Optopol Revo OCT User Manual 11.5.1

Download as pdf or txt
Download as pdf or txt
You are on page 1of 387

OPTOPOL Technology Sp. z o. o.

ul. Żabia 42
42-400 Zawiercie
POLAND
www.optopol.com
info@optopol.com.pl

User Manual
REVO FC 130
REVO FC

REVO nx 130
REVO nx

REVO 80
REVO 60

SOCT Copernicus REVO


SOCT Copernicus

Software Version 11.5.1


User Manual Rev. C

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.

SOCT User Manual Version 11.5 rev. C


Copyright

© 2023 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 11.5.1 rev. C

Date of issue of manual: October 2022


Date of review: June 2023

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 REVO nx 130/REVO nx/REVO FC 130/REVO FC/SOCT Copernicus/REVO 60/REVO 80/SOCT
Copernicus REVO 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 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.

2 / 387
SOCT User Manual Version 11.5 rev. C
CONTENTS

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
USER PERFORMING DATA PROCESSING ....................................................................................... 15
........................................................................................................................................ 15
PLACES OF USE ..................................................................................................................... 16
PATIENT POPULATION ............................................................................................................. 16
PROPER INSTRUMENT USE ....................................................................................................... 16
CONTRAINDICATION ............................................................................................................... 16
INSTRUCTION MANUAL AVAILABILITY ................................................................................. 16
INSTRUCTION MANUAL APPLICABILITY ............................................................................... 17
DISPOSAL ..................................................................................................................... 17
PROTECTIVE MEASURES FOR IT SYSTEMS ................................................................................... 17
CYBERSECURITY FUNCTIONS .................................................................................................... 17
SYSTEM OVERVIEW ........................................................................................................ 18
AUTHENTICATION OF USERS ............................................................................................. 18
AUTO-LOGOFF .............................................................................................................. 18
ENSURE TRUSTED CONTENT ............................................................................................. 18
CYBERSECURITY EVENT .................................................................................................... 18
RECOVER...................................................................................................................... 18
OTHER IMPLEMENTED MECHANISMS .................................................................................. 19

2 TECHNICAL DATA................................................................................................................ 20
REVO FC 130 [REFERENCE NUMBER 193-130] ....................................................................... 20
REVO FC [REFERENCE NUMBER 190-80] ................................................................................ 21
REVO NX 130 [REFERENCE NUMBER 192-130]........................................................................ 22
REVO 60 [REFERENCE NUMBER 191-60] / REVO 80 [REFERENCE NUMBER 191-80] .................... 23
REVO NX 130 [REFERENCE NUMBER 156-130]/ REVO NX [REFERENCE NUMBER 156-110].......... 24
SOCT COPERNICUS REVO / SOCT COPERNICUS [REFERENCE NUMBER 155-27]/REVO 60 [REFERENCE
NUMBER 155-60]/ REVO 80 [REFERENCE NUMBER 155-80]................................................................... 25
DEVICE CLASSIFICATION .......................................................................................................... 26
MINIMUM COMPUTER SYSTEM REQUIREMENTS ........................................................................... 26
CAPTURE STATION .......................................................................................................... 26

3 / 387
SOCT User Manual Version 11.5 rev. C
REVIEW STATION ............................................................................................................ 27

3 SAFETY .............................................................................................................................. 29
SAFETY INFORMATION ............................................................................................................ 29
PRODUCT LABEL ................................................................................................................... 30
SAFETY STANDARDS ............................................................................................................... 32
WARNINGS .......................................................................................................................... 33
CAUTIONS ........................................................................................................................... 37
GENERAL NOTES ................................................................................................................... 40
NOTES ON USE ..................................................................................................................... 43
BEFORE USE .................................................................................................................. 43
AFTER USE .................................................................................................................... 43

4 UNPACKING AND INSTALLATION ........................................................................................ 44


UNPACKING ......................................................................................................................... 44
CONNECTING CABLES ............................................................................................................. 45
EDITING PERSONAL DATA......................................................................................................... 47
DEVICE CONNECTION ............................................................................................................. 47
FACTORY DEFAULT CALIBRATION AND CONFIGURATION .................................................................. 49

5 SOCT SOFTWARE ............................................................................................................... 51


RUNNING SOCT APPLICATION ................................................................................................. 51
SOCT APPLICATION STRUCTURE ............................................................................................... 51

6 PATIENT WINDOW ............................................................................................................. 52


PATIENT LIST VIEW ................................................................................................................. 52
CUSTOMIZATION OF THE PATIENT LIST VIEW. ........................................................................ 53
REGISTERING NEW PATIENTS .................................................................................................... 53
UNREGISTERING PATIENTS ....................................................................................................... 55
EXAMINATION LIST ................................................................................................................ 55
DELETING EXAM/S ................................................................................................................ 56
CONNECTING SCANS CONNECTED TO THE WRONG PATIENT ............................................................. 56
EXPORTING EXAMINATIONS ..................................................................................................... 56
EXPORT WITH ANONYMIZATION ........................................................................................ 57
IMPORTING EXAMINATIONS ..................................................................................................... 57
FILTER ................................................................................................................................. 57
OUTPUT .......................................................................................................................... 58
WORK LIST ....................................................................................................................... 58

7 EXAMINATION ACQUSITION TAB ........................................................................................ 59


SELECTION OF SCAN PATTERN MODE .......................................................................................... 64
SELECTION OF SCANNING PROGRAM .......................................................................................... 65

4 / 387
SOCT User Manual Version 11.5 rev. C
OCT BIOMETRY PROGRAMS ............................................................................................. 66
OCT TOPOGRAPHY PROGRAMS ........................................................................................ 66
OCT ANGIOGRAPHY PROGRAMS* ..................................................................................... 66
FUNDUS CAMERA PROGRAMS* ........................................................................................ 67
OCT + FUNDUS PHOTOGRAPHY*...................................................................................... 67
SELECTION OF PROTOCOL ........................................................................................................ 68
DEVICE HEAD MOVEMENT CONTROLS ........................................................................................ 69
EYE PREVIEW ........................................................................................................................ 70
FUNDUS PREVIEW ................................................................................................................. 71
PSLO LIVE FUNDUS PREVIEW............................................................................................ 71
IR PREVIEW .................................................................................................................. 71
OPERATION ON THE FUNDUS PREVIEW ....................................................................................... 73
MOVING THE SCANNING AREA ......................................................................................... 73
ROTATION OF THE SCANNING ANGLE.................................................................................. 73
MOVING THE INTERNAL FIXATION TARGET........................................................................... 74
CHANGING THE SCAN WIDTH ............................................................................................ 74
CHANGING THE SCANS DISTANCE ....................................................................................... 75
FIXATION TARGET CHANGE....................................................................................................... 75
CUSTOMIZING SCAN PARAMETERS ............................................................................................. 75
LIVE OCT PREVIEW ............................................................................................................ 78
ITRACKING .................................................................................................................... 79
EYE TRACKING .................................................................................................................. 79
ACCEPTANCE WINDOW FOR A 3D SCAN .................................................................................. 80

8 CONDUCTING EXAMINATION ............................................................................................. 82


PREPARATION FOR EXAMINATION .............................................................................................. 82
ACQUISITION MODES DESCRIPTION ........................................................................................... 83
FULL AUTO MODE .......................................................................................................... 83
SEMI AUTO MODE.......................................................................................................... 83
MANUAL MODE............................................................................................................. 85
SCANNING PROGRAMS DESCRIPTION ......................................................................................... 86
RETINA EXAMINATION ..................................................................................................... 86
WIDEFIELD EXAMINATION ................................................................................................ 86
DISC AREA EXAMINATION ................................................................................................. 87
OCT ANGIOGRAPHY EXAMINATION ................................................................................... 88
OCT ANGIOGRAPHY MOSAIC MODE .................................................................................. 89
ANTERIOR MEASUREMENT ............................................................................................... 90
WIDE ANTERIOR PROGRAMS ............................................................................................ 92
BIOMETRY PROGRAM...................................................................................................... 95
TOPOGRAPHY PROGRAM ................................................................................................. 95
FUNDUS IMAGE REVO FC (REVO FC ONLY) ...................................................................... 95

5 / 387
SOCT User Manual Version 11.5 rev. C
FULL RANGE EXAMINATION MODE ............................................................................................ 99
ANTERIOR FULL RANGE EXAMINATION MODE .................................................................... 100
WIDEFIELD FULL RANGE EXAMINATION MODE ................................................................... 101
EXTERNAL FIXATION ............................................................................................................. 102
CHORIORETINAL/VITREORETINAL MODE .................................................................................. 102
EXAMINATION TIPS .............................................................................................................. 102
TIPS FOR AUTOMATIC EYE ALIGNMENT............................................................................. 102
TIPS FOR MANUAL EYE ALIGNMENT ................................................................................ 103
AUTO C-GATE ISSUES.................................................................................................... 103
TIPS TO SUCCESSFULLY SCAN DIFFICULT PATIENTS ............................................................... 106
CRITERA FOR EXAM ACCEPTANCE ........................................................................................... 109
EVALUATION OF OCT FUNDUS RECONSTRUCTION FOR POSTERIOR 3D EXAMS. ......................... 109
EVALUATION OF OCT TOMOGRAMS FOR POSTERIOR AND ANTERIOR SCANS ..................................... 113
...................................................................................................................................... 113
OCT IMAGES .............................................................................................................. 115
FUNDUS PHOTOGRAPHY ................................................................................................ 115
3D EXAMINATION ACCEPTANCE CRITERIA ................................................................................ 115
SACCADES .................................................................................................................. 115
BANDING ................................................................................................................... 116
WEAK LOCAL SIGNAL ........................................................................................................ 116
BLINKS....................................................................................................................... 116
FLOATERS ................................................................................................................... 116
CROPPED IMAGE.......................................................................................................... 116
OCT ANGIOGRAPHY ACCEPTANCE CRITERIA ......................................................................... 117
SEGMENTATION ERRORS ................................................................................................ 117
IMAGE QUALITY........................................................................................................... 118

9 RESULT REVIEW ............................................................................................................... 119


TYPE OF VIEW MODE........................................................................................................... 119
[SINGLE] TAB SCREEN .................................................................................................... 119
[BOTH EYES] TAB SCREEN .............................................................................................. 119
[COMPARISON] TAB SCREEN ........................................................................................... 119
[PROGRESSION] TAB SCREEN .......................................................................................... 119
LOCK FUNCTION........................................................................................................... 119
TYPES OF ANALYSIS .............................................................................................................. 120
SINGLE RETINA ANALYSIS ............................................................................................... 120
AI DENOISE ....................................................................................................................... 120
3D TAB ..................................................................................................................... 121

10 POSTERIOR ANALYSIS .................................................................................................. 122


RETINA THICKNESS ANALYSIS ............................................................................................. 122
SINGLE TAB ................................................................................................................ 122
6 / 387
SOCT User Manual Version 11.5 rev. C
BOTH EYES TAB ............................................................................................................ 126
COMPARISON .............................................................................................................. 129
PROGRESSION ............................................................................................................. 131
OPTIC NERVE HEAD ANALYSIS .................................................................................... 134
[BOTH] ...................................................................................................................... 134
[SINGLE] 3D ............................................................................................................... 136
[PROGRESSION] ........................................................................................................... 139
ADVANCED VIEW – RETINA AND OPTIC NERVE HEAD ANALYSIS................................................. 141
STRUCUTRE & FUNCTION – COMBINED OCT AND VF REPORT .......................................... 143
RELATIONSHIPS BETWEEN VF AND RNFL/GANGLION MAPS ................................................. 145
REQUIREMENTS THAT MUST BE MET FOR LOADING PERIMETER TESTS IN THE SOCT APPLICATION .. 146
STRUCTURE & FUNCTION – VF RESULTS LAYER IN COMBINED VIEW ....................................... 147
STRUCTURE & FUNCTION – VF LOCATIONS LAYER .............................................................. 149
WIDEFIELD EXAMINATION ................................................................................................. 151
WIDEFIELD 3D EXAMINATION......................................................................................... 151
2D SCAN PROGRAMS RESULTS REVIEW. ................................................................................ 153
SINGLE LINE EXAMINATION REVIEW. ................................................................................ 154
RASTER EXAMINATION RESULTS REVIEW. ........................................................................... 155
RADIAL EXAMINATION RESULTS REVIEW. ........................................................................... 157
CROSS EXAMINATION RESULTS REVIEW. ............................................................................ 158
3D VISUALIZATION ........................................................................................................... 159
MANIPULATION OF THE 3D CUBE .................................................................................... 159
SELECTION OF DISPLAYED LAYERS ..................................................................................... 160
OPERATION PANEL........................................................................................................ 160
[SOLID] VIEW ............................................................................................................. 162
[VOLUME VIEW] .......................................................................................................... 163

11 ANTERIOR SEGMENT ANALYSIS.................................................................................... 164


ANTERIOR RADIAL ........................................................................................................... 167
[SINGLE] TAB SCREEN .................................................................................................... 167
[BOTH EYES] TAB SCREEN .............................................................................................. 169
[COMPARISON] TAB SCREEN ........................................................................................... 169
[PROGRESSION] TAB SCREEN .......................................................................................... 170
EDIT ANTERIOR SURFACE................................................................................................ 172
AOD MEASUREMENT ................................................................................................... 173
ANGLE MEASUREMENT TOOL .......................................................................................... 174
CALIPER TOOL ............................................................................................................. 174
TOMOGRAM REVIEW ANALYSIS ....................................................................................... 175

12 FULL SCREEN WINDOW ............................................................................................... 176


FUNDUS RECONSTRUCTION, EYE PREVIEW OR PSLO ................................................................ 176
IMAGING TOOLS .............................................................................................................. 177
7 / 387
SOCT User Manual Version 11.5 rev. C
MEASUREMENT TOOLS AND ANNOTATIONS ........................................................................... 177
BRIGHTNESS AND CONTRAST ADJUSTMENT............................................................................ 178
FULL SCREEN MODE EXIT ................................................................................................... 179
TOMOGRAM WINDOW MANIPULATION ................................................................................ 179
EDITION OF RECOGNIZED LAYERS ......................................................................................... 180
MANUAL DISC CONTOUR EDITION ....................................................................................... 181
REDRAW THE DISC CONTOUR .......................................................................................... 182

13 PRINT.......................................................................................................................... 183
POSTERIOR SEGMENT EXAMINATION REPORTS/OUTPUTS ......................................................... 183
RETINA 3D ................................................................................................................. 183
DISC 3D .................................................................................................................... 187
OPTIC NERVE HEAD ANALYSIS REPORTS ............................................................................. 189
TOPOGRAPHY EXAMINATION REPORTS .............................................................................. 195
FUNDUS EXAMINATION REPORTS......................................................................................... 198
ANGIOGRAPHY EXAMINATION REPORTS ................................................................................ 200
DISC OCT-A EXAMINATION REPORTS ................................................................................... 204
BIOMETRY EXAMINATION REPORTS ...................................................................................... 208
MULTI B-SCAN REPORT ..................................................................................................... 210
MANUALLY SELECT TOMOGRAMS .................................................................................... 210
MULTI B-SCAN REPORT FOR BOTH AND COMPARISON VIEW. ................................................. 211
SINGLE TOMOGRAM REPORT .............................................................................................. 211
SELECT DESIRED PRINTER ................................................................................................... 212

14 OUTPUT ...................................................................................................................... 213

15 SELECTING FUNDUS PHOTO ......................................................................................... 214


ADDING FUNDUS PHOTO TO THE EXAMINATION...................................................................... 214
FUNDUS IMAGE REGISTRATION CORRECTION.......................................................................... 216
LINKING A FUNDUS PHOTO TO AN EXAMINATION. ................................................................... 216

16 EXAMINATIONS REGISTRATION ................................................................................... 217


OCT-OCT REGISTRATION ................................................................................................. 217
AUTOMATIC REGISTRATION ............................................................................................ 218
MANUAL REGISTRATION ................................................................................................ 219
FUNDUS REGISTRATION .................................................................................................... 219
AUTOMATIC REGISTRATION ............................................................................................ 219
MANUAL REGISTRATION ................................................................................................ 221
MOVING THE OVERLAID OCT IMAGE ............................................................................... 222
CLOSING FUNDUS AND OCT REGISTRATION WINDOW ......................................................... 223
EXTRACTING TOMOGRAMS FROM A 3D EXAM ....................................................................... 223
FUNDUS CAMERA – RESULT REVIEW .......................................................................... 225

8 / 387
SOCT User Manual Version 11.5 rev. C
COLOR FUNDUS PHOTO [SINGLE] VIEW X 1 ........................................................................ 225
COLOR FUNDUS PHOTO [SINGLE] VIEW X 4 ........................................................................ 225
COLOR FUNDUS PHOTO FULL SCREEN VIEW ........................................................................ 226
COLOR FUNDUS PHOTO [BOTH] VIEW ............................................................................... 228
COLOR FUNDUS PHOTO [COMPARISON] VIEW .................................................................... 228

17 ANGIOGRAPHY OCT .................................................................................................... 229


RETINA OCT-A ............................................................................................................. 229
[SINGLE] VIEW – STANDARD .......................................................................................... 229
[SINGLE] VIEW - DETAILED ............................................................................................. 230
ANGIO OCT ANALYSIS. ................................................................................................. 232
QUANTIFICATION TOOLS: FAZ, VFA, NFA ............................................................................ 240
FAZ TOOL .................................................................................................................. 240
VFA TOOL .................................................................................................................. 243
NFA TOOL .................................................................................................................. 244
QUANTIFICATION MAPS [DENSITY AND SKELETON] ............................................................. 246
ANGIO OCT ANALYSIS TABLE ......................................................................................... 250
[BOTH] VIEW. ............................................................................................................. 250
[COMPARISON] VIEW.................................................................................................... 252
[PROGRESSION] VIEW ................................................................................................... 253
MOTION CORRECTION ...................................................................................................... 254
MOTION CORRECTION IN 3D EXAMINATIONS .................................................................... 255
DISC OCT-A.................................................................................................................. 256
[SINGLE] VIEW. ........................................................................................................... 256
[BOTH] VIEW .............................................................................................................. 257
ANGIO DISC COMPARISON VIEW ..................................................................................... 259
[PROGRESSION] VIEW ................................................................................................... 259
MOSAIC ........................................................................................................................ 260
REGISTRATION STATUS ................................................................................................... 261
SELECT SCREEN ............................................................................................................ 262
OPERATION ON THE MOSAIC ........................................................................................... 262

18 BIOMETRY OCT ........................................................................................................... 265


BIOMETRY SAFETY INFORMATION ........................................................................................ 265
BIOMETRY ACQUISITION MODE ......................................................................................... 268
FULL AUTO MODE ........................................................................................................ 270
SEMI AUTO MODE........................................................................................................ 271
ACCEPTANCE SCREEN .................................................................................................... 273
WHITE TO WHITE ........................................................................................................ 274
RESULT REVIEW ............................................................................................................... 275
SINGLE VIEW .............................................................................................................. 276
BOTH VIEW................................................................................................................. 278
9 / 387
SOCT User Manual Version 11.5 rev. C
FULL SCREEN ............................................................................................................... 278

19 IOL CALCULATION TAB ................................................................................................. 281


IOL CALCULATION SAFETY NOTES: ....................................................................................... 281
PERFORMING IOL CALCULATION ......................................................................................... 283
MARKING IMPLEMENTED LENSES ........................................................................................ 284
IOL EDITOR .................................................................................................................... 285
IMPORTING IOL DATA ................................................................................................... 285
EXPORTING IOL DATA ................................................................................................... 286
ADDING LENSES MANUALLY ............................................................................................ 286
DELETING LENSES MANUALLY .......................................................................................... 286
VIEWING THE LIST OF LENSES .......................................................................................... 286
EDITING IOL DATA........................................................................................................ 287
ADDING ADDITIONAL POWER RANGES AND INCREMENTS ...................................................... 288

20 TOPOGRAPHY OCT ...................................................................................................... 289


TOPOGRAPHY - SAFETY NOTES ........................................................................................... 289
TOPOGRAPHY ACQUISITION MODE ..................................................................................... 292
FULL AUTO MODE ........................................................................................................ 293
SEMI AUTO MODE........................................................................................................ 294
ACCEPTANCE SCREEN .................................................................................................... 295
TOTAL QUALITY FACTOR ................................................................................................ 295
RESULT REVIEW ............................................................................................................... 296
[SINGLE] VIEW ............................................................................................................ 296
[BOTH] VIEW .............................................................................................................. 299
[COMPARISON] VIEW.................................................................................................... 299
[PROGRESSION] VIEW ................................................................................................... 300
ANALYSIS ....................................................................................................................... 300
CENTRAL KERATOMETRY – SIMK ..................................................................................... 302
KERATOMETRY (MERIDIAN) ........................................................................................... 303
KERATOMETRY (SEMIMERIDIAN) .................................................................................... 303
KERATOCONUS SCREENING ............................................................................................ 303
PACHYMETRY .............................................................................................................. 306
MAP TYPES .................................................................................................................... 307
COLOR SCALE - STANDARDS ............................................................................................... 310

21 CALIBRATION .............................................................................................................. 314


CALIBRATION PROCEDURE PREPARATION ............................................................................... 314
TOPOGRAPHY CALIBRATION ............................................................................................... 315
INTITIAL TOPOGRAPHY CALIBRATION PROCEDURE................................................................ 315
STANDARD CALIBRATION ................................................................................................ 316
CALIBRATION PROCESS .................................................................................................. 316
10 / 387
SOCT User Manual Version 11.5 rev. C
AXIAL LENGTH (BIOMETRY) CALIBRATION .............................................................................. 318
BIOMETRY CALIBRATION WITH THE IOL CALCULATION TAB UNACTIVATED ................................. 318
BIOMETRY CALIBRATION WITH THE IOL CALCULATION TAB ACTIVATED ...................................... 319
CALIBRATION PROCESS .................................................................................................. 320
ENTERING BIOMETRY CALIBRATION PARAMETERS ................................................................ 321
COMMON CALIBRATION ................................................................................................ 321

22 SETUP WINDOW ......................................................................................................... 325


GENERAL ....................................................................................................................... 325
DATABASE ...................................................................................................................... 326
STORAGE ....................................................................................................................... 328
USERS ACCOUNTS ............................................................................................................ 329
CREATING USER ACCOUNTS ............................................................................................ 330
LDAP SETTINGS ......................................................................................................... 331
PREFERENCES ................................................................................................................. 332
CMDL INTERFACE ........................................................................................................ 332
DEVICES SETUP ............................................................................................................ 333
PARAMETERS TAB ........................................................................................................ 335
VOICE MESSAGES. ........................................................................................................ 336
RESULTS SETTINGS ........................................................................................................ 337
ANONYMIZATION ......................................................................................................... 338
VISUAL FIELD .............................................................................................................. 341
INPUT SETTINGS WINDOW ............................................................................................. 342
EDIT DISEASE LIST WINDOW ............................................................................................... 343
OUTPUT SETTINGS ........................................................................................................... 343
OUTPUT SET WINDOW .................................................................................................. 343
EXPORTING TOMOGRAMS WITH OR WITHOUT AI DENOISE ................................................... 344
CREATING AN OUTPUT SET ............................................................................................. 344
GRAPHIC FILE STANDARD ............................................................................................... 344
NUMERIC VALUES OUTPUT SET ....................................................................................... 346
DICOM C-STORAGE OUTPUT SET.................................................................................... 347
BACKUP ......................................................................................................................... 348
RECOVERY ...................................................................................................................... 349
DICOM ........................................................................................................................ 349
SYSTEM SETTINGS ..................................................................................................... 350
MWL SETTINGS....................................................................................................... 351
C-STORAGE ............................................................................................................. 352
INFO TAB ....................................................................................................................... 352
PATIENT RECORD CHANGE TRACEABILITY AND LOGREADER SOFTWARE ........................................ 353

23 MAINTENANCE AND CLEANING PROCEDURE ............................................................... 353


ROUTINE CLEANING ......................................................................................................... 353
11 / 387
SOCT User Manual Version 11.5 rev. C
SOFTWARE MAINTENANCE ACTIVITIES .................................................................................. 354
HARD DISK DEFRAGMENTATION ......................................................................................... 354
ORDERING CONSUMABLES ................................................................................................. 355
FUSE ............................................................................................................................. 357
BLOWN FUSES EXCHANGE .............................................................................................. 357

24 NETWORK CONFIGURATION ........................................................................................ 358


NETWORK CONNECTION CONFIGURATION ............................................................................. 358
SOCT NETWORK ......................................................................................................... 358
SOCT SOFTWARE - VIEWING STATION CONFIGURATION ........................................................ 359

25 REMOTE CONNECTION ................................................................................................ 362


PTS APPLICATION FOR STRUCTURE & FUNCTION REPORT......................................................... 362

26 ENVIRONMENTAL CONDITIONS ................................................................................... 366

27 WARRANTY AND SERVICE ............................................................................................ 368

28 UTILIZATION ................................................................................................................ 368

29 TROUBLESHOOTING .................................................................................................... 369

30 LIST OF FIGURES .......................................................................................................... 371

31 PRODUCT COMPLIANCE .............................................................................................. 381


RADIO INTERFERENCE ....................................................................................................... 381
CANADIAN REGULATIONS .................................................................................................. 382
EMC INFORMATION......................................................................................................... 382

12 / 387
SOCT User Manual Version 11.5 rev. C
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 high-
resolution 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

13 / 387
SOCT User Manual Version 11.5 rev. C
(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,
- Adjust position of the patient, position of the instrument, the table height, and the
patient’s chair,

14 / 387
SOCT User Manual Version 11.5 rev. C
- 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 eye-
related 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.

User performing data processing


In addition to the skills required for performing measurements, the biometry module user
should have knowledge of pathological factors that influence measurement quality, in
particular:
- Corneal opacity-related light scattering of examined media
- Cataract and related light scattering of optical media
- Optimization of work flow in order to minimize pathological factors that influence
examination quality
- Handling of standard measurement protocols and measurement results such as
refraction values, corneal radius, corneal thicknes, anterior chamber depth, eye length,
lens thickness, WTW.
- Evaluation of the quality of the examination

15 / 387
SOCT User Manual Version 11.5 rev. C
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).
- 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) within 48 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.
16 / 387
SOCT User Manual Version 11.5 rev. C
Instruction Manual Applicability
This document applies to the SOCT running with the application software version 8.0 or higher,
unless superseded.

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.

17 / 387
SOCT User Manual Version 11.5 rev. C
System Overview
The SOCT device has the following interfaces that are critical for cybersecurity:
- ETHERNET port /Wireless connection for DICOM interface
- 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 auto-
logoff/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 22.4 Users accounts.

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
18 / 387
SOCT User Manual Version 11.5 rev. A
• The SOCT allows configuration to be backed up automatically at each launch or close of the
SOCT application

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 site-
specific 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

19 / 387
SOCT User Manual Version 11.5 rev. A
2 TECHNICAL DATA
REVO FC 130 [Reference Number 193-130]

Fundus Camera REVO FC


Type Non-mydriatic fundus camera
Photography type Color
Camera Built-in 12,3-megapixel CMOS camera
Angle of view 45 × (1 ± 5,0 %)°
Light source White LED
Min. pupil size for fundus 3.3 mm
Working distance Fundus photo 37 mm
OCT image
Signal source Super Luminescent Diode (SLED)
Wavelength 850 nm
Scanning speed 130 000 measurements per second
Optical power 1 575 × (1 ± 4,5 %) μW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, Line, Radial, Raster, Raster 21, Cross, Angio1, Axial
length1, Topography1
Axial resolution 5 µm (in tissue), 2.8 μm (digital)
Transversal resolution ideal 12 µm, typical 18 µm
Scanning range Posterior: 3 - 15 mm
Angio: 3 - 15 mm
Anterior scan width: 3 - 18 mm
Scanning depth 2.8 mm / ~6.0 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

1
- OCT Angiograph, Biometry and Topography are optional software module available in REVO FC 130. If you
do not have this feature and want to purchase it, contact Optopol’s local distributor.

20 / 387
SOCT User Manual Version 11.5 rev. A
REVO FC [Reference Number 190-80]

Fundus Camera REVO FC


Type Non-mydriatic fundus camera
Photography type Color
Camera Built-in 12,3-megapixel CMOS camera
Angle of view 45 × (1 ± 5,0 %)°
Light source White LED
Min. pupil size for fundus 3.3 mm
Working distance Fundus photo 37 mm
OCT image
Signal source Super Luminescent Diode (SLED)
Wavelength 850 nm
Scanning speed 80 000 measurements per second
Optical power 1200 × (1 ± 4,5 %) μW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, Line, Radial, Raster, Raster 21, Cross, Angio2, Axial
length2, Topography2,3
Axial resolution 5 µm (in tissue), 2.8 μm (digital)
Transversal resolution ideal 12 µm, typical 18 µm
Scanning range Posterior: 5 - 15 mm
Angio: 3 - 9 mm
Anterior scan width: 3 - 18 mm
Scanning depth 2.8 mm / ~6.0 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

2
- OCT Angiography, Biometry and Topography are optional software module available in REVO FC. If you do
not have this feature and want to purchase it, contact Optopol’s local distributor.
3
- available only for the devices with serial number: S/N 1905xxx

21 / 387
SOCT User Manual Version 11.5 rev. A
REVO nx 130 [Reference Number 192-130]

OCT Image
Signal source Super Luminescent Diode (SLED)
Wavelength 850 nm
Scanning speed 130 000 measurements per second
Optical power 1 575 × (1 ± 4,5 %) μW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, Line, Radial HD, Raster, Raster 21, Cross, Angio4,
Axial length4, Topography4
Axial resolution 5 µm (in tissue), 2.8 μm (digital)
Transversal resolution ideal 12 µm
typical 18 µm
Scanning range Posterior: 3 – 15 mm
Angio: 3 – 9 mm
Anterior scan width: 3 – 18 mm
Scanning depth 2.8 mm / ~6.0 mm in Full Range mode
Min. pupil size for OCT 2.4 mm
Working distance Posterior segment 37 mm, Anterior segment 52
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 29 kg

4
- OCT Angiography, Biometry and Topography are optional software module. If you do not have this feature
and want to purchase it, contact Optopol’s local distributor.

22 / 387
SOCT User Manual Version 11.5 rev. A
REVO 60 [Reference Number 191-60] / REVO 80 [Reference
Number 191-80]

OCT Image
Signal source Super Luminescent Diode (SLED)
Wavelength 850 nm
Scanning speed
REVO 60/REVO 80 60 000/80 000 measurements per second
Optical power
REVO 60/REVO 80 1 100 × (1 ± 4,5 %) μW/ 1 200 × (1 ± 4,5 %) μW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, Line, Radial HD, Raster, Raster 21, Cross, Angio5, Axial
length5, Topography5
Axial resolution 5 µm (in tissue), 2.8 μm (digital)
Transversal resolution ideal 12 µm
typical 18 µm
Scanning range Posterior: 5 – 15 mm
Angio: 3 – 6 mm
Anterior scan width: 3 – 18 mm
Scanning depth 2.8 mm / ~6.0 mm in Full Range mode
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 29 kg

5
- OCT Angiography, Biometry and Topography are 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.

23 / 387
SOCT User Manual Version 11.5 rev. A
REVO nx 130 [Reference Number 156-130]/ REVO nx
[Reference Number 156-110]

OCT Image
Signal source Super Luminescent Diode (SLED)
Wavelength 830 nm
Scanning speed
REVO nx 130/REVO nx 130 000/110 000 measurements per second
Optical power 1 575 × (1 ± 4,5 %) μW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, Line, Radial HD, Raster, Raster 21, Cross, Angio6, Axial
length6, Topography6
Axial resolution 5 µm (in tissue), 2.6 μm (digital)
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

6
- OCT Angiography, Biometry and Topography are 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.

24 / 387
SOCT User Manual Version 11.5 rev. A
SOCT Copernicus REVO / SOCT Copernicus [Reference
Number 155-27]/REVO 60 [Reference Number 155-60]/ REVO
80 [Reference Number 155-80]
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 1 100 × (1 ± 4,5 %) μW
REVO 60/ REVO 80 1 100 × (1 ± 4,5 %) μW / 1 200 × (1 ± 4,5 %) μW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning programs 3D, Line, Radial, Raster, Cross, Angio7, Axial length8,
Topography13
Axial resolution 5 µm (in tissue), 2.6 μm (digital)
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

7
- 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.
8
- Biometry and Topography are optional software modules. If you do not have this feature and want to
purchase it, contact Optopol’s local distributor.

25 / 387
SOCT User Manual Version 11.5 rev. A
Device classification

Classification Class 1 Laser Device (IEC 60825-1:2014)


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 (8 logical cores)
RAM minimum 16 GB, recommended 32 GB
Operating system Windows 11, Windows 10
HDD minimum 500 GB; recommended 256 GB SSD for OS
and 1TB SSD for Patient Data
Graphic card NVIDIA GeForce chipset with CUDA support version
11.2.0 or higher and graphics drive NVIDIA version
461.92 or higher (studio type)
Screen resolution 1920 x 1080 (Full HD), 3840 x 2160 (4K)***

Communication ports 1 available USB 3.0 port


2 available USB minimum 2.0 ports
Network card Network card supporting 1Gb/s
Mouse Mouse Wheel
Touch screen Recommended
* List of compatible computers is available in the “List_of_compatible_computers_Optopol_02” file.

**Desktop type processors are supported (K,F,S,T,X,XE) only. Learn more from
https://www.intel.com/content/www/us/en/processors/processor-numbers.html

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

26 / 387
SOCT User Manual Version 11.5 rev. A
Review station
Processor Intel® Core™ i5 2.4 GHz or higher
No of cores: min. 2 physical cores (4 logical cores)
RAM min. 16 GB
Operating system Windows 11, Windows 10
HDD Minimum 256 GB of disk space (256 GB SSD
recommended)
Graphic card NVIDIA GeForce RTX with CUDA support version
11.2.0 or higher and graphics drive NVIDIA version
461.92 or higher (studio type) or Intel graphic
chipset e.g. 630
Screen resolution: 1920 x 1080 (Full HD), 3840 x 2160 (4K)*
Communication ports 2 available USB minimum 2.0 ports
Network card Network card supporting 1Gb/s
Mouse Mouse Wheel

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

27 / 387
SOCT User Manual Version 11.5 rev. A
28 / 387
SOCT User Manual Version 11.5 rev. A
3 SAFETY
Safety information

CAUTION

Follow operating instruction

Indicates a fuse is present near this symbol

On / Off (power)

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 (Medical Device Directive MDD


93/42/EEC)

Class 1 Laser Product (IEC 60825-1:2014)

Warning, electricity

General warning sign

Warning: Laser radiation

29 / 387
SOCT User Manual Version 11.5 rev. A
Caution: Federal law restricts this device to sale by or on the order of a physician or
practitioner.

Product Label
A sample label of the REVO FC [REF 190-80]/REVO FC 130 [REF 193-130] is presented below

A sample label of the REVO nx [REF 192-110]/REVO nx 130 [REF 192-130] is presented below.

A sample label of the SOCT Copernicus REVO/SOCT Copernicus [REF 191-27] is presented
below.

A sample label of the REVO 60 [REF 191-60]/REVO 80 [REF 191-80] is presented below.

30 / 387
SOCT User Manual Version 11.5 rev. A
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 (Medical Device Directive MDD
93/43/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)

31 / 387
SOCT User Manual Version 11.5 rev. A
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
Device 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.
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.

32 / 387
SOCT User Manual Version 11.5 rev. A
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

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: Eye Care 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: It is strictly forbidden to connect any non-medical or medical devices


which are not included within the SOCT system to the Multiple Socket -Outlet.

WARNING: All activities that demand removing main body housing may be
performed by Manufacturer or Authorized Personnel trained by Manufacturer only.

WARNING: No modification of this equipment is allowed.

33 / 387
SOCT User Manual Version 11.5 rev. A
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 60950-1 or 62368-1 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.

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: This 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.

34 / 387
SOCT User Manual Version 11.5 rev. A
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.

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: Users should not rely solely on measurements made using the SOCT in
making decisions regarding the calculation and implantation of intraocular lenses or
other therapeutic procedures, but should rely on their own expertise and judgment.

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.

35 / 387
SOCT User Manual Version 11.5 rev. A
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.

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.

WARNING: Only the PC, monitor and printer have to be connected to the isolating
Transformer. Do not plug in any non-medical devices into the same wall supply
socket as the SOCT device. 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.

WARNING: 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.

WARNING: 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.

WARNING: 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.

WARNING: Use an isolating transformer if non-medical external devices are located


within 1.5 meters from the patient (patient environment). If the non-medical
external devices are connected to the medical device and located outside the

36 / 387
SOCT User Manual Version 11.5 rev. A
patient environment, a separation device must be used in the system or there shall
be no electrical connection between the non-medical external devices and the
device.

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


death or serious injury.

WARNING: The user should not rely solely on measurements made using the REVO
in making decisions regarding the treatment, calculation and implantation of IOL
lenses or other therapeutic procedures, but should rely on their own expertise and
judgment.

WARNING: The user is fully responsible for the verification of provided data using
to IOL implementation or any other medical procedure.

WARNING: The user is fully responsible for all values entered or changed
manually.

WARNING: 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.

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
37 / 387
SOCT User Manual Version 11.5 rev. A
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.

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: Prior to the measurement, the user must verify that the patient is not
wearing contact lenses. Wearing contact lenses will result in erroneous measuring
results.

CAUTION: The wearing contact lenses (soft or hard) may have an effect on the
surface geometry of the cornea and thus the optics of the eye. Therefore, for
measurements conducted on wearers of contact lenses using SOCT topography
module, a rest period should be observed from the time the contact lens is removed
to the time of measurement. The required duration of the time from removal of the
lens to the time of measurement may vary individually and must be determined by
a qualified physician.

38 / 387
SOCT User Manual Version 11.5 rev. A
CAUTION: Use of eye drops prior to topography measurement may lead to
incorrect results in the measurement of corneal curvature. The use of tear drops
substitute may impact the measured keratometry values.

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: Do not perform any contact measurements or examinations in which


the eye is touched. They may result in incorrect readings, particularly for biometry
and corneal topography measurements. Contact measurements or examinations
should only be performed after the patient has been measured with the SOCT.

CAUTION In patients with strong nystagmus may not be possible to take a reliable
examination data.

CAUTION The measurements taken with REVO may serve as the central element
for the calculation of intraocular lenses (IOL). A further important parameter in
calculating the lens to be implanted is the IOL constant. When using the REVO
devices only IOL constants optimised for optical biometers should be used. Please
contact your IOL manufacturer for information on optimised IOL constants for
optical biometry.

CAUTION: Risk due to measuring errors. Unstable fixation can lead to measuring
errors and the calculation of incorrect IOL refractive powers. Check that the patient
fixates correctly on all the scan and the fovea is visible in the all tomograms. Repeat
the measurement in case of doubt or check the measuring results by using
alternative methods, if necessary.

39 / 387
SOCT User Manual Version 11.5 rev. A
CAUTION: In patients with morphological changes of the retinal anatomy in the
region of the fovea (e.g. retinal detachment, edema), the axial length measurement
result may be erroneous and thus is not usable or only of limited use for IOL
calculation. In case of retina segmentation errors user can do correction after
verification of the region of interest.

CAUTION: Correct detection of boundaries should be checked with particular care


during measurement, especially when measuring very long eyes, eyes with dense
cataracts, pseudophakic or aphakic eyes, eyes with any kind of pathology. Despite
various plausibility checks, measuring errors can be manually be excluded or
corrected in individual cases.

CAUTION: The IOL calculation is valid only if the biometric measurement was
correct, an appropriate IOL calculation formula was selected and the IOL constants
were optimized for the specific application in advance.

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

40 / 387
SOCT User Manual Version 11.5 rev. A
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
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

41 / 387
SOCT User Manual Version 11.5 rev. A
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.

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 pre-
operative 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 4K resolution, 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.

NOTE: The aperture of the optics for the scans of the posterior segment is 15 mm.
For this reason, when using the maximum scan width for 3D and Angio scans, the
OCT signal is not visible in the corners.

NOTE: Low quality examination result can be expected in the following situations:
– Patients with complete or partial coverage of the cornea, caused by palpebral
fissure which is closed or too small.
– The patient is unable to steadily fixate the fixation light with the eye under
examination

42 / 387
SOCT User Manual Version 11.5 rev. A
Reporting adverse events
If any serious incidents have occured, they must be reported to the manufacturer or the
distributor and a competent authority of the Member States in which the user is established.

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.

43 / 387
SOCT User Manual Version 11.5 rev. A
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 the devices with reference number REF 190, 191,
192 and 193),
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. Devices with reference numbers 155 and 156.

44 / 387
SOCT User Manual Version 11.5 rev. A
Figure 2. Devices with reference numbers 190, 191, 192 and 193.

CAUTION: The SOCT weighs approximately 23 kg (REF 155 and 156), 29 kg (REF 191
and 192) or 30 kg (REF 190 and 193). 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.

45 / 387
SOCT User Manual Version 11.5 rev. A
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.

Power connector Power switch USB 3.0 Type B

Fuse socket

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

USB 3.0 Type B


Power switch

Fuse socket

Power connector

Figure 4. Rear panel of the REF 190, 191 and 192 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.

46 / 387
SOCT User Manual Version 11.5 rev. A
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.

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.

47 / 387
SOCT User Manual Version 11.5 rev. A
Applied part:
forehead support

Applied part:
chin rest support

PS2/USB 2.0 cable Keyboard*

PS2/USB 2.0 cable Mouse*

AC cord USB 3.0 PC Computer*

AC cord

Printer
USB 2.0 cable

Monitor

AC LINE AC cord
Isolating
AC socket
AC LINE transformer AC cord
lilineLcor

Figure 5 Electrical connection scheme

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

48 / 387
SOCT User Manual Version 11.5 rev. A
• REVO FC130 (REF 193); REVO FC (REF 190); SOCT Copernicus REVO (SOCT
Copernicus)/REVO 60/REVO 80 (REF 191); REVO nx 130 (REF 192)

Figure 6. The chassis (front and side), applied parts and external fixation

• SOCT Copernicus REVO (SOCT Copernicus)/REVO 60/REVO 80 (REF 155);


REVO nx/REVO nx 130 (REF 156)

External fixation
External fixation

Applied part:
forehead support

Applied part:
chinrest support

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

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.

49 / 387
SOCT User Manual Version 11.5 rev. A
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

50 / 387
SOCT User Manual Version 11.5 rev. A
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.

51 / 387
SOCT User Manual Version 11.5 rev. A
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.

Filter
Fast search
mechanism
Scanned area
preview
Add patient

Examinations list
Patient list

Device status
and SN
Figure 9. Patient tab

Result It enables to preview and analyze taken examinations.


Software version Version of application.
Device Status and SN 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
menu. To customize width of each column, grab the end of the column’s header and move to
desired position.
52 / 387
SOCT User Manual Version 11.5 rev. A
Patient filter: use this field to quickly find a patient on the list.

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

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.

53 / 387
SOCT User Manual Version 11.5 rev. A
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]

54 / 387
SOCT User Manual Version 11.5 rev. A
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.

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.

List of the patient’s Right Click to open


examinations. The last visit Visit menu
expanded
Right Click to open
Hold cursor to enlarge Exam menu
fundus reconstruction

Thumbnail of Click to expand the exam list from


scanned image specific visit

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.

55 / 387
SOCT User Manual Version 11.5 rev. A
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].

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].

56 / 387
SOCT User Manual Version 11.5 rev. A
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.

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.

57 / 387
SOCT User Manual Version 11.5 rev. A
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, Anterior Wide, Widefield – depending on
the analyzing program different views are available.
Program 3D, Angio, Line, Line FR, Cross, Radial FR, 3D, Raster, Raster 21,
Topography.
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.

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.

58 / 387
SOCT User Manual Version 11.5 rev. A
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:

Patient
Examination panel Parameters panel
information

Device head
movement
controls

pSLO live
fundus preview

Fixation control and voice Live OCT preview Examination list


guide language selection

Figure 14.Examination window view for REVO nx 130 / SOCT COPERNICUS REVO/ SOCT COPERNICUS /
REVO 60/REVO 80

59 / 387
SOCT User Manual Version 11.5 rev. A
Examination panel Patient information

Device head
movement
controls

Examination list

pSLO live
fundus preview

Fixation control and voice Live OCT preview Scan parameters and
guide language selection settings panel

Figure 15. Examination window view for REVO FC 130 and REVO FC *

Examination Panel

1 2 3 4 5

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

60 / 387
SOCT User Manual Version 11.5 rev. A
Movement control

1 2
1. Eye selector - the measurement unit moves to
5 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.
4 3. Forward/backward control - move the
3
scanning head towards or away from the patient.
6
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).
6. Pupil size indicator14 – shows if the measured diameter of the pupil is suitable for Eye
Tracking, Fundus photo or both. The indicator can have three states:
- the diameter of the pupil is smaller than the required minimum. Eye Tracking
is not available.
- the diameter of the pupil is borderline value, but it is still smaller than the
optimal. Optimal performance of Eye Tracking is not guaranteed.
- the diameter of the pupil is equal to or bigger as required value.

Detailed instructions on the operation of the movement control panel can be found in
section 7.4 Device head movement controls.

psLO preview

1
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
2. iTracking button - select checkbox
to use the iTracking technology.
3. EyeTracking9 - select checkbox to use the hardware Eyetracking. Green status confirms
fundus IR condition eye for tracking.

9
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

61 / 387
SOCT User Manual Version 11.5 rev. A
Fixation control and voice guide control

3
1. Voice guide – the icon shows the status of
2
the voice guidance system. Press to
mute/unmute. The voice guidance system
1 4
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.
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
5 tomograms correspond to the
color cross on the pSLO fundus
4 preview window. Note that
6 poorly aligned tomograms have
influence on quality of
tomograms and reliability of
3
analysis.
2
2. Focus slider - used to
1 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.

62 / 387
SOCT User Manual Version 11.5 rev. A
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.
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
1 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
1. Thumbnail - double click on the thumbnail to
open chosen examination in the tomogram
window.

Patient information

1
Patient information section - shows personal data
of the patient
2 1. The field Patient presents the name of the
patient

63 / 387
SOCT User Manual Version 11.5 rev. A
2. The DOB field presents the patient’s date of
birth

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.

64 / 387
SOCT User Manual Version 11.5 rev. A
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.
[Biometry] group – AL scan program.
[Topography] group
Widefield: 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
W-Widefield, 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.
65 / 387
SOCT User Manual Version 11.5 rev. A
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.

Raster 21 This program enables taking 21 B-scans in the highest resolution. The
default pattern is 21 horizontal lines whose length depends on the scannig program.
You can adjust the length, tomogram spacing and the angle of the scan.

Full range programs


Line Anterior Chamber Full range scan of the anterior chamber

Anterior Chamber radial Full range scan of the anterior chamber

Widefield Full Range Posterior B – scan

OCT Biometry10 programs

AL – scan provides: AL, CCT, ACD, LT

OCT Topography programs

OCT Topography11 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 .
OCT Angiography mosaic programs – merge together 3x3 or 6x6 mm scans to create high
resolution mosaics of a larger area.

10
Biometry OCT is an optional feature. It is available as an upgrade purchased separately.
11
Topography OCT is an optional feature. It is available as an upgrade purchased separately.
66 / 387
SOCT User Manual Version 11.5 rev. A
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 Anterior Photo12

OCT + Fundus Photography*

3D scanning Radial scanning B – scan + Fundus Cross scanning Raster + Fundus


program + Fundus program + Fundus Photo program + Fundus Photo
Photo Photo Photo

OCT Angiography programs with Fundus Photo available with ANGIO module:

Retina Retina OCT


Angiography + Angiography + Angiography
Fundus Photo Fundus Photo mosaic 10x6 +
Fundus Photo

12
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

67 / 387
SOCT User Manual Version 11.5 rev. A
* 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 [Widefield
Raster]
[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 Line]
[Screening] This examination set captures tomograms of the macula, disc and central
region of the retina. Scan programs: [Retina 3D] [Disc 3D] [Widefield 3D]

68 / 387
SOCT User Manual Version 11.5 rev. A
Device head movement controls
System is operated by mouse or touch screen14. 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.
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.

14
Touch screen control is an option. Contact Optopol representative for availability.

69 / 387
SOCT User Manual Version 11.5 rev. A
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.

Measurement head
back/forward
movement controls

Figure 18. Movement control buttons.

When the cursor is over the eye preview window: movement control buttons
(Up/Down/Right/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).

Click to center the pupil when


working distance is aligned

Figure 19.Device aligns to the place of clicking on the preview

Properly align the pupil to start searching for the oct signal.

70 / 387
SOCT User Manual Version 11.5 rev. A
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.
Scroll forward to compensate narrowest pupils size pupil

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)
b. Live preview window – you can move the fixation target or scroll the mouse wheel over
the window to change the working position

71 / 387
SOCT User Manual Version 11.5 rev. A
c. Grab and move the horizontal and/or vertical tomogram windows.

a. The eye preview


window D

b. Grab and move on c. Horizontal and/or


the live preview vertical tomogram
window windows

Figure 21 IR mode acquire window

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:

Color IR On/Off

Enhance On/Off

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.

Enhance Off Enhance On

Figure 23. IR preview window display options with the Enhance mode OFF and ON.
Color IR – places a pseudo-color mask on the IR image

7.6.2.1 Auto IR function15


The Auto IR function controls the parameters of the IR preview in real time and keeps the
brightness of the image stable regardless of the pigmentation or opacity level of the patient’s
eye.

15
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

72 / 387
SOCT User Manual Version 11.5 rev. A
Auto IR button

IR Quality index bar

To turn the function on or off, click the or button on the left-hand side of the
acquisition window. The Auto IR buttons presents the current state of the function:

- Auto IR function on (IR preview gain and illumination are adjusted automatically).
The IR gain and illumination sliders in the scan parameters window are disabled.

- Auto IR function off (IR preview gain and illumination can be adjusted only
manually). The bars above the letter M indicate the IR gain level ranging from 1 bar
(the lowest level) to 5 bars (the highest level), as set by the user in the scan parameters
window.
The Auto IR settings can be modified in the scan parameters window

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.

Grab the cross and drag it to change


position
Rotation of the Scanning Angle

For Raster and Line 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.

Grab the arrow end


and drag it to rotate
scan angle

73 / 387
SOCT User Manual Version 11.5 rev. A
Moving the Internal Fixation target

Drag the internal fixation target mark in the pSLO Live fundus preview. When retina/disc cross-
section 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.

Drag to move the fixation point

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.

Grab and move the corner to change the scan width

74 / 387
SOCT User Manual Version 11.5 rev. A
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.

Small fixation point


External fixation
Large fixation point point

See chapter
Figure 24. Fixation target selection 8.4 External
fixation
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, Widefield) and scanning
program (3D, Radial, Line). 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.
Number of A-scans per B-
Scan mode scan Use slider to change
value
Scan program
Number of B-scans
Scanned area change
Averaging( available for:
Line, Cross, Raster)
Scanning angle change
C gate focus mode selection
Reset to factory settings.
Press [Save] to apply Tomogram color selection
changes
Saves current parameters pSLO mode selection
as default for scan mode
Position of fixation target
Figure 25. OCT examination settings panel

75 / 387
SOCT User Manual Version 11.5 rev. A
Scanning mode Number of A-scans per B-scan.
Use the slider to change the
value
Scanning program
Number of B-scans
Scanned area change
Averaging (available for: Line,
Cross, Raster)
Scanning angle change
Fundus Camera mode
Auto Flash on/off
Fundus Camera on/off
FC Flash level adjustment
Fundus Camera mode
FC Gain settings
Tomogram color selection

FC acceptance window on/off

Fundus photo preview settings


Saves current parameters
as default for scan mode IR preview settings13

Reset to factory settings Position of the fixation target C-gate focus mode selection

Figure 26. OCT + Photo examination settings panel 16

Fundus Camera program Fundus Camera mode

Fixation position Auto Flash on/off

FC Flash level adjustment


Number of shots
FC Gain adjustment

FC acceptance window on/off

Saves current parameters


Fundus photo preview settings
as default for scan mode
IR preview settings
Reset to factory settings

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.

16
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

76 / 387
SOCT User Manual Version 11.5 rev. A
- 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 Line, Cross and Raster scanning program).
- 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 Line 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.
- Auto Flash – the function controls the FC flash and gain levels automatically and
disables the manual flash and gain sliders. To turn the function on/off, click on the icon.
- Tomogram color selection.
- Fundus Camera mode 17 – set the level of the flash – increase the value when the photo
is too dark or decrease the value when the photo is overexposed. there are three
modes available: high, normal and low. Choose the mode suitable for color of the eye
and the size of the pupil
- 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.

17
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

77 / 387
SOCT User Manual Version 11.5 rev. A
- Auto IR18 – the function adjusts the IR gain and illuminations levels automatically and
disables the manual gain and illumination controls. To turn the function on/off
check/uncheck the checkbox.

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.
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.

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

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.

18
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

78 / 387
SOCT User Manual Version 11.5 rev. A
[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.

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 artifact-
free 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.

Eye Tracking19
Eye Tracking helps to maintain scan placement when the patient blinks or moves their eye. Eye
Tracking is available for OCT scans and can be enabled or disabled by pressing the Eye Tracking

button [ ]. It also indicates the state of the function:

All requirements for performing a scan with Eye Tracking have been met.

Poor image quality and/or too narrow pupil – Eye Tracking disabled.
If the user is working in the automatic mode, and the conditions for using Eye Tracking have
not been met, the following message is displayed: „No condition for EyeTracking. Press OK to
continue examination without EyeTracking or press Cancel to stop examination.” The user can
choose to either perform an examination without Eye Tracking or to go back to the Acquire
window by clicking [Cancel].
If the user is working in the manual mode, and the conditions for using Eye Tracking have not
been met, the following message is displayed: „No condition for EyeTracking.” The message
disappears after 3 seconds, and the user can continue to manually acquire an exam with the
Eye Tracking function off.

19
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

79 / 387
SOCT User Manual Version 11.5 rev. A
Once scanning has started, a progress bar window with the Tracking status indicator is
displayed. The indicator is green if the scanning is progressing normally. If scanning conditions
deteriorate (due to blinking, poor IR image quality etc.) or if the device is repositioning the
lens, the Tracking status indicator turns red.

If the patient eye conditions are to demending to finish or patient is bot able to keep the head
during long measurment press [Finish] OCT scanning without eye tracking.
[Cancel] – stops examination without saving results.
If Eye Tracking fails, the following message is displayed. Click OK to close it. The examination
will be saved with a negative quality index (NG).

After conducting an examination with Eye Tracking, the system displays 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.
Eye Tracking button separately stores status for each Angio OCT and 3D scans.

Acceptance window for a 3D scan

Figure 29 3D Scan Acceptance Window.

80 / 387
SOCT User Manual Version 11.5 rev. A
[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.
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.

Figure 30 Angio Scan Acceptance Window

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.
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
81 / 387
SOCT User Manual Version 11.5 rev. A
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, WIDEFIELD - 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).

82 / 387
SOCT User Manual Version 11.5 rev. A
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.
[Start] becomes active

when device status is


Device status
“READY”

Full auto active when marked

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


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].

Full auto mode is disabled

Figure 32. Semi auto examination

OCT signal will be placed between horizontal lines.

Figure 33. Semi-automatic examination mode

83 / 387
SOCT User Manual Version 11.5 rev. A
Scan optimization and tomogram position alignment. Double click or [Acquire] button starts
measurement.
If QI and position of the tomogram are proper proceed to point 0.

Figure 34. Proper quality and position of the tomogram

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.
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.
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.
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.

84 / 387
SOCT User Manual Version 11.5 rev. A
Manual mode
Uncheck [Auto Acquire]
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.

Full auto mode is


disabled

Press forward
movement until two
images crate one
Figure 35. Manual examination mode

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

In case QI and position of the tomogram is proper proceed to point 6.

Figure 37. Proper position and the quality of the tomogram

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.

85 / 387
SOCT User Manual Version 11.5 rev. A
• Change scanners offset.

• In order to visualize the interesting retina structures better you can choose
Chorioretinal and Vitreoretinal C-gate mode.
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.
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.
After examination is over the system transfers the captured image into database.

Scanning programs description


Retina examination
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.
Verify scan program and change to RETINA if required.
Follow the procedure depending on Acquisition mode. See chapter 8.3 Acquisition modes
description

Figure 38. Proper Alignment of retina tomogram

Widefield examination
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.
Verify scan program and change to WIDEFIELD if required.
Follow the procedure depending on Acquisition mode. See chapter 8.2 Acquisition modes
description

86 / 387
SOCT User Manual Version 11.5 rev. A
Figure 39. Widefield examination proper scan alignment

Disc area examination


Prepare the patient as explained in chapter 8.1 Preparation for examination.
Select Disc mode and scan type from program panel.
NOTE: Program settings do not change Fixation position.

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.
Press [START] button for Full Auto or Semi Auto mode.
In Semi Auto or Manual when OCT signal is aligned properly, after a while the pSLO fundus
preview image of the optic nerve appears.
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.

87 / 387
SOCT User Manual Version 11.5 rev. A
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.
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


Prepare the patient as explained in chapter 8.1 Preparation for examination.
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.
Select one of Angiography scan program.
Follow the procedure depending on the Acquisition mode. See chapter 8.2 Acquisition modes
description
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.

88 / 387
SOCT User Manual Version 11.5 rev. A
OCT Angiography mosaic mode
Prepare a patient as explained in chapter 8.1 Preparation for examination.
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.

Figure 42 Exam List - Angio Scans.

8.3.5.1 Predefined mosaic modes


Select one of Angiography Mosaic mode program.
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.
System will load next examination and start shifting the fixation and the scanners position.
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.
If voice guide is switched off inform the patient to follow fixation target.
If required correct position of tomogram and press Acquire to capture next image.
After last examination system will not load the next scan program.

8.3.5.2 Manual mosaic acquisition mode


Prepare a patient as explained in chapter 8.1 Preparation for examination.
Instruct patient that you are going to take a few examinations and fixation target may change
the position.
Select one of Angiography mode program. If required you can change default parameters.
After Acquire the first Angio scan on the confirmation screen check [Mosaic mode] to activate
the mosaic mode.

89 / 387
SOCT User Manual Version 11.5 rev. A
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.
If voice guide is switched off inform the patient to follow fixation target.
If required, correct the position of the tomogram and acquire the image.
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.

Area already scanned


Frame color as guide
marked

Figure 43. Scanned area marked on pSLO window

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 Preparation 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.

90 / 387
SOCT User Manual Version 11.5 rev. A
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.

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.

91 / 387
SOCT User Manual Version 11.5 rev. A
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 & NX & FC
The Anterior Chamber Adapter is not applicable for REF 190, 191 and 192 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 (REF 155 and 156)
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:
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.

92 / 387
SOCT User Manual Version 11.5 rev. A
Figure 47.Side views of Anterior Adapter

In order to conduct examination of anterior segment, prepare the anterior adapter and follow
the instructions below:
1. Select one of Wide Anterior scan program. The scanning head has moved back.
2. Install Anterior Chamber Adapter on the objective lens.
3. Grab the Anterior Adapter as shown on the image (two fingers are close to insertions
positioned horizontally.

Figure 48. Anterior adapter mounting

4. Get the adapter to the objective and rotate 900 clockwise.

Figure 49. Anterior adapter mounting. Rotate to lock.

93 / 387
SOCT User Manual Version 11.5 rev. A
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

- 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

9. 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.

94 / 387
SOCT User Manual Version 11.5 rev. A
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
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.
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.
Verify the scanning program and change it to the required mode.
Follow the procedure depending on Acquisition mode analogical to the OCT scanning modes.
See chapter 8.2 Acquisition modes description

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.

95 / 387
SOCT User Manual Version 11.5 rev. A
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.

The cross identifies the


centre of the lens and
has to be place in the
centre of the pupil.

Figure 53. Aligned pupil position in Fundus Camera mode

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.

CORRECT WRONG
D 96 / 387
SOCT User Manual Version 11.5 rev. A
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

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.

97 / 387
SOCT User Manual Version 11.5 rev. A
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 left


side of the retina

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.

Vertical tomogram
Grab and move the tomogram to
optimize the retina preview when the
reflex is at the top or at the bottom

Visible reflex on the bottom


of the retina

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.

8.3.10.3 Fundus Image Acceptance Window


After taking a Fundus photo with or without OCT, the fundus acceptance window is displayed.

Fundus image taken


[Rescan]

[Reject]

[Accept]

Figure 59. Fundus image acceptance window for Fundus mode

98 / 387
SOCT User Manual Version 11.5 rev. A
[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.

Tomogram form centrum of the


Fundus image taken
scanning area

fundus reconstruction (only for 3D


[Accept] scans and Angio)

[Rescan]

[Reject]

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] – 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 2.8 mm to
~6.0 mm (Revo FC, Revo 60, Revo 80, Revo nx 130) or from 2.4 mm to 4.8 mm
(SOCT Copernicus, SOCT Copernicus Revo, Revo nx,). 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).

99 / 387
SOCT User Manual Version 11.5 rev. A
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 Line 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).
In the semi-automatic and manual modes, the image visible in the tomogram window can be
displayed in two modes:
Simple mode Complex mode
Fast refresh Full Range discoupled – faster Full Range coupled mode – default – lower
refresh. In the simple mode the user can see the refresh. In the complex mode the original and
original image together with its inverted inverted images are coupled to form a detailed,
reflection. homogenous image.

100 / 387
SOCT User Manual Version 11.5 rev. A
Widefield Full Range examination mode

Figure 62.Full Range Posterior Line 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.
In the semi-automatic and manual modes, the image visible in the tomogram window can be
displayed in two modes:
Simple mode Complex mode

Fast refresh Full Range discoupled – faster Full Range coupled mode – default – lower
refresh. In the simple mode the user can see the refresh. In the complex mode the original and
original image together with its inverted inverted images are coupled to form a detailed,
reflection. homogenous image.

101 / 387
SOCT User Manual Version 11.5 rev. A
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

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 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.
102 / 387
SOCT User Manual Version 11.5 rev. A
Tips for Manual Eye Alignment e

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.

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.

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;
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.

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.

103 / 387
SOCT User Manual Version 11.5 rev. A
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.
e

Focus correction may improve the


saturation of the tomogram.

If shadows are displayed on tomogram


edges, check whether the pupil is
centered.
To eliminate shadows, drag the
tomogram into the shadow.

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.

104 / 387
SOCT User Manual Version 11.5 rev. A
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 Widefield Peripheral, align the retina


between the two dashed horizontal lines.

3D Widefield, align the retina between


the two dashed horizontal lines.

For all Vitreous scans, align the Vitreous


structure between the two dashed
horizontal lines.

Anterior Line Angle C-Gate top, place the


angle structure below the dashed
horizontal lines.

Anterior Wide Line with Two Angles,


align the two angles between the dashed
horizontal lines.

105 / 387
SOCT User Manual Version 11.5 rev. A
Anterior Wide Line 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.

Full Range Anterior, make sure the


cornea is aligned with the dashed vertical
line, align the cornea between the
dashed horizontal lines.

Full Range Posterior, for the best image


quality align the retina between the two
dashed horizontal lines indicating the
area with the highest scanning
sensitivity. If, however, the user wants to
broaden the visualization range above or
below the retina, the image can be
aligned below or above the dashed lines.

Tips to Successfully Scan Difficult Patients


Problem: A patient with poor sight has difficulty following the fixation, causing the scan to
be invalid.
Possible solution: Utilize the large fixation or external fixation (see chapter 8.4) as an aid in
keeping the scanned eye in the scanning area. If the eye moves outside of the scanning area,
stop the scan and help the patient relax and focus on the fixation. Re-scan the patient.
Patients with large refraction error may be challenging for the automated processes to find
the retina.

106 / 387
SOCT User Manual Version 11.5 rev. A
In this case, the refraction error has to be compensated manually with C-Gate scrolling until
the retinal structure is recognized. If the issue still persists, verify pupil position and adjust if
necessary. Utilize the large fixation target. It is important to enter patient refraction error to
each patient so that the system can automatically adjust C-Gate in further scans.
Stressed, nervous or scared patients are likely to have excessive upward-downward
movements in the scan window causing poor scans.
Patient movement will not necessarily affect scan sequence, but will always affect the quality
(observe QI index bar). Action is required if such movements occur. Try asking the patient to
minimize movement during scan.
Also, try moving the device head slightly towards or away from the patient to stabilize the scan
window.
Lastly, the stability of the table can be utilized. If possible, position the table low enough so
that the patient can rest their head firmly in the headrest and ask them to wrap their arms
around the base of the device. This will place the patient in a firm and locked position and
minimize movements.
NOTE: If after scanning the patient begins to drift, remind them to continue being
in this same position in case a repeat would be necessary.

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
movement.

The pictures below show how to make proper measurement and how to align the device.
Dashed lines identify the right position of the retina in the live OCT window.

Horizontal scan Vertical scan

Figure 64. Properly aligned retina between dashed lines

In the picture below the tomogram is upside down, C-gate position is too low. Move C-gate.
You can get a proper examination position by scrolling the mouse wheel or dragging to the
desired position.

107 / 387
SOCT User Manual Version 11.5 rev. A
Figure 65. Improper-flipped tomogram preview

Figure 66. Shadow on tomogram, grab and drag towards left side

Vertical line in fundus preview window is related to the right part of scan preview window. This
line shows the position of the scan in the eye. A scan should be horizontal, drag tomogram and
move left/right. (Left/Right drag movement on the vertical OCT live window corresponds to
up/down movement of the head. In the case here above the device is too high, so it should be
dragged left (move down).

Figure 67. Shadow on tomogram, grab and drag towards right side

Horizontal line in fundus preview window relates to left part of scan preview window. This scan
also should be horizontal. In the case here above the tomogram should be dragged right (head
movement device should be moved right to align scan and remove shadow.
The easiest way to align the tomograms is to drag a tomogram to the proper position.
If it is required to manually align working position across the center of the pupil, move first the
scanning head (usually forward) to working distance. At the working distance images created

108 / 387
SOCT User Manual Version 11.5 rev. A
from two preview cameras create one equal view. Then click on the pupil or use up/dw and
right/left movements to place the white cross in the center of equally aligned pupil.

Figure 68. Proper live eye preview while manual acquire mode

Critera for Exam Acceptance


Use the following criteria to ensure that an OCT image you have captured is suitable. Evaluate
Fundus reconstruction to see the quality of the OCT exam and then evaluate OCT images.

Evaluation of OCT Fundus reconstruction for Posterior 3D exams.


• The fundus reconstruction image should be sharp and clear, preferably with good
visibility of the branching blood vessels
• The Fundus reconstruction image should have uniform saturation without dark corners
• The Fundus reconstruction image should have no or minimal saccades throughout the
scan
• The operator should review the Fundus reconstruction image to ensure that there are
minimal saccades and no saccades in the area of interest (e.g. macula).
• A saccade can be detected by discontinuities in the appearance of the blood vessels
(for example, a horizontal shift of the vessel at a specific location).
• The Fundus reconstruction should have no blinks
• The Fundus reconstruction: there should be no, if any, artefacts that may cast shadows
on the OCT scan. Shadows can come from media opacity such as e.g. cataract or floaters.
Small pupil scan
There is a visible dark area on the edges of the scan.

109 / 387
SOCT User Manual Version 11.5 rev. A
Figure 69. OCT scan through a very small pupil

Figure 70. Examples of scans with dark corners

Locally Weak Signal


Regional drop of the signal, either caused by floaters or by media opacity e.g. cataract can be
recognized in the fundus reconstruction image and confirmed in corresponding B-scans.

Figure 71. Example of a cataract patient with a loss of saturation

Floaters
Similar to blinks, floaters are obstructions of the OCT scan beam, thereby reducing the signal
strength reflected from the tissue beneath the obstruction. If a floater has sufficient density
and size, the vessels below can appear as weak or missing completely as visible in the example
below. This example also shows saccadic motion.

110 / 387
SOCT User Manual Version 11.5 rev. A
Floater artifcact Floater artifcact

Saccadic motion Saccadic motion

Floater artifcact

Figure 72. Examples of floaters with saccadic motion

These above “shadows” can be identified as floater artifacts by cross-checking for the same
pattern of shadows across the enface scan and B-scan. The above example displays the shadow
that starts in the vitreous and proceeds through the retina, which effectively shows that there
was an opacity between the light source and the tissue. This can further be identified as a local
signal reduction.
Although this type of local signal reduction is not analyzed by the Quality Index calculations, it
may significantly affect results analysis. These examinations should therefore be analyzed
carefully or repeated without floaters. The above examination in particular also has saccadic
motion, therefore it should be repeated regardless.
Blinks
Blink artifacts are obstructions of the OCT scan beam during acquisition causes absence of
information while the eye is closed. These artifacts appear as straight black lines without any
structure within the lines. These lines are easily visible and can also be recognized due to the
loss of image. Motion Correction is designed to prevent these artifacts from forming, however
it may still be possible for blinks to be visible in exams without iTracking™ enabled. Below is
an example of a blink in the OCT image.

Figure 73 Example of an uncorrected blink

111 / 387
SOCT User Manual Version 11.5 rev. A
Example of blinks corrected by Motion Correction that is acceptable for analysis.

Exam 1 Exam 2 MC Result

Figure 74 Blink artifacts corrected to an acceptable standard

Blinks can also be identified as a local signal reduction. Although this type of local signal
reduction is not analyzed by the Quality Index calculations, it may significantly affect results
analysis. These examinations should therefore be analyzed carefully or repeated without
artifacts.
Saccades
A saccade can be detected by discontinuities in the appearance of blood vessels, usually visible
as a horizontal shift of the image. For 3D exams it is important to ensure that there is minimal
if any, saccadic motion. There should be no protrusion into or through the areas of interest,
such as the macula or optic disc. iTracking™ is purposed with minimizing the possibility of
saccadic motion being captured. Below is an example of multiple horizontal shifts known as
saccades and is not acceptable for analysis.

Figure 75. Example of a saccade

Example of saccadic motion corrected by Motion Correction that is acceptable for analysis
after processing.

112 / 387
SOCT User Manual Version 11.5 rev. A
Exam 1 Exam 2 MC Result

Figure 76 Saccadic Motion corrected to an acceptable standard

Evaluation of OCT tomograms for Posterior and Anterior scans


• The central part of the scan has to be centered on the fovea or the apex of the cornea
or Anterior Angle has to be in the center.
• OCT scans should be complete and without missing data.
• Verify the position of the retina or the cornea in the scan window. No part of the signal
can touch the upper or lower edge of the tomogram. If the tissue of the eye is captured
too low or too high in the axial field of view of the scan, then part of the signal will be
overlaid by a ghost signal and it can present an untrue structure.
• The intensity of the signal has to be uniform from one end of the tomogram to the
other.
• The retinal image should be well-defined. Retina surface has to be strongly
distinguished from the background and hiper-reflective layer. (ILM, OS/RPE) should not
have excessive motion artifacts.
• The corneal image should have well–defined posterior and anterior surfaces, should
not have excessive motion artifacts.
• The corneal image should have well–defined posterior and anterior surfaces, should
not have excessive motion artifacts and strong reflections from anterior surface.
If the image does not meet the criteria the operator has to retake it.
Example of a well saturated and centered tomogram with the fovea in the center.
The signal is equally saturated across the whole scan.

113 / 387
SOCT User Manual Version 11.5 rev. A
Figure 77. Example of a well saturated and properly centered tomogram

Figure 78. Example of a scan with shadowing visible on the side

Example of Cataract
Example shows an image with a poor signal quality throughout part of the OCT image. On the
left side of the OCT image a properly saturated structure is brightly visible. The retinal layers
on the right side are not visible on All A-scans.

Figure 79. Example of a scan with cataract

Example of an OCT image placed too high with a part of the Scan out of range. A part of the
retina cross-sectional OCT image is cropped. A part of the OCT structure is out of the scan
window.

114 / 387
SOCT User Manual Version 11.5 rev. A
Figure 80. Example of an OCT image placed too high

Example of an OCT image placed too high. The whole scan is out of the scan window.

Figure 81. Example of an OCT image placed high and out of the scan window

OCT images
• For optimal quality, the signal strength should be rated 7 or more.

• Scans should be complete in all windows without missing fields.

• Density of color and features should be the same throughout.

Fundus photography
• The scan should be overlaid and centered directly on the fovea or optic nerve head.

• Photo focus should be sharp and clear. Branching blood vessels should be clearly
visible.

• Artifacts that may cast shadows on the OCT scan should be kept to a minimum.

3D Examination Acceptance Criteria


Prior to accepting a 3D examination, the user must ensure that the acceptance criteria are
met.

Saccades
Obstructions in the form of saccades are described in section 8.8.2 Evaluation of OCT
tomograms for Posterior and Anterior scans
115 / 387
SOCT User Manual Version 11.5 rev. A
Banding
Carrying out 3D exams with iTracking™ enabled may lead individual B-Scans being acquired at
different horizontal positions. Due to this, there may be vertical tissue variations in the B-scan
window. Although iTracking™ is also purposed with correcting for this motion, it may
nevertheless cause the OCT images to contain intensity artifacts. These artifacts appear as
horizontal lines or form bands in the OCT image, as shown in the examples below:

Figure 82. Examples of banding

Given that there are no saccades, exams with OCT images like these should be sufficient for
analysis as there is no protrusion into or through the areas of interest. The operator is
therefore advised to save the exam.

Weak local signal


Weak local signal is often caused by media opacities between the OCT scan beam and the eye.
There are several causes and sometimes carrying out an examination again will resolve the
problem.

Blinks
Visual obstructions in the form of blinks are described in section 8.8.2 Evaluation of OCT
tomograms for Posterior and Anterior scans.

Floaters
Visual obstructions in the form of floaters are described in section 8.8.2 Evaluation of OCT
tomograms for Posterior and Anterior scans.

Cropped Image
In cases where the retina is placed too high or too low in the OCT acquire window, it will usually
lead to image cropping. These can be recognized in the reconstruction image and cross-
checked against corresponding B-scan images.

116 / 387
SOCT User Manual Version 11.5 rev. A
Figure 83. Example of a cropped image

These artifacts can also be identified as a local signal reduction. Although this type of local
signal reduction is not analyzed by the Quality Index calculations, it may significantly affect
results analysis. These examinations should therefore be analyzed carefully or repeated
without artifacts.

OCT Angiography Acceptance Criteria


Prior to accepting an Angiography exam, the user must take the following points into
consideration:

• Segmentation errors

• Image quality

Segmentation errors
These errors may result in incorrect visualization of Angio flow. The two boundary lines are
used to determine the particular enface image shown appear as purple and green lines
overlying the B-scan. It is important to confirm the presence or absence of Angio flow and
whether it is associated with the layers of interest. It may happen that Angio flow is present in
areas where it shouldn’t be.
For example, the below image that should be avascular shows several bright areas.
Examination of the B-scan shows an area that has pushed the segmentation up into the hyper-
reflective outer plexiform layer. This was caused by a drusen, therefore any bright signal
detected at this location is likely due to ordinary inner retinal vasculature and should be
regarded as an error.

Figure 84. Example of a segmentation error in OCT Angiography

117 / 387
SOCT User Manual Version 11.5 rev. A
This example shows an avascular retinal layer which demonstrates that the segmentation is
not correctly passing through the outer retinal layer that is expected to be free of signal.

Image Quality
OCT Angiography is far more sensitive to signal quality than structural OCT imaging. Poor signal
quality will have great effect on image quality and may lead to dark areas, which can affect
interpretation of the exam. OCT Angiography may therefore occasionally display dark spots
that are not a result of capillary dropout but rather due to poor local signal. See examples
below.

Figure 85. Example of poor image quality caused by saccadic motion

It is clear that the issue in this example is caused by saccadic motion. In other cases, floaters
or other media opacities are causes for concern when accepting an OCT Angiography exam.
The operator may also examine the B-scan and the structural enface image.
In a real disease, the image will appear dark, but the B-scan and enface image will not. To
cross-check this for errors, it is advisable to carry out more than one examination in cases
where floaters or other media opacities may be an issue.

118 / 387
SOCT User Manual Version 11.5 rev. A
9 RESULT REVIEW
This chapter describes kind of reports which show the analysis results of examinations.
Analysis depends on the scan mode and diagnostic purpose of analysis.
Results review window enables operator to browse all the stored examination results. This
window contains all tools for analysis of acquired data. The main window contains tabs:
Tomogram, 3D-Imaging, Retina, Glaucoma or cornea analysis, Comparison, Fundus camera
image.

Type of View Mode


Depending on the type of examination the system can display different analysis views.
Not all views are available for each scan.

[Single] tab screen


This screen shows the analysis results of one eye.

[Both Eyes] tab screen


This screen shows the analysis results comparing examinations of both eye in the same scan
mode on the same date.

[Comparison] tab screen


This screen shows the analysis results comparing two examinations of one eye on the same
side in the same scan mode, from different dates. The comparison tab also features the lock
function for common manipulation of tomograms. More information on the lock function can
be found in section 9.1.5 Lock function.

[Progression] tab screen


This screen shows the analysis results comparing six examinations arranged in time sequence
of eyes on the same side in the same scan mode, and same size of scanning area.

Lock function
9.1.5.1 Standard Lock function
The Lock Function enables simultaneous and synchronized manipulation of several
tomograms. Available operation: scrolling examination, zooming in/out, moving tomograms,
changing display parameters i.e. brightness/contrast, display method. The Lock is available in
the Both Eyes, Comparison and Progression tabs for Posterior scans. To lock tomograms, click

the arrow next to the lock button to unfold a drop-down menu and choose .

119 / 387
SOCT User Manual Version 11.5 rev. A
Lock function
button

Figure 86. Progression view – Lock function on

9.1.5.2 Lock function with extracted tomograms


The Lock Function is also available in conjunction with the function of extracting tomograms
described in detail in section 16.3 Extracting tomograms from a 3D exam. To both lock and

extract correlated tomograms click the arrow next to the lock button to unfold a

drop-down menu and choose .

Types of Analysis
Single Retina analysis
This shows the tomogram image of the macula and analysis results of retinal thickness from
Retina 3D scan. There are two analysis views available.

AI DeNoise
The AI DeNoise algorithm filters out noise form the tomogram for the highest and smoothest
image quality. The function is available on all tomograms and in every tab featuring them,
including the 3D tab. On averaged tomograms the function is on by default.
The moment a tomogram is loaded for review the software starts denosing it. After a short
moment the original “undenoised” tomogram is replaced with a noise-free image.
This process is started each time you load or scroll to display a new tomogram.
The figures below present the same tomogram with the AI DeNoise function off (left)
and on (right).

120 / 387
SOCT User Manual Version 11.5 rev. A
Figure 87. AI DeNoise off (left) and on (right)

CAUTION The AI DeNoise algorithm works to enhance the visibility of morphological


structures by processing the original image. However, tomograms with very low
signal level or low QI may be challenging to be processed correctly. When working
with such tomograms it is recommended that the user always compares the denoised
image with the unprocessed image to make sure there is no variance between
morphological structures presented on both tomograms.

Turning AI DeNoise on and off


When the AI DeNoise function is on it is indicated by the sign in
the upper right-hand corner of the tomogram.
You can always turn the function off and go back to the original
image. To do that hover your mouse over the sign. It will change into the switch for
you to click the function off. Clicking the switch again turns the function back on.
The state of the switch on shutdown is remembered to be restored when you launch the
software again.

3D Tab
The AI DeNoise function in 3D tab is available in both the Solid and the
Volume view. To turn it on go to the settings section inside the tab and click
Display. At the bottom of the Display tab there is an AI DeNoise checkbox.
Select it to apply the AI DeNoise algorithm to the image. If you deselect the
checkbox the denoise function is turned off. The state of the checkbox
inside the 3D tab does not influence the AI DeNoise switch in other tabs.
Figure 88. DeNoise checkbox in the 3D tab

121 / 387
SOCT User Manual Version 11.5 rev. A
10 POSTERIOR ANALYSIS
Retina Thickness Analysis
Requirements that must be met for loading perimeter tests in the SOCT application.

Single Tab
In „Single Tab” single eye retina analysis is presented. For each examination retina charts and
maps used for diagnosing are calculated. Except for maps interpretation it is possible to browse
single tomograms that illustrate changes in the retina structure.

Quality index
Scroll to change
Double click to displayed tomogram
open Full Screen
Retina thickness
Retina map
signification
Retina
Dragging up/down to deviation map
adjust brightness
NFL+GCL+IPL map
Sectors grid

Retina thickness
Information table graph
map
Figure 89. Single eye retina analysis

10.1.1.1 Tomogram window


Scroll the Mouse wheel to change displayed tomogram.
Double click to open Tomogram Full screen window.
Press right mouse button to display Functional menu.
Hold right mouse button and move right/left and up/down to change brightness and contrast.
10.1.1.2 Retina signification
The fundus reconstruction image is created from all A-scans made in the scanned area.
From the menu available by the right mouse button you can select the image to overlay.
The following images are available:
• Fundus reconstruction,
• pSLO,
• Fundus photo,
• Import fundus photo.
To change transparency level, turn the mouse wheel on the fundus reconstruction image.

122 / 387
SOCT User Manual Version 11.5 rev. A
Right Click (long press using touch screen) over the eye preview window opens the following
display and actions menu.
Enables B scan cursor to get reference on fundus
preview
Shows border of the scan on the fundus photo

Display Fundus photo, Reconstruction or pSLO in


eye preview window

Import fundus photo


Registration of the fundus photo

Fit Fundus or OCT to the window


Enables color reconstruction

Figure 90. Eye preview widow context menu

10.1.1.3 Sectors grid


Sectors graph corresponds to the grid overlaid on the Retina thickness map. In the sectors
graph the retinal thickness of each sector appears. Background colors are color-coded based
on the normative database.
It is possible to show sector with diameter: 1 / 3 / 6 [mm] or 0.6 / 2.22 / 3.45 [mm]. When
“Grid” option is selected, the whole map will be covered by grid of numbers. Each number
represents thickness at a selected point.
You can choose which value you want to observe in sectors: Mean, Maximum, Minimum or
Volume of the zone. The thickness map is further organized and presented in the nine ETDRS-
like Zones.
10.1.1.4 Information table
In the information table there are: average thickness of central sector, volume of scanned cube
and average retina thickness in scanned cube.

10.1.1.5 Retina thickness graph


Background of Retina Thickness graph shows the normative margin, the vertical blue line
corresponds to the horizontal position of the pointer on the tomogram. These graphs are
obtained only after detecting layers by means of Layers function.
The normative data are applicable to scans acquired with 3D scan mode. When the “Layers”
checkbox is marked and 3D protocol is applied to an applicable scan, normative data ranges
appear in the background. It uses a light red, light yellow, light green, yellow, red color codes

123 / 387
SOCT User Manual Version 11.5 rev. A
like in the legend below, to indicate values. The color code applies to each particular A-scan
location in the graph.
NOTE: Make sure that the marker which shows the center of macula in retina
analysis tab locates the fovea properly.

White area on the retina thickness chart identifies the area that is not covered by normative
data. e.g. scan length higher than 7mm and fovea not in the center of a scanned area.

10.1.1.6 Macula Normative distribution:


1% 1% falls within the light red band, considered outside the normal limit

4% 4% fall within or above the light-yellow band

90 % 90% fall within the green band

4% 4% fall within or below the yellow band

1% 1% falls within the red band, considered outside the normal limit

NOTE: Clinicians must exercise judgment in the interpretation of the normative


data. For any particular measurement, note that 2 out of 20 normal eyes (10%) will
fall above or below green.

DISCLAIMER: OPTOPOL Technology Sp. z o.o. takes no responsibility for diagnostic


interpretation of OCT images. It is the clinician’s responsibility to make diagnostic
interpretations of OCT scans.

10.1.1.7 Retina thickness map


Scroll over the tomogram to change the tomogram. Thickness at the single point of map can
be measured. Place mouse cursor over any map at the desired point and click left mouse
button. Detailed values will be displayed in the panel in the upper left corner of every map.
Macula location is detected automatically. There is possibility to correct fovea detection. Move
mouse cursor over a center of central sector. Click and hold left mouse button on a white dot
at “Retina thickness map” and move pointer to the desired position.

10.1.1.8 Quality index


Quality Index is a numerical value which represents the OCT exam image intensity and signal
coverage. The QI is a quantitative measure of signal strength, greater intensity corresponds to
a higher QI. Quality index takes values in the range from 0 to 10, where:
0 - represents the noise level (i.e. examination scanned without any object)
10 - represents a scan of a healthy patient with high saturation of signal and lack of shadings
in the boundary areas.

124 / 387
SOCT User Manual Version 11.5 rev. A
The Quality Index is a global examination index, which represents an average quality of all
tomograms. Quality Index uses all b-scans for 3D scans. When averaging is used (Line, cross,
radial, raster) the system calculates QI only from averaged images.
QI should be displayed on the thumbnails area under the exam date in single, both,
comparison and progression views.

NG (Rejected Status): if the examination has been marked as rejected, the NG mark is displayed
instead of QI on the examination list (only)
When the examination has QI=0 it is automatically labelled NG. If the NG label is not selected
to be automatically displayed on the tomogram – the TQF window is displayed instead.

QI must be placed on every report printed or saved into a file. QI must be displayed below the exam
date. Depending on the particular view the QI label position may differ.

Single view
10.1.1.9 Retina Deviation Map
Retina Deviation Map shows the percentage loss of the retinal thickness from the norm
determined from the normative database. Each pixel value on the map is calculated as
percentage value by the following formula:
(Thickness value – Normal value)/(Normal Value ) * 100.
The range of the color-coding of the map corresponds to -50% to 50% deviation.
The color-coding is roughly defined as below.
Red: Maximum (+50%)
Yellow: Around Upper Middle
Green: Around Middle (0 %)
Cyan: Around Lower Middle
Blue: Minimum (-50%)

125 / 387
SOCT User Manual Version 11.5 rev. A
10.1.1.10 Thickness map
• Retina Significant • Inner Retinal thickness

• Retina deviation • Outer Retinal thickness

• RPE deformation • NFL+GCL+IPL thickness

• NFL thickness • GCL+IPL thickness

• MZ/EC-RPE thickness

10.1.1.11 RPE Deformation Map


This color-coded map displays the elevation of the RPE from a normalized plane.
The RPE deformation is a difference between a normalized RPE parabolic fit and an outer
boundary of RPE layer.

Both eyes tab


In the tab „Both eyes” it is possible to make comparison of both eyes’ analysis i.e. left and right
eye. As a consequence, symmetry analysis of both eyes can be done there.

10.1.2.1 Retina view


Retina view on a Both eyes tab displays the output of the retinal thickness map,
thickness/volume sectors map plus two other maps. It is possible to choose from the bottom
Retina thickness/Retina signification/Retina deviation/Not overlaid.
This analysis protocol operates on one Right and one Left examination made with the 3D or
Radial of Macula protocols.

Retina Retina
thickness signification
map map

RPE
deformation
Sectors grid
map

Information
table
Tomogram

Figure 91. Both eyes retina analysis

Sectors Map shows either average, maximum, minimum retinal thickness (in microns) or
volume (in mm3) in each area. From Map Sector Dimension checklist choose circle diameters
0.6 / 2.22 / 3.45 mm or 1 / 3 / 6mm.

126 / 387
SOCT User Manual Version 11.5 rev. A
10.1.2.2 Ganglion view
This tab is enabled only with Retina 3D scan.

Change exam

Analysis selector

Thickness map Fovea axis

Deviation map

Information
table
Hemisphere R–L–
asymmetry asymmetry map

Figure 92. Ganglion Cell Analysis (GCC)

Software offers two methods of an indirect measurement of the Ganglion Cell layer:
- RNFL+GCL+IPL
- GCL+IPL
Thickness map to overlay on the fundus reconstruction can be selected from the list box:
- RNFL+GCL+IPL Thickness Map
- GCL+IPL Thickness Map

VF Locations
Right click on any of the above maps to view the context menu from which VF locations display
can be enabled. See chapter 10.4.4 Structure & Function - VF Locations layers.
To change transparency level, turn the mouse wheel over the object.
RNFL+GCL+IPL NDB / GCL+IPL NDB Reference Map
This color map shows a comparison of RNFL+GCL+IPL / GCL+IPL thickness with the normative
database.
Blue dashed line shows axis used for asymmetry analysis. To modify the axis, place the cursor
over the line, press and hold the left mouse button and move line to the desired position.
RNFL+GCL+IPL / GCL+IPL Deviation Map
This color map shows the difference between thickness of analyzed layers and the normative
database.
S – I – asymmetry map
Asymmetry Maps – Asymmetry Maps compare the analyzed thickness of corresponding grid
cells (or super pixel) within the same eye across the anatomic axis (Hemisphere Asymmetry).
Mean thickness of corresponding cells is compared and displayed in a grayscale.

127 / 387
SOCT User Manual Version 11.5 rev. A
Right click the asymmetry map and select [Set standard grid resolution] or [Set super grid
resolution] to change the display method.

Standard grid
resolution

Super grid
resolution

Figure 93. Asymmetry maps

If the difference between the "superior region” and “inferior region" is a negative value, the
background color is shown. The background color is not shown for positive values.

NOTE: RNFL distribution in the macula depends on the individual anatomy, while the
GCL+IPL appears regular and elliptical for most normal cases.

When RNFL+GCL+IPL method is used for some cases it may be required to make the manual
correction of axis fovea-disc.
R- L – asymmetry map
R - L and L -R Asymmetry – Compares thickness of cells (or super pixels) between eyes by
highlighting in color scale all cells, that are thinner than corresponding cells in the other eye.
If the difference between the "right eye” and “left eye" is a negative value, the background
color is shown. The background color is not shown for positive values.
Tomogram
Use mouse scroll to change the displayed tomogram. Press and hold [CTRL] button to change
the zoom level while turning the mouse wheel.
Double click the tomogram to open it on full screen.
Table
Table contains average and minimum thicknesses of the RNFL+GCL+IPL /GCL+IPL which are
measured in an elliptical annulus.
Sector maps
Sectors divide the elliptical annulus of the Thickness Map into 6 regions: 3 equally sized sectors
in the superior region and 3 equally sized sectors in the inferior region. Dimensions of sectors:
vertical inner diameter 1 mm and vertical outer diameter 4.2 mm, horizontal inner diameter
1.2 mm and horizontal outer diameter 4.8 mm. Values are compared to normative data.

128 / 387
SOCT User Manual Version 11.5 rev. A
The size and shape of the annulus are the result of an analysis of a normative thickness of
GCL+IPL layers.
NOTE: The user should visually evaluate the image to determine if the segmentation
lines are correctly finding the analyzed boundaries.

DISCLAIMER: OPTOPOL Technology Sp. z o.o. takes no responsibility for diagnostic


interpretation of OCT images. It is the clinician’s responsibility to make diagnostic
interpretations of OCT scans.

10.1.2.3 Fundus view


This tab is only available to examinations carried out along with a fundus photo. This view
presents the results in a clear way.

Date of the first


examination

Eye selector

Tomogram

Figure 94 Both Eyes Fundus View

Comparison
The comparison module is used to observe follow up changes in the eye structure.
System automatically tries to correlate examinations. System displays registration status as
a right side of exam time. Available statuses:

Automatically correlated

Manually correlated

Not correlated. In this case press the [Registration] button to correlate exams
manually.

129 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: In case when examinations are not correlated, evaluation of the
quantified values has to be done carefully. For registration, see chapter
16 EXAMINATIONS REGISTRATION.

Software automatically selects outermost examinations (the oldest and the newest) in order
to compare them. The user can manually choose examinations from the list depending on
chosen comparison protocols that are highlighted.

Lock function allows to lock and


Date of the first manipulate parrarel exams Date of the second examination
examination
Retina thickness map
Eye selector
Retina signification map
Retina thickness map Retina difference map
Retina difference map
Information table

Retina signification map


Retina difference map

Tomogram

Figure 95. Follow up comparison of the two retina examinations

In the Comparison tab it is possible to compare different kinds of maps. The user can choose
Retina thickness, signification and difference map.
The user can also change the way the measurements are displayed.
Two options are available:

• rings: 1; 3 and 6 mm (standardized ETDRS testing),


• grid.

Lock Function enables locking or locking and extracting tomograms for synchronized
manipulation of exams and is available in the Both Eyes, Comparison and Progression tabs. The
function is described in detail in section 9.1.5 Lock function.
For the COMPARISON view after clicking the Examination selector button the options
[Equal interval] or [Latest scanned] are available. [Equal interval] chooses examinations for the
COMPARIOSN view scanned in equal intervals between baseline and current examination.
[Latest scanned] chooses the current and the latest scanned examinations.
For Disc examination the [Equal interval] is set as default.
For Retina and Widefield examinations, the [Latest scanned] is set as default.

130 / 387
SOCT User Manual Version 11.5 rev. A
The system stores information about the selection method separately for Disc, Retina &
Widefield. This information is stored globally (remains unchanged after restarting the
software).

[Equal interval] selector

[Latest scanned] selector

Figure 96. Latest scanned and Equal interval selector for COMPARISON view

Progression
In the Progression tab it is possible to see differences in the zones on the plots.
System automatically tries to correlate examinations. System displays registration status as a
right side of exam time. Available statuses:

Automatically correlated

Manually correlated

Not correlated. In this case press the [Registration] button to correlate exams
manually.
NOTE: In case when examinations are not correlated, evaluation of the quantified
values has to be done carefully. For registration, see chapter 16 EXAMINATIONS
REGISTRATION.

10.1.4.1 Retina view


The Retina View allows the user to compare Retina thickness, Retina difference, Retina
Signification and Retina deviation between all the examinations selected, sector by sector.
Single sector plot shows differences in a graph regarding the selected sector. It is possible to
decide which zone/s are compared: Central sector, Full retina thickness or Total retina volume.

131 / 387
SOCT User Manual Version 11.5 rev. A
Correlation status

Examination selector
Retina thickness
Eye selector map for the
succeeding
examinations

Sectors grid of
the succeeding
examinations
Tomograms of
the succeeding
examinations
Trend plot
Information table

Figure 97. Follow up of the selected retina examination

Consolidated plot shows the differences in each zone on one plot.


For the PROGRESSION view after clicking the [Select] button the options [Equal interval] or
[Latest scanned] are available. [Equal interval] chooses examinations for the PROGRESSION
view scanned in equal intervals between baseline and current examination.
[Latest scanned] chooses the current and the latest scanned examinations.
For Disc examination the [Equal interval] is set as default.
For Retina and Anterior examinations, the [Latest scanned] is set as default.

10.1.4.2 Ganglion view


The Ganglion view is available for 3D Retina scan only.

Analysis selector

Eye selector
Thickness or
difference map

Signification map

Deviation map

Trend plot for


average/superior Information table
/inferior zone in
exams

Figure 98. Follow up of the changes in ganglion cell analysis

132 / 387
SOCT User Manual Version 11.5 rev. A
1. The Thickness or Difference map can be selected from the list box and overlaid on the
reconstruction image. Values corresponding to the map are shown on the RNFL+GCL+IPL or
GCL+IPL grid:

• [RNFL+GCL+IPL/GCL+IPL Thickness]: shows the thickness map for four examinations,

• [RNFL+GCL+IPL Difference]: shows the difference between the Baseline (oldest


examination) and displayed examinations as a color map and values. For the Baseline
examination the Thickness Map is shown instead of difference.
2. RNFL+GCL+IPL/GCL+IPL Progression plot.
This plot shows changes in the analyzed thickness over time. Plot shows differences in a graph
with regard to the analysis selector. It is possible to decide which zone/s are compared. Linear
regression analysis is performed to fit a straight line through the longitudinal data to estimate
the rate of change.
3. Summary table
This table shows the overall average value of annulus ring and the average values of the
superior and inferior sectors for the analyzed thickness. The rightmost column is the rate of
change. The rate value appears only if the time interval between baseline and next exams is
at least three months. Background colors are color-coded according to the normative
database.

10.1.4.3 Tomogram view


On the tomogram view tab, the software displays tomograms and fundus reconstruction of
each compared examination. The user can manually select examinations from the list. Press
“V” icon near the time of examination to open selection list.

Eye selector

Fundus
reconstruction

Retina
thickness
graph

Tomogram

Figure 99. Comparison of the tomograms from succeeding examinations

NOTE: Pay attention when you evaluate the tomogram with different parameters
setting and/or with different scanned widths, proportion of retina shape may not
be kept.

133 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: Pay attention when you evaluate the tomograms on the Quick Printout if
scanned widths were different between examinations.

This shows the tomogram image from the macula up to the optic disc, and analysis results of
retinal thickness.

OPTIC NERVE HEAD ANALYSIS


This shows the thickness of NFL (Nerve Fiber Layer) and analysis results of the shape of the
optic nerve head. The compatible scan mode is [Disc 3D].
The measurement result of the optic disc and TSNIT region is analyzed based on the captured
OCT image of the optic disc in the [Disc 3D] mode. The results of RNFL analysis are shown, for
example, as a map relating to the RNFL thickness, RNFL profile indicating the thickness of
locations through which a measurement circle (diameter 3.45 mm centering on the optic disc)
passes, and RNFL grid indicating the thickness of the region inside the measurement circle.
The results of shape analysis of the optic disc are shown in Disc, Cup, Rim, and other ONH
parameters.
These analysis results can be shown on the [Single] [Both Eyes] and [Progression] tab screens.

[Both]
The Both tab is a default view for Disc 3D scan. It shows the measurement result of the optic
nerve head, RNFL thickness and TSNIT region is analyzed based on the captured OCT data. The
results of NFL analysis are shown as a map relating to the RNFL thickness, RNFL profile
indicating the thickness of locations through which a measurement circle passes, and RNFL
grid indicating the thickness of the region inside the measurement circle. The results of shape
analysis of the optic disc are shown in Disc, Cup, Rim, and other ONH parameters.

Exam selector
NFL Significant thickness

NFL thickness
thickness
Fundus photo
TSNIT Sector
thickness
ONH table
Symmetry NFL
TSNIT profile profile

NFL
Tomogram preview
parameters

Figure 100. Disc [Both] tab

134 / 387
SOCT User Manual Version 11.5 rev. A
1. NFL Significance map
This color map shows singular points by comparing RNFL thickness with the normative
database. Disc contour is marked as blue color, cup contour is marked as green color.
Displayed map to overlay on the fundus reconstruction can be selected from the list box:

• NFL Significant
• NFL Deviation
• NFL thickness
To change transparency level, turn the mouse wheel over the object.
VF locations display - Right click on any of the above maps to view the context menu from
which VF locations display can be enabled. See more in chapter 10.4.4 Structure & Function -
VF Locations Layer

2. Fundus photo
A fundus photo of the right and/or left eye is displayed if the user has imported or linked a
photo. To do that click the right mouse button over the reconstruction image to open a context
menu shown below and choose [Import fundus photo] or [Link examination].

• To zoom the photo in or out hold the CTRL key and scroll with your mouse over the
image.

• To move the image hold you left mouse button over the image and move it.

• To change the brightness/contrast of the image hold your right mouse button and
move the mouse over the image.

• To open the photo in the Fundus Photo tab double click on the image.

Figure 101. Context menu of the disc reconstruction image

3. ONH table
It displays selected ONH parameters for Right and Left eye.

135 / 387
SOCT User Manual Version 11.5 rev. A
4. NFL TSNIT profile
The NFL thickness at the TSNIT region for the right or left eyes is shown. Changes of Ring
thickness and Ring diameter are implemented symmetrically to the opposite eye.

5. Tomogram preview
It shows OCT image in selected location with marked ILM, NFL layer.

6. Exam selector
If there are more exams of the same location from the same date, operator can change the
displayed exam. Click the exam date and select desired scan from the list.

7. NFL thickness map


NFL thickness map shows thickness of NFL layer on scanned area. Detailed description of NFL
thickness >> NFL thickness map

8. NFL symmetry profile


The NFL thickness at the TSNIT region for the right and left eye is shown. Changes in the Ring
thickness and Ring diameter are implemented symmetrically to the opposite eye. There is a
possibility to switch the NDB background on/off by right clicking on the NFL symmetry profile
chart and selecting or deselecting the NDB background.

9. NFL sector
The inside of the measurement circle is divided into 4 or 12 sectors, and the NFL thickness
from TSNIT is shown. Background colors are color-coded based on the normative database.

10. NFL parameters table


This table summarizes the measurement values relating to the RNFL thickness at the TSNIT
region for the right and left eyes. Background colors are color-coded based on the normative
database.
TSNIT Average Standard Deviation of retinal thickness of TSNIT region Symmetry
Average value of NFL thickness of TSNIT region (μm)
Inter Eye Symmetry of both eyes relating to TSNIT region
[Single] 3D
This view is automatically open only in case where is no Disc 3D scan of opposite eye from that
same visit. Default view for Disc 3D scan is Both.
This view shows Fundus reconstruction with preview of selected tomogram, table with ONH
Data information, RNFL thickness map in scan area and RNFL thickness graph.

136 / 387
SOCT User Manual Version 11.5 rev. A
Fundus photo

NFL thickness
NFL Significant

TSNIT profile
ONH table thickness

Tomogram preview TSNIT sectors

Figure 102. Disc 3D [Single] tab

10.2.2.1 Fundus photo


A fundus photo is displayed if the user has imported or linked a photo. To do that click the right
mouse button over the disc reconstruction image to open a context menu shown below and
choose [Import fundus photo] or [Link examination].

Figure 103. Context menu of the disc reconstruction image

• To zoom the photo in or out hold the CTRL key and scroll with your mouse over the
image

• To move the image hold your left mouse button over the image and move it.

• To change the brightness/contrast of the image hold your right mouse button and
move the mouse over the image.

• To open the photo in the Fundus Photo tab double click on the image.

10.2.2.2 NFL Significance map


This color map shows singular points by comparing RNFL thickness with the normative
database. Disc contour is marked as blue color, cup contour is marked as green color.
137 / 387
SOCT User Manual Version 11.5 rev. A
10.2.2.3 Tomogram image of the optic disc
Tomogram preview image shows selected tomogram. Markers points left and right edge of BM
on actual scan (if actual scan crosses disc). If necessary, marker points can be moved.

• Double click to open full screen image.


• Press [Edit disc].
• Dragging them on tomogram image area (changes in single scan will occur on shape of
disc and cup and will take effect in all analysis) to proper location.
• Yellow line shows Cup Offset Line (parallel to purple disc which represents disc
surface).
• Distance between Cup Offset Line and disc surface line may be changed by editing the
value on Cup Offset Panel or moving the slider.
• It is possible to change default cup offset value in the setup.
10.2.2.4 NFL thickness map
NFL thickness map shows thickness of NFL layer on scanned area. Map has the rings around
the disc, where the RNFL thickness data are used for TSNIT analysis. This ring is divided into
four zones representing Temporal, Superior, Nasal and Inferior side.

• If operator clicks anywhere in the map, the thickness of the RNFL in the chosen point
will be displayed.

• The black rings around the disc represent edges of ring used to calculate TSNIT RNFL
thickness displayed on RNFL graph.

• Dimensions of ring (diameter and thickness) are shown below the map.

• It is possible to manually change the dimensions of the ring by grabbing them in desire
position.

• On the map is drawn contours of the Disc (color: blue) and Cup (color: green).

• If you disagree with shape of the cup and disc operator can manually modify them.

• The red horizontal line on thickness map shows position of actual display tomogram.

• To display measured value from specific location left click to desire place and display
from this place.

10.2.2.5 ONH (Optic Nerve Head) Data


ONH data show morphology quantification of papilla parameters. All the data from this part
are calculated from Disc and Cup parameters on all scans. All ONH data base on automatic
recognition of ILM surface, BM tips, Cup Offset and layers segmentation on all tomograms. Any
manual modification of recognition causes ONH Data calculation.

138 / 387
SOCT User Manual Version 11.5 rev. A
DDLS (Disc Damage Likelihood Scale) score is based on DDLS scale introduced by George L.
Spaeth, MD. It centers on the appearance of the neuroretinal rim of the optic disc corrected
for disc diameter. It is a method for prognostic evaluation of the amount of optic disc damage
in patients with glaucoma. This can be treated as supplementary information and cannot be
treated as disease confirmation.
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.

Source: “THE DISC DAMAGE LIKELIHOOD SCALE: REPRODUCIBILITY OF A NEW METHOD OF ESTIMATING THE AMOUNT OF OPTIC NERVE
DAMAGE CAUSED BY GLAUCOMA” by George L. Spaeth, MD et al., 2002.

• Operator can manually modify automatic recognition.

• Operator has influence on default Cup offset and all other parameters (Layers
segmentation, ILM surface, BM tips, Cup Offset)

• Changing the Cup Offset will move cup closer or further from disc, this will be also
visible in cup shape on fundus reconstruction.

• All ONH data are automatically recalculated if Cup Offset or RPE edge factors change.

• It is possible to restore default analysis by pressing [Reanalyze].

10.2.2.6 TSNIT profile


The NFL thickness graph shows the mean values of NFL thickness which are calculated as mean
value in selected ring for each angle from 0 to 360 degrees.
Normative range band can change from 2.4 to 5 mm. The vertical blue line in the graph is
correlated with the angle on RNFL map. Value on the top shows the mean of RNFL thickness,
expressed in microns. Operator can change RD - Ring Diameter from 2.0 to 4.5 mm, step
0.1mm; RT Ring thickness - from 0.1 to 0.9 mm, step 0.1 mm.

10.2.2.7 RNFL Sector


The inside of the measurement circle is divided into 4 or 12 sectors, and the RNFL thickness is
shown. Background colors are color-coded based on the normative database. Mean TSNIT
value and TSNIT SD are displayed above.
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.

[Progression]
The Disc 3D Progression displays a selection of up to six scans of the same eye displayed
chronologically to help track RNFL and ONH changes over time. On the side of each date of
examination you can find registration status. Press the [Registration] button to verify or
correlate examination manually if required. See details in chapter 16 EXAMINATIONS
REGISTRATION.
139 / 387
SOCT User Manual Version 11.5 rev. A
Correlation
window
Correlation status

NFL thickness map

NFL Significant map

NFL trend plot ONH table

NFL
TNIST profile parameters

Figure 104. Progression 3D disc

1. NFL thickness map


You can select the map that is shown from the list box.
• NFL Thickness: Shows the RNFL thickness map for six examinations.
• NFL Difference: Shows the difference between the oldest examination (Baseline -
leftmost examination) as a color map and values
• NFL Significance: Color map which shows result by comparing NFL thickness with the
normative database
• NFL Deviation: Color map which shows differences between NFL thickness and the
normative database.
Disc contour blue color, Cup contour green color and measurement circles are shown.
2. NFL Significance
You can select the map that is shown from the list box.
• NFL Difference: Shows the difference between the Baseline (oldest) examination
(Baseline - leftmost examination) as a color map and values
• NFL Significance: Color map which shows result by comparing NFL thickness with the
normative database
• NFL Deviation: Color map which shows differences between NFL thickness and the
normative database.
NDB comparison RNFL map
You can select the map that is shown from the list box. Disc (color: gray), Cup (color: light gray)
and measurement circle (color: yellow) are shown.

140 / 387
SOCT User Manual Version 11.5 rev. A
3. RNFL trend plot
This plot displays examinations performed for the same patient to show changes in the RNFL
thickness in the TSNIT region over time. You can select what is shown from the list box.

• TSNIT Average: Average value at entire measurement circle


• Superior Average: Average value at superior semicircle
• Inferior Average: Average value at inferior semicircle
The regression line is shown on the graph. Placing the cursor over any point on the graph
displays value from selected point.
4. TSNIT profile
TSNIT graph provides an overlay showing the NFL thickness results along the TSNIT from the
eye as different color lines.
5. ONH parameters
It shows most important parameters of ONH. This table shows the values for each examination.
The rightmost column is the rate of change. Background colors are color-coded based on the
normative database.
6. NFL parameters
The items are the same as on the [Both Eyes] tab screen. This table shows the values for each
examination. The rightmost column is the rate of change. Background colors are color-coded
based on the normative database. The NFL parameter contains a difference column (from
baseline) and rate of regression slope (the rate value appears only if the difference between
baseline and next exams is at least three months).

Advanced View – Retina and Optic Nerve Head analysis


The tab „Advanced” allows to view the glaucoma summary report for 3D exams of retina and
disc scans for both eyes from the same visit. It can operate only on Right and Left 3D Retina
and 3D Disc examinations.

Exam selector

ONH table

Thickness map
NFL parameters

Deviation map
Symmetry NFL profile
NFL thickness

Information table

TSNIT Sectors thickness

141 / 387
SOCT User Manual Version 11.5 rev. A
Figure 105. Advanced View - Retina and Optic Nerve Head analysis.

Exam selector
If there are more exams of the same location from the same date, the operator can change
the exam displayed. Click the exam date and select the desired scan from the list.
Thickness map
A map to overlay the fundus reconstruction can be selected from the list box:
• NFL+GCL+IPL thickness
• GCL+IPL thickness
• NFL thickness
To change the transparency level, turn the mouse wheel over the object.
Deviation map
A map to overlay the fundus reconstruction can be selected from the list box:
• NFL+GCL+IPL thickness
• NFL+GCL+IPL signification
• NFL+GCL+IPL deviation
NFL thickness
A map to overlay on the fundus reconstruction can be selected from the list box:
• NFL thickness
• NFL signification
• NFL deviation
VF locations display - Right click on any of the above maps to view the context menu from
which VF locations display can be enabled. See more in chapter 10.4.4 Structure & Function -
VF Locations Layer.
ONH table
It displays selected ONH parameters for the Right and Left eye.
NFL parameters
This table summarizes the measurement values for the right and left eye relating to the RNFL
thickness at the TSNIT region. The Background is color-coded based on the normative
database.
Symmetry NFL profile
Shows the NFL thickness at the TSNIT region for the right and left eye. Changes of Ring
thickness and Ring diameter are implemented symmetrically to the opposite eye.

142 / 387
SOCT User Manual Version 11.5 rev. A
SNITS Sectors thickness
The NFL thickness graph shows the mean values of NFL thickness which are calculated as mean
values in the selected ring for each angle from 0 to 360 degrees. Normative range band can
change from 2.4 to 5 mm. The vertical blue line in the graph is correlated with the angle on
the RNFL map. The value on the top shows the mean of RNFL thickness, expressed in microns.
The operator can change RD - Ring Diameter from 2.0 to 4.5 mm, in 0.1 mm steps; RT Ring
thickness - from 0.1 to 0.9 mm, in 0.1 mm steps.
There is a possibility to switch the NDB background on/off by right clicking on the NFL
symmetry profile chart and selecting or deselecting the NDB background.

STRUCUTRE & FUNCTION – Combined OCT and VF Report


Combination of information about the functional quality of vision from Visual Field* device
with comprehensive data on retinal Ganglion Cells, RNFL and Optic Nerve Head from Retina
and Disc OCT scans for both eyes on a single combined report page, that compares in a natural
way the anatomical relationship between VF and RNFL/Ganglion maps. Combined View is
accessible only if the Visual Field (VF) database connection has been configured in the setup

VF testing range Select the VF examination Key for VF results


and examination
date
Sensitivity map Combined map of

Total Deviation map Structure

Pattern Deviation map & Function

VF parameters
ONH table
Retina thickness map
NFL parameters
Disc thickness map

Retina deviation map Symmetry NFL


profile
Disc deviation map

section20. For more information on setting up VF database go to chapter 22.5.7 Visual Field.

20
Visual and structure is available only for customers using PTS 920, PTS 925 and PTS 2000 with
software version 3.4 and have configured SOCT applications. See more in chapter 25 Remote
Connection and requirements in chapter 10.4.2 Requirements that must be met for loading
perimeter tests
143 / 387
SOCT User Manual Version 11.5 rev. A
• Select the VF examination - the operator can change the VF exam displayed by choosing
from available examinations.

• Sensitivity map from examinations 24-2, 30-2 or 10-2

• Total Deviation map and Pattern Deviation map – probability graphs for VF results

• VF parameters – reliability and global indices for VF results

• Retina/Disc thickness map - a map to overlie the fundus reconstruction can be selected
from the list box:
o NFL+GCL+IPL thickness
o GCL+IPL thickness
o NFL thickness

• To change the transparency level, turn the mouse wheel over the object.

• Retina/Disc deviation map - a map to overlie the fundus reconstruction can be selected
from the list box:
o NFL+GCL+IPL signification
o NFL+GCL+IPL deviation

• Key for VF information on the OCT map

• VF Locations / Results - Right click on any of the above maps to view the context menu
from which VF locations and/or VF results display can be enabled. See more in chapters
10.4.4 Structure & Function - VF Locations Layer and 10.4.3 Additional layer with VF
Results.

• Combined map of Structure & Function – an overlay of information from the PPD field of
vision map on the map of sectors from the OCT image (the Significance map)

• ONH table – displays the selected ONH parameters for the Right and Left eye

• NFL parameters – summarizes the measurement values for the Right and Left eye relating
to the RNFL thickness at the TSNIT region. Background color based on NDB

• Symmetry NFL profile – shows the NFL thickness at the TSNIT region for the Right and
Left eye
Once a user selects the [COMBINED] tab, the system will search the VF database for the patient
by their name, DOB and ID. If the data matches and corresponding exams from the same day
are found, the results are displayed. By default, the system presents one retina, disc and VF
exam for each eye. If any of these exams is missing for a given eye, the system displays results
for the eye for which a full set of exams is found.
If the VF database features a patient with the same name and DOB but a different ID, the
patient selection window pops up. In the window there is a list of patients with the same name,
144 / 387
SOCT User Manual Version 11.5 rev. A
surname and DOB but a different ID. After a patient is chosen, the system displays the list of
their exams. If there is only one patient, their name is highlighted automatically.
If the VF database features a patient record with matching data, but lacking a VF exam with
the same date as the OCT exam, the system displays a selection window allowing the choice
of a VF exam to be displayed.

List of available
List of corresponding VF examinations
patients in VF database

Figure 107 Selecting the patient and VF examination window

Relationships between VF and RNFL/Ganglion maps


Structure & Function relationship is measured by eight corresponding regions of neuroretinal
rim area, peripapillary retinal never fiber layer and visual field.21 This concept is based on
Structure & Function map introduced by Garway-Heath et al.13.22

IN

IT NL
TL
TU
ST NU

SN

Figure 108 Relationships between OCT and VF by Garway-Heath et al.

21
Concept adaptation based on a publication by Garway-Heath et al., after own modification. Source below.
22
Structure–Function Relationships between Spectral Domain OCT and Standard Achromatic Perimetry Naveed
Nilforushan ,1,2 Nariman Nassiri,1 Sasan Moghimi,1,3 Simon K. Law,1 JoAnn Giaconi,1 Anne L. Coleman,1 Joseph
Caprioli,1 and Kouros Nouri-Mahdavi. Investigative Ophthalmology & Visual Science, May 2012, Vol. 53, No. 6

145 / 387
SOCT User Manual Version 11.5 rev. A
Requirements that must be met for loading perimeter tests in the
SOCT application
• PTS software version 3.4.0 or higher
• A configured connection between the SOCT and the PTS applications
• Input data from the SOCT: at least one Retina 3D or Disc 3D examination
• A patient record in the SOCT application with the same personal details as the patient
record in the PTS application (first name, second name, date of birth)
An exception is the patient id which can differ between the SOCT and PTS applications. If the
patient’s ids are identical, only the patient record from the PTS application is used. Otherwise,
the SOCT application loads the list of all patient records with the same personal data without
taking into account the patient id - the list of the patients and their exams is then displayed. If
there is a full correspondence of patient data (the same name, surname, date of birth, id) all
test data, if they meet the conditions of the automatically selectable test, will be added to the
Combined tab automatically without displaying the list of tests. Otherwise, a list of the
patient's tests will be displayed for the selection of the test/tests of the left and/or right eye.
The test for a given eye will not be automatically added if there is no consistence between the
SOCT and PTS tests, e.g. when there is a test for both the left and the right eye in the SOCT
software, but in the PTS software the test for only one eye is 100% consistent.
The following conditions must be met for the compatibility of a test with Structure &
Function:

• Eye correspondence in both tests - for a given perimetric test there must exist an SOCT
test of the same eye.

• The size of the stimulus used in the perimetric test: Goldman 3.

• The colon of the stimulus used in the perimetric test: white or green.

• Strategy of the perimetric test: any threshold strategy (threshold, fast threshold,
dynamic, advance, zeta, zeta fast, zeta faster, top, top+).

• A fully finished perimetric test.

• Test field: arbitrary (a thumbnail of the original field on the list of tests, after adding the
test to the Combined tab, the field is interpolated to one of three orthogonal fields with a
maximum radius of 10, 24 or 30)
The following conditions must be met for a full compatibility of tests from the PTS application
(automatically selected) with tests from the SOCT application:

• The difference between the dates of tests cannot exceed 182 days (half a year)

• The perimetric test must be accompanied by reliability tests such as H-K, false positive
errors, false negative errors.

146 / 387
SOCT User Manual Version 11.5 rev. A
• The result of each reliability test must be lower than 25% (error/test ratio)

Structure & Function – VF Results Layer in Combined view


This additional layer provides the ability to overlay OCT Structure & Function maps with Visual
Field (VF) Results and VF Locations.
VF Results overlay is available only in [Combined] view. VF Locations overlay is available in
Retina 3D Both Eyes [Ganglion] view, Disc 3D |Both Eyes|, [Advanced] and [Combined] views.
The VF Results layer displays the Pattern Deviation probability (PPD) results of Visual Field
points, at appropriate locations adjusted to foveola and disc area in the Retina and Disc maps.
The VF Results layer can be enabled in the context menu of any of NFL+GCL+IPL significance
map and NFL+GCL+IPL deviation maps. This functionality requires an active connection with
PTS software, otherwise the [Combined] tab will be inaccessible and VF results will not be
loaded. PTS software version later than 3.4 is required for this functionality.

Figure 109 PPD Probability Results Figure 110 Disc area

PPD results of 10-2 and 30-2 Visual Field are arranged in a way that takes into account the non-
linear relationship of distance on the VF maps and the distance on the retina (only when
connection is established with PTS v3.4 or higher)
The PPD results for the combined view with the Disc sectors never take into account the
nonlinearity of the relationship, as seen below:

Figure 111 PPD Combined view results

If you select PD result, it is presented with numerical values as shown below.

147 / 387
SOCT User Manual Version 11.5 rev. A
VF results are also visible in the magnified windows available by double-clicking on the
selected view with the VF results displayed.

10.4.3.1 Availability of VF results


VF results layer is available in the [Combined] tab:

• In Retina maps if a Macula or Central visual field test is currently loaded (displayed as
either point 10-2, point 24-2 or 30-2) for a given eye;

• In Disc maps if a central or macula visual field test is currently loaded (displayed as either
point 24-2, point 30-2 or 10-2) for a given eye.
It can be toggled on and off by selecting VF results in the context menu from select views.
Context menu can be accessed by right-clicking on a suitable preview.

Figure 112 Enable VF results from Context menu

If the VF results layer is available and enabled, the VF locations layer for the map is hidden (if
enabled). Enabling VF results in one view enables it in all views for which VF locations can be
displayed.
Printouts from individual views reflect the display state of the VF locations function in the user
interface. The VF results display state is saved to the specific user and the state is saved after
the application restart.

148 / 387
SOCT User Manual Version 11.5 rev. A
Structure & Function – VF Locations Layer
The VF Locations layer displays the position of points of Visual Field, at appropriate locations
adjusted to foveola hole and disc area in the Retina and Disc maps. VF points of 10-2 and 30-2
test fields are arranged in a way that takes into account the non-linear relationship of VF results
and retina OCT imaging.
The VF Locations layer can be enabled in the context menu in any of NFL thickness, NFL
Signification and NFL deviation maps.
This functionality does not require an active connection with PTS software.

Small circles
belong to field
10-2

RNFL

Hollow circles
belong to fields
30-2 and 24-2

An example Points of visual field 10-2 and 30-2 are arranged in a way that takes into account
the non-linear relationship of distance on visual field maps and distance on the retina, see
below:

Figure 113 Non-linear relationship


example

149 / 387
SOCT User Manual Version 11.5 rev. A
10.4.4.1 Availability of VF Locations layers
It can be toggled on and off by selecting VF locations in the context menu from select views.
Enabling VF locations in one view, will enable this functionality for all views that can display VF
locations. Context menu is brought up by right-clicking on a suitable view, see below:

Figure 114 Enable VF locations from context menu

The context menu with the option to enable VF locations is available for Retina 3D and Disc 3D
examinations when viewing:

• Retina 3D: Tab |Both| sub view [Ganglion]


• Disc 3D: Tab |Both|
• Retina 3D and Disc 3D: Tab | Advanced |
• Retina 3D and Disc 3D: Tab | Combined |
The VF locations layer is also visible when in magnification
windows after double clicking select view with VF locations
displayed, as seen from the example on the right:
Printouts from individual views reflect the display state of the
VF locations function in the user interface, so printouts are the
same. Figure 115 Magnified view

The display state of VF locations is saved to the specific user and the state is remembered after
the application restart. This setting is enabled by default.

150 / 387
SOCT User Manual Version 11.5 rev. A
Widefield examination
Result review of Widefield examination can give below options of display:
- Depending on type of conducted examination:

Widefield 3D examination.
Display method depends on amount of taken examinations. It is the same as for retina 3D
exam. We are able to display the following views:
• Single - displays single examination with possibility of editing layers recognition, this type
of exam does not provide retina thickness maps.
• Both eyes - used to compare Left and right eye
• Comparison - to compare two exams on one sheet (no thickness maps available)
• Progression - used for treatment steps and compare up to 6 exams.
• 3D – three-dimensional visualization of Widefield exam
For more details refer to retina display modes.

3
7 4

5
1
5

6
2

Figure 116. Widefield examination single scan review window.

Object 1: Combobox:

• Retina Thickness
• Retina Significance
• Fundus Photo/Reconstruction/pSLO/IR
The fundus reconstruction image is created from all A-scans acquired in the scanned area.
Right click to select the image to overlay.
The following images are available:

• Fundus reconstruction
151 / 387
SOCT User Manual Version 11.5 rev. A
• pSLO
• Fundus photo
• IR
To change the transparency level, turn the mouse wheel on the fundus reconstruction image.
A Right Click (long press using touch screen) over the eye preview window opens the following
display and actions menu.

Object 2: Combobox:

• Retina sectors value


• MZ/EZ-RPE thickness
• RPE deformation
Object 3: Combobox:

• H & V B-scan – displays the horizontal and the vertical b-scan.


• H & V B-scan – displays only the horizontal b-scan.
Object 4: Combobox:

• Retina thickness
• Retina significance
• Retina deviation
• RPE deformation

Object 5: Combobox:

• NFL+GCL+IPL thickness
• NFL+GCL+IPL significance

152 / 387
SOCT User Manual Version 11.5 rev. A
• NFL+GCL+IPL deviation
• NFL+GCL+IPL thickness sectors
• GCL+IPL thickness
• GCL+IPL significance
• GCL+IPL deviation
• GCL+IPL thickness sectors
Object 6: Combobox:

• NFL thickness
• NFL significance
• NFL deviation
• NFL thickness sectors
Object 7: tomogram window

2D scan programs results review.


Depending on scanned area (Retina, Disc, Anterior segment) it is possible to use scanning
programs other than 3D. This chapter will describe the possible results. Below is the list of
possibilities:
Retina:
• Raster
• Single Line
• Cross scan
Disc:
• Raster
• Single Line
• Cross scan
• Radial
Anterior:
• Raster
• Single Line
• Radial
For more detailed description of above scan modes refer to chapter 7.2 Selection of scanning
program.

153 / 387
SOCT User Manual Version 11.5 rev. A
Single Line examination review.
Single Line exam allows to show detailed result and acquire it in a very short time (averaging is
possible). Depending on amount of taken examinations it is possible to view:
• Single scan

Layers display selection

Figure 117. Single Scan view.

• Both Eyes
Eye indicator
and examination
date
Graph
selection

Figure 118. Single Line both eyes review.

• Comparison

154 / 387
SOCT User Manual Version 11.5 rev. A
Figure 119. Single Line comparison window.

• Progression

Figure 120. Single B scan progression window.

Raster examination results review.


Raster examination result provides averaged image with enhanced resolution. One/Five
tomograms are displayed depending on scanned region. Below examples of views:

• Single scan

155 / 387
SOCT User Manual Version 11.5 rev. A
Figure 121. Retina raster, single scan view.

Figure 122. Widefield raster single scan view.

• Both eyes

Figure 123. Raster both eyes view

• Comparison
156 / 387
SOCT User Manual Version 11.5 rev. A
Figure 124. Raster scan comparison.

• Progression

Figure 125. Raster progression view.

Radial examination results review.


Radial examination result provides asterisk scan images (number of B-scans taken here can be
adjusted). Single B scan is displayed and by clicking on fundus preview it is possible to select
different B-scan. Tomograms are displayed depending on scanned region. Below example of single
view:

157 / 387
SOCT User Manual Version 11.5 rev. A
Figure 126 Radial examination single view

Retina thickness map

Retina signification map Information table

RPE deformation map


Sectors grid

Tomogram

Figure 127. Radial examination both view.

Retina thickness
map
Retina signification map

Information table Retina difference

Tomogram
RPE deformation map

Figure 128. Radial examination comparison view.

Progression displays are adequate to previously presented examples.

Cross examination results review.


Cross examination result provides image similar to Single Line. Averaging is possible. Single B scan
is displayed and by clicking on fundus preview it is possible to select different B-scan (vertical or
horizontal). Below example of single view:

158 / 387
SOCT User Manual Version 11.5 rev. A
Figure 129. Cross scan horizontal B-scan view.

Figure 130. Cross scan vertical B-scan view.

Both eyes, Comparison, Progression displays are adequate to previously presented examples.

3D visualization
3D visualization tab is enabled only for posterior scans which have been taken using 3D and Angio
scanning program. The window shows the 3D reconstruction of the retina structure. Software has
the possibility of two 3D visualization modes: Solid and Volume.

Manipulation of the 3D cube


The following describes an example of how to operate the 3D view:
• Rotating: Drag the 3D tomogram image in any direction. 3D reconstruction can be rotated
by 360 degrees around the vertical axis and from -90 to +90 around horizontal axis.
• Slicing - In order to slice reconstruction, press right mouse button, gray balls appear.
Direction of cutting is chosen by balls placed on proper axis. Click one of six balls to make one
active (clicked ball changes from grey to red) and then user can slice tomograms by dragging
the ball along the axis line or use scroll button to slice tomograms.
• Moving: Right Drag the 3D tomogram image in any direction with the shift key held down.
• Resizing: The ctrl keyboard button held down button and turn the mouse wheel.

159 / 387
SOCT User Manual Version 11.5 rev. A
• Restoring the 3D tomogram image to its original state. Press the [Reset] button.

Selection of displayed layers


Selection of layer that is shown
[Visible]: Shows selected layers in the 3D tomogram image. Uncheck ‘Visible’ checkbox to hide
selected retina layer.
[Peeling]: Marked layers will be peeled during movement of red ball over tomograms.
Operator can separately peel each layer. Easiest way to restore view is to use [Reset] button.
[Select All]: Mark this item to select all layers.

Operation panel
10.7.3.1 Mask tab
On the mask tab it is possible to change the item overlay on the surface of the cube.
[En face] – it displays enface image of displayed layer.
[Map] – it displays thickness map of retina or selected layer.
[Surface] – It display non-transparent color-coded layers on the surface of each retina layer.
[Fundus photo] – Option enabled only whenever a fundus image has been imported to the
examination. Option shows common part of the imported image fundus image on the surface
of retina.
10.7.3.2 Shifting mask tab
Shifting mas tab is available for Solid view.
On the mask tab it is possible to shift position of specific layers and change brightness and contrast
level.
[Shifting] – Separate the position of layers. 0 – layers together.
[Brightness] – change the brightness level
[Contrast] – change the contrast level
10.7.3.3 Tuning tab
Tuning tab is available for Volume view.
On the mask tab it is possible to shift position of specific layers and change brightness and contrast
level.
[Brightness] – Change Brightness level
[Contrast] – Change Contrast level
[Opacity] – Change Opacity level
[Threshold] – Change threshold of displayed points in retina
[Vitreous] – Change threshold of displayed points in vitreous

160 / 387
SOCT User Manual Version 11.5 rev. A
10.7.3.4 Display tab
The display options allow the user to change the visualization of the 3D.
B-scan alignment: Aligns B-scans displayed on the 3D visualization, in order to
facilitate the view in the 3D reconstruction.
Thickness marker: Displayed boards with Retina, RNFL and RPE thicknesses for a
selected point. In order to display thickness double, click on any
point on the surface of the retina. A board will appear with values
from selected point. All the values are expressed in microns. The
software allows to show up to 4 measurements.
Color: Displays the 3D reconstruction in color or black and white.
Inverse: Inverses the color of tomograms.
White background: Changes the background color.
Flattening: It flats scanned cube base on RPE layer
Display details: Displays detailed tomogram on the front surface of the cube.
Fundus: Option enabled only whenever a fundus camera photo has been
added to the examination. It displays fundus image on the bottom
of scanned cube. It is possible to drag this image to desired position.
[Reset] This button resets all parameters of the displayed image (angle of
rotation, scale, displayed maps, tuning settings) to default settings.
[Play/Stop button] Enables slicing tomogram automatically. After clicking this button
control elements appear on the screen. Choose one direction to
start animation slicing. It is possible to rotate reconstruction during
slicing. To finish click [Stop] button which appears instead of play.
[Save as] Saves currently displayed picture in JPEG format.

161 / 387
SOCT User Manual Version 11.5 rev. A
[Solid] View
Shows the surface, layers of the retina and choroid as non-transparent images.

Operation panel 3D view mode

Orientation direction
Orientation direction
3D reconstructed
Layer selection
image

Peeling control

Frame

Figure 131. 3D Solid view

1. 3D tomogram image
This 3D image is constructed from B-scan tomograms.
2. Orientation direction
Letters show the orientation or view direction of the 3D tomogram image.
3. Peeling control ball
Right-click to activate control balls. The front view of the cube image corresponds to the position
of the balls.
4. Frame
This is the boundary of the 3D tomogram cube.
5. 3D view mode
Select the format for viewing 3D tomogram images. [Volume], [Cross-Section] view only.
6. Selection of layer that is shown
[Visible]: Shows selected layers in the 3D tomogram image.
[Peeling]: Controls selected layers by using the peeling ball. The position of the layer is
maintained when this is deselected.
[Select All]: Clicking this item selects all layers.

162 / 387
SOCT User Manual Version 11.5 rev. A
7. Operation table
Display operation table allows user to modify the initial view.

[Volume view]
Shows the surface, layers of the retina and choroid as semi-transparent images.
Tunning tab is available for the Volume view.
On the mask tab it is possible to shift position of specific layers and change brightness and contrast
level.
[Brightness] - Change Brightness level
[Contrast] - Change Contrast level
[Vitreous Threshold] - Change threshold of displayed points in vitreous
[Vitreous Gamma] - Change gamma of displayed points in vitreous
[Retina Gamma] - Change gamma of displayed points in retina
[Frame Refresh] - Change the number of times in a second the view is being updated

Figure 132. Volume view

163 / 387
SOCT User Manual Version 11.5 rev. A
11 ANTERIOR SEGMENT ANALYSIS
The SOCT was designed to posterior and anterior imaging. To obtain corneal and anterior segment
images use Anterior Scan programs.
Anterior scans for 3-5 mm width do not require anterior lens.
Except for the REVO FC device, performing a wide anterior scan with a scan width of up to 16 mm
requires the anterior adapter being installed on the objective lens for better segmentation
processing.
During analysis the System classifies recognized structures on the image and classifies as
Cornea,
Cornea Lens,
Angle,
Angle to Angle,
IOL,
Iris,
Lens Front,
Lens Back,
Sclera,
Anterior Segment

In the case of a Full Range examination the system classifies recognized structures as
Anterior Chamber,
Lens,
Angle,
Cornea,
Sclera.

Recognition status is displayed in the top left corner of the Anterior scan tomogram thumbnail.
Depending on the scan classification proper analysis is displayed.

164 / 387
SOCT User Manual Version 11.5 rev. A
To change the classification of the scanned object, press the right mouse button on the
examination thumbnail and select Change the recognized structure from the list. Choose the
structure classification type. The system changes the type of the structure and reanalyzes the
examination using a different algorithm.

Figure 133. Structure classification menu for Anterior (on the right) and Full Range (on the right)

Epithelium

Bowman’s
membrane

Stroma

Figure 134. Short cornea scan

165 / 387
SOCT User Manual Version 11.5 rev. A
Schwalbe’s line
Schlemm’s
canal

Scleral Iris
spur

Figure 135. Short Anterior Angle scan

Figure 136. Sclera and Cornea Wide Anterior 11 mm scan

Figure 137. Angle to Angle view. Sample of wide anterior B-scan

166 / 387
SOCT User Manual Version 11.5 rev. A
Anterior Radial
The corneal thickness analysis is performed on the basis of the recognized structure of OCT images
of the anterior segment captured in [Anterior Radial] and [Wide Anterior Radial] mode.
The analysis results are shown on maps, corneal grids and tables. These analysis results can be
shown on the [Single], [Both Eyes], [Comparison], and [Progression] tab screens.
NOTE: Quantitative analysis is available only if the system classifies the scanned
structure as Cornea.

[Single] tab screen


This screen shows the analysis results of one eye.

IOP table

Eye preview

Thickness

graph

Pachymetry
Click to see the
table
thickness in a
specific point
Thickness
map

Figure 138. Single Anterior Radial

1. Eye preview
It shows the location of the scan on the image. It can be selected from the list:
• Eye preview – captured image from front cameras
• pSLO – pseudo SLO image
2. Information table
The table displays a summary of pachymetry data.

167 / 387
SOCT User Manual Version 11.5 rev. A
3. Thickness map
Pachymetry or Epithelium maps are thickness color coded. Overlaid values correspond to
displayed settings.
Changing display settings:
Right click to open the menu.

• B-scan reference enable on/off


• Select the grid option from the list:
2 / 5 / 7 [mm]
Grid - the whole map will be covered by grid of numbers. Each number represents
thickness at a selected square.
None.

• Values: average, maximum or minimum


• White background on/off

Color scales - to change the scale click one of the scale descriptions in the bottom corner of the
map. The scale settings widow shows up. The user can change the scale type and units.
Color scales are available for the Pachymetry map: OScale, American and RevoScale.
Color scales are available for the Epithelium map: OScale and RevoScale.
For more information on scales go to chapter 20.6 Color scale – Standards.
IOP formula
Displays IOP correction. Enter the patient’s IOP into the form to see the adjusted IOP. The SOCT
software can calculate the correction of IOP (Intraocular Pressure) reading from pneumo-
tonometer on the basis of the cornea thickness. After obtaining a complete tonometry value the
program calculates the level of correction (Correction) and the corrected IOP value (Adjusted IOP)
for the examined eye. The calculation formula is predefined.
NOTE: In case of a later detection failure, modify the layer boundaries manually.
NOTE: The cornea analysis tab is available only when the system classifies the scanned
object as a Cornea scan. See the letter in the top left corner. To change scan type, go to
Tomogram tab-> Menu -> Change Analysis type. The anterior Analysis type window will
appear. Select [Cornea] type.

168 / 387
SOCT User Manual Version 11.5 rev. A
[Both Eyes] tab screen

Exam info
Eye preview

Tomogram

Color map

Measurment
table

This screen shows the analysis results comparing examinations of both eyes in the same scan
mode on the same date.

[Comparison] tab screen


This screen shows the analysis results comparing two examinations of one eye on the same side
in the same scan mode, from different dates.

Exam info
Eye preview

Tomogram

Thickness
map

Measurement
Difference map
table

1. Eye preview
2. Thickness map
3. Corneal thickness (μm)

169 / 387
SOCT User Manual Version 11.5 rev. A
The items are the same as on the [Single] tab screen. This table shows the values for each
examination. The rightmost column is the difference between the two examinations.
4. Tomogram
Same as [Single] tab screen.
5. Difference map
This color maps show the differences in corneal thickness and corneal epithelium thickness
between both examinations. Values for the differences between both examinations are shown on
the grids.

[Progression] tab screen


This screen shows the analysis results comparing six examinations arranged in time sequence of
eyes on the same side in the same scan mode, and same size of scanning area.

11.1.4.1 Maps view

Type of view Exam selector

Pachymetry map
Exam date

Epithelium map
Tomogram

Trend graph Thickness table

Figure 139. Progression Anterior radial maps view

1. Type of view:
Available views:
• Maps allow to evaluate quantitatively.
• Tomograms allow to evaluate morphology of scanned tissue
2. Pachymetry map
The values overlay on the color-coded thickness map. Values corresponding to the map are shown
on the corneal grid.

170 / 387
SOCT User Manual Version 11.5 rev. A
3. Epithelium map.
Shows the corneal epithelium thickness map for five examinations.
4. Trend graph
This graph plots all examinations performed for the same patient to show changes in the corneal
thickness over time. Plots display results of all examinations. The selected examinations are
displayed on the reports are indicated in black and other examinations not displayed on the report
are indicated in grey.
You can select what is shown from the list box.
• Cornea thickness graph
• Epithelium thickness graph
5. Thickness table
This table shows the values for each examination. The rightmost column is the rate of change.
[Central Corneal Thickness]: Central corneal thickness
[Minimum Thickness]: Minimum corneal thickness
[Maximum Thickness]: Maximum corneal thickness
[Minimum - Maximum]: Difference between the minimum and maximum corneal thicknesses
[SN-IT]: Difference between SN sector and IT sector within the corneal grid
[S-I]: Difference between S sector and I sector within the corneal grid

11.1.4.2 Tomogram view


Tomogram view allows to analyze morphology of the anterior structure.

Type of view

Thickness
graph
Eye preview

Tomogram

Latest exam

Figure 140. Anterior Progression Tomogram view

171 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: When layers detection has failed, modify boundary of layers manually.

NOTE: Cornea analysis tab is available only when the system classifies the scanned
object as Cornea scan. To change scan type, go to Examination list -> Right-Click ->
Tomogram tab-> Menu -> Change Analysis type. Anterior Analysis type window will
appear. Select [Cornea] type.

Edit anterior surface.


SOCT finds the anterior (outer) and posterior (inner) surfaces of the cornea automatically.
Dewarping calculation (a form of image processing) is conducted for all Anterior scans used to
transfer the OCT image in “optical distance space” to “physical distance space.” The algorithm
requires properly recognized boundary between the Air and Anterior structure of the eye.
In some cases, the corneal surface lines clearly do not fit the corneal contours, due to anomalies
in the scan image, such as may be caused by the interference of eyelids or eyelashes.
To edit the surface boundary lines so they fit better, double click on the Tomogram window. Press
[Edit layers] button and select desired boundary. Then draw correct shape of anterior structure.

11.1.5.1 Angle or Angle to Angle scan


When you edit the layers, if required remove unnecessary data to change the portion of image
data included into mathematic model of ray tracing analysis in which that image is used.
Automatically, SOCT excludes portions of the image to which ray tracing correction model (a form
of image processing) cannot be confidently applied. The size of the excluded margin can be larger
when the processing algorithm cannot detect the corneal surfaces due to poor image quality.
Figure 141. Edit Anterior layer

Hold Left mouse


button to draw
boundaries

Hold Right mouse


button to delete
boundaries

172 / 387
SOCT User Manual Version 11.5 rev. A
AOD measurement
Measurement tools is available only from the full scan window.

This tool enables to evaluate the angle opening. In order to use this tool, click the ‘AOD’
button, position mouse cursor over Sclera Spure and press the left mouse button. In order to
replace the apex of the tool move the cursor over them, press and hold the left button and point
at the right places. You can replace the position of the information table in the same way.

Figure 142. Example of an AOD measurement

AOD500: Angle Opening Distance of 500 micron measured between two upper points along
the posterior cornea surface. One of this point shall be located on sclera spur, the
second one on the cornea surface away from sclera spur. Another point has to be
located on Iris.
AOD750: Angle Opening Distance of 750 micron.
TISA: Trabecular Iris Segment Area.
NOTE: Only when border air-anterior surface is correct are AOD and TISA
measurements accurate. Verify recognition correction before judging the Anterior
Angle morphology.

173 / 387
SOCT User Manual Version 11.5 rev. A
Angle measurement tool

This tool enables to measure an angle. Click ‘Angle measurement’ button, put mouse cursor
over the place where you want the apex of the angle and click left-mouse button. Now click in the
place where you want to set one of the arms, place cursor of the angle to the desired position and
click for the second time. Information about angle will be displayed between the angle sides.
Measurements are expressed in degrees. It is also possible to move the position of the angle and
its measurement, by dragging and dropping its apex and the 2 points of measurement. The
measurement checkbox will affect also the angle visibility in the tomogram window, so select or
deselect this in order to show or hide the angle measurement.

Figure 143. Example of an angle measurement

NOTE: Only when border air-anterior surface is correct Angle measurement is accurate.
Verify recognition correction before judging the Anterior Angle morphology.

Caliper tool
Caliper tool is used to measure the length of various structures within the anterior chamber. To

activate the tool, click the button. Next, click and hold the left mouse button in the place on
the image where you want to start the measurement and extend it by moving the mouse to the
point you want the measurement to end at.

174 / 387
SOCT User Manual Version 11.5 rev. A
Figure 144. Example of a caliper measurement

Each of the three variants of the tool is optimized for measuring a specific structure type.

To pick a variant click the button and choose the desired option.

C – Caliper toll for measuring the thickness of cornea


AQ – Caliper tool for measuring distances within the anterior chamber

Tomogram review analysis


This shows the tomogram image and the defined thickness of the specified part. The compatible
scan modes are [Raster], [Line], [Cross] and [Radial]. The tomogram images can be averaged.

175 / 387
SOCT User Manual Version 11.5 rev. A
12 FULL SCREEN WINDOW
To open Full screen tomogram window double click on the tomogram window. Full screen window
enables operator to browse all the stored examination results. It contains all tools for editing of
the layers, manual measurements and putting comments or descriptions in the tomogram.

Fundus
reconstruction,
Eye preview or
pSLO

Imaging tools

Layers displaying
and edition
Measuerement
tools and
annotations
Brightness and
contrast
Closing the full
screen

Figure 145. Full screen tomogram

Fundus reconstruction, eye preview or pSLO


Drop-down list box allows to toggle between fundus reconstruction, eye preview, pSLO or fundus
photo.

Figure 146. Eye preview type selection.

176 / 387
SOCT User Manual Version 11.5 rev. A
The fundus photo is set as default.

Color fundus
photo

Single eye view with a fundus photo

Imaging tools
Imaging tools – module including tools for change color and tomogram proportions.

Switching between colors and greyscale Invert colors

Switch on/off the Enhance mode Preview all RAW tomograms

Fitting tomogram to window Zoom in

Real scal tomogram Zoom out

Fitting tomogram hotizontal Fiitting tomogram vertical


horizontally
Figure 147. Imaging tools

Preview all RAW tomograms as default is unmarked.


This function is active only when examination contains averaged tomograms. When it is
unmarked the user can display and review only averaged images. When enabled, first the
current averaged tomogram is displayed and after scrolling, the corresponding series of RAW
for that averaged tomogram is displayed, until the next averaged tomogram is reached, after
which the corresponding series of RAW will be displayed for that next averaged tomogram.
Scroll down to go to the next tomograms and up to go to the previous ones.

Measurement tools and annotations


On the fundus reconstruction object and on the tomogram it is possible to use measurement
tools. It is possible to make measurement of area and make measurement of the distance
between two points or the angle between two sections.

177 / 387
SOCT User Manual Version 11.5 rev. A
Measurement of the section

Distance measurement Area measurement tool

Figure 148. Measurement tools

Annotation tab makes possible inputting text field with operator comments as well as arrow
symbol pointing exactly to the place which the comment concerns. Operator can also choose
the color in which the particular marking will be displayed on tomogram. Additional two
buttons allow the user to delete single marking or all markings on particular tomogram.

Delete single marking

Input arrow marking Delete all markings

Choice of marking color


Input text field

Figure 149. Tab of tomogram annotations

The above tools and annotations remain enabled and are able to continuously insert additional
measurements and markings until disabled by clicking on them again.

Brightness and contrast adjustment


Brightness and contrast adjustment is done with the sliders presented below. . The adjustment
is sometimes necessary because of the difference in the optical transparence of the examined
eyes. To the right of each slider there is a button restoring the default brightness and contrast
settings.

Enhance Retina

Enhance Vitreous Enhance Choroid

Brightness adjustment slider Restore Brightness

Contrast adjustment slider Restore Contrast settings

Figure 150. Brightness and contrast manipulation

Recommended tool to adjust Brightness and contrast is to move the cursor over the tomogram
or angiogram window and drag the cursor up/down or right/left.
Dragging up and down: Adjusts the brightness. Dragging right and left: Adjusts the contrast.

178 / 387
SOCT User Manual Version 11.5 rev. A
Resetting Brightness and Contrast After Adjustment: Right-click the OCT image, and select
[Reset Brightness/Contrast] from the menu.
Enhanced mode highlights the details of the morphological structures above and below the
retina. While in the mode it is possible to adjust the brightness and contrast in one of three
zones: Vitreous, Retina and Choroid. The vitreous mode adjusts brightness and contrast above
the ILM layer. Retina mode adjusts brightness and contrast between the RPE/BM and ILM
layers. Choroid mode adjusts brightness and contrast below the RPE/BM layer.

Full screen mode exit


Full screen mode exit – the button makes possible full screen mode exit and going to exam
analysis. The same result is achieved by double clicking on tomogram.

Tomogram window manipulation


Right Click (long press using touch screen) over the tomogram preview opens the display and
actions menu. Moving the mouse up or down with the right button pressed continuously
adjusts brightness and contrast. The list of options is presented below.
Auto fit function has been modified.
Auto fit – it fits tomogram horizontally.
Note that the proportion of the scan may be different between examinations.
Manual selection of Foveola location

Enables A scan cursor to get reference on fundus preview

Resetting brightness and contrast to default value

Tomogram display options

Size and scale fitting options

Flattening

Saving as

Figure 151. Tomogram display options window.

Double click on the tomogram preview switches the view to full screen and allows to edit
layers recognition in the same way as in the Retina examination viewing tab.

179 / 387
SOCT User Manual Version 11.5 rev. A
Edition of recognized layers
System automatically recognizes layers. Whenever you find out that the recognition of layers
is incorrect, you can manually correct them. This feature is especially useful in cases where
the retina has structural anomalies or pathology that may cause the algorithms to incorrectly
trace the actual boundaries.

Display visible layers


Edit layers Edition of ONH edges
Cancel introduced change
Accept introduced changes

Figure 152. Selection and edition of layers

In order to correct recognized layers, press the [Edit layers] button. In order to correct
recognition of layers, choose the layer from the list and draw its outline on the tomogram.
After correction of tomogram/s press [Accept] option. The software will automatically
recalculate all the data, on the basis of the user modifications. Correction can be used for fovea
and disc analysis. It is enabled only after analysis is done.
Pressing the [H] button on the keyboard will hide all of the layers. This functionality works both
when editing layers and when only viewing. Pressing [H] again will make the layers visible. This
tool is used to toggle the layers on and off when looking at examinations.
[Reanalyze] function is used to recover default recognition of layers. It is recommended to
make reanalysis of examinations taken with previous software versions.
ILM - Inner Limited Membrane - surface of the retina
RNFL/GCL - Outer boundary of Retina Nerve Fiber Layer
GCL/IPL - Outer boundary of Ganglion layer
IPL/INL - Outer boundary of Inner Plexiform Layer
INL/OPL - Outer boundary of Inner Nuclear Layer
OPL/ONL - Outer boundary of Outer Plexiform Layer
MZ/EZ - Junction of Myoid and Ellipsoid zones
OS/RPE - Junction of photoreceptors and Pigment epithelium
RPE/BM - Outer boundary of RPE
BM - Bruch’s Membrane modeling based on outer boundary of RPE
BM fit - parabolic fit for end of RPE layer

The abbreviations and names of the layers and boundaries shown in analysis are as follows.
ILM Internal Limiting Membrane
180 / 387
SOCT User Manual Version 11.5 rev. A
NFL Nerve Fiber Layer
GCL Ganglion Cell Layer
IPL Inner Plexiform Layer
INL Inner Nuclear Layer
OPL Outer Plexiform Layer
ONL Outer Nuclear Layer
IS Photoreceptor Inner Segment
OS Photoreceptor Outer Segment
RPE Retinal Pigment Epithelium
BM Bruch’s Membrane
Manual disc contour edition
For Disc examination it is possible to edit position of recognized end of BM membrane which
defines the disc shape. Press [Edit disc] button to correct the markers.
On the tomogram preview windows white markers points will appear on left and right edge of
BM on actual scan (if actual scan crosses disc). If necessary, marker points can be moved by
clicking and dragging them on tomogram image area (changes in single scan will occur on
shape of disc and cup and will take effect in all analysis) to proper location. Yellow line shows
Cup Offset Line (parallel to purple disc which represents disc surface). Distance between Cup
Offset Line and disc surface line may be changed by editing the value on Cup Offset Panel or
moving the cup offset line. To reset cup offset values double click on the cup offset line on the
tomogram window.
After disc analyzing, operator can manually edit position of end of RPE markers. In order to
replace markers which identify the edge of RPE click white marker, hold the button and drag
to proper location in the disc profile (for each scan). It is possible to change position of edge
by drawing shape of the disc in Manual disc contour option.
Changing the Cup Offset will move cup closer or further from disc, this will be also visible in
cup shape on fundus reconstruction. All ONH data are automatically recalculated if Cup Offset
or RPE edge factors change. It is possible to restore default analysis by using [Reanalyze]
option. Right Click on the preview exam.
[Edit shape] – Opens “Manual disc contour edition” window which allows the physician to
draw manually the shape of the disc.
This window allows the user to redefine shape of disc and its
position.
[Apply] – applies the changes of the disc and closes the window.
[Cancel] – exits the window without changes.
[Reset] – resets a disc shape to condition which was before
opening the window.
[ Clear] – clears the disc’s factors. New shape of disc should be drawn manually.
181 / 387
SOCT User Manual Version 11.5 rev. A
There are two ways to correct shape of disc.
One is to remove contour of disc by using [Clear] button and drawing it again. To draw a new
shape of the disc, click on the center of a disc and at least two points on the edge of a disc.
Recognition of the disc will be automatically circled between selected points around disc
center. All other points will be automatically added after [Apply] button is used. If operator
decides to draw disc contour more accurately (with non-elliptic shape) it's possible to add
more disc points manually by clicking on the image
The other way is to redraw existing shape.
The disc shape adjustment window can be opened by double clicking on the NFL signification
map in either the SINGLE or BOTH EYES view.

Redraw the disc contour


Operator can redraw disc contour position in two ways:
Click and hold left mouse button and draw desired shape.
Put the cursor over the blue point to activate it. Point will highlight. To move active point to
new position click left mouse button and move mouse. To delete active point click right mouse
button on it – the point will disappear and white disc contour line will be updated to connect
two neighboring points.

Click and move the centre End of the blue tracking line points mouse
point cursor position. Click the left mouse
button to move the active (highlighted)
point from its position to the position of
the mouse cursor. Click right mouse
button to delete active point.

Disc contour lines are always restricted to image margins.


Whenever the manual analysis is still not helpful to perfectly draw the shape of the disc, the
user can still fix the manual analysis, by means of 2 white markers in the tomogram preview

182 / 387
SOCT User Manual Version 11.5 rev. A
of the main disc analysis window, as explained in Tomogram preview chapter 7.10 Live OCT
preview.

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.

13 PRINT
Posterior segment examination reports/outputs
Retina 3D
Press the [Print] button to print the displayed report.

Figure 153. Examination report for Retina 3D Single output

183 / 387
SOCT User Manual Version 11.5 rev. A
Figure 154. Examination report for Retina 3D both output

Figure 155. Examination report for Retina Comparison single view

184 / 387
SOCT User Manual Version 11.5 rev. A
Figure 156. Examination report for Retina Progression single view

Figure 157. Examination report for Retina Ganglion both view

185 / 387
SOCT User Manual Version 11.5 rev. A
Figure 158. Examination report for Retina Progression Ganglion single view

Figure 159. Examination report for Retina Progression Tomogram Morphology view

186 / 387
SOCT User Manual Version 11.5 rev. A
Disc 3D

Figure 160. Examination report for Retina + Disc Advanced both view

Figure 161. Examination report for Retina Widefield view

187 / 387
SOCT User Manual Version 11.5 rev. A
Figure 162. Examination report for 3D Retina single view

188 / 387
SOCT User Manual Version 11.5 rev. A
Optic nerve head analysis reports

Figure 163. Examination report for single disc view

Figure 164. Examination report for 3D single disc view

189 / 387
SOCT User Manual Version 11.5 rev. A
Figure 165. Examination report for both disc view

Figure 166. Examination report for single disc progression view

190 / 387
SOCT User Manual Version 11.5 rev. A
Figure 167. Examination report for Disc + Retina advanced both view Anterior segment examination reports

Figure 168. Structure and function examination report

191 / 387
SOCT User Manual Version 11.5 rev. A
Figure 169 Examination report for Anterior segment single view

Figure 170. Examination report for Anterior segment both view

192 / 387
SOCT User Manual Version 11.5 rev. A
Figure 171. Examination report for Anterior segment comparison view

Figure 172. Examination report for Anterior segment progression view

193 / 387
SOCT User Manual Version 11.5 rev. A
Figure 173. Examination report for Wide Anterior Line single view

Figure 174. Examination report for Wide Anterior Line both view

194 / 387
SOCT User Manual Version 11.5 rev. A
Figure 175. Examination report for Wide Anterior segment progression Line view

Topography examination reports

Figure 176. Examination report for Topography pachymetry single view

195 / 387
SOCT User Manual Version 11.5 rev. A
Figure 177. Examination report for Topography pachymetry both view

Figure 178. Examination report for Topography comparison view

196 / 387
SOCT User Manual Version 11.5 rev. A
Figure 179. Examination report for Topography comparison pachymetry view

Figure 180. Examination report for Topography progression view

197 / 387
SOCT User Manual Version 11.5 rev. A
Figure 181. Examination report for Topography progression, tomograms view

Figure 182. Examination report for Topography progression pachymetry view

Fundus examination reports

198 / 387
SOCT User Manual Version 11.5 rev. A
Figure 183. Examination report for Fundus single view

Figure 184. Examination report for Fundus both view

199 / 387
SOCT User Manual Version 11.5 rev. A
Figure 185. Examination report for Fundus single view x4

Figure 186. Examination report for Fundus comparison view

Angiography examination reports

200 / 387
SOCT User Manual Version 11.5 rev. A
Figure 187. Examination report for Angiography standard single view

Figure 188. Examination report for Angiography detailed single view

201 / 387
SOCT User Manual Version 11.5 rev. A
Figure 189. Examination report for Angiography both view

Figure 190. Examination report for Angiography comparison view

202 / 387
SOCT User Manual Version 11.5 rev. A
Figure 191. Examination report for Angiography progression analysis view

Figure 192. Examination report for Angiography progression standard view

203 / 387
SOCT User Manual Version 11.5 rev. A
Figure 193. Examination report for Angiography 3D view

Figure 194. Examination report for Angiography advanced view

Disc OCT-A examination reports

204 / 387
SOCT User Manual Version 11.5 rev. A
Figure 195. Examination report for Disc OCT-A standard single view

Figure 196. Examination report for Disc OCT-A detailed single view

205 / 387
SOCT User Manual Version 11.5 rev. A
Figure 197. Examination report for Disc OCT-A both view

Figure 198. Examination report for Disc OCT-A comparison view

206 / 387
SOCT User Manual Version 11.5 rev. A
Figure 199. Examination report for Disc OCT-A progression analysis view

Figure 200. Examination report for Disc OCT-A progression standard view

207 / 387
SOCT User Manual Version 11.5 rev. A
Figure 201. Examination report for Disc OCT-A 3D volume view

Biometry examination reports

Figure 202. Examination report for Biometry single view

208 / 387
SOCT User Manual Version 11.5 rev. A
Figure 203. Examination report for Biometry both view

Figure 204. Examination report for IOL Calculation

209 / 387
SOCT User Manual Version 11.5 rev. A
Multi B-scan report
Multi B-scan procedure allows to print 4 tomograms on one printout. Press v on the [Print]
button and select Multi B-scan from menu. System places 4 tomograms on printout.
Tomograms can be automatically selected by system or selected by users.
New Multi B-scan acceptance window allows to verify, save, output and print Multi B-scan
reports. The Multi B-scan acceptance window appears after selecting the Multi B-scan from
the menu.

Choose the
number of copies
Fundus image
on/off

Figure 205. Multi B-scan acceptance window.

Manually select tomograms


It is possible to select tomograms individually to the Multi B-scan report. To select desired
tomogram to Multi B-scan printout press Right Click and select ‘Add to printout’ from menu or
hold [ctrl] button and Left-click anywhere in a printout preview. On the tomogram in the right-
top corner the letter P will appear. When you select more than 4 tomograms last selected
tomogram replaces the first selected. Press P letter on the tomogram to unselect tomogram
from the Multi B-scan printout.

Figure 206. Multi B-scan report

210 / 387
SOCT User Manual Version 11.5 rev. A
Multi B-scan report for Both and Comparison view.

Figure 207. Multi B-scan report for Both Eyes and Comparison view

The Multi B-scan report output settings is available in the SETUP/Preference/Output settings
window.

Multi b scan output


content

Single tomogram report

In order to print one tomogram on the whole page. Go to full screen view (double click on the
tomogram window) and press Print button.

Figure 208. Single tomogram printout

211 / 387
SOCT User Manual Version 11.5 rev. A
Select desired printer
It is possible to select desired printer before printing. Press “v” on the button and
select [Select printer and Print] option from the list. Choose desired printer and press OK
button.

212 / 387
SOCT User Manual Version 11.5 rev. A
14 OUTPUT
Output function allows to save examination results. When the output set is not created,
system saves report to the file. When set is created, output window appears after pressing.
User can select desired set(s) and then press [OK]. When the set is marked then output
examination data are displayed on the right. If the option „When printing” is selected the
system outputs data in the moment when user presses [Print] button.

Figure 209. Output screen

User can define the output sets. In the set it is possible to specify kind of data (tomogram,
series of tomograms, multibscan reports or tomogram plus report), location of saving data,
the type of data (graphic format or SOP class) and moment of exporting. The Output function
can be sent to the DICOM, EMR server or to any other specified location.
More details on how to define output sets can be found in chapter 22 Setup Window.

213 / 387
SOCT User Manual Version 11.5 rev. A
15 SELECTING FUNDUS PHOTO
Fundus images captured by another device such as SLO or retinal camera, can be imported
and shown instead of fundus reconstruction images. Retinal image can be added to the
posterior scans.
Allowed image formats are .png, .tiff, .jpeg, .gif, .bmp and .jpg. When a retinal image is
imported image is added to the visit as separate exam or can be displayed for reference image
instead of fundus reconstruction.
The right-click context menu is available in the following views:
• Retina 3D Single • Disc Radial Single
• Retina Raster Single • Disc Raster Single
• Retina Raster 21 Single • Disc Angio Single
• Retina Line Single • Widefield 3D Single
• Retina Cross Single • Widefield Raster Single
• Retina Radial Single • Widefield Line Single
• Retina Angio Single

Adding fundus photo to the examination.


1 Right-click on the fundus reconstruction image and select [Import Fundus photo...]
from the context menu.

Figure 210 Context Menu

2 In the window that opens, select a fundus photo to import. Directories from which
photos should be displayed can be easily changed in the [Look In] field. In case of a
directory with many files, use the View selection menu to see previews smaller or
larger. See below.

214 / 387
SOCT User Manual Version 11.5 rev. A
View selection
menu

Image type
selection

Figure 211 Fundus Import Selection

3 The user can indicate the type of the fundus photo which is to be imported in the
[Image type] selection field on the right side of the window. Indicating the type of the
image allows the system to apply an image-optimized registration algorithm.

4 Once the desired file has been selected, click [Open]. A Fundus and OCT Registration
window will now open. At this point, place the markers on any characteristic points of
the retina i.e. blood vessels on both fundus(1) and retinal*(2) image previews. Right-
click anywhere to view more options such as to reset all markers. Use standard controls
to zoom and move the previews.
Retinal image
preview (1)

Fundus image preview Result review window


Figure 212 Fundus Registration Blank and Marked
(2)

4 Verify whether selected points are placed precisely on both previews. Right-click a
point to remove it. Closing the window will not import the photo and discard any

215 / 387
SOCT User Manual Version 11.5 rev. A
changes. Registration between the imported fundus image and retinal preview may be
reviewed by changing transparency over result review window (3).
Clicking [OK] will save the registration and import the fundus photo.

* For Angio OCT scans, the preview can be changed to other vascular layers such as superficial,
SVC, depth coded etc. as long as selected in the top left window.

Preview selection layer

Figure 213 Vascular layer previews

Fundus image registration correction


Right-click on the fundus reconstruction window. From the context menu, select [Fundus
Registration] option.

A ‘Fundus Registration screen’ will open. To correct the position, proceed as described in
chapter 15.1 Adding fundus photo to the examination.

Linking a fundus photo to an examination.


The user can link a single fundus photo to several OCT exams.
Every OCT exam can be linked to only one photo. It is always recommended to perform this
operation to reduce the number of shots per eye.
To link a photo to an exam click the right mouse button on the reconstruction image to open
the context menu shown below. Choose [Link examination].

216 / 387
SOCT User Manual Version 11.5 rev. A
Figure 214. Context menu

A list of photos available for linking opens. If the user marks the [NG] checkbox, all available
photos, including the ones with an NG status are listed. To go to the Fundus and OCT
Registration window double click on a selected image.

NG checkbox

Figure 215. Fundus photo selection for linking with an examination

16 EXAMINATIONS REGISTRATION
OCT-OCT Registration
The SOCT software automatically correlates examinations thanks to recognized shape of the
blood vessels. If operator uses examinations free from eye movement artifacts for analysis,
then the dense scanning provides enough data for precise overlaying which eliminates X, Y and
rotation shifts between compared examinations. When above conditions are met, then this
function serves as post processing tracking.

217 / 387
SOCT User Manual Version 11.5 rev. A
Exams with artefact can be marked by operator as not correct – NG examination status appears
on the scan. Exams with NG status are not chosen automatically to any analysis (e.g.
comparison, progression, etc.).

Automatic registration

Original image
Scroll to change
transparency

Figure 216. The result of OCT correlation – registration

The system displays the registration status ( A - Automatically correlated, M - manual

correlated, - Manual registration required). If automatic registration is not possible, the


system displays status registration failed. To verify automatic registration or to correlate exams
manually, press the [Registration] button, results are displayed on a pop-up screen, as shown
above screen.
In this screen, images in top row are the original fundus reconstruction images. The bottom
images are result images. The reconstruction images from each examination that has been
registered are overlaid on the baseline exam.
Registration between the exams and baseline can be verified. Place the mouse cursor over one
of the result images and scroll the mouse wheel to change the transparency.

218 / 387
SOCT User Manual Version 11.5 rev. A
Manual registration
If examinations have not been correlated automatically, the user can correlate them manually.
Place each point markers on any characteristic points of retina (e.g. characteristic retina blood
vessels) that appear in baseline and registered scans. It is required to select from two to five
corresponding points on baseline image and compared examination image by using the mouse
click.
Use the mouse scroll as needed, to change the transparency to see more of Exam Image or
Baseline Image. By moving the scroll back and forth, you can see if blood vessels or other
features from one image align with the identical features in the other image.
To return the registration to the original setting, press the [Reset] button.
If you are not satisfied with the positioning of the points, to delete selected point right Click
over desired marker. To delete all markers, press [Clear] and then make new point selections.
It is possible to correct marker position. Press and hold the left mouse button and drag the
point to desired position. Corresponding marker/s on other images highlight during dragging.
To call automatic registration press [Analyze].
To see the final registered image, change the transparency slider over to result object. When
you are satisfied with the resulting overlay, select [OK]. To reset the values to the original
registration, click [Cancel].

Fundus registration
The SOCT software can automatically correlate fundus photographs with OCT examinations by
recognizing patterns in the shape of vessels. To open the Fundus and OCT Registration window
click the right mouse button on a reconstruction image or a fundus photo and choose Fundus
registration from the drop-down menu.

Automatic registration
To perform automatic registration, choose the type of the image in the Image type section and
click [Analyze]. The result of the registration will be shown in the Registration preview. If

automatic registration is not possible the system displays the symbol meaning that
manual registration is required. If the Image type is set to Auto and the result of the
registration is not satisfactory, the user can indicate the image type manually to further
optimize the performance of the algorithm. If the result of the automatic registration is still
not acceptable, the user can perform manual registration. The procedure is described in
section 16.2.2 Manual registration .

219 / 387
SOCT User Manual Version 11.5 rev. A
Registration status
Precise registration button
Image type section

Precise registration field Analyze button


Reset button

Transparency slider
Registration review
window Select Fundus Photo

Figure 217. Fundus and OCT Registration window


Precise registration Activates the precise correlation field for manual correlation.
Precise registration field In this field you can manually correlate the fundus photo with
the OCT image. To do that place markers on any characteristic
points of the retina such as blood vessels on both the fundus (1)
and the OCT image. Right-click anywhere to view more options.
Registration review window Shows the result of automatic registration and allows the user
to correct it manually. The OCT image is overlaid over the fundus
image with 50% transparency. The level of transparency can be
changed with the Transparency slider.
Registration Status Indicates the status of automatic registration:

Automatic registration

Manual registration (quick or precise)

No automatic registration
Image type Allows the user to indicate the type of the imported image to
optimize the performance of the registration algorithm.
Analyze Runs the registration algorithm for analysis. The algorithm is
optimized for the image type selected in the Image type field.
Reset Rejects all actions performed by the operator and restores the
initial state of the Registration window.
Transparency slider Allows the user to adjust the level of transparency of the OCT
image overlaid over the fundus photo from 0% to 100%.
Transparency can also be adjusted by scrolling over the result
preview section.
220 / 387
SOCT User Manual Version 11.5 rev. A
Select Fundus Photo Allows the user to select a fundus photo for registration
OK Clicking OK closes the window and saves the result of the
registration with changes introduced by the user.
Cancel Clicking Cancel closes the window without saving changes.

Additional options
For more options click your right mouse button over the Precise registration field or
Registration preview to open the following context menu:

Remove points Removes all markers form the Precise registration field and
Registration preview
Reset zoom Restores the original zoom
Reset all Removes all markers and restores the original zoom
Reset brightness/contrast Reset brightness ands contrast to default levels

Manual registration
If you are not satisfied with the result of automatic registration, you can correct it manually.
To enter manual mode, click [Precise registration]. Place markers on any characteristic
morphological structures such as blood vessels on the OCT image. Then place markers on the
fundus image by replicating the positions of markers on the OCT image. When the first pair of
corresponding points is set, the preview image changes to show the current state of
registration. Continue adding markers until good registration is achieved. The result can be
further fine-tuned in the result preview by moving individual points.
Use the mouse scroll as needed to change the transparency to see more of the OCT or fundus
image. By moving the scroll back and forth, you can see if blood vessels or other features from
one image align with identical features in the other image.
To return the registration to the original setting, press [Reset all] in the context menu.
If you are not satisfied with the positioning of the points, to delete a selected point right click
over the desired marker. To delete all markers, choose [Clear all markers] from the context
menu.
221 / 387
SOCT User Manual Version 11.5 rev. A
16.2.2.1 Fast manual registration
If the user needs a quick, “on the spot” registration result, they can manually stretch, move
and rotate the OCT image over the fundus photo until a visual registration of the structures is
achieved. In order to stretch the OCT image, place the mouse cursor over any of the edges of
the image. The cursor icon will change into a double ended arrow indicating the direction
of stretching. Press and hold the left mouse button and drag the edge of the image until the
desired stretch is achieved. Similarly, to rotate the image, place the cursor over any corner of

the image. The cursor icon will change into a bent arrow . Press and hold the left mouse
button and rotate the image.

Figure 218. Registration screen with arrows indicating the direction of the manipulation of the image

Moving the overlaid OCT image


Dragging the image
The OCT image overlaid over the fundus photo can be dragged to the desired position by
holding the left mouse button and moving the mouse.
Rotating the image
You can rotate the image in relation to its center. To do that hover the mouse cursor over any
of the corners of the image until the cursor changes into the “rotate” sign. Click and hold the
left mouse button and rotate the image right or left.
Changing the size of the image
To change the size of the OCT image, hover the cursor over any of the corners of the image

until it changes into one of the following symbols indicating the direction of change: ,

, , . Click and hold the left mouse button and move the mouse to change the size

222 / 387
SOCT User Manual Version 11.5 rev. A
of the image.

Closing Fundus and OCT Registration window


To exit the window and save registration results click [OK]. Clicking [Cancel] rejects any changes
to the images and closes the window without saving the results of the registration.

Extracting tomograms from a 3D exam


The function makes it possible to display a follow-up tomogram that is tied-in location wise
to the reference tomogram so that all tomograms always present the equivalent location of
the patient’s retina for precise comparison or tracking of disease progression. To reach the
correct alignment of all tomograms, the software compensates the images for differences in
scan positioning and rotation which occurred during acquisition.
Before the function can be used, examinations must be correlated automatically or manually.
Registration of examinations is explained in the chapter 16 Examinations Registration .
An extracted tomogram is created by extracting A-scans of the follow-up tomogram on the
basis of the registration with the reference tomogram.
To display an extracted tomogram, go to Comparison or Progression tab. Make sure the

examinations have been correlated. Click the arrow next to the lock button to unfold

a context menu and choose the extraction function by clicking . (if the examinations are
not correlated, the extraction function is not available). The extracted tomogram is displayed
in the bottom right-hand corner. From now on, scrolling over either of the tomograms causes
both of them to act in sync, always presenting the same location of the patient’s retina.

Lock button Blue navigation


line indicating
the extraction
function is on

Extracted
tomogram

Figure 219. Comparison tab with an extracted tomogram displayed in the bottom right-hand corner

Different options in the lock button drop down menu indicate the following:

223 / 387
SOCT User Manual Version 11.5 rev. A
Lock is off, no Registration

Lock is on, no Registration

Lock with Extracted tomogram function is on

224 / 387
SOCT User Manual Version 11.5 rev. A
FUNDUS CAMERA – RESULT REVIEW
This functionality is available for Fundus camera photography acquisition by REVO FC or
imported to the SOCT application from an external device.

Color fundus photo [Single] view x 1

Type of view
Display settings

Color fundus photo

Scale

Figure 220. Single eye color fundus photo x1 view

Color fundus photo [Single] view x 4

Type of view
Display settings

Color fundus Red color mode of


photo the fundus photo

Green color mode of


the fundus photo Blue color mode of
the fundus photo

Scale

Figure 221. Single eye color fundus photo x4 view

225 / 387
SOCT User Manual Version 11.5 rev. A
Color fundus photo Full screen view
Color channels
manipulation

Brightness, Contrast

Gamma
Color fundus photo
Sharpness
Display settings

Loupe tool - hint


Highlights

Reset all
Color balance

Figure 222. Single eye color fundus photo full screen view

The Color Fundus Photo Full Screen View can be opened by clicking the left mouse button on

the icon available on the Eye Preview object with the Fundus Photo.

Color Fundus Photo Full


Screen View icon

The user can choose all channels tab (RGB) or a single channel (R, G or B).
RGB tab allows the operator to adjust each channel separately or all channels simultaneously.
Also, the adjustment of brightness and contrast is available.
When the user chooses a single channel (R, G or B), it is only possible to manipulate brightness
and contrast of the selected channel. Color channels manipulation – The user can choose only
one option at a time. The RGB button controls 3 channels; R – only red channel, G – only green
channel, B – only blue channel. When the button is pressed, the image is displayed in one of
the channels or in RGB. With the button selected the user can adjust the Brightness, Contrast,
Gamma and Sharpness sliders which affect only the displayed channel. The RGB button is
selected by default. Choosing a different channel for display closes the previously chosen
channel. Displaying multiple channels simultaneously is not possible. Deactivating all of the
channels results in displaying the image in gray scale. If the RGB button is engaged the tab with
the sliders for all individual channels is available with three sliders respectively for the three
channels (R, G, B).

226 / 387
SOCT User Manual Version 11.5 rev. A
Loup - enlarges an area of
Fit to window
the image

Original size Zoom in/out

Flip horizontally/vertically

Figure 223. Display settings in single eye color fundus photo full screen view

Gamma - sets the gamma value.


Sharpness - affects the contrast at a pixel level - makes the contrast between each pixel
more or less pronounced. Adjusting the sharpness slider can add or reduce perceived texture
in a photo.
Color balance23 – allows to change predefined color balance setting for Neutral and
Standard.

Neutral Color balance Standard Color balance

Highlights – Function darkens highlights on the photo. Useful for disc observation.

NOTE: Highlights desaturate of highlighted areas. It may affect the local color
presentation.

23
available only for the devices REVO FC 130 and REVO FC with REF #: 1905xxx

227 / 387
SOCT User Manual Version 11.5 rev. A
Color fundus photo [Both] view

Display settings

Right eye Left eye

Comments

Figure 224. Both eyes color fundus photo view

Color fundus photo [Comparison] view


Left/Right eye Examinaton date

Display settings
Lock function

Comments

Figure 225. Comparison color fundus photo view

228 / 387
SOCT User Manual Version 11.5 rev. A
17 ANGIOGRAPHY OCT

RETINA OCT-A
Prepare the patient as explained in chapter 8.1 Preparation for examination.
For details on acquisition procedure consult chapter 7. EXAMINATION ACQUISITION TAB
Angio OCT module is available as an upgrade to the SOCT system.
Angio can be used to detect flow within ocular tissue. The algorithm uses the variation
information in the repeated B-scans to detect locations of flow within ocular tissue. The Angio
scan protocol create a 3D scan data set, that combines the results of repeated B-scans. The
Angio mode graphically represents the results giving by OCT images that contrast areas of flow
and static tissue. The Angio scan which constructs angiography OCTA data is acquired by 230
A-scans and 230 B-scans as default for REVO. In REVO nx operator can modify scanning
protocol with maximum resolution 512 A-scan and 512 B-scan. The Angio scan which
constructs angiography OCTA data is acquired by 320 A-scans and 320 B-scans as default for
REVO FC.

[Single] view – Standard

Figure 226. Single - Standard view

The Single Standard Angiography view includes:


The upper row features four angiogram windows of different predefined retina layers depths.
On the bottom left there is an OCT enface image, next is a depth coded color map, and at the
bottom right there is a B-scan image. Each angiogram has red (horizontal) lines that indicate
the current B-scan location. You can drag these lines to display tomogram from desired
location.

229 / 387
SOCT User Manual Version 11.5 rev. A
It is possible to show only one retina layer in one angiogram window. You cannot show the
same retina layer in two different angiogram windows.
The user can customize the layer boundaries and offsets. The Customized recognition is saved
with the examination. The reanalyze function deletes, among other things, the customized
data. Thanks to that the user can evaluate the customized angiograms.
It is possible to import fundus images for the enface object. Right click on the enface object
and choose import fundus photo from the context menu.

[Single] view - Detailed


Detailed view allows to see large objects and quantify results.

Angiogram
Arrow for moving the
list of layers
Enface image

Vasuclar Thumbnails
FAZ//NFA/VFA Table
layer, list of the layers.
Grabe to move
Layer selection
Retina

Vertical tomogram
window

Horizontal tomogram
window

Figure 227. Single detailed Retina Angio view

Hold right mouse button


Density and move right/left and
up/down to change
map brightness and contrast.

Quantification tools
results

Quantification
B-scan horizontal measurement results
alignment
B-scan vertical
alignment

Figure 228. Single - Detail view – vertical and horizontal alignment

230 / 387
SOCT User Manual Version 11.5 rev. A
Thumbnails of vascular layers: click on the thumbnail to display the object in the large window.
The user can move the list by clicking on the arrows or by scrolling over the list. You may also
change the thumbnails order by grabbing and moving them to a new position.
Angiogram and enface images respond to manipulations and changes in offsets and layers.
Enface image displays an image generated between the boundaries of the active angiogram
window.
Tomogram window shows the selected tomogram overlaid with layer boundaries from the
active angiogram window. It is possible to change the position of the desired layer. You can
type in the offset over the tomogram window or grab and move it. The offset is expressed in
microns from the original position of the recognized retinal layer. The negative offset value
indicates the position below the original position.
The tomogram is overlaid with a semi-transparent, red decorrelation mask. The user can
change the level of decorrelation mask on the B-scan. Press simultaneously the ctrl button on
the keyboard and the Right mouse button and move the mouse up/down and left/right to
change the intensity level. To switch off the Flow press the right mouse button and uncheck
Flow from the menu.
Context menu initiated with a mouse right-click:
Angiogram context menu offers:
- Reset brightness/contrast - restore brightness/contrast default
- B-scan reference enable – enable/disable the reference B-scan on the angiogram
- Save as…/Save anonymized as… - save angiogram
- Projection removal - enable/disable the projection Artefact removal algorithm
Enface Image context menu offers:
- Reset brightness/contrast - restore brightness/contrast default
- B-scan reference enable enable/disable the reference B-scan on the angiogram
- Invert - invert the colors of the enface image
- Save as…/Save anonymized as… - save enface image

231 / 387
SOCT User Manual Version 11.5 rev. A
Angio OCT Analysis.
17.1.3.1 Angiogram object

Depth color coded


map

Angiogram
Scroll window
thickness

Enface image Layer selection

Layers selector
Layer offset
layers
Range of scale
selector Tomogram
window
Angiogram

Figure 229. Single - Standard view – B-scan vertical alignment

Right click on the tomogram window opens the context menu and allows to turn on/off the
Angio flow on the tomogram.
The SOCT algorithm calculates the decorrelation value for each pixel in the B-scan by
comparing the OCT signal intensity variations across the B-scans in each set. Static tissue
locations, without flow, exhibit little variation in OCT signal intensity over the repeated B-
scans; therefore, the decorrelation values would be low.
Tissue locations with flow (for example inside a flowing vessel), show large variations in OCT
signal intensity over the repeated B-scans. At these pixel locations, the decorrelation values
would be high, indicating the presence of flow. The Angiogram image is a graphical
representation of the calculated decorrelation values, with high decorrelation values
indicating flow and low decorrelation values indicating static tissue.
Information displayed on the angiogram object is extracted from the space limited by position
of the top (selected retina layer and their offset) boundary and bottom (retina layer and their
offset) boundary.
At the angiogram window the user can select one of the predefined vasculature layers based
on the position of the recognized retina layer. The vascular layer can be selected from the list
box of available layers:

232 / 387
SOCT User Manual Version 11.5 rev. A
Vascular layer Slab preview Description of layer Offset
Retina Retinal vasculature ILM 0µm,
angiogram BM -30µm

Vitreous Vitreous structure (above ILM 250µm,


ILM layer) ILM 3µm

Superficial Superficial Capillary Plexus ILM 0µm,


IPL/INL -15µm

SVC Superficial Vascular Plexus ILM 0µm,


IPL/INL 10µm

233 / 387
SOCT User Manual Version 11.5 rev. A
RPCP Radial Peripapillary Capillary ILM 0µm,
Plexus NFL/GCL 0µm

Deep Deep Capillary Plexus IPL/INL -15µm,


IPL/INL -70µm

DVC Deep Vascular Plexus IPL/INL 10µm,


OPL/ONL -10µm

ICP Intermediate Capillary Plexus IPL/INL 10µm,


INL/OPL 10µm

234 / 387
SOCT User Manual Version 11.5 rev. A
DCP Deep Capillary Plexus INL/OPL 10µm,
OPL/ONL -10µm

Outer Outer retina layers (avascular IPL/INL -70µm,


zone) BM 0µm

Choriocapillaris Choroidal Capillary BM -15µm,


BM -45µm

Choroid Choroidal Vessels BM -45µm,


BM -160µm

235 / 387
SOCT User Manual Version 11.5 rev. A
Depth Coded Color coded Retinal ILM 0µm,
vasculature angiogram BM 0µm

Exact information about boundaries used to generate angiogram for active object is displayed
in the upper part of the tomogram window.

NOTE: In an OCT image, the intensity of the section under a blood vessel will be changed by
the blood flow. The intensity will affect the visualization of the highly reflective layers such as
IS/OS or RPE. Therefore, the angiogram images including IS/OS or RPE layer appear to be
similar to the angiogram of blood vessel structure of the inner retina. This effect is called
Projection Artifact. In a healthy eye there are no blood vessels in the outer retina.

17.1.3.2 Operation on the angiogram object


Enlarge - Double click on the angiogram image.
Brightness and Contrast modification - press and hold the right mouse button and move it
up/down and left/right to adjusts the brightness and contrast of the Angiogram image.
Modify boundary position – the user can modify the depth position of the top and bottom
boundaries simultaneously. Scroll mouse wheel to go deeper or up from the initial position.
Save as – click the right mouse button and select ‘Save as...’ from the menu to save the
Angiogram image.
Zoom in / Zoom out - press [ctrl] button and scroll over the angiogram window.

Figure 230. Zoom out/in over the angiogram window


236 / 387
SOCT User Manual Version 11.5 rev. A
Angiogram context menu offers:
- Reset brightness/contrast - restore brightness/contrast default
- B-scan reference enable – enable/disable the reference B-scan on the angiogram
- Save as… - save angiogram
- Projection removal - enable/disable the projection Artefact removal algorithm
Left Click to desired position to see the tomogram from specific location. Hold left mouse
button and move to smoothly change the position.
Projection Artefact Removal algorithm.
Angio OCT techniques are based on the principle of motion contrast.
Visualization of the deeper vascular layers is affected by flow projection
artefacts form fluctuating shadows of the flowing blood cells in the more
superficial blood vessels that create “false flow” in the deeper layers. This
phenomenon is called “projection artefacts”. On cross-sectional Angio
OCT projection artefacts are seen as elongated signal tail. On enface
OCTA images the higher layer blood vessels network gets duplicated on
the deeper slabs.
You can turn on/off the projection Artefact removal by right-clicking in the context menu over
the angiogram. As default PAR is activate for Outer, Choriocapillaris, Choroid and Deep layer.

Figure 231. Projection artefact removal algorithm OFF / ON

NOTE: When PAR is turned off the vessels from above are projected downwards.
The ability to turn PAR off is included so the operator can evaluate the image
without the filter.

NOTE: Verify retina layer recognition boundaries and layers offsets before
evaluating angiogram of vascular layer.

NOTE: Due to projection artifacts of the retinal flow signal onto deeper layers,
such as the retinal pigment epithelium and choroid carefully evaluate the signal
deeper vascular layer especially RPE and choriocapillaris.

237 / 387
SOCT User Manual Version 11.5 rev. A
17.1.3.3 Enface window
Enface window. The object displayed can be selected from the list box.
Enface – it displays an enface image generated between the boundaries from
the active angiogram window.
Fundus – it displays color photo fundus image
Structure – it shows color coded thickness map of the retina. Sector dimension
on the map is 1/3mm in diameter.
Retina thickness – it displays Retina thickness map
Inner Thickness – it displays Inner Retina thickness map
When the Structure map is selected it is possible to hide thickness sectors. To hide the sector,
position the mouse cursor over the Structure map, press the right button and uncheck the
‘Sectors’.

Enface Image context menu offers:


- Reset brightness/contrast - restore brightness/contrast default
- B-scan reference enable - enable/disable the reference B-scan on the angiogram
- Invert - invert the colors of the enface image
- Save as… - save enface image

Invert – It inverts the gray scale in the images. When the invert function is used for choroid it
allows to see shadows from choroidal blood vessels which are usually black as white/gray color
which more correspondence to choroid image from ICG.

Figure 232. Enface image for the Choroid layer - invert OFF / ON

238 / 387
SOCT User Manual Version 11.5 rev. A
17.1.3.4 Tomogram window
It shows the selected tomogram overlaid with layers boundaries from the active angiogram
window. On the tomogram a semitransparent, red decorrelation mask is overlaid. It is possible
to change the position of the desired layer. You can type in the offset over the tomogram
window or grab and move the selected layer. Offset is expressed as microns from the original
position of the recognized retinal layer. The negative offset value describes the position below
the original position.

Operation on the tomogram object


Standard manipulation of the tomogram window is described in chapter 12.6 Tomogram
window manipulation. Additionally, it is possible to modify the position of boundary layers
which create the angiogram view. Select the boundary from the list box. Grab the desired layer
and move it to the desired position. It is possible to change the depth position of any
boundary.
Tomogram window context menu offers
- Add to print
- Set Foveola
- A-scan enabled
- Reset brightness/contrast
- Angio Flow
- Gray
- Colored
- Inverted
- Window fit
- Auto fit
- Real scale
- Fit horizontal
- Fit vertical
- Flattening
- Vertical scan
- Save as…
- Save anonymized as…
When vertical scan is marked:
• the system displays a composed vertical tomogram (created from B-scans) with layers
boundaries

239 / 387
SOCT User Manual Version 11.5 rev. A
• on the enface and angiogram object additional green vertical reference line appears
• B-scan alignment function is turned on (the same function as used in 3D)
• scrolling vertical tomograms is not synchronized with the horizontal tomogram
• additionally, on the context menu (RMB) the B-scan alignment function is available (it
is turned on by default). When it is off b-scans are not aligned along the Z axis
Angio flow –this option is checked by default. When the operator selects the angio flow option
they can adjust the brightness and contrast of the red color of the Angio flow areas. To adjust
the brightness and contrast of the flow mask, right click and hold the right mouse button, place
the cursor over the tomogram and move it up/down or right/left.
Dragging up and down: adjusts the brightness. Dragging right and left: adjusts the contrast.
Right-clicking the OCT image and selecting [Reset Brightness/Contrast] from the menu resets
the brightness and contract adjustments.

Figure 233. Angio flow tool

Quantification tools: FAZ, VFA, NFA


FAZ tool
In angiographic analysis of the retina, the center of the macula is generally capillary-free, this
area being named the foveal avascular zone (FAZ).
Foveal avascular zone (FAZ) measurements are based on Angio Retina scans and are available
only on the superficial, SVC, deep, DVC, ICP, DCP layers. Only one measurement per scan is
possible.
FAZ – Foveal Avascular Zone tool is available with the angiography module. It can be open by
double click on the Angiogram object. FAZ is not available on enface view and depth coded
map...

240 / 387
SOCT User Manual Version 11.5 rev. A
Switch on/off FAZ– Semi Auto
mode

Switch on/off FAZ – Manual mode Angiogram

Ctrl + scroll to zoom in/out


Erase measurement
Scroll to move both layers
Sensitivity sliders are active only
for FAZ Semi Auto tool

Calculated areas

Brightness and contrast controls

Figure 234. Foveal Avascular Zone tool

Erase measurements – clear all measurements.


Calculated areas - the following parameters are provided:
- Area: FAZ area in mm2
- Perimeter: FAZ perimeter in mm
- Circularity: ratio between the measured perimeter and the perimeter of a circular area
of the same size.
Brightness and contrast adjustment – two sliders for brightness and contrast adjustment.
Erase measurements – clear all measurements.

Foveal Avascular Zone – Semi Auto

FAZ – Semi Auto

Curvature and strength sliders

Applied FAZ measurement

241 / 387
SOCT User Manual Version 11.5 rev. A
Figure 235. Foveal Avascular Zone tool – Semi Auto

Curvature and strength sliders allow to manually adjust the automatic FAZ area detection. For
best results it is recommended to click on the measured area and set the value of the strength
slider to 0. Then adjust the curvature value to get the best shape of the measured area. Adjust
the strength sliders for the best coverage of the measured are.
Brightness and contrast adjustment – two sliders for brightness and contrast adjustment.
Foveal Avascular Zone – Manual

FAZ – Manual

Manual FAZ measurement

Figure 236. Foveal Avascular Zone tool – Manual

FAZ – Manual – Click where you want the first node and click again where you want to put the
next one to begin. Continue clicking to create further nodes. CTRL + z keys combination
removes the last seed.
Close the selection border by doing either of the following:
Position the pointer over the starting point and click. The mouse pointer changes to a hand
icon when you are over the starting point.
If the pointer is not over the starting point click the right mouse button.
After closing to polygon, the user can correct the position of each node by grabbing and
moving it. You may also grab and move the polygon. Over the node the mouse pointer changes
to a hand icon. The area inside the polygon has a yellow mask.

NOTE: The final measurement depends on the brightness, contrast and sensitivity
adjustments. The user is responsible for the right adjustment of the brightness,
contrast and sensitivity to highlight only the proper structure of the changes.
OPTOPOL Technology Sp. z o.o. cannot be held responsible for misdiagnosis of
results.

242 / 387
SOCT User Manual Version 11.5 rev. A
VFA tool
Vascular Flow Area measurement is based on Angio scans detecting the white vessels which
usually run in the pre-defined layers. To use VFA (Vascular Flow Area tool) double click on the
Angiogram object. This tool is available only for outer retina and Choricapillary, Vitreous and
Choroid layers and allows to measure the area and the area of vasculature inside the selected
area. The flow detection can be performed either by using the circle tool or the manual pointer.
In the selected space the area and the flow area parameters will be provided [mm 2].

Circle VFA Tool

Angiogram
Manual VFAol
Ctrl + scroll to zoom

Scroll to move both layers


Sensitivity slider

Calculated areas

Brightness and contrast


manipulation

Figure 237. Vascular Flow Area tool

VFA tool – Circle Area Tool

Switch on/off Circle Area Tool

Grab and move to change the


size of the selected area

Selected area. Grab and move to


Sensitivity slider change the position

Figure 238. Vascular Flow Area tool – Circle Area Tool

Circle Area Tool. To draw an oval selection simply click at the point where you want to position
the middle of the selection, then hold your mouse button down and move it in the desired
direction until the object or area is surrounded by the selection outline. Release your mouse
button to complete the selection. You may correct the selection by grabbing the oval and

243 / 387
SOCT User Manual Version 11.5 rev. A
moving it to the proper position. You may also change the shape and size of the selected area
by grabbing and moving individual nodes.
Sensitivity slider changes the tolerance of the tool.
VFA tool – Manual Pointer Area Tool

Switch on/off Manual Area Tool

Grab and move to change the


position of vertex point

Selected area. Grab and move to


Sensitivity slider change the position.

Figure 239. Vascular Flow Area tool – Manual Pointer Area Tool

Manual Pointer Area Tool creates irregularly shaped selections defined by a series of line
segments. To create a polygon selection, click repeatedly with the mouse to create line
segments. When finished, click at the starting point (or double click), and the software will
automatically draw the last segment. The vertex points that define a polygon selection can be
moved and deleted. CTRL + z – removes the last setting seed.
To move a vertex, point just grab and move the chosen point. To delate the vertex point, click
the right mouse button and chose one of two option: Delete Current Polygon or Delete Current
Node. To cancel click any other place.
User can modify thresholding using sensitivity slider.

NOTE: The final measurement depends on the brightness, contrast and sensitivity
adjustments. The users are responsible for the right adjustment of the brightness,
contrast and sensitivity adjustments to highlight only the proper structure of the
changes. OPTOPOL Technology Sp. z o.o. cannot be held responsible for
misdiagnosis of results.

NFA tool
Non-Flow Area measurement allows to quantify the Non-flow Area on the OCT Angio
examination. To use NFA (Non-Flow Area tool) double click on the Angiogram object. The tool
is available only for Superficial, SVC, Deep, DVC, ICP and DCP layers. The nonflow detection can
be performed either by using the Semi Auto tool or the manual pointer. For the selected space
the area of the nonflow area will be provided [mm2].

244 / 387
SOCT User Manual Version 11.5 rev. A
Provides:

• Non-Flow Area provides Area of as a sum of all marked spots


• Up to 30 spots can be analyzed.

Switch on/off Semi Auto Tool

Switch on/off Manual Tool Angiogram

Ctrl + scroll to zoom

Scroll to move both layers


Sensitivity slider
Grab and move to change the
size of the selected area
Calculated areas

Brightness and contrast


manipulation

Figure 240. Non-Flow Area tool

NFA tool - Semi Auto

Switch on/off the semi auto


tool
Grab and drag to change the
size of the selected area

Selected area. Grab and drag to


Sensitivity slider move

Figure 241. NFA tool – semi auto

For best results it is recommended to click on the measured area and set the value of the
strength slider to 0. Then adjust the curvature value to get the best shape of the measured
area. Adjust the strength sliders for the best coverage of the measured area.

245 / 387
SOCT User Manual Version 11.5 rev. A
NFA tool – Manual

Switch on/off the manual tool

NFA manual measurement

Figure 242. NFA tool - manual

Click where you want to position the first node. Then move the mouse to the spot where you
want to place the next node and click again. Continue in this fashion to create further nodes.
The CTRL + z combination cancels the last move.

Quantification Maps [Density and Skeleton]


Quantification provides the quantification of vasculature in specific sectors and heat map
corresponding to the vasculature.
Density display - Vessel Area Density (VAD) - it is defined as the total area of perfused
vasculature per unit area in a region of measurement. This metric is calculated by summing up
the number of pixels which contain perfused vasculature, and dividing the sum by the total
number of pixels in the considered region. The result is a unitless number ranging from 0 (no
perfusion) to 1 (fully perfused) (mm²/mm²).
Skeleton display – Vessel Skeleton Density (VSD) – it is defined as the total area of skeletonized
vasculature per unit area in a region of measurement. Skeletonization performs thinning of all
vessels down to 1 pixel width and thus makes analysis more sensitive to small vasculature (as
the large vessels lose more area than the thin ones in the skeletonization process). This metric
is calculated by summing up the number of pixels that represent the skeleton of the
vasculature, and dividing the sum by the total number of pixels in the considered region. The
result is a unitless number ranging from 0 (no perfusion) to 1 (mm²/mm²).
Both VAD and VSD can detect abnormal vasculature and provide repeatable quantitative
results equally in normal and diseased eyes.
Quantification is available for Retina Angio

• Superficial
246 / 387
SOCT User Manual Version 11.5 rev. A
• Deep and Disc Angio
• RPC

Analysis is available to all previously acquired examinations.

NOTE: Due to the method of calculating the pixel density there may be slight differences
between the results for the examination with different size and/or density scanning.

Layers selector

Quantification map

Analysis selector

Reference scale

Figure 243. Quantification data field in Angio [SINGLE] Standard and Detail View

Skeleton Density map Vessel Density Map

Layers selector – allows to select the layer. The quantification is not available for all layers.

Analysis selector – Three types of scales are available. In the Single and Detailed view, the
Density and Skeleton scales are available. The comparison and progression views offer the
choice of Density, Skeleton, Reference scales.

247 / 387
SOCT User Manual Version 11.5 rev. A
Quantification heat map - the results of the Quantification are displayed in the form of a mask
over the analyzed area, with values according to the selection.
The results can be presented as values in the table acquired in the specific folder

Quantification table – presents the results of the quantification. The Comparison and
Progression table can only display a comparison of exams which meet the following criteria:
they are identical width and the difference in their scanning densities does not exceed 30%. If
the exams do not conform to these criteria, N/A is displayed in the difference column.
In order to change the transparency of the quantification mask scroll over the quantification
map.
Measurement Zones for Retina from 3 to 5 mm scan
Region Density
Total 56.1 całość
Superior 56.2 gorna polowa - plamka t
Inferior 56.3 Dolna polowa
Total Superior Inferior Central 56.4 sektor centalny
Inner 56.5 okrąg srodkowy
Superior Inner 56.6 gorna czesc okrąg srodk
Inferior Inner 56.5 dolna czesc okrąg srodk
Full 56.6 wszystko z sekotrów

Central Inner Superior


Inner

Inferior Full
Inner

Measurement Zones for 6 mm width Retina scans

Total Superior Inferior

Center Inner Superior


Inner

248 / 387
SOCT User Manual Version 11.5 rev. A
Region Density
Total 56.1 całość
Superior 56.2 gorna polowa - plamka t
Inferior 56.3 Dolna polowa
Inferior Outer Superior Center 56.4 sektor centalny
Inner Outer Inner 56.5 okrąg srodkowy
Superior Inner 56.6 gorna czesc okrąg srodk
Inferior Inner 56.5 dolna czesc okrąg srodk
Outer 56.6 okrąg zewnetrzny
Superior Outer 56.7 gorna polowa okregu ze
Inferior Outer 56.8 dolan polowa okregu ze
Inferior ETDRS
ETDRS 56.9 wszystko z sekotrów
Outer

Measurement Zones for Disc

Region Density
Total 56.1 całość
Superior 56.2 gorna polowa - plamka to
Inferior 56.3 Dolna polowa
Total Superior Inferior Inside disc 56.4 w srodku 2 mm
Peripapillary 56.5 okrag 2-4
Superior Peripa 56.6 polowa gorna okregu 2-4
Inferior Peripa 56.5 polowa gorna okregu 2-4

Inside Disc Peripapillary Superior


Peripapillary

Inferior
Peripapillary

249 / 387
SOCT User Manual Version 11.5 rev. A
Angio OCT Analysis Table

Single view

FAZ measured values VFA measured values

NFA measured values


Table with the values

Figure 244. Angio OCT Analysis Table for Single View

Comparison view

FAZ measured values VFA measured values

Table with the values


NFA measured values

Figure 245. Angio OCT Analysis Table for Comparison View

If the measurements are performed on exams differing in size and/or on different layers, the
„!” symbol is displayed in the table next to the result. Difference is calculated as: newer scan -
baseline scan. The percentage value is a percentage change compared to the baseline
(change/baseline)*100%

If the operator uses only one analysis tool the tab with the measurements results is activate.

[Both] view.
In the „Both eyes” tab it is possible to make a comparison of both eyes’ analysis, i.e. left and
right eye, which can be followed by asymmetry analysis of both eyes.
This analysis protocol operates only on one Right and one Left angio retina examinations from
the same visit.

250 / 387
SOCT User Manual Version 11.5 rev. A
Enface drop list Angiogram window
drop list

Enface window
Angiogram

Layer selection

Tomogram window

FAZ/VFA Table

Figure 246. Both eyes Retina Angio view

Enface window: object displayed can be selected from the enface drop list.
- Enface - displays an enface image generated between the boundaries from the active
angiogram window.
- Structure - shows a color-coded thickness map of the retina. Sector dimension on the
map is 1/3mm in diameter.
- pSLO - shows the location of Angio scan on pSLO image of the retina.

In the angiogram window the user can select one of predefined vasculature layers which are
based on the position of recognized retina layer. The vascular layer can be selected from the
angiogram drop list box:
- Retina - Retinal vasculature angiogram
- Depth Coded - Color coded Retinal vasculature angiogram
- Superficial - Superficial capillary plexus
- Deep - Deep capillary plexus
- Outer - Outer retina layers (avascular zone)
- Custom view - User defines top and bottom boundaries to generate angiogram
- Vitreous - Structure above ILM layer
- Choriocapillaris - Choroid choriocapillaris visualization
- Choroid - Choroid visualization.

251 / 387
SOCT User Manual Version 11.5 rev. A
Tomogram window shows the selected tomogram overlaid with the boundaries of layers from
the active angiogram window. On the tomogram, semitransparent, red colored decorrelation
mask is overlaid. It is possible to change the position of a layer. You can type in the offset over
the tomogram window or grab and move it to the selected layer. Offset is expressed in microns
from the original position of the recognized retinal layer. The negative offset value describes
the position below the original position.

FAZ/VFA Table shows difference between eyes.


Changing the type of vascular layer on one object affects both eyes and both objects
(angiogram and enface). FAZ tool can be used only on the superficial, deep, icp, dcp layers. VFA
tool is available only for Outer retina and Choricapillary, vitreous layer and Choroid.

[Comparison] view.
This screen shows the analysis results comparing two examinations of one eye on the same
side in the same scan mode, from different dates.
Comparison view is used to observe follow up changes in the eye structure. The software
automatically selects outermost examinations (the oldest and the newest) in order to compare
them. The user can manually choose examinations from the list depending on the chosen
comparison protocols that are highlighted.

Date of the first Date of the second


examination examination

Angiogram window
Enface drop list
drop list
Angiogram window

Enface window
Layer selection

Tomogram window

FAZ/VFA/NFA Table
Quantification Table

Figure 247. Comparison Retina Angio view

In the Comparison tab it is possible to compare different kinds of vasculature layers which are
based on the position of the recognized retina layer (Retina, Depth Coded, Superficial, Deep,
Outer, Vitreous, Choriocapillaris, Choroid). In the Enface window it is possible to display
Enface, Structure or pSLO.

252 / 387
SOCT User Manual Version 11.5 rev. A
The user can also change the dimension of the measurement rings. There are two options
available:
- rings: 1; 3 and 6 mm (standardized ETDRS testing),
- rings: 0,6; 2,22 and 3,45 mm.
Tomogram window shows the selected tomogram overlaid with the boundaries of layers from
the active angiogram window.

[Progression] view
This screen shows the analysis results comparing four examinations, done on the same side in
the same scan mode, and on the same size of scanning area, arranged in a time sequence.

Angiogram window
Angiogram
drop list

Layer selection

Tomogram window

Quantification tools Quantification


results measurement results

Figure 248. Progression Retina Angio Analysis view

Angiogram window
Angiogram
drop list

Layer selection

Analysis selector

Quantification map

Figure 249. Progression Retina Angio Standard view

253 / 387
SOCT User Manual Version 11.5 rev. A
In the angiogram window the user can select one of the predefined vasculature layers based
on the position of the recognized retina layer. Vascular layer can be selected from the
angiogram drop list box:
- Retina - Retinal vasculature angiogram
- Vitreous - Structure above ILM layer
- Superficial - Superficial capillary plexus
- SVC - Structure between ILM and IPL/INL layers
- RPCP - Structure between ILM and NFL/GCL layers
- Deep - Deep capillary plexus
- DVC - Structure between IPL/INL and OPL/ONL layers
- ICP - Structure between IPL/INL and INL/OPL layers
- DCP - Structure between INL/OPL and OPL/ONL layers
- Outer - Outer retina layers (avascular zone)
- Choriocapillaris - Choroid choriocapillaris visualization
- Choroid - Choroid visualization
- Depth Coded - Color coded Retinal vasculature angiogram
- Custom view - User defines top and bottom boundaries to generate angiogram
Tomogram window - it shows selected tomogram overlaid with the boundaries of layers from
the active angiogram window. On the tomogram, semitransparent, red color decorrelation
mask is overlaid. It is possible to change the position of a layer. You can type in the offset over
the tomogram window or grab and move it to the selected layer. Offset is expressed in microns
from the original position of the recognized retinal layer. The negative offset value describes
the position below the original position.
FAZ/VFA/NFA Table shows difference between eyes.

Motion Correction
Motion correction algorithm is implemented to eliminate or minimize eye movement artifacts
on Angio OCT and 3D exams. The algorithm allows to create an artifact-free exam from one or
more scans.
The MC algorithm can be used on the number of examinations ranging from one to six. It is
recommended to use at least 2 examination of the same area.
A single exam needs to provide sufficient data. If there is enough data the algorithm will
generate correct result.

254 / 387
SOCT User Manual Version 11.5 rev. A
Mark the desired examinations on the Exam List in Results view (hold the ctrl button and click
on each exam), press the right mouse button and select “Motion correction” from the Menu.
The system will generate a new exam free of or with reduced motion artifacts.
If you use the Repeat function you can choose the Motion Correction function from the menu
without selecting exams. The system will use all repeated examinations from the specified
location.
The user can run the MC automatically by right-clicking on the chosen exam and selecting
“Motion correction” from the context menu. The software generates the results from 1 up to
6 examinations depending on the number of identical exams available.

Note: All marked examinations must have the same physical dimensions and the same number
of A and B scans and the same exam type. Please note, if the affected area repeats exactly in
the same position on all scans, the system will not be able to eliminate the artifact from this
area.

Note: The right amount of data and the quality of the examination are necessary for correct
motion artifacts reduction.

Exam 1 Exam 2 MC Result

Figure 250. Example of Motion Corrected examination

Motion Correction in 3D Examinations


See chapter 7.11.1 Acceptance window for a 3D scan.

255 / 387
SOCT User Manual Version 11.5 rev. A
DISC OCT-A
[Single] view.
17.4.1.1 Standard

Drop list of predefined Angiogram window drop


vasculature layers list

Angiogram

Layer selection

Structure map
Tomogram window

Figure 251. Single Standard Disc Angio view

In the angiogram window for Optic nerve head the user can select one of the predefined
vasculature layers based on the position of the recognized retina layer. The vascular layer can
be selected from the list box:

Vascular layer Description of layer Offset


Retina Retinal vasculature angiogram ILM 0µm, BM -30µm
Vitreous Vitreous Structure (above ILM layer) ILM 250µm, ILM 3µm
Superficial Superficial Capillary Plexus ILM 0µm, IPL/INL -15µm
SVC Superficial Vascular Plexus ILM 0µm, IPL/INL 10µm
RPCP Radial Peripapillary Capillary Plexus ILM 0µm, NFL/GCL 0µm
Deep Deep Capillary Plexus IPL/INL -15µm, IPL/INL -70µm
DVC Deep Vascular Plexus IPL/INL 10µm, OPL/ONL -10µm
ICP Intermediate Capillary Plexus IPL/INL 10µm, INL/OPL 10µm
DCP Deep Capillary Plexus INL/OPL 10µm, OPL/ONL -10µm
Outer Outer retina layers (avascular zone) IPL/INL -70µm, BM 0µm
Choriocapillaris Choroidal Capillary BM -15µm, BM -45µm
Choroid Choroidal Vessels BM -45µm, BM -160µm
Depth Coded Color coded Retinal vasculature angiogram ILM 0µm, BM 0µm
Custom view User defined top and bottom boundaries to generate angiogram

256 / 387
SOCT User Manual Version 11.5 rev. A
17.4.1.2 Detailed
Detailed view allows to view large objects and quantify results.

Arrow for moving


the list of layers
Enface drop list
Thumbnails, list of the Angiogram drop list
layers. Grab to move
Angiogram
Nerve Head
Enface image
Superficial

Vitreous Layer selection

Tomogram window
RPC

Deep

Figure 252. Single Detailed Disc Angio view

List of the layers: click on the thumbnail to display the object in the large window. The user
can move the list by clicking on the arrows or by scrolling over the list. You may also change
the thumbnails order by grabbing and moving them.
Angiogram and enface images respond to manipulations and changes in offset and layers.
Enface image displays the enface image generated between the boundaries from the active
angiogram window.
Tomogram window shows the selected tomogram overlaid with the outlines of layers from the
active angiogram window. On the tomogram, a semitransparent, red colored decorrelation
mask is overlaid. It is possible to change the position of the desired layer. You can type in the
offset over the tomogram window or grab and move it to the selected layer. Offset is expressed
in microns from the original position of the recognized retinal layer. The negative offset value
describes the position below the original position.

[Both] view
In the „Both eyes” tab it is possible to make a comparison of the analysis of both eyes, i.e. the
left and right eye, which can be followed by the asymmetry analysis of both eyes

This analysis protocol operates only on one Right and one Left Disc Angio examinations from
the same visit.

257 / 387
SOCT User Manual Version 11.5 rev. A
Angiogram window
Enface drop list
drop list

Angiogram

Enface window

Layer selection

NFL Thickness

Tomogram window

Figure 253. Both Discs Angio view

Enface window: to display an object, select it from the enface drop down menu.
- Enface- displays an enface image generated between the boundaries from the active
angiogram window.
- Structure - shows a color-coded thickness map of the retina. Sector dimension on the
map is 1/3 mm in diameter.
- pSLO - shows the location of the Angio scan on the pSLO image of the retina.
In the angiogram window the user can select one of the predefined vasculature layers which
are based on the position of the recognized retina layer. The vascular layer can be selected
from the drop list box.
- Nerve Head
- Superficial
- Vitreous
- RPC
- Deep
- Outer
- Choroid
- Depth Coded
- Custom view
Tomogram window shows the selected tomogram overlaid with the boundaries of layers from
the active angiogram window. On the tomogram, a semitransparent, red decorrelation mask
is overlaid. It is possible to change the position of the desired layer. You can type in the offset
over the tomogram window or grab and move it to the selected layer. Offset is expressed in

258 / 387
SOCT User Manual Version 11.5 rev. A
microns from the original position of the recognized retinal layer. The negative offset value
describes the position below the original position.
Changing the type of vascular layer on one object affects both eyes and both objects
(angiogram and enface).
NFL thickness map shows the thickness of the NFL layer on the scanned area.
To change the transparency level, turn the mouse wheel over the object.

Angio Disc Comparison view


This screen shows the analysis results comparing two examinations of one eye on the same
side in the same scan mode, from different dates.

Angiogram window
drop list Enface drop list

Angiogram

Layer selection

Tomogram window

NFL Thickness

Figure 254. Comparison Disc Angio view

NFL thickness map shows the thickness of the NFL layer on the scanned area. A map to be
overlaid on the fundus reconstruction can be selected from the list box:
- NFL+GCL+IPL thickness
- GCL+IPL thickness
- NFL thickness
To change the transparency level, turn the mouse wheel over the object.

[Progression] view
This screen shows the analysis results comparing four examinations done on the same side in
the same scan mode, and the same size of scanning area, arranged in a time sequence.

259 / 387
SOCT User Manual Version 11.5 rev. A
Angiogram window
drop list Angiogram

Layer selection

Tomogram window

Figure 255. Progression Disc Angio view

In the angiogram window the user can select one of the predefined vasculature layers based
on the position of the recognized retina layer. Vascular layer can be selected from the drop list
box.
Tomogram window - it shows the selected tomogram overlaid with the boundaries of layers
from the active angiogram window. On the tomogram, a semitransparent, red decorrelation
mask is overlaid. It is possible to change the position of the desired layer. You can type in the
offset over the tomogram window or grab and move it to the selected layer. Offset is expressed
in microns from the original position of the recognized retinal layer. The negative offset value
describes the position below the original position.
Changing the type of vascular layer on one object affects both eyes and both objects
(angiogram and enface).

Mosaic
Angio mosaic feature can be used to present wider field of view with that same level of details.
The algorithm uses examination from predefined sets of data of at least 2 examinations to
superimpose the mosaic image. The Angio Mosaic can be created from 2 up to 12 images.
Open the Advance tab to see superimpose images. User can modify initial position of images.
The SOCT allows to create mosaic from the examinations included from predefined set,
manually created set (activated by Mosaic mode button). It is also possible to create the set
from examinations with the same parameters of scan (size, A&B scan number, same date)
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.

260 / 387
SOCT User Manual Version 11.5 rev. A
Location number and Angiogram boundaries
order of exam inforamation

Mosaic information Select vascular layer

Exam selection Type of data

Registration status

Figure 256. Advance tab – Angio mosaic.

At the mosaic window user can select one of predefined vasculature layers which base on
position of recognized retina layer. Vascular layer can be selected from the list box:
Vitreous - Structure above ILM layer
Retina - Retinal vasculature angiogram
Superficial - Superficial capillary plexus
RPC - Radial Peripapillary Capillaries
Deep - Deep capillary plexus
Outer - Outer retina layers (avascular zone)
Choriocapillaris - Choroid choriocapillaris visualization
Choroid - Choroid visualization.

Type of displayed data can be selected from the list box. User can select from the list box:
Angio - Vascular angiogram from selected vascular layer
Enface - Enface structure from selected vascular layer
Depth Coded - Color-coded Retinal vasculature angiogram
Retina thickness - Retina thickness map
RNFL thickness - RNFL thickness map

Registration status
It informs about the method of superimposition.
Automatically superimpose
261 / 387
SOCT User Manual Version 11.5 rev. A
Manually superimposed (by the operator)

Select screen
On the select screen you can change, remove or add exams used in mosaic composition.
Once you select or unselect the exams [Analyze] button becomes active. Press [Analyze] to
start automatic superimpose process.

Figure 257. Select screen.

Operation on the mosaic


17.5.3.1 Operation on the whole mosaic
Zoom in/out Press [ctrl] button and mouse scroll.
Move zoomed image Hold left mouse button and move to smoothly change the
position.
Brightness and Contrast Press and hold the right mouse button and move the mouse
up/down and left/right to adjusts the brightness and contrast of
the Angiogram image.
Transparency When Enface view or thickness map is selected mouse scroll
change transparency level.
User can modify depth position of the top and bottom boundaries at once. Scroll mouse wheel
to go deeper or upper from the initial position.
Right mouse menu
Inverse Inverses the color of tomograms.
Save as Click Right mouse button and select ‘Save as...’ from menu to save mosaic
image.

262 / 387
SOCT User Manual Version 11.5 rev. A
Navigation mark
Grab and move to
view around

Ctrl + scroll to zoom

Figure 258. Advance tab – Manipulation of whole mosaic.

17.5.3.2 Operation on a single exam


Operator can modify the original position of superimpose images. Only selected exam/s can
be manipulated.

Click + ctrl
select the exam

Grab and move to


change position

Grab and move the


corner to rotate

Figure 259. Advance tab – Manipulation of single image.

Select In order to select/s exam [ctrl] keyboard and click on desired image/s. It is
possible to select more than one examination.
Move Grab and move to desired position. For precise alignment use [up]/[down]
[right]/[left] arrows on the keyboard
Order Use [page up] and [pg down] keyboards to changing angiogram layer order to
front of layers and to back of layers.
263 / 387
SOCT User Manual Version 11.5 rev. A
Rotate Grab and move the corner to rotate.

264 / 387
SOCT User Manual Version 11.5 rev. A
18 BIOMETRY OCT

NOTE: Biometry OCT is optional software modules. If you do not have this feature and want to
purchase it, contact Optopol’s local distributor.
The SOCT software with optional OCT Biometry function is intended for biometric
measurements and visualization of ocular structures for high myopia management and
performing IOL power calculations based on the patient’s biometric data and a selection of
recognized IOL calculation formulas.
The software measures the following parameters: Axial Length (AL), Central Corneal Thickness
(CCT), Anterior Chamber Depth (ACD), Lens Thickness (LT), Pupil Diameter (P), White-to-White
distance (WTW). The measurement and visualization assist in the determination of the
appropriate power and type of intraocular lens.
Axial length (AL) is the distance from the corneal apex to the fovea or more specifically, to the
RPE (Retnal Pigment Epithelium). The calculation is performed as the sum of the thicknesses
of the cornea, aqueous humor, lens, and vitreous humor and neurosensory retina.
Corneal thickness (CCT) is the distance between the anterior and the posterior surface of the
cornea.
Anterior Chamber Depth (ACD) is the distance between the anterior surface of the crystalline
(anterior capsule) and the outermost stratum of the cornea (epithelium).
Lens thickness (LT) is the distance between the anterior and the posterior surfaces of the lens
divided by its refractive index.
WTW is the distance from limbus to limbus of the eye.
Pupil diameter –is measured horizontally through the center of the pupil

Biometry safety information

WARNING! Users should not rely solely on measurements made using the REVO in
making decisions regarding the calculation and implantation of intraocular lenses or
other therapeutic procedures, but should rely on their own expertise and judgment.

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

265 / 387
SOCT User Manual Version 11.5 rev. A
account the type (e.g., posterior subcapsular cataract) and density of the cataract
when evaluating plausibility.

CAUTION: Prior to the measurement, the user must verify that the patient is not
wearing contact lenses. Wearing contact lenses will result in erroneous
measuring results.
CAUTION Do not perform any contact measurements or examinations in which the
eye is touched. They may result in incorrect readings, particularly for
biometry and corneal topography measurements. Contact
measurements or examinations should only be performed after the
patient has been measured with the SOCT.
CAUTION: Correct detection of boundaries should be checked with particular care
during measurement, especially when measuring very long eyes, eyes
with dense cataracts, pseudophakic or aphakic eyes, eyes with any kind
of pathology. Despite various plausibility checks, measuring errors can
be manually be excluded or corrected in individual cases.
CAUTION: In patients with morphological changes of the retinal anatomy in the
region of the fovea (e.g. retinal detachment, edema), the axial length
measurement result may be erroneous and thus is not usable or only of
limited use for IOL calculation. In case of retina segmentation errors user
can do correction after verification of the region of interest.

CAUTION: Risk due to measuring errors. Unstable fixation can lead to measuring
errors and the calculation of incorrect IOL refractive powers. Check that
the patient fixates correctly on all the scan and the fovea is visible in the
all tomograms. Repeat the measurement in case of doubt or check the
measuring results by using alternative methods, if necessary.

NOTE Since the device measures up to the retinal pigmented epithelium, the
reading displayed is adjusted to the internal limiting membrane, as a function of
axial length or manually.

NOTE If the patient has previously undergone cataract surgery, available records
should be consulted for plausibility check of the measurement.

266 / 387
SOCT User Manual Version 11.5 rev. A
NOTE It may not be possible, under certain circumstances, to carry out
measurements on persons with fixation problems.

NOTE In cases of thick and dense cataracts and uncertain measurement of the axial
length ultrasound biometry should be performed as a control examination.

NOTE Dense lenticular opacities may make it impossible to measure the axial eye
length and lens thickness.

NOTE Pronounced opacities of the central cornea can likewise make it impossible
to measure corneal thickness, anterior chamber depth, lens thickness or axial eye
length.

NOTE Blood in the vitreous in cases of extremely dense cataract may make it
impossible to measure the axial eye length.

NOTE The user must check the tomograms when measuring anterior chamber depth
in pseudophakic mode. If only one IOL boundary is visible it may lead to errors.
Uncertainty in this case can lead to the displayed reading for anterior chamber
depth being inaccurate by the thickness of the IOL.
NOTE You are recommended always to examine both of the patient’s with at least
10 repeats. The user should subject the measurement readings to extra scrutiny if
there is a notable difference between the right and left eye. The following are
classified as notable differences:
• More than 1 D with respect to central corneal refractive power
=> 0.18 mm difference with respect to the corneal curvature radius
• More than 0.3 mm with respect to axial eye length

NOTE: The precision of axial length measurement may be different in eyes with
cataracts.

NOTE Users should check the OCT images to determine that the eye is not
excessively tilted or decentered which may result in inaccurate or implausible values
for measurement.

NOTE Users should verify detection on all scanned images.

NOTE Depending on the patient’s gaze at the fixation light, the optical path length
of the visual axis is measured. Make sure that foveola is in the center of scan.
267 / 387
SOCT User Manual Version 11.5 rev. A
NOTE All distance - thickness parameters (Axial length, Corneal thickness, Anterior
chamber depth, Lens thickness, White-to-white, Pupil size) are measured in
sequence captured tomograms.
NOTE An excessively tilted or decentered IOL may make it impossible to measure
the anterior chamber depth, lens thickness and aqueous depth.
NOTE The user must verify that the eye assignment (OD, OS) is correct for the
entered data.

Biometry Acquisition Mode


Before a biometry examination can be carried out the operator is required to perform the
initial calibration of the device. The calibration procedure is described in chapter 21
Calibration.
Prepare the patient as explained in chapter 8.1 Preparation for examination.
Ask the patient to look at the center of the green spot 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.
Select biometric scan program. SOCT provides biometric scan program in Anterior tab group.
Measurement window to collect and automatically process the biometric data allows to take
exams of one or both eyes of the patient. Measurement is done in two steps. First step is
finding and optimizing the signal from retina, cornea and intraocular lens. In second step
system acquires automatically series of tomograms. Each series contains 4 tomograms at
prepared earlier positions. A single measurement can perform acquisition of 5, 10 or 15 series.
Acquisition time of 5 series is around 3 seconds.

Note: Collecting the data from both eyes is highly recommended.

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

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

Biometry scan programs are available in Anterior scan list.


268 / 387
SOCT User Manual Version 11.5 rev. A
AL – scan provides: AL, CCT, ACD, LT
Once scan program is selected operator has to confirm type of scanned eye.

Select the eye type

Select the type of vitreous

Figure 260. Type of eye selection window.

For each eye, select the type of crystalline currently present:


Phakic (natural lens) the patient has a natural crystalline lens.
Aphakic (no lens) the patient does not have any crystalline lens from birth or as a result
of surgery.
Pseudophakic eye where the patient has an IOL (intra ocular lens) substituting the crystalline.
In this case, it is very important to determine the type of material used by the surgeon and
select one of the following option
IOL PMMA
IOL Acrylate
IOL Silicon
IOL Unknown
IOL User The user has to determine and enter the refraction index of the patient’s IOL.
For the vitreous humor you can choose between:
269 / 387
SOCT User Manual Version 11.5 rev. A
Natural: The vitreous body has never been operated or treated such as to alter its
composition.
Silicon Oil The vitreous body has been filled, even only partly, with silicon oil.
The measured axial eye length depends on the measuring mode selected. Depending on the
measuring mode selected, SOCT corrects the measurement with a constant defined as follows.
SOCT takes into consideration two conditions of the eye that can alter the measurement of
axial length:

• Vitreous body filled of silicone oil

• Implant of IOL intra ocular lens


The difference of the measurement is caused by a different group refraction index considered
in the formula. According to bibliographic data, the calculations have been performed to assess
the amount of correction that must be applied to correct the measurement in these special
cases.
The correction values (in mm) of the natural vitreous body
Phakic (natural lens) 0
Aphakic (no lens) 0.21
IOL PMMA 0.11
IOL Silicone 0.12
IOL Acrylic 0.1
IOL Unknown material 0.11

The correction values (in mm) of the vitreous body filled by Silicon Oil
Phakic (natural lens) -0.74
Aphakic (no lens) -0.86
IOL PMMA -0.75
IOL Silicone -0.74
IOL Acrylic -0.76
IOL Unknown material -0.75

Full Auto mode


Select the desired biometry scanning program. If required, change the number of repeats.
1. Mark the AutoAcquire checkbox and Press the START button
3. Press START button. Wait until the system finishes two phases of the examination.
Patient will be voice guided by the software.

270 / 387
SOCT User Manual Version 11.5 rev. A
[Start] becomes active
Device status
when device status is
“READY”
Full auto active when
marked

Figure 261. 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 condition
occurs optimize the OCT signal manually.

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 the retina (e.g. patient
is shaking) operator has to switch off tracking and make examination manually.

Semi Auto mode


In nontypical and dense cataract cases it will be required for the operator to optimize signal
manually. The operator is guided along the examination by text messages displayed in the
tomogram preview window.
1. Uncheck [Auto Acquire]

Full auto mode is


disabled

Press forward
movement until two
images crate one
Figure 262. Manual examination mode.

271 / 387
SOCT User Manual Version 11.5 rev. A
2. Retina OCT signal should appear in tomogram preview. If not adjust C Gate manually by
moving the sliding bar or scroll over the tomogram window. If you cannot find adjust the
patient refraction value and try to find the signal one more time.
3. 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.
4. Verify position of the retina which should be placed on the one dashed horizontal line. If
possible, the center of the foveola should be set on the vertical dashed line.
5. Once the retina position is aligned press NEXT button.
NOTE: In dense cataract patient we can achieve only weak signal of retina. It will be enough

Press NEXT when


the signal is
optimized

Figure 263. Manual examination process.

6. System will move to align the cornea signal. Operator can press [Start] button for automatic
cornea alignment or align and optimize cornea manually as explained in chapter 8.3.6 Anterior
measurement. Once cornea OCT image is optimized press the NEXT button.

Figure 264. Proper position of the cornea.

6. System will move to align the intraocular lens or IOL if selected. Operator can press [Start]
button for automatic lens alignment or align and optimize lens position manually as
explained in chapter 8.3.6 Anterior measurement.
272 / 387
SOCT User Manual Version 11.5 rev. A
Figure 265. Proper position of the intraocular lens

7. Once Lens image is optimized ask the patient to blink and start final biometry acquisition.
Click twice on the tomogram or press [Acquire] button. Device will initialize measurement
immediately and then full scan will be performed.
During biometry series acquisition patient can blink. System will reject improper
measurements from calculation.
8. After examination is over the system will display acceptance window.

Acceptance screen
After capturing biometry examination system displays Acceptance window. Operator has to
verify if the desired ocular structure has been scanned. All elements are relevant to evaluate
measurement quality. The correct positioning of the measurement marks in the images must
be checked.

Mouse scroll to review


biometry exams
tomogram signal
forward movement until
two images crate one
Double click on the
structure to use proper
Rescan mode

Figure 266. Biometry acceptance window

NOTE: It is strongly recommended to review all biometry series. Verify if interested desired
eye structures are properly visible. During review of the exam ask patient to keep the
examination position. May be required to repeat exam with corrected conditions.

273 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: When in the Acceptance window specific boundary repeat exam according to the below
procedure:
The retina image is not properly visible on all tomograms Use repeat function or double click
on the retina image.

• The cornea image is incorrect double click on the cornea tomogram. System repeats
measurement in simplified biometry mode. It will start procedure from the cornea and
will use retina data from previous scan. After adjusting the Cornea press [Next] button
to align the lens.

• The front or back of the lens is not correctly visible double click on the lens tomogram.
System repeats measurement in simplified biometry mode. It will start procedure from
the cornea and will use retina data from previous scan. After adjusting the Cornea
press [Next] button and manually align the lens position. Use C-gate slider or scroll on
the tomogram window until lens image appears on the scan window. It may be
required to use focus to optimize the strength of signal. In cases of very long lenses
place image of front of the lens higher than on originally dashed lines and lower for
shorter lenses. System behaves differently for natural and intra ocular lenses.

• the half of series you cannot see requested boundaries use [Repeat] function to repeat
the series.

[<] [>] Press arrow button to change displayed image.


Rescan Come back to the Acquisition of scan. Examination is saved in database.
Accept Save examination
Reject Come back to Acquisition window. Examination is not stored.

White to White
White to White (WTW) is a measurement of the distance from limbus to limbus. The
measurement yields two values:
1. White to White – the distance form limbus to limbus measured
horizontally through the center of the pupil.
2. P – the diameter of the pupil measured horizontally through the
center of the pupil.

274 / 387
SOCT User Manual Version 11.5 rev. A
The software automatically recognizes the edge of the pupil and the edge of the limbus. The
diagram below presents the concept of the WTW measurement.

Figure 267. WTW and P measurement ranges

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.
The results of the WTW measurement are presented in the Biometry and IOL calculation tabs
in a form of a WTW measurement table as shown below.

Figure 268. WTW and P measurement result table

The user can make adjustments to WTW and P results. After the circular WTW and P indicators
are modified manually, they change color to blue and the results in the WTW and P table are
marked by the * symbol.
Editing WTW and P parameters is described in section 18.1.4. White to White

Result review
In the Single and Both Eyes tab, B-scans, Tomogram and eye preview image values are
displayed to support the user in evaluating the measurement. In those tabs, the user must
check whether the measured values are plausible and consistent for both eyes (if both OD and
OS were measured).
In order to be sure of the validity of the results, it is recommended to review all series of
measurements and their values with the corresponding boundary detection of the signal on
the tomograms. In order to make manual correction of boundaries open Full screen by
double click on tomogram from the Single or Both view.

275 / 387
SOCT User Manual Version 11.5 rev. A
Single view
Figure 269. Biometry Single view

Type of the eye

Click to reject exam

Result table

Vertical scan

Horizontal scan

Information field

Type of the eye


Depending the type of eye results may vary.
Table
Shows a table with the number of acquisitions in rows. Table containing Biometric results of
each biometry series, the standard deviation and the average value.
Checkbox
Uncheck to exclude biometric exam from series. Excluded results are rejected from AVG and
SD analysis.
Horizontal/Vertical tomograms
Operation similar to standard tomogram window. Zoom in/out, Brightness & Contrast
manipulation, color display mode, Right click menus are available as on the standard
tomogram window.
Reset Brightness/contrast
-------------------
Gray
Colored
Inverse
-------------
Save as… Saves the composed image

276 / 387
SOCT User Manual Version 11.5 rev. A
18.3.1.1 Table
In the table system displays result of each measurement.
In the rows data from examination series are displayed.
In the column there are results of specific parameters.
AVG – calculated averaged value for specific parameters. Only highlighted examinations are
included for calculation.
SD – Standard deviation values of several individual measurements
In the table system marks measurement.
(!) Indicates an uncertain measurement value
(*) Indicates that this value has been edited
--- Indicates a measurement failure
(!-!) Significant difference between L and R
(n/a) measurement in this type of eye not available
Clicking the right mouse button on the results Topography and Biometry table enables
exporting the data as a .txt file.

Right click on the


Biometry results
shows [Save as txt…]

277 / 387
SOCT User Manual Version 11.5 rev. A
Both view

Type of the eye

Click to reject

Result table

Vertical scan

Horizontal scan

Legend

Figure 270. Biometry Both view

Full screen
SOCT provides Full screen window to manually edit the values obtained. There may be
instances of detecting the wrong boundaries, especially in the posterior of the lens as well as
the retinal position. User can visually adjust the value by positioning the line-markers on the
tomogram image and signal graph. Signal graph shows the value marked by horizontal line.

Mouse scroll to
display next scan

Horizontal line

Change to next
measurements

Gain

Grab and move to


correct postion
gnal graph

Signal graph

Figure 271. Biometry Full screen window

278 / 387
SOCT User Manual Version 11.5 rev. A
18.3.3.1 Editing distances
[<] [>] Press the arrow button to change displayed image.
Gain Amplify strength of intensity signal graph
Signal graph Display intensity of A-scans along composed tomogram. It displays result
identify by horizontal line.
The operator can edit the distance by dragging the line markers to the desired location
determined to be adequate.
Moving the line-markers automatically adjusts the values for distance calculation for all the
related parameters and their SD and average value. Adjusted parameters will be shown with a
caution (*) notation. In order to provide more control to the operator, a zoom-in & zoom is
available.

Editing WTW and P


Double click on the Eye preview window to open editor. If required grab and move holder to
desired position.

Figure 272. White to white distance measurement window

Figure 273. Editing WTW and P results – eye preview

279 / 387
SOCT User Manual Version 11.5 rev. A
To edit WTW and P grab any of the blue squares and move it to increase or decrease the
diameter of the circles. You can zoom in and out the eye preview with the Ctrl key + scroll
combination.

280 / 387
SOCT User Manual Version 11.5 rev. A
19 IOL CALCULATION TAB

IOL Calculation Tab allows the user to calculate the lens power of a selected IOL model on the
basis of the patient’s morphological data (AL, K’s, ACD) and a IOL formula selected by the user.
Before staring work with the calculation tool, the user needs to enter IOL lens data in section 19.3
IOL Editor.
Running IOL calculations requires an active Biometry module installed in the system as well as
valid licenses for using IOL calculation formulas. The function is available only for exams which
were carried out on a properly calibrated device. Detailed information on the calibration of the
device can be found in Section 21.3 Axial length (biometry) calibration.

IOL calculation safety notes:

WARNING! Users should not rely solely on measurements made using the REVO in
making decisions regarding the calculation and implantation of intraocular lenses or
other therapeutic procedures, but should rely on their own expertise and judgment.
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.
WARNING! Measurements must always be checked for plausibility which entails
checking the following: keratometry values, A and B-scans, the cursors automatically
adjusting to the signal, pupilometry and the white-to-white distance values.
Performing a plausibility check is especially important if any of the measurements
shows an unusually high standard deviation. Also, the characteristics of the cataract
such as the type (for example posterior subcapsular cataract) and density must be
taken into account.
CAUTION! The measurements taken with REVO may serve as the central element for
the calculation of intraocular lenses (IOL). A further important parameter in

281 / 387
SOCT User Manual Version 11.5 rev. A
calculating the lens to be implanted is the IOL constant. When using the REVO
devices only IOL constants optimised for optical biometers should be used. Please
contact your IOL manufacturer for information on optimised IOL constants for optical
biometry.
WARNING! The user is fully responsible for the verification of provided data using to
IOL implementation or any other medical procedure.
WARNING! The user is fully responsible for all values entered or changed manually.
CAUTION! Using data from acoustic instruments also requires the constant of every IOL
to be optimized for ultrasound applanation of instrument. At present, it is more common
to find online only databases of lenses optimized for optical biometry instruments.

CAUTION! The IOL calculation is valid only if the biometric measurement was correct, an
appropriate IOL calculation formula was selected and the IOL constants were optimized
for the specific application in advance.

Note: Only biometry exam with valid calibration allows to open IOL Calculation tab.
Biometry results with an NG status are not available in the IOL Calculation Tab.

Biometry exam
selection Warning field

Calculate
Keratometry data button

Target refraction
field

IOL result section IOL database editor

Figure 274. IOL Calculation Tab

282 / 387
SOCT User Manual Version 11.5 rev. A
Performing IOL calculation
Click on the „Biometry exam selection” field to open a drop-down menu and choose a biometry
exam by date. If any of the loaded biometry data is changed by the user, the name of the data set
is replaced with “Manual entry”. Next, enter keratometric data. To calculate IOL parameters it is
also necessary to provide the target refraction value after the IOL exchange procedure. Click on
the target refraction value field and enter the target value.

Keratometry data section


Biometry exam
selection
Refractive index

Target refraction value

Figure 275. Entering biometry and keratometry data

Choose the IOL manufacturer and model by clicking on the drop-down menus as shown below.
Similarly, specify the calculation formula.
You can choose from the following IOL power calculation formulas:
- Hoffer®Q24
- Holladay I25
- Haigis26
- Theoretical/T27
- Regression II28

24
Hoffer KJ. The Hoffer Q formula: a comparison of theoretic and regression formulas. J Cataract Refract Surg 1993;
19(6):700–712; errata 1994; 20(6):677 and 2007; 33(1):2-3.
25
Holladay JT, Praeger TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A three-part system for refining intraocular
lens power calculations. J Cataract Refract Surg 1988; 14(1):17–24.
26
Haigis W. The Haigis formula. In: Shammas HJ ed. Intraocular Lens Power Calculations. Thorofare, NJ: Slack, Inc.;
2004:41–57.
27
Based on the idea of the Development of the Theoretical intraocular lens implant power calculation.
28
Second generation IOL formula which is now expired.

283 / 387
SOCT User Manual Version 11.5 rev. A
For each eye, the user can choose even 4 formulas at the same time. Next click [Calculate] in the
center of the Calculation Tab. The result of the calculation will be displayed in the results table in
6 lines. The third line presents the value closest to the target refraction. The two lines above and
below the third line show lower and higher values respectively. The line at the bottom presents
the value of Emmetropia.

IOL manufacturer
IOL constants

IOL model
Calculation results
table
Calculation formula

Figure 276. IOL Calculation results table


WARNING! The user chooses calculation parameters at their own discretion.
The responsibility for the chosen parameters and the interpretation of results lies on the
user.
CAUTION To ensure plausibility of 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.

Marking implemented lenses


You can mark two lenses, one for each eye. To do that click the right mouse button on the value
you wish to mark to unfold a drop-down menu and choose Select IOL. Clicking Remove IOL
Selector reverses the operation. The marked lens is identified by the sign which is also
present on printout.

Mark/unmark
„Marked lens” sign drop-down menu

284 / 387
SOCT User Manual Version 11.5 rev. A
Figure 277. Marking lenses

IOL Editor
The IOL Editor window is where the user can import and export IOL data or edit data already
present in the system. To go to the window, click the “IOL Editor” button in the center of the IOL
Tab. Lenses tree on the left side of the window lists all available lenses sorted by manufacturer.
The right-hand side of the window is the IOL constants editing section.

IOL import and export IOL data section


buttons
IOL data revision menu

Manual IOL
entry/remove
buttons IOL type selector

Lenses list sorted


by manufacturer
and model
Save IOL data
The number of
lenses available Cancel IOL import/edit

Figure 278. IOL Editor window

Importing IOL data

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.
CAUTION The measurements taken with REVO may serve as the central element for the
calculation of intraocular lenses (IOL). A further important parameter in calculating the
lens to be implanted is the IOL constant. When using the REVO devices only IOL constants

285 / 387
SOCT User Manual Version 11.5 rev. A
optimized for optical biometers should be used. Please contact your IOL manufacturer for
information on optimized IOL constants for optical biometry. An alternative source of
information for IOL constants optimized for optical biometry is the website:
IOLCon.org - IOL Con is an international platform for characteristics of intraocular lenses
and the optimization of lens constants. The IOLCon team is located at University of
Saarland and working under the head of Steinbeis.
ULIB User Group for Laser Interference Biometry” (ULIB): http://ocusoft.de/ulib/c1.htm.
To import IOL data in the .mdb (ULIB), .xml (IOLcon) or .odb (Optolpol Database) format click the

import button and choose the data file to be imported.

Exporting IOL data


To export the full database or a single lens in the .odb (Optopol Database) format click the export

button .

Adding lenses manually

In order to add a new lens manually click the button in the upper left-hand corner of the
editor window and enter the details of the lens.

Deleting lenses manually


If you want to delete a single lens, highlight its name by clicking on it and then click the delete

button . Similarly, to delete all lenses by the same manufacturer click on the manufacturer’s

name and then click the delete button . In either case, after clicking the delete button, a
dialogue box is displayed to confirm the deletion.

Viewing the list of lenses


In order to unfold the list of lenses by a chosen manufacturer double click the manufacturer’s
name. The list unfolds showing available lenses together with their type information.
To choose a lens for editing simply click on its name. The data of the selected IOL will be displayed
in the IOL editing section to the right of the lenses tree.

286 / 387
SOCT User Manual Version 11.5 rev. A
IOL manufacturer/
number of lenses

IOL type and


model

Figure 279. List of lenses in the IOL Editor window

Editing IOL data


The IOL data section to the right of the lenses tree allows the user to optimize or personalize IOL
data.
The manufacturer and model of the lens can be entered
manually in their respective fields at the top of the section.
This triggers the auto-suggest function to speed up the IOL
selection process.
Revision shown drop-down menu allows the user to choose
the revision of IOL data they wish to use for calculation.
A new revision is created whenever the user introduces
changes to the data and saves them by clicking [Save] at the bottom of the window. Consecutive
IOL revisions are indicated by a number next to the date. By default, the system uses the latest
revision of data.

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

The Constants source field shows the source of the constants. The user can set the constant source
displayed as the default source by clicking [Set as
default].
CAUTION Calculation constants 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 circumstances, case and practice.
To calculate the constants based on the a-constant of manufacturer enter the
A-constant value in the A-const field and click [Calculate constants].

287 / 387
SOCT User Manual Version 11.5 rev. A
CAUTION Remember that the A-constant 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 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.
NOTE The user should always seek to ever improve their IOL optimization. IOL personalized
and optimized data should be created through the analysis of pre-operative data obtained
with the device and the results of stable refraction tests performed 3 months after the
surgery.

Adding additional power ranges and increments


The default power range in the IOL Editor window is -10 to +40 dioptres with the increment of 0.5
dioptres. It is also possible to create additional power ranges and increments. To add a new power

range, click the button. To modify the range and increment values double click on the value
you wish to modify and enter a new value. To remove a power range, click on it to highlight it and

then click .

Add/delete
a power range

Editing a power
range field

Figure 280. Adding additional power ranges and increments

Using a toric IOL requires the user to provide both the corneal astigmatism range and the cylinder
power.

288 / 387
SOCT User Manual Version 11.5 rev. A
20 TOPOGRAPHY OCT29
Topography module 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 (Ray tracing).
Topography scan program is available in Anterior scan list. It has fixed scan parameters:

• B scans: 16,

• A scans: 1024,

• Width: 8 [mm],

• Scan time:
- 0.14 sec. for REVO FC 130/NX 130: 0.14 sec.
- 0,22 sec. for REVO FC/80: 0,22 sec.
- 2.40 sec. for REVO 60: 2.40 sec.

Topography - Safety Notes


- NOTE: Allow only well-trained operators to use the topography module

NOTE: Layers recognition is used for tracing.

NOTE: Fully examine the measured data for layer recognition results. In particular,
if the difference between the 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 tracing and/or reliability on the check screen. If the
measurement result is not conclusive, review the inspection result by performing
another measurement or inspection.

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

CAUTION: When using the data taken by this instrument to select intraocular
lenses, thoroughly determine the selection by also examining cataract surgery
methods and other inspections. If incorrect measurement data is used to select
intraocular lenses, further surgery might be required.

29
OCT Topography is an optional feature. It is available as an upgrade purchased separately.

289 / 387
SOCT User Manual Version 11.5 rev. A
CAUTION: The wearing contact lenses (soft or hard) may have an effect on the
surface geometry of the cornea and thus the optics of the eye. Therefore, for
measurements conducted on wearers of contact lenses using SOCT topography
module, a rest period should be observed from the time the contact lens is removed
to the time of measurement. The required duration of the time from removal of the
lens to the time of measurement may vary individually and must be determined by
a qualified physician.

CAUTION : Use of eye drops prior to topography measurement may lead to v


incorrect results in the measurement of corneal curvature. The use of
tear drops substitute may impact the measured keratometry values.
CAUTION Do not perform any contact measurements or examinations in which the
eye is touched. They may result in incorrect readings, particularly for
biometry and corneal topography measurements. Contact
measurements or examinations should only be performed after the
patient has been measured with the SOCT.

CAUTION: When using the data taken by this instrument for refractive correction
surgery, thoroughly determine the selection by also examining surgery methods
and 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: Fully examine the measured data for tracing results. In particular, if the
difference between measurement values for the left and right eyes is significant or
any problem is found on the anterior chamber during the preliminary examination,
check the tracing and/or reliability on the check screen. If the measurement result
is not conclusive, review the inspection result by performing measurement again or
performing another inspection.

NOTE: It may be difficult to trace the border 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.

290 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: The 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.

NOTE: When using the 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 this instrument to select intraocular lenses, thoroughly


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

NOTE: When using the data taken by this instrument for refractive correction
surgery, thoroughly determine the selection by also examining surgery methods
and performing 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: Patients with complete or partial coverage of the cornea, caused by palpebral
fissure which is closed or too small.
NOTE: Low quality examination result can be expected in the following situations:
– Patients with complete or partial coverage of the cornea, caused by palpebral
fissure which is closed or too small.
– The patient is unable to steadily fixate the fixation light with the eye under
examination

NOTE: When using the anterior adapter, do not move the head too fast and monitor
the proximity to the patient in order to avoid hitting the patient’s eye incidentally
with the Anterior adapter lens surface.

NOTE: Ensure that the scanning head is in maximum backward position and the
patient will not incidentally hit the anterior adapter.

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

291 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: When using the anterior adapter, do not move the head too fast and monitor
proximity to the patient in order to avoid hitting the patient’s eye incidentally with
the Anterior adapter lens surface.

NOTE: Ensure that scanning head is in maximum backward position and the patient
will not incidentally hit the anterior adapter.

NOTE: Shaded areas indicate questionable data - such scans should be reviewed for
determine accuracy. Data is often compromised by lid or ghost from the iris related
issues.

Topography Acquisition Mode


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 spot 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 the Topography scan program.
Once the scan program is selected the topography acquire window is available.

Figure 281. Topography acquire window

While capturing the scan the following steps should be observed.


The cornea tomogram should be positioned within the range defined by the two horizontal
dashed lines.
Operator should make sure that the lids of the eye are not blocking or shadowing a
significant portion of the image in vertical meridians.

292 / 387
SOCT User Manual Version 11.5 rev. A
NOTE: The system automatically selects C-gate mode from top to bottom. In cases when the
ghost image touches the cornea (e.g. shallow anterior chamber) the user has to change the
C-Gate mode from bottom to top.
4. After the result is acquired, it is displayed in the Acceptance window. The operator should
verify the measurement reliability indexes. A measurement with poor measurement
reliability indicates an increased risk of measurement variability. Measurements with
poor reliability should be replaced.
5. Follow the procedure depending on the Acquisition mode.

Full Auto mode


1. Mark AutoAcquire checkbox and Press the START button
2. Wait until the system finishes the examination. The patient will be voice guided
by the software.

[Start] becomes active


when the device status is
“READY”

Device status
Full auto active when
marked

Figure 282. Full auto examination

NOTE: There are a number of conditions in which auto functions processes could fail.
For example: dense media opacities, eyelashes or eyelids blocking the beam of light,
inability of subjects to maintain fixation, strong nystagmus. When an adverse condition
occurs optimize the OCT signal manually.

NOTE: If the system does not detect the pupil, the user has to adjust the center of the
patient’s pupil manually. In order to set the working position properly, align the center
of the pupil on a proper height.

NOTE: In case the system is not able to keep the proper position of the retina (e.g. the
patient is shaking) the operator needs to switch off tracking and do the examination
manually.

293 / 387
SOCT User Manual Version 11.5 rev. A
Semi Auto mode
1. Uncheck [Auto Acquire]

Full auto mode is disabled

Press forward
movement until
two images crate
one
Figure 283. Manual examination mode

2. Cornea OCT signal should appear in the tomogram preview. If it does not, adjust C
Gate manually by moving the sliding bar or scrolling over the tomogram window.
If you cannot find cornea OCT signal adjust the patient refraction value and try to
find the signal once more.
3. Some refracting correction may be needed to obtain the best tomogram quality.
Observe the QI bar in order to obtain the best signal while changing [FOCUS] the
bar position.
4. Verify the position of the cornea which should be placed on the dashed horizontal
line. The center of the cornea should be on the vertical dashed line whenever
possible.
5. Once the cornea position is aligned ask the patient to blink and start the final
topography acquisition. Click twice on the tomogram or press the [Acquire] button.
The device will initialize the measurement immediately to perform a full scan.

Press NEXT when the


signal is optimised
signal

Figure 284. Manual examination process

6. After the examination is over the system will display an acceptance screen.

294 / 387
SOCT User Manual Version 11.5 rev. A
Acceptance screen
After capturing a topography examination the system checks if all measurement parameters
are on an acceptable level. If any of them is not, the system displays an Acceptance window.

Figure 285. Topography Exam Acceptance window

[Rescan] – the examination is saved with the NG information. The system is ready to repeat
the examination.
[Accept] - the examination is saved.
[Reject] - the examination is rejected and the system returns to the acquire window.
If [Rescan] is selected, pressing the right mouse button on the tomogram in the acquire
window initiates automatic alignment of tomograms along the X and Y axis. The Z axis remains
the same. If Auto Acquire check is selected the system automatically acquires a scan.

Total Quality Factor


Total Quality Factor – a summary factor that determines whether the operator can trust the
measurement. The total quality factor is based on the values of all individual factors: CI, AAA,
PAA
Correlation Index – information about tomograms correlation in the measurements
OK [Accepted] Not correlated >87 %
! [Borderline] Unreliable, 86%> to >70%
NG [Not correlated] Not correlated to <69%
Analyzed Area - information about the relation of the scanned area in ideal condition to the
recognized area in the anterior and posterior. It is expressed in %
AAA – [Anterior Analyzed Area] –
295 / 387
SOCT User Manual Version 11.5 rev. A
OK [Accepted] >85 %
! [Borderline] 84> to >65%
NG [Not correlated] Not correlated to <64%

PAA – [Posterior Analyzed Area]


OK [Accepted] >63 %
! [Borderline] 63> to >41%
NG [Not correlated] Not correlated to <40%

Artifact– this warning appears when on 3 consecutive scans the system detects places where
the recognition algorithm has uncertainty sections. This problem makes it possible to detect
artefacts relate to the close Eyelid, ghost signal from the iris, lack of signal due to long
eyelashes or decreasing the signal due opacity in the cornea.
Results for the Topography scan are not displayed for scans with poor quality in which an
algorithm failed. In this case, the scan should be repeated.

For clinical use, it is recommended for the user to take at least three corneal power scans and
calculate mean corneal power for further measurement variability reduction.

Result review
[Single] view
The overview display is a compilation of several evaluation representations which gives a quick
overview of the anterior eye segment being measured.

Map list box

Eye preview
Active map graphs
Thickness graph

Tomogram window

Double click to enlarge

Analysis summary table

Click to change display


settings

296 / 387
SOCT User Manual Version 11.5 rev. A
Figure 286. Single Topography view

At the topography window the user can select one of the predefined maps from the list box:
- Axial [Anterior]
- Axial [Posterior]
- Refractive Power map [Kerato]
- Refractive Power map [Anterior]
- Refractive Power map [Posterior]
- Refractive Power map [Total]
- Tangential map [Anterior]
- Tangential map [Posterior]
- Net Map
- Axial True Net
- Equivalent Keratometer
- Elevation Map [Anterior]
- Elevation Map [Posterior]
- Height map
- Pachymetry
- Epithelium

Clicking the right mouse button on the results Topography and Biometry table enables
exporting the data as a .txt file.

Right click on the


Topography results
shows [Save as txt...]

297 / 387
SOCT User Manual Version 11.5 rev. A
20.3.1.1 Enlarged detailed map view
Double click on the active map for a new window with an enlarged detailed map.

Scale
The tip of the cornea

Click in any point to


display the value

Map type

Analysis summary table


Figure 287. Enlarged detailed Topography map view

After pressing the right mouse button on the map, a context menu appears
with the following options:

- B-scan reference enable – it enables to show b-scan line. Changes are visible on all maps. It
is inactive for an enlarged detailed map.
- Sectors – it allows sectors to be superimposed on the map. Changes are visible on all maps.
- Grid – it allows sectors to be superimposed on the map. Changes are visible on all maps.
- None – it allows to show map without sector i grid. Changes are visible on all maps.
- Markers - it enables the display of corneal markers. Changes are visible on all maps.
- White background – it changes the background illumination of all maps to white. Changes
are visible on all maps.
- Save as - saving the current map to a file.

298 / 387
SOCT User Manual Version 11.5 rev. A
Markers on maps

[Both] view
This screen shows the analysis results comparing examinations of both eyes performed in the
same scan mode and on the same date.

Active map graphs

Analysis summary table:

Figure 288. Both Topography view

[Comparison] view
This screen shows the analysis results comparing two examinations of one eye on the same
side in the same scan mode, from different dates.

299 / 387
SOCT User Manual Version 11.5 rev. A
Analysis summary table

Active map graphs

Figure 289. Comparison Topography view

[Progression] view
This screen shows the analysis results comparing six examinations of eyes on the same side in
the same scan mode, and the same size of scanning area, arranged in a time sequence.

Active map graphs

Figure 290. Progression Topography view

Analysis
Definitions of basic keratometry values:
- AAA/PAA – Anterior/Posterior Analyzed Area [%]. The standards are given in section 1.2.4
Total Quality Factor.

- Ant – The average power of the central 3 mm front sector; displayed only as refractive
power [D].

300 / 387
SOCT User Manual Version 11.5 rev. A
- Apex – Corneal thickness from the epithelium to endothelium at the anterior corneal apex
position.
- CCT – Central Corneal Thickness; displayed in micrometres [μm].
- Cyl – The Cylinder power (Astigmatism). The amount of anterior/posterior/true net
corneal astigmatism, calculated as a difference between K1/Kf and K2/Ks; displayed only
as refractive power [D]. The tilt angle of the astigmatism axis is equal to the K1/Kf tilt
angle.
- Ecc – Eccentricity, calculated according to the mathematical definition as a difference
between the corneal model and the best-fitting sphere in the range of 7 mm. Eccentricity
is calculated according to the formula:

R - value of the radius of curvature (ant


or post) at a given point,
r - the radius of the best-fit sphere,
d - flat distance to the tested point.

- K1/Kf – The anterior/posterior/true net, simulated keratometer reading obtained from


a circle with the K diameter value chosen in the Setup, and a width of 1 mm. K1 - flat
meridian (blue) is displayed as the refractive power [D]. The tilt angle of the astigmatism
axis is equal to the K1/Kf tilt angle.
- K2/Ks – The anterior/posterior/true net, simulated keratometer reading obtained from
a circle with the K diameter value chosen in the Setup, and a width of 1 mm. K2 - steep
meridian (red) is displayed as the refractive power [D]. The tilt angle of the astigmatism
axis is equal to the K2/Ks tilt angle.
- avg K – The arithmetic average of the central keratometry (SimK), calculated as an
arithmetic mean from K1/Kf and K2/Ks; displayed as the refractive power [D].
- min K – The steepest radius of the curvature of the anterior/posterior/true net corneal
surface, displayed in [mm] or the largest value of refractive power of the
anterior/posterior/true net corneal surface, displayed in [D].
- Post – The power of the posterior surface ranging 3 mm; displayed only as refractive
power [D].
- Real – The power of the cornea is calculated from the sagittal curvature values of the
anterior and the posterior surface. Anterior sagittal power is calculated using refractive
indices of n=1 for air and n=1.376 for corneal tissue, whereas posterior sagittal power is
301 / 387
SOCT User Manual Version 11.5 rev. A
calculated using refractive indices of n=1.376 for corneal tissue and n=1.336 for the
aqueous, and the results are then aggregated; displayed only as refractive power [D].
- Thinnest – Corneal thickness at the thinnest location.

Central Keratometry – SimK


It displays the Simulated Keratometry values from the central area bases on Axial maps.

Four Karatometry values are distinguished:

- Anterior – Anterior Corneal Surface. Values are calculated based on the Axial [Anterior] map.

- Posterior – Posterior Corneal Surface. Values are calculated based on the Axial [Posterior]
map.

- Real - the power of the cornea. Values are calculated based on the Axial True Net map.

- Central Power – the central power of the cornea. Values are calculated based on the Axial
[Anterior], Axial [Posterior], Axial True Net and Pachymetry map.

302 / 387
SOCT User Manual Version 11.5 rev. A
Keratometry (Meridian)
It calculates Astigmatism base on the mean diameter in each zone (3, 3-5, 5-7 [mm]).
Calculations base on Axial [Anterior] and Axial [Posterior] maps.

Keratometry (SemiMeridian)
It calculates irregular Astigmatism base on the minimum and maximum radius in each zone
(3, 3-5, 5-7 [mm]). Calculations base on Axial [Anterior] and [Posterior] maps.

Keratoconus screening

KPI Value

Keratoconus indication

Values of indices

To classify the keratoconus occurrence in the examined cornea, a Keratoconus Prediction Index
(KPI) is calculated by the software after the examination is completed. KPI Result is displayed
in a table and it will determine whether keratoconus had been detected based on the indices.

303 / 387
SOCT User Manual Version 11.5 rev. A
20.4.4.1 KPI Result
This system can be used as a screening procedure to distinguish clinical keratoconus from other
corneal topographies. It may also aid in refining the clinical interpretation of topographic
maps. If the system detects a result a calculated KPI value greater than 0.23 or K2 greater than
38.5, it is indicative of keratoconus, which later is distinguished by the method of elimination.
See Figure 291 Keratoconus screening classification.
Keratoconus prediction index (KPI) is calculated by a combination of 8 topographic indices and
relies on a linear discriminant function. The indices DSI, OSI, CSI, SAI, K1, K2, IAI and AA are
described below.

Caution: KPI bases on a publication by Naoyuki Maeda and can only be treated as
supplementary information and cannot be treated as disease confirmation. Use for
reference only.

Source: Automated Keratoconus Screening with Corneal Topography Analysis by Naoyuki Maeda, Stephen D. Klyce, Michael K. Smolek,
and Hilary W. Thompson in 1994.

KPI is a result of linear function, calculated according to the following formula:


KPI = 0,30 + 0,01(–41,23 – 0,15DSI + 1,18OSI + 1,49CSI + 4,13SAI – 0,56K1 + 1,08K2 – 3,74IAI +
0,10AA)
KPI value is calculated on the basis of Quantitative Indices, which are the components of the
formula.

20.4.4.2 Definition of Quantitative Indices


DSI (Differential Sector Index) – the greatest difference in average power between any two
(out of eight) sectors
OSI (Opposite Sector Index) – the greatest difference of the average power in opposite
sectors
To calculate Differential Sector Index and Opposite Sector Index, the analyzed area is divided
into eight equal sectors. One of the sectors covers the area with the greatest power. Each
sector has a specific average power calculated by the system (see picture below).
Before the calculation of Differential Sector Index and Opposite Sector Index, the sectors are
rotated at an angle, until the average power of one of the sectors reaches the highest value
(Dmax).

304 / 387
SOCT User Manual Version 11.5 rev. A
OSI = Dmax - Dopposite
DSI = Dmax - Dmin

Dmax – average power value of the sector with maximum power


Dopposite – average power value of the sector which is opposite to the sector with maximum
power
Dmin – average power value of the other sector with minimum power
CSI (Central/Surrounding Index) – difference in the average area-corrected corneal power
between the central area and an annulus surrounding the
central area (see picture below)

Dsurround

Dcentral

CSI = Dcentral – Dsurround


SAI (Surface Asymmetry Index) – difference in corneal powers at every ring (except for
180⁰) over the entire cornea surface
K1 (Keratometry K1) – average maximum radius in 3 mm zone
K2 (Keratometry K2) – average minimum radius in 3 mm zone

IAI (Irregular Astigmatism Index) – experimentally selected value based on examinations


from a test database, within the normal range for healthy
eyes.

AA (Analyzed Area) – analyzed area of the examined cornea.

Classification of keratoconus screening is performed according to the following graph:

305 / 387
SOCT User Manual Version 11.5 rev. A
Figure 291 Keratoconus screening classification

Pachymetry
The table displays a summary of pachymetry data. Calculation bases on Pachymetry and
Epithelium maps.

Definitions of pachymetry parameters:

- Central thickness – the corneal/epithelial thickness at the central point of the


Pachymetry/Epithelium Grid; displayed in micrometres [μm].
306 / 387
SOCT User Manual Version 11.5 rev. A
- Minimum (marked as) – minimum corneal/epithelial thickness within the area;
displayed in micrometres [μm].
- Median – thickness median; displayed in micrometres [μm].
- Minimum - Maximum – the difference between the minimum and median corneal/
epithelial thicknesses within the area; displayed in micrometres [μm].
- Min – Median – the difference between the minimum and median corneal/epithelial
thicknesses within the area; displayed in micrometres [μm].

Sector difference analysis:


- SN-IT – the difference between the average thickness in the Superior-Nasal and
Inferior-Temporal parts of the grid.
- S-I – the difference between the average thickness in the Superior and Inferior parts of
the grid.
- ST-IN – the difference between the average thickness in the Superior-Temporal and
Inferior-Nasal parts of the grid.
- T-N – the difference between the average thickness in the Temporal and Nasal parts
of the grid.

Map Types
Axial maps - Axial Power is a curvature radius map that defines the center of curvature on the
measurement axis. It is converted to refractive power using the refractive index for conversion
based on a paraxial calculation. This map represents the sphericity of the entire cornea, which
can be a useful indication of the refractive power of the cornea and the corneal shape. The
spherical cornea without astigmatism is displayed in one color in this map, which makes it is
easy to identify the normal cornea.
The picture below describes this solution graphically. Unlike the tangential radius, the axial
map always ends at the optical axis, and therefore the surface of the cornea should be
considered as one lens with radius different at each point. The alternative name of the sagittal
map is axial map.

307 / 387
SOCT User Manual Version 11.5 rev. A
Axial [Anterior] - an axial power map of the anterior surface. Refractive index: 1.3375.
Axial [Posterior] - an axial power map of the posterior surface. Refractive index: 1.376.
Tangential maps clearly define small or “instantaneous” curvature changes. It calculates each
measured point of data at a 90° “tangent” to its surface. Tangential maps provide a more
detailed description of the corneal shape and provide a clearer view of the size and shape of
the cone in a keratoconus patient, for instance. The ability to measure the size of the cone is
very helpful in determining the ideal lens design and optic zone size. Additionally, tangential
maps define the position of the treatment or effect of corneal reshaping and refractive surgery.
Tangential map is calculated on the basis of digitally recognized ring pattern reflected from the
surface of the cornea. It calculates the local curvature radius which gives very accurate
information about the shape of the cornea. In the case of spherical surface, all radii end at the
optical axis at the same point. If the surface has defects, then the radii can end at any place
and not on the axis.
From this point the cornea should be treated as an infinite set of small spherical lenses, where
each of them has a different radius length and origin.
The picture below shows the calculation of tangential map graphically.

Tangential map [Anterior] - a tangential power map of the anterior surface. Refractive index:
1.3375
Tangential map [Posterior]- a tangential power map of the posterior surface Refractive index:
1.376.

308 / 387
SOCT User Manual Version 11.5 rev. A
Refractive Power map [Kerato] calculates the focal length from Snell's law and the corneal
refractive power. This map uses only values from the anterior surface, but it also takes
refractive effect into account. It calculates corneal power according to Snell’s law of refraction
assuming a refractive index of 1.3375 to convert curvature into refractive power.

Refractive Power map [Anterior] - Refractive index of the cornea: 1.376. Calculate base on the
Snell’s law.
Refractive Power map [Posterior] – is calculated as difference between Refraction equivalent
power map and Refraction Power Anterior. Refractive index of the cornea: 1.376.
Refractive Power map [Total] - This map uses ray tracing to calculate the refractive power of
the cornea and the lens thickness formula. It takes into account how parallel light beams are
refracted according to the relevant refractive indices (1.0, 1.376 and 1.336), the exact location
of refraction and the slope of the surfaces. The location of refraction is a determinant of the
surface slope, since the anterior and posterior surfaces have slightly differing principal planes
due to corneal thickness. In this way the map takes the refractive effect, inclusion
Anterior/Posterior surface and the location of the principle planes into account. Its results are
more realistic than any other, but they will deviate from normal Simulated K values so they

cannot be used in conventional IOL formulas.

Net Map This map shows the optical power of the cornea based on two different refractive
indices, one for the anterior n=1.376 and for the posterior surface aqueous humour: 1.336, as
well as the sagittal curvature of each. These results are aggregated.
The equation used: Net power = [(1.376-1)/RAnt]*1000+[(1.336-1.376)/RPst]*1000
Axial True Net - a total power map of the anterior and posterior surfaces is calculated by the
lens thickness formula. It is calculated by adding the corneal thickness correction to the sum
of the refractive powers of the anterior and posterior surfaces. It considers how parallel light
beams are refracted according to the relevant refractive indexes 1.0, 1.376 and 1.336.

309 / 387
SOCT User Manual Version 11.5 rev. A
The equation used: kA=[(1.376-1)/RAnt] kP=[(1.336-1.376)/RPst]
CTP- Cornea Thickness at the Point
K = kA + kP –[(CTP/1.376)* kA *kP
Equivalent Keratometer This map was designed to consider the refractive effects of both the
anterior and the posterior surface. The map considers how parallel light beams are refracted
according to the relevant refractive indexes 1.0, 1.3375 and 1.336. The Equivalent keratometer
map condsiders effects refractive effect, inclusion Anterior/Posterior surface and the corneal
refractive index. The map calculates power according to Snell`s law using the refractive indices
of the corneal tissue and aqueous humour and aggregating the values for anterior and
posterior power. In this way it provides equivalent K-values that can be used in IOL formulas
that correct for n=1.3375.
Elevation Map indicates the difference obtained by subtracting the height of the reference
sphere (Best Fit Sphere) from the height of the cornea in 6 mm radius with least square
method.
Positive value: the measurement point of the cornea is above the reference sphere
Negative value: the measurement point of the cornea is below the reference sphere
Elevation Map [Anterior] Differences maps between the best-fit sphere in the anterior layer
and this layer.
Elevation Map [Posterior] Differences maps between the best-fit sphere in the posterior layer
and this layer.
Height map is a difference from tangent surface to highest point of the cornea.
Pachymetry map of the corneal thickness with vertical direction to the anterior surface of the
cornea. It allows visual capturing of the thin part of the cornea, providing extremely useful
information for refractive surgery.
Epithelium thickness map shows the corneal epithelium thickness map for examination. It
provides information for refractive lasik and Keratoconus patients.

Color scale - Standards


Switching the scale - to change the scale click one of the scale descriptions in the
bottom corner of the map. Scale settings widow shows up. User can change the
scale type, step and units. Only steps available for the chosen scale will show up.
The system remembers maps chosen on each view position. After closing the
examination the setting are saved and used for other examinations.
Standard scale - scale with predetermined ranges and steps of numerical values (absolute and
relative scales).
Normalized scale - scale with equal increments ranging from the smallest to the largest value
of a given map in the 7mm area.

310 / 387
SOCT User Manual Version 11.5 rev. A
Scales, steps and units available for:
Axial [Anterior], Tangential [Anterior]
Available scales: Steps: Units:
D
Absolute
mm
0,25 D D
0,05 mm mm
0,5 D D
O scale
0,1 mm mm
1D D
0,25 mm mm
D
Normalized
mm
D
Absolute
mm
0,5 D D
0,1 mm mm
ISO
1D D
0,2 mm mm
D
Normalized
mm
D
Absolute
mm
0,25 D D
0,05 mm mm
0,5 D D
American
0,1 mm mm
1D D
0,25 mm mm
D
Normalized
mm
D
Absolute
mm
Atlas
D
Normalized
mm
D
Absolute
S-K USS (Smolek mm
Klyce) D
Normalized
mm

Axial [Posterior], Refractive Power [Kerato], Tangential [Posterior]


Available scales: Steps: Units:
D
Absolute
mm
0,25 D D
O scale
0,05 mm mm
0,5 D D
0,1 mm mm

311 / 387
SOCT User Manual Version 11.5 rev. A
1D D
0,25 mm mm
D
Normalized
mm
D
Absolute
mm
0,25 D D
0,05 mm mm
0,5 D D
American
0,1 mm mm
1D D
0,25 mm mm
D
Normalized
mm
D
Absolute
mm
Atlas
D
Normalized
mm
D
Absolute
S-K USS (Smolek mm
Klyce) D
Normalized
mm

Refractive Power [Kerato], Refractive Power [Posterior], Refractive Power [Total], Net map,
Axial True Net, Equivalent Keratometer,
Available scales: Steps: Units:
Absolute D
0,25 D D
O scale 0,5 D D
1D D
Normalized D
Absolute D
0,25 D D
American 0,5 D D
1D D
Normalized D
Absolute D
Atlas
Normalized D
S-K USS (Smolek Absolute D
Klyce) Normalized D

Elevation [Anterior], Elevation [Posterior]


Available scales: Steps: Units:
Absolute µm
25 µm µm
O scale 10 µm µm
2,5 µm µm
Normalized µm
312 / 387
SOCT User Manual Version 11.5 rev. A
Height map
Available scales: Steps: Units:
Absolute µm
O scale
Normalized µm

Pachymetry map
Available scales: Steps: Units:
Absolute µm
5 µm µm
O scale
10 µm µm
20 µm µm
Absolute µm
5 µm µm
American
10 µm µm
20 µm µm
Absolute µm
5 µm µm
RevoScale
10 µm µm
20 µm µm

Epithelium map
Available scales: Steps: Units:
O scale Absolute µm
RevoScale Absolute µm

313 / 387
SOCT User Manual Version 11.5 rev. A
21 CALIBRATION

To ensure system stability over time, before the first examination the topography module
automatically prompts for a daily validation test. The validation test is performed with the
calibration tool. The result of the validation test is compared with the stored value obtained
during the initial calibration to verify system stability. The limit of acceptable difference is ±0.15
D; if it is exceeded, the software will not allow the acquisition of topography scans. A warning
message with instructions for further actions is displayed on the screen.

Calibration procedure preparation


Before the calibration you have to install the Calibration tool.

Figure 292. Calibration tool.

Take the tool from the box and open as it is shown on the following images.

1 2 3

Figure 293. Opening the calibration tool.

Put the opened calibration tool on the forehead frame as shown on the following image. Mount the
upper hooks first. Then push the lower hooks to the frame. Make sure there is no free space
between the frame and the calibration tool.

314 / 387
SOCT User Manual Version 11.5 rev. A
1 2 3

Figure 294. Mounting the calibration tool.

NOTE: Make sure the calibration tool is well fitted to the frame.

WRONG CORRECT
D

Topography calibration
Intitial Topography calibration procedure
If the following information pops up, the device needs to go through the initial calibration
procedure.

NOTE: The system requires initial calibration


Attach the calibration tool and press OK to continue.
If you do not have the calibration tool, please contact technical support
[TEST] – starts the calibration process
[SKIP] – skips the calibration and closes the information window
315 / 387
SOCT User Manual Version 11.5 rev. A
If the device has gone through the initial calibration successfully, the system starts to display
the information as for standard calibration.

Note: the initial calibration is usually longer and it make take a while. If the calibration ends in
failure, verify if: the Anterior adapter is installed, the tool is properly installed, the testing
surface inside the calibration tool is free from pollution, no strong light is reflected from
testing surface.

Standard calibration
When the calibration is not required, after selecting the Topography examination no
information is displayed. When the calibration is required the system displays the following
information:

[OK] – starts the calibration process


[Cancel] – skips the calibration and closes the information window
Instead of standard calibration, the user can choose to perform common calibration of
Biometry, Topography and WTW all in one go. The common calibration procedure is described
in section 21.3.5 Common calibration.
Before the examination the system checks when the device was calibrated for the last time
and display the following information:
“Last calibration X days ago. Before starting a measurement on a patient self-calibration is
recommended. Press OK to continue”.
[Skip] – goes to Acquire window
[OK] – starts the calibration process

Calibration process
At the start of the calibration process the user will be asked to “Install the calibration tool on
the chinrest and press Test”

316 / 387
SOCT User Manual Version 11.5 rev. A
[TEST] – starts an automatic calibration process
After calibration the system displays a calibration summary:

If the system passes calibration, the following message is displayed in the calibration window:
“Calibration successful. Next test required within 7 days”
If the system fails calibration the following message is displayed in the calibration window:
“NOTE: Topography analysis will be DISABLED due to the failure of the validation test.
Please re-run the Test. If failure persists, please contact the Service support.”

317 / 387
SOCT User Manual Version 11.5 rev. A
[Cancel] – close the window
[Test] – repeat calibration
If the device does not pass the software calibration, it is impossible to test and analyze in the
topography mode.
If both the Topography and Biometry modules have been activated in the system, the user
can calibrate them in one go. This procedure is described section 21.3.5 Common calibration.

Axial length (biometry) calibration


Performing calibration of the Biometry module ensures high precision of measurements.

Biometry calibration with the IOL Calculation tab unactivated


Once the Biometry module is opened for the first time the system prompts the user to perform
the initial calibration. After a year since the initial calibration the user will be prompted to
repeat the calibration procedure.

To skip calibration, click [Skip]. The calibration prompt will be displayed on the next day.

318 / 387
SOCT User Manual Version 11.5 rev. A
To start calibration, click [Calibration]. If the calibration parameters provided with the
calibration tool have not been entered, the system prompts the user to do that, as shown
below.

To close the window, click [OK].


When the calibration process starts, the system displays the calibration procedure window.

Biometry calibration with the IOL calculation tab activated


The user is prompted daily to perform calibration at the first attempt to take a Biometry
measurement. Carrying out Biometry exams is not possible if the calibration of the Biometry
module fails. If the user skips calibration, it is still possible to carry out exams, but the IOL
Calculation tab will not be available for exams performed after skipping calibration. The tab is
available only for exams carried out on a day of calibration (after calibration).

If the calibration parameters provided with the calibration tool have not been entered, the
system prompts the user to do that, as shown below. Entering biometry calibration parameters
is described in section 21.3.4 Entering biometry calibration parameters.

319 / 387
SOCT User Manual Version 11.5 rev. A
Calibration process
The calibration process can be started from within the Biometry or Topography Acquire
window by choosing [Settings] and clicking [Start calibration]. The calibration procedure starts
with the window presenting calibration details and the calibration tool test parameters, as
shown below.

Figure 295. Calibration procedure window

The user is asked to install the calibration tool (the installation procedure is described in
section 21.1 Calibration procedure preparation) and to verify the correctness of the tool
parameters with the values provided displayed in the window. If the values are correct, the
user can start calibration by clicking the [TEST] button. To cancel calibration and close the
window click [Cancel].
Once the calibration begins, information in the window shows the progress of the process.

Figure 296. Calibration procedure in progress

A successful calibration is indicated by Calibration successful message inside the window. From
now on every examination performed on the day of the calibration can be used for IOL
calculations.
If calibration fails, performing biometry examinations is not possible if the IOL Calculator tab
is activated in the system.

320 / 387
SOCT User Manual Version 11.5 rev. A
Entering biometry calibration parameters
Before you start calibration, it is necessary to enter calibration parameters provided with the
calibration tool. To do that go to SETUP/Preferences/Device Setup/Parameters.

Calibration parameters section


(available only if the biometry
module is activated)

Common Biometry and


Topography calibration
checkbox

Figure 297. Entering biometry calibration parameters

Enter the parameters provided with the calibration tool (Length AL and Length ACD) in their
respective fields in the calibration parameters section. If you want to perform a common
calibration for both the Biometry and Topography module, select the Common Biometry and
Topography calibration checkbox. If you leave the checkbox deselected, the system will
perform two separate calibration tests, each for the individual module. To learn more about
common calibration, go to section 21.3.5 Common calibration.

Common calibration
Common calibration allows the user to perform Biometry, Topography and WTW calibration
all in one go. To enable common calibration, go to SETUP/Preferences/Device
Setup/Parameters and select the Common Biometry and Topography calibration checkbox as
shown below. If you leave the checkbox deselected, the common calibration function is off.

Common Biometry and


Topography calibration
checkbox

With common calibration enabled in the Preferences tab, each time a calibration is required,
the system displays the common calibration window presented below.
321 / 387
SOCT User Manual Version 11.5 rev. A
Topography calibration
checkbox

Biometry calibration
checkbox

Figure 298. Common calibration window

To calibrate the Topography and Biometry modules simultaneously, make sure that their
respective checkboxes are selected. If you want to exclude either of the modules from
calibration, deselect its checkbox. The system will then perform calibration of the module
which remains selected.
The window presents the calibration tool parameters. The user is asked to install the
calibration tool and verify the correctness of the tool parameters with the values provided
displayed in the window. If the values are correct, the user can start calibration by clicking the
[TEST] button. To cancel calibration and close the window click [Cancel].

If the Topography checkbox is selected, after clicking [Test], the user is prompted to attach
the Anterior Adapter.

Once the adapter has been installed click [OK] to start calibration. To cancel the process and
close the window click [x].
When Topography calibration is over the user is prompted to remove the Anterior Adapter
and continue with WTW and Biometry calibration.

322 / 387
SOCT User Manual Version 11.5 rev. A
Once the adapter has been removed click [Next] to continue. To cancel the process and close
the window click [x].
You can follow the progress of the calibration in the common calibration window. To stop the
process at any time, click [Cancel].

Figure 299. Common calibration in progress

The result of the calibration is presented in the common calibration result window.

Figure 300. Common calibration result window

323 / 387
SOCT User Manual Version 11.5 rev. A
A successful calibration is indicated by Calibration successful message inside the window. From
now on every examination performed on the day of the calibration can be used for IOL
calculations.
If calibration of any of the Modules fails, performing examinations with the module is not
possible.

324 / 387
SOCT User Manual Version 11.5 rev. A
22 SETUP WINDOW
Setup window is used to set various parameters of SOCT system. In order to enter it, type in a user
and password and select [Setup] button. If you use the software for the first-time new user should
be created in USERS tab.

Select SETUP to
enter

Figure 301. Entering device settings tab.

General
This tab allows the user to enter clinic details, change language or software skin layout.

Language selection
Skin selection
Institution name
name
Enter address Select to load
new logo
Enter contact details

Confirm [OK] or
Cancel changes

Figure 302.General setup window.

On this tab select desired language, select application skin (layout) and type the practice details
and add practice logo. Practice details and logo will be visible on the printout header.

325 / 387
SOCT User Manual Version 11.5 rev. A
Database
Select ‘Database’ tab to be able to access all the tools needed to handle database and set
networking parameters. This is a path to the folder containing database tables (Copernicus.db
file). It can be typed manually or selected using the [Select] button. Connection with remote
database can be tested. Storage of examination data is described below.

Local/remote
database mode
selection Local database
tables location
Press to test Press to select folder
connection selection

Confirm [OK] or
Cancel changes

Figure 303. Database tab.

Select “db” folder


containing the
Copernicus.db file
Choose to confirm
the selection

Figure 304. Selecting database table location.

Information appears in case “db” folder is not present in indicated directory. Make sure you are
selecting right folder. Don’t mark SOCT folder location only.

Figure 305. Example of connection error.


326 / 387
SOCT User Manual Version 11.5 rev. A
This message appears in case of wrong path indication or mistake in folder name

Figure 306. Lack of directory error.

Confirmation of proper connection with database tables file.

Figure 307. Confirmation of proper connection.

Database server address

Database server User

Press to test Server password


connection

Confirm [OK] or
Cancel changes

Figure 308. Remote server connection settings.

Local database – this mode should be selected in case database tables (Copernicus.db) file is
located on SOCT device PC. Storage of examination data can be in different location (HDD or
network location folder).

327 / 387
SOCT User Manual Version 11.5 rev. A
Remote database – mode used when connecting viewing stations to external database (Server
application that is storing data on a server e.g mysql). There is no limit in the number of users
connected to remote database. In that case all software applications also SOCT PC should have
the same settings of host and login to server application.
It is obligatory to enter login and password of the database server software we are connected to.
For more details see chapter 24.1.1 SOCT network.
Simultaneously viewing station PC should have access to Storage locations containing
examination data (all folders should be shared and visible to all users)

Storage
SOCT software allows to locate the database in various combined folders. It is possible to add
more space for data storage if required and just indicate additional folder.

Press [Select] to
indicate exams
Adding storage location
storage folder
after selection
connection

Mark desired location Select to remove


and set as current empty directory
storage place for new
exams connection Moves examinations
from one to another
location

Figure 309. Storage administration tab.

Press desired
folder to select
directory

Press choose
to select

328 / 387
SOCT User Manual Version 11.5 rev. A
Figure 310. Selection of additional storage folder.

SOCT software will display all examinations from indicated folders. Folder marked as “Current”
will be a storage for new examinations taken by the device.
[Move examinations] It allows to move examinations from one location to another. It allows to
moves latest examinations from main HDD to another location and keep high performance of the
system. Click to open a new window and select destination folder to move examinations.
[Recover] It allows to connect the examinations from the existing folder (.opt files) to current
database. Use [Add] storage function to add a new location to existing database.
Note: This function does not copy data from recovered location! Do not remove folder after
recover.
In case of viewing station connections storage locations should be shared in the network. For
details see chapter 24 Network Configuration.

Users accounts
It is possible to login into the system by different operators. This tab allows to manage all SOCT
software users. Here you can add, remove and edit users. It is mandatory to create at least one
user to use the software. First user should have admin rights.
In the [Auto-Logoff time] field, the user can select the time of inactivity after which they will be
automatically logged off to prevent unauthorized access to the software. For example, setting of
30 minutes will mean that if the software is not being used for 30 minutes, it will automatically
log the user out.
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.

Editing selected user

Removing user

Adding new user


Auto-logoff

LDAP configuration
Confirm [OK] or
Cancel changes

329 / 387
SOCT User Manual Version 11.5 rev. A
Figure 311.Users tab.

Enter user login


Enter password

User Name
Retype the password

User rights options


selection Confirm [OK] or
Cancel changes

Figure 312. Users tab. Creating new user.

Creating user accounts


In order to create a new user account, press add new user and the window [Add Account] will pop
up. The required fields in order to successfully create a user are Login, Password, Confirm
Password and Privileges. Real name is not necessary to proceed. When the password is being
typed in, it will show as asterisks, therefore ensure that the password is entered correctly.
Privileges drop-down list allows to set the user rights. It is then possible to search for patient
records by association with users. Software automatically and permanently associates saved scans
with the current user when saving. Each operator can have own default scan parameters and
printouts styles.

• Admin – entitles the user to perform, review and analyze all results. Also, this user is able
to remove and/or edit patient data. It also allows the creation of additional modified user
accounts and management of the application global setup

• Advanced user – entitles the user to perform, review and analyze all results with the
option to export and import examinations

• Operator – entitles the user to perform, review and analyze all results with the option to
export examinations. This user is unable to enter application setup, delete patients, move
patients’ exams, modify patients’ data and import images as well as patient examinations
The last field is a checkbox [Active] which if left unchecked, will disallow the user to login. This is
useful in order to disable specific user accounts for any reason.

330 / 387
SOCT User Manual Version 11.5 rev. A
LDAP Settings

Enable LDAP
Communications List of LDAP users

Connection
settings
Option to edit or
remove users
Adding users

Figure 313 LDAP Settings

A common use of LDAP (Lightweight Directory Access Protocol) is to provide a central account
management to store usernames and passwords. This allows many different applications and
services to connect. It allows the server owner to directly control all users, require periodic
password updates, lock or close accounts that are unused or when necessary and to set a
password difficulty requirement.
[Server] – correctly configured host server address/domain
[Port] – host server port
[Schema] – protocol to be used with a choice of active directory, Apache directory or custom.

In order to correctly setup LDAP, a server address with port must be entered. Logins and
passwords must already be entered within the server in order for the application to fetch any
users. The [Schema] field allows the user to select the query/response protocol to be used by the
software. Users will only be allowed to login if their account exists on the host server.

331 / 387
SOCT User Manual Version 11.5 rev. A
Preferences
The preferences tab allows to customize the device and software settings.

Device connection Entering device setup

Activate CMDL
interface
Results settings

Create Output
protocols

Figure 314. Preferences tab.

Devices
Select the type of the OCT device connected to PC. When the device is selected the device, Setup
is available. If no checkbox is selected the device stays in Offline mode and works as a review
station.

CMDL interface
This application was designed as an independent system to operate the device and to manage
examination and patient data.
Use Command Line Interface from different instances – active CMDL communication. It features
data exchange interfaces with external applications and the EMR systems.
When ‘Use command line interface from different application instances’ checkbox is selected
create a new Output set. After choosing a ‘Yes’ option in ‘Export to EMR’ section system will
automatically name the Output ‘Export to EMR’. User can edit any parameter of the Output set
with the exception of its name. Find more details how to customize out protocol in chapter 22.7.1
Output set window.
The application can be ordered to run various orders (tasks) by external EMR system. All tasks are
queued in the list of Work List when the application operates. The following tasks can be
performed, based on data collected from the data exchange interface:

• Adding patient to one day Worklist

332 / 387
SOCT User Manual Version 11.5 rev. A
• Registering patients in a local database

• Displaying the examination results belonging to a patient

• Preparing to acquire examination or protocols according to received order from EMR

• Exporting output as report or tomogram file to a predefined directory for examination

Receiving worklist is accepted from one active modality. Outputting interfaces are independent
and can be used in parallel.

Interface exchange protocol is available on request. The document allows to your Electronic
Medical Record provider to implement communication protocol. Please contact your local Optopol
Technology representative to receive the communication interface document.

Devices setup
When the device checkbox is marked [Setup] button is available. Press to open device
configuration tabs.

22.5.2.1 Protocols tab


In order to change protocol settings press [Setup] button in Preferences tab. New window screen
will appear. Select Protocol tab. In Protocol tab you can create, edit and delete a set of
examinations. Up to 12 protocols can be registered. Up to 7 scan modes can be registered in a
single protocol set. 6 protocols have been registered in the SOCT by default. These examination
sets can be edited and deleted, but they cannot be returned to their default once they are edited
and deleted.

Change protocols
Protocols list
sequence

Change examination
Scanning programs sequence
list In current
protocol Save or Cancel
changes

333 / 387
SOCT User Manual Version 11.5 rev. A
Figure 315. Protocol editor tab.

[Add protocol] – add new protocol to the list.


[Edit protocol] – allows to edit existing protocol
[Delete protocol] – remove protocol from the list
[Up and down arrow] - Move the position of selected protocol down or up on the list.
Each protocol contains set of examinations. Operator can add or remove examination on the list.
It is possible to change sequence of scan program. Note: Anterior wide scans are always on the
bottom of program list.
[Add] – Add new exam for selected protocol.
[Delete] – Remove examination from protocol.
[Save] – Save changes in protocol
Exam setting parameters (scan width, No. of A-scan, No of B-scan) are the same as settings in
Acquire window.
There is a possibility to add Fundus Image to the protocols.

22.5.2.2 Creating New Protocol


1. Click [Add Protocol], a new window appears, type a protocol name there.
2. Input the name of the protocol and press [OK] button to register the protocol.
3. Select the scan program from the Program list box and then click [Add].
4. The selected scan program name appears on the Program list.
5. To add another scan program, repeat the step as described in point 3.
To change the display order of protocols or tomogram on the list, select desired item and then
click [Up arrow] or [Down arrow].
Note: Scan programs with Anterior Adapter are always on the bottom position of the Program list.
When operator acquires tomogram using the Protocol in Full Auto mode the system executes
all programs from the protocol one by one automatically.

22.5.2.3 Editing a Protocol


Use the Protocol management screen to edit the Protocol, add and delete a scan program, or
change the order of scan modes to be executed.
334 / 387
SOCT User Manual Version 11.5 rev. A
1. Select a Protocol, and then click [Edit] to change the name.
2. On the Program list you can add scan program by selecting desired scan program from the list
box and pressing [Add] button.
3. To delete the scan program from the protocol: select Protocol, on the Programs list select the
scan program you want to remove and click [Delete].
4. To delete the protocol, select desired Protocol from the Protocol list and click [Delete Protocol].
5. To change the display order of Protocols or scan program, select desired item on the list, and
then click [Up arrow] or [Down arrow].

Parameters tab

In order to change parameters, press [Setup] button in Preferences tab.

Entering device
setup
Device selection

Anonymization settings

Input settings
Activate CMDL interface Visual Field settings

Results settings

Create Output protocols

Figure 316. Preference tab.

‘Default eye to exam’ – set the initial position of the scanning head. The scanning head moves to
the eye which will be examined for new patient. When Latest scanned is selected unit does not
move from previous examination position.
‘Working position’ – change to Opposite if the patient and operator working positions are face to
face. In this mode direction Left/Right movement is changed.
‘Load program’ – allows to select first loaded scan program when opening Acquire tab. When
‘Protocol’ is selected, the first protocol from the list is loaded.
‘Primary OCT Angiography’ - allows to use an original when checked or enhances the Angio
algorithms when unchecked.

335 / 387
SOCT User Manual Version 11.5 rev. A
Switch on/off the Angio
Change default eye to Algorithm
exam
Set photo retake delay
Change working position
Switch the color photo
compression

Set the color photo balance


Set the default
examination program

Figure 317. Parameters tab.

Voice messages.

In order to change voice settings press [Setup] button in Preferences tab.


'Voice message' tab contains options enabling customization of voice guide support or disabling
it.

Marked checkbox
activates voice
guidance

Performed action
during examination

Save or Cancel
changes

Figure 318. Voice messages settings

The system uses synthesized sentences to assist the patient during alignment and acquiring
examination process. User can decide to customize the playing sound when device is working on
fully auto mode (alignment with automatic acquiring data) or when operator decides to press
[START] to optimize the signal and acquire examination by pressing [Acquire] button.
Auto – When ‘Auto Acquire’ function is checked.
Manual – When ‘Auto Acquire’ in unchecked.

336 / 387
SOCT User Manual Version 11.5 rev. A
Uncheck field to disable playing sound in situations described below. The system plays the
following sentences:
Placing a patient head Sound “Please, place the head on the chinrest and blink freely”
when Acquire tab is open. Sound plays once per Acquire session.
Informing about fixation Sound “Please look at the center of the green cross and blink freely.”
– when operator presses the [Start] button and objective lens is
coming on the front of the eye. Sound plays once for selected eye.
Start of scanning Voice message “Please blink than keep your eyes open“ is played
before starting the acquisition of the examination.
Delay The time period counted from the end of playing the sound to the
start of acquisition of examination. When it has negative value
scanning starts before end of message.
Ending of scanning “Thank you, you can blink freely” – when system finishes acquiring
examination.
Shifting fixation for a disc Sound “Follow the green cross” – when system is changing fixation
target during disc examination.

Note: Language of voice guide can be changed on the Acquire tab.

Results settings

In order to change results, display settings press [Results] button in Preferences tab.

Figure 319. Results review settings tabs.

Review tab
Eye identifier – R/L or OS/OD can be selected
Map interpolation – it selects method of how interpolated areas are presented on the maps.
Semitransparent, dashed, regular or none can be selected
Remove background – allows the operator to enable or disable fundus mask display.
337 / 387
SOCT User Manual Version 11.5 rev. A
Color balance – enables selection of the color balance used for Fundus Photos.

Analysis tab
NFL Ring diameter – It sets default ring diameter on RNFL map to calculate TSNIT plot
NFL Ring thickness - It sets default ring thickness on RNFL map to calculate TSNIT plot
Cup offset - It defines default value to calculate cup and rim parameters.
NFL zones - Allows the operator to decide which NFL zones are presented. 10/4 or
12/4 can be selected. 12/4 is the default selection. Due to the different
analyzed areas change of selection affects the displayed results.
User IOL refraction index – Type refraction index of used IOL lens. The parameters will be used to
IOL lens thickness calculation.

Retina thickness – define measured retina thickness definition. Select the one from available
retina thickness measurement definition.
Select the RNFL thickness profile graph - TSNIT or NSTIN methods are available.
Topography
Keratometry - It sets the default topography summary table (SimK; Meridians; Semimeridians)
K presentation - It sets the default method of displaying values in the tables (K1/K2 or K steep/K flat)
K diameter - It defines the diameter values for SimK calculation (ø center of ring 2.5mm +/-0,5
mm thick ring or center ø3.0 thick ring mm)
Show sign of astigmatism - Yes or No can be selected. Allows the operator to decide which
standard is used.
Astigmatism Axis - K flat/K1 or K steep/K2 can be selected. Allows the operator to
decide how astigmatism axis is displayed.

Anonymization
In order to configure the anonymization press [Anonymization] in the Setup/Preferences tab.
Pressing [Anonymization] initiates the Anonymization settings window where the user can adjust
the settings for the anonymization of personal information when outputting data. You can set the
anonymization function for personal data and the items to be anonymized while printing,
exporting data, saving images or text files.
338 / 387
SOCT User Manual Version 11.5 rev. A
Figure 320. Anonymization settings window.

The Annonymization settings window has two main fields: Anonymization data and
Anonymization object.
The user can select which information will be anonymized and choose the method of
anonymization.

• Patient ID – Replace by/ Encrypt/Random

• Patient Name – Replace by/ Encrypt/Random

• Birth Date – Replace by/ Encrypt/Random

• Gender – removed when checked

• Ethnic grout – removed when checked

• Disease – removed when checked

• Remarks – removed when checked

Anonymization methods:

• Replace by - replaces the information with a specified text string typed in the type box.
The text field is active. The user can enter the text string in the field.

• Encrypt - information is always coded in same way (using only letters and numbers).

• Random - information is converted randomly (using only letters and numbers).

• Replace by YYYY-MM-01' - only the day of birth is changed to 01.

339 / 387
SOCT User Manual Version 11.5 rev. A
• Remove when checked - information is removed

The user can select anonymization action for Print, Save as…, Export, Save txt.

Print

• Disable

• Enable data on the printout header anonymized as defined in anonymization data

• On request - displays a new position on the list box


Anonymization affects Print and multi B-scan print.

Save as...

• Disable

• Enable

• On request - displays "save anonymized as..." in the RMB context menu below Export in all
menus when export is available
In this situation the system does not include personal information in the name of the file.
The system saves the item without the personal information of the selected patient.

Export:

• Disable

• Enable

• On request - displays "Export anonymized" in RMB context menu below “Export in all
menus” when export is available

Save as...

• Disable

• Enable

340 / 387
SOCT User Manual Version 11.5 rev. A
• On request - displays ""save anonymized as..."" in RMB context menu below “Export in all
menus” when export is available
In this situation the system does not include personal information in the name of the file. The
system saves the item without information concerning the selected patient.
Text files (saving numerical data from Topography Table, Biometry Table, and in the future also
form maps and as an output).

• Disable

• Enable

Output.
Each output can have the anonymization function enabled or disabled. By default, it is disabled
(unchecked). The settings for output are taken from the anonymization tab.
For example, if the output is set to printout – the system anonymizes the information and method
according to 'Anonymization data' group.
For more details go to chapter 22.7.2 Creating an Output set.

Visual Field
The configuration with the PTS database is done by pressing [Visual Field] in the
Setup\Preferences tab.
The system displays the Visual Field window where the user adjusts the settings necessary for the
configuration of data transfer between the PTS software and SOCT.

PTS communication Auto-search

Press for manual searching


PTS directory
PTS database
Use an account

Remote host

Database name

Figure 321 Visual Field settings window

341 / 387
SOCT User Manual Version 11.5 rev. A
1. PTS communication - checking this field activates the other VF settings fields, the
COMBINED tab, and the PTS-SOCT data transfer mechanism.
2. Auto-search - on clicking this field the application searches the system registry for an
instance of the PTS software. If it is found, the field [PTS folder] is filled automatically
and the [Database name] is derived from the PTS application settings located in the [PTS
folder].
3. PTS directory – location of the Use an account folder - checking this field activates with
the PTS.exe file.
4. Settings for the PTS user account. Checking the field is necessary if the PTS software is
configured with user accounts. Otherwise, the access to the PTS result database will not
be granted. If that is the case the user must enter the Username and Password.
5. Remote host - checking this field activates the remaining two settings of the PTS
database. If the application is to transfer VF data from an external database (not
localhost), the user should check this field and configure [Host name] and [Port].
6. Database name – location of the folder with the PTS database.

Input settings window

Patient ID

Prefix
Suffix

Verify Patient ID according to


PESEL
Disease list

Figure 322 Input settings window

Patient ID - mandatory, standard or disable


Suffix - standard or disable
Prefix - standard or disable
Verify Patient ID according to - checks the compatibility of entered data with the PESEL system i.e.
whether the date of birth has been entered correctly.
Disease list - allows to create a diseases list. The user can set and manage the disease list. The
disease list can be enabled on the patient registering screen. The user can select a disease from
the examination list.

342 / 387
SOCT User Manual Version 11.5 rev. A
Add new record
Insert new disease

Disease list

Delete record

Figure 323. Disease list window

Edit disease list window


On the Output screen, perform the settings to output the examination data. Up to 10 output
destinations can be registered. When the output destination is created a list appears on the left
side of the screen.

Output settings
Output set window
This section describes how to create, modify and remove sets of outputted data.

Figure 324 Output set window

[Add] – Press to create a new output set


[Edit] – Press to Edit currently existing set
[Delete] – Remove existing set
[Up and down arrow] - Move the position of selected output set down or up on the list.
Arrows - Change sequence position of desired set on the list
343 / 387
SOCT User Manual Version 11.5 rev. A
Exporting tomograms with or without AI DeNoise
The user can decide if the tomograms are exported with the AI DeNoise function on or off.
To determine the export manner go to Setup → Preferences → Output Settings. In the output
configuration window find the Image Denoise section. Click on the drop-down menu in that
section to unfold it. Choose AI DeNoise if you wish to export tomograms denoised or click No AI
DeNoise to export tomograms with the denoise function off.
The choice between the two export manners is always there regardless of the selected output
type (DICOM, JPG, BMP).

Figure 325. AI DeNoise export settings

CAUTION Keep in mind that tomograms with very low signal level or low QI might degrade
the performance of the AI DeNoise algorithm, potentially leading to an altered image. If
you use such tomograms always make sure the exported denoised images are identical
with the original unprocessed images

Creating an Output set


Output configuration window has two views. One view for DICOM storage configuration and the
other for different file types.

Graphic file standard


Outputted data can be viewed in standard graphic file.

344 / 387
SOCT User Manual Version 11.5 rev. A
Figure 326. Output configuration screen.

Name Input the Output set name


Output content Tomogram, Series of tomogram and Report is available
Output type Select from one of graphic standard file .jpg, .png, .bmp, .pdf and .avi for
tomograms series.
Add fundus image Reference fundus reconstruction image will be added on the side of
tomogram object.
Output folder location to save data. It can be local or network location.
Folder creation Saved files can be placed automatically in the folder. Folder name is a date
of preparing report (Output Date folder) or examination date (Study Date
folder).
Automatic output Select the moment when system data can be output.
When printing System output data when operator initiate printing the report.
After capture This option is available for tomogram/s only.
The output destinations are used to send DICOM with network or write result to
DICOM/JPEG/BMP/PDF/Movie in a specified location (local or network).
Anonymization – by default it is disabled. Anonymization can be enabled or disabled for each
output file.

345 / 387
SOCT User Manual Version 11.5 rev. A
Numeric Values output set

Name Input the Output set name


Output content Numeric Values
Output type CSV
Output folder Location for saving data. It can be a local or a network location.
Exported in Data can be saved in a Single file or in one Batch file for one type of
examination.
Separator Select type of data`s separator
Anonymization – by default it is disabled. Anonymization can be enabled or disabled for each
output file.

346 / 387
SOCT User Manual Version 11.5 rev. A
DICOM C-storage output set

Figure 327. DICOM output configuration screen.

Name Input the Output set name.


Output content Tomogram, Report + tomogram, Series of tomograms and Report,
Series of tomograms + Fundus photography examinations, Fundus
photo, tomograms from – are available
Output type DICOM file – it can be saved in any location
DICOM Network.
Add fundus image On the side of tomograms reference fundus reconstruction
Image will be added.
Host Name Enter the host name or the IP address (IPv4).
Port Number Enter the port number.
Server AE Title Enter the server AE title. Be sure to input the value.
SOP Instance UID Fixed or Unfixed SOP Instance UID is available.
SOP class Select an SOP class for the model to be configured.
Secondary Capture Encapsulated PDF Storage,
Multiframe True Color Secondary Capture Image Storage,
Multiframe Gray Scale 8bit Secondary Capture Image Storage,
Ophthalmic Tomography Image Storage, Fundus Image Storage
Specific Character Set Select the specific character set. Default Unicode.
Image Compression No compression is available.
Automatic output Select the moment when system data can be output.

347 / 387
SOCT User Manual Version 11.5 rev. A
When printing System output data when operator initiates printing the report.
No User must press Output and select desired set.
[Connection check] Check the connection with DICOM server.
Anonymization Disabled by default. Anonymization can be enabled or disabled for
each specific output file

Backup
Database and examinations backup can be performed on external HDD or in network server
location.

Backup folder Press to indicate


directory backup folder

Backup type selection Activate Auto Backup


full/incremental

Enable prefix for


backup files

Figure 328. Backup tab.

Manual backup options:


Full backup - complete database will be saved as a spare copy.
Incremental - only new exams are added to previously archived with this method.

Automatic backup options:


Auto Backup – Activates automatic backup process.
- On close or on start – it decides when the SOCT application starts backup.
- Incremental or full backup – types of backup.

Backup reminder – When backup is not performed, the system displays backup reminder after
specified period of time.
Add prefix to backup files – When backup is performed, files will have a prefix added for the user
to easily distinguish an original file from a backup.

WARNING: Make sure there is enough free space on HDD/remote folder before performing
backup process.

348 / 387
SOCT User Manual Version 11.5 rev. A
In case this window appears please select backup folder location. Or check external HDD
connection.

Figure 329. Backup error example.

Recovery
The SOCT provides an option for a data recovery from the internal and external storage.

Recovery folder
directory

Press to indicate
Select if you want the recovery folder
software automatically add
new patients with different
birth date or ID

Press to start recovery

Click if you want to recovery


database from software 6.1
or earlier

Figure 330. DICOM tab.

Database recovery from software 6.1 or earlier - after pressing the Select button, an additional
window opens, allowing selection of the folder from which the database will be imported. Before
it is done, the function checks the list of patients for any Patient ID conflicts (this field in version
6.1 was not unique). If the conflicts occur, the program adds a random string sign to the Patient
ID field. When all the conflicts are solved it imports ale examinations to the database.

DICOM
DICOM Interface consists of two client modules (SCU):
- Result Storage (Reports, Tomograms)

349 / 387
SOCT User Manual Version 11.5 rev. A
- Modality Work List
DICOM client modules are based on communication with service providers (SCP hosts) within LAN
TCP/IP. DICOM identifies the application based on unique ID (AE Title) and TCP/ID address. AE Title
and TCP/ID address should be saved in the application settings and in all SCP

Figure 331. DICOM tab.

System settings

Figure 332. System settings window.

AE title Enter the server AE title. This is obligatory value


Station Name Input the station name.
Location Input the location.
Institutional Department Name Input the institutional department name. This is obligatory
value
Institution Name Input the institution name. This is an obligatory value

350 / 387
SOCT User Manual Version 11.5 rev. A
MWL settings

The module communicates with the Modality Work List whose ID (AE Title) and TCP/IP address
can be configured in MWL screen settings.
The Modality Work List client module collects demographic data of patients registered for tests
from an external Modality Work List. Orders are created from the patient data which, together
with orders from other data exchange systems, are added to the Work Manager list.
When the MWL settings is selected a new window will appear.

Figure 333. MWL Interface Settings.

MWL Communication enable Activate Work list. When selected the application will monitor the
work list on the configured host on a continuous basis. Order records are created from the
identified patient data, and are added to the Work Manager list.
Host Name Enter the Host name
Port Number Enter the port number.
Server AE Title Enter the server AE title. Be sure to input the value.
Specific Character Set Select the specific character set.
Maximum number of worklist Maximum length of worklist.
Search Worklist by Retrieve the records from the Worklist sort by AE Title,
Modality, Station name, Location.
[Connection check] Check the connection with DICOM server. After you check
the communication and compatibility of the settings, you will

351 / 387
SOCT User Manual Version 11.5 rev. A
see a message indicating successful completion of the order,
or a list of errors

NOTE: Make sure that the SCP host delivering patients’ demographic data for tests is
correctly configured and active. Otherwise collecting data will fail.

C-storage

Examination results can be sent to DICOM network or DICOM file.


SOCT saves files in standard: Encapsulated PDF Storage, Multiframe True Color Secondary Capture
Image Storage, Multiframe Gray Scale 8bit Secondary Capture Image Storage, Ophthalmic
Tomography Image Storage
System can output in DICOM format: Tomogram, Series of tomograms, Series of tomograms +
report, Report.
Series of tomograms + Fundus photography examinations can be exported to DICOM.
See details in DICOM statement in file “SOCT DICOM Conformance Statement.pdf”
Detailed explanation how to configure DICOM storage can be found in chapter 22.7.4 DICOM C-
storage output set.

Info tab
Information label

Figure 334. Information label

352 / 387
SOCT User Manual Version 11.5 rev. A
Patient record change traceability and LogReader software
The LogReader.exe is located in the SOCT application directory. Only users with Admin rights can
log in the LogReader tool. Each login to the SOCT application and patient data modification is
recorded in a Log file. This application will allow the administrator to have a recorded history of
any changes and logins made by all users. For more information please contact your local
distributor.

23 MAINTENANCE AND CLEANING PROCEDURE


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.

NOTE: It is not allowed to make any modifications of the SOCT.

During the whole period of use, SOCT does not need any special maintenance procedures. The
outside surfaces of device should be kept tidy and free of dust and cleaned using mild cleaning
solutions.
Take care not to get water or any other liquid inside the device. For hygienic reasons, after each
examination the chinrest and forehead support should be disinfected.

Routine Cleaning
a) Cleaning of the device casing and equipment of the ME System (PC, monitor LCD, printer,
keyboard and mouse PC)
Clean the casing with soft cloth. Use only cleaners dedicated for cleaning of electronic
equipment. Clean periodically or when needed.
b) Cleaning of the applied parts (forehead and chinrest support)
The applied parts should be disinfected after examination of each and every patient. Use
soft cloth, wet with alcohol-free solution for cleaning and disinfection of alcohol-sensitive
medical-equipment surfaces or alcohol-free wipes for disinfecting of alcohol sensitive
medical-equipment surfaces.
The applied parts are to be disinfected also after longer period of no use.
353 / 387
SOCT User Manual Version 11.5 rev. A
c) Cleaning of the lens
The lens should be cleaned sporadically, when contamination of lens surface is observable.
For lens cleaning, use only cleaners applied in optics, that do not cause scratching of the
lens. Clean the lens softly with little force. It comes with a lens cap to cover it when not in
use. You should clean it to remove dust and oily smudges sporadically to ensure true
tomogram images are obtained. You may use an alcohol prep swab or cotton swab dipped
in isopropyl alcohol. Wipe dry with a soft, non-lining cloth or tissue.
d) Dust Prevention: When not using the SOCT, make sure the cloth dust cover is placed over
the unit.

NOTE: Periodically one has to check if there are no mechanical damages to the device,
damages to any of the cables and fuses.

Software maintenance activities


To keep software in good condition user should perform below activities as minimum:
1. Windows automatic updates should be checked periodically at least once a month. In
order to do the update: Enable automatic updates, wait until system finishes the update
process. During the process do not acquire examination. Once the system finishes the
update process, disable automatic updates.
2. If it is not possible to have automatic updates turned on (for security reasons or internet
availability), system administrator should manually keep operating system updated.
System administrator should check regularly for new updates at least once a month.
3. Installed antivirus software should be updated at least once a week.
4. For OPTOPOL's software upgrades and patches OPTOPOL will inform users through its
distributors.

Hard Disk Defragmentation


Defragmentation of the OCT PC hard disk becomes necessary when you delete, analyze old scans
regularly. The process of recalculation, deleting data and then writing again to the hard disk
fragments the hard drive, which degrades system performance over time. To maintain peak
performance, we recommend that you defragment the hard disk regularly.

NOTE: Since hard disk defragmentation usually requires several hours to complete, we
recommend that you start defragmentation at the end of the day and let the process

354 / 387
SOCT User Manual Version 11.5 rev. A
run overnight. If defragmentation is not complete in the morning, it does no harm to
stop defragmentation and continue using the instrument.

To defragment the hard drive, follow these steps:


1. Close the SOCT software.
2. Click Windows Start > Programs > Accessories > System Tools > Disk Defragmenter. The
Select Drive dialog appears.
3. Select the desired drive e.g. D: and click OK to begin defragmentation.

Ordering consumables
When ordering consumables and spare parts, contact your local dealer and tell them the article
name, article code and quantity.

Article name: Article code: Description:


Single use chinrest labels R C003P

Fuses (applicable to REVO FC R B006P 2 x F 4 A H 250V


models)
Fuses R018 2 x F 3,15 A L 250 V
Dust cover R C005P
R C005 FC

External fixation with LED R024F


(interchangeable)
USB 3.0 cable R035

Lens cover R037

Anterior Adapter R036


(interchangeable)

USB Flash drive with the SOCT R042


software, drivers and the User
manual
355 / 387
SOCT User Manual Version 11.5 rev. A
356 / 387
SOCT User Manual Version 11.5 rev. A
Fuse
Blown fuses exchange

If the device does not work when the power is on, the possible reason is a blown fuse.
IMPORTANT: Before exchanging the fuses, make sure that there are no other visible
reasons causing the device not to work (broken cables, not connected cables, etc.).
Before exchanging the fuses, turn the device off and unplug it from power supply socket.

The fuses are located in the power supply socket at the back of the device. In order to
replace the fuses, unplug the power supply cable, press the small plastic lever and pull
the fuses casing.

357 / 387
SOCT User Manual Version 11.5 rev. A
24 NETWORK CONFIGURATION
Networking configuration procedure is described in the Installation Manual provided on the USB
Installation Disc.

Network connection configuration


SOCT network
SOCT software allows to locate examination data on external network locations or HDD. Besides
that, it is possible to share the database table from SOCT device PC. There is unlimited number of
PCs connected to the same LAN which have access to SOCT database. All applications connected
to server database should have the same settings in setup database tab (SOCT device software,
viewing stations). Efficiency of work is limited by network structure and PC performance (OS
Windows required). It is recommended to use minimum 1000 Mbps network structure. There is
no additional synchronization button, this mechanism is done in the background.
Server application (e.g. MySQL, firebird) can also be installed on SOCT PC, in that case it will have
to be on to share the database with viewing stations.

NOTE: Database tables storage has to be done with a use of server software e.g. MySQL.

SOCT database
SERVER/HDD
tables stored in
location Data 2 Data 3
ClientServer
1 application

Data 1

Client n-1

Data 1,2,3- examination


Viewing stations results

Client n
Figure 335. Networking possibilities scheme.

Networking functionality restrictions

358 / 387
SOCT User Manual Version 11.5 rev. A
When software is configured as Client, there are some limitations applied to its functionality:
- Only client connected to OCT device can perform new examinations.
- In case specific patient’s file is used on any PC connected to database, there is no possibility
to access this patient’s data from any other PC. ‘Selected patient is occupied by another
user’ message is displayed. It means it is not possible to edit, review, perform, remove,
analyze, import, export patients on more than one PC at that same time.
- Users’ accounts modification and settings can be changed from any software application
connected to database on Server.
- All viewing stations need to have access to examination data folders (sharing enabled)
- The sleep mode option on the review station's Windows system should be disabled. If the
computer enters sleep mode, communication with the SOCT application is lost. Using the
SOCT application after starting up the review station requires restarting the application.

NOTE: Internal network settings should be adjusted by IT personnel to provide free


access and communication between folders. Be aware of firewall exceptions for
SOCT software

NOTE: When sharing database with viewing stations it is mandatory to share data
folders in the network and allow other users read/write rights.

SOCT software - viewing station configuration


1. In order to configure database client, you need to install SOCT Software on each PC
you want to use as a viewing station. You can find SOCT Software on the installation
disc. To install it, run setup.exe and follow instruction on the screen.
2. Go to Start/Control Panel/Network and Internet/Network and Sharing
Centre/Advance sharing settings and select:
- Turn on network discovery
- Turn on file and printer sharing
Accept and Save Changes.
3. Verify the type of database engine you want to use.
4. Before starting the software
For Firebird copy “fbclient.dll” file from C:\Program Files\Firebird\Firebird_3_0 and paste
it to SOCT installation folder: C:\Program Files\Optopol\SOCT 7.1.0.

359 / 387
SOCT User Manual Version 11.5 rev. A
In Case of using MySQL copy ‘libmysql.dll’ from folder where MySQL is installed
C:\Program files\MySQL
5. On the review station run SOCT software. Press LOGIN without entering any user
details. Go to below window and select Connect to existing database.

Figure 336. Window after login to new system.

6. Type name of the computer in the network group or IP address. Enter login and
password for MySQL database.

Database PC address

Remote database User

Confirm [OK] or
Cancel changes

Figure 337.Remote database configuration.

Engine – Select type of the database engine (MySQL or Firebird)


Address - here enter IP number or Host name of remote server application that is used as a storage
for database tables.
Login – enter username of the remote server software (e.g. MySQL)
Password – enter password to remote database software

NOTE: Server application location has to be active to share the database.

360 / 387
SOCT User Manual Version 11.5 rev. A
7. Restart SOCT Software.
8. The next time you start the software, the system will connect to remote database.

361 / 387
SOCT User Manual Version 11.5 rev. A
25 REMOTE CONNECTION
PTS application for Structure & Function report
To configure the PTS application for remote communication with the application database, follow
these steps:

• On the computer with the remote database (the host) run the PTS application, go to the

settings page by clicking on the settings button (the cogwheel button ) and choose
the Users tab.

• Add a user in the Users Manager window. To do that click the Add new user button, fill
the User name and Password fields and add the Administrator privileges in the Role field.

• Click the Save button to save the changes.

Login

Password

Privileges

Figure 338.Users tab in PTS application.

• On the computer with the SOCT application run the PTS application, go to the Database
tab. In the Database settings window mark the Remote database option and fill the Host
name field by entering the name or the IP address of the remote server, the Port field by
entering the port of the remote server, the Username and Password fields, and the path
for the Database in the Database path field.

• Click the Save button to save the changes.

362 / 387
SOCT User Manual Version 11.5 rev. A
Remote database
option

Host name

Port of the remote


server

User name and


password fields

Figure 339.Database tab in PTS application.

On the computer with the remote database (the host) and on the computer with the SOCT
application (the client) it is necessary to enable ports 3051 and 8100 by entering the following
commands in the command line:
netsh advfirewall firewall add rule name="Perimeter Firebird 3051 in" dir=in action=allow
protocol=TCP localport=3051
netsh advfirewall firewall add rule name="Perimeter Firebird 3051 out" dir=out action=allow
protocol=TCP localport=3051
netsh advfirewall firewall add rule name="Perimeter Firebird 8100 in" dir=in action=allow
protocol=TCP localport=8100
netsh advfirewall firewall add rule name="Perimeter Firebird 8100 out" dir=out action=allow
protocol=TCP localport=8100
If a Firewall and/or antivirus program is installed, it may be necessary to manually unblock ports
3051 and 8100 in these programs.

Configuration of a remote connection with the database in the SOCT application


In order to configure the SOCT application for a remote connection with the PTS software
database, follow these steps:

• Run the SOCT application, enter the login data and go to the application configuration
option by clicking the Setup button.
363 / 387
SOCT User Manual Version 11.5 rev. A
• Go to the Preferences tab (the default tab) and click the Visual field button.

Visual field button

Figure 340.Preferemce tab in SETUP SOCT application.

• In the Visual field window check the Use PTS communication option and click the Auto-
search button. An installation of the PTS application version 3.4.0 or higher is required.
The PTS folder and Database text boxes should now be updated. If this does not happen,
it is possible to fill these fields manually by choosing the path for the PTS installation folder
(the folder with the PTS.exe file) in the PTS folder text box by clicking the Select button.

• Check the Use an account option and enter the user name and the password for the PTS
application database in the Username and Password fields.

• In the case of a remote connection, check the Remote host option and enter the IP of the
database server and the port in the Host name and Port fields.

• Click the Save button to save the changes.

364 / 387
SOCT User Manual Version 11.5 rev. A
PTS communication
option

Auto-search button option

Use an account option

User name and the


password for the PTS
application

Remote host option and


the Host name and Port
fields

Figure 341. Visual field window in SOCT application.

365 / 387
SOCT User Manual Version 11.5 rev. A
26 ENVIRONMENTAL CONDITIONS
ENVIRONMENTAL CONDITIONS OF USE:

CRITERION ENVIRONMENTAL CONDITIONS


Temperature + 10 °C to + 35 °C
Relative humidity 30 % to 75 %
Atmospheric pressure 800 hPa to 1060 hPa
Dust on the air No visible particles

STORAGE CONDITIONS:

CRITERION ENVIRONMENTAL CONDITIONS


Temperature -10 °C to + 55 °C
Relative humidity 10 % to 95 %
Atmospheric pressure 700 hPa to 1060 hPa

TRANSPORT CONDITIONS:

CRITERION ENVIRONMENTAL CONDITIONS


Temperature -10 °C to + 55 °C
Relative humidity 10 % to 95 %
Atmospheric pressure 500 hPa to 1060 hPa
Shock 30 g, duration 6 ms
Bump 10 g, duration 6 ms
Patient Environment
The patient environment where the patient/examiner may contact the equipment (including the
connected devices) or where the patient/examiner may contact the person who touches the
equipment (including the connected devices).
The SOCT with the optional power table requires an area at least (1,5 m by 2,4 m) for installation
and patient comfort during use.
Measurement Units

366 / 387
SOCT User Manual Version 11.5 rev. A
All units on the SOCT are measured in the SI format. Unless otherwise noted, measurements are
made in micrometers.

367 / 387
SOCT User Manual Version 11.5 rev. A
27 WARRANTY AND SERVICE
In case of problems contact your local distributor:

On request the supplier will make available circuit diagrams, components part lists, descriptions,
calibration instructions, or other information which will assist the user’s appropriately qualified
technical personnel to repair those parts of equipment which are designated by the manufacturer
as repairable.
Service life
The service life of this product is ten years if specified inspections and maintenance are
performed.
About repairs
If a problem cannot be solved even after taking the measures indicated in “Chapter 29
TROUBLESHOOTING” contact OPTOPOL distributor for repairs.

When requesting repair, please provide the following information:


Full Name of the device and Serial Number: number on the rating label.
Description of malfunction: Report as much detail as possible.

28 UTILIZATION
After usage period is over, contact your distributor for utilization instructions.

Maximum lifetime of device – 10 years since date of manufacture.

368 / 387
SOCT User Manual Version 11.5 rev. A
29 TROUBLESHOOTING
Q1: The tomogram images have good quality,
but there is a shadow at horizontal
tomogram image (left image) on the left
or right edge and the image is diagonal.

A1: The scanning beam is not centered on


the pupil in the horizontal direction. This effect is observed mostly for very small pupils
and wide scanning ranges. Grab and move the tomogram to left or right to obtain the best
image quality.

Q2: The tomogram images have good quality, but the horizontal retina cross section image is
diagonal.
A2: See A1

Q3: The tomogram images have good


quality, but there is shadow at
vertical tomogram image (right
image) on the left or right edge and
image is diagonal.

A3: The scanning beam is not centered on the pupil in the vertical direction. This effect is
observed mostly for very small pupils and wide scanning ranges. Grab and move slightly
tomogram (in this case in right direction) on Vertical window right to obtain equal image
saturation.

Q4: The tomogram images have good quality, but the vertical tomogram image (right image) is
diagonal.

A4: See A3
369 / 387
SOCT User Manual Version 11.5 rev. A
Q5: Live tomogram images are visible, but the image
is fuzzy and upside down.

A5: This means the C-gate position is too far from optimal position. Move the C-gate position
(scroll or grab) closer to the patient. The retina cross section image will go down on the
window and then up again in a straight orientation.

Q6: After starting the software communication errors are displayed.

A6: Make sure that the scanning head finished self-test before you run the application.

Q7: Software displays massage “No signal detected”.

A7: Run the “Skantest_lt” (START/ALL PROGRAMS/SOCT/Skantest_lt) application [Open]


communication and run [STRAT] calibration procedure.

Q8: The tomograms images have bad quality.

A8: 1. Check cleanliness of the objective lens. Clean it if necessary. If it is not changed go to
point 2. Make sure that system calibrates itself before the first examination.

Q9. The SOCT application is connected with the device but I get error messages when I open the
Acquire tab or during work in Acquire tab.
A9. If Fast Speed USB 3.0 Connection is not available in the system, Aviva camera is not able to
work in required mode. Verify points below:
1. Make sure that SOCT USB cable is connected to 3.0 USB port
2. Verify if the USB cable is protected from any unintentional tension, movement or push.
Protect physically USB plug from any loose.

370 / 387
SOCT User Manual Version 11.5 rev. A
3. Unplug and plug again the USB cable. Make sure there is no play (slack) on the port. Wait
a while until system recognizes the devices again.
4. Verify if the system has properly installed Universal Serial Bus controller 3.0 hub Start-
>Control panel->System->Device manager->Universal Serial Bus controller.
5. Verify if the system has properly installed all devices Control panel->System->Device
manager. There should not be any exclamation sign.

Q10: During Acquisition of tomograms OCT live windows become black.


A10: See the status of the device in left bottom corner of the OCT image. In case of error restart
application. If the problems occur again see A9.

Q11: I have no connection to remote database.


A11: Verify procedure of connection according to user manual again. Make sure network settings
are proper. Verify if Host name /IP is properly entered in all software applications connected to
server.

Q12: The analyze window is displayed only in a quarter of the screen.

A12: Verify the screen and Windows resolution. Go to Control Panel=>Appearance and
Personalization=>Display and select “Larger – 150%”

30 LIST OF FIGURES
Figure 1. Devices with reference numbers 155 and 156 ................................................................ 44
Figure 2. Devices with reference numbers 190, 191, 192 and 193 ................................................ 45
Figure 3. Rear panel of the REF 155 and 156 series device ........................................................... 46
Figure 4. Rear panel of the REF 190, 191 and 192 series device.................................................... 46

371 / 387
SOCT User Manual Version 11.5 rev. A
Figure 5 Electrical connection scheme ........................................................................................... 48
Figure 6. The chassis (front and side), applied parts and external fixation ................................... 49
Figure 7. The chassis (front and side), applied parts and external fixation ................................... 49
Figure 8. Login screen ..................................................................................................................... 51
Figure 9. Patient tab ....................................................................................................................... 52
Figure 10. Patient list ...................................................................................................................... 53
Figure 11. Patient edit screen ....................................................................................................... 54
Figure 12. Examination list ............................................................................................................. 55
Figure 13. Filter panel .................................................................................................................... 57
Figure 14.Examination window view for REVO nx 130 / SOCT COPERNICUS REVO/ SOCT
COPERNICUS / REVO 60/REVO 80 .................................................................................................. 59
Figure 15. Examination window view for REVO FC 130 and REVO FC * ......................................... 60
Figure 16. Protocol selection tab.................................................................................................... 68
Figure 17. Device movement controls............................................................................................ 69
Figure 18. Movement control buttons. .......................................................................................... 70
Figure 19.Device aligns to the place of clicking on the preview .................................................... 70
Figure 20. Properly aligned measurement head position .............................................................. 71
Figure 21 IR mode acquire window ................................................................................................ 72
Figure 22. IR preview window context menu ................................................................................. 72
Figure 23. IR preview window display options with the Enhance mode OFF and ON. .................. 72
Figure 24. Fixation target selection ................................................................................................ 75
Figure 25. OCT examination settings panel .................................................................................... 75
Figure 26. OCT + Photo examination settings panel ..................................................................... 76
Figure 27. Fundus Camera mode examination settings panel ....................................................... 76
Figure 28. Tomogram preview images, manual position adjustment ............................................ 78
Figure 29 3D Scan Acceptance Window ......................................................................................... 80
Figure 30 Angio Scan Acceptance Window .................................................................................... 81
Figure 31. Full auto examination .................................................................................................... 83
Figure 32. Semi auto examination .................................................................................................. 83
Figure 33. Semi-automatic examination mode .............................................................................. 83
Figure 34. Proper quality and position of the tomogram .............................................................. 84
Figure 35. Manual examination mode ........................................................................................... 85
Figure 36. Manual examination process. Scan optimization and tomogram position alignment . 85
Figure 37. Proper position and the quality of the tomogram ........................................................ 85
Figure 38. Proper Alignment of retina tomogram .......................................................................... 86
Figure 39. Widefield examination proper scan alignment ............................................................. 87

372 / 387
SOCT User Manual Version 11.5 rev. A
Figure 40. Proper Disk examination alignment .............................................................................. 87
Figure 41. Angio acceptance window............................................................................................. 88
Figure 42 Exam List - Angio Scans................................................................................................... 89
Figure 43. Scanned area marked on pSLO window ........................................................................ 90
Figure 44. Proper Anterior measurement alignment ..................................................................... 91
Figure 45. Single angle measurement proper alignment ............................................................... 91
Figure 46.Single angle measurement proper alignment ................................................................ 91
Figure 47.Side views of Anterior Adapter ...................................................................................... 93
Figure 48. Anterior adapter mounting ........................................................................................... 93
Figure 49. Anterior adapter mounting. Rotate to lock. .................................................................. 93
Figure 50. Wide Cornea scan proper alignment............................................................................. 94
Figure 51. Angle to angle scan proper alignment .......................................................................... 94
Figure 52. Fundus Camera modes .................................................................................................. 96
Figure 53. Aligned pupil position in Fundus Camera mode ........................................................... 96
Figure 54. Eye preview window and pupil position........................................................................ 97
Figure 55. Live fundus preview modes ........................................................................................... 97
Figure 56. Live fundus preview IR mode ........................................................................................ 97
Figure 57. Fundus Photo mode acquire window ........................................................................... 98
Figure 58. Fundus Photo mode acquire window ........................................................................... 98
Figure 59. Fundus image acceptance window for Fundus mode ................................................... 98
Figure 60. Acceptance window for FUNDUS/OCT mode ............................................................... 99
Figure 61. Anterior Line Wide Full Range examination view .......................................................100
Figure 62.Full Range Posterior Line examination window ...........................................................101
Figure 63. Difference in Chorioretinal and Vitreoretinal scanning mode ....................................102
Figure 64. Properly aligned retina between dashed lines ............................................................107
Figure 65. Improper-flipped tomogram preview..........................................................................108
Figure 66. Shadow on tomogram, grab and drag towards left side .............................................108
Figure 67. Shadow on tomogram, grab and drag towards right side ...........................................108
Figure 68. Proper live eye preview while manual acquire mode .................................................109
Figure 69. OCT scan through a very small pupil ...........................................................................110
Figure 70. Examples of scans with dark corners ..........................................................................110
Figure 71. Example of a cataract patient with a loss of saturation ..............................................110
Figure 72. Examples of floaters with saccadic motion .................................................................111
Figure 73 Example of an uncorrected blink ..................................................................................111
Figure 74 Blink artifacts corrected to an acceptable standard.....................................................112
Figure 75. Example of a saccade ..................................................................................................112

373 / 387
SOCT User Manual Version 11.5 rev. A
Figure 76 Saccadic Motion corrected to an acceptable standard ................................................113
Figure 77. Example of a well saturated and properly centered tomogram .................................114
Figure 78. Example of a scan with shadowing visible on the side ...............................................114
Figure 79. Example of a scan with cataract ..................................................................................114
Figure 80. Example of an OCT image placed too high ..................................................................115
Figure 81. Example of an OCT image placed high and out of the scan window ..........................115
Figure 82. Examples of banding ...................................................................................................116
Figure 83. Example of a cropped image .......................................................................................117
Figure 84. Example of a segmentation error in OCT Angiography ...............................................117
Figure 85. Example of poor image quality caused by saccadic motion........................................118
Figure 86. Progression view – Lock function on ...........................................................................120
Figure 87. AI DeNoise off (left) and on (right) ..............................................................................121
Figure 88. DeNoise checkbox in the 3D tab .................................................................................121
Figure 89. Single eye retina analysis .............................................................................................122
Figure 90. Eye preview widow context menu ..............................................................................123
Figure 91. Both eyes retina analysis .............................................................................................126
Figure 92. Ganglion Cell Analysis (GCC)........................................................................................127
Figure 93. Asymmetry maps .........................................................................................................128
Figure 94 Both Eyes Fundus View.................................................................................................129
Figure 95. Follow up comparison of the two retina examinations ..............................................130
Figure 96. Latest scanned and Equal interval selector for COMPARISON view............................131
Figure 97. Follow up of the selected retina examination .............................................................132
Figure 98. Follow up of the changes in ganglion cell analysis ......................................................132
Figure 99. Comparison of the tomograms from succeeding examinations .................................133
Figure 100. Disc [Both] tab ...........................................................................................................134
Figure 101. Context menu of the disc reconstruction image .......................................................135
Figure 102. Disc 3D [Single] tab ....................................................................................................137
Figure 103. Context menu of the disc reconstruction image .......................................................137
Figure 104. Progression 3D disc ...................................................................................................140
Figure 105. Advanced View - Retina and Optic Nerve Head analysis. .........................................142
Figure 106 Combined View Structure & Function ........................................................................143
Figure 107 Selecting the patient and VF examination window....................................................145
Figure 108 Relationships between OCT and VF by Garway-Heath et al.......................................145
Figure 109 PPD Probability Results ..............................................................................................147
Figure 110 Disc area .....................................................................................................................147
Figure 111 PPD Combined view results ........................................................................................147

374 / 387
SOCT User Manual Version 11.5 rev. A
Figure 112 Enable VF results from Context menu ........................................................................148
Figure 113 Non-linear relationship example ................................................................................149
Figure 114 Enable VF locations from context menu ....................................................................150
Figure 115 Magnified view ...........................................................................................................150
Figure 116. Widefield examination single scan review window. .................................................151
Figure 117. Single Scan view. ........................................................................................................154
Figure 118. Single Line both eyes review. ....................................................................................154
Figure 119. Single Line comparison window. ...............................................................................155
Figure 120. Single B scan progression window.............................................................................155
Figure 121. Retina raster, single scan view. ..................................................................................156
Figure 122. Widefield raster single scan view. .............................................................................156
Figure 123. Raster both eyes view ...............................................................................................156
Figure 124. Raster scan comparison.............................................................................................157
Figure 125. Raster progression view.............................................................................................157
Figure 126 Radial examination single view ..................................................................................158
Figure 127. Radial examination both view. ..................................................................................158

Retina thickness
map
Retina signification map

Information table Retina difference

Tomogram
RPE deformation map

Figure 128. Radial examination comparison view. .......................................................................158


Figure 129. Cross scan horizontal B-scan view. ............................................................................159
Figure 130. Cross scan vertical B-scan view..................................................................................159
Figure 131. 3D Solid view .............................................................................................................162
Figure 132. Volume view ..............................................................................................................163
Figure 133. Structure classification menu for Anterior (on the right) and Full Range (on the right)
......................................................................................................................................................165
Figure 134. Short cornea scan ......................................................................................................165
Figure 135. Short Anterior Angle scan..........................................................................................166
Figure 136. Sclera and Cornea Wide Anterior 11 mm scan .........................................................166
Figure 137. Angle to Angle view. Sample of wide anterior B-scan ...............................................166
Figure 138. Single Anterior Radial ................................................................................................167
Figure 139. Progression Anterior radial maps view......................................................................170
375 / 387
SOCT User Manual Version 11.5 rev. A
Figure 140. Anterior Progression Tomogram view .......................................................................171
Figure 141. Edit Anterior layer .....................................................................................................172
Figure 142. Example of an AOD measurement ............................................................................173
Figure 143. Example of an angle measurement ...........................................................................174
Figure 144. Example of a caliper measurement ...........................................................................175
Figure 145. Full screen tomogram ................................................................................................176
Figure 146. Eye preview type selection. .......................................................................................176
Figure 147. Imaging tools .............................................................................................................177
Figure 148. Measurement tools ...................................................................................................178
Figure 149. Tab of tomogram annotations ...................................................................................178
Figure 150. Brightness and contrast manipulation ......................................................................178
Figure 151. Tomogram display options window. ..........................................................................179
Figure 152. Selection and edition of layers ..................................................................................180
Figure 153. Examination report for Retina 3D Single output .......................................................183
Figure 154. Examination report for Retina 3D both output .........................................................184
Figure 155. Examination report for Retina Comparison single view ............................................184
Figure 156. Examination report for Retina Progression single view ............................................185
Figure 157. Examination report for Retina Ganglion both view ..................................................185
Figure 158. Examination report for Retina Progression Ganglion single view .............................186
Figure 159. Examination report for Retina Progression Tomogram Morphology view ...............186
Figure 160. Examination report for Retina + Disc Advanced both view.......................................187
Figure 161. Examination report for Retina Widefield view ..........................................................187
Figure 162. Examination report for 3D Retina single view ...........................................................188
Figure 163. Examination report for single disc view ....................................................................189
Figure 164. Examination report for 3D single disc view ...............................................................189
Figure 165. Examination report for both disc view ......................................................................190
Figure 166. Examination report for single disc progression view ................................................190
Figure 167. Examination report for Disc + Retina advanced both view Anterior segment
examination reports .....................................................................................................................191
Figure 168. Structure and function examination report ..............................................................191
Figure 169 Examination report for Anterior segment single view ...............................................192
Figure 170. Examination report for Anterior segment both view ................................................192
Figure 171. Examination report for Anterior segment comparison view ....................................193
Figure 172. Examination report for Anterior segment progression view ....................................193
Figure 173. Examination report for Wide Anterior Line single view ............................................194
Figure 174. Examination report for Wide Anterior Line both view ..............................................194

376 / 387
SOCT User Manual Version 11.5 rev. A
Figure 175. Examination report for Wide Anterior segment progression Line view ...................195
Figure 176. Examination report for Topography pachymetry single view ...................................195
Figure 177. Examination report for Topography pachymetry both view .....................................196
Figure 178. Examination report for Topography comparison view ..............................................196
Figure 179. Examination report for Topography comparison pachymetry view ..........................197
Figure 180. Examination report for Topography progression view ..............................................197
Figure 181. Examination report for Topography progression, tomograms view .........................198
Figure 182. Examination report for Topography progression pachymetry view ..........................198
Figure 183. Examination report for Fundus single view ...............................................................199
Figure 184. Examination report for Fundus both view ................................................................199
Figure 185. Examination report for Fundus single view x4 ..........................................................200
Figure 186. Examination report for Fundus comparison view .....................................................200
Figure 187. Examination report for Angiography standard single view .......................................201
Figure 188. Examination report for Angiography detailed single view ........................................201
Figure 189. Examination report for Angiography both view ........................................................202
Figure 190. Examination report for Angiography comparison view ............................................202
Figure 191. Examination report for Angiography progression analysis view ...............................203
Figure 192. Examination report for Angiography progression standard view .............................203
Figure 193. Examination report for Angiography 3D view ...........................................................204
Figure 194. Examination report for Angiography advanced view ................................................204
Figure 195. Examination report for Disc OCT-A standard single view ..........................................205
Figure 196. Examination report for Disc OCT-A detailed single view ...........................................205
Figure 197. Examination report for Disc OCT-A both view ...........................................................206
Figure 198. Examination report for Disc OCT-A comparison view ...............................................206
Figure 199. Examination report for Disc OCT-A progression analysis view ..................................207
Figure 200. Examination report for Disc OCT-A progression standard view ................................207
Figure 201. Examination report for Disc OCT-A 3D volume view .................................................208
Figure 202. Examination report for Biometry single view............................................................208
Figure 203. Examination report for Biometry both view .............................................................209
Figure 204. Examination report for IOL Calculation .....................................................................209
Figure 205. Multi B-scan acceptance window. .............................................................................210
Figure 206. Multi B-scan report....................................................................................................210
Figure 207. Multi B-scan report for Both Eyes and Comparison view .........................................211
Figure 208. Single tomogram printout .........................................................................................211
Figure 209. Output screen ............................................................................................................213
Figure 210 Context Menu .............................................................................................................214

377 / 387
SOCT User Manual Version 11.5 rev. A
Figure 211 Fundus Import Selection ............................................................................................215
Figure 212 Fundus Registration Blank and Marked......................................................................215
Figure 213 Vascular layer previews ..............................................................................................216
Figure 214. Context menu ............................................................................................................217
Figure 215. Fundus photo selection for linking with an examination ..........................................217
Figure 216. The result of OCT correlation – registration .............................................................218
Figure 217. Fundus and OCT Registration window ......................................................................220
Figure 218. Registration screen with arrows indicating the direction of the manipulation of the
image ............................................................................................................................................222
Figure 219. Comparison tab with an extracted tomogram displayed in the bottom right-hand
corner ...........................................................................................................................................223
Figure 220. Single eye color fundus photo x1 view .....................................................................225
Figure 221. Single eye color fundus photo x4 view .....................................................................225
Figure 222. Single eye color fundus photo full screen view ........................................................226
Figure 223. Display settings in single eye color fundus photo full screen view ..........................227
Figure 224. Both eyes color fundus photo view ..........................................................................228
Figure 225. Comparison color fundus photo view ......................................................................228
Figure 226. Single - Standard view ...............................................................................................229
Figure 227. Single detailed Retina Angio view .............................................................................230
Figure 228. Single - Detail view – vertical and horizontal alignment ...........................................230
Figure 229. Single - Standard view – B-scan vertical alignment ...................................................232
Figure 230. Zoom out/in over the angiogram window ................................................................236
Figure 231. Projection artefact removal algorithm OFF / ON ......................................................237
Figure 232. Enface image for the Choroid layer - invert OFF / ON ...............................................238
Figure 233. Angio flow tool ..........................................................................................................240
Figure 234. Foveal Avascular Zone tool ........................................................................................241
Figure 235. Foveal Avascular Zone tool – Semi Auto ...................................................................242
Figure 236. Foveal Avascular Zone tool – Manual........................................................................242
Figure 237. Vascular Flow Area tool .............................................................................................243
Figure 238. Vascular Flow Area tool – Circle Area Tool ................................................................243
Figure 239. Vascular Flow Area tool – Manual Pointer Area Tool ................................................244
Figure 240. Non-Flow Area tool ...................................................................................................245
Figure 241. NFA tool – semi auto .................................................................................................245
Figure 242. NFA tool - manual ......................................................................................................246
Figure 243. Quantification data field in Angio [SINGLE] Standard and Detail View .....................247
Figure 244. Angio OCT Analysis Table for Single View..................................................................250

378 / 387
SOCT User Manual Version 11.5 rev. A
Figure 245. Angio OCT Analysis Table for Comparison View ........................................................250
Figure 246. Both eyes Retina Angio view .....................................................................................251
Figure 247. Comparison Retina Angio view .................................................................................252
Figure 248. Progression Retina Angio Analysis view ....................................................................253
Figure 249. Progression Retina Angio Standard view...................................................................253
Figure 250. Example of Motion Corrected examination ..............................................................255
Figure 251. Single Standard Disc Angio view................................................................................256
Figure 252. Single Detailed Disc Angio view.................................................................................257
Figure 253. Both Discs Angio view ...............................................................................................258
Figure 254. Comparison Disc Angio view .....................................................................................259
Figure 255. Progression Disc Angio view ......................................................................................260
Figure 256. Advance tab – Angio mosaic. ....................................................................................261
Figure 257. Select screen..............................................................................................................262
Figure 258. Advance tab – Manipulation of whole mosaic. .........................................................263
Figure 259. Advance tab – Manipulation of single image. ...........................................................263
Figure 260. Type of eye selection window. ..................................................................................269
Figure 261. Full auto examination. ...............................................................................................271
Figure 262. Manual examination mode. ......................................................................................271
Figure 263. Manual examination process. ...................................................................................272
Figure 264. Proper position of the cornea. ..................................................................................272
Figure 265. Proper position of the intraocular lens .....................................................................273
Figure 266. Biometry acceptance window ...................................................................................273
Figure 267. WTW and P measurement ranges .............................................................................275
Figure 268. WTW and P measurement result table .....................................................................275
Figure 269. Biometry Single view .................................................................................................276
Figure 270. Biometry Both view ...................................................................................................278
Figure 271. Biometry Full screen window ....................................................................................278
Figure 272. White to white distance measurement window .......................................................279
Figure 273. Editing WTW and P results – eye preview .................................................................279
Figure 274. IOL Calculation Tab ....................................................................................................282
Figure 275. Entering biometry and keratometry data..................................................................283
Figure 276. IOL Calculation results table ......................................................................................284
Figure 277. Marking lenses ..........................................................................................................285
Figure 278. IOL Editor window .....................................................................................................285
Figure 279. List of lenses in the IOL Editor window .....................................................................287
Figure 280. Adding additional power ranges and increments .....................................................288

379 / 387
SOCT User Manual Version 11.5 rev. A
Figure 281. Topography acquire window .....................................................................................292
Figure 282. Full auto examination ................................................................................................293
Figure 283. Manual examination mode .......................................................................................294
Figure 284. Manual examination process ....................................................................................294
Figure 285. Topography Exam Acceptance window .....................................................................295
Figure 286. Single Topography view .............................................................................................297
Figure 287. Enlarged detailed Topography map view ..................................................................298
Figure 288. Both Topography view ...............................................................................................299
Figure 289. Comparison Topography view ...................................................................................300
Figure 290. Progression Topography view ....................................................................................300
Figure 291 Keratoconus screening classification ..........................................................................306
Figure 292. Calibration tool. .........................................................................................................314
Figure 293. Opening the calibration tool. ....................................................................................314
Figure 294. Mounting the calibration tool. ..................................................................................315
Figure 295. Calibration procedure window ..................................................................................320
Figure 296. Calibration procedure in progress .............................................................................320
Figure 297. Entering biometry calibration parameters ................................................................321
Figure 298. Common calibration window ....................................................................................322
Figure 299. Common calibration in progress ...............................................................................323
Figure 300. Common calibration result window ..........................................................................323
Figure 301. Entering device settings tab. .....................................................................................325
Figure 302.General setup window................................................................................................325
Figure 303. Database tab..............................................................................................................326
Figure 304. Selecting database table location..............................................................................326
Figure 305. Example of connection error. ....................................................................................326
Figure 306. Lack of directory error. ..............................................................................................327
Figure 307. Confirmation of proper connection. .........................................................................327
Figure 308. Remote server connection settings. ..........................................................................327
Figure 309. Storage administration tab. .......................................................................................328
Figure 310. Selection of additional storage folder........................................................................329
Figure 311.Users tab. ....................................................................................................................330
Figure 312. Users tab. Creating new user. ....................................................................................330
Figure 313 LDAP Settings ..............................................................................................................331
Figure 314. Preferences tab..........................................................................................................332
Figure 315. Protocol editor tab. ...................................................................................................334
Figure 316. Preference tab. ..........................................................................................................335

380 / 387
SOCT User Manual Version 11.5 rev. A
Figure 317. Parameters tab. .........................................................................................................336
Figure 318. Voice messages settings ............................................................................................336
Figure 319. Results review settings tabs. .....................................................................................337
Figure 320. Anonymization settings window. ..............................................................................339
Figure 321 Visual Field settings window ......................................................................................341
Figure 322 Input settings window ................................................................................................342
Figure 323. Disease list window ...................................................................................................343
Figure 324 Output set window .....................................................................................................343
Figure 325. AI DeNoise export settings ........................................................................................344
Figure 326. Output configuration screen. ....................................................................................345
Figure 327. DICOM output configuration screen. ........................................................................347
Figure 328. Backup tab. ................................................................................................................348
Figure 329. Backup error example. ..............................................................................................349
Figure 330. DICOM tab. ................................................................................................................349
Figure 331. DICOM tab. ................................................................................................................350
Figure 332. System settings window. ...........................................................................................350
Figure 333. MWL Interface Settings. ............................................................................................351
Figure 334. Information label .......................................................................................................352
Figure 335. Networking possibilities scheme. ..............................................................................358
Figure 336. Window after login to new system. ..........................................................................360
Figure 337.Remote database configuration. ................................................................................360
Figure 338.Users tab in PTS application. ......................................................................................362
Figure 339.Database tab in PTS application. ................................................................................363
Figure 340.Preferemce tab in SETUP SOCT application. ..............................................................364
Figure 341. Visual field window in SOCT application. ..................................................................365

31 PRODUCT COMPLIANCE
Radio Interference
The REVO FC 130 has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of FCC rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a

381 / 387
SOCT User Manual Version 11.5 rev. A
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help.

Canadian Regulations
The REVO FC 130 does not exceed the Class B limits for radio noise emissions from digital
apparatus as set out in the radio interference regulations of the Canadian Department of
Communications.

EMC information
Guidance and manufacturer’s declaration – electromagnetic emissions

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

Emission test Compliance Electromagnetic environment - guidance

RF emissions Group 1 The SOCT uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic equipment.

RF emissions Class A

382 / 387
SOCT User Manual Version 11.5 rev. A
CISPR 11 The SOCT is suitable for use in all establishments other than
domestic and those directly connected to the public low-
Harmonic emissions Class A
voltage power supply network that supplies buildings used
IEC 61000-3-2 for domestic use, provided the following WARNING is
Voltage fluctuations/ Complies heeded:
flicker emissions Note: The emissions characteristic of this
IEC 61000-3-3 equipment makes it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If the SOCT is used in
a residential environment (for which CISPR 11 class B is
normally used) this equipment might not offer adequate
protection to radio-frequency communication service. The
user might need to take mitigation measures such
relocating or re-orienting equipment.

Guidance and manufacturer’s declaration – electromagnetic immunity

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

IMMUNITY test IEC 60601 test Compliance Electromagnetic environment - guidance


level level

Electrostatic ± 8 kV contact Floors should be wood, concrete or ceramic


± 8 kV contact
discharge (ESD) tile. If floors are covered with synthetic
± 2,4,8,15 kV ± 2,4,8,15 kV material, the relative humidity should be at
IEC 61000-4-2 air air least 30 %.

Electrical fast ± 2 kV for ± 2 kV for


transient/burst power supply power supply Mains power quality should be that of a typical
lines lines commercial or hospital environment.
IEC 61000-4-4

Surge ± 0,5; 1kV ± 0,5; 1kV


line(s) to line(s) line(s) to line(s) Mains power quality should be that of a typical
IEC 61000-4-5
± 0,5; 1; 2 kV ± 0,5; 1; 2 kV commercial or hospital environment.
line(s) to earth line(s) to earth

Voltage dips, 0% Ut, 0,5 0% Ut, 0,5 Mains power quality should be that of a typical
short cycle cycle commercial or hospital environment. If the
interruptions user of the SOCT requires mains interruptions,
383 / 387
SOCT User Manual Version 11.5 rev. A
and voltage at: 0°, 45°, 90°, at: 0°, 45°, 90°, it is recommended that the SOCT be powered
variations on 135°, 180°, 135°, 180°, from an uninterruptible power supply or a
power supply 225°, 270°, 225°, 270°, battery.
input lines 315°; 315°;
IEC 61000-4-11 0% Ut, 1 cycle; 0% Ut, 1 cycle;
70% Ut, 25/30 70% Ut, 25/30
cycles; cycles;
Singe phase at Singe phase at
0° 0°

Power
frequency Power frequency magnetic fields should be at
(50/60 Hz) 30 A/m 30 A/m levels characteristic of a typical location in a
magnetic field typical commercial or hospital environment.
IEC 61000-4-8

NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity

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

IMMUNITY test IEC 60601 Compliance Electromagnetic


test level level environment - guidance

Portable and mobile RF


communications equipment
should be used no closer to
any part of the SOCT,
including cables, than the
recommended separation

384 / 387
SOCT User Manual Version 11.5 rev. A
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
Conducted RF 3 Vrms 3V distance
IEC 61000-4-6 150 kHz to 80
𝑑 = [1,17]√𝑃
MHz

Radiated RF 3 V/m
𝑑 = [1,17]√𝑃 80 MHz to 800
3 V/m
IEC 61000-4-3 MHz
80 MHz to 2,5
𝑑 = [2,33]√𝑃 800 MHz to 2,5
GHz
GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey,a should be less than
the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:

385 / 387
SOCT User Manual Version 11.5 rev. A
NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in with the SOCT is used exceeds the applicable RF compliance level above,
the SOCT should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the SOCT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

Recommended separation distance between portable and mobile RF communications equipment


and the SOCT

The SOCT is intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the SOCT can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the SOCT as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum output power of transmitter Separation distance according to frequency of


transmitter
W
m

150 kHz to 80 MHz to 800 800 MHz to 2,5


80 MHz MHz GHz
𝑑 𝑑 = [1,17]√𝑃 𝑑 = [2,33]√𝑃
= [1,17]√𝑃
0,01 0,12 0,12 0,23

0,1 0,37 0,37 0,74

1 1,17 1,17 2,33

10 3,7 3,7 7,37

100 11,7 11,7 23,3

386 / 387
SOCT User Manual Version 11.5 rev. A
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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

387 / 387
SOCT User Manual Version 11.5 rev. A

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy