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Optopol REVO nx User Manual

Optopol REVO nx
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SOCT User Manual Version 10.0 rev. A
Manufacturer:
OPTOPOL Technology Sp. z o. o.
ul. Żabia 42
42-400 Zawiercie
POLAND
www.optopol.com
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
0197
Make sure you read this manual before using
the instrument. Keep this manual in a safe
place so that you can use it in the future.

Table of Contents

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Optopol REVO nx Specifications

General IconGeneral
BrandOptopol
ModelREVO nx
CategoryMedical Equipment
LanguageEnglish

Summary

1 DESCRIPTION OF THE DEVICE

1.1 Intended Use

Defines the purpose of the SOCT device for diagnosing and managing ocular diseases.

1.2 Intended User

Specifies the required qualifications and skills for operating the SOCT system.

1.6 Contraindication

Lists conditions where the SOCT device should not be used to ensure patient safety.

1.7 Protective Measures for IT Systems

Outlines essential cybersecurity measures for IT systems connected to the SOCT.

1.8 Cybersecurity Functions

Summarizes cybersecurity controls for the SOCT with Windows 10 operating system.

2 TECHNICAL DATA

2.1 Technical Data REVO nx 130 / REVO nx

Provides detailed technical specifications for the REVO nx and REVO nx 130 models.

2.5 Minimum computer system requirements

Specifies the hardware and software requirements for the capture and review stations.

3 SAFETY

3.3 Safety standards

Details the safety standards and compliance requirements for the SOCT system.

3.4 Warnings

Highlights critical hazards that may result in property damage, injury, or death.

3.5 Cautions

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

4 UNPACKING AND INSTALLATION

4.1 UNPACKING

Provides step-by-step instructions for safely unpacking the SOCT device.

4.3 DEVICE CONNECTION

Explains how to physically connect the SOCT device to the PC and power.

5 SOCT SOFTWARE

5.1 Running SOCT application

Guides users on how to start and activate the SOCT software application.

6 PATIENT WINDOW

6.1 Patient list view

Covers viewing and managing the list of patient examinations.

6.2 Registering new patients

Details the process for adding new patient records into the SOCT database.

6.5 Examination list

Describes how to view and manage the list of patient examinations.

6.8 Exporting examinations

Explains how to export examination data in various formats.

7 EXAMINATION ACQUISITION TAB

7.1 SELECTION OF SCAN PATTERN MODE

Covers choosing the scan mode for retina, disc, anterior, and central scans.

7.2 SELECTION OF SCANNING PROGRAM

Details how to select specific scanning programs like 3D, Radial, and B-scan.

7.4 DEVICE HEAD MOVEMENT CONTROLS

Explains how to operate the device head movement controls via mouse or touchscreen.

7.9 CUSTOMIZING SCAN PARAMETERS

Guides on adjusting scan parameters and saving custom settings.

8 CONDUCTING EXAMINATION

8.1 PREPARATION FOR EXAMINATION

Covers essential steps for preparing the patient and the device before an exam.

8.2 ACQUISITION MODES DESCRIPTION

Explains the differences and usage of Full Auto, Semi Auto, and Manual acquisition modes.

8.3 SCANNING PROGRAMS DESCRIPTION

Details various scanning programs like Retina, Central, Disc, and Angiography.

8.8 CRITERA FOR EXAM ACCEPTANCE

Defines the criteria for evaluating the quality and suitability of captured OCT images.

9 RESULT REVIEW

9.1 TYPE OF VIEW MODE

Describes different analysis views like Single, Both Eyes, Comparison, and Progression.

9.3 AI DENOISE

Explains the AI DeNoise algorithm for noise reduction and image quality enhancement.

10 POSTERIOR ANALYSIS

10.1 RETINA THICKNESS ANALYSIS

Details the analysis of retinal thickness, including maps, graphs, and sector data.

10.2 OPTIC NERVE HEAD ANALYSIS

Covers the analysis of NFL thickness and optic nerve head shape parameters.

10.4 STRUCUTRE & FUNCTION – COMBINED OCT AND VF REPORT

Explains how to combine OCT and Visual Field data for a comprehensive report.

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

Lists prerequisites for loading perimeter tests into the SOCT application.

11 ANTERIOR SEGMENT ANALYSIS

11.1 ANTERIOR RADIAL

Details corneal thickness analysis using Anterior Radial and Wide Anterior Radial modes.

11.1.6 AOD MEASUREMENT

Explains how to use the tool to evaluate the angle opening (AOD).

11.1.7 ANGLE MEASUREMENT TOOL

Guides on using the tool to measure angles in the anterior segment.

11.1.8 CALIPER TOOL

Describes the Caliper tool for measuring lengths of anterior chamber structures.

11.1.9 TOMOGRAM REVIEW ANALYSIS

Explains how to review tomogram images and defined thicknesses.

12 FULL SCREEN WINDOW

12.2 IMAGING TOOLS

Covers tools for changing color and tomogram proportions.

12.3 MEASUREMENT TOOLS AND ANNOTATIONS

Explains how to use measurement tools and add annotations to images.

12.7 EDITION OF RECOGNIZED LAYERS

Details how to manually correct layer recognition for accurate analysis.

12.8 MANUAL DISC CONTOUR EDITION

Guides on manually editing the disc contour for accurate optic nerve head analysis.

13 PRINT

13.1 POSTERIOR SEGMENT EXAMINATION REPORTS/OUTPUTS

Covers the generation of reports and outputs for posterior segment examinations.

13.4 DISC OCT-A EXAMINATION REPORTS

Covers the specific reports for Disc OCT-A examinations.

13.5 BIOMETRY EXAMINATION REPORTS

Details the reports generated for biometry examinations.

13.6 MULTI B-SCAN REPORT

Explains how to generate and manage multi B-scan reports.

13.8 SELECT DESIRED PRINTER

Guides on selecting the printer before initiating a print job.

14 OUTPUT

15 SELECTING FUNDUS PHOTO

Guides on importing and selecting fundus photos for analysis.

15.1 ADDING FUNDUS PHOTO TO THE EXAMINATION

Details the process of adding fundus photos to an existing examination.

16 EXAMINATIONS CORRELATION

16.1 OCT-OCT REGISTRATION

Explains how the system automatically correlates OCT examinations.

16.2 FUNDUS CORRELETION

Covers correlating fundus photographs with OCT examinations.

16.3 EXTRACTING TOMOGRAMS FROM A 3D EXAM

Explains how to display follow-up tomograms for comparison with a reference.

16.4 FUNDUS CAMERA – RESULT REVIEW

Guides on reviewing results from Fundus camera photography acquisition.

17 ANGIOGRAPHY OCT

17.1 RETINA OCT-A

Provides details on acquiring and analyzing Retina OCT-A scans.

17.2 QUANTIFICATION TOOLS: FAZ, VFA, NFA

Introduces tools for quantifying vascular parameters like FAZ, VFA, and NFA.

17.3 MOTION CORRECTION

Explains the algorithm for eliminating eye movement artifacts in Angio OCT and 3D exams.

17.4 DISC OCT-A

Covers the analysis of Disc OCT-A scans.

17.5 MOSAIC

Describes the Angio mosaic feature for presenting a wider field of view.

18 BIOMETRY OCT

18.1 Biometry Acquisition Mode

Details how to perform biometry measurements, including acquisition modes.

18.2 Result review

Guides on reviewing biometry measurement results for validity.

18.1.4 White to White

Defines White to White measurement and its values.

19 IOL CALCULATION TAB

19.1 Performing IOL calculation

Guides on calculating intraocular lens power using patient biometric data.

19.3 IOL EDITOR

Explains how to import, export, and edit IOL data and constants.

20 TOPOGRAPHY OCT

20.1 TOPOGRAPHY - SAFETY NOTES

Provides critical safety notes for using the topography module.

20.2 TOPOGRAPHY ACQUISITION MODE

Explains the different acquisition modes for topography scans.

20.3 RESULT REVIEW

Guides on reviewing topography scan results.

20.4 ANALYSIS

Covers various analysis types for topography data.

20.4.4 KERATOCONUS SCREENING

Details the keratoconus screening process and KPI results.

20.5 MAP TYPES

Explains different types of topography maps available for analysis.

21 CALIBRATION

21.1 CALIBRATION PROCEDURE PREPARATION

Details how to prepare and install the calibration tool for device calibration.

21.2 TOPOGRAPHY CALIBRATION

Guides on performing initial and standard topography calibration.

21.3 AXIAL LENGTH (BIOMETRY) CALIBRATION

Explains the calibration procedure for the biometry module.

21.3.5 COMMON CALIBRATION

Covers performing calibration for Biometry, Topography, and WTW simultaneously.

22 SETUP WINDOW

22.1 GENERAL

Covers general settings like language, skin, and clinic details.

22.2 DATABASE

Details database management and networking parameter setup.

22.3 STORAGE

Explains how to manage data storage locations and add folders.

22.4 USERS ACCOUNTS

Covers managing user accounts, privileges, and security settings.

22.5 PREFERENCES

Allows customization of device and software settings.

22.7 OUTPUT SETTINGS

Guides on creating, modifying, and removing output data sets.

22.8 BACKUP

Explains how to perform database and examination backups.

22.9 RECOVERY

Details the process for data recovery from storage.

22.10 DICOM

Covers DICOM interface modules and configuration.

23 MAINTENANCE AND CLEANING PROCEDURE

23.1 ROUTINE CLEANING

Provides instructions for routine cleaning of the device and its components.

23.2 SOFTWARE MAINTENANCE ACTIVITIES

Outlines essential activities for maintaining software in good condition.

23.3 HARD DISK DEFRAGMENTATION

Explains the importance and process of hard disk defragmentation for performance.

23.4 ORDERING CONSUMABLES

Provides information on ordering consumables and spare parts.

23.5 FUSE

Covers fuse identification and replacement procedures.

24 NETWORK CONFIGURATION

24.1 NETWORK CONNECTION CONFIGURATION

Details the procedure for configuring network connections for SOCT.

25 REMOTE CONNECTION

25.1 PTS APPLICATION FOR STRUCTURE & FUNCTION REPORT

Explains how to configure PTS application for remote communication and data transfer.

26 ENVIRONMENTAL CONDITIONS

27 WARRANTY AND SERVICE

28 UTILIZATION

29 TROUBLESHOOTING

31 PRODUCT COMPLIANCE

31.1 Radio Interference

Details compliance with FCC rules regarding radio frequency energy and interference.

31.2 Canadian Regulations

Outlines compliance with Canadian regulations for radio noise emissions.

31.3 EMC INFORMATION

Provides guidance and manufacturer's declarations on electromagnetic emissions and immunity.

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