Optopol REVO nx User Manual
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Optopol REVO nx User Manual

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REVO nx
REVO nx 130
SOCT Copernicus REVO
SOCT Copernicus
REVO 60
REVO 80
REVO FC
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.
User Manual
Software Version 10.0
User Manual Rev. A
0197
SOCT User Manual Version 10.0 rev. A
Manufacturer:
OPTOPOL Technology Sp. z o. o.
42-400 Zawiercie
www.optopol.com
info@optopol.com.pl
ul. Żabia 42
POLAND

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  • Page 1 Manufacturer: OPTOPOL Technology Sp. z o. o. ul. Żabia 42 42-400 Zawiercie POLAND www.optopol.com info@optopol.com.pl 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...
  • Page 2 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.

  • Page 3: Table Of Contents

    DESCRIPTION OF THE DEVICE ..................... 13 ........................13 NTENDED USE ........................14 NTENDED .................... 14 HE MINIMUM KNOWLEDGE ............14 DUCATION NEEDED FOR OPERATING THE TOMOGRAPH ......................14 PERATING KILLS ..................... 15 CCUPATIONAL SKILLS ..................15 OB REQUIREMENTS FOR THE USER ........................
  • Page 4 ........................38 EFORE USE ........................38 FTER USE UNPACKING AND INSTALLATION ..................39 ......................... 39 NPACKING ......................40 ONNECTING CABLES ......................42 EVICE CONNECTION ..............44 ACTORY DEFAULT CALIBRATION AND CONFIGURATION SOCT SOFTWARE ....................... 45 SOCT ....................45 UNNING APPLICATION SOCT ....................
  • Page 5 IR P ........................66 REVIEW ..................68 PERATION ON THE FUNDUS PREVIEW ..................68 OVING THE CANNING .................. 68 OTATION OF THE CANNING NGLE ................68 OVING THE NTERNAL IXATION TARGET .................... 68 HANGING THE SCAN WIDTH ..................69 HANGING THE SCANS DISTANCE .......................
  • Page 6 OCT F ......103 VALUATION OF UNDUS RECONSTRUCTION FOR OSTERIOR EXAMS ......107 VALUATION OF TOMOGRAMS FOR OSTERIOR AND NTERIOR SCANS ......................109 IMAGES ....................110 UNDUS PHOTOGRAPHY 3D E ................110 XAMINATION CCEPTANCE RITERIA ........................110 ACCADES ........................110 ANDING ......................
  • Page 7 ................. 149 SCAN PROGRAMS RESULTS REVIEW ................150 INGLE SCAN EXAMINATION REVIEW ................151 ASTER EXAMINATION RESULTS REVIEW ................153 ADIAL EXAMINATION RESULTS REVIEW ................154 ROSS EXAMINATION RESULTS REVIEW ......................155 VISUALIZATION ..................155 ANIPULATION OF THE CUBE ..................
  • Page 8 ................197 NGIOGRAPHY EXAMINATION REPORTS OCT-A ................... 201 EXAMINATION REPORTS ..................205 IOMETRY EXAMINATION REPORTS ..................... 206 ULTI SCAN REPORT ..................207 ANUALLY SELECT TOMOGRAMS ..........207 ULTI SCAN REPORT FOR OTH AND OMPARISON VIEW ....................208 INGLE TOMOGRAM REPORT ....................
  • Page 9 ] ............. 240 UANTIFICATION ENSITY AND KELETON OCT A ..................244 NGIO NALYSIS ABLE ......................244 VIEW ....................246 OMPARISON VIEW ....................247 ROGRESSION VIEW ...................... 248 OTION ORRECTION 3D E ..............249 OTION ORRECTION IN XAMINATIONS DISC OCT-A........................250 .
  • Page 10 ..................284 OPOGRAPHY CQUISITION ......................285 UTO MODE ......................286 UTO MODE ....................287 CCEPTANCE SCREEN ....................288 OTAL UALITY ACTOR ....................... 288 ESULT REVIEW ......................288 INGLE VIEW ......................290 VIEW ....................291 OMPARISON VIEW ....................291 ROGRESSION VIEW ........................
  • Page 11 ......................325 ARAMETERS TAB ......................326 OICE MESSAGES ......................327 ESULTS SETTINGS ......................328 NONYMIZATION ......................331 ISUAL IELD ..................... 332 NPUT SETTINGS WINDOW ....................333 DIT DISEASE LIST WINDOW ......................333 UTPUT SETTINGS ....................333 UTPUT SET WINDOW AI D ............
  • Page 12 TROUBLESHOOTING ....................356 LIST OF FIGURES ......................359 PRODUCT COMPLIANCE ....................369 ....................... 369 ADIO NTERFERENCE ....................369 ANADIAN EGULATIONS ......................369 INFORMATION 12 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 13: Description Of The Device

    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.

  • Page 14: Intended User

    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.

  • Page 15: Occupational Skills

    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.

  • Page 16: Contraindication

    PDF format. The Instruction Manual in paper form is available on request. To receive user manual in hardcopy please contact authorized OPTOPOL representative to receive it. Instruction Manual Applicability This document applies to the SOCT running with the application software version 8.0 or higher, unless superseded.

  • Page 17: Disposal

    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.

  • Page 18: Authentication Of Users

    For questions regarding cyber security contact the Manufacturer. Ensure Trusted Content Restrict Software of Firmware Updates to Authenticated Code. Software and firmware updates are performed by OPTOPOL representative from a protected source. All updates require a Privileged account. Cybersecurity event Provide information to the end user concerning appropriate actions to take upon detection of a cybersecurity event.

  • Page 19: Other Implemented Mechanisms

    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.

  • Page 20: Technical Data

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

  • Page 21: Soct Copernicus Revo/ Soct Copernicus / Revo 60/Revo 80

    23 kg OCT Angiography is an optional software module available only for REVO 60/REVO 80. If you do not have this feature and want to purchase it, contact Optopol’s local distributor. Biometry and Topography are optional software modules. If you do not have this feature and want to purchase it, contact Optopol’s local distributor.

  • Page 22: Technical Data Revo Fc

    30 kg OCT Angiography is an optional software module available in REVO FC. If you do not have this feature and want to purchase it, contact Optopol’s local distributor. Biometry and Topography optional software modules. If you do not have this feature and want to purchase it, contact Optopol’s local distributor.

  • Page 23: Device Classification

    Device classification Classification Class 1 Laser Device Protection against electric shock Class 1 Degree of protection against electric Type B applied parts (chin rest, forehead rest) shock and ground Degree of Protection against IPX0 ingress of water Mode of operation Continuous operation Minimum computer system requirements Capture station...

  • Page 24: Review Station

    Review station Processor Intel® Core™ i5 2.4 GHz or higher No of cores: min. 2 physical cores, 4 logical min. 16 GB Operating system Windows 7 Professional or Ultimate SP1 or later, Windows 10 Professional 64-bits Minimum 256 GB Screen resolution: minimum 1920 x 1080 (Full HD), 3840 x 2160 (4K) (For graphical objects to be scaled correctly while using 4K...

  • Page 25: Safety

    3 SAFETY Safety information CAUTION Follow operating instruction Indicates a fuse is present near this symbol On / Off Type B Applied Parts Date of manufacture Manufacturer Electrical and Electronic Equipment waste. Do not throw the product away with normal household waste at the end of its life Sign of conformity with essential requirements –...

  • Page 26: Product Label

    The sample label of the SOCT Copernicus REVO/SOCT Copernicus is presented below. The sample label of the REVO 60/REVO 80 is presented below. The sample label of the REVO nx is presented below. The sample label of the REVO FC is presented on the right.
  • Page 27 The following table describes the marks and indications on the product label. Manufacturer’s name and address Year of manufacture Serial Number in eight digits and coded year of production Sign of conformity with essential requirements – The Medical Device Directive 93/42/EEC;...

  • Page 28: Safety Standards

    The Isolating Transformer can be installed in patient environment in accordance with IEC 60601-1 standard. OPTOPOL recommends connecting the system via an uninterruptible power supply (UPS) to the wall outlet. NOTE: Only the PC, monitor and printer have to be connected to the isolating Transformer.
  • Page 29 NOTE: In situation when the cameras housing cover is removed, while examining the patient, the system operator must not touch at the same time the patient and uncovered parts of the device. SOCT is connected to PC using USB 3.0 cable. There are no user serviceable parts inside SOCT device.

  • Page 30: Warnings

    WARNING: No modification of this equipment is allowed. WARNING: OPTOPOL recommends that no accessories other than those specifically called out in this user manual may be connected to the system. Any customer accessory equipment connected to the interface ports must...
  • Page 31 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.
  • Page 32 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.
  • Page 33 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.

  • Page 34: Cautions

    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.
  • Page 35 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.

  • Page 36: General Notes

    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.
  • Page 37 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.

  • Page 38: Notes On Use

    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.

  • Page 39: 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.

  • Page 40: Connecting Cables

    Figure 2. REF 190 and 193 series device CAUTION: The SOCT weighs approximately 23 kg or 30 kg. It should be lifted by at least two persons. Use only the indicated positions for lifting. After unpacking, one should check the whole set for any mechanical damages, cables damages, etc.
  • Page 41 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...

  • Page 42: Device Connection

    AC cord AC LINE Isolating AC socket AC cord transformer AC LINE lilineLcor Figure 5 Electrical connection scheme * - Elements of medical system are not provided by OPTOPOL Technology. 42 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 43 • REVO FC External fixation External fixation Applied part: forehead support Applied part: chinrest support Figure 6. The chassis (front and side), applied parts and external fixation of the REVO FC • REVO External fixation External fixation Applied part: forehead support Applied part: chinrest support Figure 7.

  • Page 44: Factory Default Calibration And Configuration

    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.

  • Page 45: Soct Software

    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.

  • Page 46: Patient Window

    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.

  • Page 47: Customization Of The Patient List View

    menu. To customize width of each column, grab the end of the column’s header and move to desired position. Patient filter: use this field to quickly find a patient on the list. Enter the first few letters of the patient's name and the system will find the closest match Sort the patients according...
  • Page 48 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.

  • Page 49: Editing Personal Data

    It means that there is a suspicion, that the patient already exists, but the reference number was entered incorrectly. The operator should make sure the data is correct and can decide whether to register the patient or cancel registration. Editing personal data In order to edit currently selected patient's data, find the patient on the Patient list, Right-Click over patient record and select [Edit].

  • Page 50: Deleting Exam/S

    Right Click to open List of the patient’s Visit menu examinations. The last visit expanded Right Click to open Hold cursor to enlarge Exam menu fundus reconstruction Click to expand the exam list from Thumbnail of specific visit scanned image Figure 12.

  • Page 51: Connecting Scans Connected To The Wrong Patient

    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.

  • Page 52: Filter

    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 examinations are displayed. Today “Today’s”...

  • Page 53: Work List

    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.

  • Page 54: Examination Acqusition Tab

    Fixation control and voice Live OCT preview Examination list guide language selection Figure 14.Examination window view for REVO nx / SOCT COPERNICUS REVO/ SOCT COPERNICUS / REVO 60/REVO 80 54 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 55 Examination panel Patient information Device head movement controls Examination list pSLO live fundus preview Fixation control and voice Scan parameters and Live OCT preview guide language selection settings panel Figure 15. Examination window view for REVO FC Examination Panel 1. Scan mode - enables the user to choose the mode of scanning. For each eye area (Retina, Disc, Anterior, Central) a set of examinations is available.
  • Page 56 Movement control 1. Eye selector - the measurement unit moves to the patient's selected eye. 2. Start - press the start button to automatically align and optimize the scanning signal. When Auto Acquire is checked the system will capture an examination.
  • Page 57 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.
  • Page 58 Scan parameters panel Scan parameters panel shows the parameters of the loaded examination. 1. Settings - enables the user to change the parameters of the exam such as width, number of A-scan, number of B-scan, exam mode (vitreous or choroid). List of examinations List of taken examinations - shows the previews of taken examinations.

  • Page 59: Selection Of Scan Pattern Mode

    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.

  • Page 60: Selection Of Scanning Program

    [Biometry] group – AL and ACD scan programs. [Topography] group Central: The fixation target is offset to allow placing the macula and the optic disc in the center of the scanned area. Useful for peripheral observation. Protocol: Protocol allows to perform predefined set of exams of different type one by one.

  • Page 61: Oct Biometry Programs

    Full range programs B-scan Anterior Chamber Full range scan of the anterior chamber Anterior Chamber radial Full range scan of the anterior chamber Central Full Range Posterior B – scan OCT Biometry programs AL – scan provides: AL, CCT, ACD, LT OCT Biometry provides biometric axial lengths measurement.

  • Page 62: Fundus Camera Programs

    * 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.

  • Page 63: Selection Of Protocol

    OCT Angiography programs with Fundus Photo available with ANGIO module: Retina Retina Angiography Angiography Angiography + Fundus + Fundus mosaic 10x6 Photo Photo + Fundus Photo * Programs available only for the REVO FC (OCT with Fundus Camera). Selection of protocol The Protocol function enables operators to use a set of predefined scanning programs to capture tomograms according to certain diseases and the anatomy being examined.

  • Page 64: Device Head Movement Controls

    On the Z working distance, images create one view. Click on the pupil to correct the objective lens position. Touch screen control is an option. Contact Optopol representative for availability. 64 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 65: Eye Preview

    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.

  • Page 66: Fundus Preview

    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. Figure 20. Properly aligned measurement head position Fundus preview pSLO Live fundus preview Pseudo SLO (pSLO) live image shows the enface view of fundus.
  • Page 67 b. Live preview window – you can move the fixation target or scroll the mouse wheel over the window to change the working position c. Grab and move the horizontal and/or vertical tomogram windows. a. The eye preview window D c.

  • Page 68: Operation On The Fundus Preview

    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.

  • Page 69: Changing The Scans Distance

    Changing the scans distance change 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.
  • Page 70 Number of A-scans per B-scan. Scanning mode Use the slider to change the value Scanning program Number of B-scans Scanned area change Averaging (available for: B-scan, Cross, Raster) Scanning angle change Fundus Camera mode Fundus Camera on/off FC Flash level adjustment FC Gain settings Fundus Camera mode FC acceptance window on/off...
  • Page 71 No. of Averaging number defines how many times B-scan is repeated in one location. It is used to compose averaged image. It is available for B-scan and Raster. Color mask - Toggles live OCT preview in grey scale or color. C- gate mode, Vitreous and Choroid modes can be selected.

  • Page 72: Live Oct Preview

    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.

  • Page 73: Itracking

    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.
  • Page 74 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.
  • Page 75 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.

  • Page 76: Conducting Examination

    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.

  • Page 77: Acquisition Modes Description

    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”...
  • Page 78 Scan optimization and tomogram position alignment. Double click or [Acquire] button starts measurement. 3. If QI and position of the tomogram are proper proceed to point 6. Figure 34. Proper quality and position of the tomogram 4. Manually optimize signal and if required (low saturation, shadows on edges), change the scanned area e.g.

  • Page 79: Manual Mode

    Manual mode 1. Uncheck [Auto Acquire] 2. Align the pupil position. Move forward until both images create one. Then press the center of the pupil to align the lens across the center of the pupil. Full auto mode is disabled Press forward movement until two images crate one...

  • Page 80: Scanning Programs Description

    • Change scanners offset. • In order to visualize the interesting retina structures better you can choose Chorioretinal and Vitreoretinal C-gate mode. 6. Some refracting correction may be needed to obtain the best quality of tomogram. Observe the QI bar in order to obtain the best signal while changing [FOCUS] bar position. 7.

  • Page 81: Disc Area Examination

    Figure 39. Central examination proper scan alignment Disc area examination 1) Prepare the patient as explained in chapter 8.1 Preparation for examination. 2) Select Disc mode and scan type from program panel. NOTE: Program settings do not change Fixation position. 3) When sound support system is not active instruct the patient to look at the fixation point and follow it when it moves.

  • Page 82: Oct Angiography Examination

    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.

  • Page 83: Oct Angiography Mosaic Mode

    OCT Angiography mosaic mode 1. Prepare a patient as explained in chapter 8.1 Preparation for examination. 2. Instruct patient that in mosaic examination you are going to take a few scans. If a scan is carried out again, roman numerals indicative of the repeat number will be shown at the top of the exam on the list.
  • Page 84 8.3.5.2 Manual mosaic acquisition mode 1. Prepare a patient as explained in chapter 8.1 Preparation for examination. 2. Instruct patient that you are going to take a few examinations and fixation target may change the position. 3. Select one of Angiography mode program. If required you can change default parameters.

  • Page 85: Anterior Measurement

    Anterior measurement In order to conduct examination of anterior segment, follow the instructions below: 1) Select Anterior, and scan program if required. 2) Prepare the patient as explained in chapter 8.1 Preparartion for examination. 3) Press the [START] button to switch to the Full Auto or Semi Auto acquisition mode. 4) In Semi Auto or Manual verify the position of the OCT signal before pressing [Acquire] button.

  • Page 86: Wide Anterior Programs

    Figure 46.Single angle measurement proper alignment 5) Once the scan location is set in selected place, click twice on the tomogram or press [Acquire] button. PC will initialize measurement process and then full scan will be performed. NOTE: Only when border air - anterior surface is correct are AOD and TISA measurements accurate.
  • Page 87 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.
  • Page 88 5.1. Get the adapter to the objective and rotate 90 clockwise. Figure 49. Anterior adapter mounting. Rotate to lock. NOTE: Ensure that scanning head is in maximum backward position and patient will not incidentally hit the anterior adapter. CAUTION: Be careful when mounting anterior adapter in order not to scratch the objective lens.

  • Page 89: Biometry Program

    − 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.
  • Page 90 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.
  • Page 91 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.
  • Page 92 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.
  • Page 93 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 [Accept] – Closes the acceptance window and the Acquire window is displayed. The exam is saved.

  • Page 94: Full Range Examination Mode

    5.0 mm (Revo FC) or 4.8 mm (SOCT Copernicus, SOCT Copernicus Revo, Revo 60, Revo 80, Revo nx, Revo nx 130). In order to perform a Full Range scan of the anterior segment of the eye it is necessary to install the anterior adapter on the lens of the SOCT device. Anterior adapter installation instructions can be found in section 8.3.7 Wide Anterior...

  • Page 95: Central 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 refresh.

  • Page 96: External Fixation

    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 refresh.

  • Page 97: Examination Tips

    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: ▪...

  • Page 98: Auto C-Gate Issues

    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.: ▪...
  • Page 99 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.
  • Page 100 3D Central, align the retina between the two dashed horizontal lines. For all Vitreous scans, align the Vitreous structure between the two dashed horizontal lines. Anterior B-Scan Angle C-Gate top, place the angle structure below the dashed horizontal lines. Anterior Wide B-Scan with Two Angles, align the two angles between the dashed horizontal lines.

  • Page 101: Tips To Successfully Scan Difficult Patients

    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 highest...
  • Page 102 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.

  • Page 103: Critera For Exam Acceptance

    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.
  • Page 104 • 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).
  • Page 105 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.
  • Page 106 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.

  • Page 107: Evaluation Of Oct Tomograms For Posterior And Anterior Scans

    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.
  • Page 108 • 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 •...

  • Page 109: Oct Images

    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.

  • Page 110: Fundus Photography

    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.

  • Page 111: Weak Local Signal

    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.

  • Page 112: Image Quality

    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.
  • Page 113 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. 113 / 374 SOCT User Manual Version 10.0 rev.

  • Page 114: Result Review

    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.

  • Page 115: Types Of Analysis

    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...

  • Page 116: 3D Tab

    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.

  • Page 117: 10 Posterior Analysis

    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.
  • Page 118 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 Correlation of the fundus photo...
  • Page 119 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.
  • Page 120 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 (b-scan, 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.

  • Page 121: Both Eyes Tab

    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.
  • Page 122 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 map asymmetry 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:...
  • Page 123 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. Right click the asymmetry map and select [Set standard grid resolution] or [Set super grid resolution] to change the display method.
  • Page 124 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.

  • Page 125: Comparison

    Comparison The comparison module is used to observe follow up changes in the eye structure. System automatically tries to correlate examinations. System displays correlation status as a right side of exam time. Available statuses: A - Automatically correlated M - Manually correlated Not correlated.

  • Page 126: Progression

    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.
  • Page 127 NOTE: In case when examinations are not correlated, evaluation of the quantified values has to be done carefully. For correlation, see chapter 16 EXAMINATIONS CORRELATION. 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.
  • Page 128 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 The Thickness or Difference map can be selected from the list box and overlaid on the reconstruction image.

  • Page 129: Optic Nerve Head Analysis

    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...
  • Page 130 10.2.1.1 [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.
  • Page 131 • 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.
  • Page 132 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 10.2.1.2...
  • Page 133 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. •...
  • Page 134 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. •...
  • Page 135 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.
  • Page 136 Correlation window Correlation status NFL thickness map NFL Significant map NFL trend plot ONH table parameters TNIST profile 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...
  • Page 137 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. 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.

  • Page 138: Advanced View - Retina And Optic Nerve Head Analysis

    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.

  • Page 139: Strucutre & Function - Combined Oct And Vf Report

    • 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. 5.
  • Page 140 Select the VF examination VF testing range Key for VF results and examination date Combined map of Sensitivity map Structure Total Deviation map & Function Pattern Deviation map VF parameters ONH table Retina thickness map NFL parameters Disc thickness map Symmetry NFL Retina deviation map profile...
  • Page 141 10.4.4 Structure & Function - VF Locations Layer 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) •...

  • Page 142: Relationships Between Vf And Rnfl/Ganglion Maps

    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. This concept is based on Structure & Function map introduced by Garway-Heath et al.13. Figure 108 Relationships between OCT and VF by Garway-Heath et al.

  • Page 143: Structure & Function - Vf Results Layer In Combined View

    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 •...
  • Page 144 Figure 110 Disc area Figure 109 PPD Probability Results 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:...

  • Page 145: Structure & Function - Vf Locations Layer

    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; •...
  • Page 146 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...
  • Page 147 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 | •...

  • Page 148: Central Examination

    Central examination Result review of Central examination can give below options of display: - Depending on type of conducted examination: Central 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: •...

  • Page 149: 2D Scan Programs Results Review

    None 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 Cross scan Single B-scan Disc: Raster...

  • Page 150: Single B-Scan Examination Review

    For more detailed description of above scan modes refer to chapter 7.2 Selection of scanning program. Single B-scan examination review. Single B-scan 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.

  • Page 151: Raster Examination Results Review

    Comparison Figure 119. Single B-scan 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: 151 / 374 SOCT User Manual Version 10.0 rev.
  • Page 152 Single scan Figure 121. Retina raster, single scan view. Figure 122. Central raster single scan view. Both eyes Figure 123. Raster both eyes view 152 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 153: Radial Examination Results Review

    Comparison 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.

  • Page 154: Cross Examination Results Review

    Figure 126 Radial examination single view Retina thickness map Retina signification map Retina thickness map Information table RPE deformation map Retina signification map Sectors grid Information table Tomogram Sectors grid RPE deformation map Tomogram Figure 127. Radial examination both view. Figure 128.

  • Page 155: 3D Visualization

    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.

  • Page 156: Operation Panel [Solid ]

    [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.
  • Page 157 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.

  • Page 158: [Solid] View

    [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.

  • Page 159: [Volume 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.

  • Page 160: 11 Anterior Segment Analysis

    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.
  • Page 161 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.
  • Page 162 Schwalbe’s line Schlemm’s canal Iris Scleral 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 162 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 163: Anterior Radial

    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.
  • Page 164 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.

  • Page 165: [Both Eyes] Tab Screen

    Tomogram tab-> Menu -> Change Analysis type. The anterior Analysis type window will appear. Select [Cornea] type. [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.

  • Page 166: [Progression] Tab Screen

    1. Eye preview 2. Thickness map 3. Corneal thickness (μm) 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.
  • Page 167 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. 3. Epithelium map. Shows the corneal epithelium thickness map for five examinations. 4.

  • Page 168: Edit Anterior Surface

    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 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.

  • Page 169: Aod Measurement

    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.

  • Page 170: Angle Measurement Tool

    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.

  • Page 171: Caliper Tool

    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.

  • Page 172: 12 Full Screen Window

    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...

  • Page 173: Imaging Tools

    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...

  • Page 174: Brightness And Contrast Adjustment

    Measurement of the section Area measurement tool Distance measurement 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.

  • Page 175: Full Screen Mode Exit

    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. Resetting Brightness and Contrast After Adjustment: Right-click the OCT image, and select [Reset Brightness/Contrast] from the menu.

  • Page 176: Edition Of Recognized Layers

    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. Edition of recognized layers System automatically recognizes layers. Whenever you find out that the recognition of layers is incorrect, you can manually correct them.

  • Page 177: Manual Disc Contour Edition

    The abbreviations and names of the layers and boundaries shown in analysis are as follows. Internal Limiting Membrane Nerve Fiber Layer Ganglion Cell Layer Inner Plexiform Layer Inner Nuclear Layer Outer Plexiform Layer Outer Nuclear Layer Photoreceptor Inner Segment Photoreceptor Outer Segment Retinal Pigment Epithelium Bruch’s Membrane Manual disc contour edition...

  • Page 178: Redraw The Disc Contour

    [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] –...
  • Page 179 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.

  • Page 180: 13 Print

    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 Figure 154. Examination report for Retina 3D both output 180 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 181 Figure 155. Examination report for Retina Comparison single view Figure 156. Examination report for Retina Progression single view 181 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 182 Figure 157. Examination report for Retina Ganglion both view Figure 158. Examination report for Retina Progression Ganglion single view 182 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 183: Disc 3D

    Figure 159. Examination report for Retina Progression Tomogram Morphology view Disc 3D Figure 160. Examination report for Retina + Disc Advanced both view 183 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 184 Figure 161. Examination report for Retina Central view Figure 162. Examination report for 3D Retina single view 184 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 185: Optic Nerve Head Analysis Reports

    Optic nerve head analysis reports Figure 163. Examination report for single disc view Figure 164. Examination report for 3D single disc view 185 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 186 Figure 165. Examination report for both disc view Figure 166. Examination report for single disc progression view 186 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 187 Figure 167. Examination report for Disc + Retina advanced both view Anterior segment examination reports Figure 168. Structure and function examination report 187 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 188 Figure 169 Examination report for Anterior segment single view Figure 170. Examination report for Anterior segment both view 188 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 189 Figure 171. Examination report for Anterior segment comparison view Figure 172. Examination report for Anterior segment progression view 189 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 190 Figure 173. Examination report for Wide Anterior B-scan single view Figure 174. Examination report for Wide Anterior B-scan both view 190 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 191: Topography Examination Reports

    Figure 175. Examination report for Wide Anterior segment progression B-scan view Topography examination reports Figure 176. Examination report for Topography pachymetry single view 191 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 192 Figure 177. Examination report for Topography pachymetry both view Figure 178. Examination report for Topography comparison view 192 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 193 Figure 179. Examination report for Topography comparison pachymetry view Figure 180. Examination report for Topography progression view 193 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 194 Figure 181. Examination report for Topography progression, tomograms view Figure 182. Examination report for Topography progression pachymetry view 194 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 195: Fundus Examination Reports

    Fundus examination reports Figure 183. Examination report for Fundus single view Figure 184. Examination report for Fundus both view 195 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 196 Figure 185. Examination report for Fundus single view x4 Figure 186. Examination report for Fundus comparison view 196 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 197: Angiography Examination Reports

    Angiography examination reports Figure 187. Examination report for Angiography standard single view Figure 188. Examination report for Angiography detailed single view 197 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 198 Figure 189. Examination report for Angiography both view Figure 190. Examination report for Angiography comparison view 198 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 199 Figure 191. Examination report for Angiography progression analysis view Figure 192. Examination report for Angiography progression standard view 199 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 200 Figure 193. Examination report for Angiography 3D view Figure 194. Examination report for Angiography advanced view 200 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 201: Disc Oct-Aexamination Reports

    Disc OCT-A examination reports Figure 195. Examination report for Disc OCT-A standard single view Figure 196. Examination report for Disc OCT-A detailed single view 201 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 202 Figure 197. Examination report for Disc OCT-A both view Figure 198. Examination report for Disc OCT-A comparison view 202 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 203 Figure 199. Examination report for Disc OCT-A progression analysis view Figure 200. Examination report for Disc OCT-A progression standard view 203 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 204 Figure 201. Examination report for Disc OCT-A 3D volume view 204 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 205: Biometry Examination Reports

    Biometry examination reports Figure 202. Examination report for Biometry single view Figure 203. Examination report for Biometry both view 205 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 206: Multi B-Scan Report

    Figure 204. Examination report for IOL Calculation 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.

  • Page 207: Manually Select Tomograms

    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.

  • Page 208: Single Tomogram Report

    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.

  • Page 209: 14 Output

    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.

  • Page 210: 15 Selecting Fundus Photo

    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.
  • Page 211 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 correlation algorithm.

  • Page 212: Fundus Image Registration Correction

    changes. Registration between the imported fundus image and retinal preview may be reviewed changing transparency over result review window (3). Clicking [OK] will save the correlation 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.
  • Page 213 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 correlation window double click on a selected image. NG checkbox Figure 215.

  • Page 214: 16 Examinations Correlation

    16 EXAMINATIONS CORRELATION 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.

  • Page 215: Manual Registration

    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.
  • Page 216 Correlation status Precise registration button Image type section Analyze button Precise registration field Reset button Transparency slider Correlation review window Select Fundus Photo Figure 217. Fundus and OCT correlation 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.

  • Page 217: Manual Correlation

    Select Fundus Photo Allows the user to select a fundus photo for correlation Clicking OK closes the window and saves the result of the correlation 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 Correlation preview to open the following context menu:...

  • Page 218: Moving The Overlaid Oct Image

    16.2.2.1 Fast manual correlation If the user needs a quick, “on the spot” correlation result, they can manually stretch, move and rotate the OCT image over the fundus photo until a visual correlation of the structures is achieved. In order to stretch the OCT image, place the mouse cursor over any of the edges of the image.

  • Page 219: Closing Fundus And Oct Correlation Window

    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 of the image.

  • Page 220: Fundus Camera - Result Review

    Blue navigation Lock button 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: Lock is off, no correlation Lock is on, no correlation Extracted tomogram function is on FUNDUS CAMERA –...

  • Page 221: Color Fundus Photo

    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 Color fundus photo Full screen view Color channels manipulation...

  • Page 222: Color Fundus Photo [Both] View

    the sliders for all individual channels is available with three sliders respectively for the three channels (R, G, B). Loup - enlarges an area of Fit to window the image Zoom in/out Oryginal size Flip horizontally/vertically Figure 223. Display settings in single eye color fundus photo full screen view Color fundus photo [Both] view Display settings Left eye...

  • Page 223: 17 Angiography Oct

    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.

  • Page 224: [Single] View - Detailed

    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.
  • Page 225 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.

  • Page 226: Angio Oct Analysis

    Angio OCT Analysis. 17.1.3.1 Angiogram object Depth color coded Angiogram Scroll window thickness Layer selection Enface image Layers selector Layer offset layers Range of scale Tomogram selector 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.
  • Page 227 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 Superficial Vascular Plexus ILM 0µm, IPL/INL 10µm 227 / 374 SOCT User Manual Version 10.0 rev.
  • Page 228 RPCP Radial Peripapillary Capillary ILM 0µm, Plexus NFL/GCL 0µm Deep Deep Capillary Plexus IPL/INL -15µm, IPL/INL -70µm Deep Vascular Plexus IPL/INL 10µm, OPL/ONL -10µm Intermediate Capillary Plexus IPL/INL 10µm, INL/OPL 10µm 228 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 229 Deep Capillary Plexus INL/OPL 10µm, OPL/ONL -10µm Outer retina layers (avascular Outer IPL/INL -70µm, zone) BM 0µm Choriocapillaris Choroidal Capillary BM -15µm, BM -45µm Choroid Choroidal Vessels BM -45µm, BM -160µm 229 / 374 SOCT User Manual Version 10.0 rev. A...
  • Page 230 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.
  • Page 231 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.
  • Page 232 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 –...
  • Page 233 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.

  • Page 234: Quantification Tools: Faz, Vfa, Nfa

    • 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).
  • Page 235 Switch on/off FAZ– Semi Auto mode Angiogram Switch on/off FAZ – Manual mode 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.
  • Page 236 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. 236 / 374...

  • Page 237: Vfa Tool

    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.

  • Page 238: Nfa Tool

    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.
  • Page 239 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 Angiogram Switch on/off Manual Tool Ctrl + scroll to zoom Scroll to move both layers Sensitivity slider Grab and move to change the size of the selected area...

  • Page 240: Quantification Maps

    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.
  • Page 241 • 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...
  • Page 242 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 –...
  • Page 243 Region Density 56.1 Total całość 56.2 Superior gorna polowa - plamka Inferior 56.3 Dolna polowa Superior Inferior Outer Center 56.4 sektor centalny Outer Inner 56.5 okrąg srodkowy Inner Superior Inner 56.6 gorna czesc okrąg srod Inferior Inner 56.5 dolna czesc okrąg srodk Outer 56.6 okrąg zewnetrzny...

  • Page 244: Angio Oct Analysis Table

    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.
  • Page 245 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.

  • Page 246: [Comparison] View

    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.

  • Page 247: [Progression] View

    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.

  • Page 248: Motion Correction

    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...

  • Page 249: Motion Correction In 3D Examinations

    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.

  • Page 250: Disc Oct-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.

  • Page 251: [Both] View

    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 Layer selection Vitreous Tomogram window Deep...
  • Page 252 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.

  • Page 253: Angio Disc Comparison View

    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.

  • Page 254: Mosaic

    Angiogram window Angiogram drop list 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.
  • Page 255 Angiogram boundaries Location number and inforamation order of exam Mosaic information Select vascular layer Exam selection Type of data Correlation 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.

  • Page 256: Correlation Status

    Correlation status It informs about the method of superimposition. Automatically superimpose 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.
  • Page 257 Save as Click Right mouse button and select ‘Save as...’ from menu to save mosaic image. 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.
  • Page 258 [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. Rotate Grab and move the corner to rotate. 258 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 259: 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 and performing IOL power calculations based on the patient’s biometric data and a selection of recognized IOL calculation formulas.
  • Page 260 NOTE It may not be possible, under certain circumstances, to carry out measurements on persons with fixation problems. NOTE In cases of thick 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.

  • Page 261: Biometry Acquisition Mode

    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. 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.
  • Page 262 Biometry scan programs are available in Anterior scan list. AL – scan provides: AL, CCT, ACD, LT ACD – scan program provides CCT, ACD Once scan program is selected operator has to confirm type of scanned eye. Select the eye type Select the type of vitreous Figure 260.

  • Page 263: Full Auto Mode

    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: 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.

  • Page 264: Semi Auto Mode

    [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.
  • Page 265 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.

  • Page 266: Acceptance Screen

    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.

  • Page 267: White To White

    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.

  • Page 268: Result Review

    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.

  • Page 269: Single View

    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.
  • Page 270 18.2.1.1 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.

  • Page 271: Both View

    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.
  • Page 272 18.2.3.1 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.
  • Page 273 Figure 273. Editing WTW and P results – eye preview 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.

  • Page 274: 19 Iol Calculation Tab

    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.

  • Page 275: Performing Iol Calculation

    WARNING! Using data from acoustic instruments also requires the constant of every IOL to be optimized for those kinds of instrument. At present, it is more common to find online only databases of lenses optimized for optical interferometry instruments. 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.
  • Page 276 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®Q Holladay I Haigis Theoretical/T Regression II For each eye, the user can choose even 4 formulas at the same time. Next click [Calculate] in the center of the Calculation Tab.

  • Page 277: Marking Implemented Lenses

    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.

  • Page 278: Importing Iol Data

    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.

  • Page 279: Exporting Iol Data

    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.

  • Page 280: Editing Iol Data

    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.

  • Page 281: Adding Additional Power Ranges And Increments

    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.

  • Page 282: 20 Topography Oct

    If you do not have this feature and want to NOTE: purchase it, contact Optopol’s local distributor. 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).
  • Page 283 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.

  • Page 284: Topography Acquisition Mode

    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. 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.

  • Page 285: Full Auto Mode

    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.

  • Page 286: Semi Auto Mode

    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. Semi Auto mode 1. Uncheck [Auto Acquire] Full auto mode is disabled Press forward...

  • Page 287: Acceptance Screen

    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. Acceptance screen After capturing a topography examination the system checks if all measurement parameters are on an acceptable level.

  • Page 288: Total Quality Factor

    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: QI, CI, AAA, APA Correlation Index – information about tomograms correlation in the measurements [Accepted] Not correlated >87 %...
  • Page 289 Map list box Eye preview Active map graphs Thickness graph Tomogram window Double click to enlarge Analysis summary table Click to change display settings 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]...

  • Page 290: [Both] View

    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...] 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...

  • Page 291: [Comparison] View

    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. Analysis summary table Active map graphs Figure 289.

  • Page 292: Analysis

    Active map graphs Figure 290. Progression Topography view Analysis Central Keratometry – SimK It displays the Simulated Keratometry values from the central area bases on Axial map. Keratometry (Meridian) It calculates Astigmatism base on the mean diameter in each zone. Steep Axis is read as 90 shift from flat axis.

  • Page 293: Keratometry (Semimeridian)

    Keratometry (SemiMeridian) It calculates irregular Astigmatism base on the mean radius in each zone. Calculation bases on Axial map. 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.
  • Page 294 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.
  • Page 295 OSI = D opposite DSI = D – average power value of the sector with maximum power – average power value of the sector which is opposite to the sector with maximum opposite power – average power value of the other sector with minimum power CSI (Central/Surrounding Index) –...
  • Page 296 – semi meridional position – ring number – corneal power of the point (i, j) i, j ΔA – area which corresponds to power P i, j – normalization by power – normalization by number of points – scaling constant i, j+1 Corneal power of the appropriate points: P i, j-1...

  • Page 297: Pachymetry

    Pachymetry The table displays a summary of pachymetry data. Map Types The formula for converting geometrical radius [mm] values into optical power values in Diopters [D]. Diopter: D=[(Ref index-1)*1000]/Rmm Axial maps - Axial Power is a curvature radius map that defines the center of curvature on the measurement axis.
  • Page 298 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.
  • Page 299 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.

  • Page 300: Color Scale - Standards

    Elevation Map [Anterior] An axial power map of the anterior surface. The map is drawn based on the center of the anterior surface of the cornea. Elevation Map [Posterior] An axial power map of the posterior surface. 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.
  • Page 301 Normalized Absolute S-K USS (Smolek Klyce) Normalized Axial [Posterior], Refractive Power [Kerato], Tangential [Posterior] Available scales: Steps: Units: Absolute 0,25 D 0,05 mm 0,5 D O scale 0,1 mm 0,25 mm Normalized Absolute 0,25 D 0,05 mm 0,5 D American 0,1 mm 0,25 mm Normalized...
  • Page 302 Refractive Power [Kerato], Refractive Power [Posterior], Refractive Power [Total], Net map, Axial True Net, Equivalent Keratometer, Available scales: Steps: Units: Absolute 0,25 D O scale 0,5 D Normalized Absolute 0,25 D American 0,5 D Normalized Absolute Atlas Normalized Absolute S-K USS (Smolek Klyce) Normalized Elevation [Anterior], Elevation [Posterior]...
  • Page 303 Epithelium map Available scales: Steps: Units: O scale Absolute µm RevoScale Absolute µm 303 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 304: 21 Calibration

    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.

  • Page 305: Topography Calibration

    Figure 294. Mounting the calibration tool. NOTE: Make sure the calibration tool is well fitted to the frame. WRONG CORRECT Topography calibration Intitial Topography calibration procedure If the following information pops up, the device needs to go through the initial calibration procedure.

  • Page 306: Standard Calibration

    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.
  • Page 307 [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.

  • Page 308: Axial Length (Biometry) Calibration

    [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.

  • Page 309: Biometry Calibration With The Iol Calculation Tab Activated

    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.

  • Page 310: Calibration Process

    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.

  • Page 311: Entering Biometry Calibration Parameters

    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.
  • Page 312 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.
  • Page 313 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.
  • Page 314 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.

  • Page 315: 22 Setup Window

    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.

  • Page 316: Database

    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 tested.
  • Page 317 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...

  • Page 318: Storage

    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.

  • Page 319: Users Accounts

    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.

  • Page 320: Creating User Accounts

    Enter user login Enter password User Name Retype the password User rights options Confirm [OK] or selection 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.

  • Page 321: Ldap Settings

    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.

  • Page 322: Preferences

    Preferences The preferences tab allows to customize the device and software settings. Device selection 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.

  • Page 323: Devices Setup

    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.
  • Page 324 [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.

  • Page 325: Parameters Tab

    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].

  • Page 326: Voice Messages

    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 Marked checkbox activates voice...

  • Page 327: Results Settings

    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.”...

  • Page 328: Anonymization

    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. User IOL refraction index –...
  • Page 329 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 •...
  • Page 330 • 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.

  • Page 331: Visual Field

    • 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).

  • Page 332: Input Settings Window

    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].

  • Page 333: Edit Disease List Window

    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.

  • Page 334: I. Exporting Tomograms With Or Without Ai Denoise

    i. 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.
  • Page 335 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.

  • Page 336: Dicom C-Storage Output Set

    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 –...

  • Page 337: Backup

    When printing System output data when operator initiates printing the report. 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.

  • Page 338: Recovery

    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...

  • Page 339: System Settings

    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.

  • Page 340: Mwl Settings

    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.

  • Page 341: C-Storage

    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 data collecting 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...
  • Page 342 any changes and logins made by all users. For more information please contact your local distributor. 342 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 343: 23 Maintenance And Cleaning Procedure

    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.

  • Page 344: Software Maintenance Activities

    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.

  • Page 345: Ordering Consumables

    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.

  • Page 346: Fuse

    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.

  • Page 347: 24 Network Configuration

    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.

  • Page 348: Soct Software - Viewing Station Configuration

    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. In Case of using MySQL copy ‘libmysql.dll’ from folder where MySQL is installed C:\Program files\MySQL 5.
  • Page 349 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 –...

  • Page 350: 25 Remote Connection

    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.
  • Page 351 Remote database option Host name Port of the remote server User name 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"...
  • Page 352 • 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.
  • Page 353 PTS communication option Auto-search button option Use an account option User name password for the PTS application Remote host option and the Host name and Port fields Figure 341. Visual field window in SOCT application. 353 / 374 SOCT User Manual Version 10.0 rev. A...

  • Page 354: 26 Environmental Conditions

    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...

  • Page 355: 27 Warranty And Service

    About repairs If a problem cannot be solved even after taking the measures indicated in “Chapter 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.
  • Page 356 29 TROUBLESHOOTING 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. 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.
  • Page 357 Live tomogram images are visible, but the image is fuzzy and upside down. 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.
  • Page 358 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.
  • Page 359 Figure 12. Examination list ......................50 Figure 13. Filter panel ........................52 Figure 14.Examination window view for REVO nx / SOCT COPERNICUS REVO/ SOCT COPERNICUS / REVO 60/REVO 80 ........................54 Figure 15. Examination window view for REVO FC ................ 55 Figure 16.
  • Page 360 Figure 35. Manual examination mode ................... 79 Figure 36. Manual examination process. Scan optimization and tomogram position alignment . 79 Figure 37. Proper position and the quality of the tomogram ............79 Figure 38. Proper Alignment of retina tomogram ................80 Figure 39.
  • Page 361 Figure 71. Example of a cataract patient with a loss of saturation ..........105 Figure 72. Examples of floaters with saccadic motion ..............105 Figure 73 Example of an uncorrected blink .................. 106 Figure 74 Blink artifacts corrected to an acceptable standard............. 106 Figure 75.
  • Page 362 Figure 107 Selecting the patient and VF examination window ............ 141 Figure 108 Relationships between OCT and VF by Garway-Heath et al........142 Figure 109 PPD Probability Results ....................144 Figure 110 Disc area ........................144 Figure 111 PPD Combined view results ..................144 Figure 112 Enable VF results from Context menu ................
  • Page 363 Figure 142. Example of an AOD measurement ................169 Figure 143. Example of an angle measurement ................170 Figure 144. Example of a caliper measurement ................171 Figure 145. Full screen tomogram ....................172 Figure 146. Eye preview type selection..................172 Figure 147.
  • Page 364 Figure 177. Examination report for Topography pachymetry both view ........192 Figure 178. Examination report for Topography comparison view ..........192 Figure 179. Examination report for Topography comparison pachymetry view ......193 Figure 180. Examination report for Topography progression view ..........193 Figure 181.
  • Page 365 Figure 213 Vascular layer previews ....................212 Figure 214. Context menu ......................213 Figure 215. Fundus photo selection for linking with an examination .......... 213 Figure 216. The result of OCT correlation – registration ............. 214 Figure 217. Fundus and OCT correlation window ................ 216 Figure 218.
  • Page 366 Figure 247. Comparison Retina Angio view ................. 246 Figure 248. Progression Retina Angio Analysis view ..............247 Figure 249. Progression Retina Angio Standard view..............247 Figure 250. Example of Motion Corrected examination .............. 249 Figure 251. Single Standard Disc Angio view ................250 Figure 252.
  • Page 367 Figure 283. Manual examination mode ..................286 Figure 284. Manual examination process ..................287 Figure 285. Topography Exam Acceptance window ..............287 Figure 286. Single Topography view ..................... 289 Figure 287. Enlarged detailed Topography map view ..............290 Figure 288. Both Topography view ....................291 Figure 289.
  • Page 368 Figure 319. Results review settings tabs..................327 Figure 320. Anonymization settings window................329 Figure 321 Visual Field settings window ..................331 Figure 322 Input settings window ....................332 Figure 323. Disease list window ....................333 Figure 324 Output set window ..................... 333 Figure 325.
  • Page 369 31 PRODUCT COMPLIANCE Radio Interference The REVO nx has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with this user manual, may cause interference to radio communications.
  • Page 370 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...
  • Page 371 Power frequency Power frequency magnetic fields should be at (50/60 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 U is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration –...
  • Page 372 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, should be less than the compliance level in each...
  • Page 373 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 150 kHz to 80 MHz to 800...
  • Page 374 equipment and the other equipment should be observed to verify that they are operating normally 374 / 374 SOCT User Manual Version 10.0 rev. A...

This manual is also suitable for:

Revo nx 130Soct copernicus revoSoct copernicusRevo 60Revo 80Revo fc

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