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Operating Manual
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CenterVue SpA
Via San Marco 9h, 35129 Padova – ITALY
Tel. +39 049 739 6147
Fax +39 049 739 6148
MANUAL INFORMATION
Date of release: November 6th, 2015
Revision number: 21
Reference software version: v2.4
Manufacturer:
SUMMARY
1. INTRODUCTION ....................................................................................................................................... 4
2. SYSTEM .................................................................................................................................................... 5
3. LABELING ................................................................................................................................................. 6
4. SYMBOLS.................................................................................................................................................. 7
4.1 Symbols adopted on the device ............................................................................................................ 7
4.2 Symbols adopted in this manual ............................................................................................................ 7
5. PREPARING THE DRS ............................................................................................................................. 8
6. PREPARING THE PATIENT ..................................................................................................................... 9
7. WARNINGS AND PRECAUTIONS ......................................................................................................... 10
8. NOTES TO OPERATOR ......................................................................................................................... 11
9. PERFORMING THE TEST ...................................................................................................................... 12
9.1 Adding a new patient ........................................................................................................................... 12
9.2 Selecting an existing patient ................................................................................................................ 12
9.3 Starting the image acquisition process ................................................................................................ 13
9.4 Automated acquisition ......................................................................................................................... 14
9.5 Manual alignment ................................................................................................................................ 15
9.6 Anterior Eye ......................................................................................................................................... 16
9.7 Stereo exams ....................................................................................................................................... 17
9.8 Warning messages .............................................................................................................................. 17
10. REVIEWING THE IMAGES ..................................................................................................................... 19
10.1 Patient record screen ........................................................................................................................... 19
10.2 Full image screen ................................................................................................................................ 20
11. REMOTE VIEWER .................................................................................................................................. 23
12. PRINTOUT............................................................................................................................................... 25
12.1 Single image printout ........................................................................................................................... 25
12.2 Dual image printout .............................................................................................................................. 25
13. RETINAL FIELDS .................................................................................................................................... 27
14. SETTINGS ............................................................................................................................................... 28
14.1 Fields ................................................................................................................................................... 28
14.2 Exam .................................................................................................................................................... 28
14.3 Network ................................................................................................................................................ 30
14.4 System ................................................................................................................................................. 34
14.5 EKN ...................................................................................................................................................... 41
14.6 About .................................................................................................................................................... 42
15. AUTOMATIC SOFTWARE UPDATE ...................................................................................................... 43
16. SYSTEM SHUTDOWN ............................................................................................................................ 44
17. CLEANING............................................................................................................................................... 45
17.1 Front lens ............................................................................................................................................. 45
17.2 Patient cushions .................................................................................................................................. 46
17.3 Touch screen panel ............................................................................................................................. 47
17.4 Plastic shells ........................................................................................................................................ 47
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18. MAINTENANCE ....................................................................................................................................... 48
19. ELECTROMAGNETIC COMPATIBILITY ................................................................................................ 49
20. FCC (USA) and IC (Canada) radio certification ....................................................................................... 49
21. TECHNICAL SPECIFICATIONS ............................................................................................................. 50
22. DISPOSAL ............................................................................................................................................... 51
23. TROUBLESHOOTING ............................................................................................................................. 52
APPENDIX A - DICOM Statement .................................................................................................................. 53
APPENDIX B – AUTOMATED MOSAIC FUNCTION ..................................................................................... 55
APPENDIX C – EYE KNOWLEDGE NETWORK (EKN) ................................................................................. 57
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The clinical interpretation of the images acquired by the DRS is restricted to
licensed eye care practitioners. The process of making a diagnosis using DRS
results is the responsibility of the eye care practitioner.
A device specific training is required for any operator to become able to use the
system.
Federal laws (US) restrict this device to sale by or on the order of a physician or a
properly licensed practitioner.
1. INTRODUCTION
The Digital Retinography System (DRS) is a fundus camera for the acquisition of digital images of
the retina without the use of a mydriatic agent.
In particular, the DRS allows to acquire color images of the retina over a field of view of 45° x 40°,
in a fully automatic mode. Seven different retinal fields can be framed using multiple internal
fixation targets.
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The DRS system is supplied with:
Power cord;
Spare fuses;
This Operating Manual;
Dust cover;
Microfiber cleaning tissue for touch screen;
Front lens photographic cleaning paper, pack of single-use sheets
Silicone forehead rest;
Hand blower;
Glasses with adjustable prisms;
USB 2.0 extension cord.
Chin rest =
applied part
Forehead rest =
applied part
Patient side
Operator side
Touch screen
USB ports
Ethernet port
Power switch
Power inlet
Fuses
2. SYSTEM
Figure 1 - DRS left side view
Figure 2 - Detail of the device right side
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3. LABELING
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Symbol
Explanation
Manufacturer Data
Manufacturing Date (year/week of production)
Electronic and electric devices must be recycled.
Refer to Instruction Manual
CE mark: the device complies with the essential requirements of the
European Medical Devices Directive 93/42/EC
Warning: Do Not Touch
Type B Applied Part
Generic Warning
Note
Warning
4. SYMBOLS
4.1 Symbols adopted on the device
4.2 Symbols adopted in this manual
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The test should be performed in conditions of semi-obscurity to facilitate natural
dilation of the pupil.
Figure 3 - Forehead rest patient side
Figure 4 - Forehead rest rear side
1
5. PREPARING THE DRS
Read carefully and thoroughly paragraph 7 WARNINGS AND PRECAUTIONS before
proceeding with first use.
To set up your DRS follow these steps:
extract the system from its box;
place the DRS on a suitable electrical table1;
connect the power cord provided with the unit to the power inlet (see Figure 2);
optionally connect a compatible printer1 to any of the USB ports (see Figure 2);
attach the silicon forehead rest (included in the tool box) on the forehead rest frame as
shown in the pictures below (Figure 3 and Figure 4);
Time zone configuration
The first time the DRS is powered on, the operator is requested to set the time zone. The
configuration request (Figure 5) will appear every time the DRS is started, until the time zone is set
(see §14.4).
Figure 5 – Request to configure time zone
Request for camera auto-tuning
After a software upgrade to the latest version a message as in Figure 6 may appear. Such
message appears only once when a new software is started for the first time: please apply the lens
cap and press ok, then wait until the completion message (Figure 7) appears.
Not provided with the DRS
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Patients wearing Contact Lenses: image quality may be affected by contact lenses. It is
recommended to have contact lenses removed before imaging the patient.
Figure 6 – Request to perform camera auto-tuning
Figure 7 – Camera auto-tuning completion message
6. PREPARING THE PATIENT
This paragraph explains how to prepare a patient for the DRS test. There are no restrictions as to
the selection of the patients undergoing DRS testing. The DRS is a non-mydriatic device (minimum
pupil diameter 3.8 mm), so there is no need to dilate the subject’s pupil. Patient contacting parts
are indicated in Figure 1.
Before the test inform the patient about the following:
1) the test is non-invasive, in particular the system will never touch your eye and you will only
see a flash of light when a photograph is taken;
2) find a comfortable position, keeping the chin and forehead firmly pressed against the rests;
3) at the beginning of each test, the unit will move around to find your pupil: this is absolutely
normal;
4) when the test starts look straight in front of you and when a small green circle becomes
visible anywhere within the field look steady at it;
5) open your eyes wide so that eyelids do not interfere and try to not blink during the test;
6) do not move during the test;
7) if you follow these instructions the acquisition of a single photo will take less than 30
seconds.
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Federal laws (US) restrict this device to sale by or on the order of a physician or a
properly licensed practitioner.
The clinical interpretation of DRS images is restricted to licensed eye care
practitioners.
A device specific training is required for any operator to become able to use the
system.
Do not open the device: this could lead to electric shocks or damage to the system.
Do not use the instrument in the event that the cover or other parts of the device
have been removed.
Only technicians authorized by CenterVue may service the DRS. CenterVue
cannot be held responsible for system safety should the DRS be opened, repairs
carried out, third parties software be installed, or parts be replaced by unauthorized
persons.
Do not expose the device to water: this could lead to fire or electric shock.
Stand clear from moving parts during operation.
The instrument is supplied with an earth ground by means of a protection
conductor contained inside the power supply cable. Before turning on the system,
make sure the power supply socket is correctly grounded to avoid the risk of
electric shock.
The room where the DRS is operated must respect IEC or ISO safety standards
relative to medical use of a room or area.
The DRS must NOT be used in an oxygen rich environment or in presence of
flammable anesthetics.
External equipment connected to the DRS within the patient environment must be
compliant with IEC 60601. Equipment not complying with IEC 60601-1 shall be
kept outside the patient environment and complying with IEC 60950. Any person
who connects external equipment to signal input, signal output or other connectors
of the DRS has formed a Medical Electrical System according the definition of
IEC 60601-1 and is therefore responsible for the system to comply with the
requirements of IEC 60601-1, § 16. If in doubt, contact the local representative.
Data Backup: the DRS contains Patient Health Information. It is strongly
recommended the use of the “backup” utility. See par. Settings >> System.
The device must be placed in a room which is not exposed to adverse chemical-
physical conditions, such as the presence of sulfur, salt, dust, direct sunlight, lack
of ventilation, high humidity, sudden temperature drops or peaks. The safety and/or
effectiveness of the instrument cannot be guaranteed if these conditions are not
fulfilled.
The DRS needs to be operated in a semi dark room (except when taking Anterior
Eye photos).
The DRS needs to be operated under the following environmental conditions:
Temperature: 10 - 40 C° (50 - 104 F°) / Humidity (max): 90% not condensing
The DRS needs to be stored under the following environmental conditions:
Temperature: -10 - 60 C° (14 - 140 F°) / Humidity (max): 90% not condensing
A not optimal pupil alignment may cause the acquisition of an image of the retina
7. WARNINGS AND PRECAUTIONS
The following precautions are particularly relevant to the device safety:
The following precautions are particularly relevant to prevent use errors:
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that has a growing light crescent on a board. Such growing light should be
considered an artifact and not a feature of the retina under examination.
Do not leave the front lens uncovered while the system is not in use.
The auto-alignment process may fail in some circumstances such as:
long eye-lashes;
presence of make-up;
room too bright;
direct light on a patient’s face;
very big pupil.
Under such circumstances the exam should be repeated after removing the cause of
the failure.
Note on auto-alignment:
8. NOTES TO OPERATOR
No specific skills are required to operate the DRS.
A minimal, device specific, training is required to become able to use the system.
The operator needs to be acquainted with the following concepts:
pupil: the central part of the external surface of the eye, through which light goes in;
retina: the internal surface of the eye ball;
fixation / fixating: the ability of a subject to stare at a specific point in space and specifically
the DRS internal fixation targets.
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When the DRS is enabled for data transmission to EKN a new icon appears in the
home screen top bar, providing data upload status information. See also par. Settings
>> EKN and Appendix C for additional information regarding the EKN.
9. PERFORMING THE TEST
This paragraph explains how to operate the DRS to perform a complete test.
When the unit is turned on and the boot process is over, the Home screen shows up (see Figure
8).
Figure 8 - Home screen
Several options are available at this point, such as:
- adding a new patient (see 9.1 below);
- selecting an existing patient from the list (see 9.2 below);
- starting the image acquisition process without identifying the patient (see 9.3 below).
9.1 Adding a new patient
To add a new patient to the list, type the last name (mandatory), first name and date of birth in the
corresponding boxes. Optionally select the gender and type a Code of your choice and any patient
related notes. Then click on save.
9.2 Selecting an existing patient
To select an existing patient from the list, click on the PATIENT LIST button: the complete list of
stored patients will show up (see Figure 9).
The following mechanisms are available to find a specific patient:
scroll the list by dragging the screen up or down;
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The START button is only enabled if the chin rest is engaged. If the patient is
not properly positioned on the chin rest, the START button will not be enabled
and it will not be possible to start the acquisition process.
sort the list by one of the available field (the list can be sorted by last name, date of birth or
date of last visit) by clicking on the corresponding arrows ( for descending, for
ascending) located at the header of the list (by default patients are sorted by their numeric
ID, in ascending order);
search for a specific patient by typing the initials of the last name or first name or code in
the search box.
Once the desired patient has been identified in the list, click on the corresponding line to select and
open the Patient Record screen (see Figure 23).
Figure 9 - Patient list screen
9.3 Starting the image acquisition process
When a new patient has been created or an existing one selected or none of the above
(anonymous), it is possible to start the image acquisition process. Before proceeding, be sure that
the patient received complete explanations concerning the test and what she/he is required to do,
as explained at par. 6 above.
Then choose among the different options / parameters:
a. Click OU to acquire images from both eyes (default), OD for the right eye and OS for the
left eye;
b. Select SINGLE FIELD to acquire one 45° image of the retina (default);
c. Select MULTI FIELD to acquire multiple 45° fields. See par. 14.1 for details on how to
configure the fields acquired in each of the above two options;
d. Select ANTERIOR EYE to acquire the external part of the eye;
e. Select STEREO to acquire a stereo pair of the nasal field and produce a stereoscopic view
of the optic disc (see details below);
f. Position the patient on the chin rest and head rest and use the CHINREST UP and
CHINREST DOWN buttons to adjust the chin rest position, if needed. When the
AUTOMATIC CHIN REST flag is selected from the settings menu (see par. 14), the chin
rest is automatically adapted to the patient head characteristics.
Press the START button to start the acquisition procedure.
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At any time during the above sequence it is possible to stop the acquisition process
by pressing the CANCEL button. In case the auto-alignment process fails, manual
alignment is possible: see par. 9.5 below for details.
Figure 10 - Eye search in progress
Figure 11 – Auto-alignment in progress
Figure 12 - Auto-focus in progress
Figure 13 - Image processing and saving in progress
9.4 Automated acquisition
Once the START button is pressed, the DRS will automatically perform the following steps:
a. Move the optical head to locate the patient’s pupil (see Figure 10);
b. Move the optical head to center the patient’s pupil to the front lens (see Figure 11); the
system will also display the pupil current diameter and which eye is being acquired; the red
circle in Figure 11 represents the pupil and becomes green when proper centering is
achieved.
c. Perform auto-focus (see Figure 12);
d. Capture an image, by flashing the retina. This step involves also automatic tuning of the
flash level;
e. Store the image in the local hard drive (see Figure 13);
f. In case of acquisition of both eyes and/or multiple fields, the acquired images can be
displayed before proceeding to the next one, depending on the settings (see par. 14.2).
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9.5 Manual alignment
If, for some reasons, the automated eye search fails, a message as in Figure 14 shows up.
Reasons for failure include: improper patient positioning, patient not fixating steadily, patient
moving the head and / or the gaze during eye search.
If any of the above situations applies, try to fix the cause (re-position the patient, instruct her/him to
steadily fixate at the target and/or to not move) before proceeding with manual alignment.
Use the UP / DOWN / LEFT / RIGHT buttons to adjust the optical head position and align the
patient’s eye to the instrument front lens. As soon as the eye is detected the automated procedure
will resume.
Figure 14 – Message indicating failure of automatic eye search
The result of the acquisition process is one or more retinal images as the one shown in Figure 15.
Figure 15 – Example of retinal image captured by the DRS
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In order to capture a focused image of the anterior part of the eye, the patient’s
forehead must be placed on the chinrest at a distance of 3-5 cm (1-2 inches)
from the instrument forehead rest. The patient’s chin should be placed near the
edge of the chin rest (see Figure 16).
The room must be sufficiently lit in order to take an anterior eye image.
Figure 16 - Anterior eye: correct patient position
Figure 17 - Anterior eye acquisition
Figure 18 - Full screen view of the anterior eye
9.6 Anterior Eye
Once the process is started, the optical head moves in front of the selected eye and performs a
rough alignment. When it reaches the optimal position, a live color view of the eye is displayed
(Figure 17) so that manual alignment and focus can be performed using the on-screen buttons.
Manual adjustment of alignment and focus may be necessary to capture a good quality picture.
Click on the live image to toggle a full-screen view (Figure 18). Once satisfied with alignment and
focus, press SHOOT to acquire the image.
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9.7 Stereo exams
If Stereo is selected before starting the exam, two slightly offset images of the central-nasal field
will be captured with automatic alignment and focus. A delay between the shots is applied in order
to let the pupil recover. The delay amount can be set in the Settings page (see par. 14). At the end
of the acquisition process the resulting two images will appear in the Patient Record screen
(Figure 19). See par. 10 for details on how to review stereo pairs.
Figure 19 - Patient record with stereo pair
9.8 Warning messages
If the lens cap is placed on the front lens when an exam is started, the message shown in Figure
20 will appear (unless “check lens cap presence” is off, see 14.2). Press OK to exit and restart the
exam after having removed the lens cap.
Figure 20 - Message when lens cap is detected
If the pupil – measured immediately before the snapshot - is smaller than 3.8 mm, a warning
message is shown to inform the operator about the possible degradation of image quality (see
Figure 21).
Figure 21 - Warning due to small pupil
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When the auto-focus process is not able to find an optimal focus, a warning message is shown to
inform the operator about the possible occurrence of poor focusing conditions (see Figure 22).
Figure 22 - Warning due to incorrect focusing
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Function
Icon
Command
Image scroll
-
Point on any thumbnail and drag to the left / right or press the left / right
buttons located at the bottom on the sides
Edit patient
record
Click on this icon to enter the edit mode and correct any mistyped
information or provide additional details
Delete patient
record
Click on this icon to permanently delete the current patient and all
related exams. A confirmation is required.
Batch image
export
Click on this icon to export all images of the selected patient as JPG
files on a USB key (only available if a USB key is plugged in any of the
USB ports)
Retake
images
Click on this icon to select one or more images to be retaken. When all
images have been selected, click on RETAKE. Images can be retaken
within 5 minutes after they have been captured.
Open full
image screen
-
Click on the corresponding thumbnail to open the full image screen
Open 3D
image view
Click on the STEREO button between the two thumbnails of a stereo
couple thumbnail: this command will open the 3D viewer. Only
10. REVIEWING THE IMAGES
Once the image(s) has (have) been acquired, the system will open the patient’s individual record
and present a thumbnail view of all the available images (see Figure 23).
10.1 Patient record screen
For each image thumbnail, the following information is displayed:
the eye (OD/OS) and field information, in the top-left corner;
the image number, in the top-right corner;
the acquisition date and time, in the bottom-right corner.
Available functions include:
Figure 23 - Patient record screen
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Function
Icon
Command
available for stereo pairs.
Print
Click on the printer icon to print two images in a single sheet. Icon is
enabled when a supported printer is connected.
Export to pdf
Click on the Acrobat icon to generate and export a dual image printout
(available if a USB key is connected, see par. 12.2 for further details).
Automated
mosaic
Click on this icon to start generation of a mosaic (a composition) of
multiple retinal fields. This icon is only available if the related license is
installed. See Appendix B for explanations on how to use this function.
Please contact your CenterVue representative for information on how
to obtain the license.
Function
Icon
Command
Zoom image
-
The slider on the right side of the screen allows zooming
Pan image
-
Click on the image and drag it around to frame the desired area
Red-free filter
Click on this icon to display a black and white image corresponding
to the green component of the image
10.2 Full image screen
The Full Image screen (see Figure 24) is used to review individual images at full screen.
The information available in this screen includes the eye (OD, OS), pupil size at capture, date and
time when the image was captured and any image related notes.
Figure 24 - Full image screen
Functions available in this screen include:
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Export image to
shared folder
Click on this icon to export the selected image to a shared folder
(see Settings >> Network >> Shared folder)
Export image
file to USB
Click on this icon to export the selected image as a jpg file on any
USB key (only available if a USB key is connected)
Image print
Click on this icon to print the current image (only available if a
compatible USB printer is connected)
Image delete
Click on this icon to permanently delete the selected image
Move to next /
previous image
Click on these icons to move to the next/previous image of the
current patient
3D viewer
Click on this icon to toggle between normal and 3D viewer for the
stereo images. Only available when showing a stereo pair.
Swap stereo
images
Click on this icon to swap right and left image of a stereo pair
(“crossed-eye” format). Only available when showing a stereo pair.
Add image
notes
Add
Notes
Click on Add Notes to add / edit image specific comments (see
Figure 25)
Figure 25 – Notes editing screen
Figure 26 - Stereo Images 3D viewer
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To obtain a three dimensional view, images must be looked at with appropriate
prismatic goggles (see Figure 27). A crossed-eye format is also supported.
Figure 27 – Example of prismatic goggles for three-dimensional viewing
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The DRS remote viewer uses standard Internet browsers and does not require
installation of any software application on the remote PC.
Supported browsers include: Microsoft Internet Explorer (version 8 or later), Mozilla
Firefox (version 3 or later), Apple Safari, Google Chrome.
2
11. REMOTE VIEWER
There are two ways to review DRS data and images from a remote PC, a tablet or a smart-phone.
The first is by connecting to an existing network (LAN) and the second is by creating a private
network, even in absence of an existing network infrastructure. The DRS supports both wired and
Wi-Fi connections in both the regular and private network modes2.
Remote visualization through a LAN
To configure the DRS for LAN access see par. 14.3. In order to use the remote viewer with an
existing LAN proceed as follows:
1. Connect the DRS to the LAN;
2. Connect the remote PC to the LAN;
3. In case the local area network does not provide automatic IP assignments, configure the
DRS as explained at par. 14.3 and configure the remote PC with a different IP;
4. Retrieve the DRS IP, as explained in Settings >> Network (see par. 14.3, Figure 36);
5. Type the DRS IP in the URL box of the remote PC’s Internet browser.
Remote visualization through a private network
To configure the DRS for a private network access see par. 14.3.
To use the viewer in wireless mode proceed as follows:
1. Enable the wireless connection of your PC, tablet or smart-phone (some restrictions apply:
not all devices support private network);
2. Select the wireless network created by the DRS that will be called “drs-s/n”;
3. Open the browser;
4. Type http://drs in the URL box of the remote PC’s Internet browser.
Once the connection is established, the DRS patient list will show up on the remote PC, tablet or
smart-phone (please consider that not all devices support the private network). You might be
required to type a password depending whether password protection was enabled in the DRS
settings (see 14.3). Available functions include:
Patient list (same as Figure 9);
Patient record screen (same as Figure 23)
Access to individual images.
some Wi-Fi network cards may fail to establish connection with the DRS when using the private network
mode. In such case an external router is required to successfully connect via Wi-Fi
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Figure 28 - DRS patient list in remote viewer
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The single image printout uses portrait format, while the dual image printout uses
landscape format.
12. PRINTOUT
12.1 Single image printout
When a compatible USB printer is connected, any acquired image can be printed by clicking on the
printer icon in the Full Image screen. Also red-free images (see par. 10) can be printed using the
same procedure. In the same way a pdf file containing the single printout can be generated if a
USB key is connected.
12.2 Dual image printout
By clicking on the printer icon in the Patient Record screen it is possible to print two images on the
same sheet. Once the button is pressed a dialog box appears prompting for the selection of two
images. The list can be scrolled to select the images to be printed by clicking on the printer icon
that is placed on the top right corner of each image. Once two images are selected click the Print
button. In the same way a pdf file containing the dual printout can be generated if a USB key is
connected.
Figure 29 – image selection screen for dual image printout
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Figure 30 - Single and dual image printout
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optic disk
c
d
g
13. RETINAL FIELDS
The following fields can be acquired (see Figure 31 for fields representation for the right eye):
a. CENTRAL: centered on the foveal pit;
b. NASAL: centered 17° nasally to the foveal pit ;
c. TEMPORAL: centered 17° temporally to the foveal pit ;
d. SUPERO-TEMPORAL: centered 12° superiorly and 12° temporally to the foveal pit;
e. PERI-CENTRAL: centered 5° nasally to the foveal pit ;
f. SUPERIOR: centered 17° superiorly to the foveal pit ;
g. INFERIOR: centered 17° inferiorly to the foveal pit;
Figure 31 - DRS retinal fields
The field(s) acquired respectively when using the SINGLE FIELD or MULTI FIELD acquisition
modes described previously can be configured in the Settings (see par. 14).
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14. SETTINGS
To access the settings screen click on the button.
In the Settings screen several different tabs as described in the following pages are available.
14.1 Fields
This page allows configuring the fields acquired by the SINGLE and MULTI acquisition modes: any
45° field, among the 7 available ones (see par. 13), can be associated to the SINGLE mode, while
up to seven 45° fields can be associated to the MULTI mode.
Figure 32 - Fields tab in Settings (Home >> Settings >> Fields >> SINGLE FIELD)
14.2 Exam
The Exam tab has three sub-tabs, namely EXAM, SAVING and ADVANCED.
14.2.1 EXAM
Use this tab (see Figure 33) to:
set a time delay in seconds (default 0) between subsequent snapshots;
set a time delay between stereo images;
set the fixation target to be permanent or blinking at 3 different speeds;
enable automatic chin rest adjustment;
select UNIFORMITY or CONTRAST image processing strategy (see note below).
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Image Processing Strategy.
It is possible to select between two different image processing strategies: Uniformity
and Contrast. This setting affects the internal gains and color tunings of the Camera.
The final retina image has different color balance and luminosity, but the original
image details are the same.
UNIFORMITY: with this setting the image appears very uniform in color, with mild
shades. Micro aneurisms and macula details may appear more visible with this
setting.
CONTRAST: with this setting the image will show higher contrast. Details may
appear more evident but image has a more grainy aspect.
Figure 33 - Exam tab in Settings (Home >> Settings >> Exam >> EXAM)
14.2.2 SAVING
Use this tab (see Figure 34) to:
set the name of the Doctor or Clinic that will appear in the header of the printouts (this
value is saved in the DICOM tag 0008, 0080 Institution name).
choose to automatically create a folder for each patient name and/or a folder for each
exam ID when saving on USB key.
enable DICOM export of images from the Remote Viewer. (The DICOM file format contains
both the retina image and some corollary field, for example: exam date/time, patient name,
type of medical instrument, etc., see Appendix A).
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Figure 34 - Exam tab in settings (Home >> Settings >> Exam >> SAVING)
14.2.3 ADVANCED
Use this tab (see Figure 35) to:
enter the Institution Dept. Name: this value is saved in the DICOM tag 0008,1040;
enter the Study Description: this value is saved in the DICOM tag 0008,1030;
enter the Series Description: this value is saved in the DICOM tag 0008,103e;
find the option to disable the lens cap detection at the start of the exams.
set the threshold of the auto-exposure meter (Exposure Value box). The higher the value
specified, the brighter the flash level. The value can be set from 0.5 to 5.0. The “default”
button sets the value to the default level (2.0).
Figure 35 - Exam tab in Settings (Home >> Settings >> Exam >> ADVANCED)
14.3 Network
Each time the “Network” tab is selected, a network test is performed. Once it completes, the result
is displayed on the screen next to the Current network status label. The result can be any of the
following (see Figure 36):
Internet connection fully available on address xxx.xxx.xxx.xxx: the DRS is fully connected to
the Internet (required for EKN connection and support purpose, see Settings >> EKN).
LAN working on IP xxx.xxx.xxx.xxx: a valid network is set and the local network is ready.
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The Private Network always enables the wireless interface. If the DRS is
plugged into an existing network (where another DHCP server is active),
unplug the network cable before enabling the Private Network in order not to
interfere with the existing DHCP server. The DRS wireless Private Network is
compatible with Apple iPad and Microsoft Windows XP, 7, Vista and 8 (up to
version 8.0). Android-based devices and Windows 8.1 have known limitations
that prevent the correct use with the DRS wireless Private Network.
No working connection: the DRS is not connected to any network.
The Network tab has 4 sub-tabs: GENERAL, WIRELESS, SHARED-FOLDER and LAN ACCESS.
Figure 36 – Network tab in Settings (>> GENERAL)
14.3.1 GENERAL
To enable a wired connection, plug a network cable into the DRS and wait a few seconds. Press
“SET NETWORK” to refresh the network configuration. Most networks do not require the operator
to set the IP address manually, but in case it’s needed, click on the Manual button and enter the
IP address (mandatory), netmask (mandatory), gateway (optional) and DNS (optional). Then select
“SET NETWORK” (see Figure 37).
To allow the DRS to create a private network click on Private Network button (see Figure 37). The
Private Network allows the use of the DRS remote viewer without using existing networks. It can
be used both in wired and wireless configuration. To go back and use an existing network click on
Set Network.
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Figure 37 – Network tab in Settings when a private network has been set-up
14.3.2 WIRELESS
To enable the wireless network select the WIRELESS tab and click the ENABLE button. Make sure
that no cable is plugged into the Ethernet port: this could create problems in wireless connection.
Press RESCAN to refresh the list of available networks, then select the network you want to
connect to. Enter the WiFi password/key and click “Connect” to establish the wireless connection.
See example in Figure 38.
Figure 38 - Network tab in Settings (>> WIRELESS)
14.3.3 SHARED FOLDER
The DRS can export images into a shared network folder. To enable exporting to shared folder
select the SHARED FOLDER tab and then press ON.
Choose the format type to be exported (JPEG, DICOM or PDF) and the mode (MANUAL or
AUTO). If the AUTO mode is chosen, at the end of each exam, a copy of the photo will be
automatically saved to the shared network folder. The images in the shared folder can be deleted
at any time by the operator or by a program without altering the database and files inside the DRS.
The exported files are saved by creating a file whose name follows the following format:
patientID_lastname_firstname_date_time_drsNumber_eye_fieldNumber_examNumber.<ext>
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If the MANUAL option is selected, a new button will be shown in the upper right corner of the Full
image screen. This button allows you to save the exam in the shared folder (Figure 39).
Figure 39 – Network tab in Settings (>> SHARED FOLDER)
As shown in Figure 39 you can set the export function to save the images in a folder inside the
DRS (by pressing the INTERNAL button) or in a remote folder (by pressing the REMOTE button).
When INTERNAL is selected, data is saved in a folder inside the DRS. This folder can be reached
from a regular PC by searching a network resource named \\DRS-ID\shared (e.g. \\drs-0010\shared).
In case of complex networks, it may be necessary to insert the IP address of the DRS instead of its
name (e.g. \\192.168.1.10\shared). In this case you might need to seek the support of your local IT
staff.
When REMOTE is selected, the DRS needs to be configured with the name of the remote host, the
name of the share, and the username (and its password) of a user that has the necessary rights to
access the remote folder. The following figures (Figure 40, Figure 41) show the messages that will
be displayed to the operator.
Figure 40 - Remote Folder Configuration – step 1
Figure 41 - Remote Folder Configuration – step 2
A third step may require you to insert username and password on the remote folder.
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In case of correct setting a dialog box like the one in Figure 42 will appear. Press OK to confirm
and save the network folder setup.
Figure 42 - Remote Folder Configuration – Connection Successful
The most important difference between the two type of shared folder (internal and remote) is where
the data is stored and how it can be accessed. The Internal option is the easiest to set up, but the
data is available only as long as the DRS is powered on and connected to the network. The
Remote option might require additional information and special permissions (especially in complex
networks) but the data is available even when the DRS is powered off or disconnected.
14.3.4 LAN ACCESS
The LAN ACCESS sub tab lets you set a password for the Remote Viewer access to the DRS, to
prevent access to the data by unauthorized persons.
Figure 43 – Network tab in Settings (>> LAN ACCESS)
14.4 System
The System tab has five sub-tabs: GENERAL, TIME, BACKUP, PRINTERS and SERVICE.
14.4.1 GENERAL
Use this tab to:
Enable, disable and configure the screensaver: the delay can be between 5 and 60 min.
If the screensaver is enabled it can be protected by a password: the operator will also be
prompted for the password when the DRS starts;
Enable third party EMR systems to interface the DRS using their web programming
interface. This feature can be enabled only if a valid license is installed.
Enable or disable the “DARK MODE”: a configuration that reduces the emission of light,
useful when using the device in a dark room.
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Figure 44– System tab in Settings (>> GENERAL)
14.4.2 TIME
The system date and time can be set-up:
Automatically from Internet
Manually from the pull-down menus
In this submenu, you can also set: the correct time zone, format the date and time
Figure 45 - System tab in Settings (>> TIME)
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It is very important to frequently use the backup function to store the data on
an external drive. In case of a hardware failure resulting in data loss, the data
can be then restored from the last performed backup.
Manual modification of backup files on the external drive prevents the ability to
restore that backup: do never alter those files.
14.4.3 BACKUP
The Backup tab allows full management of the backup (and restore) of DRS data.
To perform a backup, connect a USB key or hard disk to the DRS and start the backup operation
by pressing the Backup Data button (see Figure 46).
Figure 46 - System tab in Settings (>> BACKUP)
If a backup of the same unit is found in the external device, the operator is warned of the number
of exams and patients that would be lost by executing a new backup. You can cancel the operation
by pressing the Cancel button (see Figure 48) and afterwards connect another external device and
launch the backup operation again.
Figure 47 – System tab in Settings (>> BACKUP) when an existing backup file is found on external drive
To restore data from an existing backup, press the Restore Data button (see Figure 46). A wizard
will let you choose between a full restore (existing data are replaced with the ones contained in the
backup) or a fusion of the data (imported data are merged with that present in the DRS). The
restore function has a “same patient” recognition and in case of ambiguity the wizard asks for
confirmation on handling duplicate patients.
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Figure 48 - Message shown when pressing UPDATE BACKUP
Figure 49 – Backup confirmation message
On the Restore process. Full operation compatibility is guaranteed with backups generated using
previous software versions (whose backups were stored in a unique archive format). Here below
you can see the Restore mode selection view.
Figure 50 - Restore mode
Using the first mode (ERASE mode) the current DRS exams and patient's data are overwritten by
data of the selected backup source. In the second mode (APPEND mode), the system properly
recognizes identical patients and exams and executes a restoration into the DRS of the differences
only. Only in case of ambiguity, the system asks the operator to select from a pool of “similar”
patients into whom appending the exams (see Figure 51 - Duplicated patients , where patient John
Doe is asked to be merged into a target patient with the same name or be duplicated).
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Figure 51 - Duplicated patients dialog
An ambiguity between patients arises when they have the same name, no other useful information
(like birth date, etc.) and they do have different database creation dates. For both backup and
restore, a percentage indicator informs the operator about the progress.
14.4.4 PRINTERS
Use this tab to:
chose among different printer drivers (built-in drivers or generic postscript driver);
adjust image brightness on the printout;
optionally enable the “Automatic fit to page” for printouts.
Figure 52 – System tab in Settings (>> PRINTERS)
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Reset Patients ERASES the whole database content. Once the operation has
been confirmed there is NO WAY to restore the data. Use this function with
caution.
14.4.5 SERVICE
This tab provides access to various functionalities and tools, in particular:
Reset Head this tool resets the position of the optical head (same procedure performed at
unit startup);
Lens cleaning assistant: this tool helps checking the cleaning condition of the front lens.
See below for additional information.
Service gives access to a special password-protected panel available for authorized
personnel only.
Remote assistance opens a remote connection that allows authorized service
technicians to connect to the DRS. Once pressed, the disclaimer shown in Figure 54
appears, informing the operator that he/she is authorizing access to all data present on
the device, for servicing purposes. Once confirmed with the OK button, the DRS contacts
CenterVue servers and generates a random password and a port to connect to. These
parameters must be sent to the service operator in order to connect. The connection can
be closed by clicking the Close Remote Assistance button. Please note that, as stated in
the disclaimer (see Figure 54), the remote assistance is closed automatically if the
machine is restarted.
Image rebuild allows to regenerate image thumbnails, in case some are missing following
a data restore from backup;
Reset Parameters erases all device settings to Factory defaults (selected fields, network
configuration, shared folder, preferences, etc.).
Reset Patients erases all stored patient data and images. This function is disabled when
the DRS is connected to the EKN.
Figure 53 - System tab in Settings (>> SERVICE)
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Figure 54 - Remote Assistance, steps 1 and 2
Lens cleaning assistant
Clicking the Lens Cleaning Assistant button opens the box shown in Figure 55.
Clicking on Instructions opens the instructions box shown in Figure 56.
Clicking on Tools opens a box describing the tools to be used for cleaning the lens.
Clicking on SHOOT captures an image which should be mostly black: white particles indicate
presence of residual dirt on the outer surface of the lens.
Figure 55 – Lens cleaning Assistant information dialog
Figure 56 – Lens cleaning instructions
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The EKN functionality requires activation of a dedicated license. Please visit
www.eyeknowledge.net for further information on how to activate the EKN. Free trial
periods may be available from time to time.
Use Ethernet (wired) connection in order to maximize performance.
14.5 EKN
The EKN tab is used to manage DRS connection to the Eye Knowledge Network (EKN).
See Appendix C and www.eyeknowledge.net/about for additional information about this feature.
Figure 57 - EKN tab in Settings
14.5.1 Enabling the EKN service
To enable the EKN service and start accessing DRS data online, you need to first register the DRS
on the EKN:
Make sure that you have a valid EKN license;
press the SHOW button to show the Secret Key. Press ENABLE to activate DRS
synchronization with the EKN server;
from any PC, navigate to www.eyeknowledge.net and setup a new account by clicking on
the “Sign Up” button.
on the EKN website click on “Register now” to open the registration page. Type the serial
number of your DRS (e.g. drs-0123), use lowercase characters. Then carefully type the
One Time Secret Key shown on your DRS. This operation is done only once;
go back to the DRS and have it connected to the internet. After maximum half an hour the
unit will display in Settings >> EKN as "registered" and any existing patients and exams will
start being uploaded on the EKN. The upload time depends on the number of patients and
images stored in the DRS and on the available bandwidth.
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14.5.2 Checking the EKN upload status
Once the DRS is configured for data transmission to the EKN, the Settings >> EKN tab provides
status information on the upload process (see Figure 58).
Figure 58 - EKN tab in Settings with upload status information
14.6 About
This screen shows the DRS serial number, the software and firmware version, the OS version, the
Ethernet / WiFi MAC address, the total number of patients and exams stored and the list of
compatible printers.
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15. AUTOMATIC SOFTWARE UPDATE
When a new software update is released by the manufacturer and the DRS is connected to the
internet, a new icon in the Home screen top bar, notifies availability of the update. Clicking on the
icon, the message shown in Figure 59 will appear. To download and install the new software
version click Install, otherwise click Cancel.
Figure 59 - Message to confirm the installation of the new software version
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Do not leave the front lens uncovered while the system is not in use.
16. SYSTEM SHUTDOWN
To shut down the system go to the startup screen, Patient list or Patient record screen and click on
the power off button . Wait for the progress bar to completely roll back. A message on the
screen will inform you when it is safe to turn off the main switch. Always put back the cap on the
front lens.
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Extreme care should be given to always protect the front lens.
Figure 60 – Hand air blower
Do not attempt cleaning the front lens with a dry cloth.
This could lead to scratching its surface.
Figure 61 – Cleaning
liquid and wipes
Figure 62 – Spray the wipes
Figure 63 – Clean the lens
17. CLEANING
This paragraph explains how to clean the system. The device must be powered off, and the power
cord shall be disconnected from mains.
17.1 Front lens
The front lens should be cleaned by using a small hand pump air blower (e.g. Kaiser Typhoon
6316), to blow away dust.
Only if really needed, for instance due to the presence of a fingerprint, the front lens should be
cleaned using photographic cleaning paper (e.g. Edmund Optics NT53-984) and a suitable lens
cleaning fluid (e.g. Edmund Optics P57-727) as illustrated in Figure 61.
Pass a wet wipe on the front lens with a single circular motion: never reuse it after each pass.
Several passes may be needed in order to achieve a good cleaning level.
Use the Lens cleaning assistant tool in order to check the cleaning status of the front lens.
Please note that some small white dots will always appear due to dust (see Figure 65), but they do
not affect image quality.
See Lens cleaning assistant at par.14.4.5, for a detailed assisted procedure.
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Chin rest cushion is not removable.
NO
OK
Figure 64 – Sample picture of a very dirty front lens
17.2 Patient cushions
The chin rest and the forehead rest are the only parts in direct contact with the patient: they should
be wiped with an antiseptic wipe, before each use and allowed to dry prior to reuse.
Take care not to sprinkle parts not belonging to the patient rest.
If the unit is equipped with silicon cushions, it is possible to remove the forehead rest, and rinse it
with warm water and a mild hand detergent.
Figure 65 – Sample picture of a clean front lens
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Do not use alcohol or detergents to clean the touch screen, as these
may damage the film covering the panel.
Do not use alcohol or detergents to clean the plastic shells, as they
might erase labels or indications.
17.3 Touch screen panel
The touch screen panel should be cleaned only with a cloth damped in water.
17.4 Plastic shells
If needed, the external covers of the unit can be cleaned by means of a cloth slightly damped in
water.
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All service interventions other than the above should be carried out by authorized
CenterVue personnel.
18. MAINTENANCE
The only operation the operator can do on the device is the replacement of the fuses.
Following is the relevant procedure:
Disconnect the power cord from the mains
Remove the fuse holder with the help of a small screwdriver
Remove and replace the fuses (see section ”Technical specifications”)
Insert the fuse holder
Connect the power cord to the mains.
CenterVue recommends to require a service to the instrument in order to:
check the electrical safety (IEC 60601-1) every year.
check the general functionality every 5 years.
CenterVue and its authorized personnel can provide on demand specific maintenance contracts.
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19. ELECTROMAGNETIC COMPATIBILITY
This device is classified in class B according to IEC 60601-1-2.
This device has been tested and found to comply with the limits for medical devices contained in
IEC 60601-1-2 and Medical Device Directive 93/42/EEC. These limits are intended to provide
reasonable protection against harmful interference in a typical medical installation. This instrument
generates, uses and can radiate radio frequency energies and, if not installed and used in
accordance with these instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation. If the
system does cause harmful interference to other devices, which can be determined by turning the
system off and on, try to eliminate the interference by adopting one or more of the following
measures:
reorient and/or relocate the receiving device;
increase the distance between the devices;
connect the system to an outlet on a different circuit than that to which the other devices is
connected;
consult the manufacturer or field service technician for help.
20. FCC (USA) and IC (Canada) radio certification
The DRS contains a radio module that complies with regulations of the USA and Canada, in
particular with part 15 of the FCC rules.
Changes or modifications not expressly approved by the party responsible for compliance could
void user’s authority to operate the equipment.
Operation is subject to the following 2 conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received, including interference that
may cause undesired operation.
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21. TECHNICAL SPECIFICATIONS
Class and type of applied part
I, B (according to IEC 60601-1).
IP classification
IPX0 (according to IEC 60529, related to the degree of protection provided by the enclosure with
respect to harmful penetration of particulate matter or water).
Retinal Imaging
Field of view: 45° x 40°
Non-mydriatic operation (3.8 mm minimum pupil size)
Fixation target: internal LEDs
Operating distance: 37 mm.
Sensor size: 5 MPixel (2592 x 1944)
Resolution: 48 pixels/deg
Resolution on retina: 15 µm
Pixel pitch on retina: 6 µm
Other features:
Patient presence sensor
Motorized chin-rest
Automatic alignment
Auto-focus (adjustment range: from -15D to +15D)
Auto-flash level adjustment
Touch-screen color display
Embedded PC
Ethernet connectivity
Dimensions:
Weight: 19 Kg (42 lbs.)
Size: 55 × 55 × 33 cm (22 × 22 × 13 in)
Accessories:
Power cord;
Spare fuses;
Operating Manual;
Dust cover;
Microfiber cleaning sheet for touch screen;
Front lens photographic cleaning tissue, pack of single-use sheets;
Silicone forehead rest;
Hand blower;
Glasses with adjustable prisms;
USB 2.0 extension cord.
Power requirements:
Voltage: 100-240 VAC, 50-60 Hz, fuse 3.15 A (T type)
Power consumption: 100 VA
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22. DISPOSAL
The DRS is made of different materials, such as plastics, aluminum, electronic parts. In case of
instrument disposal, please separate the various materials and follow the laws and regulations
regarding disposal or recycling for each material effective in your own country.
Separate collection for electrical and electronic equipment
The European Directive 2002/96/EC establishes the separate collection for Waste of Electrical and
Electronic Equipment (WEEE). The users of Electric and Electronic Equipment (EEE) have not to
dispose of WEEE as unsorted municipal waste, they have to collect such WEEE separately. The
available return and collection system is defined by the local public administration, or in alternative
an authorized company can recycle the WEEE. Please refer to public administration about the
separate collection, if this information is not available, contact the manufacturer of the equipment.
Users have a fundamental role in contributing to reuse, recycling and recovery of WEEE. The
potentially dangerous substances contained in the WEEE can pollute the environment and produce
harmful effects to the human health. Below, there are a few indications of specific dangers of some
substances, which may leach in the environment and in the water system.
Lead: damages the nervous system of humans, it affects the endocrine system, the cardiovascular
system and kidneys. It accumulates and is very toxic for animals, plants and micro-organisms.
Cadmium: accumulates with a half-life of 30 years and can damage the kidneys and cause cancer.
Mercury: is easily accumulated in organisms and concentrates through the food chain. It has
chronic effects and can cause brain damage. Chromium (Hexavalent): easily absorbed into cells
with toxic effects. The results can be allergic reactions, asthma and it is considered to be genotoxic
(damages the DNA). Especially dangerous when incinerated.
Brominated Flame Retardants: widely used to reduce flammability (e.g. cables, connectors and
plastic cases).
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Issue
Possible cause
Solution
The unit does not turn on
Main fuses are blown up.
Replace main fuses according
to the § “Maintenance”
After a period of functioning, the
DRS computer becomes very
slow
Overheating of the computer
Remove the objects under the
DRS that are blocking the cooling
air flow
After the system booting, the
software application send a
connection error with the control
board:
“Robot initialization error” or
“Unable to connect to control
board”.
The control board is not powered
with 12V, or there is no USB
connection between the computer
and the control board, or the
BIOS of the embedded PC is set
not to power control board logic
Contact an Authorized Service
Center
The retinal image is
blurred/defocused
The motor of the focus LED
doesn’t move.
The motor of the camera lens
doesn’t move.
Try repeating the exam, possibly
on a different eye. If still
defocused, contact an Authorized
Service Center
During the exam, the software
application fails the auto-
alignment.
One (or both) of the pupil LEDs is
damaged or not powered
Contact an Authorized Service
Center
The USB key does not work
The mechanical connection of the
USK key is not appropriate
Use the USB extension cord that
comes with the DRS (inside the
accessories box) to connect the
USB key.
23. TROUBLESHOOTING
If any problem occurs, check the following table and try to apply the proposed solution.
If this does not solve the problem, immediately stop the unit operation, switch off the main power,
disconnect the power supply cord and contact CenterVue authorized personnel.
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Tag
Description
VR
Len
Value
(0002,0000)
Group Length
UL
4
180
(0002,0001)
File Meta Information Version
OB
2
0
(0002,0002)
Media Storage SOP Class UID
UI
32
1.2.840.10008.5.1.4.1.1.77.1.5.2
(0002,0003)
Media Storage SOP Instance UID
UI
22
2.16.840.1.114496.6.4
(0002,0010)
Transfer Syntax UID
UI
20
1.2.840.10008.1.2.1
(0002,0012)
Implementation Class UID
UI
26
1.2.826.0.1.3680043.8.641
(0002,0013)
Implementation Version Name
SH
8
CVUEDRS
(0002,0016)
Source Application Entity Title
AE
10
RUBY_DICOM
(0008,0016)
SOP Class UID
UI
32
1.2.840.10008.5.1.4.1.1.77.1.5.2
(0008,0018)
SOP Instance UID
UI
22
CenterVue ANSI registration code
(unique id number) plus machine id
and actual exam id.
Example: 2.16.840.1.114496.6.4
(0008,0020)
Study Date
DA
8
Exam date
(0008,0021)
Series Date
DA
8
Exam date
(0008,0022)
Acquisition Date
DA
8
Exam date
(0008,0023)
Image Date
DA
8
Exam date
(0008,002A)
Acquisition Datetime
DT
14
Exam datetime
(0008,0030)
Study Time
TM
14
Exam time
(0008,0031)
Series Time
TM
14
Exam time
(0008,0032)
Acquisition Time
TM
14
Exam time
(0008,0033)
Image Time
TM
14
Exam time
(0008,0050)
Accession Number
SH
0
This tag is always empty
(0008,0060)
Modality
CS
2
OP
(0008,0064)
Conversion Type
CS
2
DI
(0008,0070)
Manufacturer
LO
16
CenterVue S.p.A.
(0008,0090)
Referring Physician's Name
PN
0
This tag is always empty
(0008,0100)
Code Value
SH
8
R-1021A
(0008,0102)
Coding Scheme Designator
SH
4
SRT
(0008,0104)
Code Meaning
LO
14
Fundus Camera
(0008,1030)
Study Description
LO
2
Value entered in Settings | Exam |
Advanced | Study Description
(0008,103E)
Series Description
LO
2
Value entered in Settings | Exam |
Advanced | Series Description
(0010,0010)
Patient's Name
PN
10
Value entered in the patient’s Last
Name and First Name fields (last +
first)
(0010,0020)
Patient ID
LO
2
Value entered in the patient’s “code”
field
(0010,0030)
Patient's Birth Date
DA
8
Value entered in the patient’s date of
birth fields
(0010,0040)
Patient's Sex
CS
2
Value entered in the patient’s gender
field
(0010,1000)
Other Patient IDs
LO
2
Value entered in the patient’s “code”
field
(0018,7004)
Detector Type
CS
4
CMOS
(0020,000D)
Study Instance UID
UI
22
2.16.840.1.114496.6.4
(0020,000E)
Series Instance UID
UI
22
2.16.840.1.114496.6.4
APPENDIX A - DICOM Statement
DRS can export a DICOM-compliant file format. Refer to the table below for the list of supported
tags.
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Tag
Description
VR
Len
Value
(0020,0010)
Study ID
SH
0
This tag is always empty
(0020,0011)
Series Number
IS 0 This tag is always empty
(0020,0013)
Instance Number
IS 0 This tag is always empty
(0020,0020)
Patient Orientation
CS
2
LF
(0020,0062)
Image Laterality
CS
2
R or L (left or right eye)
(0022,000C)
Horizontal Field of View
FL
4
45.000000
(0028,0002)
Samples per Pixel
US
2 3 (0028,0004)
Photometric Interpretation
CS
4
RGB
(0028,0006)
Planar Configuration
US
2
0
(0028,0010)
Rows
US
2
1944
(0028,0011)
Columns
US
2
2592
(0028,0030)
Pixel Spacing
DS
6
0.0064
(0028,0100)
Bits Allocated
US
2
8
(0028,0101)
Bits Stored
US
2
8
(0028,0102)
High Bit
US
2
7
(0028,0103)
Pixel Representation
US
2
0
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This function is not active by default on the DRS system and requires installation of a
dedicated license. Please contact your CenterVue representative for further
information on how to activate the mosaic function.
Presence of a central field is always required for mosaic generation. 2 to 6 fields can
be used. Only images of the same eye captured on the same day can be used. Only
one eye at a time can be selected.
Once the mosaic is started it cannot be interrupted before its completion. Generation
of a mosaic image may take 1-3 minutes, depending on how many fields are used.
The DRS cannot be used while mosaic generation is in progress.
APPENDIX B – AUTOMATED MOSAIC FUNCTION
The automated mosaic function is available since software version 2.4.
A mosaic is the composition of multiple, partially overlapping, fields of the same retina and it is
used to obtain a wider view. Mosaic images are permanently stored on the local memory and can
be reviewed at any time as individual fields. Typical examples of fields used are: central, temporal
and nasal or central, temporal, nasal, superior and inferior.
Figure 66 – Patient Record screen when mosaic function is enabled
To create a mosaic, check that the fields of interest have been captured then click on the
mosaic button in the Patient Record screen (see Figure 66) to open the image selection
screen: the first step requires selection of the eye, the second one requires selection of the fields to
be composed.
Once field selection is completed click on the Create Mosaic button to start mosaic generation, or
click on Cancel to abort (see Figure 68).
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Images resulting from the mosaic process may contain artifacts (such as duplicated or
disconnected vessels) that are generated at the transition between two adjacent fields
and that are not present in the original images. Such artifacts can be easily ruled out by
comparing the mosaic image with the original single-field images.
Figure 67 – Mosaic function, eye selection screen
Figure 68 – Mosaic function, field selection screen
During mosaic generation a message will inform that the mosaic is still in progress and eventually
that it has completed. Click on Ok to go back to the Patient Record screen and review the mosaic
image (see Figure 69).
Figure 69 – Example of a 3-fields mosaic image
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This function is not present by default on the DRS and requires activation of a
dedicated license. Please visit www.eyeknowledge.net for further information on how
to activate the EKN. Free trial periods may be available from time to time.
See par. Settings >> EKN of this manual for further information on how to register a
DRS on the EKN.
Functionality
EKN Cloud
EKN telemedicine
Cloud based backup / restore
Online image review
Online mosaic function
Support for grading request
Multi-user handling
Clinical Reports generation and handling
Icon
Meaning
Upload in progress (3 images missing)
Data upload is complete.
EKN problem: the EKN license may be expired or there is a temporary problem with
the EKN server. Please click the status icon to go to Settings >> EKN and check the
error code.
Network problem: EKN server is not reachable, please check your Internet
connection.
APPENDIX C – EYE KNOWLEDGE NETWORK (EKN)
The Eye Knowledge Network is CenterVue Cloud solution for data management.
EKN is used to transfer, store and display DRS images and textual information to a remote server
and make them available for online consultation, using the web browser, to authorized users.
The EKN service is available in two different options (EKN Cloud and EKN Telemedicine), offering
the functionalities described below.
Following is a description of the main functionalities as available throughout the various sections:
Home page: allows user sign up and login;
Inbox page: provides a sorted list of all stored patients [and download of Clinical Reports];
Patient page: provides patient data and image review capabilities [and generation of
Clinical Reports through customizable grading templates];
Profile page: allows editing of user profile, including password management;
Admin page: reserved to the Administrator user
Data upload messages
When the DRS is enabled for data transmission to EKN a new icon set appears on the top bar of
the home screen, besides the settings icon. Icons have the following meaning:
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