Optopol REVO nx User manual

SOCT User Manual Version 10.0 rev. A
Manufacturer:
OPTOPOL Technology Sp. z o. o.
ul. Żabia 42
42-400 Zawiercie
POLAND
www.optopol.com
inf[email protected]
User Manual
REVO nx
REVO nx 130
SOCT Copernicus REVO
SOCT Copernicus
REVO 60
REVO 80
REVO FC
Software Version 10.0
User Manual Rev. A
0197
Make sure you read this manual before using
the instrument. Keep this manual in a safe
place so that you can use it in the future.

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SOCT User Manual Version 10.0 rev. A
Copyright
© 2021 OPTOPOL Technology Sp. z o. o. All rights reserved. No part of this publication may be stored
in a retrieval system, transmitted or reproduced in any way, including but not limited to photocopy,
photograph, magnetic or other record, without the prior agreement and written consent of OPTOPOL
Technology Sp. z o. o.
User Manual Version 10.0 rev. A
Date of issue of manual: February 2021
Date of review: February 2021
For Customer Service or Technical Service contact your authorized dealer of OPTOPOL Technology
Sp. z o. o. Contact details are available on www.optopol.com.
Note: The SOCT Copernicus REVO/SOCT Copernicus/REVO 60/REVO 80/REVO nx
REVO nx 130/REVO FC is hereinafter referred to as the “SOCT”.
The name of application which controls the scanning device is SOCT.
Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a
physician. Proper procedures and techniques are the responsibility of the medical professional.
License and use of the SOCT is intended only for trained medical personnel in accordance with the
license agreement –all other usage is prohibited –warranty restrictions and possible claim
limitations apply.

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SOCT User Manual Version 10.0 rev. A
1DESCRIPTION OF THE DEVICE .............................................................................................13
INTENDED USE ......................................................................................................................13
INTENDED USER....................................................................................................................14
THE MINIMUM KNOWLEDGE ............................................................................................14
EDUCATION NEEDED FOR OPERATING THE TOMOGRAPH..........................................................14
OPERATING SKILLS .........................................................................................................14
OCCUPATIONAL SKILLS.....................................................................................................15
JOB REQUIREMENTS FOR THE USER ....................................................................................15
PLACES OF USE.....................................................................................................................15
PATIENT POPULATION.............................................................................................................15
PROPER INSTRUMENT USE.......................................................................................................15
CONTRAINDICATION...............................................................................................................16
INSTRUCTION MANUAL AVAILABILITY.................................................................................16
INSTRUCTION MANUAL APPLICABILITY ...............................................................................16
DISPOSAL .....................................................................................................................17
PROTECTIVE MEASURES FOR IT SYSTEMS ...................................................................................17
CYBERSECURITY FUNCTIONS ....................................................................................................17
SYSTEM OVERVIEW ........................................................................................................17
AUTHENTICATION OF USERS.............................................................................................18
AUTO-LOGOFF ..............................................................................................................18
ENSURE TRUSTED CONTENT.............................................................................................18
CYBERSECURITY EVENT ....................................................................................................18
RECOVER......................................................................................................................18
OTHER IMPLEMENTED MECHANISMS..................................................................................19
2TECHNICAL DATA................................................................................................................20
TECHNICAL DATA REVO NX 130 / REVO NX .............................................................................20
SOCT COPERNICUS REVO/ SOCT COPERNICUS / REVO 60/REVO 80 ........................................21
TECHNICAL DATA REVO FC ....................................................................................................22
DEVICE CLASSIFICATION ..........................................................................................................23
MINIMUM COMPUTER SYSTEM REQUIREMENTS...........................................................................23
CAPTURE STATION ..........................................................................................................23
REVIEW STATION............................................................................................................24
3SAFETY ..............................................................................................................................25
SAFETY INFORMATION ............................................................................................................25
PRODUCT LABEL ...................................................................................................................26
SAFETY STANDARDS ...............................................................................................................28
WARNINGS..........................................................................................................................30
CAUTIONS ...........................................................................................................................34
GENERAL NOTES ...................................................................................................................36
NOTES ON USE .....................................................................................................................38

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SOCT User Manual Version 10.0 rev. A
BEFORE USE..................................................................................................................38
AFTER USE....................................................................................................................38
4UNPACKING AND INSTALLATION ........................................................................................39
UNPACKING .........................................................................................................................39
CONNECTING CABLES .............................................................................................................40
DEVICE CONNECTION .............................................................................................................42
FACTORY DEFAULT CALIBRATION AND CONFIGURATION ..................................................................44
5SOCT SOFTWARE ...............................................................................................................45
RUNNING SOCT APPLICATION .................................................................................................45
SOCT APPLICATION STRUCTURE ...............................................................................................45
6PATIENT WINDOW .............................................................................................................46
PATIENT LIST VIEW.................................................................................................................46
CUSTOMIZATION OF THE PATIENT LIST VIEW.........................................................................47
REGISTERING NEW PATIENTS ....................................................................................................47
EDITING PERSONAL DATA.........................................................................................................49
UNREGISTERING PATIENTS .......................................................................................................49
EXAMINATION LIST ................................................................................................................49
DELETING EXAM/S................................................................................................................50
CONNECTING SCANS CONNECTED TO THE WRONG PATIENT.............................................................51
EXPORTING EXAMINATIONS .....................................................................................................51
EXPORT WITH ANONYMIZATION ........................................................................................51
IMPORTING EXAMINATIONS .....................................................................................................51
FILTER .............................................................................................................................52
OUTPUT ..........................................................................................................................52
WORK LIST.......................................................................................................................53
7EXAMINATION ACQUSITION TAB........................................................................................54
SELECTION OF SCAN PATTERN MODE..........................................................................................59
SELECTION OF SCANNING PROGRAM..........................................................................................60
OCT BIOMETRY PROGRAMS.............................................................................................61
OCT TOPOGRAPHY PROGRAMS ........................................................................................61
OCT ANGIOGRAPHY PROGRAMS*.....................................................................................61
FUNDUS CAMERA PROGRAMS*........................................................................................62
OCT + FUNDUS PHOTOGRAPHY*......................................................................................62
SELECTION OF PROTOCOL........................................................................................................63
DEVICE HEAD MOVEMENT CONTROLS ........................................................................................64
EYE PREVIEW........................................................................................................................65
FUNDUS PREVIEW .................................................................................................................66
PSLO LIVE FUNDUS PREVIEW............................................................................................66

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SOCT User Manual Version 10.0 rev. A
IR PREVIEW..................................................................................................................66
OPERATION ON THE FUNDUS PREVIEW.......................................................................................68
MOVING THE SCANNING AREA .........................................................................................68
ROTATION OF THE SCANNING ANGLE..................................................................................68
MOVING THE INTERNAL FIXATION TARGET...........................................................................68
CHANGING THE SCAN WIDTH ............................................................................................68
CHANGING THE SCANS DISTANCE .......................................................................................69
FIXATION TARGET CHANGE.......................................................................................................69
CUSTOMIZING SCAN PARAMETERS.............................................................................................69
LIVE OCT PREVIEW............................................................................................................72
ITRACKING ....................................................................................................................73
ACCEPTANCE WINDOW FOR A 3D SCAN..............................................................................73
8CONDUCTING EXAMINATION.............................................................................................76
PREPARATION FOR EXAMINATION..............................................................................................76
ACQUISITION MODES DESCRIPTION ...........................................................................................77
FULL AUTO MODE ..........................................................................................................77
SEMI AUTO MODE..........................................................................................................77
MANUAL MODE.............................................................................................................79
SCANNING PROGRAMS DESCRIPTION .........................................................................................80
RETINA EXAMINATION.....................................................................................................80
CENTRAL EXAMINATION...................................................................................................80
DISC AREA EXAMINATION.................................................................................................81
OCT ANGIOGRAPHY EXAMINATION ...................................................................................82
OCT ANGIOGRAPHY MOSAIC MODE ..................................................................................83
ANTERIOR MEASUREMENT...............................................................................................85
WIDE ANTERIOR PROGRAMS............................................................................................86
BIOMETRY PROGRAM......................................................................................................89
TOPOGRAPHY PROGRAM .................................................................................................89
FUNDUS IMAGE REVO FC (REVO FC ONLY)......................................................................89
FULL RANGE EXAMINATION MODE ............................................................................................94
ANTERIOR FULL RANGE EXAMINATION MODE ......................................................................94
CENTRAL FULL RANGE EXAMINATION MODE ........................................................................95
EXTERNAL FIXATION ...............................................................................................................96
CHORIORETINAL/VITREORETINAL MODE ....................................................................................96
EXAMINATION TIPS ................................................................................................................97
TIPS FOR AUTOMATIC EYE ALIGNMENT...............................................................................97
TIPS FOR MANUAL EYE ALIGNMENT ..................................................................................97
AUTO C-GATE ISSUES......................................................................................................98
TIPS TO SUCCESSFULLY SCAN DIFFICULT PATIENTS ...............................................................101
CRITERA FOR EXAM ACCEPTANCE ...........................................................................................103

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EVALUATION OF OCT FUNDUS RECONSTRUCTION FOR POSTERIOR 3D EXAMS..........................103
EVALUATION OF OCT TOMOGRAMS FOR POSTERIOR AND ANTERIOR SCANS .............................107
OCT IMAGES ..............................................................................................................109
FUNDUS PHOTOGRAPHY ................................................................................................110
3D EXAMINATION ACCEPTANCE CRITERIA ................................................................................110
SACCADES ..................................................................................................................110
BANDING ...................................................................................................................110
WEAK LOCAL SIGNAL ........................................................................................................111
BLINKS.......................................................................................................................111
FLOATERS ...................................................................................................................111
CROPPED IMAGE..........................................................................................................111
OCT ANGIOGRAPHY ACCEPTANCE CRITERIA .........................................................................111
SEGMENTATION ERRORS ................................................................................................111
IMAGE QUALITY...........................................................................................................112
9RESULT REVIEW ...............................................................................................................114
TYPE OF VIEW MODE...........................................................................................................114
[SINGLE] TAB SCREEN....................................................................................................114
[BOTH EYES] TAB SCREEN ..............................................................................................114
[COMPARISON] TAB SCREEN ...........................................................................................114
[PROGRESSION] TAB SCREEN ..........................................................................................114
LOCK FUNCTION...........................................................................................................114
TYPES OF ANALYSIS..............................................................................................................115
SINGLE RETINA ANALYSIS ...............................................................................................115
AI DENOISE.......................................................................................................................115
3D TAB .....................................................................................................................116
10 POSTERIOR ANALYSIS..................................................................................................117
RETINA THICKNESS ANALYSIS .............................................................................................117
SINGLE TAB ................................................................................................................117
BOTH EYES TAB ............................................................................................................121
COMPARISON..............................................................................................................125
PROGRESSION .............................................................................................................126
OPTIC NERVE HEAD ANALYSIS ....................................................................................129
ADVANCED VIEW – RETINA AND OPTIC NERVE HEAD ANALYSIS.................................................138
STRUCUTRE & FUNCTION – COMBINED OCT AND VF REPORT ..........................................139
RELATIONSHIPS BETWEEN VF AND RNFL/GANGLION MAPS .................................................142
REQUIREMENTS THAT MUST BE MET FOR LOADING PERIMETER TESTS IN THE SOCT APPLICATION ..142
STRUCTURE & FUNCTION – VF RESULTS LAYER IN COMBINED VIEW .......................................143
STRUCTURE & FUNCTION – VF LOCATIONS LAYER ..............................................................145
CENTRAL EXAMINATION ....................................................................................................148
CENTRAL 3D EXAMINATION...........................................................................................148

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2D SCAN PROGRAMS RESULTS REVIEW.................................................................................149
SINGLE B-SCAN EXAMINATION REVIEW.............................................................................150
RASTER EXAMINATION RESULTS REVIEW............................................................................151
RADIAL EXAMINATION RESULTS REVIEW............................................................................153
CROSS EXAMINATION RESULTS REVIEW.............................................................................154
3D VISUALIZATION...........................................................................................................155
MANIPULATION OF THE 3D CUBE ....................................................................................155
SELECTION OF DISPLAYED LAYERS .....................................................................................155
OPERATION PANEL........................................................................................................156
[SOLID] VIEW .............................................................................................................158
[VOLUME VIEW]..........................................................................................................159
11 ANTERIOR SEGMENT ANALYSIS....................................................................................160
ANTERIOR RADIAL ...........................................................................................................163
[SINGLE] TAB SCREEN....................................................................................................163
[BOTH EYES] TAB SCREEN..............................................................................................165
[COMPARISON] TAB SCREEN ...........................................................................................165
[PROGRESSION] TAB SCREEN ..........................................................................................166
EDIT ANTERIOR SURFACE................................................................................................168
AOD MEASUREMENT ...................................................................................................169
ANGLE MEASUREMENT TOOL..........................................................................................170
CALIPER TOOL .............................................................................................................171
TOMOGRAM REVIEW ANALYSIS .......................................................................................171
12 FULL SCREEN WINDOW ...............................................................................................172
FUNDUS RECONSTRUCTION, EYE PREVIEW OR PSLO................................................................172
IMAGING TOOLS ..............................................................................................................173
MEASUREMENT TOOLS AND ANNOTATIONS ...........................................................................173
BRIGHTNESS AND CONTRAST ADJUSTMENT............................................................................174
FULL SCREEN MODE EXIT ...................................................................................................175
TOMOGRAM WINDOW MANIPULATION ................................................................................175
EDITION OF RECOGNIZED LAYERS.........................................................................................176
MANUAL DISC CONTOUR EDITION .......................................................................................177
REDRAW THE DISC CONTOUR ..........................................................................................178
13 PRINT..........................................................................................................................180
POSTERIOR SEGMENT EXAMINATION REPORTS/OUTPUTS .........................................................180
RETINA 3D.................................................................................................................180
DISC 3D ....................................................................................................................183
OPTIC NERVE HEAD ANALYSIS REPORTS .............................................................................185
TOPOGRAPHY EXAMINATION REPORTS..............................................................................191
FUNDUS EXAMINATION REPORTS.........................................................................................195

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ANGIOGRAPHY EXAMINATION REPORTS................................................................................197
DISC OCT-A EXAMINATION REPORTS...................................................................................201
BIOMETRY EXAMINATION REPORTS......................................................................................205
MULTI B-SCAN REPORT.....................................................................................................206
MANUALLY SELECT TOMOGRAMS ....................................................................................207
MULTI B-SCAN REPORT FOR BOTH AND COMPARISON VIEW..................................................207
SINGLE TOMOGRAM REPORT..............................................................................................208
SELECT DESIRED PRINTER...................................................................................................208
14 OUTPUT......................................................................................................................209
15 SELECTING FUNDUS PHOTO.........................................................................................210
ADDING FUNDUS PHOTO TO THE EXAMINATION......................................................................210
FUNDUS IMAGE REGISTRATION CORRECTION..........................................................................212
LINKING A FUNDUS PHOTO TO AN EXAMINATION....................................................................212
16 EXAMINATIONS CORRELATION ....................................................................................214
OCT-OCT REGISTRATION .................................................................................................214
AUTOMATIC CORRELATION .............................................................................................214
MANUAL REGISTRATION ................................................................................................215
FUNDUS CORRELETION .....................................................................................................215
AUTOMATIC CORRELATION .............................................................................................215
MANUAL CORRELATION.................................................................................................217
MOVING THE OVERLAID OCT IMAGE ...............................................................................218
CLOSING FUNDUS AND OCT CORRELATION WINDOW ..........................................................219
EXTRACTING TOMOGRAMS FROM A 3D EXAM .......................................................................219
FUNDUS CAMERA – RESULT REVIEW..........................................................................220
COLOR FUNDUS PHOTO [SINGLE] VIEW X 1........................................................................220
COLOR FUNDUS PHOTO [SINGLE] VIEW X 4........................................................................221
COLOR FUNDUS PHOTO FULL SCREEN VIEW........................................................................221
COLOR FUNDUS PHOTO [BOTH] VIEW...............................................................................222
COLOR FUNDUS PHOTO [COMPARISON] VIEW ....................................................................222
17 ANGIOGRAPHY OCT ....................................................................................................223
RETINA OCT-A.............................................................................................................223
[SINGLE] VIEW – STANDARD ..........................................................................................223
[SINGLE] VIEW - DETAILED.............................................................................................224
ANGIO OCT ANALYSIS..................................................................................................226
QUANTIFICATION TOOLS: FAZ, VFA, NFA............................................................................234
FAZ TOOL ..................................................................................................................234
VFA TOOL ..................................................................................................................237
NFA TOOL..................................................................................................................238

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QUANTIFICATION MAPS [DENSITY AND SKELETON].............................................................240
ANGIO OCT ANALYSIS TABLE .........................................................................................244
[BOTH] VIEW..............................................................................................................244
[COMPARISON] VIEW....................................................................................................246
[PROGRESSION] VIEW ...................................................................................................247
MOTION CORRECTION......................................................................................................248
MOTION CORRECTION IN 3D EXAMINATIONS ....................................................................249
DISC OCT-A..................................................................................................................250
[SINGLE] VIEW............................................................................................................250
[BOTH] VIEW ..............................................................................................................251
ANGIO DISC COMPARISON VIEW .....................................................................................253
[PROGRESSION] VIEW ...................................................................................................253
MOSAIC ........................................................................................................................254
CORRELATION STATUS ...................................................................................................256
SELECT SCREEN............................................................................................................256
OPERATION ON THE MOSAIC...........................................................................................256
18 BIOMETRY OCT ...........................................................................................................259
BIOMETRY ACQUISITION MODE .........................................................................................261
FULL AUTO MODE........................................................................................................263
SEMI AUTO MODE........................................................................................................264
ACCEPTANCE SCREEN ....................................................................................................266
WHITE TO WHITE ........................................................................................................267
RESULT REVIEW ...............................................................................................................268
SINGLE VIEW ..............................................................................................................269
BOTH VIEW.................................................................................................................271
FULL SCREEN...............................................................................................................271
19 IOL CALCULATION TAB.................................................................................................274
PERFORMING IOL CALCULATION.........................................................................................275
MARKING IMPLEMENTED LENSES ........................................................................................277
IOL EDITOR....................................................................................................................277
IMPORTING IOL DATA ...................................................................................................278
EXPORTING IOL DATA ...................................................................................................279
ADDING LENSES MANUALLY............................................................................................279
DELETING LENSES MANUALLY..........................................................................................279
VIEWING THE LIST OF LENSES..........................................................................................279
EDITING IOL DATA........................................................................................................280
ADDING ADDITIONAL POWER RANGES AND INCREMENTS ......................................................281
20 TOPOGRAPHY OCT ......................................................................................................282
TOPOGRAPHY - SAFETY NOTES...........................................................................................282

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TOPOGRAPHY ACQUISITION MODE .....................................................................................284
FULL AUTO MODE........................................................................................................285
SEMI AUTO MODE........................................................................................................286
ACCEPTANCE SCREEN ....................................................................................................287
TOTAL QUALITY FACTOR ................................................................................................288
RESULT REVIEW ...............................................................................................................288
[SINGLE] VIEW ............................................................................................................288
[BOTH] VIEW ..............................................................................................................290
[COMPARISON] VIEW....................................................................................................291
[PROGRESSION] VIEW ...................................................................................................291
ANALYSIS .......................................................................................................................292
CENTRAL KERATOMETRY – SIMK.....................................................................................292
KERATOMETRY (MERIDIAN)...........................................................................................292
KERATOMETRY (SEMIMERIDIAN)....................................................................................293
KERATOCONUS SCREENING ............................................................................................293
PACHYMETRY ..............................................................................................................297
MAP TYPES....................................................................................................................297
COLOR SCALE - STANDARDS ...............................................................................................300
21 CALIBRATION ..............................................................................................................304
CALIBRATION PROCEDURE PREPARATION...............................................................................304
TOPOGRAPHY CALIBRATION ...............................................................................................305
INTITIAL TOPOGRAPHY CALIBRATION PROCEDURE................................................................305
STANDARD CALIBRATION................................................................................................306
CALIBRATION PROCESS ..................................................................................................306
AXIAL LENGTH (BIOMETRY) CALIBRATION..............................................................................308
BIOMETRY CALIBRATION WITH THE IOL CALCULATION TAB UNACTIVATED .................................308
BIOMETRY CALIBRATION WITH THE IOL CALCULATION TAB ACTIVATED......................................309
CALIBRATION PROCESS ..................................................................................................310
ENTERING BIOMETRY CALIBRATION PARAMETERS ................................................................311
COMMON CALIBRATION ................................................................................................311
22 SETUP WINDOW .........................................................................................................315
GENERAL .......................................................................................................................315
DATABASE......................................................................................................................316
STORAGE .......................................................................................................................318
USERS ACCOUNTS............................................................................................................319
CREATING USER ACCOUNTS ............................................................................................320
LDAP SETTINGS .........................................................................................................321
PREFERENCES .................................................................................................................322
CMDL INTERFACE........................................................................................................322
DEVICES SETUP............................................................................................................323