Optopol SOCT Copernicus REVO User manual

Manufacturer:
OPTOPOL Technology Sp. z o.o.
ul. Żabia 42
42-400 Zawiercie
POLAND
www.optopol.com
[e-mail]
SOCT Copernicus REVO
User Manual
Software Version 7
User Manual Rev. A
0197
Make sure you read this manual before using
the instrument. Keep this manual in a safe
place so that you can use it in the future.

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SOCT Copernicus REVO User Manual Version 7.0 rev. A
Copyright
© 2016 OPTOPOL Technology Sp. z o.o. All rights reserved.
User Manual Version 7 Rev. A
Date of issue of manual: December 2016
Date of review: December 2016
For Customer Service or Technical Service contact your authorized dealer of OPTOPOL Technology
Sp. z o.o. Contact details are available on www.optopol.com.

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1DESCRIPTION OF THE DEVICE ...............................................................................................8
1.1 INTEND OF USE .......................................................................................................................8
1.2 INTENDED USER......................................................................................................................8
1.2.1 THE MINIMUM KNOWLEDGE ..............................................................................................8
1.2.2 EDUCATION NEEDED FOR OPERATING THE TOMOGRAPHER ........................................................8
1.2.3 OPERATING SKILLS ...........................................................................................................9
1.2.4 OCCUPATIONAL SKILLS.......................................................................................................9
1.2.5 JOB REQUIREMENTS FOR THE USER ......................................................................................9
1.2.6 CONTRAINDICATION .........................................................................................................9
1.2.7 INSTRUCTION MANUAL AVAILABILITY.................................................................................10
1.2.8 INSTRUCTION MANUAL APPLICABILITY ...............................................................................10
1.2.9 DISPOSAL .....................................................................................................................10
2TECHNICAL DATA................................................................................................................11
2.1 DEVICE CLASSIFICATION ..........................................................................................................11
2.2 MINIMUM COMPUTER SYSTEM REQUIREMENTS...........................................................................12
2.2.1 CAPTURE STATION ..........................................................................................................12
2.2.2 REVIEW STATION............................................................................................................12
3SAFETY ..............................................................................................................................13
3.1 SAFETY INFORMATION ............................................................................................................13
3.2 PRODUCT LABEL ...................................................................................................................14
3.3 SAFETY STANDARDS ...............................................................................................................15
3.4 NOTES ON USE .....................................................................................................................17
3.4.1 BEFORE USE..................................................................................................................17
3.4.2 AFTER USE....................................................................................................................17
4UNPACKING AND INSTALLATION ........................................................................................18
4.1 UNPACKING .........................................................................................................................18
4.2 CONNECTING CABLES .............................................................................................................19
4.3 DEVICE CONNECTION .............................................................................................................20
4.4 FACTORY DEFAULT CALIBRATION AND CONFIGURATION ..................................................................21
5SOCT COPERNICUS REVO SOFTWARE .................................................................................22
5.1 RUNNING SOCT COPERNICUS REVO APPLICATION......................................................................22
5.2 SOCT COPERNICUS REVO APPLICATION STRUCTURE ...................................................................22
6PATIENT WINDOW .............................................................................................................23
6.1 PATIENT LIST VIEW.................................................................................................................24
6.2 REGISTERING NEW PATIENTS ....................................................................................................24
6.3 EDITING PERSONAL DATA.........................................................................................................25
6.4 UNREGISTERING PATIENTS .......................................................................................................26

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6.5 EXAMINATION LIST ................................................................................................................26
6.6 DELETE EXAM/S...................................................................................................................27
6.7 EXPORT EXAMINATION ...........................................................................................................27
6.8 IMPORT EXAMINATION ...........................................................................................................27
6.9 FILTER.................................................................................................................................28
7EXAMINATION WINDOW ...................................................................................................29
7.1 SELECTION OF SCAN PATTERN MODE..........................................................................................32
7.2 SELECTION OF SCANNING PROGRAM..........................................................................................33
7.3 SELECTION OF PROTOCOL ........................................................................................................34
7.4 FOLLOW UP..........................................................................................................................35
7.5 DEVICE HEAD MOVEMENT CONTROLS ........................................................................................35
7.6 EYE PREVIEW........................................................................................................................37
7.7 PSLO LIVE FUNDUS PREVIEW...................................................................................................38
7.7.1 MOVING THE SCANNING AREA .........................................................................................38
7.7.2 ROTATION OF THE SCANNING ANGLE..................................................................................38
7.7.3 MOVING THE INTERNAL EYE FIXATION TARGET .....................................................................38
7.8 FIXATION TARGET CHANGE.......................................................................................................39
7.9 CUSTOMIZING SCAN PARAMETERS.............................................................................................39
7.10 LIVE OCT PREVIEW............................................................................................................41
8CONDUCTING EXAMINATION.............................................................................................42
8.1 PREPARING FOR EXAMINATION.................................................................................................42
8.2 ACQUISITION MODES DESCRIPTION ...........................................................................................43
8.2.1 FULL AUTO MODE ..........................................................................................................43
8.2.2 SEMI AUTO MODE..........................................................................................................43
8.2.3 MANUAL MODE.............................................................................................................45
8.3 SCANNING PROGRAMS DESCRIPTION .........................................................................................46
8.3.1 RETINA EXAMINATION.....................................................................................................46
8.3.2 CENTRAL EXAMINATION...................................................................................................47
8.3.3 DISC AREA EXAMINATION.................................................................................................47
8.3.4 ANTERIOR MEASUREMENT ....................................................................................................48
8.3.5 WIDE ANTERIOR PROGRAMS .................................................................................................50
8.4 EXTERNAL FIXATION ...............................................................................................................52
8.5 CHORIORETINAL/VITREORETINAL MODE ....................................................................................52
8.6 EXAMINATION TIPS ................................................................................................................53
9RESULT REVIEW .................................................................................................................55
9.1 TYPE OF VIEW MODE.............................................................................................................55
9.1.1 [SINGLE] TAB SCREEN......................................................................................................55
9.1.2 [BOTH EYES] TAB SCREEN ................................................................................................55

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9.1.3 [COMPARISON] TAB SCREEN .............................................................................................55
9.1.4 [PROGRESSION] TAB SCREEN ............................................................................................55
9.2 TYPES OF ANALYSIS................................................................................................................55
9.2.1 SINGLE RETINA ANALYSIS .................................................................................................55
10 POSTERIOR ANALYSIS ....................................................................................................56
10.1 RETINA THICKNESS ANALYSIS ...............................................................................................56
10.1.1 SINGLE TAB ..................................................................................................................56
10.1.2 BOTH EYES TAB ..............................................................................................................59
10.1.3 COMPARISON................................................................................................................63
10.1.4 PROGRESSION ...............................................................................................................64
10.2 OPTIC NERVE HEAD ANALYSIS ......................................................................................67
10.3 CENTRAL EXAMINATION ANALYSIS ......................................................................................74
10.4 2D SCAN PROGRAMS RESULTS REVIEW...................................................................................75
10.4.1 SINGLE B-SCAN EXAMINATION REVIEW...............................................................................76
10.4.2 RASTER EXAMINATION RESULTS REVIEW..............................................................................77
10.4.3 RADIAL EXAMINATION RESULTS REVIEW..............................................................................79
10.4.4 CROSS EXAMINATION RESULTS REVIEW...............................................................................79
10.5 3D VISUALIZATION .............................................................................................................80
10.5.1 MANIPULATION OF THE 3D CUBE ......................................................................................80
10.5.2 SELECTION OF DISPLAYED LAYERS .......................................................................................80
10.5.3 OPERATION PANEL..........................................................................................................81
10.5.4 [SOLID] VIEW ...............................................................................................................83
10.5.5 [VOLUME VIEW]............................................................................................................84
11 ANTERIOR SEGMENT ANALYSIS......................................................................................85
11.1 ANTERIOR RADIAL .............................................................................................................87
11.1.1 [SINGLE] TAB SCREEN......................................................................................................87
11.1.2 [BOTH EYES] TAB SCREEN................................................................................................90
11.1.3 [COMPARISON] TAB SCREEN .............................................................................................90
11.1.4 [PROGRESSION] TAB SCREEN ............................................................................................91
11.1.5 EDIT ANTERIOR SURFACE..................................................................................................93
11.1.6 AOD MEASUREMENT .....................................................................................................94
11.1.7 ANGLE MEASUREMENT TOOL............................................................................................95
11.1.8 TOMOGRAM REVIEW ANALYSIS .........................................................................................95
12 FULLSCREEN WINDOW ..................................................................................................96
12.1 FUNDUS RECONSTRUCTION, EYE PREVIEW OR PSLO..................................................................96
12.2 IMAGING TOOLS ................................................................................................................97
12.3 SELECTION AND LAYERS EDITION ...........................................................................................97
12.4 MEASUREMENT TOOLS AND ANNOTATIONS .............................................................................97

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12.5 BRIGHTNESS AND CONTRAST ADJUSTMENT..............................................................................98
12.6 FULL SCREEN MODE EXIT .....................................................................................................98
13 IMPORT FUNDUS IMAGES .............................................................................................99
13.1 ADDING FUNDUS PHOTO TO THE EXAMINATION........................................................................99
13.2 EXAMINATIONS CORRELATION...................................................................................100
13.2.1 MANUAL REGISTRATION ................................................................................................100
13.3 TOMOGRAM WINDOW MANIPULATION ................................................................................101
13.4 EDITION OF RECOGNIZED LAYERS.........................................................................................102
14 ANGIO RETINA ............................................................................................................103
14.1 [SINGLE] VIEW...............................................................................................................103
14.1.1 ANGIOGRAM OBJECT ....................................................................................................104
14.1.2 ENFACE WINDOW:.......................................................................................................105
14.1.3 TOMOGRAM WINDOW..................................................................................................105
15 SETUP WINDOW .........................................................................................................106
15.1 GENERAL .......................................................................................................................106
15.2 DATABASE ......................................................................................................................107
15.3 STORAGE .......................................................................................................................108
15.4 USERS ACCOUNTS ............................................................................................................110
15.5 PREFERENCES .................................................................................................................111
15.5.1 PROTOCOLS TAB...........................................................................................................111
15.5.2 PARAMETERS TAB ........................................................................................................113
15.5.3 VOICE MESSAGES.........................................................................................................113
15.5.4 RESULTS SETTINGS........................................................................................................115
15.6 BACKUP.........................................................................................................................116
16 MAINTENANCE AND CLEANING PROCEDURE ............................................................... 117
16.1 ROUTINE CLEANING .........................................................................................................117
16.2 SOFTWARE MAINTENANCE ACTIVITIES ..................................................................................118
16.3 HARD DISK DEFRAGMENTATION .........................................................................................118
16.4 ORDERING CONSUMABLES.................................................................................................119
16.5 FUSE.............................................................................................................................119
16.5.1 BLOWN FUSES EXCHANGE ..............................................................................................119
17 NETWORK CONNECTION CONFIGURATION .................................................................. 120
17.1 SOCT NETWORK .............................................................................................................120
17.2 SHARING SOCT EXAMINATION DATABASE FOLDER(S) ON WINDOWS 7(STORAGE LOCATIONS).........121
17.3 SOCT VIEWING STATION CONFIGURATION/ SOCT PC.............................................................123
17.4 FAQ .............................................................................................................................124

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18 ENVIRONMENTAL CONDITIONS ...................................................................................125
19 WARRANTY AND SERVICE............................................................................................126
20 UTILIZATION................................................................................................................ 126
21 TROUBLESHOOTING ....................................................................................................127

1DESCRIPTION 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 to make a good use of
it.
SOCT Copernicus REVO uses Spectral domain Optical Coherence Tomography method to
obtain 3-dimensional, cross-section images of the retina.
SOCT Copernicus REVO is an optical coherence tomography system indicated for the in vivo
imaging and measurement of the retina layers, retina nerve fiber layer, and optic nerve head
as an aid in the diagnosis and management of posterior segment diseases. The device
produces a light beam, which is focused on the human retina. The light that reflects from
internal structures of an eye is then interferometrically analyzed by the device. The raw data
are processed by a PC to obtain images of eye cross-sections. The SOCT Copernicus REVO
contains features including: Retina Thickness, Optical Nerve Head, Retinal Nerve Fiber Layer,
Angle assessment, Cornea measurement.
1.1 Intend of use
It is intended for use as a diagnostic device to aid the detection and management of ocular
diseases, including but not limited to, age-related macular degeneration, macular holes,
diabetic retinopathy, macular edema and glaucoma.
NOTE: The SOCT Copernicus REVO is not intended to be used as the sole diagnostic
aid for disease identification, classification and management. A patient diagnosis is
the sole domain of eye care clinician.
1.2 Intended User
The SOCT Copernicus REVO can be used by Ophthalmologists, Optometrists, Opticians,
Orthoptists or other trained health personnel.
1.2.1 The minimum knowledge
The user must be able to distinguish right eye and left eye, chin and forehead, read and
understand the language and the functionality used in the SOCT application software.
1.2.2 Education needed for operating the tomographer
Ophthalmologist, Optometrist, Nurse, Certified Medical Technician, Assistant.

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1.2.3 Operating Skills
For instrument operation, the user should be able to perform the following functions:
-Power on and power off the device,
-Disinfect surfaces which interact with the patient,
-Enter and modify the patient data,
-Adjust position of the patient, position of the instrument, the table height, and the
patient’s chair,
-Set the examination parameters, acquire examination,
-Select or create the required type of printout,
-Verify the printout for completeness of data,
-Print, export and save the selected report,
-Archive and recover the patient database.
1.2.4 Occupational skills
The user should be able to work with elderly patients, disabled patients and with children.
1.2.5 Job requirements for the user
The SOCT training in the scope of usage and operation is mandatory before the first use. The
user should be also trained in the analysis and treatment of ophthalmic diseases or other
eye-related medical issues, as it is stated by governing bodies. The user should be a
computer literate person.
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.
1.2.6 Contraindication
Do not use the SOCT Copernicus REVO for those patients who:
-Have an anamnestic history of photodermatosis,
-Have undergone photodynamic therapy (PDT) within a short period (refer to the
product document of administered photosensitizer about the prohibition period),
-Are on medication with side effects that may possibly cause photodermatosis.

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1.2.7 Instruction Manual Availability
The SOCT Copernicus REVO Instruction Manual in PDF format is available on the computer
with installed SOCT application. To open the file, press START  Application  SOCT  User
Manual. The manual is included on USB flash drive delivered with the standard package of
the SOCT. Install the .pdf file viewer e.g. free Adobe Reader from the www.adobe.com
website or flash drive to read the manual in PDF format.
The Instruction Manual in paper form is available on request. To receive user manual in
hardcopy please contact authorized Optopol representative to receive it.
1.2.8 Instruction Manual Applicability
This document applies to the SOCT Copernicus REVO running with the application software
version 6.0 or higher, unless superseded.
1.2.9 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.