Drs Operating Manual

Operating Manual
CenterVue DRS Operating Manual Pg. 1 of 64

MANUAL INFORMATION
Date of release: August 26th, 2016
Revision number: 22
Reference software version: v2.5
Manufacturer:
CenterVue SpA
Via San Marco 9h, 35129 Padova – ITALY
Tel. +39 049 739 6147
Fax +39 049 739 6148
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............................................................................................................................................... 24
12.1 Single image printout ........................................................................................................................... 24
12.2 Dual image printout .............................................................................................................................. 24
13. RETINAL FIELDS .................................................................................................................................... 26
14. BACKUP .................................................................................................................................................. 27
14.1 First-time, total, backup ....................................................................................................................... 28
14.2 Incremental backups ............................................................................................................................ 30
14.3 Removing a backup disk...................................................................................................................... 31
14.4 Partial backups .................................................................................................................................... 31
14.5 Restore ................................................................................................................................................ 32
15. SETTINGS ............................................................................................................................................... 34
15.1 Fields ................................................................................................................................................... 34
15.2 Exam .................................................................................................................................................... 34
15.3 Network ................................................................................................................................................ 36
15.4 System ................................................................................................................................................. 40
15.5 EKN ...................................................................................................................................................... 45
15.6 About.................................................................................................................................................... 45
16. AUTOMATIC SOFTWARE UPDATE ...................................................................................................... 46

17. SYSTEM SHUTDOWN ............................................................................................................................ 47
18. CLEANING............................................................................................................................................... 48
18.1 Front lens ............................................................................................................................................. 48
18.2 Patient cushions .................................................................................................................................. 49
18.3 Touch screen panel ............................................................................................................................. 50
18.4 Plastic shells ........................................................................................................................................ 50
19. MAINTENANCE ....................................................................................................................................... 51
20. ELECTROMAGNETIC COMPATIBILITY ................................................................................................ 52
21. FCC (USA) and IC (Canada) radio certification ....................................................................................... 52
22. TECHNICAL SPECIFICATIONS ............................................................................................................. 53
23. DISPOSAL ............................................................................................................................................... 54
24. TROUBLESHOOTING AND ERROR MESSAGES................................................................................. 55
APPENDIX A - DICOM Statement .................................................................................................................. 57
APPENDIX B – AUTOMATED MOSAIC FUNCTION ..................................................................................... 59
APPENDIX C – EYE KNOWLEDGE NETWORK (EKN) ................................................................................. 61
Enabling the EKN service ............................................................................................................................. 61
Data upload status ........................................................................................................................................ 62
Multi-unit patient list ...................................................................................................................................... 63
Retrieving the patient list from EKN .............................................................................................................. 64

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.
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.

2. SYSTEM
Forehead rest =
applied part
Chin rest =
applied part
Touch screen
Patient side Operator side
Figure 1 - DRS left side view
Power switch
Power inlet
USB ports
Fuses
Ethernet port
Figure 2 - Detail of the device right side
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.

3. LABELING

4. SYMBOLS
4.1 Symbols adopted on the device

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
4.2 Symbols adopted in this manual
Note
Warning

5. PREPARING THE DRS
Read carefully and thoroughly paragraph 7 WARNINGS AND PRECAUTIONS before
proceeding with first use.
The test should be performed in conditions of semi-obscurity to facilitate natural

dilation of the pupil.
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);
Figure 3 - Forehead rest patient side Figure 4 - Forehead rest rear side
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.
1 Not provided with the DRS

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.
Patients wearing Contact Lenses: image quality may be affected by contact lenses. It is
recommended to have contact lenses removed before imaging the patient.
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.

7. WARNINGS AND PRECAUTIONS
The following precautions are particularly relevant to the device safety:
 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 A
RESPONSIBILITY OF THE OPERATOR TO KEEP AN UPDATED COPY OF THE
DATA GENERATED BY THE DRS, BY PERIODICALLY USING THE BACKUP
UTILITY IN ORDER TO BE PROTECTED AGAINST UNPREDICTABLE DATA
LOSS.. See par.14.4.3
The following precautions are particularly relevant to prevent use errors:

 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: from 10 °C to 40 °C (50 °F to 104 °F) / Humidity (max): 90% not

condensing
 The DRS needs to be stored under the following environmental conditions:
Temperature: from -10 °C to 60 °C (14 °F to 140 °F) / Humidity (max): 90% not
condensing
 A not optimal pupil alignment may cause the acquisition of an image of the retina
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.
Note on auto-alignment:
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.
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.
ITI IS A RESPONSIBILITY OF THE OPERATOR TO KEEP AN UPDATED COPY OF

THE DATA GENERATED BY THE DRS, BY PERIODICALLY USING THE BACKUP
UTILITY, IN ORDER TO BE PROTECTED AGAINST UNPREDICTABLE DATA
LOSS.

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;
 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.
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.

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).
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.
The DRS stores any images and data on the local hard disk. If the hard disk capacity
is reached, no more images can be saved and a warning message is displayed saying
“Hard disk full”.
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

9.5 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

9.6 Anterior Eye
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.
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.
Figure 16 - Anterior eye: correct patient position
Figure 17 - Anterior eye acquisition Figure 18 - Full screen view of the anterior eye

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

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

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.
Figure 23 - Patient record screen
Available functions include:

Function Icon Command
Point on any thumbnail and drag to the left / right or press the left / right
Image scroll -
buttons located at the bottom on the sides
Edit patient Click on this icon to enter the edit mode and correct any mistyped
record information or provide additional details
Delete patient Click on this icon to permanently delete the current patient and all
record related exams. A confirmation is required.
Click on this icon to export all images of the selected patient as JPG
Batch image
files on a USB key (only available if a USB key is plugged in any of the
export
USB ports)
Click on this icon to select one or more images to be retaken. When all
Retake
images have been selected, click on RETAKE. Images can be retaken
images
within 5 minutes after they have been captured.
Open full
- Click on the corresponding thumbnail to open the full image screen
image screen
Click on the STEREO button between the two thumbnails of a stereo
Open 3D
couple thumbnail: this command will open the 3D viewer. Only
image view
available for stereo pairs.

Click on the printer icon to print two images in a single sheet. Icon is
Print
enabled when a supported printer is connected.
Click on the Acrobat icon to generate and export a dual image printout
Export to pdf
(available if a USB key is connected, see par. 12.2 for further details).
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
Automated
installed. See Appendix B for explanations on how to use this function.
mosaic
Please contact your CenterVue representative for information on how
to obtain the license.
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:

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
Click on this icon to display a black and white image corresponding
Red-free filter
to the green component of the image

Export image to Click on this icon to export the selected image to a shared folder
shared folder (see Settings >> Network >> Shared folder)
Export image Click on this icon to export the selected image as a jpg file on any
file to USB USB key (only available if a USB key is connected)
Click on this icon to print the current image (only available if a
Image print
compatible USB printer is connected)
Image delete Click on this icon to permanently delete the selected image
Move to next / Click on these icons to move to the next/previous image of the
previous image current patient
Click on this icon to toggle between normal and 3D viewer for the
3D viewer
stereo images. Only available when showing a stereo pair.
Swap stereo Click on this icon to swap right and left image of a stereo pair
images (“crossed-eye” format). Only available when showing a stereo pair.
Add image Add Click on Add Notes to add / edit image specific comments (see
notes Notes Figure 25)
Figure 25 – Notes editing screen
Figure 26 - Stereo Images 3D viewer

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

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.
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.
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 on 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
 Possibility to download this Operating Manual in pdf format in About page
Figure 28 - DRS patient list in remote viewer
2 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
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.
The single image printout uses portrait format, while the dual image printout uses
landscape format.
Figure 29 – image selection screen for dual image printout

Figure 30 - Single and dual image printout

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;
f
d
c a
b
optic disk
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).

14. BACKUP
The Backup utility allows to perform the backup of DRS data and can be found in the
Settings, under the “System” tab (see Figure 46).
The backup utility in based on the concept of incremental backup. The following paragraphs
explain: i) how to perform the first-time backup and ii) how to perform any subsequent incremental
backups. The backup utility is structured as a wizard and will guide you through the process.
 IT IS A RESPONSIBILITY OF THE OPERATOR TO KEEP AN UPDATED

BACKUP COPY OF THE DATA GENERATED BY THE DRS, BY
PERIODICALLY USING THE BACKUP UTILITY, IN ORDER TO BE
PROTECTED AGAINST UNPREDICTABLEFAILURES RESULTING IN DATA
LOSS
 THE MANUFACTURER CANNOT BE HELD RESPONSIBLE FOR LOSS OF

DATA DUE TO UNPREDICTABLE FAILURES
 IN CASE OF A FAILURE RESULTING IN DATA LOSS, THE DATA CAN BE

RESTORED FROM THE LAST PERFORMED BACKUP
 MANUAL MODIFICATION OF BACKUP FILES STORED ON THE BACKUP

MEDIA MAY PREVENT THE ABILITY TO RESTORE THE DATA: DO NOT
EVER ALTER THOSE FILES
Figure 32 - System >> BACKUP tab in Settings when no backup was ever performed

14.1 First-time, total, backup
To perform the first-time backup, insert a USB drive in any of the DRS USB ports. The USB drive
should preferably be a hard disk and its capacity should exceed 320 GB (although initially the data
size is much smaller).
The firs-time backup process involves two steps:

1. initializing the USB drive;
2. creating the backup file.
 A BACKUP IS ONLY EFFECTIVE WHEN THE “BACKUP COMPLETED”

MESSAGE IS DISPLAYED (SEE Figure 36)
 IF THE BACKUP PROCESS IS INTERRUPTED USING THE “STOP BACKUP”

COMMAND THE BACKUP IS NOT EFFECTIVE, DATA CANNOT BE RESTORED
AND THE PROCESS SHALL BE REPATED
 IF DURING THE BACKUP PROCESS AN ERROR MESSAGE IS DISPLAYED

(SEE Figure 37) THE RESULTING BACKUP IS NOT EFFECTIVE, DATA
CANNOT BE RESTORED AND THE PROCESS SHALL BE REPATED
 A BACKUP CANNOT BE SPLIT INTO DIFFERENT USB DRIVES
Duration of the backup process depends on the amount of data stored in the DRS and
on the speed of the USB drive used. Typically, first time backups may take longer than
subsequent incremental backups.
Figure 33 – Backup process, step 1
Figure 34 – Backup process, step 2

Figure 35 – Backup in progress message
Figure 36 – Backup completed message
Figure 37 – Error message during backup

14.2 Incremental backups
To perform an incremental backup, click on Settings and select the BACKUP tab: information
about the USB drive used for previous backups will be displayed (see Figure 38). Retrieve the
same USB drive, insert it in any of the DRS USB ports and click on START BACKUP (see Figure
39): information on progress will be displayed.
If you use a different USB drive than indicated above you will actually be performing
again a first-time, total, backup
Figure 38 – System >> BACKUP tab in Settings when a previous backup was already performed
Figure 39 – System >> BACKUP tab in Settings when the USB drive containing the previous backup is
connected

14.3 Removing a backup disk
If you do not use a backup disk anymore and wish to remove it from the DRS list, click on Settings,
select the BACKUP tab and click on the icon corresponding to the disk you want to remove, then
click on “REMOVE BACKUP” (see Figure 40).
Figure 40 – Removing a backup disk from the list
 Backup files are not altered by this operation and remain on the disk
 It is still possible to perform a Restore using the data on the disk
 It is not possible anymore to perform an incremental backup on the disk
14.4 Partial backups

Using the backup utility, you can also create a one-time partial backup (see Figure 39): this
option allows to create a backup copy of all exams performed after a specified date. Such partial
backups can be restored as any other backup.
PARTIAL BACKUPS SHALL BE USED ONLY IN THOSE SITUATIONS WHERE NOT

ALL PATIENTS / EXAMS ARE OF INTEREST, AS PARTIAL BACKUPS DO NOT
ALLOW RESTORE OF EXAMS THAT WERE PERFORMED BEFORE THE
SELECTED DATE

14.5 Restore
To restore data from an existing backup, click on Settings and select the BACKUP tab: information
about the USB drive used for previous backups will be displayed. Retrieve the same USB drive,
insert it in any of the DRS USB ports and click on START RESTORE (see Figure 39).
The restore process involves two steps:

1. selecting the backup file from which data shall be restored (if more than one is available);
2. selecting the restore modality (erase & restore or restore new data).
 DO NOT DISCONNECT THE USB DRIVE WHILE THE RESTORE PROCESS IS

IN PROGRESS
 THE “ERASE & RESTORE” MODALITY WILL PERMANENTLY ERASE ALL
DATA STORED ON THE DRS BEFORE RESTORING THAT PRESENT IN THE
BACKUP: USE THIS MODALITY WITH CARE
 THE “RESTORE NEW DATA” MODALITY WILL PRESERVE EXISTING DATA
AND ADD THE PATIENTS CONTAINED IN THE BACKUP. THIS MODALITY
MAY RESULT IN DUPLICATED PATIENTS
 THE RESTORE PROCESS CANNOT BE INTERRUPTED
 IF THE HARD DISK CAPACITY IS REACHED, NO DATA CAN BE RESTORED
AND A WARNING MESSAGE IS DISPLAYED
Figure 41 – Restore process, step 1
Figure 42 – Restore process, step 2

Figure 43 – Restore in progress
Figure 44 – Restore completed

15. 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.
15.1 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 45 - Fields >> SINGLE FILED tab in Settings
15.2 Exam
The Exam tab has three sub-tabs, namely EXAM, SAVING and ADVANCED.
15.2.1 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).

Figure 46 - Exam >> EXAM tab in Settings
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 grainier aspect.
15.2.2 SAVING
 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).
Figure 47 - Exam >> SAVING tab in settings

15.2.3 ADVANCED
 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 48 - Exam >> ADVANCED tab in Settings
15.3 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 purposes, see Settings >> EKN).
 LAN working on IP xxx.xxx.xxx.xxx: a valid network is set and the local network is ready.
 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 49 – Network >> GENERAL tab in Settings
15.3.1 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.
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.

Figure 50 – Network tab in Settings when a private network has been set-up
15.3.2 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 51 – Network >> WIRELESS tab in Settings
15.3.3 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>

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 52 – Network >> SHARED FOLDER tab in Settings
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 53 - Remote Folder Configuration – step 1
Figure 54 - Remote Folder Configuration – step 2
A third step may require you to insert username and password on the remote folder.
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 55 - 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.
15.3.4 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 56 – Network >> LAN ACCESS tab in Settings
15.4 System
The System tab has five sub-tabs: GENERAL, TIME, BACKUP, PRINTERS and SERVICE.
15.4.1 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.

Figure 57– System >> GENERAL tab in Settings
15.4.2 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 58 - System >> TIME tab in Settings
15.4.3 PRINTERS
Use this tab to:
 choose 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 59 – System >> PRINTERS tab in Settings

15.4.4 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.
 Save log files to USB allows to export the log file of your DRS unit onto a USB key, for
troubleshooting purposes.
 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.
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.
Figure 60 - System >> SERVICE tab in Settings

Figure 61 - 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 62 – Lens cleaning Assistant information dialog
Figure 63 – Lens cleaning instructions

15.5 EKN
The EKN tab in the Settings is used to activate and manage the connection of the DRS to the Eye
Knowledge Network (EKN). See Appendix C and www.eyeknowledge.net for additional
information about this optional feature.
15.6 About
This screen shows the DRS serial number, the software and firmware version, the OS version, the
Ethernet and WiFi MAC address, the total number of patients and exams stored, the space left on
the hard disk, the presence of any optional licenses and the list of compatible printers.
It also allows to download this Operating Manual on a USB key, in pdf format.
Figure 64 - About tab in Settings

16. 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 65 - Message to confirm the installation of the new software version

17. 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.
Do not leave the front lens uncovered while the system is not in use.

18. CLEANING
This paragraph explains how to clean the system. The device must be powered off, and the power
cord shall be disconnected from mains.
Extreme care should be given to always protect the front lens.
18.1 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.
Figure 66 – Hand air blower
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.
Do not attempt cleaning the front lens with a dry cloth.

This could lead to scratching its surface.
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.
Figure 67 – Cleaning Figure 68 – Spray the wipes Figure 69 – Clean the lens
liquid and wipes
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.

NO
Figure 70 – Sample picture of a very dirty front lens
OK
Figure 71 – Sample picture of a clean front lens
18.2 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.
Chin rest cushion is not removable.

18.3 Touch screen panel
The touch screen panel should be cleaned only with a cloth damped in water.
Do not use alcohol or detergents to clean the touch screen, as these

may damage the film covering the panel.
18.4 Plastic shells

If needed, the external covers of the unit can be cleaned by means of a cloth slightly damped in
water.
Do not use alcohol or detergents to clean the plastic shells, as they
might erase labels or indications.

19. 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.
All service interventions other than the above should be carried out by authorized
CenterVue personnel.
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.

20. 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.
21. 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.

22. 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

23. 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).

24. TROUBLESHOOTING AND ERROR MESSAGES
If any problem occurs, check the following table and try to apply the proposed solution. If the
problem persists, please contact CenterVue Service representative.
Issue Possible cause Solution

Replace main fuses
Main fuses are blown
The unit does not turn on according
up
to the § “Maintenance”
Remove the objects under
After a period of functioning, the DRS computer becomes very Overheating of the
the DRS that are blocking
slow computer
the cooling air flow
The control board is
not powered with 12V,
or there is no USB
After the system booting, the software application sends a connection between
Contact an Authorized
connection error saying: “Robot initialization error” or “Unable to the computer and the
Service Center
connect to control board”. control board, or the
BIOS of the embedded
PC is set not to power
control board logic
The motor of the focus Try repeating the exam,
LED doesn’t move. possibly on a different
The retinal image is blurred/defocused The motor of the eye. If still defocused,
camera lens doesn’t contact an Authorized
move. Service Center
One (or both) of the
During the exam, the software application fails the auto- Contact an Authorized
pupil LEDs is damaged
alignment. Service Center
or not powered
Use the USB extension
The mechanical cord that comes with the
The USB key does not work connection of the USK DRS (inside the
key is not appropriate accessories box) to
connect the USB key.
The database got

Click on “proceed with
corrupted because of a
data recovery”
hard shutdown
None needed, the units

The unit underwent a
will check data integrity
hard shutdown
and restart

Issue Possible cause Solution
No valid USB drive is

Use a different USB drive
connected

APPENDIX A - DICOM Statement
DRS can export a DICOM-compliant file format. Refer to the table below for the list of supported
tags.
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
CenterVue ANSI registration code
(unique id number) plus machine id
(0008,0018) SOP Instance UID UI 22
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
Value entered in Settings | Exam |
(0008,1030) Study Description LO 2
Advanced | Study Description
Value entered in Settings | Exam |
(0008,103E) Series Description LO 2
Advanced | Series Description
Value entered in the patient’s Last
(0010,0010) Patient's Name PN 10 Name and First Name fields (last +
first)
Value entered in the patient’s “code”
(0010,0020) Patient ID LO 2
field
Value entered in the patient’s date of
(0010,0030) Patient's Birth Date DA 8
birth fields
Value entered in the patient’s gender
(0010,0040) Patient's Sex CS 2
field
Value entered in the patient’s “code”
(0010,1000) Other Patient IDs LO 2
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
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

APPENDIX B – AUTOMATED MOSAIC FUNCTION
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.
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.
Figure 72 – 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.
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 field selection is completed click on the Create Mosaic button to start mosaic generation, or
click on Cancel to abort (see Figure 68).
Once the mosaic is started it cannot be interrupted before its completion. Generation
of a mosaic image may take from 2 to 6 minutes, depending on how many fields are
used. The DRS cannot be used while mosaic generation is in progress.

Figure 73 – Mosaic function, eye selection screen
Figure 74 – 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).
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 75 – Example of a 3-fields mosaic image

APPENDIX C – EYE KNOWLEDGE NETWORK (EKN)
Introduction
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 not active by default on the DRS and requires the purchase and
activation of a dedicated license. Please visit www.eyeknowledge.net or contact us
at www.eyeknowledge.net/contact for further information on how to activate the
EKN.
 This section of the manual explains some features of the DRS when used in
connection with the EKN service. Please refer to the EKN Operating Manual for
specific information on the use of EKN service.
Enabling the EKN service

To enable the EKN service and start accessing DRS data online, you need to first register as a
User on EKN and then register the DRS on EKN:
 Make sure that you have a valid EKN license;
 press the SHOW button to show the “One Time Secret Key”;
 press ENABLE to activate DRS synchronization with the EKN server;
 setup a new user account on www.eyeknowledge.net by clicking on the “Sign Up” button
(refer to the EKN Operating Manual for additional details);
 once the account is active, login with your credentials, click on “Admin”, then on “Register
new DRS”, type the serial number of your DRS (e.g. drs-0123), use lowercase characters.
Then type the One Time Secret Key shown on your DRS (this step is required only once);
 make sure the DRS is connected to the internet. After maximum half an hour the DRS
status as displayed in Settings >> EKN >> GENERAL should read "REGISTERED" (see
Figure 76) and any existing patients and exams will start being uploaded on the EKN.
Figure 76 - EKN tab in Settings

 The upload time depends on the number of patients and images stored in the DRS
and on the available bandwidth.
 Use Ethernet (wired) connection to maximize performance.
Data upload status

When the DRS is enabled for data transmission to EKN, the Settings >> EKN >> GENERAL tab
provides status information on the upload process (see Figure 76). Furthermore, a new icon
appears on the top bar of the home screen, besides the settings icon.
Icons have the following meaning:

Icon Meaning
Upload in progress (3 images missing)
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 >> GENERAL
and check the error code.
Network problem: EKN server is not reachable, please check your Internet
connection.

Multi-unit patient list
If your DRS is part of a group of units connected to EKN, you can combine the patient lists
of all units belonging to the group.
Patients retrieved from the EKN (including those who were not generated by your DRS will be
listed in the patient list screen (see Figure 9) and can be searched for, exactly as local patients.
 the multi-unit patient list has no value if your DRS is not part of a group of units
connected to EKN
 all patients of the EKN device group to which the DRS belongs will be downloaded
 only the patient anagraphics is retrieved, not the exams and images, in particular
exams and images generated on a different DRS unit will not be accessible
 exams and images that are not available locally can only be accessed on the EKN
 all retrieved patients can be selected, new exams captured, stored locally and then
uploaded on EKN
To enable this multi-unit modality, click on Settings, select the EKN >> CLOUD SYNC tab, click on
“enter your EKN account credentials”, type your EKN credentials, click on login and then click on
“sync enabled” in the “Sync EKN remote patient list with local list” box (see Figure 77). When the
synchronization is enabled, the DRS will periodically retrieve from the EKN the updated patient list,
as resulting from the activity of all DRS units belonging to the group.
Figure 77 - EKN >> CLOUD SYNC tab in Settings

Retrieving the patient list from EKN
In several situations you may want to retrieve the patient list from the EKN server. This can be
useful, for example, if you are periodically erasing part of the data from the DRS following its
upload on EKN (see next paragraph).
To retrieve the patient list from the EKN server at any time, click on Settings, select the EKN >>
CLOUD SYNC tab, click on “enter your EKN account credentials”, type your EKN credentials, click
on login, then click on “start download of full patient list” (see Figure 77) and eventually click on
“proceed”. A progress bar will display and a message will acknowledge completion.
 all patients of the EKN device group to which the DRS belongs will be downloaded
 only the patient anagraphics is retrieved, not the exams and images
 exams and images that are not available locally can only be accessed on the EKN
 all retrieved patients can be selected, new exams captured, stored locally and then
uploaded on EKN
 data contained in the DRS unit will be preserved
Figure 78 – Patient list retrieval completed message

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Operating Manual

CenterVue DRS Operating Manual Pg. 1 of 64

CenterVue DRS Operating Manual Pg. 2 of 64

CenterVue DRS Operating Manual Pg. 3 of 64

The clinical interpretation of the images acquired by the DRS is restricted to

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Patient side Operator side

Figure 1 - DRS left side view

The DRS system is supplied with:

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4.1 Symbols adopted on the device

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

Warning: Do Not Touch

Type B Applied Part

4.2 Symbols adopted in this manual

CenterVue DRS Operating Manual Pg. 7 of 64

The test should be performed in conditions of semi-obscurity to facilitate natural

To set up your DRS follow these steps:

Time zone configuration

Figure 5 – Request to configure time zone

Request for camera auto-tuning

1 Not provided with the DRS

CenterVue DRS Operating Manual Pg. 8 of 64

Figure 7 – Camera auto-tuning completion message

6. PREPARING THE PATIENT

Before the test inform the patient about the following:

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The following precautions are particularly relevant to prevent use errors:

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The operator needs to be acquainted with the following concepts:

ITI IS A RESPONSIBILITY OF THE OPERATOR TO KEEP AN UPDATED COPY OF

CenterVue DRS Operating Manual Pg. 11 of 64

Figure 8 - Home screen

Several options are available at this point, such as:

9.1 Adding a new patient

9.2 Selecting an existing patient

The following mechanisms are available to find a specific patient:

CenterVue DRS Operating Manual Pg. 12 of 64

Figure 9 - Patient list screen

9.3 Starting the image acquisition process

Then choose among the different options / parameters:

Press the START button to start the acquisition procedure.

CenterVue DRS Operating Manual Pg. 13 of 64

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

CenterVue DRS Operating Manual Pg. 14 of 64

Figure 14 – Message indicating failure of automatic eye search

Figure 15 – Example of retinal image captured by the DRS

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Figure 16 - Anterior eye: correct patient position

CenterVue DRS Operating Manual Pg. 16 of 64

Figure 19 - Patient record with stereo pair

9.8 Warning messages

Figure 20 - Message when lens cap is detected