EXPORTING EXAMINATIONS ..................................................................................................... 51

EXPORT WITH ANONYMIZATION ........................................................................................ 51

IMPORTING EXAMINATIONS ..................................................................................................... 51

FILTER ............................................................................................................................. 52

OUTPUT .......................................................................................................................... 52

WORK LIST ....................................................................................................................... 53

7 EXAMINATION ACQUSITION TAB ........................................................................................ 54

SELECTION OF SCAN PATTERN MODE .......................................................................................... 59

SELECTION OF SCANNING PROGRAM .......................................................................................... 60

OCT BIOMETRY PROGRAMS ............................................................................................. 61

OCT TOPOGRAPHY PROGRAMS ........................................................................................ 61

OCT ANGIOGRAPHY PROGRAMS* ..................................................................................... 61

FUNDUS CAMERA PROGRAMS* ........................................................................................ 62

OCT + FUNDUS PHOTOGRAPHY* ...................................................................................... 62

SELECTION OF PROTOCOL ........................................................................................................ 63

DEVICE HEAD MOVEMENT CONTROLS ........................................................................................ 64

EYE PREVIEW ........................................................................................................................ 65

FUNDUS PREVIEW ................................................................................................................. 66

PSLO LIVE FUNDUS PREVIEW ............................................................................................ 66

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IR PREVIEW .................................................................................................................. 66

OPERATION ON THE FUNDUS PREVIEW ....................................................................................... 68

MOVING THE SCANNING AREA ......................................................................................... 68

ROTATION OF THE SCANNING ANGLE .................................................................................. 68

MOVING THE INTERNAL FIXATION TARGET ........................................................................... 68

CHANGING THE SCAN WIDTH ............................................................................................ 68

CHANGING THE SCANS DISTANCE ....................................................................................... 69

FIXATION TARGET CHANGE ....................................................................................................... 69

CUSTOMIZING SCAN PARAMETERS ............................................................................................. 69

LIVE OCT PREVIEW ............................................................................................................ 72

ITRACKING .................................................................................................................... 73

ACCEPTANCE WINDOW FOR A 3D SCAN.............................................................................. 73

8 CONDUCTING EXAMINATION ............................................................................................. 76

PREPARATION FOR EXAMINATION .............................................................................................. 76

ACQUISITION MODES DESCRIPTION ........................................................................................... 77

FULL AUTO MODE .......................................................................................................... 77

SEMI AUTO MODE.......................................................................................................... 77

MANUAL MODE ............................................................................................................. 79

SCANNING PROGRAMS DESCRIPTION ......................................................................................... 80

RETINA EXAMINATION ..................................................................................................... 80

CENTRAL EXAMINATION ................................................................................................... 80

DISC AREA EXAMINATION ................................................................................................. 81

OCT ANGIOGRAPHY EXAMINATION ................................................................................... 82

OCT ANGIOGRAPHY MOSAIC MODE .................................................................................. 83

ANTERIOR MEASUREMENT ............................................................................................... 85

WIDE ANTERIOR PROGRAMS ............................................................................................ 86

BIOMETRY PROGRAM ...................................................................................................... 89

TOPOGRAPHY PROGRAM ................................................................................................. 89

FUNDUS IMAGE REVO FC (REVO FC ONLY) ...................................................................... 89

FULL RANGE EXAMINATION MODE ............................................................................................ 94

ANTERIOR FULL RANGE EXAMINATION MODE ...................................................................... 94

CENTRAL FULL RANGE EXAMINATION MODE ........................................................................ 95

EXTERNAL FIXATION ............................................................................................................... 96

CHORIORETINAL/VITREORETINAL MODE .................................................................................... 96

EXAMINATION TIPS ................................................................................................................ 97

TIPS FOR AUTOMATIC EYE ALIGNMENT............................................................................... 97

TIPS FOR MANUAL EYE ALIGNMENT .................................................................................. 97

AUTO C-GATE ISSUES...................................................................................................... 98

TIPS TO SUCCESSFULLY SCAN DIFFICULT PATIENTS ............................................................... 101

CRITERA FOR EXAM ACCEPTANCE ........................................................................................... 103

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EVALUATION OF OCT FUNDUS RECONSTRUCTION FOR POSTERIOR 3D EXAMS. ......................... 103

EVALUATION OF OCT TOMOGRAMS FOR POSTERIOR AND ANTERIOR SCANS ............................. 107

OCT IMAGES .............................................................................................................. 109

FUNDUS PHOTOGRAPHY ................................................................................................ 110

3D EXAMINATION ACCEPTANCE CRITERIA ................................................................................ 110

SACCADES .................................................................................................................. 110

BANDING ................................................................................................................... 110

WEAK LOCAL SIGNAL ........................................................................................................ 111

BLINKS ....................................................................................................................... 111

FLOATERS ................................................................................................................... 111

CROPPED IMAGE .......................................................................................................... 111

OCT ANGIOGRAPHY ACCEPTANCE CRITERIA ......................................................................... 111

SEGMENTATION ERRORS ................................................................................................ 111

IMAGE QUALITY ........................................................................................................... 112

9 RESULT REVIEW ............................................................................................................... 114

TYPE OF VIEW MODE........................................................................................................... 114

[SINGLE] TAB SCREEN .................................................................................................... 114

[BOTH EYES] TAB SCREEN .............................................................................................. 114

[COMPARISON] TAB SCREEN ........................................................................................... 114

[PROGRESSION] TAB SCREEN .......................................................................................... 114

LOCK FUNCTION........................................................................................................... 114

TYPES OF ANALYSIS .............................................................................................................. 115

SINGLE RETINA ANALYSIS ............................................................................................... 115

AI DENOISE ....................................................................................................................... 115

3D TAB ..................................................................................................................... 116

10 POSTERIOR ANALYSIS .................................................................................................. 117

RETINA THICKNESS ANALYSIS ............................................................................................. 117

SINGLE TAB ................................................................................................................ 117

BOTH EYES TAB ............................................................................................................ 121

COMPARISON .............................................................................................................. 125

PROGRESSION ............................................................................................................. 126

OPTIC NERVE HEAD ANALYSIS .................................................................................... 129

ADVANCED VIEW – RETINA AND OPTIC NERVE HEAD ANALYSIS................................................. 138

STRUCUTRE & FUNCTION – COMBINED OCT AND VF REPORT .......................................... 139

RELATIONSHIPS BETWEEN VF AND RNFL/GANGLION MAPS ................................................. 142

REQUIREMENTS THAT MUST BE MET FOR LOADING PERIMETER TESTS IN THE SOCT APPLICATION .. 142

STRUCTURE & FUNCTION – VF RESULTS LAYER IN COMBINED VIEW ....................................... 143

STRUCTURE & FUNCTION – VF LOCATIONS LAYER .............................................................. 145

CENTRAL EXAMINATION .................................................................................................... 148

CENTRAL 3D EXAMINATION. .......................................................................................... 148

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2D SCAN PROGRAMS RESULTS REVIEW. ................................................................................ 149

SINGLE B-SCAN EXAMINATION REVIEW. ............................................................................ 150

RASTER EXAMINATION RESULTS REVIEW. ........................................................................... 151

RADIAL EXAMINATION RESULTS REVIEW. ........................................................................... 153

CROSS EXAMINATION RESULTS REVIEW. ............................................................................ 154

3D VISUALIZATION ........................................................................................................... 155

MANIPULATION OF THE 3D CUBE .................................................................................... 155

SELECTION OF DISPLAYED LAYERS ..................................................................................... 155

OPERATION PANEL........................................................................................................ 156

[SOLID] VIEW ............................................................................................................. 158

[VOLUME VIEW] .......................................................................................................... 159

11 ANTERIOR SEGMENT ANALYSIS .................................................................................... 160

ANTERIOR RADIAL ........................................................................................................... 163

[SINGLE] TAB SCREEN .................................................................................................... 163

[BOTH EYES] TAB SCREEN .............................................................................................. 165

[COMPARISON] TAB SCREEN ........................................................................................... 165

[PROGRESSION] TAB SCREEN .......................................................................................... 166

EDIT ANTERIOR SURFACE. ............................................................................................... 168

AOD MEASUREMENT ................................................................................................... 169

ANGLE MEASUREMENT TOOL .......................................................................................... 170

CALIPER TOOL ............................................................................................................. 171

TOMOGRAM REVIEW ANALYSIS ....................................................................................... 171

12 FULL SCREEN WINDOW ............................................................................................... 172

FUNDUS RECONSTRUCTION, EYE PREVIEW OR PSLO ................................................................ 172

IMAGING TOOLS .............................................................................................................. 173

MEASUREMENT TOOLS AND ANNOTATIONS ........................................................................... 173

BRIGHTNESS AND CONTRAST ADJUSTMENT............................................................................ 174

FULL SCREEN MODE EXIT ................................................................................................... 175

TOMOGRAM WINDOW MANIPULATION ................................................................................ 175

EDITION OF RECOGNIZED LAYERS ......................................................................................... 176

MANUAL DISC CONTOUR EDITION ....................................................................................... 177

REDRAW THE DISC CONTOUR .......................................................................................... 178

13 PRINT .......................................................................................................................... 180

POSTERIOR SEGMENT EXAMINATION REPORTS/OUTPUTS ......................................................... 180

RETINA 3D ................................................................................................................. 180

DISC 3D .................................................................................................................... 183

OPTIC NERVE HEAD ANALYSIS REPORTS ............................................................................. 185

TOPOGRAPHY EXAMINATION REPORTS .............................................................................. 191

FUNDUS EXAMINATION REPORTS......................................................................................... 195

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ANGIOGRAPHY EXAMINATION REPORTS ................................................................................ 197

DISC OCT-A EXAMINATION REPORTS ................................................................................... 201

BIOMETRY EXAMINATION REPORTS ...................................................................................... 205

MULTI B-SCAN REPORT ..................................................................................................... 206

MANUALLY SELECT TOMOGRAMS .................................................................................... 207

MULTI B-SCAN REPORT FOR BOTH AND COMPARISON VIEW. ................................................. 207

SINGLE TOMOGRAM REPORT .............................................................................................. 208

SELECT DESIRED PRINTER ................................................................................................... 208

14 OUTPUT ...................................................................................................................... 209

15 SELECTING FUNDUS PHOTO ......................................................................................... 210

ADDING FUNDUS PHOTO TO THE EXAMINATION. ..................................................................... 210

FUNDUS IMAGE REGISTRATION CORRECTION .......................................................................... 212

LINKING A FUNDUS PHOTO TO AN EXAMINATION. ................................................................... 212

16 EXAMINATIONS CORRELATION .................................................................................... 214

OCT-OCT REGISTRATION ................................................................................................. 214

AUTOMATIC CORRELATION ............................................................................................. 214

MANUAL REGISTRATION ................................................................................................ 215

FUNDUS CORRELETION ..................................................................................................... 215

AUTOMATIC CORRELATION ............................................................................................. 215

MANUAL CORRELATION ................................................................................................. 217

MOVING THE OVERLAID OCT IMAGE ............................................................................... 218

CLOSING FUNDUS AND OCT CORRELATION WINDOW .......................................................... 219

EXTRACTING TOMOGRAMS FROM A 3D EXAM ....................................................................... 219

FUNDUS CAMERA – RESULT REVIEW .......................................................................... 220

COLOR FUNDUS PHOTO [SINGLE] VIEW X 1 ........................................................................ 220

COLOR FUNDUS PHOTO [SINGLE] VIEW X 4 ........................................................................ 221

COLOR FUNDUS PHOTO FULL SCREEN VIEW ........................................................................ 221

COLOR FUNDUS PHOTO [BOTH] VIEW ............................................................................... 222

COLOR FUNDUS PHOTO [COMPARISON] VIEW .................................................................... 222

17 ANGIOGRAPHY OCT .................................................................................................... 223

RETINA OCT-A ............................................................................................................. 223

[SINGLE] VIEW – STANDARD .......................................................................................... 223

[SINGLE] VIEW - DETAILED ............................................................................................. 224

ANGIO OCT ANALYSIS. ................................................................................................. 226

QUANTIFICATION TOOLS: FAZ, VFA, NFA ............................................................................ 234

FAZ TOOL .................................................................................................................. 234

VFA TOOL .................................................................................................................. 237

NFA TOOL .................................................................................................................. 238

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QUANTIFICATION MAPS [DENSITY AND SKELETON] ............................................................. 240

ANGIO OCT ANALYSIS TABLE ......................................................................................... 244

[BOTH] VIEW. ............................................................................................................. 244

[COMPARISON] VIEW. ................................................................................................... 246

[PROGRESSION] VIEW ................................................................................................... 247

MOTION CORRECTION ...................................................................................................... 248

MOTION CORRECTION IN 3D EXAMINATIONS .................................................................... 249

DISC OCT-A.................................................................................................................. 250

[SINGLE] VIEW. ........................................................................................................... 250

[BOTH] VIEW .............................................................................................................. 251

ANGIO DISC COMPARISON VIEW ..................................................................................... 253

[PROGRESSION] VIEW ................................................................................................... 253

MOSAIC ........................................................................................................................ 254

CORRELATION STATUS ................................................................................................... 256

SELECT SCREEN ............................................................................................................ 256

OPERATION ON THE MOSAIC ........................................................................................... 256

18 BIOMETRY OCT ........................................................................................................... 259

BIOMETRY ACQUISITION MODE ......................................................................................... 261

FULL AUTO MODE ........................................................................................................ 263

SEMI AUTO MODE........................................................................................................ 264

ACCEPTANCE SCREEN .................................................................................................... 266

WHITE TO WHITE ........................................................................................................ 267

RESULT REVIEW ............................................................................................................... 268

SINGLE VIEW .............................................................................................................. 269

BOTH VIEW ................................................................................................................. 271

FULL SCREEN ............................................................................................................... 271

19 IOL CALCULATION TAB ................................................................................................. 274

PERFORMING IOL CALCULATION ......................................................................................... 275

MARKING IMPLEMENTED LENSES ........................................................................................ 277

IOL EDITOR .................................................................................................................... 277

IMPORTING IOL DATA ................................................................................................... 278

EXPORTING IOL DATA ................................................................................................... 279

ADDING LENSES MANUALLY ............................................................................................ 279

DELETING LENSES MANUALLY .......................................................................................... 279

VIEWING THE LIST OF LENSES .......................................................................................... 279

EDITING IOL DATA........................................................................................................ 280

ADDING ADDITIONAL POWER RANGES AND INCREMENTS ...................................................... 281

20 TOPOGRAPHY OCT ...................................................................................................... 282

TOPOGRAPHY - SAFETY NOTES ........................................................................................... 282

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TOPOGRAPHY ACQUISITION MODE ..................................................................................... 284

FULL AUTO MODE ........................................................................................................ 285

SEMI AUTO MODE........................................................................................................ 286

ACCEPTANCE SCREEN .................................................................................................... 287

TOTAL QUALITY FACTOR ................................................................................................ 288

RESULT REVIEW ............................................................................................................... 288

[SINGLE] VIEW ............................................................................................................ 288

[BOTH] VIEW .............................................................................................................. 290

[COMPARISON] VIEW .................................................................................................... 291

[PROGRESSION] VIEW ................................................................................................... 291

ANALYSIS ....................................................................................................................... 292

CENTRAL KERATOMETRY – SIMK ..................................................................................... 292

KERATOMETRY (MERIDIAN) ........................................................................................... 292

KERATOMETRY (SEMIMERIDIAN) .................................................................................... 293

KERATOCONUS SCREENING ............................................................................................ 293

PACHYMETRY .............................................................................................................. 297

MAP TYPES .................................................................................................................... 297

COLOR SCALE - STANDARDS ............................................................................................... 300

21 CALIBRATION .............................................................................................................. 304

CALIBRATION PROCEDURE PREPARATION ............................................................................... 304

TOPOGRAPHY CALIBRATION ............................................................................................... 305

INTITIAL TOPOGRAPHY CALIBRATION PROCEDURE ................................................................ 305

STANDARD CALIBRATION ................................................................................................ 306

CALIBRATION PROCESS .................................................................................................. 306

AXIAL LENGTH (BIOMETRY) CALIBRATION .............................................................................. 308

BIOMETRY CALIBRATION WITH THE IOL CALCULATION TAB UNACTIVATED ................................. 308

BIOMETRY CALIBRATION WITH THE IOL CALCULATION TAB ACTIVATED ...................................... 309

CALIBRATION PROCESS .................................................................................................. 310

ENTERING BIOMETRY CALIBRATION PARAMETERS ................................................................ 311

COMMON CALIBRATION ................................................................................................ 311

22 SETUP WINDOW ......................................................................................................... 315

GENERAL ....................................................................................................................... 315

DATABASE ...................................................................................................................... 316

STORAGE ....................................................................................................................... 318

USERS ACCOUNTS ............................................................................................................ 319

CREATING USER ACCOUNTS ............................................................................................ 320

LDAP SETTINGS ......................................................................................................... 321

PREFERENCES ................................................................................................................. 322

CMDL INTERFACE ........................................................................................................ 322

DEVICES SETUP ............................................................................................................ 323

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PARAMETERS TAB ........................................................................................................ 325

VOICE MESSAGES. ........................................................................................................ 326

RESULTS SETTINGS ........................................................................................................ 327

ANONYMIZATION ......................................................................................................... 328

VISUAL FIELD .............................................................................................................. 331

INPUT SETTINGS WINDOW ............................................................................................. 332

EDIT DISEASE LIST WINDOW ............................................................................................... 333

OUTPUT SETTINGS ........................................................................................................... 333

OUTPUT SET WINDOW .................................................................................................. 333

I. EXPORTING TOMOGRAMS WITH OR WITHOUT AI DENOISE .......................................................... 334

CREATING AN OUTPUT SET ............................................................................................. 334

GRAPHIC FILE STANDARD ............................................................................................... 334

DICOM C-STORAGE OUTPUT SET .................................................................................... 336

BACKUP ......................................................................................................................... 337

RECOVERY ...................................................................................................................... 338

DICOM ........................................................................................................................ 338

SYSTEM SETTINGS ..................................................................................................... 339

MWL SETTINGS ....................................................................................................... 340

C-STORAGE ............................................................................................................. 341

INFO TAB ....................................................................................................................... 341

PATIENT RECORD CHANGE TRACEABILITY AND LOGREADER SOFTWARE ........................................ 341

23 MAINTENANCE AND CLEANING PROCEDURE ............................................................... 343

ROUTINE CLEANING ......................................................................................................... 343

SOFTWARE MAINTENANCE ACTIVITIES .................................................................................. 344

HARD DISK DEFRAGMENTATION ......................................................................................... 344

ORDERING CONSUMABLES ................................................................................................. 345

FUSE ............................................................................................................................. 346

BLOWN FUSES EXCHANGE .............................................................................................. 346

24 NETWORK CONFIGURATION ........................................................................................ 347

NETWORK CONNECTION CONFIGURATION ............................................................................. 347

SOCT NETWORK ......................................................................................................... 347

SOCT SOFTWARE - VIEWING STATION CONFIGURATION ........................................................ 348

25 REMOTE CONNECTION ................................................................................................ 350

PTS APPLICATION FOR STRUCTURE & FUNCTION REPORT ......................................................... 350

26 ENVIRONMENTAL CONDITIONS ................................................................................... 354

27 WARRANTY AND SERVICE ............................................................................................ 355

28 UTILIZATION ................................................................................................................ 355

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29 TROUBLESHOOTING .................................................................................................... 356

30 LIST OF FIGURES .......................................................................................................... 359

31 PRODUCT COMPLIANCE .............................................................................................. 369

RADIO INTERFERENCE ....................................................................................................... 369

CANADIAN REGULATIONS .................................................................................................. 369

EMC INFORMATION ......................................................................................................... 369

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1 DESCRIPTION OF THE DEVICE

This manual explains the details of the function and method of application to make a good use
of the SOCT system. Before using the device, read this manual carefully to ensure that you
operate it efficiently and safely. Always keep this manual at hand for reference.

SOCT uses Spectral Domain Optical Coherence Tomography method to obtain 3-dimensional
and cross-sectional images of the retina.

SOCT is an optical coherence tomography system indicated for the in vivo imaging and
measurement of the retina layers, retina nerve fiber layer, and optic nerve head as an aid in
the diagnosis and management of posterior segment diseases as well as imaging of anterior
segment structure. The device produces a light beam, which is focused on the human eye
tissue. The light that reflects from internal structures of an eye is then interferometrically
analyzed by the device. The raw data are processed by a PC to obtain images of eye tissue
cross-sections.

The SOCT contains features including: Retina Thickness, Optical Nerve Head, Retinal Nerve
Fiber Layer, Angle assessment, Cornea measurement, Blood vessels visualization, measuring
distances along the visual axis.

The SOCT software with optional OCT Angiography visualization functionality is indicated as
an aid in the visualization of vascular structures of the retina and choroid.

The SOCT software with optional Corneal Topography function is intended to measure and
visualize anterior and posterior corneal curvatures.

The SOCT software with optional OCT Biometry function is intended for biometric
measurements and visualization of ocular structures and performing IOL power calculations
based on the patient’s biometric data and a selection of recognized IOL calculation formulas.

REVO FC version allows non-contact biomicroscopic imaging that incorporates a high­resolution digital camera for photographing, displaying and storing images of the retina and
surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.

REVO FC version provides images which are display only and the device does not provide any
diagnostic, pathological analysis or classification of ocular health based on the acquired
images.

Intended use

The SOCT is intended for use as a diagnostic device to aid the detection and management of
ocular diseases, including but not limited to, age-related macular degeneration, macular holes,
diabetic retinopathy, macular edema and glaucoma.

With optional OCT Biometry software feature the device is intended to measure ocular
structure along the eye axis. It measures the following parameters: Axial Length (AL), Central
Corneal Thickness (CCT), Anterior Chamber Depth (ACD), Lens Thickness (LT), Pupil Diameter

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(P), White-to-White distance (WTW). The measurement and visualization assist in the
determination of the appropriate power and type of intraocular lens.

With optional OCT Topography software feature the device is intended to quantify curvatures
of the anterior and posterior surfaces of the cornea. It measures the following parameters:
Corneal curvature (K1 and K2 keratometry values), Cylindrical power (CYL) and Axis, Average
and Total corneal power (ACP and TCP), anterior and posterior power and Keratoconus
prediction index (KPI).

With optional OCT Angiography software feature the device is indicated as an aid in the
visualization of vascular structures of the retina and choroid.

FC version provides the images of the retina and external area of the eye and are intended for
use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

NOTE: The SOCT is not intended to be used as the sole diagnostic aid for disease
identification, classification and management. A patient diagnosis is the sole domain
of eye care clinician.

DISCLAIMER: OPTOPOL Technology is not offering and does not offer advice,
instruction in the diagnosis and interpretation of SOCT images. It is the clinician’s
responsibility to make diagnosis and interpretation of OCT scans.

Intended User

The SOCT can be used by Ophthalmologists, Optometrists, Opticians, Orthoptists or other
trained health personnel.

The minimum knowledge

The user must be able to distinguish right eye and left eye, chin and forehead, read and
understand the language and the functionality used in the SOCT application software.

Education needed for operating the tomograph

Ophthalmologist, Optometrist, Nurse, Certified Medical Technician, Assistant.

Operating Skills

For instrument operation, the user should be able to perform the following functions:

- Power on and power off the device,

- Disinfect surfaces which interact with the patient,

- Enter and modify the patient data,

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- Adjust position of the patient, position of the instrument, the table height, and the

patient’s chair,

- Set the examination parameters, acquire examination,

- Select or create the required type of printout,

- Verify the printout for completeness of data,

- Print, export and save the selected report,

- Archive and recover the patient database.

Occupational skills

The user should be able to work with elderly patients, disabled patients and with children.

Job requirements for the user

The SOCT training in the scope of usage and operation is mandatory before the first use. The
user should be also trained in the analysis and treatment of ophthalmic diseases or other eye­related medical issues, as it is stated by governing bodies. The user should be a computer
literate person.

Users must be suitably trained and be familiar with the instructions, cautions, warnings
contained in this user manual.

CAUTION: This manual does not provide guidance on interpretation of clinical
results. The clinician must ensure that he or she has received appropriate medical
training in such interpretation. OPTOPOL Technology Sp. z o. o. cannot be held
responsible for misdiagnosis of results.

Places of Use

The device is intended for use in hospitals, eye care center/clinics, and surgery/operating rooms.

Patient population

The patient must be capable of sitting up straight and keeping his/her head still. They must be
physically and mentally able to cooperate well and mentally capable of following the
examination. Patients must be at least 5 years old.

Proper instrument use

- Always enter patient information first.

- Clean patient contact surfaces (forehead and chin rest).

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- To avoid pinching the patient, check the patient’s head position before raising the chin
rest

- Clean the ocular lens frequently to ensure good image quality.

- Adjust power table height properly to ensure patient comfort during the examination.

- Raise or lower the patient’s head so the eye aligns with the canthus mark on the chin
and forehead rest assembly.

- Warn others not to sit or stand on any part of the table, including the base and the top.

- When lowering the table, make sure that pinch point areas are clear of people and
articles; do not store articles in these areas.

Note: Chemically induced pupil dilation is not normally needed.

This device is not designed, sold or intended for use except as indicated.

Contraindication

Do not use the SOCT for those patients who:

- Have an anamnestic history of photodermatosis,

- Have undergone photodynamic therapy (PDT) within48 hours (refer to the product

document of administered photosensitizer about the prohibition period),

Instruction Manual Availability

The SOCT Instruction Manual in PDF format is available on the computer with installed SOCT
application. To open the file, press START → Application → SOCT → User Manual. The manual
is included on USB flash drive delivered with the standard package of the SOCT. Install the .pdf
file viewer e.g. free Adobe Reader from the www.adobe.com website or flash drive to read the
manual in PDF format.

The Instruction Manual in paper form is available on request. To receive user manual in
hardcopy please contact authorized OPTOPOL representative to receive it.

Instruction Manual Applicability

This document applies to the SOCT running with the application software version 8.0 or
higher, unless superseded.

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Disposal

For disposal at the end of the product life cycle, please follow national regulations.

CAUTION: Do not use this instrument for purposes other than intended and
specified.

Protective Measures for IT Systems

Manufacturer recommends operating SOCT only on password-protected systems.
SOCT must only be operated on virus-protected computers/networks. The institution

operating the device is responsible for the safety of the network.
When using external storage media, the user is responsible for ensuring that the media is free

from viruses. The consequences of virus attacks cannot be foreseen.
Manufacturer will not accept any liability for damage due to a computer virus.

NOTE: User must periodically backup patient data. Manufacturer will not accept any
liability for lost data.

Manufacturer recommends the use of an established antivirus software and/or firewall such
as e.g. Norton, McAfee.

The SOCT is tested by the manufacturer with anti-virus protection provided with Windows 10
“Microsoft Security Essentials”.

Make sure that your operating system, your medical device software and your antivirus
software are always working properly and up-to-date.

Make sure that all changes, updates and patches including operating systems are validated
prior to installation.
For questions regarding cyber security contact Manufacturer.

Cybersecurity Functions

The purpose of this section is to summarize the cybersecurity controls for the SOCT with Windows
10 operating system.

Cybersecurity risk management is a shared responsibility among stakeholders including the
medical device manufacturer, the user, and the health care facility. Failure to maintain
cybersecurity can result in compromised device functionality, loss of data availability or integrity,
or expose other connected devices or networks to security threats.

System Overview

The SOCT device has the following interfaces that are critical for cybersecurity:

- ETHERNET port /Wireless connection for DICOM interface

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- USB ports for connecting to various USB devices

Authentication of Users

The SOCT device uses Microsoft Windows 10 as the operating system. The operating system
itself allows the end user to establish and configure “User Accounts” and “User Passwords” so
that authentication is performed by password.

Auto-Logoff

User can select one of two available methods of automated log-off when working with the
SOCT application.

- The operating system has the ability to prevent access and misuse by unauthorized users if
the device is left idle for a period of time. The length of inactivity time before auto­logoff/screen lock is user/administrator configurable. The auto-logoff/screen lock can be
manually invoked by the user.

- The SOCT application also comes with an automated log-off capability which the user can
easily setup in chapter 22.4 Users accounts.

For questions regarding cyber security contact the Manufacturer.

Ensure Trusted Content

Restrict Software of Firmware Updates to Authenticated Code. Software and firmware updates
are performed by OPTOPOL representative from a protected source. All updates require a
Privileged account.

Cybersecurity event

Provide information to the end user concerning appropriate actions to take upon detection of
a cybersecurity event.

- Disconnect the SOCT device from any network

- Contact the IT Administrator at the user facility for on-site evaluation

- Run a scan using the anti-virus software

- Quarantine and delete any identified threats using the anti-virus software

- Restore the database

- Reconnect to the network

- Contact OPTOPOL Technology representative if additional assistance is required

Recover

Methods for retention and recovery of device configuration by an authenticated privileged
user.

• The SOCT provides an option for a data backup on internal and externa storage

• The SOCT allows configuration to be backed up automatically at each launch or close of the
SOCT application

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Other implemented mechanisms

1.8.7.1 Institutional IT Infrastructure

The SOCT software uses the Windows 10 operating system and supports integration into the
IT infrastructure and domain at the institution or facility where the device is installed. Some
facilities/institutions will have their own cybersecurity infrastructure, such as remote control
of User Accounts, firewalls, encryption, and so forth. The SOCT device will support these site­specific IT systems and this is verified during the installation process by OPTOPOL
representatives.

1.8.7.2 Stand Alone Mode

The SOCT can be run completely without internet connection. There is no specific requirement
to be connected to the internet for the device to operate properly.

1.8.7.3 Cybersecurity and Data Back-up Configurations

- On the Windows 10 PC where SOCT will be installed the “Windows Firewall” has to be

enabled.

- The SOCT was validated on computers with anti-virus protection provided by

“Microsoft Security Essentials”

- Data encryption can be added by a third-party tool

- The SOCT provides an option for an external data backup

- OPTOPOL Technology recommend to backup data on the drive with RAID system

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2 TECHNICAL DATA

Technical Data REVO nx 130 / REVO nx

OCT Image

Signal source Super Luminescent Diode (SLED)
Wavelength 830 nm
Scanning speed
REVO nx 130 130 000 measurements per second
REVO nx 110 000 measurements per second
Optical power 1575 µW ± -4,5%
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, B-scan, Radial HD, Raster, Cross, Angio1, Axial length2,

Topography2
Axial resolution 5 µm (in tissue)
Transversal resolution ideal 12 µm
typical 18 µm
Retina scan width 5 – 12 mm
Anterior scan width 3 – 16 mm
Scan depth 2.4 mm / 4.8 mm in Full Range mode
Working distance Posterior segment 23 mm

Anterior segment 52 mm
Anterior segment with adapter 27 mm

Power supply 100 – 240 V, 50 / 60 Hz
Power consumption 115 – 140 VA
Fuse ratings 2 x F 3,15 A L 250 V
Multiple socket-outlet max. load 500 VA
Dimensions 556 mm L × 382 mm W × 469 mm H
Weight 23 kg

1

- OCT Angiography is an optional software module available for the SOCT device. If you do not have this

feature and want to purchase it, contact Optopol’s local distributor.

2

- Biometry and Topography are optional software modules. If you do not have this feature and want to

purchase it, contact Optopol’s local distributor.

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SOCT Copernicus REVO/ SOCT Copernicus / REVO 60/REVO 80

OCT Image

Signal source Super Luminescent Diode (SLED)
Wavelength 830 nm
Scanning speed
SOCT Copernicus REVO/ SOCT Copernicus 27 000 measurements per second
REVO 60/REVO 80 60 000/80 000 measurements per second

Optical power

SOCT Copernicus REVO / SOCT Copernicus 1050-1150 µW
REVO 60/ REVO 80 1050-1150 µW/1150-1250 µW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, B-scan, Radial, Raster, Cross, Angio3, Axial length4,

Topography4
Axial resolution 5 µm (in tissue)
Transversal resolution ideal 12 µm
typical 18 µm
Retina scan width 5 – 12 mm
Anterior scan width 3 – 16 mm
Scan depth 2.4 mm / 4.8 in Full Range mode
Working distance Posterior segment 23 mm

Anterior segment 52 mm
Anterior segment with adapter 27 mm

Power supply 100 – 240 V, 50 / 60 Hz
Power consumption 115 – 140 VA
Fuse ratings 2 x F 3,15 A L 250 V
Multiple socket-outlet max. load 500 VA
Dimensions 556 mm L × 382 mm W × 469 mm H
Weight 23 kg

3

- OCT Angiography is an optional software module available only for REVO 60/REVO 80. If you do not have

this feature and want to purchase it, contact Optopol’s local distributor.

4

- Biometry and Topography are optional software modules. If you do not have this feature and want to

purchase it, contact Optopol’s local distributor.

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Technical Data REVO FC

Fundus Camera REVO FC

Angle of view 45 × (1 ± 5 %) °
Light source White LED
Min. pupil size for fundus 3.6 mm

OCT image

Signal source Super Luminescent Diode (SLED)
Wavelength 830 nm
Scanning speed 80 000 measurements per second
Optical power 1150-1250 µW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, B-scan, Radial, Raster, Cross, Angio5, Axial length6,

Topography6

Axial resolution 5 µm (in tissue)
Transversal resolution ideal 12 µm, typical 18 µm
Retina scan width 5 – 15 mm
Anterior scan width 3 – 16 mm
Scan depth 2.4 mm / 5 mm in Full Range mode
Min. pupil size for OCT 2.4 mm

Working distance Posterior segment 37 mm, Anterior segment 52 mm
Power supply 100 – 240 V, 50 / 60 Hz
Power consumption 90-110 VA
Fuse ratings 2 x F 4 A H 250 V
Multiple socket-outlet max. load 500 VA
Dimensions 479 mm L × 367 mm W × 493 mm H
Weight 30 kg

5

- OCT Angiography is an optional software module available in REVO FC. If you do not have this feature and

want to purchase it, contact Optopol’s local distributor.

6

- Biometry and Topography are optional software modules. If you do not have this feature and want to

purchase it, contact Optopol’s local distributor.

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Device classification

Classification Class 1 Laser Device
Protection against electric shock Class 1
Degree of protection against electric Type B applied parts (chin rest, forehead rest)

shock and ground

Degree of Protection against IPX0
ingress of water

Mode of operation Continuous operation

Minimum computer system requirements

Capture station

Processor Intel® Core™ i7 3.0 GHz or higher
No. of cores 4 physical cores
RAM minimum 16 GB, recommended 32 GB
Operating system Windows 7 Professional 64-bit, Windows 10 PRO

64bit,
HDD minimum 500 GB; recommended 256 GB SSD for OS

1TB SSD for Data
Graphic card NVIDIA chipset, Intel 630
Screen resolution 1920 x 1080 (Full HD), 3840 x 2160 (4K)

(For graphical objects to be scaled correctly while
using 4K resolution, it is necessary to set text
scaling to 200% in the screen settings
window of the operating system)

Communication ports 1 available USB 3.0 port
2 available USB minimum 2.0 ports

Mouse Mouse Wheel
Touch screen Recommended

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Review station

Processor Intel® Core™ i5 2.4 GHz or higher
No of cores: min. 2 physical cores, 4 logical
RAM min. 16 GB
Operating system Windows 7 Professional or Ultimate SP1 or later,

Windows 10 Professional 64-bits
HDD Minimum 256 GB
Screen resolution: minimum 1920 x 1080 (Full HD), 3840 x 2160 (4K)

(For graphical objects to be scaled correctly while
using 4K resolution, it is necessary to set text
scaling to 200% in the screen settings
window of the operating system)

Communication ports 2 available USB minimum 2.0 ports
Mouse Mouse Wheel

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3 SAFETY

Safety information

CAUTION

Follow operating instruction

Indicates a fuse is present near this symbol

On / Off

Type B Applied Parts

Date of manufacture

Manufacturer

Electrical and Electronic Equipment waste. Do not throw the product away with
normal household waste at the end of its life

Sign of conformity with essential requirements – The Medical Device Directive
93/42/EEC

Class 1 Laser Product

Warning: Dangerous voltage

General warning sign

Warning: Laser radiation

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

practitioner.

Product Label

The sample label of the SOCT Copernicus REVO/SOCT Copernicus is presented below.

The sample label of the REVO 60/REVO 80 is presented below.

The sample label of the REVO nx is presented below.

The sample label of the REVO FC is
presented on the right.

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The following table describes the marks and indications on the product label.

Manufacturer’s name and address

Year of manufacture

Serial Number in eight digits and coded year
of production

Sign of conformity with essential
requirements – The Medical Device Directive
93/42/EEC; 0197 - Notified Body Number

Type B Applied Parts

Follow operating instruction

Caution

Indicates a fuse and specification of the fuse

Alternating current

Electrical and Electronic Equipment waste.
Do not throw the product away with normal
household waste at the end of its life

Catalogue Number

Prescription Use Only (U.S.A)

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Safety standards

CAUTION: Before the first use, the device operator should be trained how to use

the system efficiently and safely.

NOTE: SOCT system can be connected only to power supply socket equipped with
properly connected grounding pin.

The SOCT system complies with all requirements of the directive 93/42/EEC (MDD - Medical
Devices Directive).

The SOCT is type B applied parts (chin rest support and forehead support) and class I protection
against electric shock.

Usually SOCT is a part of larger Medical System, which consists of many other medical and
non-medical devices. Medical system in general and all its components have to fulfill the
requirements of IEC 60601-1 standard.

In order to comply with the IEC 60601-1 standard all non-medical devices must be connected
to the Isolating Transformer. By connecting the devices to the Isolating Transformer, the
leakage current is reduced to the level which is in line with the IEC standard.

The Isolating Transformer fulfills requirements of IEC 60601-1 standard for medical electrical
system.

The Isolating Transformer supplies the power for non-medical devices connected to electric
not grounded mains in a room.

The Isolating Transformer can be installed in patient environment in accordance with IEC
60601-1 standard.

OPTOPOL recommends connecting the system via an uninterruptible power supply (UPS) to
the wall outlet.

NOTE: Only the PC, monitor and printer have to be connected to the isolating Transformer. Connecting non-medical devices in other way than presented in chapter 3.3 Safety standards can lead to electric shock or damage of the devices.

NOTE: It is strictly forbidden to connect any non-medical or medical devices which
are not included within the SOCT system to the Isolating Transformer e.g. lamp,
vacuum cleaner, etc.

NOTE: The SOCT must not be connected to the Isolating Transformer, but directly
to the main power supply socket or to the dedicated supply socket in the dedicated
table.

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NOTE: In situation when the cameras housing cover is removed, while examining
the patient, the system operator must not touch at the same time the patient and
uncovered parts of the device.

SOCT is connected to PC using USB 3.0 cable.
There are no user serviceable parts inside SOCT device. Light source is included inside the

device. Removing the covers can be done only by authorized personnel.
The maximum power of light radiation available outside the covers is less than 1650

microwatts providing safe operation of the device.
Objective lens is the output of light.

SOCT has been classified as a CLASS 1 laser device.

IMPORTANT:

1. If the whole Medical System has been installed by Manufacturer of SOCT or

Authorized Personnel, the manufacturer guarantees correct installation and
compliance with all required standards and directives.

2. In case installation was made not by Manufacturer or Authorized Personnel,

the manufacturer of SOCT takes no responsibility for any problems or risks that
could be created by incorrect connection and violation of safety standards.

3. Understanding and following up of chapters 5 SOCT SOFTWARE, 6 PATIENT

WINDOW, 7 EXAMINATION WINDOW, 8 CONDUCTING EXAMINATION and 9
RESULT REVIEW of this manual as well as PC experience are sufficient for

operating the SOCT device.

4. Manufacturer of SOCT takes no responsibility for incorrect medical diagnosis of

results and takes no responsibility for the consequences of such incorrect
medical diagnosis.

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Warnings

Warnings indicate hazards that, if not avoided, may result in property damage, injury or death.

WARNING: Do not scan patients who have been injected with photo-dynamic

therapy (PDT) treatment drugs in the previous 48 hours. Failure to
observe this warning could result in unintended exposure and
uncontrolled treatment of neovascular vessels.

WARNING: Medical professionals need to determine whether this device should be

used for patients who may be photosensitive, including those with
epilepsy.

WARNING: To avoid risk of electric shock, this equipment must only be connected

to a mains supply with protective earth. Ignoring safety rules can lead
to accidents.

WARNING: Multiple portable socket-outlets shall not be placed on the floor.

WARNING: Any Additional Multiple Socket-Outlet or extension cord shall not be

connected to the ME System.

WARNING: All activities that demand removing main body housing may be

performed by Manufacturer or Authorized Personnel trained by
Manufacturer only.

WARNING: Ignoring or disregarding the statements above may lead to danger of

death or serious injury.

WARNING: No modification of this equipment is allowed.

WARNING: OPTOPOL recommends that no accessories other than those specifically

called out in this user manual may be connected to the system. Any
customer accessory equipment connected to the interface ports must
be certified according to the respective IEC standards (for example, IEC
60950 for data processing equipment and IEC 60601-1 for medical
equipment) Also, all configurations shall comply with the system
standard IEC 60601-1. Any person who connects or installs accessories
to the system has the responsibility to verify the compliance. If in doubt,
consult an OPTOPOL Technology representative.

WARNING: The system cannot replace clinical judgment and is intended to be used

only in conjunction with other clinical tools considered to be the
standard of care for diagnosis of eye health and disease.

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WARNING: The system is not intended to be used as the sole diagnostic aid in

disease identification, classification or management. The system
provides data to be used in conjunction with other information,
intended to assist an eye care clinician in determining a diagnosis. A
patient diagnosis is the sole domain of a licensed eye care clinician.

WARNING: Equipment is not suitable for use in the presence of a Flammable

Anesthetic Mixture with Air, Oxygen, or Nitrous Oxide.

WARNING: The system has no special protection against harmful ingress of water

or other liquids (classified IPX0). To avoid damage to the instrument and
cause a safety hazard, the cleaning solutions, including water, should
not be directly applied to the device. Using a dampened cloth (without
dripping) is a good method to clean the exterior surface of the
enclosure. The table can be cleaned in the same manner as the system.
Care should be taken to avoid excess fluid near any of the system
components.

WARNING: While being examined, the patient must not touch any part of his or her

body to an electrical device that is not powered by the system. In
addition, while examining the patient, the system operator must not
touch at the same time the patient and any electrical device that is not
powered by the system. Failure to observe these warnings could result
in electrical shock to the patient and/or operator.

WARNING: The Real Corneal Power value determined by the topography is not

interchangeable with the corneal power value determined by any other
device. The Real Corneal Power determined by the topography function
is not intended to be used in lieu of, or replace a value from another
device into your standard IOL calculation formula.

WARNING: Make sure, that patient does not put his head inside the frame when

“up” or “down” chinrest elevation button is pressed.

WARNING: Users must check measurement readings for plausibility. This includes

the checking of the detected position boundaries on B-scan and the
adjusted lines, which automatically adjust to the signal, whenever one
of the measurements displays an unusually high standard deviation. The
operator must also take into account the type (e.g., posterior
subcapsular cataract) and density of the cataract when evaluating
plausibility.

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WARNING: Do not forget user LOGIN and PASSWORD the only way to open the

software is to enter this information. In case of problems please contact
your local distributor.

WARNING: Make sure there is enough free space on HDD/remote folder before

performing backup process.

WARNING: All maintenance activities can only be made when the device is turned

off and unplugged from power supply socket.

WARNING: There are no user serviceable parts inside the device. Any covers can be

removed only by authorized service staff.

WARNING: The main lens of the device should not contact the patient's eye or face.

WARNING: Use of accessories, transducers and cables other than those specified or

provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.

WARNING: Use of this equipment 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.

WARNING The user is fully responsible for all data entered or changed manually in

the IOL Calculation tab. Calculation parameters are determined at the
user’s discretion and it is the user’s responsibility to make sure they
guarantee obtaining a result optimized for a given case.

WARNING Any imported IOL data must be reviewed and accepted by the operator

prior to using it. The full responsibility for using any imported IOL data
form any source lies on the user. Imported IOL data must not be
regarded as recommendation in favor or against using any particular
lens on a patient. IOL data obtained from ULIB, IOL Con or any other
source only presents an overview of available lenses. OPTOPOL
Technology does not take any responsibility for the quality or
correctness of data imported into the system.

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WARNING The user chooses IOL calculation parameters at their own discretion.

The responsibility for the chosen parameters and the interpretation of
results lies on the user.

WARNING The IOL Calculation function is provided as an additional tool in the hands

of the physician to aid in the selection of an appropriate IOL for a
particular patient. The tool is intended to be used in combination with a
proper and comprehensive ophthalmic examination and diagnostic
tests. The results of calculations obtained with the IOL Calculation tool
do not serve as surgical or medical instruction and they are not
conclusive. OPTOPOL Technology cannot guarantee accuracy or correct
functioning of the tool at all times. The choice of a particular IOL model
and surgical procedure lies exclusively with the Physician who takes the
sole responsibility for the medical outcome of the procedure.

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Cautions

Cautions indicate hazards that, if not avoided, may result in property damage or injury.

CAUTION: This manual does not provide guidance on interpretation of clinical

results. The clinician must ensure that he or she has received
appropriate medical training in such interpretation. OPTOPOL
Technology Sp. z o. o. cannot be held responsible for misdiagnosis of
results.

CAUTION: Do not use this instrument for purposes other than intended and

specified.

CAUTION: Federal law restricts this device to sale by or on the order of a physician

or practitioner (CFR 801.109(b) (1)).

CAUTION: Before the first use, the device operator should be trained how to use

the system efficiently and safely.

CAUTION: Applicable Phototoxicity Statements (FDA CDRH Ophthalmologist

Guidance #71): Because prolonged intense light exposure can damage
the retina, the use of the device for ocular examination should not be
unnecessarily prolonged. While no acute optical radiation hazards have
been identified for direct or indirect ophthalmoscopes, it is

recommended that the exposure time for the patient’s eye be limited

to the minimum time that is necessary for image acquisition. Infants,
aphakes, and persons with diseased eyes will be at greater risk. The risk
may also be increased if the person being examined has had any
exposure with the same instrument or any other ophthalmic instrument
using a visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography. This
medical device has no user adjustable intensity settings for light incident
on the retina, nor does it produce UV radiation or short wavelength blue
light.

CAUTION: Be extremely cautious when examining high risk group of optical

radiation, patient without crystalline lens, infants and patient who is
insensitive to light for having ocular fundus disease with optical
coherence topographer (OCT).

CAUTION: The SOCT weighs approximately 23 kg or 30 kg. It should be lifted by at

least two persons. Use only the indicated positions for lifting.

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CAUTION: Be careful when mounting anterior adapter in order not to scratch the

objective lens.

CAUTION: Be sure to keep the patient’s face away from the chin rest and forehead

rest when the Anterior Chamber Adapter is still attached. Otherwise, a
patient may be injured by the Anterior Segment Adapter making contact
with him/her when the scanning head moves in any direction.

CAUTION: DDLS scale bases on a publication by George L. Spaeth, MD in 2002, and

can only be treated as supplementary information and cannot be
treated as disease confirmation. Use for reference only.

CAUTION: KPI bases on a publication by Naoyuki Maeda in 1994, and can only be

treated as supplementary information and cannot be treated as disease
confirmation. Use for reference only.

CAUTION Calculation constants used in the IOL Calculation tab do not depend solely

on the IOL type and calculation formula used. They can also be
influenced by factors such as measurement technology and surgical
technique which is why the user is strongly advised to optimize the
constants for their particular conditions and practice.

CAUTION While using an A-constant for IOL Calculations Remember that it is an

estimate and should only be used for reference if no better constants
are available. Use only IOL constants optimized for optical biometers.

CAUTION The software for taking measurements and performing IOL calculations

must be operated only be appropriately trained and experienced staff
with knowledge suitable for interpreting the results. All members of the
stuff must read this user manual thoroughly, paying special attention to
the safety related points and instructions.

CAUTION The white-to-white distance value is merely an indirect measurement of

the inner lateral dimensions of the anterior ocular section. For this
reason it provides only approximate indications of the actual inner
lateral dimensions of the anterior ocular section and of the size of the
implant used.

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General notes

Please avoid the use of extension cords or a power strip.

IMPORTANT:

1. If the whole Medical System has been installed by Manufacturer of SOCT or

Authorized Personnel, the manufacturer guarantees correct installation and
compliance with all required standards and directives.

2. In case installation was made not by Manufacturer or Authorized Personnel, the

manufacturer of SOCT takes no responsibility for any problems or risks that could
be created by incorrect connection and violation of safety standards.

3. Understanding and following up of chapters 5 SOCT SOFTWARE, 6 PATIENT

WINDOW, 7 EXAMINATION WINDOW, 8 CONDUCTING EXAMINATION and 9
RESULT REVIEW of this manual as well as PC experience are sufficient for

operation of the SOCT device.

4. Manufacturer of SOCT takes no responsibility for incorrect medical diagnosis of

results and takes no responsibility for the consequences of such incorrect
medical diagnosis.

NOTE: OCT image is a plot of optical path length. Depending on the optical design
and scanning location, the image can be distorted from its actual physical shape. For
example, a relatively flat retinal OCT image might not reflect the true curvature of
the retina.

NOTE: The OCT image can be affected by the optical pathway, that is, by corneal
opacity, cataract or eye shape.

NOTE: The SOCT is a medical device. The software and hardware have been
designed in accordance with European, U.S. and other international medical device
design and manufacturing standards. Unauthorized modification of the system
software or hardware, or any addition or deletion of any application in any way, can
jeopardize the safety of operators and patients, the performance of the instrument,
and the integrity of patient data.

NOTE: Any changes, additions or deletions to factory installed applications, the
operating system, or modifications to hardware in any manner voids the warranty
completely and can cause safety hazards.

NOTE: Cornea Layers recognition is used for tracing.

NOTE: For Corneal topography scan fully examine the measured tomograms for

layer recognition and examination results. In particular, if the difference between

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measurement values for the left and right eye is significant or any problem is found
in the anterior chamber during the preliminary examination, check the correctness
of layers recognition and/or reliability indices on the check screen. If the
measurement result is not conclusive, review the inspection result by performing
measurement again or performing another inspection.

NOTE: Allow only well-trained operators to use the instrument

NOTE: When using the data taken by this instrument to select intraocular lenses,

thoroughly determine the selection by also examining cataract surgery methods
and exercising other inspections. If incorrect measurement data is used to select
intraocular lenses, further surgery might be required

NOTE: When using corneal topography or biometry data taken by this instrument
for diagnosis or determination of treatment, proceed carefully by taking
measurements multiple times and/or conducting other examinations.

NOTE: When using the data taken by this instrument for refractive correction
surgery, thoroughly determine the selection by also examining surgery methods
and exercising other inspections. Refractive correction surgery conducted according
to incorrect measurements or analysis results may result in further surgery or
severe complication such as keratectasia.

NOTE: Since simultaneous use of multiple devices can cause misdiagnosis or result
in a hazardous situation, exercise caution when using this instrument

NOTE: For Topography and Anterior scan it may be difficult to recognize the
boundaries when capturing an image of an eye with opacity or malformation such
as corneal disease, shallow anterior chamber, aphakic eye, pseudophakic eye or
dense cataract eye. In this case if required to correct the layers or reject
measurement values. Oct image

NOTE: No SOCT is intended to be used as the sole diagnostic aid in disease
identification of classification.

NOTE: The following artifact may appear on the OCT image, but this does not
indicate any failure.

NOTE: When the measurement light enters the cornea, sclera, conjunctiva or
intraocular lens perpendicularly, a bright line appears in the depth direction.

NOTE: Ghost noise may occur in areas with strong reflection such as cornea, sclera,
conjunctiva and iris.

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NOTE: Correct patient fixation and alignment centered on the pupil are both critical
to obtaining a consistent corneal power measurement.

NOTE To ensure plausibility of IOL Calculation results the operator should always use
more than one calculation formula for a given IOL model and patient. This enables
the user to exercise closer scrutiny of obtained results.

NOTE The user should always seek to ever improve their IOL optimization. IOL
personalized and optimized data should be created through the analysis of pre­operative data obtained with the device and the results of stable refraction tests
performed 3 months after the surgery.

NOTE For graphical objects to be scaled correctly while using 4Kresolution, it is
necessary to set text scaling to 200% in the screen settings window of the operating
system.

NOTE As the Anterior Chamber, wide Angle to Angle and Pachymetry scans are
compensated for beam scanning geometry and reflection from the surface of the
cornea, during acquisition it is important that the scan is centered on the vertex of
the cornea so that a strong vertical reflex is visible through the corneal vertex. The
compensation algorithm works with greatest accuracy when corneal scans are
centered this way.

Notes on Use

Before use

- Inspect the SOCT daily. Make sure that no foreign matter on the front lens is present

that can affect image readings or diagnoses.

- Any dirt or scratches on the objective lens appear as black spots which may affect the

image quality. Check and clean the objective lens before taking an image. You cannot
take good images if the objective lens is dusty.

- Sudden heating of a room during winter or in cold regions may cause condensation to

form on the objective lens or on optical parts inside the SOCT, resulting in an inability
to obtain optimal images. In this case, wait until condensation disappears before taking
images.

- Before turning the device on, make sure that Anterior Chamber Adapter is not installed

on the objective lens.

After use

After using the SOCT device, turn off the power, attach the objective lens cap to protect the
objective lens from dust and place the dust cover over the device.

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4 UNPACKING AND INSTALLATION

NOTE: Check for any damage to the package. Every transportation box is equipped

with the shock watches. If any shock watch is broken (red indicator) please contact
OPTOPOL Technology and lodge a complaint to the carrier.

The SOCT set consists of the following components:

1. SOCT device,

2. External fixation adapter,

3. Anterior adapter (not applicable to REVO FC models),

4. Dust cover,

5. USB 3.0 communication cable,

6. Power supply cable,

7. USB Flash drive with the SOCT software, drivers and the User manual,

8. Calibration tool (option),

9. Chinrest papers.

Unpacking

This section describes how to unpack the device shipped from the factory. Remove the top of
the box and side walls. Remove transport foams. The figures indicate where to grab the SOCT
during moving. It should be lifted by at least two persons. Firmly hold the instrument body at
the base of device as indicated below, and put it on the automatic instrument table. Do not
lift the device holding it by indentation area located at the back of the device above the rear
panel.

Figure 1. REF 155 and 156 series device

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Figure 2. REF 190 and 193 series device

CAUTION: The SOCT weighs approximately 23 kg or 30 kg. It should be lifted by at
least two persons. Use only the indicated positions for lifting.

After unpacking, one should check the whole set for any mechanical damages,
cables damages, etc. In case any damage is found, don't connect the device and
contact your local distributor.

IMPORTANT: Always let the device reach room temperature before it is powered
up. This is particularly important if the device was exposed to extreme temperature.
Always operate the device within operating ranges of temperature and humidity.

Transportation position of the SOCT device is to be set by turning it off and on –
the device will go to base position. Turn it off and pack to the box securing with
packing foams.

Connecting cables

To connect the SOCT to a PC, you need one USB 3.0 cable shipped with the device:
USB 3.0 cable to connect SOCT (type B) and PC (type A):

Power supply cables are provided by local distributor.

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All sockets and plugs are different, so it is not possible to connect plugs improperly. The

figure below shows the rear panel view of SOCT.

Figure 3. Rear panel of the REF 155 and 156 series device

Figure 4. Rear panel of the REF 190 and 193 series device

First connect USB cable, in the next step connect power supply cables.
The power switch has two positions: I – the device is ON, O the device is Off.

NOTE: To remove power from the device turn OFF the power switch (Position O) or
unplug the power cord from the wall or from the device.

NOTE: Regarding EMC (Electro-magnetic compatibility) standards all signal cables
have to be put together.

Power connector

Power switch

USB 3.0 Type B

Fuse socket

USB 3.0 Type B

Power connector

Power switch

Fuse socket

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Device connection

The SOCT is connected to the PC using USB 3.0 cable.

NOTE: The SOCT must be directly plugged into the mains with protective earth. Connect
the PC, printer and monitor into the multiple portable socket-outlet, which is directly
connected to the Isolating Transformer. By connecting the PC set to the Isolating
Transformer the leakage current is reduced to the level which is in line with the IEC
standard. The Isolating Transformer is connected directly to the mains with protective
earth pin.

The diagram below shows how to connect all elements of the system.

Figure 5 Electrical connection scheme

* - Elements of medical system are not provided by OPTOPOL Technology.

USB 2.0 cable

USB 3.0

PS2/USB 2.0 cable

PS2/USB 2.0 cable

AC cord

AC cord

Isolating
transformer

AC socket

AC cord

AC LINE

AC LINE

AC cord

PC Computer*

Monitor

Printer

Applied part:

chin rest support

Applied part:

forehead support

Keyboard*

Mouse*

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• REVO FC

Figure 6. The chassis (front and side), applied parts and external fixation of the REVO FC

• REVO

Figure 7. The chassis (front and side), applied parts and external fixation of the REVO

Applied part:

forehead support

Applied part:

chinrest support

External fixation

External fixation

Applied part:

forehead support

Applied part:

chinrest support

External fixation

External fixation

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Factory default calibration and configuration

The system is delivered fully installed and configured by local OPTOPOL representative. No
user installation or configuration is needed.

On the computer connected to the SOCT screen saver, power options on the computer have
to be set as shown in the table.

Items Settings
Screen saver None
Turn off the display Never
Put the computer to sleep Never
Turn off hard disks Never
When I press the power button Shut down
Start menu power button Shut down

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5 SOCT SOFTWARE

IMPORTANT: Always turn ON the PC first and then turn ON the SOCT device.

Running SOCT application

After the Windows operating system is started and initialized, it is possible to run SOCT
application: press START → Application → SOCT → SOCT. Click SOCT icon and the application
will be loaded and activated.

NOTE: The device is ready to work when software is opened and the status is READY.

SOCT application structure

The application has been created to be user-friendly. The buttons are clear and located
ergonomically what makes the usage very effective.

The Login screen will appear after starting the SOCT application.

Figure 8. Login screen

Enter the User Login and Password then press [Login] to go into the application or [Setup] to
change settings.

SOCT software is divided into three different modules which can be easily accessed from tabs:

PATIENTS

Patients and exams list appear after logging in the application. It
enables to easily handle patients’ database.

ACQUIRE

It contains all controls necessary for performing a new
examination.

RESULTS REVIEWS

It enables to preview previously taken examinations, make
quantitative analysis and compare results.

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6 PATIENT WINDOW

The Patient tab will appear after login screen. Patient tab enables the user to easily manage
patients’ database:

- add new patients to the database,

- delete patients from the database,

- edit patients’ personal data,

- enter remarks regarding patients,

- import/export data.

All the controls of main window with short description are shown in the picture below.

Result
Software version
Device Status and SN

It enables to preview and analyze taken examinations.
Version of application.
Device status (Ready, Busy or not connected) and Serial Number.

Patient list view

By default, patients are sorted in the list by Patient name. Click the Reference number header
to sort them by ID number. It is also possible to sort by another column.

In order to search a specific patient in the list you can enter a few first letters of the name in
patient filter box. System will show the closest matching record. Customization of the patient
list is available.

It is possible to customize the patients list view. To hide columns: Gender, Ethnicity, Disease
and remarks, Right Click over the header to open menu. Uncheck unwanted column from

Examinations list

Scanned area
preview

Fast search

mechanism

Device status

and SN

Patient list

Add patient

Filter

Figure 9. Patient tab

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menu. To customize width of each column, grab the end of the column’s header and move to
desired position.

Patient filter: use this field to quickly find a patient on the list.

Figure 10. Patient list

Customization of the patient list view.

It is possible to customize the patients list view. To hide columns: Gender, Ethnicity, Disease
and remarks, Right Click over the header to open menu. Uncheck unwanted column from
menu. To customize width of each column, grab the end of the column’s header and move to
desired position.

Registering new patients

In order to register a new patient, click button [Add patient] in the main window. Patient
registration screen will open. Patient's first name, last name and date of birth must be entered
in proper fields.

Enter the first few letters of

the patient's name and the

system will find the closest

match

Sort the patients according

to the selected column

Right Click to open menu

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Figure 11. Patient edit screen

NOTE: Fields “Last name”, “First name” and “Date of birth” are obligatory and must

be properly filled in. Other fields are optional and can be left empty.

NOTE: For patients with refractive error bigger than -/+ 5D it is recommended to
fill in refraction during adding patients to the system.

NOTE: Filling refraction fields transfers information into correction of focus in
measurement mode.

NOTE: Disease field can use a user predefined dictionary of diseases as set up. The
user can also set the obligatory fields in the Patient registering window to meet the
regional regulations. For more information go to chapter 22.5.8 Input settings

window.

When all the data are entered, click [Enter] to confirm registration. The system will check if the
data are correct. If not, it will ask for correction.

NOTE: Make sure you entered correct patient name and date of birth. It prevents
you from data loss and helps to avoid empty records in the patients list.

If system detects that the patient entered is already registered in the database, a warning
message will appear.

[Patient with same Name, Last Name, DOB and unspecified or different Ref No.
is already registered. Do you want to [Edit details] or [Cancel].

If the system detects that the name of currently entered patient is already in the database but
the Reference number is different, a warning message will be displayed.

[Patient with same Name, Last Name, DOB with different Ref No. is already
registered. Do you want to register a new one? [Yes], [Cancel]

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It means that there is a suspicion, that the patient already exists, but the reference number
was entered incorrectly. The operator should make sure the data is correct and can decide
whether to register the patient or cancel registration.

Editing personal data

In order to edit currently selected patient's data, find the patient on the Patient list, Right-Click
over patient record and select [Edit]. The patient registration screen will appear. After checking
patient's data, click [OK] button to confirm changes. System will check the data once again and
display a warning message if entered data are incorrect. Then the same checking will be done
as during the registration of a new patient.

Unregistering patients

In order to unregister currently selected patient, Right-Click and select [Delete] from the list.
A warning message will be displayed.

[Are you sure you want to delete patient: Patient Last Name, Name, DOB, Ref

and all his data?]
After pressing [Yes] the second confirmation window will be displayed.
All examination data of selected patient will be lost. This action cannot by undone.
After choosing [Yes] for the second time, the patient and all examination results will be deleted

irreversibly.

NOTE: Once the patient is deleted it is impossible to recover the deleted data.
Please make sure you are deleting the proper patient.

Examination list

Examination list contains detailed information regarding the examinations. Thumbnail of
scanned area – fundus reconstruction for posterior scans or eye preview for anterior and
thumbnail of scanned image are displayed first. Behind thumbnails exam information such as
date and time of examination, Eye, Analysis program, Scan width, Scan dimension and
number of A-scans and B-scans are presented.

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Figure 12. Examination list

Examinations on the examination list are shown in order of date. The examinations are sorted
by visits. As default expanded is the Last visit.

Clicking the date panel stores the examination or shows it expanded.

Right-Click mouse button over the examination opens the menu:
Correct When selected system can use examination for automatic display in Both,

Comparison and Progression tab.
Follow up Allows to repeat examination. Opens Acquire window and loads previous

settings.
Cut exam Select if you want to move examination assigned to wrong patient
Delete Remove examination from the database.
Output Output exam results. Configure Output set
Export Save .oct examination in raw .opt format
Reanalyze System processing examination data

Right-Click of mouse button over the visit date opens the menu:
Cut visit Select if you want to move all exams from a visit assigned to a wrong patient
Output visit Output results from whole visit
Export visit Save all oct examinations in raw .opt format from the visit

Deleting Exam/s

Right-click on exam thumbnail and select [Delete].

Hold cursor to enlarge

fundus reconstruction

Click to expand the exam list from
specific visit

Right Click to open
Exam menu

List of the patient’s

examinations. The last visit

expanded

Right Click to open
Visit menu

Thumbnail of

scanned image

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Connecting scans connected to the wrong patient

The user has the option of moving examinations from an incorrect patient association, to the
correct patient association. It is possible to move single exam or move whole visit.

1. Select the Examination/s or the visit from Examination list - examination you wish to

move.

2. Press the right mouse button on and press [Cut examination or Cut visit].

3. Select patient on the “Patients list” where you wish to move examination.

4. Press the right mouse button and choose [Paste examination/s].

Exporting examinations

The SOCT offers the ability to export examinations data in raw format as .opt file. Exported
examination in .opt can be imported to SOCT application. Export data procedure.

Examination/s export procedure:

1. Select the Examinations on “Examinations list - examination you wish to export.

2. Press the right mouse button on the selected examination and choose from the

contest menu [Export].

3. Choose folder and press [Save].

4. At the end the following window appears.

[Examination has been exported]

5. After pressing [Ok] the procedure is completed.

Export with anonymization

SOCT gives the possibility to export examinations with anonymization. Before exporting with
anonymization, the user must define the anonymization settings in the setup window (see
chapter 22.5.6 Anonymization).

1. Select the Examinations you wish to export on the “Examinations list”.

2. Press the right mouse button on the selected examination and choose [Export
anonymized] from the contest menu.

3. Choose the folder and press [Save].

4. At the end, the following window appears. [Examination has been exported]

5. After pressing [Ok] the procedure is completed.

Importing examinations

Allows to import examination from the desired location. The system accepts .oct and .opt
format only.

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Filter

The filter window helps to find examinations easily in the database. System filters
examinations according to all patients. In order to apply filter, select the desired criteria.

Figure 13. Filter panel

User can filter examinations by date:

All All examinations are displayed.
Today “Today’s” in the list of patients you will see only that/those

examination/s which has/have been made today - all others will
be hidden.

Date From - To Select specific Date range by selecting the start day [From] to last

day [to]. In the list of all examinations you will see only
that/those which has/have been scanned between selected
days.

Eye If you want to hide examinations of Left or Right eye, unmark

check box labeled “Left eye” or “Right eye”.

Kind The filter allows to filter by type exam. It can be oct result or

imported examination.

Type Retina, Disc, Anterior, Central – depending on the analyzing

program different views are available.

Program Raster, Radial, 3D, single B-scan etc.
Users Filter patient by operator who made examination.

Use [Clear all] to reset the filter settings and disable filtering.

Output

From the Patient tab it is possible to output results from the:

- Single exam

- All examinations from single visit

- All patient results.

Right Click on the exam thumbnail, visit identifier or on the patient record and select Output
option from the menu. It is possible to output Reports, Tomogram or series of tomograms.
More details can be found in chapter 22.7.1 Output set window.

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Work list

Work list tab appears only when SOCT is configured to work with external software via CMDL
or MWL interface with third companies’ software. On the worklist a list of awaiting patients
appears. User can select (double click) the record from the worklist and start examination. If
patients exist, the system finds the patient, if patient does not exist, system adds the patient
to the database. System retrieves work list from the server periodically or on the user request
then it is required to press [Update]. With the patient lists operator can receive the
examination request. In this case software will load required exam or protocol.

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7 EXAMINATION ACQUSITION TAB

Examination acquisition tab is used to perform a new examination. In order to open the
examination window, click the “Acquire“ tab at the top of the Main window. An example of the
examination window is shown below:

Figure 14.Examination window view for REVO nx / SOCT COPERNICUS REVO/ SOCT COPERNICUS / REVO

60/REVO 80

pSLO live

fundus preview

Parameters panel

Examination panel
Examination list

Patient
information

Fixation control and voice

guide language selection

Live OCT preview

Device head

movement

controls

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Figure 15. Examination window view for REVO FC

Examination Panel

1. Scan mode - enables the user to choose the mode of scanning. For each eye area (Retina,

Disc, Anterior, Central) a set of examinations is available. Each examination has its own
predefined settings.

2. Scan program - press to expand the list of programs. Press the icon to load the desired
program.

3. Camera (Revo FC only) - allows the user to take a color fundus photo without performing
an OCT examination.

4. Fundus preview switch (Revo FC only) - IR/pSLO IR/pSLO mode are available. Live IR – Live
fundus preview in Infra-red mode

5. Scan protocol - press to expand the list of protocols. It enables the user to select a protocol
with predefined set of exams.

Device head

movement

controls

Patient information

Examination list

Scan parameters and
settings panel

Live OCT preview

pSLO live

fundus preview

1 2 3 4 5

Examination panel

Fixation control and voice

guide language selection

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Movement control

1. Eye selector - the measurement unit moves to

the patient's selected eye.

2. Start - press the start button to automatically
align and optimize the scanning signal. When Auto
Acquire is checked the system will capture an
examination.

3. Forward/backward control - move the
scanning head towards or away from the patient.

4. Eye preview - anterior segment image. The

displayed view is created from two cameras.

5. Chinrest controls - buttons used to adjust chinrest height (patient’s head position).

Detailed instructions on the operation of the movement control panel can be found in section 7.4

Device head movement controls.

psLO preview

1. pSLO preview - the projection (enface) image of
fundus will appear when proper alignment is
achieved. On the preview it is possible to change
fixation position, scanner offset and scan angle.

2. iTracking button - select checkbox to use the
iTracking technology.

Fixation control and voice guide control

1. Voice guide – the icon shows the status of

the voice guidance system. Press to
mute/unmute. The voice guidance system
guides the patient through the process of
acquiring the examination. In Setup Sound
tab you can customize or disable the voice

guidance function. For more details see chapter 22.5.4 Voice messages.

2. Fixation control - changes shape of the fixation target or selects external fixation.

1

2

3

5

4

1

2

3 4 1

2

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3. Acquire - press to start acquisition of data.

4. Voice guidance language - click to open the list. It allows the user to change the language
of the voice guidance directly from the Acquire window. The language interface remains
unchanged. Open the list from the message area and select the desired language.

Live OCT preview

1. Live OCT preview - preview
window shows horizontal and
vertical live OCT images. The
tomograms correspond to the
color cross on the pSLO fundus
preview window. Note that
poorly aligned tomograms have
influence on quality of
tomograms and reliability of
analysis.

2. Focus slider - used to
compensate for patient
refraction.

3. Auto Focus - automatically

compensates the patient refraction values.

4. C – gate slider - adjusts position of object on the tomogram window.

5. Auto C - Auto C (coherence) gate button to automatically align the OCT image. For patients

with refraction error bigger than -/+ 5D it is recommended to fill refraction value during
adding patients to the system.

Note To call [Auto Focus] function OCT signal must be visible in tomogram live
preview (eye opened).

6. QI index bar - shows signal to noise ratio. Compensate focus to achieve highest saturation
of image – try to achieve QI value as high as possible.

1

4 2 3 5 6

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Scan parameters panel

Scan parameters panel shows the parameters of
the loaded examination.

1. Settings - enables the user to change the
parameters of the exam such as width, number of
A-scan, number of B-scan, exam mode (vitreous or
choroid).

List of examinations

List of taken examinations - shows the previews of

taken examinations.

1. Thumbnail - double click on the thumbnail to
open chosen examination in the tomogram
window.

Patient information

Patient information section - shows personal data

of the patient

1. The field Patient presents the name of the
patient

2. The DOB field presents the patient’s date of
birth

1

1

1

2

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Note There are several conditions in which auto functions processes could fail.

For example: dense media opacities, eyelashes or eyelid which block the beam

of light, inability of subjects to maintain fixation, strong nystagmus. When

adverse condition occurs optimize the OCT signal manually.

Note For patients with refraction error bigger than -/+ 5D it is recommended to

fill rough refraction value during adding patients to the system.

Note Before first retina scan examination, if you set the rough focus value

(refraction power compensation) the system will align the patient data form

according to patient correction for Left and Right eye.

Note It is recommended to verify the refraction compensation set

automatically. In case of Auto focus Error function or low QI identifier value try

experimentally checking the refraction power above and under initial value in

order to obtain the best saturation of scans and highest QI value.

Double click on the refraction value resets value to 0.00D.
When cursor is over focus control panel, mouse scroll enables to compensate refraction.
Lines on the vertical and horizontal window indicate proper position of tomograms.

Selection of scan pattern mode

On opening the Acquire tab, the Retina 3D scan pattern is selected by default. You may select
any pattern mode or scan program by clicking it. Depending on scan pattern different result
analysis views are available. In order to combine more than one type of scanning program a
protocol can be used. System automatically changes the working distance.

Retina: Fixation position central: The result shows the tomogram image of the macula

and analysis results of retinal analysis for retinal disease and fibers analysis.

Disc: The fixation target is offset to allow the center of the optic nerve to move to the

center of the scanned area. The scan pattern overlay consists of concentric

rings to assist in the alignment of the optic disc in the center of scanned area.

The result shows the tomogram images of the optic disc, results of thickness of

RNFL (Retinal Nerve Fiber Layer) analysis, and quantification of the morphology

of the optic disc.

Anterior: The result shows the tomogram image of the anterior segment and analysis

result of the cornea analysis. This section has three groups of scan programs:

[Anterior] group - width of scan programs are 3 - 5 mm.

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[Biometry] group – AL and ACD scan programs.

[Topography] group
Central: The fixation target is offset to allow placing the macula and the optic disc in the

center of the scanned area. Useful for peripheral observation.

Protocol: Protocol allows to perform predefined set of exams of different type one by

one. This option allows to shorten time used for scanning program selection

CAMERA: The Fundus Camera mode allows the user to perform fundus photography in

the following programs: Central, Disc and Retina.

Selection of scanning program

User can select the desired scanning program from scan programs panel by clicking mouse
cursor on the scan pattern and selecting program from the icon list (R-Retina, D-Disc C-Central,
A-Anterior). Scanning parameters are different depending on scan modes and patterns.
Operator can reconfigure and save personal settings as default.

3D scanning program consists of a series of equally spaced parallel line scans over
a square or rectangle region, the size of which you determine. This program enables
precise and three-dimensional reconstruction of retina. In the program, analysis
modules give the most reliable and exact results.

Radial scanning program consists of a series of 2 to 32 equally spaced line scans
through a common central axis. This program enables taking scans in high resolution
in a few directions. The default pattern has 15 lines of 7 mm length. Operator can
adjust the length of scan lines by adjusting the scan width and number of scans.

B – scan Operator can adjust the length and placement of each scan. This program
enables taking a single B scan in highest resolution. If averaging is selected, the
scanning program scans one place defined number of times. It allows to enhance
information and it can be helpful for patients with a gaze problem. A cine loop from
scanned places can be observed.

Cross scanning program Enables taking two tomograms (horizontal (0°) and Vertical
(90°) of 10mm length. You can adjust the length and placement of scans. This

program enables taking B-scans in highest resolution.

Raster This program enables taking 5 B scans in highest resolution. The default
pattern is 5 horizontal lines whose length depends on the scan program. You can
adjust the length, tomogram spacing and angle of scan.

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Full range programs

B-scan Anterior Chamber Full range scan of the anterior chamber

Anterior Chamber radial Full range scan of the anterior chamber

Central Full Range Posterior B – scan

OCT Biometry programs

AL – scan provides: AL, CCT, ACD, LT

OCT Biometry7 provides biometric axial lengths measurement. It is available in the

Anterior tab group. ACD – scan program provides CCT, ACD

OCT Topography programs

OCT Topography8 provides the analysis of both surfaces based on Corneal

Curvature, Dioptric power, Elevation and Real power analysis based on both surfaces
and local cornea thickness.

OCT Angiography programs*

Allows operator to perform 3D scan. This dye free method allows visualization of retina
microvasculature, retinal morphology. For REVO FC 130 available from 3x3 mm to 9x9 mm.

Retina Angiography – This program is dedicated to presenting the highest
angiography details. By default, it is set to visualize 3x3 mm scan program.

Retina Angiography – This program is dedicated to presenting the larger view. By
default, it is set to 6x6 mm scan program .

7

Biometry OCT is an optional feature. It is available as an upgrade purchased separately.

8

Topography OCT is an optional feature. It is available as an upgrade purchased separately

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OCT Angiography mosaic programs – merge together 3x3 or 6x6 mm scans to create high
resolution mosaics of a larger area.

10x6** – This mode contains two examinations. Retina and Disc program.

12x5 – This mode contains 3 examinations. Retina, Disc and nasal side scan.

7x7 – This mode contains 5 examinations. 4 sides scan and one central.

10x10 - This mode contains 4 sides scan.

* OCT Angiography analysis is an optional feature that may not be activated on all instruments. If you do not
have this feature and want to purchase it, contact Optopol’s local distributor.
** 10x6 is the only Angiography mosaic mode available in SOCT Copernicus/REVO device.

Fundus Camera programs*

Central Fundus Photo

Disc Fundus Photo

Retina Fundus Photo

OCT + Fundus Photography*

3D scanning

program +

Fundus Photo

Radial

scanning

program +

Fundus Photo

B – scan +

Fundus Photo

Cross scanning

program +

Fundus Photo

Raster +

Fundus Photo

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OCT Angiography programs with Fundus Photo available with ANGIO module:

Retina
Angiography
+ Fundus
Photo

Retina
Angiography
+ Fundus
Photo

OCT
Angiography
mosaic 10x6
+ Fundus
Photo

* Programs available only for the REVO FC (OCT with Fundus Camera).

Selection of protocol

The Protocol function enables operators to use a set of predefined scanning programs to
capture tomograms according to certain diseases and the anatomy being examined. After
acquisition of a tomogram, the system automatically loads the next scanning program from
the selected protocol. Check the contents full of the protocol beforehand and select one that
is appropriate for tomogram captured.

On opening the Acquire tab the Retina 3D scan pattern is selected by default. You may change
to load the protocol on opening the Acquire tab. It is possible to edit, add or remove protocols.
See more details in chapter 22.5.2.1 Protocol tab.

User can select the desired protocol from protocol panel by clicking mouse cursor on the
[Protocol] and selecting the required protocol from the list box.

Three protocols sets are registered in the SOCT by default. Types of proposed Protocols:

Figure 16. Protocol selection tab.

[Retina] This program set captures tomograms by doing a 3D scan of the macula and

Raster of central region of retina. Scan programs: [Macula 3D] and [Central
Raster]

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[Glaucoma] This program set captures tomograms of macula and optic disc, cornea and

the Angle. Scan programs: [Retina 3D], [Disc 3D], and [Anterior Radial],
[Anterior B-scan]

[Screening] This examination set captures tomograms of the macula, disc and central

region of the retina. Scan programs: [Retina 3D] [Disc 3D] [Central 3D]

Device head movement controls

System is operated by mouse or touch screen9. Press Left or Right eye button to move the
device to the desired patient’s eye.

Figure 17. Device movement controls.

[Left] [Right] buttons Shows examined eye. When clicked it moves the SOCT

head across the chosen eye. When the user clicks on
already selected eye the head will set for initial Z position
across the patient’s eye.

OU Both When [OU Both] button is ON after pressing the [START]

button the device will acquire examination of both eyes
automatically.

Chinrest control Press to align patient’s head position. The canthus has to

be set at level of reference mark.

Eye preview Anterior segment image. Displayed view is created from

two cameras. On the Z working distance, images create
one view. Click on the pupil to correct the objective lens
position.

9

Touch screen control is an option. Contact Optopol representative for availability.

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Up/Down Left/Right controls Movement controls buttons appear when the field is

active (click or place the mouse cursor over). They control
movement of the device’s head in Left, Right, Up, Down
directions.

Movement controls Movement controls buttons appear when eye preview

panel is active e.g. the mouse cursor is over it or user
touched the eye preview panel.

Auto Acquire When checked system will start acquisition of data

automatically after auto alignment of eye structure.

When the cursor is over Eye preview window: scrolling the mouse wheel moves the head back
and forth.

On Eye preview the device indicates the end of range movement, by display of red symbol and
playing ‘Prompt’ sound.

Eye preview

Eye preview window displays views from two cameras. In work distance position the image is
composed as single anterior view. System is detecting patient’s pupil. When pupil is detected,
status READY is visible and [START] button is active. Device has to be positioned in LEFT or
RIGHT side as central position will not allow to take proper exam.

Figure 18. Movement control buttons.

When the cursor is over the eye preview window: movement control buttons
(Up/Down/Righ/Left) are displayed, scrolling the mouse wheel or pressing movement buttons,
moves the scanning head back and forward. In working position X, Y, Z axis the white cross has
to be in the center of equally aligned pupil. When scanning head is in the working distance,
click on the pupil to move the scanning head across the center of the pupil (shift in X, Y axis).

Measurement head
back/forward
movement controls

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Figure 19.Device aligns to the place of clicking on the preview

Properly align the pupil to start searching for the oct signal.

Figure 20. Properly aligned measurement head position

Fundus preview

pSLO Live fundus preview

Pseudo SLO (pSLO) live image shows the enface view of fundus. pSLO image appears when
OCT signal is properly aligned. View is overlaid with a box indicating the location of the scan
pattern on the fundus and a green cross indicating the location of the fixation target. You can
adjust the patient’s fixation by moving the fixation target, and change scanner offset position.

Scrolling the mouse wheel over pSLO can change the working position
(compensate edge shadows effected by small pupil during wide and
peripheral scan of retina). Click and drag the box to adjust scan
placement. Pressing the right mouse button allows to select higher
resolution or higher refresh rate from the menu.

NOTE: During the alignment of OCT signal on the live tomogram preview pSLO
image is frozen during the tomogram alignment.

IR Preview

To optimize the image on the IR preview, move the scanning head to the optimal fundus
position in one of the following ways:

a. Over the eye preview window: by scrolling the mouse wheel or pressing the movement

buttons (Up, Down, Right, Left)

Click to center the pupil when
working distance is aligned

Scroll forward to compensate narrowest pupils size pupil

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b. Live preview window – you can move the fixation target or scroll the mouse wheel over

the window to change the working position

c. Grab and move the horizontal and/or vertical tomogram windows.

When the IR mode is selected in the live fundus preview, a context menu becomes available.
To open the menu, right click on the IR preview window:

Figure 22. IR preview window context menu

Enhance mode – process the IR image to enhance fundus signal. Useful for patients with
cataract or small pupil.

Color IR – places a pseudo-color mask on the IR image

Color IR On/Off

Enhance On/Off

c. Horizontal and/or

vertical tomogram

a. The eye preview

b. Grab and move on

the live preview

window

Figure 21 IR mode acquire window

Enhance Off Enhance On

Figure 23. IR preview window display options with the Enhance mode OFF and ON.

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Operation on the fundus preview

Moving the Scanning Area

Drag the scanning area on the pSLO Live fundus preview to change scanner
offset. To reset the offset into the center of the fundus preview, double
click on the scanned area and the fixation target will come back to default
position.

Rotation of the Scanning Angle

For Raster and B-scan programs it is possible to rotate the scan angle.
Adjustment angle range is -900 to 900 with 1-degree step. Double click on
the scanned area to reset scanners rotation.

Moving the Internal Fixation target

Drag the internal fixation target mark in the pSLO Live fundus preview. When retina/disc cross­section is visible in OCT live preview, system displays pSLO image of the fundus, then the

operator may move the internal fixation position. In order to do it, drag
the green cross into the desired position. Ask patient to follow the
moving point. To reset the scanning area into the center of the fundus
preview, double click on the fundus preview, and the fixation target will
come back to default position.

Changing the scan width

Drag the corner of scanning area on the pSLO Live fundus preview to change
scan width. Scan width step is 1 mm.

Drag to move the fixation point

Grab the arrow end
and drag it to rotate

Grab the cross and drag it to change

Grab and move the corner to change the scan width

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Changing the scans distance

To change the distance between consecutive
tomograms, place the cursor over the line representing
the scanned place, grab the line and move the mouse to
change the distance between the lines.

Fixation target change

There are two sizes of internal eye fixation target available (small and large) and external
fixation target. Click the icon to change it. Active fixation target button is highlighted.

Figure 24. Fixation target selection

Customizing scan parameters

In the software there are prepared different settings of scan parameters for each pattern and
area. Parameters depend on scanned area (Retina, Disc, Anterior, Central) and scanning
program (3D, Radial, B-scan). This control panel allows the user to adjust the parameters of
the examination. The user is able to change predefined scanning settings. It is possible to save
own settings as a default by every operator. In order to change parameters, press [Settings]
button at Acquire window.

Figure 25. Examination settings panel

Small fixation point

Large fixation point

External fixation
point

See chapter

8.4 External

Scan mode

Number of B-scans

C gate focus mode selection

Scan program

Saves current parameters

as default for scan mode

Position of fixation target

Reset to factory settings.

Press [Save] to apply

Scanned area change

Scanning angle change

Number of A-scans per B­scan Use slider to change
value

Averaging( available for:
B-scan, Cross, Raster)

Tomogram color selection

pSLO mode selection

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Figure 26. OCT examination settings panel

Figure 27. Fundus Camera mode examination settings panel

After the scanning program has been selected, the user is able to set the following parameters:

- Scan width depending on the scan mode.

- Scan height. It is available for Raster only.

- Spacing – Distance between consecutive tomograms. For Raster scan user can modify

the distance, for all other programs the system displays the value automatically.

- Scan angle – change angle of scanning.

- Number of A-scans per B-scan.

- Number of B-scans (not available for single B-scan, Cross and Raster scanning program).

Number of A-scans per B-scan.
Use the slider to change the
value

Number of B-scans

Scanning mode

Scanning program

Scanned area change

Scanning angle change

Fundus Camera mode

Saves current parameters

Reset to factory settings

Averaging (available for: B-scan,
Cross, Raster)

Fundus Camera mode

FC Gain settings

Position of the fixation target

Fundus Camera on/off

FC Flash level adjustment

FC acceptance window on/off

Fundus photo preview settings

Tomogram color selection

C-gate focus mode selection

Fundus Camera mode

Fundus Camera program

Fixation position

Number of shots

Saves current parameters

Reset to factory settings

FC Gain adjustment

FC Flash level adjustment

FC acceptance window on/off

Fundus photo preview settings

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- No. of Averaging number defines how many times B-scan is repeated in one location.

It is used to compose averaged image. It is available for B-scan and Raster.

- Color mask - Toggles live OCT preview in grey scale or color.

- C- gate mode, Vitreous and Choroid modes can be selected. It changes the sensitivity

of the spectrometer on the bottom or top of the tomogram window helping to better
visualize the observed structure.

- pSLO fast mode – user can change refresh rate on the retina fundus. Fast mode shows

smooth movement of retina but decreases number of seeing details.

- Fundus Camera on/off – turns on/off the fundus imaging after each OCT examination.

- Fundus Camera mode – there are three modes available: high, normal and low. Choose

the mode suitable for color of the eye and the size of the pupil. Each mode can be
modified and saved as needed.

- Tomogram color selection.

- FC Flash level settings – set the level of the flash – increase the value when the photo

is too dark or decrease the value when the photo is overexposed.

- FC Gain settings – set the gain level – increase the value when the photo is too dark or

decrease the value when the photo is overexposed.

- FC acceptance window on/off – turns on/off the fundus photo acceptance window.

- Fundus photo preview settings – set the live preview display type.

- Fundus Camera program – there are three programs available: Central Fundus Photo,

Disc Fundus Photo and Retina Fundus Photo.

- Fixation position – set the fixation target.

- Number of shots – set the number of shots.

The system calculates the total number of A-scans and the examination time. After the changes
have been made, the user can press [OK] to transfer new scan parameters to SOCT or [Save]
to save modified parameters as a new default value.

NOTE: Scan patterns in every scan mode have different settings.

Increasing the number of B-scan improves fundus reconstruction and map reliability,
increasing the number of A-scan improves the quality of tomograms.

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The operator is able to save their own settings as a default program for example in order to:
reduce time of examination, obtain a more detailed reconstruction of the retina.

By selecting [Restore settings] it is possible to return to the default examination settings.

To optimize the image on the IR preview, see chapter 7.7.2 IR Preview.

Live OCT preview

OCT live preview has four tomogram previews for the 3D scan types and two for viewports for
other type of scan. For 3D scans, each viewport includes a color-coded scan marker at upper
right, to identify each scan line. The color and orientation of each marker correspond to the
color and orientation of the lines that make up the scan pattern overlay in the pSLO preview.

Figure 28. Tomogram preview images, manual position adjustment

On the Horizontal and Vertical image, it is possible to correct position of the tomogram. Grab
and move the oct image (e.g. retina) to desired position. On the Horizontal preview left/right
movement corresponds to the left/right scan head movement. On the Vertical preview
left/right movement corresponds to up/down scanning head movement.

[Auto C-gate] compensates position of object on the OCT live window preview (length of
coherence gate) and [A-Focus] (Refraction compensation) buttons and sliders to the left help
you improve the scan image quality and center it vertically.

Scroll to change C-gate – the
position of the tomogram

Grab and move the tomogram to
correct its position. Left/Right
movement corresponds to up/down

Scroll above to change Focus value

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iTRACKING

iTracking™ technology can compensate involuntary eye movements and blinks. If iTracking is
enabled, each scan program is acquired twice and the system immediately creates an artifact­free MC examination using the Motion Correction Technology™. The system saves 3
examinations if artifacts are detected. Two exams will be saved if the system does not detect
blinks and movements. iTracking is available for Angio OCT and 3D scans and can be enabled

or disabled by pressing the [ ] iTracking button.
After conducting an examination with iTracking, the system will display an acceptance window

with the results after Motion Correction. The windows for Angio OCT and 3D scans differ. A
reconstruction from Motion Correction exam will be shown in the window.

iTracking button separately stores status for each Angio OCT and 3D scans.

Acceptance window for a 3D scan

[Accept] – On pressing [Accept] the system saves three scans. If after pressing [Accept] the MC
algorithm does not detect movement artifacts or blinks in two acquired scans, it will save the
two scans and will not generate any new MC scans.

[Rescan] – Saves the 2 scans and returns to the acquisition window in order to repeat the scan.
If the second or further scans yield no satisfactory result, the user can either try again or use
the Motion Correction function based on scans from two or more iTracking attempts from
within the Results tab. See chapter 17.3 Motion correction.

[Reject] – The system will not save any scans.
[Do not ask again] – When checked, it will always accept the scan for the user. This window

will not be displayed again until being re-enabled.
To enable the Acceptance window, head to Setup\Preferences\[DEVICE TYPE]

[Setup]\Parameters\ Select Checkbox Ask for acceptance window for iTracking 3D scan
under 22.5.3 Parameters tab.

Figure 29 3D Scan Acceptance Window

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When the system does not recognize any motion artifacts, it will not create an MC scan. In this
situation, instead of the MC mark the system will display the time of the exam without
artifacts.

If the user does not accept the MC results, they can [Rescan] the exam. If the new MC results
are still unacceptable, the user can call the Motion Correction function based on 4 or more
original scans from the Result tab. See details in chapter 17.3 Motion correction.

If pressing [Reject], the system will only save the two basic scans if iTracking had been enabled.
If not, the system will not save any scans.

After scan acquisition, it will appear the top of the scan list, appear as an MC (Motion
Correction) scan and be selected as the active scan. In case of opening the Result tab, the SOCT
will only perform analysis on MC marked scans. The system only performs full analysis for MC
marked scans.

Figure 30 Angio Scan Acceptance Window

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In case of Angio exams, the component description is corresponding to those carried out
with Mosaic and those will not be analyzed, but instead marked as 1,2 and MC on the list. In
case identical exams are carried out again i.e. same location, amount of A and B scans, width
and angle of scan, those will be marked as 3 and 4.

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8 CONDUCTING EXAMINATION

There are three modes of acquiring the examination available: Full Auto, Semi Auto and
Manual mode. See details in chapter 8.3 Acquisition modes description

Preparation for examination

Check patient’s pupil size. In case of narrow pupil, it might be necessary to dilate the patient’s
eye. Dilation is optional. The pupils of the examined eyes must be at least 2.45 mm in
diameter. Tomograms acquired through too small pupils may be dark on the edges, or the
SOCT signal may be weak, leading to lack of image intensity and clarity.

1. From the main window, select the patient you want to examine. Fast search mechanism

can be used to locate patients easily. If the patient is not on the list, perform the
registration. See chapter 6. PATIENT WINDOW

2. Verify the patient refraction. If the refraction value is higher than -/+5D add this

information to patient’s data (Edit Patient). See chapter 6.2 Registering new patients

3. Click 'Acquire’ tab from main window. Make sure that the proper patient is selected (look

at the upper right corner of examination window). See chapter 7. EXAMINATION

ACQUSITION TAB

4. Select the desired scanning program (RETINA, DISC, ANTERIOR, CENTRAL - see chapter 8.3

Scanning programs description) or Protocol (see chapter 7.3 Selection of protocol) and

acquisition mode (see chapter 8.2 Acquisition modes description). The way of Acquisition
mode should be selected (Full Auto-select checkbox, Semi Auto or Manual)

5. Tell the patient to sit in front of the device. Adjust the height of the table to seat the patient

comfortably. Place patient's chin on the chinrest and ask the patient to rest his/her head
firmly on chinrest and forehead support. Using the Chinrest control buttons adjust the
elevation of patient's head. Canthus has to be on the reference position on the forehead
frame. Advice the patient to look straight ahead then after its visible focus on blinking
fixation point and do not follow the scanning beam.

WARNING: Make sure, that patient does not put his head inside the frame when

“up” or “down” chinrest elevation button is pressed.

6. Change the eye if required, press [L] or [R] button to choose the desired eye.

7. When the system recognizes the pupil [START] button becomes active. If the pupil is not

visible on the eye preview, it is required to move the scanning head to left/right and/or
back/forth slightly to allow pupil detection. It is also possible to click on the eye preview
(left mouse button or touch screen press) to move the head to desired location. See
chapter 7.4 Device head movement controls and 7.5 Eye preview).

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Acquisition modes description

Full auto mode

1. Prepare patient’s position, see chapter 8.1 Preparation for examination.

2. Press START button. Wait until the system finishes the examination. Patient will be voice

guided by the software.

Figure 31. Full auto examination

NOTE: There are a number of conditions in which auto functions processes could fail.
For example: dense media opacities, eyelashes or eyelid which block the beam of light,
inability of subjects to maintain fixation, strong nystagmus. When adverse conditions
occur, optimize the OCT signal manually.

Semi Auto mode

1. Uncheck [Auto Acquire] and press [START]. The system will automatically align and

optimize tomogram [align XYZ head position, Optimize OCT signal (C-gate, Focus), align
tomogram position].

Figure 32. Semi auto examination

2. OCT signal will be placed between horizontal lines.

Figure 33. Semi-automatic examination mode

Device status

[Start] becomes active

when device status is
“READY”

Full auto active when marked

Full auto mode is disabled

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Scan optimization and tomogram position alignment. Double click or [Acquire] button starts
measurement.

3. If QI and position of the tomogram are proper proceed to point 6.

Figure 34. Proper quality and position of the tomogram

4. Manually optimize signal and if required (low saturation, shadows on edges), change the

scanned area e.g. peripheral area.

• Move position of the internal fixation target. Ask patient to follow fixation target,

compensate shadow. The OCT cross-section should be visible in OCT live preview
window. Drag the retina to move tomogram preview to correct position.

• Change scanners offset.

• In order to visualize the interesting retina structures better you can choose

Chorioretinal and Vitreoretinal C-gate mode.

5. Some refracting correction may be needed to obtain the best quality of tomogram.

Observe the QI bar in order to obtain the best signal while changing [FOCUS] bar position.

6. Once the scan location is aligned, ask patient to blink. Click twice on the tomogram or press

[Acquire] button. Device will initialize measurement immediately and then full scan will be
performed.

7. After examination is over the system transfers the captured image into database.

NOTE: If system does not detect the pupil, user has to adjust manually the center

of the patient’s pupil. In order to set working position properly, align the center of

pupil on proper height.

NOTE: In case the system is not able to keep proper position of retina (e.g. patient
is shaking) operator has to switch off tracking and make examination manually.

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Manual mode

1. Uncheck [Auto Acquire]

2. Align the pupil position. Move forward until both images create one. Then press the center

of the pupil to align the lens across the center of the pupil.

Figure 35. Manual examination mode

3. OCT signal should already appear in tomogram preview. Adjust C Gate manually by moving

the sliding bar or use [Auto C] button or scrolling mouse wheel on the tomogram.

Figure 36. Manual examination process. Scan optimization and tomogram position alignment

4. In case QI and position of the tomogram is proper proceed to point 6.

Figure 37. Proper position and the quality of the tomogram

5. Manually optimize signal (low saturation, shadows on edges), and if required change the

scanned area e.g. peripheral area.

• Move the position of the internal fixation target. Ask the patient to follow the

fixation target, compensate shadow. The OCT cross-section should be visible in OCT
live preview window. Drag the retina to move tomogram preview to correct position.

Full auto mode is

disabled

Press forward

movement until two

images crate one

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• Change scanners offset.

• In order to visualize the interesting retina structures better you can choose

Chorioretinal and Vitreoretinal C-gate mode.

6. Some refracting correction may be needed to obtain the best quality of tomogram.

Observe the QI bar in order to obtain the best signal while changing [FOCUS] bar position.

7. Once the scan location is aligned, ask patient to blink. Click twice on the tomogram or press

[Acquire] button. Device will initialize measurement immediately and then full scan will be
performed.

8. After examination is over the system transfers the captured image into database.

Scanning programs description

Retina examination

1. Ask the patient to look at the center of green cross and blink freely if the sound support is

Mute or disabled. If required, use the large fixation target. See chapter 7.9 Fixation target

change.

2. Verify scan program and change to RETINA if required.

3. Follow the procedure depending on Acquisition mode. See chapter 8.3 Acquisition modes

description

Figure 38. Proper Alignment of retina tomogram

Central examination

1. Ask the patient to look at the center of green cross and blink freely if the sound support is

Mute or disabled. If required, use the large fixation target. See chapter 7.8 Fixation target

change.

2. Verify scan program and change to CENTRAL if required.

3. Follow the procedure depending on Acquisition mode. See chapter 8.2 Acquisition modes

description

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Figure 39. Central examination proper scan alignment

Disc area examination

1) Prepare the patient as explained in chapter 8.1 Preparation for examination.

2) Select Disc mode and scan type from program panel.

NOTE: Program settings do not change Fixation position.

3) When sound support system is not active instruct the patient to look at the fixation point

and follow it when it moves. Inform that after a while the fixation target will move to the
nasal direction. Ask the patient to follow when the fixation shifts.

4) Press [START] button for Full Auto or Semi Auto mode.

5) In Semi Auto or Manual when OCT signal is aligned properly, after a while the pSLO fundus

preview image of the optic nerve appears.

6) The Optic nerve head has to be in the center of scanned area.

Figure 40. Proper Disk examination alignment

It may be required to correct the scanner position. Drag and move the scanner to the center
of optic nerve head. See details in chapter 7.7.1 Moving the Scanning Area. Dashed vertical
lines on the live tomogram preview correspond to the red circle on pSLO fundus preview.
Scanners are positioned correctly when the vertical lines on the live OCT window are equally
placed from RPE tips.

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NOTE: If there is a shadow on the edge of the tomogram some slight left/right/up/down
movement may be required to find the correct position (whole tomogram properly
saturated and QI as high as possible)

In order to obtain the best saturation of OCT signal verify correct refraction and tilt of optic
disc. Operator can drag the tomogram to desired position on the live OCT window.

7) Once the scan location is set on selected place in the disc, click twice on tomogram preview

window or press [Acquire] button. Device will begin the acquisition process and then data
calculation will be performed.

OCT Angiography examination

1. Prepare the patient as explained in chapter 8.1 Preparation for examination.

2. Ask the patient to look at the center of green cross and blink freely if the sound support is

Mute or disabled. If required, use the large fixation target. See chapter 7.8 Fixation target

change.

3. Select one of Angiography scan program.

4. Follow the procedure depending on the Acquisition mode. See chapter 8.2 Acquisition

modes description

5. After the scan has been acquired, verify the result on the acceptance screen.

8.3.4.1 Acceptance screen

Figure 41. Angio acceptance window

Rescan Comes back to the Acquisition of scan. Examination is saved in database and

localization is marked. This marker can be used for motion correction values.
Accept Saves examination. In mosaic mode system loads next examination and starts

the procedure of shifting fixation and tomogram.
Reject Comes back to Acquisition window. Examination is not stored.
Mosaic mode When selected system goes to mosaic acquisition mode.
For REVO FC 130 the acceptance window presents MC Results provided by iTracking.

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OCT Angiography mosaic mode

1. Prepare a patient as explained in chapter 8.1 Preparation for examination.

2. Instruct patient that in mosaic examination you are going to take a few scans.

If a scan is carried out again, roman numerals indicative of the repeat number will be shown
at the top of the exam on the list. If the repeated scan is carried out in a different location, this
repeat indication will not be
shown.

8.3.5.1 Predefined mosaic modes

3. Select one of Angiography Mosaic mode program.

4. After Acquire the scan on the confirmation screen verify the result.

If you accept the result system will mark scanned area on pSLO window.
If you Repeat the examination system as default will use newer examination in mosaic

mode. If you use motion correction from specific location motion corrected exam will
be used.

5. System will load next examination and start shifting the fixation and the scanners

position.

6. On the upper part of window system shows which examination is already scanned. On

the pSLO window system will draw by blue lines already scanned area.

7. If voice guide is switched off inform the patient to follow fixation target.

8. If required correct position of tomogram and press Acquire to capture next image.

9. After last examination system will not load the next scan program.

Figure 42 Exam List - Angio Scans

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8.3.5.2 Manual mosaic acquisition mode

1. Prepare a patient as explained in chapter 8.1 Preparation for examination.

2. Instruct patient that you are going to take a few examinations and fixation target may

change the position.

3. Select one of Angiography mode program. If required you can change default

parameters.

4. After Acquire the first Angio scan on the confirmation screen check [Mosaic mode] to

activate the mosaic mode.
Verify the result. If you accept the result system will mark by blue lines scanned area

on pSLO window.
If you Repeat the examination system as default will use newer examination in mosaic

mode. If you use motion correction from specific location motion corrected exam will
be used.

5. If voice guide is switched off inform the patient to follow fixation target.

6. If required, correct the position of the tomogram and Acquire the image.

7. When you shift fixation and /or scanners frame change the color to guide you.

Green frame The new showed scanned area has enough coverage to allow automatic

superimpose.

Orange frame The new showed scanned area touch previously scanned area but it will

not guarantee enough data to automatic superimpose.

Red frame The new selected scanned area does not have any common area with

already scanned area.

Figure 43. Scanned area marked on pSLO window

Frame color as guide

Area already scanned
marked

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Anterior measurement

In order to conduct examination of anterior segment, follow the instructions below:

1) Select Anterior, and scan program if required.

2) Prepare the patient as explained in chapter 8.1 Preparartion for examination.

3) Press the [START] button to switch to the Full Auto or Semi Auto acquisition mode.

4) In Semi Auto or Manual verify the position of the OCT signal before pressing [Acquire]

button.

Cornea scan – (For pachymetry map use Anterior Radial scan). Locate the cornea in
between two dashed lines to get the best cornea images. Use center reflex from cornea to
locate the scan in the middle of scanned window. Use vertical dashed lines as reference.

Figure 44. Proper Anterior measurement alignment

Angle scan – There are two techniques of acquiring single Angle scan. Use Single B scan

Method I. Ask patient to look to the side(edge of device head) or use external target to
guide the patient until cornea with sclera are parallel to the scanning window. Grab and
move the cornea until the anterior angle will be in the center of the scanned window. See
image below for reference.

Figure 45. Single angle measurement proper alignment

Method II. Ask patient to look straight forward. Move the scanning head until Anterior angle
appears in the scan window. In this method it is recommended to scan in Bottom mode.

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Figure 46.Single angle measurement proper alignment

5) Once the scan location is set in selected place, click twice on the tomogram or press

[Acquire] button. PC will initialize measurement process and then full scan will be
performed.

NOTE: Only when border air - anterior surface is correct are AOD and TISA
measurements accurate. Verify recognition correction before judging the Anterior
Angle morphology.

NOTE: Vertical dense line in the center of Cornea is a natural reflection of laser light
and has no negative influence on measurement result. It can be used to locate the
tomogram in proper position.

NOTE As the Anterior Chamber, wide Angle to Angle and Pachymetry scans are
compensated for beam scanning geometry and reflection from the surface of the
cornea, during acquisition it is important that the scan is centered on the vertex of
the cornea so that a strong vertical reflex is visible through the corneal vertex. The
compensation algorithm works with greatest accuracy when corneal scans are
centered this way.

Wide Anterior programs

8.3.7.1 Wide Anterior programs for REVO FC

The Anterior Chamber Adapter is not applicable for REVO FC models. It has an anterior lens
built in. When a user selects anterior scan program, the lens will automatically install inside
the device.

8.3.7.2 Wide Anterior programs for REVO & NX

The Anterior Chamber Adapter for the SOCT is an easy-to-install hardware attachment to allow
wide scanning of anterior segment structure.

In order to conduct examination of anterior segment, prepare the anterior adapter and follow
the instructions below:

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1) Select one of Wide Anterior scan program. The scanning head has moved back. The built-

in lens will slide out.

2) Prepare the patient as explained in chapter 8.1 Preparation for examination.

3) Press [START] button for Full Auto or Semi Auto acquisition mode.

4) In Semi Auto or Manual verify the position of the OCT signal before pressing [Acquire]

button.

5) Some slight left/right/up/down movements may be needed to find the correct position.

Drag tomograms to optimize scan position.
The lens adapter is attached and removed by a trained operator.
Note: When using the anterior adapter, do not move the head too fast and monitor proximity

to patient in order to avoid incidentally hitting the patient’s eye with the Anterior adapter lens
surface.

Figure 47.Side views of Anterior Adapter

In order to conduct examination of anterior segment, prepare the anterior adapter and follow
the instructions below:

Select one of Wide Anterior scan program. The scanning head has moved back.
Install Anterior Chamber Adapter on the objective lens.
Grab the Anterior Adapter as shown on the image (two fingers are close to insertions

positioned horizontally.

Figure 48. Anterior adapter mounting

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5.1. Get the adapter to the objective and rotate 900 clockwise.

Figure 49. Anterior adapter mounting. Rotate to lock.

NOTE: Ensure that scanning head is in maximum backward position and patient will not

incidentally hit the anterior adapter.
CAUTION: Be careful when mounting anterior adapter in order not to scratch the objective

lens.
Prepare the patient as explained in chapter 8.1 Preparation for examination.

6) Press [START] button for Full Auto or Semi Auto acquisition mode.

7) In Semi Auto or Manual verify the position of the OCT signal before pressing [Acquire]

button.

8) Some slight left/right/up/down movements may be needed to find the correct position.

Drag tomograms to optimize scan position.

− Wide Cornea scan – For pachymetry map use Anterior Radial scan. Locate the

cornea in between two dashed lines to get the best cornea images. Use center
reflex from cornea to locate the scan in the middle of scanned window. Use vertical
dashed lines as reference.

Figure 50. Wide Cornea scan proper alignment

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− Angle to Angle scan – Ask patient to look at the green cross. Place the scan in the

middle of the iris. Use pSLO view and dashed vertical line on live OCT window for
reference. Both angles have to be visible on the live OCT window.

Figure 51. Angle to angle scan proper alignment

6) Once the scan location is set in selected place click twice on the tomogram or press [Start]

button. PC will initialize measurement process and then full scan will be performed.

Remove the Anterior Chamber Adapter after use.

NOTE: Only when cornea/sclera tissue is parallel to the scanning window are the
AOD and TISA measurements accurate.

CAUTION: Be sure to keep the patient’s face away from the chin rest and forehead
rest when the Anterior Chamber Adapter is still attached. Otherwise, a patient may
be injured by the Anterior Segment Adapter making contact with them when the
scanning head moves in any direction.

Biometry program

OCT Biometry is an optional feature. It is available as an upgrade purchased separately. For
more information go to chapter 18 BIOMETRY OCT.

Topography program

OCT Topography is an optional feature. It is available as an upgrade purchased separately. For
more information go to chapter 20 TOPOGRAPHY OCT.

Fundus Image REVO FC (REVO FC only)

8.3.10.1 OCT/Fundus Mode

1. The OCT/FUNDUS exam mode is similar to standard OCT modes. The only difference is that
the OCT exam is followed by a Fundus image capture. Prepare the patient as explained in
chapter 8.1 Preparation for examination.

2. Ask the patient to look at the center of the green cross and blink freely if the sound support
is Mute or disabled. If required, use the large fixation target.

3. Verify the scanning program and change it to the required mode.

4. Follow the procedure depending on Acquisition mode analogical to the OCT scanning
modes. See chapter 8.2 Acquisition modes description

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8.3.10.2 Fundus Mode

Fundus exam is similar to the examination of the posterior segment of the eye.

1. Prepare the patient as explained in chapter 8.1 Preparation for examination.

2. Ask the patient to look at the center of the green cross and blink freely if the sound support
is mute or disabled. If required, use the large fixation target.

3. Verify the scanning program and change to the required FUNDUS mode.

4. Follow the procedure depending on the Acquisition mode similarly to the OCT scanning
modes.

Fundus Photo Semi Auto mode

NOTE: With some patients the system may not take an optimal fundus image
automatically. In this case use the Manual or the Semi Auto mode.

1. Prepare the patient’s position chapter 8.1 Preparation for examination.

2. Choose one of the desired Fundus Camera modes.

Figure 52. Fundus Camera modes

3. Uncheck [Auto Acquire] and press [START]. The system will automatically align and

optimize the device position (align XYZ head position, Optimize Focus based on OCT signal)

and then correct the position on the basis of the OCT signal.

Figure 53. Aligned pupil position in Fundus Camera mode

The cross identifies the

centre of the lens and

has to be place in the

centre of the pupil.

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4. The software aligns the position of the scanning head. The operator has to

a) Verify the position of the scanning head in Z direction. Two pupil images should create

one plane.

b) Verify the pupil size (a white circle identifies the minimum pupil size). If the pupil is

too small, dim the light or optionally dilate the pupil.

c) If necessary, correct the alignment of the pupil position. Make sure that the cross on

the Eye preview window is in the center of the pupil. You may correct the pupil
position as described in chapter 7.5 Eye preview.

Figure 54. Eye preview window and pupil position

d) To verify the correctness of the fundus alignment position, change the Live fundus

preview to IR to verify the optimal fundus alignment.

NOTE: When the IR preview is ON, the OCT signal is not visible.

Figure 55. Live fundus preview modes

Figure 56. Live fundus preview IR mode

WRONG

CORRECT

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5. Optimize the visibility and exposure of the retina in the live preview window. The retina

has to be equally well exposed. Make sure there are no reflexes on the live preview

window and you will reach the best exposure possible.

We recommend to optimize the visibility and exposure of the retina in the live preview window
by grabbing and moving the tomogram windows. That is the most accurate and precise way.

When the reflex is on the left or right side of the retina preview, grab and move the horizontal
tomogram.

Figure 57. Fundus Photo mode acquire window

To eliminate the reflex at the top or at the bottom of the retina preview, grab and move the
vertical tomogram.

Figure 58. Fundus Photo mode acquire window

Try to reach the best possible exposure of the retina. In case of a weak fundus preview image
i.e. if small pupil size, use the enhance mode. See chapter 7.6.2 IR Preview.

Once you reach the best retina exposure, ask patient to blink. Click twice on the tomogram or
press the [Acquire] button. The device will take a photo of the fundus.

Visible reflex on the left

side of the retina

Horizontal tomogram

Grab and move the tomogram to

optimize the retina preview when

the reflex is on the left or right side

Visible reflex on the bottom

of the retina

Vertical tomogram

Grab and move the tomogram to

optimize the retina preview when the

reflex is at the top or at the bottom

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8.3.10.3 Fundus Image Acceptance Window

After taking a Fundus photo with or without OCT, the fundus acceptance window is displayed.

Figure 59. Fundus image acceptance window for Fundus mode

[Accept] – Closes the acceptance window and the Acquire window is displayed. The exam is
saved. The operator can continue capturing images or leave the Acquire window. If the
operator is using a protocol, the system moves to the next exam.

[Rescan] – The exam is saved and then repeated. If the operator is using a protocol, the system
continues with the current exam type.

[Reject] – The file is not saved (it is rejected). If the user is using a protocol, the system
continues with the current exam type.

The cross in the upper right corner of the information window closes it and initiates the same
action as the [Rescan] button.

Figure 60. Acceptance window for FUNDUS/OCT mode

[Accept] – Closes the acceptance window and the Acquire window is displayed. The exam is
saved. The operator can continue capturing images or leave the Acquire window. If the
operator is using a protocol, the system moves to the next exam.

[Rescan] – The system saves the exam and displays the Acquire window in order to repeat the
exam. If the operator is using a protocol, the system continues with the current exam type.

[Reject]

[Rescan]

[Accept]

Fundus image taken

[Reject]

[Rescan]

[Accept]

Fundus image taken

Tomogram form centrum of the
scanning area

fundus reconstruction (only for 3D
scans and Angio)

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[Reject] – the file is not saved (it is rejected). The Acquire window is displayed in order to
repeat the exam. If the operator is using a protocol, the system continues with the current
exam type.

The cross in the top right corner of the information window closes it and initiates the same
action as the [Rescan] button.

Full Range examination mode

Full Range examination mode offers scanning depth increased from the standard 2.4 mm to

5.0 mm (Revo FC) or 4.8 mm (SOCT Copernicus, SOCT Copernicus Revo, Revo 60, Revo 80, Revo
nx, Revo nx 130). In order to perform a Full Range scan of the anterior segment of the eye it is
necessary to install the anterior adapter on the lens of the SOCT device. Anterior adapter
installation instructions can be found in section 8.3.7 Wide Anterior Programs. (The installation
of the anterior adapter does not apply to the Revo FC which comes with a
built-in, automatic anterior adapter).

Before conducting a Full Range examination, prepare the patient as explained in section 8.1

Preparation for examination.

A Full Range scan in the simple mode (described below in section 8.4.1 Anterior Full Range

examination mode) normally displays an inverted mirror image of the scanned structure. The

inverted image can be oriented to overlie and match the original image. As a result, the two
images become coupled to form a highly detailed image of the structure.

Anterior Full Range examination mode

Figure 61. Anterior B-scan Wide Full Range examination view

There are two ways of displaying the tomogram: simple and complex.
Simple mode is active in the following situations:

• During the automatic alignment.

• During manual alignment i.e. when using C-gate, Focus or Head movements, the eye

is disengaged.

Complex mode is active in the following situation:

• When the scanners run slowly (if the user does not manipulate the system, the system

shows a Full Range tomogram // scan with a density of 4096 B-scan).

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In the semi-automatic and manual modes, the image visible in the tomogram window can be
displayed in two modes:

Simple mode
Fast refresh Full Range discoupled – faster

refresh. In the simple mode the user can see
the original image together with its inverted
reflection.

Complex mode
Full Range coupled mode – default – lower

refresh. In the complex mode the original
and inverted images are coupled to form a
detailed, homogenous image.

Central Full Range examination mode

Figure 62.Full Range Posterior B-scan examination window

There are two ways of displaying the tomogram: simple and complex which are described in
detail in section 8.4.1 Anterior Full Range examination mode.

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In the semi-automatic and manual modes, the image visible in the tomogram window can be
displayed in two modes:

Simple mode
Fast refresh Full Range discoupled – faster

refresh. In the simple mode the user can see
the original image together with its inverted
reflection.

Complex mode
Full Range coupled mode – default – lower

refresh. In the complex mode the original
and inverted images are coupled to form a
detailed, homogenous image.

External fixation

With the external fixation method, the patient uses the second eye to fixate on an external
target light. The SOCT may be equipped with an external fixation target arm. It is attached at
the top of the forehead support. Its position is set manually. When you select external fixation
target, instruct the patient to look at the blinking target light at the end of the external fixation
arm.

Chorioretinal/Vitreoretinal mode

Vitreoretinal / Chorioretinal C-gate mode. Settings are programmed based on scan design to
enhance either the information above the RPE (Vitreoretinal), or the choroid and overall
information (chorioretinal). Press [Settings] and select C-gate mode to change mode. Press
[OK] to change scan program.

Chorioretinal positioning Vitreoretinal positioning

Figure 63. Difference in Chorioretinal and Vitreoretinal scanning mode

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Examination tips

NOTE: Patients are usually nervous and stressed during an examination. Therefore,
it is advisable to be informative about the progress of the examination to minimize
unexpected movement.

Tips for Automatic Eye Alignment

Tips for Manual Eye Alignment

To align the pupil position, move the
device forward using the back/forth
controls until both halved images (top
and bottom) combine.
Correctly aligned pupil will have a white
cross in the middle.

e

If the white cross is not in the middle,
click it into place after both halved
images combine.
The white cross has to be placed in the
middle of the pupil.

Tips in case of the [START] button being inactive:

▪ verify pupil recognition;
▪ check for obstructions such as eyelids or eyelashes;
▪ verify chinrest height;
▪ verify head position;
▪ If necessary, adjust device position using Up/Down and Left/Right controls available

when hovering over live eye preview. Red arrows indicate incorrect patient position.

In case of issues with C-Gate:

▪ check if the pupil is centered;
▪ verify whether the patient has a large refraction (if so, make a note in patient profile);
▪ if the issue persists, check for eyelids or eyelashes obscuring the scan area;
▪ verify whether focus is set correctly;
▪ if issue remains unresolved, verify whether the patient’s forehead is still fully against

the frame and set correctly;

▪ manually scroll C-Gate;

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Auto C-Gate issues

8.7.3.1 Tips to Optimize OCT Signal

Focus Alignment

There are a number of conditions in which automated function processes could fail, i.e.:

▪ dense media opacities;
▪ eyelashes or eyelids blocking the beam of light;
▪ inability of patients to maintain fixation;
▪ nervous and/or stressed patients with jerky movement;
▪ strong nystagmus.

In cases where adverse conditions occur, it may be necessary to:

▪ optimize the OCT signal manually;
▪ align the tomogram manually;
▪ carry out the exam manually.

To manually compensate patient
refraction errors, scroll over the focus
slider.
Simultaneously observe QI index bar and
scan intensity to receive best results. The
QI index bar displays the signal to noise
ratio.

If the signal strength is low, adjust the focus manually. Additionally, artificial tears may be
used for dilated and dry eye patients.

For patients with severe sight problems,
use a large fixation target.

Focus correction may improve the
saturation of the tomogram.

e

If shadows are displayed on tomogram
edges, check whether the pupil is
centered.
To eliminate shadows, drag the
tomogram into the shadow.

If ghost tomograms are displayed, move
C-Gate position and check if the pupil is
centered.
Proper examination position can be
obtained by scrolling the mouse wheel or
dragging to the desired position.

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8.7.3.2 Quality IR Preview

To avoid poor quality images:

▪ Verify the device distance to ensure good illumination by alignment to the center of

the pupil;

▪ Move the fixation target or scroll the mouse wheel over the live preview window to

change the working position.

Good image

Poor image

e

e

8.7.3.3 Tomogram Alignment

To align the position of the tomogram:

▪ For precise movement, click, hold and drag the tomogram vertically and horizontally;
▪ For large movement, scroll the mouse wheel over the tomogram.

Note: By moving one tomogram i.e. horizontal, the vertical tomogram will move as well.

Below are examples of correctly aligned horizontal tomograms.

Example: Retina Raster, align the retina
between the two dashed horizontal lines.

3D Retina, align the retina between the
two dashed horizontal lines.

3D Disc, align the retina between the
dashed lines and set foveola in the
middle of the square.

3D Central Peripheral, align the retina
between the two dashed horizontal lines.

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3D Central, align the retina between the
two dashed horizontal lines.

For all Vitreous scans, align the Vitreous
structure between the two dashed
horizontal lines.

Anterior B-Scan Angle C-Gate top, place
the angle structure below the dashed
horizontal lines.

Anterior Wide B-Scan with Two Angles,
align the two angles between the dashed
horizontal lines.

Anterior Wide B-Scan Cornea, align the
desired structure between the dashed
horizontal lines.

Biometry Axial Length, align the central
cornea reflexes with the dashed vertical
line.

Biometry ACD, align the central cornea
reflexes with the dashed vertical line.

Topography, align the desired structure
between the dashed horizontal lines and
the central cornea reflexes with the
vertical dashed line.