Manufacturer:

OPTOPOL Technology S.A.

ul. Żabia 42
42-400 Zawiercie
POLAND
www.optopol.com
[email protected]

SOCT Copernicus
User Manual

Software Version 4.3.x

User Manual Rev. C

0197 248002
1. DESCRIPTION OF THE DEVICE............................................................................................................................. 5
2. TECHNICAL DATA ............................................................................................................................................... 5
2.1 SYMBOL INFORMATION ............................................................................................................................................. 6
2.2 RECOMMENDED SYSTEM REQUIREMENTS .................................................................................................................... 7
3. UNPACKING AND INSTALLATION ........................................................................................................................ 8
3.1 UNPACKING SOCT COPERNICUS ................................................................................................................................. 8
3.2 CONNECTING CABLES ............................................................................................................................................. 10
3.3 DEVICE CONNECTION .............................................................................................................................................. 12
3.4 FACTORY DEFAULT CALIBRATION AND CONFIGURATION ................................................................................................... 13
3.5 SAFETY STANDARDS ............................................................................................................................................... 13
4. SOCT COPERNICUS SOFTWARE ........................................................................................................................ 15
4.1 RUNNING SOCT COPERNICUS APPLICATION ............................................................................................................... 15
4.2 SOCT COPERNICUS APPLICATION STRUCTURE .............................................................................................................. 15
5. MAIN WINDOW ............................................................................................................................................... 16
5.1 PATIENT LIST VIEW. ................................................................................................................................................ 16
5.2 REGISTERING NEW PATIENTS .................................................................................................................................... 17
5.3 EDITING PATIENT'S PERSONAL DATA ........................................................................................................................... 18
5.4 UNREGISTERING PATIENTS ....................................................................................................................................... 18
5.5 CURRENT EXAMINATION PANEL ................................................................................................................................ 18
5.6 FILTER ................................................................................................................................................................. 19
5.7 CONNECTING SCANS CONNECTED TO THE WRONG PATIENT............................................................................................. 19
5.8 EXPORT EXAMINATION/S ........................................................................................................................................ 20
5.8.1. Burn examinations on CD/DVD ............................................................................................................... 20
5.8.2. Export data files ...................................................................................................................................... 20
5.9 AUTOMATED ANALYSIS OF EXISTING EXAMINATIONS ...................................................................................................... 20
6. EXAMINATION WINDOW ................................................................................................................................. 21
6.1 DEVICE MOVEMENT CONTROLS ................................................................................................................................ 22
6.1.1 Joystick control.......................................................................................................................................... 23
6.1.2 Mouse Control .......................................................................................................................................... 23
6.2 SELECTION OF SCANNING PATTERN MODE .................................................................................................................. 24
6.3 CUSTOMIZING SCAN PARAMETERS ............................................................................................................................. 25
6.4 “VIEWFINDER” MODE ............................................................................................................................................ 26
6.5 TOMOGRAM POSITIONING ....................................................................................................................................... 27
6.6 SCAN POSITIONING ................................................................................................................................................ 28
6.7 FOLLOW UP .......................................................................................................................................................... 28
7. CONDUCTING EXAMINATION........................................................................................................................... 29
7.1 CONDUCTING NEW EXAMINATION ............................................................................................................................. 29
7.2 DISC AREA EXAMINATION: ....................................................................................................................................... 30
1
7.3 ANTERIOR MEASUREMENT ..................................................................................................................................... 31
7.4 EXTERNAL FIXATION................................................................................................................................................ 32
7.5 TIPS FOR EXAMINATION ........................................................................................................................................... 33
8. RESULTS REVIEW WINDOW ............................................................................................................................. 35
8.1 TOMOGRAM TAB ................................................................................................................................................... 35
8.2 CONTROL PANEL FUNCTIONS .................................................................................................................................... 36
8.3 FUNDUS CAMERA IMAGE ......................................................................................................................................... 37
8.4 IMAGE PANEL CONTROL. .......................................................................................................................................... 41
8.5 EDIT RECOGNITION OF LAYERS .................................................................................................................................. 42
8.6. RETINA THICKNESS MEASUREMENT ........................................................................................................................... 43
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 8.7 DISTANCE MEASUREMENT ....................................................................................................................................... 44
8.8 CYSTS ANALYSIS .................................................................................................................................................... 45
8.8.1 Mark and edit a new cyst ......................................................................................................................... 46
8.8.2 Editing marked cysts ................................................................................................................................. 48
8.9 3D DETECTION OF THE CYST..................................................................................................................................... 48
8.10 RETINA ANALYSIS CHARTS ...................................................................................................................................... 49
8.11 RPE CHARTS ....................................................................................................................................................... 50
8.12 INFO TAB ........................................................................................................................................................... 50
8.13 ATTACHMENTS TAB............................................................................................................................................... 51
8.14 DIAGNOSIS TAB ................................................................................................................................................... 52
8.15 TOMOGRAM SELECTION WINDOW .......................................................................................................................... 52
8.16 PRINTOUT MANAGER .......................................................................................................................................... 53
8.16.1 Quick printout ......................................................................................................................................... 54
8.16.2 Generate report ...................................................................................................................................... 54
8.16.3 Customized printout ................................................................................................................................ 55
8.16.4 Add to print manager method ................................................................................................................ 57
8.16.5 Generate report and add objects manually ............................................................................................ 57
8.16.6 Export to IRIS .......................................................................................................................................... 58
8.17 MENU ............................................................................................................................................................... 58
9. THREE DIMENSIONAL VISUALIZATION ............................................................................................................. 59
9.1 ADVANCED 3D MODE ............................................................................................................................................ 59
9.1.1 Displaying and highlighting selected retina layers ................................................................................... 61
9.1.2 Peeling layers ............................................................................................................................................ 62
9.1.3 Tuning of the picture................................................................................................................................. 63
9.1.4 Display options. ........................................................................................................................................ 64
9.1.5 Surface mapping ....................................................................................................................................... 64
9.2 STANDARD 3D ...................................................................................................................................................... 66
9.2.1 Segmentation............................................................................................................................................ 68
9.2.2 Display options ......................................................................................................................................... 69
9.2.3 Surface mapping ....................................................................................................................................... 70
9.2.4 3D preview ................................................................................................................................................ 71
10. MACULA ANALYSIS ...........................................................................................................................................72
11. GLAUCOMA ANALYSIS ..................................................................................................................................... 75
11.1 FUNDUS RECONSTRUCTION/ DEVIATION FROM NORMAL MAP ...................................................................................... 75
11.2 TOMOGRAM PREVIEW .......................................................................................................................................... 76
11.3 RNFL THICKNESS MAP AND RNFL THICKNESS GRAPH.................................................................................................. 76
11.4 ONH (OPTICAL NERVE HEAD) DATA ....................................................................................................................... 77
11.5 CONTROL BUTTONS .............................................................................................................................................. 78
11.6 MANUAL DISC CONTOUR EDITION............................................................................................................................ 78
12. COMPARISON MODULE ................................................................................................................................... 80
12.1 TOMOGRAM TAB ............................................................................................................................................ 80
12.2 FOLLOW UP ..................................................................................................................................................... 81
12.2.1 Retina Graphical Comparison ................................................................................................................. 81
12.2.2 Retina Numerical Comparison ................................................................................................................ 82
12.2.3 Glaucoma Numerical Analysis ................................................................................................................ 83
12.3 SYMMETRY ANALYSIS ...................................................................................................................................... 84
12.3.1 Retina Numerical .................................................................................................................................... 84
12.3.2 Retina Graphical ..................................................................................................................................... 85
12.3.3 Glaucoma Symmetry Analysis ................................................................................................................. 86
12.4 EXAMINATIONS CORRELATION ....................................................................................................................... 87
13. ANTERIOR ANALYSIS ........................................................................................................................................ 88
13.1 CORNEA ANALYSIS TAB .......................................................................................................................................... 89
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 13.2 ANGLE MEASUREMENT TOOL ................................................................................................................................. 90
13.3 AOD MEASUREMENT .......................................................................................................................................... 90
14. SETUP WINDOW .............................................................................................................................................. 91
14.1 BACKUP ............................................................................................................................................................. 91
14.2 RECOVER ........................................................................................................................................................... 92
14.3 DATABASE SETUP ................................................................................................................................................. 93
14.4 PARAMETERS ...................................................................................................................................................... 94
14.5 USER ACCOUNTS.................................................................................................................................................. 95
14.5.1 Creating new user ................................................................................................................................... 95
14.6 JOYSTICK CONFIGURATION ..................................................................................................................................... 96
14.6.1. Joystick checking and calibration ........................................................................................................... 96
15. MAINTENANCE AND CLEANING PROCEDURE ....................................................................................................97
15.1 ROUTINE CLEANING ............................................................................................................................................. 97
15.1 SOFTWARE MAINTENANCE ACTIVITIES ...................................................................................................................... 98
15.3 HARD DISK DEFRAGMENTATION ............................................................................................................................. 98
15.4 ORDERING CONSUMABLES ..................................................................................................................................... 98
15.4 .1 Blown fuses exchange ............................................................................................................................ 99
16. ENVIRONMENTAL CONDITIONS ......................................................................................................................100
17. SERVICE ..........................................................................................................................................................100
18. UTILIZATION ...................................................................................................................................................100
19. DIMENSION AND WEIGHT ..............................................................................................................................100
20. FAQ - FREQUENTLY ASKED QUESTIONS ...........................................................................................................101
APPENDIX A CONFIGURATION OF NETWORK CONNECTION ....................................................................................103
1. SOCT NETWORK .............................................................................................................................................103
1.1 SOCT SERVER CONFIGURATION PROCEDURE ............................................................................................................. 104
1.1.1 Sharing SOCT database folder on Windows XP ..................................................................................... 105
1.1.2 Sharing SOCT database folder on Windows 7 ........................................................................................ 106
1.2 CLIENT COMPUTER CONFIGURATION PROCEDURE ....................................................................................................... 107
2. IRIS SERVER NETWORK ...................................................................................................................................109
2.0.1 Upload on server ..................................................................................................................................... 109
2.0.2 Download from server ............................................................................................................................ 110
2.1 CLIENT COMPUTER CONFIGURATION PROCEDURE: ...................................................................................................... 111
2.2 COPERNICUS IRIS SERVER CONFIGURATION ............................................................................................................... 112
2.2.1 Introduction ............................................................................................................................................ 112
2.2.2 Requirements .......................................................................................................................................... 112
2.3 COPERNICUS SERVER IRIS INSTALLATION. ................................................................................................................. 112
2.4 MODULE CONFIGURATION ..................................................................................................................................... 115
2.5 FAQ ................................................................................................................................................................. 117
APPENDIX B .............................................................................................................................................................121
PARK POSITIONING..................................................................................................................................................... 121
APPENDIX C .............................................................................................................................................................122
EMC INFORMATION................................................................................................................................................... 122

SOCT Copernicus User Manual Version 4.3.x rev. C

 1. DESCRIPTION OF THE DEVICE

This manual explains the details of the function and use method to make a good use of the
SOCT system. Before using the device, carefully read this manual to ensure that you operate it
efficiently and safely. Always keep this manual at hand to make a good use of it.
SOCT Copernicus uses Spectral domain Optical Coherence Tomography method to obtain 3-
dimensional cross-section images of the retina.
SOCT Copernicus is an optical coherence tomography system indicated for the in vivo imaging
and measurement of the retina, 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 is processed by a computer to
obtain images of eye cross-section. The SOCT Copernicus contains features that include:
Retina Thickness, Optical Nerve Head, Retinal Nerve Fiber Layer, Angle assessment, Cornea
measurement1.

2. TECHNICAL DATA
Signal source Super Luminescent Diode (SLED), 830 nm
Optical power 750 µW
Signal analysis Spectral domain Optical Coherence Tomography
Scanning speed 25’000 measurements per second
Scanning programs Single B-scan
3D visualization
Asterisk
Animation scan (selected number of B-scans in the
same place at a retina)
Circle scan
Axial resolution 6 µm
Transversal resolution ideal 12 µm
typical 18 µm
Scan width 4 – 10 mm
Scan depth >2.5 mm
Power supply 100-240 V 50/60 Hz,
Power consumption 150 VA
Fuse ratings M 3.15 A L 250V
Multiple socket-outlet max. load 500 V
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 2.1 Symbol information

CAUTION

Follow operating instruction

WARNING – Dangerous voltage

General warning sign

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 a
normal household waste at the end of its life.

Sign conformity with essential requirements – The Medical Device Directive

93/42/EEC

Class 1 Laser Device

Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner

SOCT Copernicus User Manual Version 4.3.x rev. C

 2.2 Recommended system requirements

Processor: Intel® Core™2 Quad Q6600

RAM: XP & Win7 32bit - 4 GB
Operating system: Windows XP Professional, Windows 7 Professional
HDD: Minimum 500GB (15MB per measurement)
CD/DVD writer
Video card: OpenGL support, ATI Radeon 4850 512 MB or faster
1024 X 768 resolution
Communication: 1 available USB port
Extension slots: 2 available PCI slots
1 available PCI Express (x16)

SOCT Copernicus User Manual Version 4.3.x rev. C

 3. UNPACKING AND INSTALLATION

NOTICE!: Check for any damage to the package. Every transportation box is equipped with the
shockwatches. If any shockwatch is broken (red indicator) please contact OPTOPOL Technology S.A. and lodge
the complaint to the carrier.

SOCT Copernicus set consists of following components:

1. SOCT device with CL cable,
2. RS232 communication cable,
3. Coaxial synchronization/video cable,
4. PC Computer with preinstalled software,
5. Computer accessories
6. Power supply cables and computer accessories.

3.1 Unpacking SOCT Copernicus

This section describes how to unpack the device shipped from a factory. The SOCT Copernicus is shipped in a
special box, which protects it from mechanical damages during transport. The box has got four latches shown
in detail in pictures below.

Closed latch

Step 1

Step 2
Latch is opened

SOCT Copernicus User Manual Version 4.3.x rev. C

Remove the cover by lifting it up gently. The SOCT ’s four legs are locked at two metal rails by clamps. There
are only two removable clamps at a side. First remove screws from the clamps and then remove metal
holders. This operation is shown in a figure below.

Figures below show how to unpack SOCT Copernicus from this box.

Now shift SOCT Copernicus to the left and then lift it up. Put the SOCT on the flat stable table.

After unpacking, one should check the whole set for any mechanical damages,
cables damages, etc. In case any damage is found, don't connect the device
and contact your local distributor.

Important!

Always let the device reach room temperature before it is powered up but not less than 1 hour after
unpacking. This is particularly important if the device was exposed to temperature extremes. Always
operate the device within operating ranges of temperature and humidity (see chapter 16).

Transport position of the SOCT Copernicus is to be set manually. Head maximum to the left, to the back
and lens down. Then protect handle will fit correctly.

SOCT Copernicus User Manual Version 4.3.x rev. C

 3.2 Connecting cables

To connect the SOCT Copernicus to a computer, you need five cables shipped with the device:
 Camera link cable – connected to SOCT Copernicus (not detachable),
CL1

 RS232 cable

 Video/synchro cable connected with one plug,

Video (to PC) Synchro (BNC to BNC splitter) Video/Synchro to SOCT Copernicus
Video-synchro cables are merged together.

 Adapter cable. This is a short cable with 4 BNC plugs and VHDC plug on the other side.
Synchro cable shown above should be connected to BNC splitter (T0 port)

BNC Splitter to BNC Splitter to

Synchro cable computer

All sockets and plugs are different so it is not possible to connect plugs improperly.

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 Figure below shows rear panel view of SOCT Copernicus.

Power switch Power connector

Video / Synchro Fuses socket

Camera link cable

RS232

RS232, video and synchro cables are merged together as shown below.
First connect all signal cables described above and after that check the connections once again. In the next
step connect power supply cables.

RS232 - Computer
RS232 -SOCT
Video / Synchro - SOCT Video - Computer

Synchro – BNC splitter

NOTE: Regarding EMC (Electro-magnetic compatibility) standards all signal cables have to be put together.

Picture belowshows how to connect all cables to the computer.

Power supply connector

Keyboard and mouse PS/2

RS232

Monitor
USB (printer, joystick,
keyboard and mouse with
USB plug)

BNC splitter Camera link

Video input

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 3.3 Device connection

The SOCT Copernicus is connected to the PC using RS232 and Video/Synchro cables.
The SOCT Copernicus must be directly plugged into the mains with protective earth. Connect
the PC, printer and monitor into the multiple portable socket-outlet, which is directly
connected to the Separating Transformer. By connecting the devices to the Separating
Transformer leakage current is reduced to a level which is in line with the IEC standard. The
Separating Transformer is connected directly to the mains with protective earth pin.

Applied part:
chin rest support

Applied part:
forehead support

Locally mains look

different

Dedicated table SE-275 has built in the isolator transformer. When the SOCT system is installed on the
table SE-275, only one cable from to the set (table + OCT system) goes to the main with protective
earth pin. The device has to be connected to the main below the top of the table. Elements of
computers set have to be connected to multiple sockets in the metal box.

Multiple socket for

the computer set

Socket for SOCT

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SOCT Copernicus User Manual Version 4.3.x rev. C

 3.4 Factory default calibration and configuration

The system is delivered fully installed and configured. No user installation or configuration is
needed.
The assembly of ME Systems and modifications during actual service life shall be evaluated based on
the requirements of IEC 60601-1:2005 standard.

3.5 Safety standards

Before first use the device operator should be trained how to use the system efficiently and safely.

SOCT Copernicus system can be connected only to power supply socket equipped with
properly connected grounding pin.

The SOCT Copernicus system complies with all requirements of the directive 93/42/EEC (MDD -
Medical Devices Directive).
The SOCT Copernicus is type B applied parts (chin rest support and forehead support ) and class I
protection against electric shock.
Usually SOCT Copernicus is a part of larger Medical System, which consists of many other medical
and non- medical devices. Medical system in general and all its components have to fulfill the
requirements of IEC 60601-1:2005 standard.
In order to comply with the IEC 60601-1:2005 standard all non Medical Devices must be connected
to the Separating Transformer which is supplied with the SOCT Copernicus. By connecting the
devices to the Separating Transformer leakage current is reduced to a level which is in line with
the IEC standard.
The Separating Transformer fulfills requirements of IEC 60601-1:2005 standard for medical
electrical system.
The Separating Transformer supplies the power for non medical devices connected to electric not
grounded mains in room.
The Separating Transformer can be installed in patient environment in accordance with IEC-60601-
1:2005 standard.

Please note that only the PC, monitor and printer have to be connected to the Isolating
Transformer. Connecting non medical devices in other way than in diagram above can lead to
electric shock or damage the devices.
It is strictly forbidden to connect any non medical or medical devices which are not included
within the SOCT Copernicus system to the Separating Transformer e.g. lamp, vacuum cleaner
etc.
The SOCT Copernicus must not be connected to the transformer, but directly to the main outlet or
to the dedicated outlet in the table.

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SOCT Copernicus is connected to computer using USB cable. This cable is electrically separated
using optocouplers. It provides additional safety, when computer and SOCT Copernicus device are
connected to two different power supply sockets with different ground potentials. Video signal
and synchronization signal are transferred to computer using coaxial cables, which are electrically
separated from SOCT Copernicus device providing even more safe solution.
No user serviceable parts are inside SOCT Copernicus device. Light source is included inside the
device. Removing the covers can be done only by authorized personnel.
The maximum power of light radiation available outside covers is less than 750 microwatts
providing safe operation of the device.
Objective lens is output of light.
SOCT Copernicus has been classified as CLASS 1 LASER DEVICE

Important !
1) If the whole Medical System has been installed by Manufacturer of SOCT Copernicus
or Authorized Personnel , the manufacturer guarantees correct installation and
compliance with all required standards and directives,
2) In case installation was made not by Manufacturer or Authorized Personnel, the
manufacturer of SOCT Copernicus takes NO responsibility for any problems or risks
that could be created by incorrect connection and violation of safety standards,
3) Understanding and following up of sections 5, 6, 7, 8, 9 of this manual as well as
computer experience are sufficient level of training of user the SOCT Copernicus
device.
4) Manufacturer of SOCT Copernicus takes no responsibility for incorrect medical
diagnosis of results and takes no responsibility for the consequences of such incorrect
medical diagnosis.
Warning !
To avoid risk of electric shock, this equipment must only be connected
to a supply mains with protective earth. Ignoring safety rules can lead to
accidents.
1) If SOCT Copernicus + and the whole Medical System have been installed by the
Manufacturer or Authorized Personnel, the Manufacturer guarantees the proper
installation and compliance with MDD 93/42 EEC rules,
2) Any computer system or device attached to SOCT Copernicus must be MDD compliant
or be plugged only to Separating Transformer. Devices which are not related with
patient examination (e.g. lamp, fan) cannot be connected to Separating Transformer,
3) Multiple portable socket-outlets shall not be placed on the floor.
4) Any Additional Multiple Socket-Outlet or extension cord shall not be connected to the
ME System.
Warning !
All activities that demand removing main body housing may be performed by Manufacturer or
Authorized Personnel trained by Manufacturer only.
Ignoring or disregarding the statements above may lead to danger of death or serious injury.

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 4. SOCT Copernicus SOFTWARE
4.1 Running SOCT Copernicus application

After the Windows operating system is started and initialized, it is possible to run SOCT Copernicus
application. Click “Start” button and go to SOCT group. Click SOCT icon and the application will be
loaded and activated.

IMPORTANT: Always TURN ON the computer first and then TURN ON device.

4.2 SOCT Copernicus application structure

The application has been created to make using as easy for the operator as possible. All the buttons
are big and located ergonomically. The whole idea of software makes the usage very effective.

SOCT Copernicus software is divided into four different modules which can be easily accessed by
their tabs:

Patients It appears just after the system is started. It enables to easily handle
patients’ database,
Examination It contains all controls to perform a new examination,
Results review It enables to preview previously taken examinations, quantitative
analysis, compare results symmetrically or progressively.
Setup It enables to set all the parameters of the system. Also backup and
restore of the database can be done from this level.
Results review window Patients window

Examination Setup window

window

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 5. MAIN WINDOW

The patient tab will appear on the main window after the SOCT Copernicus HR application is started.
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/exporting data.

All the controls of main window are shown on picture below with short description.

Choose the modules

Info Card Patient data

Device ID

Patient database Fast search

management mechanism

Click to enter Setup

window Fundus reconstruction
preview

Current examination Examination filter

info
Tomogram preview

5.1 Patient list view.

In order to find a patient from the list you can enter first few letters of his Last name in fast search
edit box. Computer will show the closest matching patient. Default patients are sorted in the list by
Last name . Click the Ref. No. header to sort by ID number. It is also possible to sort by First name
and Date of Birth.
[Fast search] mechanism: use this field to quickly find patient on the list.
Sort the patients
according to selected
column .

Enter first letters of

patient's last name and
computer will mark the
closest match

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 5.2 Registering new patients

In order to register new patient, click [New patient]

button in main window. Patient registration window
will show in the right upper corner. Patient's first
name, second name, and date of birth have to be
entered in proper fields.

“Last name”, “First name” and “Date of birth” fields are

obligatory fields and have to be properly filled. Other fields are
optional and can be left empty.

It is possible to add to patient’s record information

about group classifications. Operator can create own
groups, e.g. diseases AMD, CRV, MH, LMH. To create a new group, type its name into the box.
System automatically adds this group into filters. One patient can belong to one or two groups. Each
eye can be classified as member of one group.
Operator can store also refraction value in patients record. This value will be transferred into
measurement mode.
FILLING THESE FIELDS DOES NOT RELEASE FROM CORRECTION OF FOCUS IN MEASURAMENT
MODE.
When all the data are entered, click “Enter” button to confirm registration. The system will check if
the entered data are correct. If not, it will ask to correct the data.
Important!
Make sure you have entered correct patient name and date of birth. It will prevent you from data
loss and will enable you to keep the database in good condition without having “dead souls” in
patients list.

If computer notices that the patient being entered is already registered in the database, a warning
message will appear.

If computer realizes, that the name of currently entered patient is already in database but the date
of birth is different, it will display a warning message.

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 It means that there is a suspicion, that the patient already exists, but the date of birth was entered
incorrectly. The operator should make sure the data is correct and can decide whether to register
the patient or cancel registration.

5.3 Editing patient's personal data

In order to edit currently selected patient's personal data, click [Edit] button in main window. The
fields are exactly the same as in [New patient] window. After patient's data have been changed, click
[Enter] button. Once again computer will check the data and display a warning message if entered
data are incorrect. Then the computer will do the same checking as during registering new patient.

5.4 Unregistering patients

In order to unregister currently selected patient, click [Delete] button in main window. A warning
message will be displayed.

After pressing 'Yes' button the second confirmation window will be displayed. If the answer is 'Yes'
again, the patient and all examination results will be deleted.

Once the patient is deleted, it's impossible to recover the deleted

data. Please make sure you are deleting proper patient.

5.5 Current examination panel

Current examination panel contains information regarding currently selected examination. The
image of this panel is shown below.
Analysis status

List of all patient’s

Fundus image
examinations

Thumbnail of
scanned image

Click to delete
selected Click to Import Click to Export selected
examination examination examination
examination examination examination
Click to start analysing
examinations

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Examinations window – shows all examinations made for the selected patient.
Here are information about date and time of examination, identification of the eye, chosen fixation
target, scan program, scan width, scan dimension column shows scan dimensions in number of A-
scans and B-scans.
 Fundus image – shows fundus view at the start of examination or reconstruction of fundus
in 3D mode,
 Thumbnail of scanned image shows a preview of a tomogram from the examination.

It is possible to move examination from one patient to another. Click right button and choose “Cut
examination” then choose destination patient and paste to proper patient.

5.6 Filter

The filter window helps to easily find examinations in the database. It is possible to filter
examinations for selected patient or to filter examinations with reference to all existing patients. In
order to apply filter mark [Apply filter to patients] checkbox.
User can filter examinations by:
- Date: Today’s or specific Date checkbox. In the list of all examinations
you will see only that which has been made today (or on specified
date) - all others will be hidden,
- Eye: If you want to hide examinations of Left or Right eye, unmark
check box labeled Left eye or Right eye,
- Scan program: Animation, Asterisk, 3-D, single B-scan etc – only the
selected type examinations will be visible,
- Analysis: Retina, Disc, Anterior - only the selected type’s
examinations will be visible,
- Group - Groups are made by operator on patient data editing
window and can be used to filter patients,
- Gender - Male, Female, Not defined – only patients of selected
gender will be displayed in the list.

Use [Apply] button to enable filtering.

Use [Clear filter] button to reset the filter settings and disable filtering.

5.7 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.

1. Select the Examination on examination list > examination you wish to move
2. Press the right mouse button on and press [Cut examination]
3. Select patient on the list where you wish to move examination
4. Press the right mouse button and choose [Paste examination].

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 5.8 Export examination/s

The SOCT Copernicus offers the ability to export examinations data. Thanks to the option patients
can receive CD disc with reports, movies, tomograms in format which can be easily reviewed by
another specialist.

5.8.1. Burn examinations on CD/DVD

Burning/Saving steps
1. Select the Patient on patient list > Patient you wish to burn examination results
2. Press the right mouse button on and press [Burn on CD\DVD]
3. Select examinations on the list.
4. Define exported data format. Burning disc will include chosen type of data (tomograms, reports,
movies, .oct data).
Note: .oct format of data can be reviewed only by SOCT Copernicus software.
5. Choose the drive. If you choose HDD, software will save data on it.
6. Press the [Burn/Save] button.

5.8.2. Export data files

Export steps
1. Select the Examination/s on examination list > examination/s you wish to export
2. Hold the Ctrl button on the keyboard and choose all exams you wish to export
3. Press [Export examination]
4. Choose a destination folder and press [OK] button.

5.9 Automated analysis of existing examinations

On the examination list the last column shows analysis status. The SOCT Copernicus application
enables automatic calculation collected .oct exams. Operator can choose one from two options.
- Not recognized examinations – the software calculate only examinations which have not
been analysed.
- All examination – this function recalculate all examinations from the database.
Note: By choosing this options software will delete all comments, manual measurement and
layers recognition corrections. It is recommended to use this option after upgrading the software
into newer version.

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 6. EXAMINATION WINDOW

Examination window is used to perform a new examination. In order to open the examination
window, click “Acquire“ tab. Picture of examination window is shown below:

Device control panel

Live fundus preview Scanning mode panel

Currently
selected patient Scan program

Scan parameters panel

Device status

Preview settings Quality index

List of taken examinations.

Double click here to open

Click to start examination examination.
Click right mouse button to
Live SOCT scan preview delete exams from the list.

Scanning mode panel Enables change of scanning program. For each examination area
(Retina, Disc, Anterior) there are different default settings of
examination.
Scan parameters panel Shows parameters of examination. In order to change settings press
[Setting] button.
Live OCT scan preview It shows horizontal and vertical live OCT image. The tomograms
correspond to the yellow cross on the fundus preview window. Note
that not aligned tomograms have influence on quality of tomograms
and reliability of analysis.
List of taken examinations Shows preview of taken examinations. Double click on the thumbnail
to open examination in the tomogram window.
Enhancement preview Improves live fundus preview.
Color mask Toggles live OCT image in gray-scale or color.

Lines on the vertical and horizontal window indicate proper position of tomograms.

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 6.1 Device movement controls

The following buttons are used to control the movement of the device:

Eye indicator
Movement speed selection
Left/Right
Up/down movement controls

Back/forth movement controls

Scan type and program

Fixation control Enables rescan examination

Background illumination

Refraction compensation
Chinrest movement
Refraction value / Reset controls

Movement controls It is used to control movement of the device’s head.

Eye indicator Shows examined eye.
Movement speed selection Change speed of movement. During alignment of retina LO level
is recommended.
Chinrest controls Lift or drop the chinrest.
Fixation selection Change fixation target.
Background illumination Use slider to change level of the NR illumination.
Eye detector Blocks forward movement in order to stop the device head from
touching the patient.
Settings Enable change parameters of exam such as width, number of
A-scan, number of B-scan, exam mode (vitreous or choroid)
Follow Up Open Follow up window where you can select any previous scan
as a starting point for the parameters for the current scan.

 Refraction is set based upon value used in previous examination and can be different for
each eye (L, R). Before first examination, set the refraction power according to patient
correction.
NOTE! ALWAYS CHOOSE THE REFRACTION POWER EXPERIMENTALLY CHECKING THE REFRACTION
POWER ABOVE AND UNDER INITIAL VALUE IN ORDER TO OBTAIN THE BEST SATURATION OF
SCANS.

 Clicking refraction value resets value to 0.00D

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 6.1.1 Joystick control
The device can also be controlled by using joystick controller. By default, moving the handle
back/fore moves the device back/fore. By moving the handle left/right, the device is moved
left/right. By turning the handle CW/CCW the device head moves up/down. Directions of
movements may be changed in setup. The joystick is quasi proportional – the more handle is moved
from central position, the faster movement of the device.

Joystick buttons can be user customized. By default buttons’ functions are set as shown below:

Take a new examination

Chinrest movement UP
Change fixation
Chinrest movement DOWN

Refraction Refraction compensation

compensation

6.1.2 Mouse Control

The device can be controlled by mouse. Move the head forward until tomogram appears on the
screen. Use scroll mouse button to move the head back and forth. Drag the tomogram and move to
desired position. Adjust tomograms on the vertical and horizontal window. Press [Start] button on
the screen or on the joystick when you want to start measurement.

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 6.2 Selection of scanning pattern mode

User can select the desired scanning program from scanning programs panel by clicking mouse
cursor on the scan pattern and selecting program from the icon list. Scanning parameters are
different for different scan mode and patterns. Operator can reconfigure and save own settings as
default.

 3D scanning program consists of a series of 30 to 200 equally spaced parallel line

scans over a square region, the size of which you determine. This program enables
precise three dimensional reconstruction of retina. In this program, analysis modules
give the most reliable and exact results,
 Asterisk scanning program consists of a series of 2 to 32 equally spaced line scans
through a common central axis. This program enables taking scans in high resolution
in few directions. The default pattern has 15 lines of 7 mm length. Operator can
adjust the length of scan lines by adjusting the scan width and number of scans,
 Single B-scan scanning program. The default pattern is a horizontal line (0°) of length
7mm. You can adjust the length and placement of each scan. This program enables
taking a single B scan in highest resolution,
 Animation scanning program enables taking number of scans in one place. It is
helpful for patients with a gaze problem. A cine loop from scanned places can be
observed,
 Cross scanning program. Enables taking two tomograms (horizontal (0°) and
Vertical(90°)) of length 7mm. You can adjust the length and placement of scans. This
program enables taking B-scans in highest resolution,
 Circle scanning program. This program enables a single B-scan in high resolution
around the disc. This way of scan is used to measure the RNFL thickness around the
optic disc.

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 6.3 Customizing scan parameters

In the software there are prepared different settings of scan parameters for each pattern and area.
Parameters depending on scanned area (Macula, Disc, Anterior) and scanning program (3D, Asterisk,
Single B-scan). This control panel allows the user to adjust the parameters of the examination.

Examination mode

Currently selected scan

Select scan pattern width
.
Number of A-scans per
single B-scan. Use slider to
change value

Number of B-scans.

Scan angle

Click to save
changes as default
parameters

The user is able to change predefined scanning settings. It is possible to save own settings as a
default by every operator. In order to change parameters press [Settings] button. After the scanning
program has been selected, the user is able to set following parameters:
- Scan width
- Number of A-scans per B-scan
- Number of B-scans (not available for single B-scan and circle scanning program).
- Scan Angle (rotate the scan around the center of the scan).

Computer calculates the total number of A-scans and the examination time. After the changes have
been made, user can press [OK] button to transfer new scan parameters to SOCT Copernicus or
[Save as a default] new parameters. NOTE. Scan patterns in scan mode have different settings.
Increasing number of B-scan improves fundus reconstruction and reliability of map, increasing
number of A-scan improves quality of tomograms.

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 6.4 “Viewfinder” mode

In “Viewfinder mode” system is focused on a cornea. This mode enables the operator to find center
of the pupil of the patient, before going into the fundus. The mode is automatically set when
measurement head is moved away from patient to find patient’s eye.
Move the head across the centre of pupil. When a center of the pupil of the eye is in a middle of red
cross, move the head in retina direction.

When measurement head is moved towards the examined eye, the device will turn into the retina
mode, and the system will focus on retina. The yellow cross corresponds to position of a scanner in
the preview window, as shown in the picture below.

Move the head until the retina appears on live OCT window. Operator has to initialize acquisition
process after adjustment of focus and proper position of retina.

NOTE: In case when system is not able to keep proper position of retina (e.g. patient is shaking)
operator has to switch off tracking and make exams manually.

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 6.5 Tomogram positioning

When a tomogram is visible on the tomogram window the user is able to align tomogram using the
joystick. Move the tomogram to desired position. It is possible to move tomogram also when it is
reversed.

Horizontal scan
Vertical scan

Click to turn on/off

color mask

Move tomogram
by joystick to desired
position

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 6.6 Scan positioning

When measurement head is properly aimed at the retina of the patient and OCT cross-section is
visible in OCT live preview window, operator may move scanned area. In order to do it, move the
green square in desire position. To reset the scanning area into the center of the fundus preview,
double click on the fundus preview, and the scanning area will come back to default position.
It is possible to change Scan Angle manually. Place the cursor over the left edge of horizontal line
than arrows appear which enable to change direction of scanning.

6.7 Follow up

The Follow up function enables you to repeat all the relevant parameters of any previously acquired
scan for this patient. The repeated parameters include: scan pattern, scan settings, scan placement,
focus. When disc examination is repeating, scan placement changes after changing fixation target
on disc.
Click Follow up to open the new window, where you can select a scan to repeat. The follow up
window shows lists of all previous scans for this patient by exam date and eye and shows the fundus
reconstruction and middle tomogram. Click the examination you want to repeat.
Use filter to find desired examination more easily.

-11
DRAFT/PRE-RELEASE/CONFIDENTIAL
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 7. CONDUCTING EXAMINATION

Check patients pupil size. In case of narrow pupil it might be necessary to dilate the patient’s eye.
Dilation is optional. The pupils of the examined eyes must be at least 3.0 mm. Tomograms acquired
through too small pupils may be dark on the edges, or the SOCT signal may be weak, leading to a
lack of image intensity and clarity.

7.1 Conducting new examination

In order to conduct examination properly, please follow the instructions below:

1) From main window, select the patient you want to examine. Fast search mechanism can be
used to locate patients easily. If the patient is not on the list, perform the registration.
2) Click 'Acquire’ tab from main window. Make sure that the proper patient is selected (look at
the upper left corner of examination window).
3) Choose Macula and scan type from scan program panel.
4) Tell the patient to sit next to the device. Adjust the height of the table to seat the patient
comfortably. Place patient's chin on the chinrest and ask the patient to rest his head firmly on
chinrest and forehead support. Using the height adjustment control buttons adjust the
elevation of patient's head. Move the scanning head across to desired eye. Ask the patient to
look straight forward and to blink freely. Eyes have to be on the height described by reference
lane on the forehead frame.
WARNING: Make sure, that patient does not put his head inside the frame when “up” or
“down” chinrest elevation button is pressed.
5) “Viewfinder mode” will be set automatically to obtain more focused preview while searching
the pupil. Move the head to desired position.
6) Move the device forward until fundus of the eye is visible in the image window. Some slight
left/right/up/down movements might be needed to correct the position.
7) Some focus correction may be needed to obtain the best quality of tomogram. The OCT cross-
section should be visible in OCT live preview window. Place the retina on correct position.
8) Once the scan location is set in selected place, press [Start] button. Computer will initialize
measurement system for a few moments and then full scan will be performed.
9) After examination is over, computer will move the scanning head away from patient and
transfer the captured image into database.

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 7.2 Disc area examination:

In order to conduct examination of the disc, follow the instructions below:

1) From main window, select the patient you want to examine. Fast search mechanism can be
used to locate patients easily. If the patient is not on the list, perform the registration.
2) Click 'Examination’ tab from main window. Make sure that the proper patient is selected
(look at the upper left corner of examination window).
3) Choose Disc and scan type from program panel.
NOTE: Program settings do not change Fixation.
4) Tell the patient to sit next to the device. Adjust the height of the table to seat the patient
comfortably. Place patient's chin on the chinrest and ask the patient to rest his head firmly
on chinrest and forehead support. Using the height adjustment control buttons adjust the
elevation of patient's head. Set the fixation to fovea. Ask the patient to look straight forward
and to blink freely.
5) Find the retina hole in the centre (that same procedure like for fovea examination) if possible
See chapter 7.1
6) Switch the fixation for „Disc”.
7) Ask the patient to look at the changed fixation point (this will move to the nasal direction).
8) You should obtain the optic nerve head in live preview window.
Often you have to move a device just a little bit to the nasal direction in order to find an
optic nerve head.
9) Move the scanning area as explained in the chapter 7.5, to find centre of optic disc.
Scanners are positioned correctly when the RPE tips on the live OCT window are in the
middle.
10) Some slight left/right/up/down movements may be needed to find the correct position. If
there is shadow on the edges of tomograms, this is due to the diameter of the pupil, try to
correct the position. In order to obtain the best quality of tomograms correct refraction once
again.
11) Once the scan location is set on selected place in the disc, press [Start] button. Computer will
begin the measurement process for a few moments and then full scan will be performed.

Operator is able to save own settings as a default program e.g. in order to: reduce time of
examination, obtain more detailed reconstruction of the retina.

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 7.3 Anterior measurement 1

In order to conduct examination of anterior segment, follow the instructions below:

1) From main window, select the patient you want to examine. Fast search mechanism can be
used to locate patients easily. If the patient is not on the list, perform the registration.
2) Click 'Examination’ tab from main window. Make sure that the proper patient is selected
(look at the upper left corner of examination window).
3) Choose Anterior and scan program.
4) Install Anterior Chamber Adapter on the objective lens.
5) Make sure that the head is moved back.
6) Tell the patient to sit next to the device. Adjust the height of the table to seat the patient
comfortably. Place patient's chin on the chinrest and ask the patient to rest his head firmly
on chinrest and forehead support. Using the height adjustment control buttons adjust the
elevation of patient's head. Ask the patient to look straight forward and to blink freely.
7) Place the head on desired position of the anterior chamber (e.g. cornea, iris, anterior
chamber angle).
8) Move head forward to locate tomograms in the live OCT window.
9) Some slight left/right/up/down movements may be needed to find the correct position.
Move the scanning head to correct position if there are shadows on the edges of tomograms.
 Cornea scan – Locate the cornea on the bottom of window. Use centre reflex from
cornea to locate the scan in the middle of scanned window.

1
Corneal 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 distributor.
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  Angle scan – Ask patients to look on side. Use external fixation to guide the patient
until cornea with sclera parallel to the scanning window.

10) Once the scan location is set in selected place press [Start] button. Computer will initialize
measurement process for a few moments and then full scan will be performed

Only when cornea/sclera tissue is parallel to the scanning window the AOD and TISA
measurements are accurate.

7.4 External fixation

With the external fixation method, the patient uses the second eye to fixate on a external target
light. The SOCT Copernicus is equipped with an external fixation target arm. It is attached at the top
of the forehead support. Its position it is set manually for central or disc fixation. When you select
external fixation target, instruct the patient to look at the green blinking target light at the end of
the external fixation arm.

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 7.5 Tips for examination

Information !
Usually patients are nervous and stressed during examination. That's why it is generally advised
to talk to the patient all the time during examination, informing about the progress of
examination.

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

Vertical line is
Horizontal line is representing right
representing left preview
preview

On the picture above shows scan upside down, patient’s eye is too far from the device’s head. Move
the device forward. You can get a proper examination by moving the machine head forward.

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

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 move right (head movement
device should be moved right to align scan and remove shadow.

It is possible to cancel tomogram calculation. Canceling will stop calculations. Current examination
will not be saved to the database.

Click this button to cancel

calculation.

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 8. RESULTS REVIEW WINDOW

Results review window enables operator to browse all the stored examination results. This window
contains all tools for analysis of acquired data. The main window contains tabs: Tomogram, 3D-
Imaging, Retina, Glaucoma or cornea analysis, Comparison, Fundus camera image.

8.1 Tomogram tab

Control panel
Threshold control
panel

Imaging and
Analysis tools
Click to start printout
manager
Cyst Analysis
Menu

Diagnosis
tab
Tomogram
Selection
Attachments tab
RNFL thickness
RPE deformation Retina plot
/thickness tab thickness plot
Information
panel

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 8.2 Control panel functions

Control panel enables the user to perform various operations on retina cross section image. A
detailed explanation of functions is presented below.

Scan selection controls Play button. Used to sequential

B scan change (asterisk and 3D scan)
Select to show Fundus
Scan selection controls preview
Select to show Fundus camera
Examined eye image (if it was imported)
indicator Select to show Fundus
Fundus preview, Fundus reconstruction (enabled
reconstruction or Fundus only for 3D scan)
camera image

Temporal area indicator

B-scan selection controls on
SLO reconstruction (green line
- if more B-scans were
Scan number collected)

Nasal area indicator

Scanning angle
A-scan number in B-scan

When examination with 3D scan profile has been taken, fundus preview can be used to select scan.
Click on arbitrary point in fundus preview field to select B-scan. Selected scan will be indicated with
green line.

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 8.3 Fundus camera image

It is possible to add fundus camera image to any examination.

Attached image can be imported from BMP, JPG, TIFF, PNG image file. In order to add fundus
picture, open required examination and click ‘Menu’ button at ‘Result review’ window. Then select
‘Import Fundus camera image’ item.

Click ‘Menu’ button

Select: ‘Import Fundus camera image’
item.

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 Dialog window as shown below will be opened.

Select required
image first

Click ‘Open’
button

Select required image and click ‘Open’ button. File will be attached to examination and ‘Fundus
camera image’ tab will be activated automatically.

‘Fundus camera image’ tab

OCT’s Fundus
Fundus
preview or fundus
image
reconstruction
alignment
image
Transparency
control slider

Zoom slider

Mirror effect

Now the operator should align OCT’s fundus reconstruction to imported fundus camera image. It is
possible to move and to resize both images.
In order to rotate fundus reconstruction image, move mouse cursor over small square in the corner
of fundus reconstruction. Shape of mouse pointer will be changed into double end arrow. Press and
hold left mouse button then move mouse, (holding down left mouse button all the time). Release
mouse button at the destined point.

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In order to resize fundus reconstruction image move mouse cursor over one of small squares at the
border of fundus reconstruction. Shape of mouse pointer will be changed into cross. Press and hold
left mouse button then move mouse, (holding down left mouse button all the time). Release mouse
button at the desired point.

In order to move fundus reconstruction image move mouse cursor over small green square in the
middle of fundus reconstruction. Shape of mouse pointer will be changed into cross arrows. Press
and hold left mouse button then move mouse, (holding down left mouse button all the time).
Release mouse button at the desired point.

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In order to zoom both images: fundus reconstruction and fundus camera image use Zoom control
slider.

It is possible to change transparency of fundus reconstruction image. Use ‘Transparency control

slider’.

All changes on ‘Fundus camera image’ tab will be saved automatically when closing ‘Result review’
window.

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 8.4 Image panel control.

Image panel control enables user to scale the tomogram image and to add graphical remarks to the
tomogram. All its functions are described below:

Horizontal fit Vertical fit

Show Cysts

Color /BW
Zoom OUT

Inverse Color
A-scan bar Full screen Zoom IN

Show Cysts : Display cysts on tomogram, enabled only when the examination has been analyzed in
the cyst analysis menu, and a cyst has been detected.
Colored : Show the tomogram in pseudo color or gray scale.
Inverse Color: Inverse the color range.
Full Screen: Shows tomogram on full screen.

Text Annotation
Distance tool
Measurements layer
Comments layer
Draw arrow
Remarks color Eraser Erase all remarks

Measurements layer: Show/hide distance and angle measurement indicators.

Comments layer: Show/hide layer with arrows and comments on tomograms.
Text annotation: Add comments to images.
Show Grid: Display reference range.

Brightness: Change brightness level on tomogram

Contrast: Change contrast level on tomogram
Default: Restore contrast and brightness settings
Auto Contrast: Displays tomogram with that same level of brightness and contrast for every exam.

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 Angle measurement tool
Retinal thickness analysis

An image of the
AOD measurement tool
smoothing filter
Edit recognition of
An image of the Flattening B-scans Retina thickness
layers
natural scale

Flattening of B-scan Is available after layers recognition. This option is useful for high myopic eyes
Smoothing : Turn on post-processing to reduce noise level
Layers: Marking this option for the first time, the system will start the process of
recognition of the layers, and the calculation of all the data that will be
displayed and given to the operator in the software. After the process is
ended, the check box can be used just to show/hide the layers
Retina thickness: Enable to check the thickness of each layer. Function is enabled only when
‘Layers’ checkbox is marked.
Natural scale: Tomogram is displayed in the scale 1:1 um. Default settings is 1:1 pixel.

8.5 Edit recognition of layers

Chose layer to
edit

System automatically recognizes layers. Whenever you find out that the recognition of layers is
incorrect, you can manually correct them. This feature is especially useful in cases where the retina
has structural anomalies or pathology that may cause the algorithms to incorrectly trace the actual
boundaries.
In order to correct recognized layers press the [Edit] button. In order to correct recognition of
layers, choose the layer from the list and draw its outline on the tomogram.
After correction of tomogram/s release [Edit] option. The software will automatically recalculate all
the data, on the basis of the user modifications.
Correction can be used for fovea and disc analysis. It is enabled only after analysis is done.

[Reanalyze] function is used to recover default recognition of

layers. It is helpful in reanalysis of examinations taken with previous
software versions.

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 8.6. Retina thickness measurement

It is possible to measure the thickness of the retina at any place of the selected B-scan. This tool is
available after the full retina analysis has been done, so after the ‘Layers’ checkbox has been marked
and the recognition process has finished. After clicking the ‘Retina thickness’ button, place mouse
cursor over the scan image at the desired point and click left mouse button. Information about
retina thickness, RPE (Retinal Pigment Epithelium) to inner segments or outer segments junction
distance and RNFL (Retina Nerve Fiber Layer) thickness will be displayed. All measurements are
shown in μm. There is possibility to include or exclude inner segment of photoreceptors from
thickness of retina, in order to change this parameter go to setup > parameters > checkbox “Include
IS/OS in thickness measurement”. For more details go to chapter 14.4.

Slider which sets top

threshold

RNFL thickness

Retina
thickness
Layers
recognition IS/OS junction
to RPE distance

Slider which sets

Click Retina thickness
bottom threshold
button

Red line: Inner Limited Membrane (ILM) - surface of the retina

Yellow line: Outer boundary of Retina Nerve Fibre Layer RNFL
Green line: Junction of IS and OS layer.
Sky-blue: Inner boundary of RPE
Dark blue line: Outer boundary of the RPE layer (Brusch membrane)/Choroid
White line: parabolic fit for end of RPE layer

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 8.7 Distance measurement

This tool enables to measure the distance between two selected points of retina. In order to use this
tool, click ‘Distance measurement’ button, position mouse cursor over the first point, press and hold
left mouse button, move pointer to second point (holding down left mouse button all the time).
Release mouse button at the second point. Information about distance will be displayed at the line.
All measurements are shown in μm. In order to replace the existing ruler move the cursor over the
ending pointer, press and hold left button and point at the right places. There are no limitations in
number for markers you can add. You can easily hide the layer with distance markers by means of
unmark Measurements checkbox.

Distance measurement
tool

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 8.8 Cysts analysis

SOCT Copernicus software has the possibility of analyzing the cysts and their volume. In order to
proceed with the analysis of the cyst, scroll the tomograms from up to down, finding the first
tomogram where you can already detect the first part of the cyst, and enabling the cyst edit mode.
Select the cyst on the tomogram by double clicking inside it.

Fundus reconstruction

Color of marked
cyst

Sensitivity–
regulation of cysts
shape

Remove all cysts

shape

Information table

– Turn on cysts edit mode. Enables to indicate and measure cyst/s on tomograms.
- Turn off cysts edit mode. In this mode when you place the cursor over the cyst you will see its
area.
Information table – contains information about number and area of cysts on actual scan and in all
scans expressed in [mm2], contains also information about total volume of the cysts.
Sensitivity – It changes the sensitivity of detection of the cysts.
Allow 3D detection – Enables detection cyst in whole scanned area.

In cyst analysis window there is possibility to fit, zoom IN/OUT tomograms and change between
B/W and color. To change shown scan click on fundus image or click preview/next scan buttons.

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 8.8.1 Mark and edit a new cyst
To mark cyst click button, choose a color of marker and click left mouse button on tomogram
in place where you can see the cyst. It will be automatically outlined with the sensitivity defined by
‘Sensitivity’ slider. Choosing the color of the marker, mind that the cyst will be shown with the same
color both in the tomogram window and in the 3D.

To delete marked cyst click left button mouse over the cyst. It is possible to remove all cysts from all
scans by clicking 'Clear Cysts'.
It is possible to regulate shape of cyst by changing sensitivity (information in table is changing).

If after changing the outline of cyst by sensitivity

slider the shape is still not accepted by the user,
there is possibility to edit this manually. Place
mouse pointer over the cyst and click right button.
The edit popup menu will appear - then choose
'Manual'.

In manual mode shape of cyst can be changed by replacing points.

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It is possible to add or delete control points. To add control point move mouse cursor over cyst line
(the cursor change shape and should look like this) and click right mouse button. Choose 'Add point'
from menu. New point which can be moved will appear.

To delete point put the cursor over the point, click right mouse button and choose 'Delete point'
from menu.

After editing cysts, close window by clicking 'Close' button.

NOTE: In a tomogram>info tab there is a list of tomograms on which cysts are marked. When you
click number of scan on the list, a selected tomogram will be shown.

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 8.8.2 Editing marked cysts

It is possible to re-edit marked cysts. To re-edit cyst, move cursor over the cyst and click right mouse
button. The popup menu will appear.
On a cyst’s outline 'Edit auto cyst' option will appear. Choose this option and move sensitivity bar to
change shape of a cyst.

Over the cysts which were edited manually 'Edit manual cyst' will appear. After choosing this option,
control points will appear on the line. Move control points to re-edit shape of cyst. More details you
will find on a previous page.

8.9 3D Detection of the cyst

Cysts analysis module enables to recognize cyst in scanned cube. In order to detect cyst in scanned
volume user has to indicate cyst on a tomogram and mark Allow 3D detection and press [Start]
button. System automatically will start detection algorithm. Tomograms will be analyzed
downwards. It is possible to stop recognition by [Stop] button. After cysts recognition the check box
Cyst in the 3D window will be enabled.

The software enables to calculate volume of recognized cysts.

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 8.10 Retina analysis charts

In the above picture there are two graphs.

- Retina thickness graph.
- Retina Nerve Fiber Layer thickness graph.
Background of Retina Thickness graph shows the normative margin, the vertical blue line
corresponds to the horizontal position of the pointer on the tomogram. These graphs are obtained
only after detecting layers by means of Layers function.
To acquire the normative data scan protocol: 3D, 7mm, 99 B-scans, 677 A-scans was used. The
normative data are applicable to scans acquired with 3D scan mode. When the “Layers” checkbox is
marked and 3D protocol is applied to an applicable scan, normative data appear. It uses a light red,
light yellow, light green, yellow, red color code like in the legend below, to indicate values. The colors
code applies to each particular A-scan location in the graph.
NOTE: Ensure that the marker which shows centre of macula in retina analysis tab locates the fovea
properly.

White area on the retina thickness chart identifies area which is not covered by normative data. E.g.
Scan length higher than 7mm and fovea not in centre of a scanned area.

Macula Normative distribution:

1% 1% falls within the light red band, considered outside the normal limit
4% 4% fall within or above the light yellow band
90 % 90% fall within the green band
4% 4% fall within or below the yellow band
1% 1% falls within the red band, considered outside the normal limit

Note: Clinicians must exercise judgment in the interpretation of the normative data. For any
particular measurement, note that 2 out of 20 normal eyes (10%) will fall above or below green.

Disclaimer: Optopol is not offering and does not offer advice or instruction in the diagnostic
interpretation of OCT images. It is the clinician’s responsibility to make diagnostic interpretations of
OCT scans.

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 8.11 RPE charts

 Green area denotes the norm range.

 Retina Pigment Epithelium deformation graph,.
 Retina Pigment Epithelium thickness graph.

8.12 Info Tab

Info tab contains physical details about the examination, SOCT QI and information about possible
cysts.
SOCT QI for Click here to see
examination tomogram with cysts
examination

Cyst information

Optopol provides SOCT QI (Quality Index) to enable the user to make judgments about the technical
quality of scans.
The Scan Quality Index QI interpretation is as follows:
- Images with QI values below 4 (shown in red) – re-examination is recommended.
- Images with QI values between 4 and 6 (shown in orange) - careful review of
measurements is recommended.
- Images with QI values above 6 (shown in green) - images are of good quality
and quantitative measurements are trustworthy.

For a 3D scan, composed of many B-scans, a minimum, maximum and average QI is reported.
In this way, the user can evaluate the image quality confidence for the entire 3D scan using the same
system explained above (i.e. QI<4, 4<=QI<=6, QI>6).

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 8.13 Attachments tab

It is possible to add any file to examination result, similarly as adding attachments to an email.

Click to add new

attachment
File001.jpg Click to delete selected
attachment

Click to save selected

attachment on hard disk

Click to open selected

Attachments list
attachment

When user clicks [Attach new file] button, dialog window is opened. User should select file
and click [Open] button. Selected file will be added to the examination and computer will show
message as bellow:

When user clicks [Delete attachment] button, confirmation question will be shown. If user confirms
‘yes’ button, the selected file will be deleted and computer will show message as bellow:

When user clicks [Save attachment] button, dialog window will be opened. User should set
directory path and specify file name, then click ‘Save’ button and the selected file will be saved on a
hard drive in specified directory.
When user clicks [Show attachment] button, selected file will be opened using windows registered
default application for this file type.

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 8.14 Diagnosis tab

At the bottom of the results review window you can see diagnosis tab. If you click on it, you can
choose one of the groups collected in the setup window. To add a group, type name of the new
group. In ‘Description’ field user can place examination description.

Patient
group

Any remarks can

be entered here

8.15 Tomogram Selection Window

This tab enables faster preview of sequence of tomograms.

Click to show
selected
tomogram

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 8.16 Printout Manager

The SOCT Copernicus enables you to edit printout of examination results, thanks to a print out
manager, which enables the user to choose freely what to add in the print out. And how to organize
it in the space of the Print out. Operator can prepare printout in four different ways:
- Quick printout – click to printout report
- Generate report - SOCT Copernicus offers a few standard reports. It is possible to customize
the printout standard.
- Add images or results manually – Enables to add any objects (tomograms, maps, graphs, etc.)
to printout the operator can prepare printout comprising results from different visits, both
eyes etc.
- Generate report and add objects manually.

NOTE: Printout is optimized to A4 standard and 600 DPI printer resolution.

You can choose a template from a list of predefined printouts. Note that for every type of
examination there are different templates.

Select printout
style

Select number of
objects on printout

Enter the
comments here
.

[Print] Prints the current report.

[Save as] – save a printout in JPEG, BMP, PDF format.
[Show/Hide Header Image] Mark this checkbox to include the customer logo on the printout.
[Hide personal Data] Hide the personal contact of the patient.
[Snap Grid] It helps to organize the objects on the printout, following a grid path.

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[Generate report] – generate report automatically. In case when analysis has not been carried out,
the system will firstly perform the analysis. This operation can take few seconds.
[Add Header Image] - The SOCT Copernicus enables you to customize your analysis printouts with a
clinic name and logo (or other graphic). Once selected, this element will appear in the top of all
printouts. In order to add your own logo, click [Add Header Image] and show path to the folder
where logo file is located. The logo must be a graphic file of size with ratio 10x1 (Horizontal x
Vertical). Default size is 500x50 pixels.

Note: The logo is resized to fit the entire Preview. When printed, the logo is resized to fit in a small
square area of fixed size. This can affect the appearance of the logo on printouts, especially if it is
rectangular.

Click [Print] button to print the results on a printer. A window will appear, enabling to set the
desired printer parameters.

Click to select
printer Click to set printer
parameters

Click to adjust
number of copies

Click to cancel
Click to start printing
printing

NOTE: This window can have different shape and different controls – it depends on type of
printer you have installed on your computer.

8.16.1 Quick printout

This option enables to print result of examination in a fast and convenient way. Options are enabled

on each analysis window. Press or click right mouse button over any object and choose
from the list. System starts printing immediately.
User can customize predefined “QUICK PRINT” style for own needs.

8.16.2 Generate report

If the user has not chosen any object and pressed the [Print] button, blank field of Printout Manager
will appear. Pressing [Generate report] starts automatic generation of the report. The user can
choose a template from a list of predefined printouts. Operator can add its own template to the list
of predefined printouts.
Note that for every type of examination there are different templates.

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 8.16.3 Customized printout

The SOCT Copernicus enables to customize printouts. It is possible to create and save operator
templates. To save the template type the name of new template and press [Save Template] to save
any changes. Next time when you are printing the results, you can use your own layout. Quick Print
template can be modified by operator.

NOTE: For each kind of measurement template is different. e.g. [3D, disc] and [3D, fovea] are
different. Operator can customize printout of each style.

Fill the field with own

name.

The operator can choose printout orientation (Portrait, Landscape), number of objects (1-12), type
of objects, localize them on the printout, resize them and remove noise from tomograms.

NOTE: If you want to add/remove more than one image, select number of objects on the printout.

Inserting new object

To insert a new object (tomogram, map, graph) into printout, right-click anywhere in a printout
preview. Choose from the list.
New field will appear in the preview. Active field is always marked with grey color.
Click to unroll list of
available objects Edit text displayed on
printout

Select one of available objects from the list. Title of object in the printout will be automatically
added. If you wish to change the title, put the mouse cursor over title area, click and write new title.

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Editing object
If the object is present on the preview you can edit its position, size and contents. To do so, put
the cursor over any map that is present on the preview to mark it in grey.
 To change the contents of the object unroll the list of available objects and select needed
one.

 To change the position of the map, press and hold left mouse button over the area of the
map. Move the map to desired position and then release left mouse button.

Edit text displayed on printout

 To change dimensions of the map, place mouse cursor in the bottom-right corner of the
map. When cursor changes icon, press and hold left mouse button. Moving the mouse on
the images diagonally while holding left mouse button will cause resizing of the map. Release
left mouse button if you finished resizing.

Editing tomogram
In case when map on the printout contains tomogram, it is possible to remove black noise above
and below the tissue. Move cursor over tomogram – a slider above tomogram appears. Move that
slider to desired degree to remove noise above retina.

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Deleting object from printout
To delete any map from the printout, move mouse cursor over the area of the object which you
want to delete. Right-click to open pop-up menu. Select ‘Delete image’ to remove object.

8.16.4 Add to print manager method

In order to print with Add to printout method, click right-mouse button in results review over the

object which you want to add to printout. Choose from the list. There is
possibility to add any number of tomograms, graphs, maps etc.
You can select different objects from different examinations but only belonging to the same patient.
Thanks to this option, operator can place on one printout results from different examinations.
There is the possibility to add tomogram together with the fundus reconstruction. Click right-mouse

button on the tomogram and choose from the list. This option is only
available both from the tomogram and the fundus reconstruction window.
NOTE: When you do not add any object to printout and go to printout manager then print preview
will be blank.
After adding some objects (tomograms, graphs etc) to printout, click [PRINT] button. You will see
printout window with added objects.
NOTE: When you start printout for the first time, you should see printout window with four objects
added - objects are located automatically. The SOCT Copernicus software stores last setting before
closing printout window.
NOTE: Setting will not be stored when you use [Generate report] button.
Changing the patient resets list of objects to printout. You can add new ones. In printout preview the
location of objects will be like last time using print manager.

8.16.5 Generate report and add objects manually

Operator can mix two methods to obtain the best printout. To do it, first add objects to printout
clicking [Print] button, then go to printout manager and click on [Generate report] button. The
report will be generated with use of selected template. Now you can change objects and replace
them with objects 'added to printout'.

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 8.16.6 Export to IRIS

The export to IRIS button, is enabled only when the IRIS software is installed on the computer. This
option allows the user to export the print out to the IRIS software as JPEG file.

8.17 Menu

This is a popup menu and you can activate it by clicking on the Menu button. From this menu you
can:
 Import - *.OCT file,
 Export - This option enables export examination file to *.OCT file or DICOM standard. File in
DICOM standard can be previewed by any DICOM browser.
 Save image – save selected tomogram as *.jpg or *.bmp file,
 Save to AVI – save cine loop with tomogram selected examination (3D, animation) as *.avi file,
 Import a fundus camera image from *.jpg or *.bmp file,
 Reanalyze – function is used to recover default recognition of layers. It is helpful in reanalysis
of examinations taken with previous software versions,
 Flip Tomograms – This function flips a chosen single B-scan. This function is enabled only for
the B-Scans which have been taken with the anterior chamber adapter.

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 9. THREE DIMENSIONAL VISUALIZATION

3D visualization tab is enabled only if scans have been taken using 3D scanning profile. The window
shows the 3D reconstruction of the retina structure.
Software has the possibility of two 3D visualization modes: advanced and standard. Advanced mode
is available on computers with 3D accelerator graphic cards. It allows to see all scanned tissues
separately: choroid, retina and vitreous bodies. The picture below shows 3D window sample:

9.1 Advanced 3D mode

Advanced 3D has specific visualization options.

Eye identifier Sides identifier
Displaying mode switch

Display and highlight

selected retina’s layers

Selector of peeled layers

Display options

Surface mapping

Zoom slider

Threshold level sliders

[Reset]– This button resets parameters of the image (angle of rotation, scale, displayed maps,
tuning settings) to default settings.
[Save] – saves currently displayed picture in JPEG format.
[Play/Stop button] – Enables slicing tomogram automatically. After clicking this button control
elements appear on a screen. Choose one direction to start animation slicing. It is possible to
rotate reconstruction during slicing. To finish click [Stop] button, which appear instead of play.
[Add to printout] – enables to add current view to printout
[Picture size slider] – enlarges and reduces size of 3D reconstruction.

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Rotation. In order to rotate 3D reconstruction click left mouse button, hold it and move mouse to
rotate. 3D reconstruction can be rotated by 360 degrees around the vertical axis and from -90 to +90
around horizontal axis.

Slicing – In order to slice reconstruction press right mouse button, gray balls appear. Direction of
cutting is chosen by balls placed on proper axis. Click one of six balls color (clicked ball changes from
grey to red) and then user can slice tomograms by moving ball along the red line. Use scroll button
to slice tomograms.

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 9.1.1 Displaying and highlighting selected retina layers

With ‘Highlight’ checkboxes it is possible to choose, which retina layer is highlighted e.g. on the
right image vitreous body highlight option is marked.

With ‘Visible’ checkbox it is possible to choose, which retina layers are shown or hidden.

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 9.1.2 Peeling layers

Advanced 3D enables peeling the retina layers. Marked layers will be peeled during move of red ball
over tomograms.

Operator can separately peel each layer. Easiest way to restore view is to use [Reset] button

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 9.1.3 Tuning of the picture.

Threshold sliders can be used to tune the reconstruction. Positions of sliders denote a minimal level
of transparency under the A-scans that will not be displayed on the screen.

Images obtained by setting different minimal transparency thresholds for vitreous bodies:

Example of reconstruction with different retina threshold level.

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 9.1.4 Display options.

The display options allow the user to change the visualization of the 3D.

Fundus photo: Option enabled only whenever a fundus camera photo

has been added to the examination. Option show the
fundus camera photo in the 3D visualization.
B-scan alignment: Align B-scans displayed on the 3D visualization, in order
to facilitate the view in the 3D reconstruction.
Wire Frame: Shows or hides the frame of the 3D.
Show letters: Shows or hides the letters which identify the side.
Colored image: Display the 3D reconstruction in color or black and white.
White background: Changes the background color.
Inverse color: Inverse color of tomograms.
Show Thickness: Option allows to display board with Retina, RNFL and RPE thickness for a
selected point. In order to proceed, mark this check box and then double click
in any point on the surface of the retina. A board will appear with values from
selected point. All the values are expressed in microns. The software allows
show up to 4 measurements.
Show details: Display front non transparent tomogram.
Convex Map: Change display map option.

9.1.5 Surface mapping

3D modes provide set of maps and masks on the retina analysis, but their presentation is different.
In the standard mode maps cover top of surface of retina reconstruction. In the advanced mode
maps are suspended and can be moved up and down. Moving is realized by dragging map handle
along the frame line. When a surface map is shown, the checkbox in the display option “Convex
map” is enabled, and the user can flatten the map.

Click, hold and move

to change position
of the map

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Display options offer the user to change the view of scene where reconstruction is presented.
There is also function which enables to display a fundus camera photo if it is added to examination.

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 9.2 Standard 3D

Currently selected
patient
Tomogram
display options

Segmentation

Display options

Surface maps options

Zoom slider

Reset display
options/Save as file

3D reconstruction can be displayed in 3 ways. To change them you can use ‘Fundus’ and ‘RPE’
checkboxes:
 ‘Fundus’ and ‘RPE’ unchecked - full tomograms are displayed as 3D image
 ‘Fundus’ checked - show reconstruction of surface of retina fundus
 ‘RPE’ checked - retina reconstruction, cut off the choroid tissue.

Fundus reconstruction display:

a) Fundus checked

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 b) Fundus/RPE unchecked

`
c) RPE checked

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 9.2.1 Segmentation
It is possible to display only RNFL , RPE, RNFL-RPE layers. Fundus reconstruction and maps can be
placed on the surface of layers.
a) RNFL displayed-with RNFL thickness map by default

b) RNFL-RPE displayed - without map by default

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c) RPE displayed - with RPE deformation map by default

9.2.2 Display options

- B-Scan alignment enables to diminish effects of eye movement.

- Color or Black/White displaying

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 - Show letters and Wire Frame

9.2.3 Surface mapping

This function enables to place a color mask on the surface of retina. It helps to easily locate single
tomogram from 3D visualization. Five options are available:
- Fundus mask
- Without mask
- Retina thickness map
- RNFL thickness map
- RPE deformation map

In example above RPE deformation mask is used.

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 9.2.4 3D preview

a) Cutting 3D reconstruction

Click right mouse button to display cutting tool. Click on the ball (it will change color) and move
into/out the cube to look through tomograms. User can slice in more than one directions.

b) Use slider to zoom in and zoom out model.

c) Rotation Click left mouse button and move mouse to rotate model. (holding down left mouse
button all the time)

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 10. MACULA ANALYSIS

This tab sheet is enabled only with 3D or asterisk scan profile and fixation set to fovea. It shows
retina thickness color map, RNFL thickness color map and RPE deformation color map. This tab
contains some tools described below. It is possible to enlarge one of the 4 windows by double
clicking on one of them, and come back to the 4 windows visualization, by double clicking on the
enlarged window.

Color / height scale for Retina

Retina thickness map Macula location
thickness map

RNFL thickness
“Macula analysis” tab map

Color / height scale

for RNFL thickness map

Scan preview Color / height scale

for IS/OS-RPE
thickness map
Information
table

Display IS/OS-RPE
functions thickness map
Type of data

RPE deformation map

In the information table are: average thickness of central sector, volume of scanned cube and
average retina thickness in scanned cube.

Macula location is detected automatically. There is possibility to correct fovea detection. Move
mouse cursor over middle of central sector. Click and hold left mouse button on a white dot at
“Retina thickness map” and move pointer to desired position.

To move center left click

and move mouse

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Depending on selection, retina can be divided to three round zones. Central zone should cover
macula. Second and peripheral zones are divided by four sectors. In all sectors software calculates
values of retina and RNFL thickness.

It is possible to show maps with diameter: 1 / 3 / 6 [mm] or 0.6/2.22/3.45 [mm]. Also you can
choose which value you want to observe in each zone Mean, Maximum, Minimum or Volume of
the zone.
Thickness of single point of map can be measured. Place mouse cursor over any of map at desired
point and click left mouse button. Detailed values will be displayed in the panel in upper left corner
of every map.

1/3/6 [mm] zones selected 0.6/2.22/3.45 [mm] zones selected

Larger map display Thickness under cursor

Smaller map display
(left click on the map)

Choose from the list value which will be displayed in each zone.

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 When “Grid” option is selected, the whole Retina thickness map and RNFL thickness map will be
covered by grid of numbers. Each number represents thickness at selected point.

Grid map selected

Grid map display

It is possible to relate measured thickness to normative data. When “Normative data” option is
marked, the values from all Retina Thickness map will be compared to normative data from
database. Conformity with normative data is presented by colors overlay on the map.

NOTE: Only correct point of the fovea gives solid results. Normative database was made on the
7x7mm scan area with macula in the centre.
Description of normative database see in chapter 8.10.

Colors inditicate
correlation with NDB

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 11. GLAUCOMA ANALYSIS

This tab is enabled only when the scan has been performed with the fixation target switched to the
disc. It shows Fundus reconstruction with preview of selected tomogram, table with ONH Data
information, RNFL thickness map in scan area and RNFL thickness graph.

ONH data RNFL thickness map

Color/height
scale for RNFL
Fundus thickness map
reconstruction or
Deviation from
Normal map

Ring diameter and

thickness control

The number of the

selected B-scan RNFL thickness
graph around disc
with norm
Preview of
tomogram

Average thickness
around disc

Cup offset control Manual drawing shape of disc

11.1 Fundus reconstruction/ Deviation from Normal Map

Fundus reconstruction image shows the shape of the disc (blue line) and the cup
(green line). The point of crossing of the two red lines shows the point of click –
horizontal red line shows position of selected tomogram shown on tomogram
preview below the fundus reconstruction.

On the fundus reconstruction press right mouse button and choose from popup
list “Turn on norm” to display Normal map. Darker color identifies normative
range area.

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 11.2 Tomogram preview

The red horizontal line on fundus reconstruction shows position of actual scan. In order to change
the tomogram preview and to scroll all the B-scan until the desired one, just click with the left
button on the fundus reconstruction.

Number of total scans

Tomogram preview image shows
selected tomogram. Press right mouse
button to change display scale. White
markers points left and right edge of
RPE on actual scan (if actual scan
crosses disc). If necessary, marker
points can be moved by clicking and
Press right mouse dragging them on tomogram image
button to change area (changes in single scan will occur
display scale
on shape of disc and cup and will take
effect in all analysis) to proper
location. Yellow line shows Cup Offset
Line (parallel to purple disc which
represents disc surface). Distance
between Cup Offset Line and disc
Add/Remove Previous/Next Zoom In/Out
RPE end’s markers scan surface line may be changed by
editing the value on Cup Offset Panel
or moving the slider.
After disc analyzing, operator can manually edit position of end of RPE markers. In order to replace
markers which indentify edge of RPE click white marker, hold the button and drag to proper location
in the disc profile (for each scan). It is possible to change position of edge by drawing shape of the
disc in Manual disc contour option.
Changing the Cup Offset will move cup closer or further from disc, this will be also visible in cup
shape on fundus reconstruction. All ONH data are automatically recalculated if Cup Offset or RPE
edge factors change. It is possible to restore default analysis by pressing [Reanalyse].

11.3 RNFL thickness map and RNFL thickness graph.

RNFL thickness map shows thickness of RNFL layer on scanned area. Map has a ring around the disc,
where the RNFL thickness acquire data to TSNIT analysis. This ring is divided into four zones
representing Temporal, Superior, Nasal and Inferior side. If operator click anywhere in the map, the
thickness of the RNFL in the chosen point will be displayed.
The black rings around the disc represent edges of ring used to calculate TSNIT RNFL thickness
displayed on RNFL graph. Dimensions of ring (diameter and thickness) are shown below the map. It
is possible to manually change the dimensions of the ring.

Thickness of selected
point

Click and drag to change

ring dimensions

Rings dimensions

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 The RNFL thickness graph shows the mean values of RNFL thickness
are calculated as mean value in selected ring for each angle from 0
to 360 degrees. Normative range band can change from 2.4 to 5
mm. The vertical blue line in the graph is correlated with the angle
on RNFL map. Value on the top show mean of RNFL thickness,
expressed in microns.
Graphs show average RNFL thickness in four or ten zones. Mean
TSNIT value and TSNIT SD are displayed above.

11.4 ONH (Optical Nerve Head) Data

ONH data shows morphology quantification of papilla parameters. All

the data from this part are calculated from Disc and Cup parameters
on all scans. Any change in automatic recognition (disc edge, RPE tips,
Cup Offset, layers segmentation) causes ONH Data recalculation.

DDLS section shows the DDLS stage, which is calculated from disc and
rim dimensions. Calculated value is marked by yellow frame moving
across the scale.[Preview] button allows to switch between ONH Data
view and DDLS Information view.

DDLS stage depends on rim to disc ratio, disc dimensions and area
where Rim touches Disc edge. DDLS Information view shows
dependence of DDLS stage on disc dimensions with some examples
regarding analyzed disc.
Automatic DDLS recalculation allows to observe how disc parameters
affect DDLS stage.

Disclaimer: OPTOPOL Technology is not offering and does not offer advice, instruction in the
diagnosis and interpretation of SOCT Copernicus images. It is the clinician’s responsibility to make
diagnosis and interpretation of OCT scans.

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 11.5 Control buttons

[Manual analysis] – Opens “Manual disc contour edition” window which allows physician to draw
manually the shape of the disc.
[Reanalyze] – It runs default disc recognition.
[Default Cup Offset] – Default Cup Offset sets default values, for each examination it is calculated
separately.
[Default Rings] –Sets Ring Diameter as 2.4 and Ring thickness as 0.4.
[Print] – opens “Printout Manager” window which allows to manage, generate and print
examination reports.

11.6 Manual disc contour edition

This window allows user to redefine shape of disc and its position.

[Apply] – apply the changes of the disc and close the window.
[Cancel] - Exits the window without changes.
[Reset] – resets a disc shape to condition which was before opening
the window.
[ Clear] - clears the disc’s factors. New shape of disc should be drawn
manually.

There are two ways to correct shape of disc.

One is to remove contour of disc by using [Clear] button and drawing it again. To draw a new shape
of the disc, click on the centre of a disc and at least two points on edge of a disc. Recognition of the
disc will be automatically circled between selected points around disc centre. All other points will be
automatically added after [Apply] button is used. If operator decides to draw disc contour more
accurately (with non elliptic shape) it's possible to add more disc points manually by clicking on the
image
Second way is to redraw existing shape.

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Redraw the disc contour

Operator can redraw disc contour position in two ways:

Click and hold left mouse button and draw desired shape.
Put the cursor over the blue point to activate it. Point will highlight. To move active point to new
position click left mouse button and move mouse. To delete active point click right mouse button on
it – the point will disappear and white disc contour line will be updated to connect two neighbouring
points.
Disc contour lines are always restricted to image margins.

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

Whenever the manual analysis is still not helpful to perfectly draw the shape of the disc, the user
can still fix the manual analysis, by means of the 2 white markers in the tomogram preview of the
main disc analysis window, as explained Tomgram preview chapter.

Disclaimer: OPTOPOL Technology is not offering and does not offer advice, instruction in the
diagnosis and interpretation of SOCT Copernicus images. It is the clinician’s responsibility to make
diagnosis and interpretation of OCT scans.

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 12. COMPARISON MODULE

The comparison module is useful to observe symmetry of the eyes plus follow up changes in the eye
structure. Use the radio buttons to select on the Disc or Retina plus Follow up or Symmetry. Select
examinations from the list, examinations depending from comparison protocol are highlighted. Each
compare protocol has three tabs: Tomograms, Graphical, Numerical.

12.1 TOMOGRAM TAB

On the tomogram tab operator defines protocols and examinations to compare. In order to choose
examination from the list mark checkbox. After choosing the first examination on the list,
examinations which match this kind of analysis remain.

Comparison
protocols

Manual correlation

Lock tomograms

Quick print

Examinations list

Control panel for

compared examination

[Lock] button – Enables to handle all displayed tomograms by one of tools.

[Add to printout] – Add all chosen objects to printout.
[Manual correlation] – Open to manually correlate scanned area. See chapter 12.4.
Examinations list shows detailed list of patient's examinations available to compare.

Note: Pay attention when you evaluate the tomograms on the Quick Printout if scanned
widths were different between examinations.

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 12.2 FOLLOW UP

12.2.1 Retina Graphical Comparison

In the Retina graphical analysis tab it is possible to compare different kinds of maps. User can
choose different map types: Retina thickness, RNFL thickness, RPE deformation, IS/OS-RPE
thickness. In the zone maps it is possible to display mean value, maximum, minimum and
volume of each sector.

Significance of Difference from

Thickness maps of Zone maps Difference
NDB
selected examinations from baseline baseline

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12.2.2 Retina Numerical Comparison

In the Retina Numerical comparison it is possible to see differences in the zones on the plots.
The Numerical comparison allows the user to compare Retina thickness, RNFL thickness, RPE
deformation and IS/OS RPE thickness between all the examinations selected, sector by
sector.
Single sector plot shows differences in a graph regarding the selected sector. It is possible to
decide which zone/s are compared.
Consolidated plot shows the differences in each zone on one plot.

Choosing compared
zones

Trend plot for

selected zones
exams.

Trend plot for

all zones in exams.

It is possible to export results of the numerical tab to text file. In order to export data press
right mouse button on the consolidated plot and choose export option.

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 12.2.3 Glaucoma Numerical Analysis

Up to four exams (baseline and three follow-up visit results) can be selected. The Disc Follow Up
Analysis displays a selection of up to four scans of the same eye displayed chronologically to help
track RNFL and ONH changes over time. This tab presents RNFL thickness map, difference from
baseline map, RNFL thickness data table, ONH parameters table, two TSNIT graphs and DDLS for
each eye. In addition, one TSNIT graph provides an overlay showing the TSNIT values for each eye
as a different colour line and second one plots data points for RNFL thickness average versus date of
exam.
The exam at the top of the tab is considered the baseline measurement for the selected follow up
analysis. The Difference from baseline map for each additional measurement illustrates changes
from baseline. The RNFL thickness data table, contains a difference column (from baseline) and rate
of regression slope (the rate value appears only if the difference between baseline and next exams
is at least three months).

Difference from RNFL data table Trend plot of regression for

baseline selected exams.

Baseline and
three follow-up TSNIT graph of all
exam selected exams

Deviation from
Norm map ONH progression

DDLS follow up

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 12.3 SYMMETRY ANALYSIS

12.3.1 Retina Numerical

Retina symmetry displays the output of the retinal thickness/volume analysis plus a data table that
includes thickness and volume quadrant averages, ratios and differences among the quadrants and
between the eyes.
Select Comparison/Fovea/Symmetry/Numerical examination of Left and Right eye to obtain for each
eye two maps that depict retinal thickness and volume. This analysis protocol operates on one Right
and one Left examinations made with the 3D or Asterisk of Macula protocols.

Fundus
Click on fundus to
reconstruction
change tomogram

Sector specification

Retinal thickness
map

Sectors or map

The upper map presents retinal thickness using a color code. The color scale appears to the bottom.
The lower can be NDB coded map or NDB coded sectors. Click the radio button at upper middle to
display the map or sectors. Sectors show either average, maximum, minimum retinal thickness (in
microns) or volume (in mm3 ) in each area. From Map Sector Dimension checklist choose circle
diameters 0,6/ 2.22/ 3.45 mm or 1/ 3/ 6mm

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 12.3.2 Retina Graphical

Retina Symmetry Analysis on a Graphical tab displays the output of the retinal thickness map,
thickness/volume sectors map plus two other maps. It is possible to choose on the bottom two from
RNFL thickness/RPE deformation/IS-RPE thickness/NDB map on the bottom row.
Select Comparison/Fovea/Symmetry/Graphical examination of Left and Right eye to obtain for each
eye two maps that depict retinal thickness and volume. This analysis protocol operates on one Right
and one Left examinations made with the 3D or Asterisk of Macula protocols.

Click on fundus to
change tomogram

Fundus
reconstruction

Retinal thickness
map

Sector specification

NDB sectors

The upper row presents retinal thickness map using a color code and NDB coded sectors. The color
scale appears on the bottom. The lower row can be defined by operator. Choose from the checklist
buttons in the middle of the row to display desired maps.
Sectors Map shows either average, maximum, minimum retinal thickness (in microns) or volume (in
mm3 ) in each area. From Map Sector Dimension checklist choose circle diameters 0,6 /2.22 / 3.45
mm or 1 /3 /6mm

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 12.3.3 Glaucoma Symmetry Analysis

Optic Nerve
TSNIT analysis
Head metrics

Fundus reconstruction
Fundus reconstruction

RNFL thickness
RNFL thickness map map

Deviation from the Deviation from the

Normal Map Normal Map

Left eye thickness graph

with normative data
Right eye thickness
graph with
normative data

DDLS calculation Left and right eye thickness

graph for symmetry comparison

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 12.4 EXAMINATIONS CORRELATION

The SOCT software automatically correlates examination thanks to recognized shape of the blood
vessels. In case where automatic correlation is not possible system displays message “Manual
correlation needed”. Press [Manual correlation] button to correlate exams manually. Place the
factors on any characteristic points of retina (e.g. characteristic retina blood vessels) on each
reconstruction.

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 13. ANTERIOR ANALYSIS1

The SOCT Copernicus was originally designed for retinal imaging. To obtain corneal and anterior
segments images Anterior Chamber Adapter was developed. The adapter Lens is placed in front of
objective lens to focus OCT beam on the anterior segment.

Epithelium

Bowman’s
membrane

Stroma

Schlemm’s Schwalbe’s line

canal

Scleral
spur
Iris

1
Corneal 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 your distributor.

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 13.1 Cornea analysis tab

Cornea analysis tab is enabled only for asterisk scan profile of anterior segment measurement. It
shows pachymetry map, Lasik flap thickness map.
The SOCT software can calculate correction of IOP (Intraocular Pressure) reading from pneumo-
tonometer according to the cornea thickness. After complete tonometry value program calculates
amount of correction (Correction) and corrected IOP value (Adjusted IOP) for examined Eye.
Calculation formula is predefined.

Pachymetry map Sector map

Eye preview,
Click to change
tomogram

Values in zones

Display mode

Complete IOP

When layers detection has failed, modify boundary layers manually.

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 13.2 Angle measurement tool

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

13.3 AOD measurement

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

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 second one
on the cornea surface away from sclera spur. Another point has to be located on Iris.
AOD750: Angle Opening Distance of 750 micron
TISA: Trabecular Iris Segment Area
Only when cornea/sclera tissue is parallel to the scanning window the AOD and TISA
measurements are accurate.

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 14. SETUP WINDOW
Setup window is used to set various parameters of the system.

14.1 Backup

There are three possible ways of performing backup:

burning CD/DVD,
saving backup copy on HDD storage space.
burning CD/DVD and saving backup copy on HDD

Select destination
folder for backup
copy
Select CD/DVD
burning drive
Click to create
Click to burn backup
backup copy
CD/DVD

Include HDD backup files - if this option is marked, the CD/DVD backup will not contain files which
were previously archived using HDD backup.

Warning !
Make sure there is enough free space on HDD before performing backup process

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 14.2 Recover

In order to recover data from backup copy use recover tab in setup window. Set the source
folder where backup copy is located and press Backup button.

Click Recover tab

Select source location

from which the database
should be read

Select to overwrite
records in database

Click to recover
data from backup

First user should set the source folder where backup copy is located. To select source directory
click ‘Source’ field at Recover tab. If ‘Overwrite existing records’ field is marked, all the existing
examinations from database will be overwritten by copy from backup. If this option is not
marked only examinations not found in database will be recovered and all existing will stay
unchanged. Now user should click ‘Recover’ button.

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 14.3 Database setup

Select ‘Database’ tab to be able to access all the tools needed to handle database. Database
integrity can be checked. This tab also enables to set the backup reminder messages.

Check
database
integrity

Backup
reminder

Network
database option

Check integrity - database is checked for any internal errors. This function repair simply malfunction
of damaged database.

Backup remind every xxx weeks - if this option is marked, computer will display warning message if
backup operation wasn't made for at least xxx weeks.

Backup remind every xxx examinations - if this option is marked, computer will display warning
message after making at least xxx examination without performing backup copy.

Network connections - This option is used when the SOCT system is used by many users in
computer network.

SOCT Server – The computer is working as server. It can be a separate computer or computer
connected to the device. For more details see Appendix A

SOCT Client - The database is located on Server computer. The Client can be a viewing station
computer or computer with the SOCT . For more details see Appendix A

External Database Client – The computer is working as viewing station. The examination are
downloaded to local computer from the server. Iris Copernicus Server application should be
install on server. See in more details in Appendix A

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 14.4 Parameters

'Parameters' tab contains options enabling customization of various parameters of the SOCT
Copernicus system.

Select Parameters Video source Video input

tab device (Composite, S-Video)

Click and enter text

(info card) Language
selector

Skin
selector

Currently used
COM port

All the functions are described below:

'Auto turn off' – if this option is marked, computer will be automatically turned off, when user quits
SOCT application.
'Off line mode' – if this option is turned on, computer will not require the device to be connected to
computer. It is possible only to review results in this mode.
'Auto tomogram clip' – this option is responsible for cutting top of the tomogram. If this option is checked
black area over retina on tomogram will be cut.
‘Include IS/OS in thickness measurement’- if this option is marked, computer adds thickness of
Inner/Outer Segments of Photoreceptors to total value of thickness of retina.
‘Use viewfinder’ - this options switches off the viewfinder mode.
'Video source' – here you can select video card installed in your computer to get fundus preview at
the time of measurement.
'Video input' – this combo box gives you ability to select input of your video card.
'Normative database’– here you can change file with normative data used on “Retina analysis” module
‘Language’ – this combo box gives you ability to select language of your origin. In case when your language
is not on the list, contact with your local distributor.

‘Skin’ – this options allow user to customize layout of the software.

‘Unlock anterior’ – type code to unlock anterior chamber options. Anterior chamber is optional and can be
purchased separately.

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 14.5 User accounts

It is possible to login in to the system using different operator. The user accounts appear in the drop-
down list of user names on the login screen.

Using the Staff Registration dialog, the user with admin rights can create (register) medical staff,
password and privileges to users. Users with administrator right can add, edit, delete new users.

Users can then search for patient records by association with registered staff. Software
automatically and permanently associates saved scans with the current user when saving. Each
operator can have own default scan parameters and printouts styles.

14.5.1 Creating new user

Using the user registration dialog, the user with admin rights can create (register) user name,
password and privileges to users.
It is not possible creating new users on Client computers.
Users can then search for patient records by association with registered staff.

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 14.6 Joystick configuration

To control SOCT Copernicus device 3-axis joystick controller can be used. The joystick has several
buttons whose functions can be fully customized using joystick setup window.
By pressing any of joystick buttons, the BTx button will turn green indicating the number of button
being pressed. On the right of each button, there is a selection checkbox for selecting proper
actions.

Button function
With this controls you
can customize your
Button joystick axes
identifier

Joystick sensitivity

14.6.1. Joystick checking and calibration

New connected joystick needs calibration. In this situation click menu START in windows and then
click CONTROL PANEL. Please click GAMES AND CONTROLLERS, opened window should look like this:
Click PROPERTIES button to open test window shown below.

Now you can check your joystick. To calibrate it follow the instructions on the screen.

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15.MAINTENANCE AND CLEANING PROCEDURE

Warning !

All maintenance activities can only be made when device is turned off and unplugged from
power supply socket.
There are no user serviceable parts inside device. Any covers can be removed only by
authorized service staff.

The main lens of the device should not contact the patient's eye or face.

During the whole period of use, SOCT Copernicus does not need any special maintenance
procedures. The outside surfaces of device should be kept tidy and free of dust and cleaned
using mild cleaning solutions.
Take care not to get water or any other liquid inside device. For hygienic reasons, after each
examination the chinrest and forehead support should be disinfected.

15.1 Routine Cleaning

a) Cleaning of the device casing and equipment of the ME System (PC, monitor LCD, printer,
keyboard and mouse computer, joystick)
Clean the casing with soft cloth. Use only cleaners applied for cleaning of electronic
equipment.

b) Cleaning of the applied parts (forehead and chinrest support)

The applied parts should be disinfected after examination of each and every patient. Use soft
cloth, wet with ethanol solution for disinfecting. The applied parts are to be disinfected also
after longer period of no use.
c) Cleaning of the lens
The lens should be cleaned sporadically, when contamination of lens surface is observable.
For lens cleaning, use only cleaners applied in optics, that do not cause scratching of the lens.
Clean the lens softly with a little force. It comes with a lens cap to cover it when not in use.
You should clean it to remove dust and oily smudges sporadically to ensure true tomogram
images are obtained. You may use an alcohol prep swab or cotton swab dipped in isopropyl
alcohol. Wipe dry with a soft, non-lining cloth or tissue.
Periodically one has to check if there are no mechanical damages to the device, damages to
any of the cables and fuses.

d) Dust Prevention: When not using the SOCT Copernicus, make sure the cloth dust cover is
placed over the unit.

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 15.1 Software maintenance activities

To keep software in good condition user should perform below activities as minimum:
1. Windows automatic updates should be turned on and checked at least once a week.
2. If it is not possible to have automatic updates turned on (for security reasons or internet
availability), system administrator should manually keep operating system updated. System
administrator should check regularly for new updates at least once a week.
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.

15.3 Hard Disk Defragmentation

Defragmentation of the OCT computer hard disk becomes necessary when you delete, analyze old
scans regularly. The process of recalculation, deleting data and then writing again
to the hard disk fragments the hard drive, which degrades system performance over time. To
maintain peak performance, we recommend that you defragment the hard disk regularly.

Note: Since hard disk defragmentation usually requires several hours to complete, we recommend
that you start defragmentation at the end of the day and let the process run overnight. If
defragmentation is not complete in the morning, it does no harm to stop defragmentation and
continue using the instrument.

To defragment the hard drive, follow these steps:

1. Close the SOCT software.
2. Click Windows Start > Programs > Accessories > System Tools > Disk Defragmenter. The
Select Drive dialog appears.
3. Select the desire drive e.g. D: and click OK to begin defragmentation.

15.4 Ordering consumables

When ordering consumables and spare parts, contact your local dealer and tell them the article
name, article code and quantity.

Article name: Article code: Description:

Single use chinrest labels C003

Fuses B006 Fuse: 2 x M 3.15 A L 250V (20mm x

f5mm)
Dust cover C005

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 15.4 .1 Blown fuses exchange
If the device does not work when the power is on, the possible reason is a blown fuse.

Important !
Before exchanging the fuses, make sure that there are no other visible reasons causing the device
not to work (broken cables, not connected cables, etc).
Before exchanging the fuses, turn the device off and unplug it from power supply socket.
The fuses are located in power supply socket at the back of the device. In order to replace the
fuses, unplug the power supply cable, press the small plastic lever and pull the fuses casing.

Fuse

Mains socket

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16. ENVIRONMENTAL CONDITIONS
ENVIRONMENTAL CONDITIONS OF USE:

CRITERION ENVIRONMENTAL CONDITIONS

Temperature + 10 °C to + 35 °C
Relative humidity 30 % to 75 %
Atmospheric pressure 800 hPa to 1060 hPa
Dust on the air No visible particles
STORAGE CONDITIONS:

CRITERION ENVIRONMENTAL CONDITIONS

Temperature -10 °C to + 55 °C
Relative humidity 10 % to 95 %
Atmospheric pressure 700 hPa to 1060 hPa
TRANSPORT CONDITIONS:

CRITERION ENVIRONMENTAL CONDITIONS

Temperature -10 °C to + 55 °C
Relative humidity 10 % to 95 %
Atmospheric pressure 500 hPa to 1060 hPa
Shock 30 g, duration 6ms
Bump 10 g, duration 6 ms

17. SERVICE
In case of problems contact your local distributor:

On request the supplier will make available circuit diagrams, components part lists,
descriptions, calibration instructions, or other information which will assist the user’s
appropriately qualified technical personnel to repair those parts of equipment which are
designated by the manufacturer as repairable.

18. UTILIZATION

After usage period is over, contact your distributor for utilization instructions.
Maximum lifetime of device – 10 years since date of manufacture.

19. DIMENSION AND WEIGHT

Instrument Dimensions: 520 x 630 x 675 mm

Weight: 35 kg

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 20. FAQ - Frequently asked questions

Q1: The tomogram images have good

quality, but there is a shadow at
horizontal tomogram image (left
image) on the left or right edge and
the image is diagonal.

A1: The scanning beam is not centered

on the pupil in the horizontal
direction. This effect is observed mostly for small pupils and wide scanning ranges (>4-5mm).
Move the tomogram in left or right to obtain best image quality.

Q2: The tomogram images have good quality, but the horizontal retina cross section image is
diagonal.
A2: See A1

Q3: The tomogram images have good

quality, but there is shadow at
vertical tomogram image (right
image) on the left or right edge and
image is diagonal

A3: The scanning beam is not centered on the pupil in the vertical direction. This effect is
observed mostly for small pupils and wide scanning ranges (>4-5mm). Use joystick to move
the device’s measurement head slightly up or down to obtain best image quality

Q4: The tomogram images have good quality, but the vertical tomogram image (right image) is
diagonal

A4: See A3

Q5: Live tomogram images are

visible, but the retina image is
upside down.

A5: This means the measurement

head is too far away from patient. Move the device’s measurement head closer to patient.
The retina cross section image will go down on the window and then up again in a straight
orientation

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Q6: After start of the software displays communication errors.

A6: Make sure that the scanning head finished self test before you run the application.

Q7: Software display massage “No signal detected”.

A7: Run the “Skantest_lt” (START/ALL PROGRAMS/SOCT/Skantest_lt) application [Open]

communication and run [FULL] calibration procedure.

Q8: The tomograms images have bad quality.

A8: 1) Check cleanliness of the objective lens. Clean it if necessary. If it is not changed go to point
2) Make sure that system calibrate itself before first examination.

Q9: There is no live retina image – just a black window, no noise.

A9: The synchronization cable or adapter cable is not connected or connected improperly. Make
sure the adapter cable (flat VHDCI connector) is properly connected to frame grabber card.
Make BNC connector is connected to synchro input (T0 input)

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APPENDIX A Configuration of Network Connection

1. SOCT network

All the computers working in the network use database stored on the SERVER. SERVER computer
have to run the SOCT application to have access to database files. The computer working as SERVER
can work connected to the device or work as viewing station.

There is unlimited number of PC computers connected to the same LAN which have access to
SERVER. Efficiency of work is limited by network structure and computer performance (OS Windows
required). It is recommended to use 1000 Mbps network structure. The CLIENT can be a computer
connected to the device or viewing station.

NOTE: Both SERVER and CLIENT computers have to use that same software version of SOCT
application.

Client 1

Client 2

Data
base
Server

Client n-1

Client n

Networking functionality restrictions

When software is configured as Client, there are some limitations applied to its functionality:
- Only client connected to the device can perform new examinations.
- There is no possibility to make backup, recovery and repair database on client computer.
- In case when on one of the computers specific patients is using, there is no possibility to
proceed this patient’s data from any other computer. ‘Selected patient is occupied by
another user’ message is displaying. It means there is not possible to edit, review, perform,
remove, analyze, import, export patients on more than one computer at that same time.
- Users accounts can be create only on the Server.
- There is no possibility to use the exam

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 1.1 SOCT Server configuration procedure

1) Turn on computer and start SOCT Copernicus software,

2) Click Setup,

3) Confirm by clicking Yes.

4) In Setup go to Database panel.

5) Check the checkbox Network connections
6) Choose radio button SOCT Server (see image above)
7) Go to Parameters panel.
8) On Parameters panel check “Offline mode” if the Server is not connected to the device.
9) Quit SOCT application

Note: When the Copernicus software is working as server, application should be active during
reviewing data.
On the „Server” computer to hibernation, suspend mode for any components (HDD, LAN, CPU
etc.) has to be disable.

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 1.1.1 Sharing SOCT database folder on Windows XP
1. In Windows Explorer find SOCT directory. By default it is D:\SOCT. This directory has to be
shared to other computer with full access rights.
2. Click right mouse button on directory and choose Sharing and Security….

10) Go to Sharing panel and check Share this folder on the Network and Allow network users to
change my files.
11) Now the server computer is fully configured.

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 1.1.2 Sharing SOCT database folder on Windows 7

1) Go to Start/Control Panel/Network and

Internet/Network and Sharing
Centre/Advance sharing settings and
select:
- Turn on network discovery
- Turn on file and printer sharing
- Turn off password protected
sharing.
Note: If for security reason this
option cannot be activated ask
network administrator to set up
users and access right to SOCT
folder.
Accept and Save Changes

2) Now you need to share the SOCT folder on the network. Select Computer from Start menu and
explore to SOCT folder (by default D:\SOCT). Right click on it select Properties
3) Select “Sharing” tab and open
Advance settings.

4) Select “Share this folder” checkbox. If needed enter the name which will appear in the network.

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5) Next configure share permissions. You should specify users which will have network access to
SOCT folder. Grant them ‘Full control’. You can select ‘Everyone’ if you wish to grant access to
everyone.

1.2 Client computer configuration procedure

In order to configure database client you need to install SOCT Copernicus Software on each
computer you want to use as client. SOCT Copernicus Software you can find on installation disc.
To install it run setup.exe.

1) In case when you are using the Windows 7 follow the instruction below otherwise proceed
point 2.
Go to Start/Control Panel/Network and Internet/Network and Sharing Centre/Advance
sharing settings and select:
- Turn on network discovery
- Turn on file and printer sharing
Accept and Save Changes.
2) Turn on computer and start SOCT Copernicus Software
- the software will show multiple communication errors (don’t worry about that)
3) Click Setup and confirm by clicking Yes.
4) In Setup window go to Parameters panel.
5) Check OFF LINE mode to work on computer without the device.
6) In Setup window go to Database panel.
7) Check the checkbox Network connections

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8) Mark “SOCT client” radio button.

9) Specify the folder in the network that you want to connect to.
10) Note: that the Client and Server computers have to be in that same Subnet.

11) Confirm information “OK”

12) Restart SOCT Software.

The next time you start the software, the system will connect to remote database.

The example above shows the client configuration on the network where the server c
omputer is named “Copernicus” and shared SOCT database folder is named “SOCT”.

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 2. Iris server network

The idea of networking is following:

- There is one computer in the network called a SERVER. Data from different devices are
uploading on the server. The viewing stations download date on local HDD.
- There is unlimited number of PC computers connected to server have access to “SERVER”
and can be used as reviewing station.

The computers connected to devices and CLIENT computers need to have the same SOCT
application installed. Server installation procedure is describe below.

In the Copernicus Iris server mode on the Patient tab [Upload to server] and [Download from
server] buttons are available.

2.0.1 Upload on server

[Upload to server] button start uploading new examinations on the server. Red color of the button
shows that on the computer there are new examinations which are not on the server.
Progress bar shows status of uploading. Operator can stop the process anytime.

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 2.0.2 Download from server

[Download from server] function checks list of examinations on the server.

System displays list of patients and their exams which are on the server. Non active examinations
(grey font) are already on a local computer. User can select desired examination from the list. Only
marked examinations are downloading on local computer.

Press ‘+’ to unroll the

list of examinations for
specific patients

Mark the Patient to

check all patient’s
examinations

Filter section

[Check All] button allows to check all examinations on the list.

It is possible to filter displayed examination by: Last name, First Name, Reference Number and/or
by specific date. Enter desired name in Search field.
Note: Filter searches whole string only.

Activate Filter by pressing [Apply]. To reset filter settings press [Clear filter].

Press [Synchronize] button to download all selected examinations. Operator can cancel the process
anytime.

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 2.1 Client computer configuration procedure:

1) Turn on computer and start SOCT Copernicus Software

- the software will show communication errors (don’t worry about that).
2) Click Setup and confirm by clicking Yes.
3) In Setup window go to Parameters panel.
4) Check OFF LINE mode to work on computer without SOCT Copernicus.
5) In Setup window go to Database panel.
6) Check the checkbox Network connections
7) Mark “External database client” radio button.
8) Specify the IP address of the Iris Copernicus server in the network that you want to connect
to.
9) Specify the Port

10) Mark the “Remind about synchronization” if you want to receive reminder before closing the
software.
11) Press [Check connection] to connect with server.

Note: Changes will apply after software reset.

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 2.2 Copernicus Iris server configuration

2.2.1 Introduction
The Copernicus Server IRIS cooperates with SOCT application. It allows synchronizing the content of
data base between local computers with SOCT application and the server. The Copernicus Server
IRIS is compatible with SOCT Copernicus v.4.2 or higher.

2.2.2 Requirements
Hardware requirements:
 Processor: x86/x64, min. 2GHz, dual-core recommended,
 HDD: min. 7200 rpm. For synchronized data additional disc, independent from system disc it
is recommended.
 RAM:
Windows 7/Server 2008 : 4GB
OS requirements:
 Win 7, PL/ENG, 32/64bit
 Win Server 2008, PL/ENG, 64bit
Os settings:
 Application has to run on Administrator account
 Firewall has to be switch off

2.3 Copernicus Server IRIS installation.

Step 1
If you are installing Copernicus Server IRIS on
the existing version of the program, installer will
detect that and display appropriate message.

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Step 2
Welcome window. To proceed
click [Next].

Step 3
Read the license and accept it.
Otherwise, the installation will
be aborted.

Step 4
Indicate the folder where you
want to install the application.

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Step 5
Indicate the database folder
and the folder where you
want to save the multimedia.

If the IRIS package has been previously installed, the installer will
automatically set the path to the multimedia folder (this is the path
chosen during the first installation).

If you are installing

the IRIS Package
on the early
version of the
program, you have
to decide, if you
want to use
database from the
early version.

You will have to

confirm the
replacement of
existing database.

Replacing database will delete all data stored in it.

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Step 6
Indicate the Start menu folder where
you want to put the application
shortcuts.

Step 7
Press [Install] button to begin installing
the package.

2.4 Module configuration

To launch Copernicus Server IRIS program go to Start → All programs → medi.com →Copernicus
Server IRIS → Copernicus Server. Window presented below will appear.

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Click on the [Activate service] button. Program will connect with the data base.

Next go to the Module state tab, choose Copernicus server module, click on it with right mouse
button and choose Settings.

Window presented on the right

will open. Multimedia folder is
a place where OCT
examinations acquired from
SOCT Copernicus will be
stored. You also have to choose
appropriate FTP port, which will
be used to communication
between the module and SOCT
applications. Auto run option
determines, whether the module
is to be automatically launched
when starting the server.
Entered settings will be saved after clicking [OK] button.

After configuring the module you can run it. In order to do so, choose Copernicus server module,
right-click on it and choose Run.

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Module’s state will change to „Running”.

Copernicus server module is ready to work and waiting for information from SOCT Copernicus. To
perform a successful communication it is also necessary to configure the SOCT Copernicus
application.

2.5 FAQ

Problem with running several Firebird Instances per Server Machine

Sometimes it may happen that after the installation of IRIS Copernicus Server other applications
using Firebird Service may stop working. There is no risk of data loss. Only Firebird Database Service
needs to be reconfigured. The most common problem is that other applications use the default
instance of Firebird Service.
IRIS Copernicus Server during installation adds to the registry (or changes) the entry for the default
instance of Firebird Service. Use regedit tool to check this entry:

Path: HKEY_LOCAL_MACHINE\SOFTWARE\Firebird Project\Firebird Server\Instances

Entry name: DefaultInstance
Value: Path to Firebird Service Folder on the disc.
The value of this entry is the path to the installed version of Firebird.
If other applications use this entry, and use another version of firebird, it may be the reason that
these applications no longer work correctly.
Solutions
1) Change the value of the entry in the registry on the path to the previous version of the firebird.
Such change won’t cause incorrect work IRIS Copernicus Server. To change this value please find
instreg.exe tool in the application which has stopped working and run the following command:
instreg i[nstall]

It should change this value in the registry.

2) If it doesn’t work then reinstall the application that has stopped working. Please be careful not to
overwrite the existing database. Just reinstall the program without a database.
3) In case of problems, you should read additional guidance listed below.
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This part of manual explains how to run more than one instance of Firebird on one machine, e.g.
two different versions (like 1.5 and 2.0) of Firebird.
The Firebird Service
When you install Firebird using the self-contained Setup program or use the instsvc.exe tool, a
service for the Firebird server (and, when you request it, a service for the Firebird Guardian) is
installed.
The name of these services is the same for all versions of Firebird:
 Firebird Guardian - DefaultInstance
 Firebird Server - DefaultInstance
When you install Firebird 2.1 using the IRIS Copernicus Service the name of these service is:
 FirebirdServer_medi.com_FB21(3021_XXXX)
XXXX - this is a port number of IRIS Service (this is 3335 by default)
You can use the NET START and NET STOP commands to start and stop these services from a
command line, e.g.:
NET START "Firebird Guardian - DefaultInstance"
NET STOP "Firebird Guardian - DefaultInstance"

To install a certain version of Firebird as a service, you can use the instsvc.exe tool that comes with
Firebird and is located in Firebird's bin subdirectory.
instsvc i[nstall] [ -s[uperserver]* | -c[lassic] ]
[ -a[uto]* | -d[emand] ]
[ -g[uardian] ]
[ -l[ogin] username [password] ]

sta[rt] [ -b[oostpriority] ]
sto[p]
q[uery]
r[emove]

So you can use instsvc install -s to install Firebird as a SuperServer service. Or use instsvc

remove to uninstall the service. You can also use the start and stop options to start and stop the
service, like you would do it with NET START and NET STOP.
Note that as all versions of Firebird use the same default service name, you can install only one
instance of Firebird as a service on one machine, using the Windows Installer for Firebird.
With the Windows installer, it is easy to install Firebird as a service.

Firebird 2.1, 2.5: Named Instances

Starting with Firebird 2.1 you can give your instance a name. The INSTSVC tool takes a -name
parameter for that, so you can use
instsvc install -name FB21

to install the service with the name "Firebird Server - FB21".Exactly the same Firebird Service is
installed in the IRIS Copernicus Server.

Starting Firebird as an Application

You can also start the Firebird server as an application:
fbserver -a

will start Firebird as an application, showing an icon in the taskbar notification area. You can right-

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click on this icon to shutdown this instance of Firebird.

Running Multiple Instances

You now have these general options to run multiple Firebirds at once:
 Run one of them as a service and the other(s) as an application
 Run all of them as an application
 Run them with different instance names

Port Conflicts
The default TCP port for Firebird is 3050/tcp. When you install Firebird 2.1 using the IRIS
Copernicus Server the default TCP port for Firebird 2.1 is 3021/tcp.
When you run several instances of Firebird at the same time, they must listen on different ports.
There are two ways to configure this:
 In the corresponding firebird.conf, modify the RemoteServicePort or
RemoteServiceName setting. If you change the RemoteServiceName, you must define that
service in the services file (\Windows\System32\Drivers\etc\services).
 Use the -p <port> option when you run Firebird as an application:
fbserver -a -p 3051

Connecting from the Client

The port number for the server can be specified in the database connection string, separated from
the server name by a slash:
copernicusserver/3021:D:\DB\MedicomDb.fdb
dbserver/3051:rocknroll

You can also use the service name:

copernicusserver/FirebirdServer_medi.com_FB21(3021_3335):D:\DB\MedicomDb.fdb
dbserver/fb21:rocknroll

In this case you would have to define these service names in the services file of every client.

Using the correct Client Library

Connection from the client is done using the fbclient.dll client library. Every version of Firebird
comes with a new version of fbclient.dll. However, these are backwards compatible, so you can use
the newest one for connecting to all kinds of Firebird servers. It is no problem to use the Firebird 2.1
client library to connect to a Firebird 1.5, or even Firebird 1.0 server.
A correctly coded Firebird application will look up the Firebird Client path in the Registry. The key is :
HKEY_LOCAL_MACHINE\SOFTWARE\Firebird Project\Firebird Server\Instances
and there the string DefaultInstance will contain the path name of the Firebird installation.
You can use the instreg.exe tool from Firebird's bin subfolder to install the correct path to this
Registry Key:
instreg i[nstall]

will install the Registry Key, and

instreg r[emove]

will uninstall it.

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Messages File for Firebird's Utilities
The Firebird command-line utilities like ISQL, GBAK etc. obviously use the Registry to find out the
Firebird base path. So when you have 1.5 and 2.0 installed, they will only read the old firebird.msg
Messages file, which will lead to missing texts and messages (call HELP in ISQL to see that).
So if you want to have complete messages you should call instreg i before using these tools.

Windows Vista and Windows 7 settings

UAC has to be set on lowest level UAC.

The Windows Firewall has to be switch off.

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APPENDIX B
Park positioning

1. Open Park positioning program Start/All programs/SOCT/SOCT_Park

2. Wait until scanning head finish park procedure.
3. Put the protector handle in to the hole and screw clockwise. Screw it until resistance.

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APPENDIX C
EMC information

Guidance and manufacturer’s declaration – electromagnetic emissions

The SOCT Copernicus is intended for use in the electromagnetic environment specified
below. The customer or the user of the SOCT Copernicus should assure that it is used in such
an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The SOCT Copernicus uses RF energy only for
CISPR 11 its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class A The SOCT Copernicus is suitable for use in all
CISPR 11 establishments other than domestic and those
Harmonic emissions Class A directly connected to the public low-voltage
IEC 61000-3-2 power supply network that supplies buildings
Voltage Complies used for domestic use.
fluctuations/
flicker emissions
IEC 61000-3-3

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 Guidance and manufacturer’s declaration – electromagnetic immunity
The SOCT Copernicus is intended for use in the electromagnetic environment specified below. The
customer or the user of the SOCT Copernicus should assure that it is used in such an environment.
IMMUNITY test IEC 60601 test Compliance Electromagnetic environment - guidance
level level
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or
discharge (ESD) ± 8 kV air ± 8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
Electrical fast ± 2 kV for ± 2 kV for Mains power quality should be that of a
transient/burst power supply power supply typical commercial or hospital
IEC 61000-4-4 lines lines environment.
± 1 kV for ± 1 kV for
input/output input/output
lines lines
Surge ± 1kV line(s) ± 1kV line(s) Mains power quality should be that of a
IEC 61000-4-5 to line(s) to line(s) typical commercial or hospital
± 2 kV line(s) ± 2 kV line(s) environment.
to earth to earth
Voltage dips, short <5% UT <5% UT Mains power quality should be that of a
interruptions and (>95% dip in (>95% dip in typical commercial or hospital
voltage variations on UT) UT) environment. If the user of the SOCT
power supply input For 0,5 cycle For 0,5 cycle Copernicus requires mains interruptions,
lines it is recommended that the SOCT
IEC 61000-4-11 40% UT 40% UT Copernicus be powered from an
(60% dip in (60% dip in uninterruptible power supply or a battery.
UT) UT)
For 5 cycles For 5 cycles

70% UT 70% UT
(30% dip in (30% dip in
UT) UT)
For 25 cycles For 25 cycles

<5% UT <5% UT
(>95% dip in (>95% dip in
UT) UT)
For 5s For 5s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) magnetic be at levels characteristic of a typical
field location in a typical commercial or
IEC 61000-4-8 hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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 Guidance and manufacturer’s declaration – electromagnetic immunity
The SOCT Copernicus is intended for use in the electromagnetic environment specified below. The
customer or the user of the SOCT Copernicus should assure that it is used in such an environment.
IMMUNITY test IEC Compliance level Electromagnetic environment - guidance
60601
test
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the SOCT Copernicus , including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance

Conducted RF 3 3 Vrms
IEC 61000-4-6 Vrms 150 kHz to 80 MHz
150 80 MHz to 800 MHz
kHz 3 V/m 800 MHz to 2,5 GHz
Radiated RF to 80 80 MHz to 2,5 GHz Where P is the maximum output power
IEC 61000-4-3 MHz rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
3 V/m distance in meters (m).
80 Field strengths from fixed RF transmitters,
MHz as determined by an electromagnetic site
to 2,5 survey,a should be less than the compliance
GHz level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in with the SOCT Copernicus is used exceeds the applicable RF compliance
level above, the SOCT Copernicus should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the SOCT Copernicus .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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 Recommended separation distance between portable and mobile RF communications equipment
and the SOCT Copernicus
The SOCT Copernicus is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SOCT Copernicus can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SOCT Copernicus as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power Separation distance according to frequency of transmitter
of transmitter m
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

0,01 0,12 0,12 0,23

0,1 0,37 0,37 0,74
1 1,17 1,17 2,33
10 3,7 3,7 7,37
100 11,7 11,7 23,3
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Date of issue of manual: September 2012

Date of review of manual: January 2013

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