iCare DRS Fundus Imaging System User Manual

-
Operating Manual
CenterVue
DRS Operating Manual
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MANUAL INFORMATION
Date of release:
Revision number:
Reference software version:
Manufacturer:
October 30th 2022
29
V2.9
CenterVue S.p.A.
Via San Marco 9h, 35129 Padova – Italy
Tel. +39 049 501 8399
Fax +39 049 501 8398
The information in this manual is correct at the date of issue of the manual. The device configuration
can change as product improvements are incorporated and this manual may not exactly depict your
device. Please contact the local distributor if you have any questions about differences. The original
language of the DRS Operating Manual is English: in case of conflict of terms, the English version
shall prevail.
SUMMARY
1. INTRODUCTION ....................................................................................................................................... 4
2. DEVICE...................................................................................................................................................... 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 ......................................................................................................................... 15
9.5 Manual alignment ................................................................................................................................ 16
9.6 Anterior Eye ......................................................................................................................................... 17
9.7 Stereo exams ....................................................................................................................................... 18
9.8 Warning messages .............................................................................................................................. 18
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
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15.1 Fields ................................................................................................................................................... 34
15.2 Exam .................................................................................................................................................... 34
15.3 Network ................................................................................................................................................ 36
15.4 System ................................................................................................................................................. 42
15.5 About.................................................................................................................................................... 46
16. AUTOMATIC SOFTWARE UPDATE ...................................................................................................... 47
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 ....................................................................................................................................... 50
20. ELECTROMAGNETIC COMPATIBILITY ................................................................................................ 51
21. FCC (USA) and IC (Canada) radio certification ....................................................................................... 51
22. TECHNICAL SPECIFICATIONS ............................................................................................................. 52
23. DISPOSAL ............................................................................................................................................... 53
24. TROUBLESHOOTING AND ERROR MESSAGES................................................................................. 54
APPENDIX A - DICOM Statement .................................................................................................................. 56
APPENDIX B – AUTOMATED MOSAIC FUNCTION ..................................................................................... 58
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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.
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2.
DEVICE
Forehead rest =
applied part
Chin rest
applied part
=
Touch screen
Operator side
Patient 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 device is supplied with:
1.
2.
3.
4.
5.
6.
7.
8.
9.
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Front lens cap;
Power cord;
Spare fuses;
Dust cover;
USB extension cord;
Air blower;
Removable forehead rest;
Cleaning paper;
Cleaning cloth.
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3.
LABELING
Labelling might be subject to changes depending on local regulatory requirements concerning labelling.
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4.
SYMBOLS
4.1
Symbols adopted on the device
Symbol
Explanation
Manufacturer Data
Manufacturing Date (year/week of production)
Serial Number
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
Type B Applied Part
Generic Warning
4.2
Symbols adopted in this manual
Note
Warning
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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-darkness to facilitate natural
dilation of the pupil.
To set up your DRS follow these steps:
• extract the device from its box;
• place the DRS on a suitable electrical table1;
• connect the power cord provided with the device 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
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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 patient’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 device 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 device 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 steadily 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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7.
WARNINGS AND PRECAUTIONS
The following precautions are important to use the device in 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 device 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 device 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 60601-1. Equipment not complying with IEC 60601-1 shall be
kept outside the patient environment and complying with IEC 60950-1. Any person
who connects external equipment to signal input, signal output or other connectors
of the DRS has formed a Medical Electrical System according to 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 distributor for any
additional information
• Data Backup: the DRS contains Patient Health Information. IT IS A
RESPONSIBILITY OF THE OPERATOR (END USER) 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 chemicalphysical 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).
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• 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 device 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.
Minimal device-specific training is required to become able to use the device.
The operator needs to be acquainted with the following concepts:
• pupil: is the opening located in the center of the iris, of variable diameter, which allows light
to enter the eyeball. The pupil naturally is open (dilated) and contracts when struck by light.
If the pupil is too small the image quality may be impaired.
• retina: The inner layer of the eyeball.
• fixation / fixating: the ability of a subject to stare at a specific point in space and specifically
the DRS internal fixation targets.
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.
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9.
PERFORMING THE TEST
This paragraph explains how to operate the DRS to perform a complete test.
When the device 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:
Function
Adding a new patient (see 9.1 below)
Selecting an existing patient from the list (see 9.2 below)
Icon
-
Starting image acquisition without identifying the patient (see 9.3 below)
Shutting the system down
Entering the system settings (see 15)
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).
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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 fields (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 22).
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. 15.1 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. 15), 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.
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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. 15).
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
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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 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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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
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Figure 18 - Full screen view of the anterior eye
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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. 15). At the end of the
acquisition process the resulting two images will appear in the Patient Record screen. See par. 10
for details on how to review stereo pairs.
9.8
Warning messages
If the lens cap is placed on the front lens when an exam is started, the message shown in Figure 19
will appear (unless “check lens cap presence” is off, see 15.3.2). Press OK to exit and restart the
exam after removing the lens cap.
Figure 19 - 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
20).
Figure 20 - 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 21).
Figure 21 - Warning due to incorrect focusing
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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 22).
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 22 - 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
Retake
all images have been selected, click on RETAKE. Images can be
images
retaken within 5 minutes after they have been captured.
Open full
Click on the corresponding thumbnail to open the full image screen
image screen
Open 3D
Click on this button to open the 3D viewer. Only available for stereo
image view
pairs.
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Function
Icon
Command
Click on the printer icon to print two images in a single sheet. Icon is
enabled when a supported printer is connected.
Print
Click on this icon to generate and export a dual image printout
(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 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.
Export to pdf
Automated
mosaic
10.2 Full image screen
The Full Image screen (see Figure 23) 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 23 - Full image screen
Functions available in this screen include:
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
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Click on this icon to display a black and white image
representing the green channel of the color image
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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
Click on Add Notes to add / edit image specific comments
(see Figure 25)
Figure 24 – Notes editing screen
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Figure 25 - Stereo Images 3D viewer
To obtain a three-dimensional view, images must be looked at with appropriate
prismatic goggles (see Figure 26). A crossed-eye format is also supported.
Figure 26 – Example of prismatic goggles for three-dimensional viewing
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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. 15.3. 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. 15.3 and configure the remote PC with a different IP;
4. Retrieve the DRS IP, as explained in Settings >> Network (see par. 15.3, Figure 48);
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. 15.3.
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, you will be required to type a password, which must be
configured in the DRS settings when enabling Remote Access (see 15.3). The DRS patient list will
then show up on the remote PC, tablet or smart-phone (please consider that not all devices support
the private network). Available functions include:
• Patient list (same as Figure 9);
• Patient record screen (same as Figure 22)
• Access to individual images
• Possibility to download this Operating Manual in pdf format in About page
Figure 27 - 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
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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 28 – image selection screen for dual image printout
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Figure 29 - Single and dual image printout
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13. RETINAL FIELDS
The following fields can be acquired (see Figure 30 for fields representation for the right eye):
a.
b.
c.
d.
e.
f.
g.
CENTRAL: centered on the foveal pit;
NASAL: centered 17° nasally to the foveal pit;
TEMPORAL: centered 17° temporally to the foveal pit;
SUPERIOR-TEMPORAL: centered 12° superiorly and 12° temporally to the foveal pit;
CENTRAL-NASAL: centered 5° nasally to the foveal pit;
SUPERIOR: centered 17° superiorly to the foveal pit;
INFERIOR: centered 17° inferiorly to the foveal pit;
f
d
c
a
b
e
optic disk
g
Figure 30 - 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. 15).
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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 31).
The backup utility is 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 UNPREDICTABLE FAILURES 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 31 - System >> BACKUP tab in Settings when no backup was ever performed
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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 35)
•
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 REPEATED
•
IF DURING THE BACKUP PROCESS AN ERROR MESSAGE IS DISPLAYED
(SEE Figure 36) THE RESULTING BACKUP IS NOT EFFECTIVE, DATA
CANNOT BE RESTORED AND THE PROCESS SHALL BE REPEATED
•
A BACKUP CANNOT BE SPLIT INTO DIFFERENT USB DRIVES
The 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 32 – Backup process, step 1
Figure 33 – Backup process, step 2
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Figure 34 – Backup in progress message
Figure 35 – Backup completed message
Figure 36 – Error message during backup
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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 37). Retrieve the same USB
drive, insert it in any of the DRS USB ports and click on START BACKUP (see Figure 38): 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 37 – System >> BACKUP tab in Settings when a previous backup had already been performed
Figure 38 – System >> BACKUP tab in Settings when the USB drive containing the previous backup is
connected
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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 39).
Figure 39 – 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 no longer possible 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 38): 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 TO RESTORE EXAMS THAT WERE PERFORMED BEFORE THE
SELECTED DATE
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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.
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 method (erase & restore or restore new data).
•
•
•
•
•
DO NOT DISCONNECT THE USB DRIVE WHILE THE RESTORE PROCESS IS
IN PROGRESS
THE “ERASE & RESTORE” METHOD WILL PERMANENTLY ERASE ALL DATA
STORED ON THE DRS BEFORE RESTORING THAT PRESENT IN THE BACKUP:
USE THIS METHOD WITH CARE
THE “RESTORE NEW DATA” METHOD WILL PRESERVE EXISTING DATA AND
ADD THE PATIENTS CONTAINED IN THE BACKUP. THIS METHOD 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 40 – Restore process, step 1
Figure 41 – Restore process, step 2
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Figure 42 – Restore in progress
Figure 43 – Restore completed
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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 44 - Fields >> SINGLE FIELD 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 45) 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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Figure 45 - 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
Use this tab 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. This is not a unique ID under all circumstances: several actions
(e.g. backup + restore) may alter it.
• Enable export of patient and exam data in text format when saving to USB.
• 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 46 - Exam >> SAVING tab in settings
15.2.3
ADVANCED
Use this tab 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 47 - 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:
• Internet connection fully available on address xxx.xxx.xxx.xxx: the DRS is fully connected to
the Internet.
• 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.
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The Network tab has 4 sub-tabs: GENERAL, WIRELESS, SHARED-FOLDER and REMOTE
ACCESS.
Figure 48 – Network >> GENERAL tab in Settings
(Top: valid for units supporting private network via cable and wireless
Bottom: valid for units supporting private network via cable only)
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 is needed, click on the Manual button and enter the
IP address (mandatory), netmask (mandatory), gateway (optional) and DNS (optional). Then select
“SET NETWORK”
To allow the DRS to create a private network click on Private Network button The Private Network
allows the use of the DRS remote viewer without using existing networks.
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It can be used both in wired and wireless configuration. To go back and use an existing network click
on Set Network.
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 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.
Some DRS units do not support private network via the wireless interface.
Figure 49 – 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.
Figure 50 – Network >> WIRELESS tab in Settings
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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 press ENABLE (see Figure 51).
The following options are available:
• INTERNAL or REMOTE;
• AUTOMATIC or MANUAL.
Figure 51 – Network >> SHARED FOLDER tab in Settings, when AUTOMATIC mode using a remote folder
is selected
Figure 52 - Network >> SHARED FOLDER tab in Settings, when MANUAL mode is selected
Internal vs Remote
If the INTERNAL option is selected, images will be exported in a folder inside the DRS. In this case
only jpg format is available. 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.
If the INTERNAL option is selected, exported files will be only available when the
DRS is powered and networked.
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If the REMOTE option is selected, images will be exported in a shared network folder. In this case
exported image format can be selected (JPEG, DICOM or PDF) and the remote shared folder needs
to be configured.
Remote folder configuration
A server name, shared folder name, username (including domain or workgroup) and password need
to be specified (see Figure 53). See par. 24 for possible error conditions.
Figure 53 - Network >> SHARED FOLDER tab: remote shared folder configuration
Click on CONFIGURE DESTINATION to re-configure the remote shared folder.
Click on CHECK DESTINATION to refresh the status of the remote shared folder.
If the remote shared folder becomes (temporarily) unavailable/unreachable, newly
acquired images cannot be exported and will stay in the export queue, until access is
restored.
Status icon for automatic export to remote shared folder:
Icon
Description
Folder properly configured. No file in the export queue.
Export is initiating.
Export in progress.
An error has occurred: export cannot be completed, files stay in the export
queue.
Export completed, no files pending in export queue.
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Automatic vs Manual
If the AUTOMATIC mode is selected, at the end of each exam, a copy of the image will be
automatically saved to the shared network folder. 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.
Click on REFRESH to update the status of the export queue.
Click on EMPTY QUEUE to erase all pending files in the export queue (confirmation required).
If the MANUAL mode 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.
Exported file name
The naming convention for exported files is as follows:
patientID_lastname_firstname_date_time_drsNumber_eye_fieldNumber_examNumber.<ext>
15.3.4
REMOTE ACCESS
Use the REMOTE ACCESS sub-tab to:
• enable the WebAPI service (see information box below);
• enable remote requests over http for the Remote Viewer (see par. 11) and for the WebAPI
service;
• enable remote requests over https for the WebAPI service;
• set a password for the Remote Viewer and WebAPI access to the DRS, to prevent access to
the data by unauthorized persons.
WebAPIs are Application Program Interfaces for third parties’ software solutions (e.g.
EMRs) to connect to the DRS and push/retrieve data.
Configuration of a password is mandatory, for security reasons, when any of the
Remote Access options is enabled. Passwords must comply with the following rules:
at least 8 chars AND at least one lower-case letter AND at least one capital-case letter
AND at least one number.
Figure 54 – Network >> REMOTE ACCESS tab in Settings
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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 or disable the “DARK MODE”: a configuration that reduces the emission of light,
useful when using the device in a dark room.
Screensaver passwords must comply with the following rules: at least 8 chars AND at
least one lower-case letter AND at least one capital-case letter AND at least one
number.
Figure 55 – 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, the date and time format
Figure 56 - System >> TIME tab in Settings
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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;
•
optionally enable A5 printing format (only for printers that support it).
Figure 57 – System >> PRINTERS tab in Settings
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15.4.4
SERVICE
This tab provides access to various functionalities and tools, in particular:
•
reset optical head resets the position of the optical head (same procedure performed at
device startup);
•
lens cleaning assistant helps to check 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.
•
open remote assistance opens a remote connection that allows authorized service
technicians to connect to the DRS. Once pressed, the disclaimer shown in Figure 59
appears, informing the operator that he/she is authorizing access to all data present on the
device, for servicing purposes. Once confirmed, the DRS contacts CenterVue servers and
receives a random authorization code. This code must be communicated to the service
operator in order to connect. The connection can be closed by clicking the close remote
assistance button.
•
save log files to USB allows to export the log file of your DRS unit onto a USB key, for
troubleshooting purposes.
•
upload log files allows to upload the log file to a Centervue server, for troubleshooting
•
reset settings erases all device settings to Factory defaults (selected fields, network
configuration, shared folder, preferences, etc.).
•
reset patients erases all stored patient data and images.
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 58 - System >> SERVICE tab in Settings
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Figure 59 - Remote Assistance
Lens cleaning assistant
Clicking the Lens Cleaning Assistant button opens the box shown in Figure 60.
Clicking on Instructions opens the instructions box shown in Figure 61.
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 60 – Lens cleaning Assistant information dialog
Figure 61 – Lens cleaning instructions
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15.5 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 62 - About tab in Settings
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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 63 will appear. To download and install the new software version
click Install, otherwise click Cancel.
Figure 63 - Message to confirm the installation of the new software version
17. SYSTEM SHUTDOWN
To shut down the system go to the home 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.
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18. CLEANING
This paragraph explains how to clean the device. 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 64 – 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 to clean 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 65 – Cleaning
liquid and wipes
Figure 66 – Spray the wipes
Figure 67 – Clean the lens
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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NO
Figure 68 – Sample picture of a very dirty front lens
OK
Figure 69 – 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 device is equipped with silicon cushions, it is possible to remove the forehead rest, and rinse
it with warm water and a mild hand detergent.
The chin rest
removable.
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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 device 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 requiring a service to the instrument in order to:
• check the electrical safety (IEC 60601-1) every year.
• check the general functionality every 5 years.
Upon request, CenterVue and its authorized personnel can provide specific maintenance contracts.
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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 are
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.
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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)
Power requirements:
• Voltage: 100-240 VAC, 50-60 Hz, fuse 3.15 A (T type)
• Power consumption: 100 VA
Specifications are subject to change without notice for improvement, as result of ongoing technical development
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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) must not
dispose of WEEE as unsorted municipal waste, but 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 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 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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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 / Error message
Possible cause
The unit does not turn on
Main fuses are blown
up
After a period of functioning, the DRS computer becomes very
slow
Overheating of the
computer
After the system booting, the software application sends a
connection error saying: “Robot initialization error” or “Unable to
connect to control board”.
The retinal image is blurred/defocused
During the exam, the software application fails the autoalignment.
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
The motor of the
focus LED doesn’t
move.
The motor of the
camera lens doesn’t
move.
One (or both) of the
pupil LEDs is
damaged or not
powered
Replace main fuses
according
to the § “Maintenance”
Remove the objects
under the DRS that are
blocking the cooling air
flow
Contact an Authorized
Service Center
Try repeating the exam,
possibly on a different
eye. If still defocused,
contact an Authorized
Service Center
Contact an Authorized
Service Center
The mechanical
connection of the
USK key is not
appropriate
Use the USB extension
cord that comes with the
DRS (inside the
components box) to
connect the USB key.
The database got
corrupted because of
a hard shutdown
Click on “proceed with
data recovery”
The unit underwent a
hard shutdown
None needed, the units
will check data integrity
and restart
The USB key does not work
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Issue / Error message
Mosaic does not work with error message “Unable to create
mosaic. You need to select at least two images”
Mosaic does not work with error message “Unable to create
mosaic. You need to include a central field image”
Mosaic fails with error message “Mosaic creation failed”
“Warning: remote shared folder is not reachable with the current
configuration. Do you wish to save it anyway?”
Possible cause
Solution
No valid USB drive is
connected
Use a different USB
drive
At least two images
must be selected for
mosaic generation
A central field is
missing in the
selected images
Images are not
suitable for stitching
The shared folder is
currently not
reachable or it is
incorrectly configured
Charge level of the
battery of the internal
PC is low
CenterVue
DRS Operating Manual
Select at least two
images
Add a central field to the
selection
Select (or capture)
different images
Check that the
configured folder is
reachable and shared
with write access. Check
the spelling of the
configured parameters.
Contact Authorized
Service Center
Pag. 55 of 59
APPENDIX A - DICOM Statement
DRS can export a DICOM-compliant file format. Refer to the table below for the list of supported
tags.
Tag
(0002,0000)
(0002,0001)
(0002,0002)
(0002,0003)
(0002,0010)
(0002,0012)
(0002,0013)
(0002,0016)
(0008,0016)
Description
Group Length
File Meta Information Version
Media Storage SOP Class UID
Media Storage SOP Instance UID
Transfer Syntax UID
Implementation Class UID
Implementation Version Name
Source Application Entity Title
SOP Class UID
VR
UL
OB
UI
UI
UI
UI
SH
AE
UI
Len
4
2
32
22
20
26
8
10
32
(0008,0018)
SOP Instance UID
UI
22
(0008,0020)
(0008,0021)
(0008,0022)
(0008,0023)
(0008,002A)
(0008,0030)
(0008,0031)
(0008,0032)
(0008,0033)
(0008,0050)
(0008,0060)
(0008,0064)
(0008,0070)
(0008,0090)
(0008,0100)
(0008,0102)
(0008,0104)
Study Date
Series Date
Acquisition Date
Image Date
Acquisition Datetime
Study Time
Series Time
Acquisition Time
Image Time
Accession Number
Modality
Conversion Type
Manufacturer
Referring Physician's Name
Code Value
Coding Scheme Designator
Code Meaning
DA
DA
DA
DA
DT
TM
TM
TM
TM
SH
CS
CS
LO
PN
SH
SH
LO
8
8
8
8
14
14
14
14
14
0
2
2
16
0
8
4
14
(0008,1030)
Study Description
LO
2
(0008,103E)
Series Description
LO
2
(0010,0010)
Patient's Name
PN
10
(0010,0020)
Patient ID
LO
2
(0010,0030)
Patient's Birth Date
DA
8
(0010,0040)
Patient's Sex
CS
2
(0010,1000)
Other Patient IDs
LO
2
(0018,7004)
(0020,000D)
(0020,000E)
Detector Type
Study Instance UID
Series Instance UID
CS
UI
UI
4
22
22
Value
180
0
1.2.840.10008.5.1.4.1.1.77.1.5.2
2.16.840.1.114496.6.4
1.2.840.10008.1.2.1
1.2.826.0.1.3680043.8.641
CVUEDRS
RUBY_DICOM
1.2.840.10008.5.1.4.1.1.77.1.5.2
CenterVue ANSI registration code
(unique id number) plus machine id
and actual exam id.
Example: 2.16.840.1.114496.6.4
Exam date
Exam date
Exam date
Exam date
Exam datetime
Exam time
Exam time
Exam time
Exam time
This tag is always empty
OP
DI
CenterVue S.p.A.
This tag is always empty
R-1021A
SRT
Fundus Camera
Value entered in Settings | Exam |
Advanced | Study Description
Value entered in Settings | Exam |
Advanced | Series Description
Value entered in the patient’s Last
Name and First Name fields (last +
first)
Value entered in the patient’s “code”
field
Value entered in the patient’s date of
birth fields
Value entered in the patient’s gender
field
Value entered in the patient’s “code”
field
CMOS
2.16.840.1.114496.6.4
2.16.840.1.114496.6.4
DRS Operating Manual
Pag. 56 of 59
CenterVue
Tag
(0020,0010)
(0020,0011)
(0020,0013)
(0020,0020)
(0020,0062)
(0022,000C)
(0028,0002)
(0028,0004)
(0028,0006)
(0028,0010)
(0028,0011)
(0028,0030)
(0028,0100)
(0028,0101)
(0028,0102)
(0028,0103)
CenterVue
Description
Study ID
Series Number
Instance Number
Patient Orientation
Image Laterality
Horizontal Field of View
Samples per Pixel
Photometric Interpretation
Planar Configuration
Rows
Columns
Pixel Spacing
Bits Allocated
Bits Stored
High Bit
Pixel Representation
VR
SH
IS
IS
CS
CS
FL
US
CS
US
US
US
DS
US
US
US
US
Len
0
0
0
2
2
4
2
4
2
2
2
6
2
2
2
2
DRS Operating Manual
Value
This tag is always empty
This tag is always empty
This tag is always empty
LF
R or L (left or right eye)
45.000000
3
RGB
0
1944
2592
0.0064
8
8
7
0
Pag. 57 of 59
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 may require installation of
a dedicated license. Please contact your CenterVue representative for further
information on how to activate the mosaic function.
To create a mosaic, check that the fields of interest have been captured, then click on the
mosaic button in the Patient Record screen 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 71).
Generation of a mosaic image may take from 10 to 90 seconds3, depending on how
many fields are used. The DRS cannot be used while mosaic generation is in progress.
Figure 70 – Mosaic function, eye selection screen
3 Benchmark refers to devices manufactured starting in August 2015
CenterVue
DRS Operating Manual
Pag. 58 of 59
Figure 71 – Mosaic function, field selection screen
During mosaic generation a dialog box will provide feedback on progress. Click on Cancel to abort
a mosaic at any time. Once completed, click on Ok to go back to the Patient Record screen and
review the mosaic image (see Figure 72).
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 72 – Example of a 3-fields mosaic image
CenterVue
DRS Operating Manual
Pag. 59 of 59
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