Operating Manual

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MANUAL INFORMATION
Date of release: December 14, 2019
Revision Number: 4
Reference software version: 1.4
Manufacturer: 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 are correct at the date of issue of the manual. The device configuration
can change as product improvement are incorporated and this manual may not exactly depict your
device. Please contact the customer service if you have any questions about differences.

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CONTENTS
1. Introduction ................................................................................................................................................... 5
2. Symbols .......................................................................................................................................................... 6
2.1 Symbols used on the device .................................................................................................................. 6
2.2 Other symbols found in this manual ..................................................................................................... 6
3. Product description........................................................................................................................................ 8
4. Labels ........................................................................................................................................................... 11
5. WARNINGS AND PRECAUTIONS ................................................................................................................... 12
6. Notes for the operator ................................................................................................................................. 14
6.1 Definitions ........................................................................................................................................... 14
7. Preparation of device ................................................................................................................................... 15
7.1 First usage ........................................................................................................................................... 15
7.2 Initial configuration wizard ................................................................................................................. 16
7.3 Login .................................................................................................................................................... 18
7.4 Patient list ........................................................................................................................................... 19
7.5 Navigation Bar ..................................................................................................................................... 20
8. Preparation of the patient ........................................................................................................................... 21
9. Acquisition of retinal images ....................................................................................................................... 22
9.1 Configuration of Exam Parameters ..................................................................................................... 23
9.2 Automatic acquisition of images ......................................................................................................... 24
9.3 “Fast” exam ......................................................................................................................................... 25
9.4 “External eye” examination ................................................................................................................ 26
9.5 Stereo modality (available under license only) ................................................................................... 26
10. Patients Database ........................................................................................................................................ 27
10.1 Adding a new patient .......................................................................................................................... 27
10.2 Editing an existing patient ................................................................................................................... 27
10.3 Single and multiple selection of patients ............................................................................................ 27
10.4 Deletion of patients ............................................................................................................................ 28
10.5 Export of all patients’ images .............................................................................................................. 28
11. Image review................................................................................................................................................ 29
11.1 Patient Details screen ......................................................................................................................... 29
11.2 Image review ....................................................................................................................................... 31
11.3 Side-by-side image review .................................................................................................................. 32
11.4 Visual flickering of images ................................................................................................................... 33
11.5 Mosaic ................................................................................................................................................. 33
11.6 Remote Viewer .................................................................................................................................... 35
12. Exporting images.......................................................................................................................................... 36
13. Configuring the device ................................................................................................................................. 37
13.1 Account ............................................................................................................................................... 37
13.2 Users ................................................................................................................................................... 37
13.3 Network .............................................................................................................................................. 38
13.4 Date and time...................................................................................................................................... 39
13.5 Security ............................................................................................................................................... 39
13.6 Export .................................................................................................................................................. 40
13.7 Printers ................................................................................................................................................ 41
14. Utilities ......................................................................................................................................................... 42
14.1 Assistance............................................................................................................................................ 42
14.2 Backup ................................................................................................................................................. 43

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 14.3 Restore ................................................................................................................................................ 44
14.4 Reset ................................................................................................................................................... 45
14.5 Licenses ............................................................................................................................................... 45
14.6 Update................................................................................................................................................. 46
14.7 More .................................................................................................................................................... 46
14.8 Demo dataset ...................................................................................................................................... 47
14.9 Optical head position .......................................................................................................................... 47
15. Power-off ..................................................................................................................................................... 48
16. Cleaning ....................................................................................................................................................... 49
17. Maintenance ................................................................................................................................................ 50
18. Electromagnetic Compatibility..................................................................................................................... 51
18.1 Manufacturers EMC Declaration according to ISO 60601-1-2 ............................................................ 51
18.2 Guidance and manufacturer declaration – electromagnetic immunity .............................................. 52
18.3 Immunity tests performance criteria .................................................................................................. 54
18.4 Wi-Fi specifications ............................................................................................................................. 55
18.5 FCC (USA) and IC (Canada) radio certification ..................................................................................... 56
19. Technical Specifications ............................................................................................................................... 57
20. Disposal ........................................................................................................................................................ 58
20.1 Separate collection for electrical and electronic equipment .............................................................. 58

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1. Introduction
Congratulations for choosing drsplus and its color confocal retinal imaging capabilities.

The drsplus is intended for the acquisition of colored images of the retina without the use of a
mydriatic agent. More specifically, the drsplus provides colored images of the retina with a field of
view of 45° x 40°, in fully automatic mode. The device includes a dedicated software application and
operates as a stand-alone unit.

The clinical interpretation of images acquired by the drsplus must be carried out
exclusively by ophthalmologists.

The ophthalmologist is responsible for any diagnosis based on drsplus results.

Use of the device is strictly limited to suitably trained operators.

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2. Symbols
2.1 Symbols used on the device
The meaning of the symbols adopted in the device labels is as follows:
Symbol Explanation

Information about the Manufacturer.

Manufacturing date (year/week).

Electrical and electronic waste is destined for separate recycling.

Refer to the Operating Manual.

CE mark: the device complies with the essential requirements of the European
Medical Devices Directive 93/42/EC.

Type B Applied Part.

Non-ionizing radiation - ME EQUIPMENT that includes RF transmitters.

Direct current.

Power button. See the device back panel (Fig. 7).

2.2 Other symbols found in this manual

Symbol Explanation

Important Information.

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General Warning, read carefully.

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3. Product description
The drsplus consists of:
❖ The device (with a lens cap for shipping only) (Fig. 1);
❖ Cables protection shell (Fig. 2);
❖ Device stand (Fig. 3);
❖ Headrest with silicon cushion (Fig. 4);
❖ External power supply (Fig. 5) which includes a country-specific power cable.

Fig. 1 – drsplus device Fig. 2 – Cables protection shell Fig. 3 – Device stand

Fig. 4 – Headrest Fig. 5 – External power supply

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 Headrest
Touch screen

Patient side Operator side

Back panel
(with shell)

Fig. 6 – drsplus

Power supply
connector USB ports Ethernet port
DisplayPort
(version 1.0)
LED
Device power status

Power button

Fig. 7 – Back Panel

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The drsplus can be equipped with:
❖ External fixation light (Fig. 8);
❖ Prismatic goggles for stereo view (Fig. 9).

Fig. 8 – External fixation light Fig. 9 - Stereo goggles

The drsplus is provided with:

❖ This operating manual;

❖ Contents list;
❖ Unpacking, packing and setup manual;
❖ Climatic preconditioning instructions;
❖ Electrical test report.

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4. Labels
The device label is located on the back side of the display, as shown in Fig. 10

Fig. 10 – Device label

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5. WARNINGS AND PRECAUTIONS
The following precautions are important for the device safety:

❖ The clinical interpretation of the images acquired by the drsplus is restricted to

licensed eye care practitioners.
❖ Use of the device is restricted to operators who have undergone the necessary
training.
❖ Do not open the device in order to prevent the risk of electrocution and damage
to the device itself.
❖ Do not use the device if the covers or other parts of the device have been
removed.

❖ Only technicians authorized by CenterVue may service the drsplus. CenterVue

cannot be held responsible for the device safety should drsplus be opened,
repairs carried out, third-parties’ software be installed, or parts be replaced by
an unauthorized person.
❖ Avoid all contact with water: risk of fire or electric shock.
❖ Stand clear from moving parts during operation.
❖ The device is equipped with an earth connection by means of a protective
conductor inside the power cable. Before switching on the device, check that the
power outlet is correctly earthed to avoid the risk of electrocution.

❖ The drsplus must be used in a room with an electrical system that complies with
applicable healthcare environment safety regulations.

❖ The drsplus power supply must be connected to a socket with a circuit breaker.

❖ The drsplus must NOT be used in an oxygen-rich environment or in presence of

flammable anesthetics.

❖ External devices connected to the drsplus, into the patient environment, must
comply with IEC 60601-1. Those devices that do not comply with the IEC 60601-1
must be kept out of the patient environment, and must comply with IEC 60950.
Any operator who connects external devices to drsplus creates a new Medical
Electrical System as defined by IEC 60601-1 and is therefore responsible of the
conformity of such system with the requirements defined in clause 16 of
IEC 60601-1. Please contact the local distributor for any additional information.

❖ When in operation, drsplus contains Personal Data.

IT IS THE OPERATOR’S RESPONSIBILITY TO KEEP AND MAINTAIN AN UPDATED
COPY OF THE DATA GENERATED BY THE drsplus THROUGH REGULAR USE OF THE
BACKUP FACILITY, THUS PREVENTING THE RISK OF ACCIDENTAL LOSS OF DATA.

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 ❖ drsplus needs to be operated in the following environmental conditions:
o Temperature: +10 °C to +35 °C
o Humidity (max): 90% not condensing

❖ drsplus needs to be stored in the following environmental conditions:

o Temperature: -10 °C to +60 °C
o Humidity (max): 90% not condensing
❖ 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 met.

The following precautions are important to avoid incorrect use of the device:

❖ Provide explanations to patients before placing them in front of the device.

❖ Use the device in dim light, or at least away from direct light. This will facilitate the
natural dilation of the pupil.
❖ The minimum pupil diameter required to obtain good quality images is 2.5 mm.
❖ If the patient does not fix correctly and steadily, the images acquired may relate
to portions of retina that are not what is expected.

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6. Notes for the operator
This section provides basic information for drsplus operators. No specific skills are required to use the
drsplus. However, operators must receive the minimum training in the use of the device. The
acquisition of images using the drsplus does not involve any risks. This is because the device does not
come into contact with the patient’s eye and the only perceived effect will be a flash of light when
each shot is taken. The device is controlled entirely by touchscreen. Once the acquisition sequence
has started, the drsplus will perform the examination automatically.

IT IS THE OPERATOR’S RESPONSIBILITY TO KEEP AND MAINTAIN AN UPDATED COPY

OF THE DATA GENERATED BY THE drsplus THROUGH REGULAR USE OF THE BACKUP
FACILITY, THUS PREVENTING THE RISK OF ACCIDENTAL LOSS OF DATA.

6.1 Definitions
Exam: any image acquisition session performed using the drsplus for a certain patient on a certain
date.

External eye examination: examination mode involving the acquisition of images of the ocular surface
instead of the retina.

Field: portion of the retina visible in a specific image.

Fixation: the ability of a patient to fix his/her view on a specific point, for example the internal fixation
target of the drsplus.

Fixation target: small bright green circle visible when looking into the front lens of the drsplus, used
to move the gaze of the patient and capture different fields.

Pupil: the central circular opening on the ocular surface, through which light enters the eye. The pupil
naturally contracts when struck by light. If the pupil is too small the image quality may be impaired.

Retina: the posterior pole of the ocular bulb. It is the main area of interest in the images acquired by
drsplus.

Stereo exam: examination mode that involves the acquisition of two images of the retina taken from
different angles, providing a three-dimensional view using suitable prismatic glasses.

❖ If the patient does not fixate correctly and steadily, the images acquired may
relate to portions of retina that are not what is expected.
❖ Provide explanations to patients before placing them in front of the device.

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7. Preparation of device
This section explains how to set up the drsplus for use.

7.1 First usage

Read carefully the chapter 5 before proceeding to the device operation.

To prepare drsplus for the first usage:

❖ Take the device out of its shipping box and place it onto a suitable table;
❖ Install the headrest (included in the package) on the device (Fig. 11);
❖ Connect the power supply to the back panel, and to the wall socket;
❖ (Optional) Connect a printer to one of the USB ports located in the back panel of the device;
❖ Install the cables protection shell.

drsplus needs to be operated in a semi dark environment, to ease the natural dilation
of the pupil.

Fig. 11 – Headrest

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 Fig. 12 – Back panel with cables protection shell

7.2 Initial configuration wizard

Turn on the device by pressing the power switch button: upon the first power on of the device, the
initial Configuration Wizard will be (Fig. 13).

Use the button located near the top-right corner of the screen to temporarily skip the Configuration
Wizard and go straight to the login screen. The Configuration Wizard will be shown the next time the
device is started.

To proceed with the Configuration Wizard, press the START button. In any of the wizard steps, it is
possible to browse back to the previous interface by pressing the PREVIOUS button.

Fig. 13 – Beginning of the Configuration Wizard

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In the following step it is possible to set the current time-zone (Fig. 14).

Fig. 14 – Configuration Wizard: setting of the local time-zone

In the following step it is possible to set the current date and time and configure their format (Fig. 15).

Fig. 15 – Configuration Wizard: date and time settings

In the following screen (Fig. 16) the local “System Administrator” user can be created by selecting user
name and password. The user name must contain at least 4 characters1. The password must contain
at least 6 characters. It is possible to select for such user a different language than the one selected in
the first step.

1 Moreover, “service” and “production” cannot be used as user names.

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 Fig. 16 – Configuration Wizard: creation of the System Administrator account

In the following screen (Fig. 17) it is possible to create another account (Operator account), by
following the same rules and constraints described for the Administration account.

Fig. 17 – Configuration Wizard: creation of user accounts

7.3 Login
Turn on the device by pressing the power switch button (Fig. 7). When the boot is completed, the
Login screen will be shown (Fig. 18).

Select the desired user from the menu, input the user password and press the login button.

The drsplus can now be operated.

To modify the password, see §13.1.

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 Fig. 18 –Login screen

7.4 Patient list

Upon the login, the Patient List will be shown (Fig. 19). It includes the following data, for each patient,
from left to right:
❖ Thumbnails of the last two images acquired for that patient. The total number of images
acquired for that patient is superimposed above the thumbnail, for the left and right eye
respectively;
❖ Surname;
❖ Name;
❖ Code;
❖ Date of Birth;
❖ Gender;

❖ Date of the last examination made with drsplus.

Fig. 19 – Patient List

To browse back to the Patient List, from any other screen, press
the Patients icon locate on the top left side of the screen

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7.5 Navigation Bar
Upon the login, the Navigation Bar shown in Fig. 20 is found on many screens. At the center of the
Navigation Bar the current username, date and time are found.

Fig. 20 – Navigation Bar

The Navigation Bar functionalities follows:

Function Command

Browse to the Patient List

View the USB devices ready for images export, if any

View the current status of ethernet and wireless connections.

Open the panel including Configuration (§13) and Utilities tools

(§14)

Logout, Reboot and Shutdown menu

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8. Preparation of the patient
This paragraph is dedicated to the patient preparation before taking pictures with the drsplus.

There are no specific restrictions based on the typology of patients that can be examined with drsplus.
drsplus is a non-mydriatic medical device, therefore it is not mandatory to dilate patients before taking
pictures.

It is recommended to give the patient the following instructions:

1) The acquisition of retinal images with drsplus does not involve any risk, in particular the device
will never touch the patient’s eye and the only effect perceived by the patient is a flash light
when the device acquires a picture;
2) Please find a comfortable position, keeping the forehead well placed on the device head-rest.;
3) Once a good position is found, please do not move and do not talk;
4) Open your eyes wide;
5) At the beginning of the exam, the device will move to find your eye. Such movement is normal:
when the device moves, please keep looking forward;
6) When a small green light appears, please look at such light and avoid blinking;
7) The acquisition of every picture will last less than 20 seconds.

After having given the instructions, place the patient in front of the device. Control the height of the
medical table or the height of the chair so that the patient is comfortable to place his forehead on the
head-rest of drsplus.

❖ Give the patient detailed information about the device operation before placing
the patient on the device.
❖ The minimum pupil diameter which ensures high quality of the images is 2.5 mm.

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9. Acquisition of retinal images
This paragraph explains how to acquire high quality retinal images using drsplus.

To start the acquisition process, it is necessary to select the desired patient in the Patient List.

To do so, in the Patient List screen:

❖ If the patient is already included in the local database, enter
the initial characters of the patient’s name, surname or code
in the search box →
❖ To add to the local database a new patient, press the “New
Patient” button →
Refer to §10.1 for additional details about the “New Patient”
functionality.

Upon having (saved and) located the patient in the Patient List, click on the corresponding line the
new exam button to start a new examination after configuring acquisition parameters.

Fig. 21 – Patient Details screen

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9.1 Configuration of Exam Parameters
To configure the examination, the following parameters can be set (see Fig. 22):
❖ Eye:
o OD = right eye,
o OS = left eye,
o OU = both eyes (default option);
❖ Exam modality:
o default = acquire a retinal picture,
o EXTERNAL EYE = acquire a picture of the external eye surface (see §0),
o STEREO = acquire a couple of retinal images for stereo review (see §9.5);
❖ Retinal fields to acquire: the available options follow.

Every selected field corresponds to a specific position of the internal green fixation
target.

Fig. 22 – Exam configuration screen

The following fields can be selected:

a. CENTRAL: centered on the foveal pit;
b. NASAL: centered approx. 19° nasally to the foveal pit;
c. TEMPORAL: centered approx. 19° temporally to the foveal pit;
d. CENTRAL-NASAL: centered approx. 7° nasally to the foveal pit;
e. SUPERIOR: centered approx. 19° superiorly to the foveal pit;
f. INFERIOR: centered approx. 19° inferiorly to the foveal pit;
g. SUPERIOR-TEMPORAL: centered approx. 12° superiorly and 7° temporally to the foveal pit;

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 h. SUPERIOR-NASAL: centered approx. 12° superiorly and 7° nasally to the foveal pit;
i. INFERIOR-TEMPORAL: centered approx. 12° inferiorly and 7° temporally to the foveal pit;
j. INFERIOR-NASAL: centered approx. 12° inferiorly and 7° nasally to the foveal pit.

❖ Give the patient detailed information about the device operation before
placing the patient on the device.
❖ The configuration of many fields ends in different portions of the retina being
acquired. Such fields can be stitched together using the Mosaic feature
(available under license). See §33 11.5.
❖ The live view on the left is used to visualize the position of the patient’s pupil
from the frontal lens. To ensure the correctness and speed of image
acquisitions the pupil shall fall in the area delimited by yellow bands.

When the patient is ready and the acquisition is configured, press the START EXAM button to begin
the image acquisition procedure.

9.2 Automatic acquisition of images

drsplus automatically:
a. Aligns the frontal lens toward the patient’s pupil;
b. performs the autofocus of the retina in order to correct spherical errors;
c. flashes the patient’s retina and acquires one or more images according to the number of
selected fields;
d. saves the images in the local storage for a later review.

Information shown during the acquisition process

Information Position on the screen
Patient data Top left text
Exam phase (aligning, focusing, waiting, waiting picture) Under the patient’s data

The position of the eye, with respect to the headrest

Graphics:

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 Information Position on the screen
Estimated pupil size: when yellow, indicates that the pupil size is Under the graphics of the eye
below the minimum suggested value position
Acquisition status of every field set for the current examination Under the estimated pupil
(pending, acquiring, completed) size
Live image of the retina, acquired using infrared light At the center of the screen
Position of the internal fixation target Green dot
The retinal field under acquisition, including useful instructions for
Top right text
the patient.

Fig. 23 – Running examination screen in automatic mode

The acquisition process can be interrupted at any moment by clicking the STOP EXAM
button. Being the acquisition totally automated, this is the only available control.

9.3 “Fast” exam

This functionality (Fig. 24) permits to start an examination without the need to add a new patient first.

When a “Fast Exam” is started, a new patient will be automatically created by the drsplus.
Surname and Name of the new patient are respectively “Patient”, and the date and time of
acquisition. To start a “Fast Exam”, just press the button on the right panel →
The exam configuration screen will be shown (Fig. 24). To proceed, just configure the acquisition and
press the START EXAM button.

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 Fig. 24 – Exam configuration screen (“Fast exam” mode)

After the acquisition of the images, the Patient Detail screen will be shown, where the operator can
edit any of the patient information.

9.4 “External eye” examination

When this modality is set, the drsplus will automatically acquire an image of the external surface of
the eye (see Fig. 25).

Fig. 25 – Image of the external surface of the eye (zoom)

9.5 Stereo modality (available under license only)

When this modality is set, drsplus will automatically acquire a couple of retinal images using the nasal
fixation target. The two acquisitions differ just by a small transverse displacement acquired to add the
stereoscopic effect when reviewing the two images using the prismatic goggles, as shown in §3.

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10. Patients Database
10.1 Adding a new patient
Open the “New Patient” dialog by pressing the button in the Patient List (Fig. 26). Enter
Surname and Name (mandatory fields) for the new patient; enter additional fields if
available: ID, Birthdate, Gender and Notes. Press SAVE to save the new patient or
CANCEL to cancel the operation.

Fig. 26 – New Patient dialog

10.2 Editing an existing patient

To modify the information of an existing patient, open the Patient Details screen
(see §11.1 ) and press the Edit Patient button. →
This will open the Edit Patient dialog (Fig. 27).

Fig. 27 – Edit Patient dialog

10.3 Single and multiple selection of patients

To select one or more patient, click the “Select” button on the right panel →

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or keep pressed the patient row until the selection appears.

10.4 Deletion of patients

Select the patients to be deleted and click the “Delete” button on the right panel →

10.5 Export of all patients’ images

Select the patients whose images are to be exported and click the “Export” button
in the right panel →
Refer to §12 for additional information about this feature.

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11. Image review
11.1 Patient Details screen
Upon the acquisition of images, drsplus will show the Patient Details screen (Fig. 28), which includes
patient information and all of the images acquired.

Patient information shown:

Information Position on the screen
Patient information Top left box
List of dates when the patient was examined. Each row includes the
thumbnails of the last acquired images (both OD and OS) and the Left panel
number of images for that date (OD and OS).
Thumbnails of the images acquired in the selected date, including
additional information: (eye, retinal field, estimated pupil size, Center of the screen
acquisition date and time)

Fig. 28 – Patient Details screen

Available functionalities
Function Command
Click on the date of interest
Review of images acquired in a certain date in the list located into the left
panel

New image acquisition

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 Function Command

Creation of a new mosaic2

Flicker images2

Modify patient’s information

Delete the current patient

Export all of the images of the patient

Multiple selection of images

Side-by-side comparison of two images3

Export of all of the patient’s images3

Print images3

Delete images3, 4

Fullscreen review of a single image Click on the image thumbnail

Press the icon on the

Retake an image5
bottom right corner

2 Available under license only

3 Function is active only upon selection of two images
4It is not possible to delete an image that has been mounted in a mosaic. Operator shall delete the mosaic
before deleting its images.
5It is not possible to delete an image that has been mounted in a mosaic. Operator shall delete the mosaic
before deleting its images.
5 Only images acquired in the current date can be retaken

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11.2 Image review
The image review screen (Fig. 29) is used to review a single image at full resolution.

Fig. 29 – Single image review screen

Available functionalities
Function Command

buttons located on the

Browse to the previous / next image
left / right edge of the screen

Browse back to the patient details screen button, top right

Open the list of images for quick access (Fig. 30) button, bottom left
Open the toolbar that includes: image adjustment, export, print
and deletion. button, bottom right

Fig. 30 – Image review screen. Here the list of images for quick access is shown on the left panel, and the
toolbar is shown on the right panel.

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11.3 Side-by-side image review
The “side-by-side” screen (Fig. 31) permits the operator to quickly compare any couple of images
selected from the Patient details screen. Images are shown next to each other.

Fig. 31 – Side-by-side screen

Available functionalities
Function Command
Enable / Disable the zoom and pan synchronization (any zoom and
pan operation done on an image will immediately will replicated on
the fellow image)

Swap the images

Close the side-by-side review screen

Open the toolbar that includes: right image adjustments, export,

print and deletion. button, bottom right

Open the toolbar that includes: left image adjustments, export,

print and deletion. button, bottom left

Fig. 32 – Side-by-side image review with toolbars

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11.4 Visual flickering of images
The flickering screen (Fig. 33) gives the possibility to select any couple of images of the current patient,
and shows the fast alternation of them. Prior the visualization, the images are registered one to the
other in order to ease the clinician to review them having all of the image features accurately
overlapped. The registration of images is performed by means of a special algorithm included in the
drsplus software.

Fig. 33 – Visual flickering screen

Available functionalities
Function Command

Start or pause the image flickering

Show the other image

Change the flickering speed Cursor on the right side

Close the image flickering screen

11.5 Mosaic
The drsplus includes a special software algorithm that stitches together two or more photos of a retina
to obtain an image with wider field of view, called mosaic (Fig. 35).

The mosaic function is available only under license.

To create a mosaic, in the Patient Detail screen click the “New Mosaic” button

Then, select the fields that can be stitched together and press the “Create Mosaic”
button.

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 Fig. 34 – Selection of images for mosaic

The drsplus will generate the mosaic automatically and will save it as a new image, available in the
Patient Details screen.

Fig. 35 – A mosaic

The creation of a new mosaic is possible only under certain conditions:

a) The selected retinal fields belong to the same eye;
b) The selected retinal fields have been acquired in the same date;
c) At least one CENTRAL field has been selected.

A maximum of 9 images can be stitched together into a mosaic.

The drsplus cannot be used to acquire images, during a mosaic creation. The creation
of a mosaic with 9 images takes at maximum 40 seconds.

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 A mosaic of retinal images can show visual artifacts (e.g. duplicated retinal vessels or
non-contiguous retinal vessels) in the areas where two images are stitched together.
These artifacts can be easily recognized by looking at the original images.

11.6 Remote Viewer

All of the patient database and the images stored into the drsplus memory can be remotely reviewed
by means of any standard PC connected in the same Local Area Network the drsplus is connected to.

In particular, the Remote Viewer presents to the operator the same screens and commands available
in the local interface. There are however several differences between the local user interface and the
Remote Viewer: The configuration and execution of a new exam is not permitted.

To enable the Remote Viewer, the drsplus must be connected to the Local Area Network by means of
a Ethernet or Wireless connection (Fig. 7). After the connection of the ethernet cable to the Ethernet
port located on the back panel of the device, the network connection might require additional
configuration (§13.3). Once the connection is up and running, open a browser in the remote PC and
insert the address of the device:

http://nnnnn.domain
into the address bar. Here:

- nnnnn are the 7 characters which compose the serial number of the drsplus, as reported in
the device label;
- domain is the network domain, if present (optional).

❖ The Remote Viewer functionality is available only under license.

❖ The Remote Viewer requires a standard Web Browser and does not require
any additional third-party software to be installed in the remote computer.
❖ The Remote Viewer supports the following browsers: Microsoft Edge, Mozilla
Firefox (version 60 or higher), Apple Safari (version 6.2.8 or higher), Google
Chrome (version 70 or higher).
❖ The Remote Viewer requires the user to log in using the same user credentials
(username and password) used to log in into the local user interface.
❖ Every Remote Viewer session is automatically closed after 20 minutes of
inactivity. To continue using the Remote Viewer, a new log in is required.

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12. Exporting images
The drsplus offers extreme flexibility in exporting images. In detail, it is possible to:
❖ simultaneously export all images of one or more patients (§10.5, §11.1);
❖ export a single image (§0);
❖ configure (§13.6) one or more destinations, including USB and network drives;
❖ choose export parameters (Fig. 36):
o select one or more of the following export formats: JPEG, PDF, DICOM;
o in the case of the PDF format, various parameters can be selected, including the
orientation of the paper (vertical, horizontal), sheet size (A4, A5, Letter) and number
of images per page.
❖ Once the export parameters have been defined, click on EXPORT to proceed.

Fig. 36 – Export panel

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13. Configuring the device

To access the configuration screen, click on the icon →

in the toolbar and then Settings in the drop-down menu.

The menu on the left allows access to various configuration panels, described below. Some
configuration panels are accessible or restricted, according to the user level.

13.1 Account
The “Account” panel (Fig. 37) allows users to change their password.

Fig. 37 – “Account” panel

You must know the current password in order to be able to change it.

13.2 Users
This panel (Fig. 38) is only accessible to the Administrator and enables management (creation,
modification and deletion) of user accounts.

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 Fig. 38 - “Users” panel

❖ The user name must contain at least 4 characters

❖ The password must contain at least 6 characters

13.3 Network
This panel (Fig. 39) makes it possible to configure the parameters required for the network connection
and specify the primary network using the selector.

Fig. 39 – “Network” panel

Ethernet connection (wired)

DHCP / manual setting can be configured. In this latter case the IP address and DNS must be configured
manually.

Fig. 40 – Ethernet connection settings

Wi-Fi connection
The network parameters can be configured as per the Ethernet.
The following functionalities are also available:

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 Function Command

Enable / disable Wi-Fi interface

Disconnect the device from the current Wi-Fi network

Scan for available Wi-Fi networks

To check the network connection status, click on the icon in the top bar
(Fig. 41).

Fig. 41 – Example of wired and Wi-Fi network connection status

13.4 Date and time

This panel (Fig. 42) allows you to configure the parameters relating to the date and time formats,
offering the following functions:
❖ Automatic (requires Internet connection) or manual date and time settings;
❖ Time-zone settings;
❖ Date and time format settings.

Fig. 42 – “Date & Time” panel

13.5 Security
This panel (Fig. 43) allows you to configure the security options of the Remote Viewer, or to disable
the feature entirely.

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When enabling “HTTPS” the device will use a self-signed HTTPS certificate that must be accepted into
your browser in order to dismiss the standard warning issued by all browsers.

Fig. 43 - "Security" panel

13.6 Export
This panel (Fig. 44, Fig. 45) allows you to configure the parameters relating to the export function.

Fig. 44 - "Export" panel

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 Fig. 45 – Configuration of export destination

13.7 Printers
This panel (Fig. 46) allows you to configure the printing subsystem. Refer to the on-line documentation
for details of how to configure the CUPS printing system.

Fig. 46 - "Printers" panel

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14. Utilities

To access system utilities, click on the icon →

in the toolbar and then Utilities in the drop-down menu.

14.1 Assistance
This panel (Fig. 47) can be used to open a Remote Assistance (R.A.) session or to export diagnostic
data for technical troubleshooting purposes.

Once the R.A. session is established, the panel will show the Authorization Code that the remote
operator will need in order to connect to the device.

Function Command

Open a Remote Assistance (RA) session

Upload diagnostic data to a CenterVue server

Export diagnostic data to USB

Fig. 47 – Assistance Utilities

The current status of the Remote Assistance session is always available through
the “service” icon on the top bar.
Pressing the button will open a menu that will show the current authorization
code and a button that can be used to close the session.

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14.2 Backup
This panel (Fig. 48) provides the utility to perform the backup of the patient data stored in the on-
board disk.

Fig. 48 – “Backup” panel

Data can be backed up on an external, USB-connected memory device (flash memory or disk) or a
remote network destination.

Backup jobs can be run manually or scheduled to run automatically either once a day or once a week.

Only the Administrator user can create a backup configuration. The Operator user can only execute
an already-configured backup job.

The panel displays the date and time of the last successful backup.

❖ HARD DISK FAILURES ARE UNPREDICTABLE AND MAY CAUSE IRREVERSIBLE LOSS
OF DATA
❖ IN THE EVENT OF LOSS OF DATA, IT CAN BE EASILY RECOVERED FROM THE LAST
BACKUP PERFORMED
❖ IT IS THE OPERATOR’S RESPONSIBILITY TO KEEP AN UPDATED BACKUP OF THE
DATA GENERATED BY THE drsplus THROUGH REGULAR USE OF THE BACKUP
UTILITY
❖ THE MANUFACTURER DECLINES ALL LIABILITY FOR LOSS OF DATA DUE TO HARD
DISK FAILURES
❖ MANUAL ALTERATIONS OF THE FILES GENERATED BY THE BACKUP UTILITY MAY
AFFECT THE RECOVERY OF DATA

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 Function Command

Activation of automatic backup utility and setting of frequency, day

and time of execution

Configuration of storage units in networks on which backup is

performed automatically (= destination)

Configuration of external storage units (USB keys and discs) on

which backup is performed automatically (= destination)

14.3 Restore
This panel (Fig. 49) provides the utility to restore from a backup. The panel displays a list of available
destinations that contain a compatible backup image that can be restored. Only the Administrator
user is allowed to perform a restore operation.

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 Fig. 49 – “Restore” panel

14.4 Reset
This panel (Fig. 50) can only be accessed by an Administrator and allows to reset the device.
Function Command
Deletion of all patients and examination data

On resetting to factory settings, all data will be erased and all

settings returned to initial values.
Installed licenses are not affected.

Fig. 50 – “Reset” panel

14.5 Licenses
This panel (Fig. 51) can be used to manage optional licenses. It shows the list of licenses installed on
the device and allows to either revoke a license or to install a new one.

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 Fig. 51 - "License" panel

14.6 Update
This panel (Fig. 52) provides the utility to install software updates and upgrades. Access to this panel
is limited to the Administrator user.

The installation package should be saved on the top folder of a USB flash memory which then must be
plugged into one of the three USB ports. The device will detect the installation package and prompt
the operator for a confirmation before proceeding with the installation.

Fig. 52 - "Update" panel

14.7 More
This panel (Fig. 53) provides a few utilities that can be used to

• Enable or disable the “demo” dataset

• Move the optical head to positions that are suitable for cleaning the lens, shipping or
performing the exam.

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 Fig. 53 - "More" panel

14.8 Demo dataset

Once the demo dataset is enabled, the patient list will be populated with a small number of dummy
patient records each containing a few sample images intended to showcase the quality of the images
that can be acquired with the drsplus.
The dummy patients cannot be edited. When reviewing the images of a dummy patient the
“new exam” button is not available.
The demo dataset can be enabled and disabled with no restrictions by the Administrator.

14.9 Optical head position

Except during startup and when an exam is in progress, the optical head is always positioned in the
“lens cap position”, where the back of the headrest protects the front lens.
To clean the front lens the operator can press the “Lens cleaning position” button to move the optical
head to a position that exposes the front lens to the operator. Pressing the “Lens cap position” button
will return the optical head to the default position.
Prior to shipment, the operator should press the “Shipment position” button to completely retract the
optical head so that the device can fit the shipping container.

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15. Power-off
❖ To power off the device click on the “power” icon near the top-
right corner of the screen →

❖ A menu will open: select the “Logout” option to close the

current session →

❖ or select “Reboot” to restart the device →

❖ or select “Power off” to initiate the shutdown procedure and

power off the device →

Wait a few seconds after the on-board display goes dark before removing the power
cord of switching off the power source (for example, by turning the main switch on the
electric table).

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16. Cleaning
This paragraph explains how to clean the device. The device must be powered off, and the power cord
shall be disconnected from mains.

The front lens should be cleaned using a small hand pump air blower to blow away dust.

If the lens is very dirty, for instance due to the presence of fingerprints or other impurities, the front
lens should be cleaned using photographic cleaning paper or a very clean microfiber cloth and a
suitable lens cleaning fluid.

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.

Do not attempt to clean the front lens with a dry cloth as this may scratch the surface.

The headrest silicon cushion is the only part in direct contact with the patient: it should be sanitized
with a disinfecting wipe after each use and allowed to dry prior to reuse.

Take care not to sprinkle parts not belonging to the patient rest. The headrest silicon cushion can also
be removed and washed with lukewarm water and a mild detergent.

The touch screen panel should be cleaned using a soft, lint-free cloth dampened with a small amount
of water.

Do not use alcohol or detergents to clean the touch screen, as these may damage the
protective coating.

The plastic covers of the device can be cleaned using of a cloth dampened in a small amount of water.

Do not use alcohol or detergents to clean the plastic shells, as this could erase
labelling and other indications.

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17. Maintenance

All maintenance operations must be carried out exclusively by personnel authorized

by CenterVue.

Maintenance frequency recommended by CenterVue:

❖ Safety electric tests (according to IEC 60601-1): once a year.
❖ Comprehensive system verification: every two years.

Inquire with your local distributor or Authorized Service Center for service contracts and warranty
extensions.

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18. Electromagnetic Compatibility
This device complies with the requirements of Class A as defined by the IEC 60601-1-2 standard.

This device has been tested and found to comply with the limits for medical devices contained in
IEC60601-1-2 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;
• contact the manufacturer or field service technician for help.

This device needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided within this document. Portable and mobile RF
communications equipment can affect the readings made by this device.

18.1 Manufacturers EMC Declaration according to ISO 60601-1-2

The following tables provide specific information regarding compliance of the drsplus.

drsplus is intended for use in the electromagnetic environment specified below. The customer or the
user of the drsplus should ensure that it is used in such environment.

The device has radio disturbance characteristics that make it suitable for use in industrial and hospital
environments (CISPR 11 class A). If used in a residential environment (for which CISPR 11 class B is
normally required), this device may not offer adequate protection of radio-frequency
communications. It may therefore be necessary to take steps to mitigate the problem, such as
reorienting or moving the device.

Other cables and accessories not supplied with the drsplus could adversely affect the
electromagnetic compatibility performance.

Table 1 – Electromagnetic Emissions

Emissions test Compliance Electromagnetic environment - guidance

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 drsplus uses RF energy for its internal function.
RF emissions Therefore, its RF emissions are very low and not
Group 1
CISPR 11 likely to cause any interference in nearby electronic
equipment.

RF emissions Warning: The EMISSIONS characteristics of this

Class A
CISPR 11 equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a
Harmonic emissions IEC
Class A residential environment (for which CISPR 11 class B is
61000-3-2
normally required) this equipment might not offer
adequate protection to radio-frequency
Voltage fluctuations/ flicker communication services. The user might need to take
Complies
emissions IEC 61000-3-3 mitigation measures, such as relocating or re-
orienting the equipment.

18.2 Guidance and manufacturer declaration – electromagnetic immunity

Table 2 – Electromagnetic Immunity (ISO 60601-1-2:2007 5.2.2.1f)

Electromagnetic
Immunity Test IEC60601 test level Compliance Level
environment guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
Electro-static
±8 kV contact ±8 kV contact should be at least 30%.
discharge (ESD)
±15 kV air ±15 kV air Avoid touching the
IEC 61000-4-2
exposed conductive
parts of connectors
when handling the
device or connecting
cables.
±2 kV for power supply ±2 kV for power supply Mains power quality
Electrical fast
lines lines should be that of a
transient burst IEC
±1 kV for input/output ±1 kV for input/output typical commercial or
61000-4-4
lines lines hospital environment.
Mains power quality
Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s) should be that of a
IEC61000-4-5 ±2 kV line(s) to earth ±2 kV line(s) to earth typical commercial
hospital environment.
<5% U T (>95% dip in U T) <5% U T (>95% dip in
Voltage dips, short
for 0,5 cycle UT) for 0,5 cycle
interruptions and Mains power quality
<5% U T (>95% dip in U T) <5% U T (>95% dip in
voltage variations should be that of a
for 1 cycle UT) for 1 cycle
on power supply typical commercial or
70% UT (30% dip in UT) 70% UT (30% dip in U T)
input lines hospital environment.
for 25 cycles for 25 cycles
IEC61000-4-11
<5% U T (>95% dip in U T) <5% U T (>95% dip in

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 for 5s UT) for 5s intervals.
Power frequency
magnetic fields should
Power frequency be at levels
(50/60 Hz) magnetic 30 A/m 30 A/m characteristic of a
field IEC 61000-4-8 typical location in a
typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level

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Table 3 – Electromagnetic Immunity (ISO 60601-1-2:2007 5.2.2.2)

IEC60601 test Compliance

Immunity Test Electromagnetic environment guidance
level Level

Portable and mobile RF equipment should be used

no closer to any part of drsplus, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.17√P
d = 1.17√P 80MHz to 800MHz d = 1.17√P 800MHz to
3 Vrms
2.5GHz
Conducted RF 150KHz to
Where P is the maximum output power rating of
IEC61000-4-6 80MHz
3Vrms the transmitter in watts (W) according to the
3V/m transmitter manufacturer and d is the
Radiated RF 3V/m
recommended separation distance in meters (m).
IEC61000-4-3 80MHz to
Field strengths from fixed RF transmitters, as
2.7GHz
determined by an electromagnetic sight surveya,
should be less than the compliance level in each
frequency rangeb
Interference may occur in the vicinity of equipment
marked with the following symbol.

NOTE 1: At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflections from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which drsplus is used exceeds the applicable RF compliance level above, drsplus should
be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orientating or relocating drsplus.
b Over the frequency range 150Khz to 80MHz, field strengths should be less than 3V/m.

18.3 Immunity tests performance criteria

Function Immunity tests performance criteria

Device operation - During application of the test stimulus, any temporary cessation or
main unit interruption of the intended operation remains within acceptable limits.

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drsplus is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of drsplus can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and drsplus as recommended below, according to the maximum output power of the
communications equipment.

Do not use portable radio frequency (RF) communication devices (including peripheral devices such
as antenna cables and external antennas) at distances of less than 30 cm from any component of the
drsplus,
including manufacturer recommended cables. Failure to observe this precaution may
compromise the performance of the device

Rated maximum Separation distance according to frequency of transmitter

output power of
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800MHz to 2.5 GHz
d = 1.17√P d = 1.17√P d = 1.17√P
0,01 0.12 0.12 0.12
0,1 0.37 0.37 0.37
1 1.17 1.17 1.17
10 3.70 3.70 3.70
100 11.70 11.70 11.70
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum power rating of the transmitter in (W) according to the
transmitter manufacturer.
NOTE 1: At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflections from structures, objects and people.

18.4 Wi-Fi specifications

Model: Intel Dual Band Wireless-AC 7265 (Intel)
Main chipset: 7265D2W
Diversity Supported
Radio ON/OFF Control Supported in both hardware and software
Connector interface M.2: PCIe, USB
IEEE WLAN Standard IEEE 802.11abgn, 802.11ac, 802.11d, 802.11e, 802.11i, 802.11h,
802.11w

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 Authentication WPA and WPA2, 802.1X (EAP-TLS, TTLS, PEAP, LEAP, EAP-FAST),
EAP-SIM, EAP-AKA
Authentication Protocols PAP, CHAP, TLS, GTC, MS-CHAP*, MS-CHAPv2
Encryption 64-bit and 128-bit WEP, AES-CCMP, TKIP
Wi-Fi Direct Encryption and WPA2, AES-CCMP
Authentication
Product Safety UL, C-UL, CB (IEC 60950-1)
Management Frame 802.11w (WFA- Protected Management Frames)
Protection

18.5 FCC (USA) and IC (Canada) radio certification

drsplus contains a radio module that complies with regulations of Canada and the USA and in
particular with Part 15 of FCC regulation.

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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20. Disposal
drsplus 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.

20.1 Separate collection for electrical and electronic equipment

The European Directive 2012/19/EU establishes separate collection for Waste of Electrical and
Electronic Equipment (WEEE). Users of Electric and Electronic Equipment (EEE) must not dispose of
WEEE as unsorted municipal waste, but collect such WEEE separately. The available return and
collection system is defined by the local public administration, or alternatively an authorized company
can recycle the WEEE. Please refer to public administration about separate collection, if this
information is not available, contact the equipment manufacturer. Users play a major role in
contributing to the reuse, recycling and recovery of WEEE. The potentially dangerous substances
contained in WEEE can pollute the environment and produce harmful effects on human health. Below
is a list of specific hazards related to some substances, which may leach in the environment and in the
water system.

Lead: damages the nervous system of humans, 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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