iCare DRSplus Fundus Imaging System User Manual

DRSplus
User manual
MANUAL INFORMATION
The information in this document is subject to change without prior notice and it is correct
at revision date. 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 this User Manual is English. Should a conflict situation arise
concerning a translated document, the English language version shall prevail.
Date of release: May 24th, 2023
Revision number: 13
Software Version: 2.2
Reference device: DRSplus (REF: AXSDRME100)
Copyright © 2023 CenterVue Spa. All rights reserved.
CenterVue S.p.A.
Via San Marco 9h, 35129 Padova – ITALY
www.icare-world.com
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CONTENTS
1.
INTRODUCTION ........................................................................................................... 8
2.
LABELS, SYMBOLS AND DEFINITIONS ..................................................................... 9
2.1
LABELS................................................................................................................. 9
2.2
SYMBOLS USED ON THE DEVICE ........................................................................... 10
2.3
OTHER SYMBOLS FOUND IN THIS MANUAL.............................................................. 10
2.4
DEFINITIONS ....................................................................................................... 11
3.
DEVICE DESCRIPTION .............................................................................................. 12
4.
SAFETY INFORMATION ............................................................................................. 15
5.
FIRST USAGE ............................................................................................................. 17
6.
7.
5.1
PREPARATION OF THE DEVICE .............................................................................. 17
5.2
CONFIGURATION WIZARD ..................................................................................... 18
5.3
LOGIN SCREEN ................................................................................................... 23
5.4
PREPARATION OF THE PATIENT ............................................................................ 24
5.5
ACQUISITION OF RETINAL IMAGES ......................................................................... 25
5.6
REVIEW OF THE ACQUIRED EXAM.......................................................................... 27
PATIENT DATABASE ................................................................................................. 28
6.1
INSERT A NEW PATIENT ....................................................................................... 29
6.2
SELECT PATIENTS ............................................................................................... 31
6.3
DELETE PATIENTS ............................................................................................... 31
6.4
EXPORT PATIENTS ............................................................................................... 32
6.5
EDITING AN EXISTING PATIENT .............................................................................. 32
6.6
PATIENT MERGE ................................................................................................. 33
6.7
PRIVACY MODE ................................................................................................... 34
ACQUISITION OF RETINAL IMAGES ........................................................................ 36
7.1
7.1.1
Select an existing patient ............................................................................... 36
7.1.2
Insert a new patient........................................................................................ 37
7.1.3
Fast exam ...................................................................................................... 37
7.2
4
START OF THE ACQUISITION ................................................................................. 36
CONFIGURATION OF EXAM PARAMETERS .............................................................. 37
7.2.1
Exam mode ................................................................................................... 37
7.2.2
Eye selection ................................................................................................. 38
7.2.3
Imaging modality............................................................................................ 38
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7.2.4
Exposure ....................................................................................................... 39
7.2.5
Retinal fields .................................................................................................. 40
7.3
AUTOMATIC ACQUISITION OF IMAGES .................................................................... 42
7.4
MANUAL MODE .................................................................................................... 44
7.5
EXTERNAL EYE EXAMINATION ............................................................................... 47
7.6
STEREO MODALITY .............................................................................................. 47
8.
REVIEW THE PATIENT VISITS .................................................................................. 48
8.1
IMAGE REVIEW .................................................................................................... 49
8.2
COMPARISON OF TWO EXAMS .............................................................................. 52
8.2.1
Side-by-side Image review ............................................................................. 52
8.2.2
Visual flickering of the images ........................................................................ 53
8.3
IMAGE ADJUSTMENT ............................................................................................ 54
8.4
MOSAIC CREATION .............................................................................................. 55
8.5
STEREO REVIEW ................................................................................................. 57
9.
EXPORTING IMAGES ................................................................................................. 58
9.1
EXPORT A ZOOMED IMAGE ................................................................................... 60
9.2
REVIEW EXPORTED IMAGES ................................................................................. 61
10.
REMOTE VIEWER ................................................................................................... 64
10.1
REMOTE VIEWER ENABLING ................................................................................. 64
10.2
REMOTE EXAM .................................................................................................... 65
10.3
EXPORT AND PRINT FROM BROWSER .................................................................... 67
10.4
REMOTE IMAGE REVIEW....................................................................................... 67
10.4.1
Cup to disc..................................................................................................... 67
10.4.2
Shortcuts ....................................................................................................... 69
10.5
11.
PRIVACY MODE ................................................................................................... 69
DEVICE CONTROLS ............................................................................................... 70
11.1
NAVIGATION BAR ................................................................................................ 70
11.2
DASHBOARD ....................................................................................................... 71
11.2.1
Notifications ................................................................................................... 71
11.3
CONTROL CENTER .............................................................................................. 73
11.4
MAINTENANCE .................................................................................................... 74
11.4.1
System logs ................................................................................................... 74
11.4.2
Audit logs ....................................................................................................... 76
11.5
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ABOUT SCREEN .................................................................................................. 77
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12.
DEVICE SETTINGS ................................................................................................. 79
12.1
ACCOUNT ........................................................................................................... 79
12.2
USERS ............................................................................................................... 80
12.3
NETWORK ........................................................................................................... 83
12.4
DATE AND TIME ................................................................................................... 85
12.5
EXAM ................................................................................................................. 86
12.5.1
Fixations ........................................................................................................ 86
12.5.2
Default imaging modality ................................................................................ 87
12.5.3
Default exposure value .................................................................................. 87
12.6
PATIENT DATA ..................................................................................................... 87
12.7
DEVICE ACCESS.................................................................................................. 88
12.7.1
12.8
EXPORT.............................................................................................................. 90
12.9
PRINTERS ........................................................................................................... 94
12.9.1
Add Printer – Local Printer ............................................................................. 95
12.9.2
Add Printer – Network Printer ........................................................................ 98
12.9.3
Add Printer – Other Network Printers ............................................................. 99
12.9.4
Find New Printers ........................................................................................ 101
12.9.5
Printers panel............................................................................................... 101
12.10
DICOM FUNCTIONALITY .................................................................................... 104
12.11
ICARE CLOUD ................................................................................................... 105
12.11.1
iCare cloud Registration ........................................................................... 106
12.11.2
iCare Cloud de-registration....................................................................... 107
12.11.3
iCare cloud status icon ............................................................................. 107
13.
UTILITIES .............................................................................................................. 108
13.1
6
WebAPI ......................................................................................................... 90
ASSISTANCE ..................................................................................................... 108
13.1.1
Remote assistance ...................................................................................... 108
13.1.2
Log Export ................................................................................................... 110
13.2
BACKUP............................................................................................................ 112
13.3
RESTORE ......................................................................................................... 116
13.4
STORAGE ......................................................................................................... 118
13.5
LICENSES ......................................................................................................... 121
13.6
UPDATE ............................................................................................................ 123
13.7
ONLINE UPDATES .............................................................................................. 123
13.7.1
USB updates................................................................................................ 124
13.7.2
Installation of the updates ............................................................................ 124
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13.8
OTHER ............................................................................................................. 127
13.8.1
Demo dataset .............................................................................................. 127
13.8.2
Optical head position ................................................................................... 127
14.
POWER OFF.......................................................................................................... 128
15.
CLEANING ............................................................................................................ 129
16.
MAINTENANCE ..................................................................................................... 130
17.
ELECTROMAGNETIC COMPATIBILITY ............................................................... 131
17.1
MANUFACTURERS EMC DECLARATION ACCORDING TO IEC 60601-1-2 ................ 131
17.2
GUIDANCE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY ... 132
17.3
IMMUNITY PASS CRITERIA................................................................................... 132
17.4
WI-FI SECIFICATIONS ......................................................................................... 133
17.5
FCC (USA) AND IC (CANADA) RADIO CERTIFICATION .......................................... 134
18.
TECHNICAL SPECIFICATIONS ............................................................................ 135
19.
DISPOSAL ............................................................................................................. 136
19.1
SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT ............... 136
EXTERNAL FIXATION TARGET USAGE ............................................ 137
EXTERNAL DISPLAY SETUP ............................................................. 139
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1. Introduction
Congratulations for choosing DRSplus and its confocal retinal imaging capabilities.
DRSplus is a fundus imaging device, based on a confocal scanning imaging system, which
uses infrared and visible light to obtain confocal images of the retina.
DRSplus works with DRSplus Software, and it operates as a standalone unit.
DRSplus is intended for the acquisition of retinal images with or without1 a mydriatic agent and
their review. The intended End-users are heath care professionals with training in the
ophthalmology field (or equivalent).
The clinical interpretation of the images acquired by DRSplus is
restricted to licensed eye care practitioners. The process of making a
diagnosis using DRSplus results is the responsibility of the eye care
practitioner.
Federal law (U.S.) restricts this device to sale by or on the order of a
physician.
DRSplus works in a non-mydriatic condition for patients with minimum pupil size of 2.5 mm: the decision to use
the mydriatic agent on patient's pupil eye is under the responsibility of the eye care practitioner.
1
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2. Labels, Symbols and Definitions
2.1 Labels
Device information such as device model, serial number, manufacturing date and UDI barcode
are reported in the label located on the back side of the display, as shown in Fig. 1: please do
not remove it.
Fig. 1 – Device label2
2 Labelling might be subject to changes depending on local regulatory requirements. The label QR Code does not
contain information for the End-user and it is intended for internal use only.
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2.2 Symbols used on the device
The meaning of the symbols adopted in the device label and on the device back panel is as
follows:
Symbol
Explanation
Information about the Manufacturer.
Manufacturing date (year-month).
DRSplus identifier (catalogue number–product code).
DRSplus is a Medical Device.
DRSplus Serial number.
UDI number.
Electrical and electronic waste is destined for separate recycling.
Refer to the User 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. 8).
2.3 Other symbols found in this manual
The meaning of the additional symbols adopted in the manual is as follows:
Symbol
Explanation
Important Information.
General Warning, read carefully.
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2.4 Definitions
Word
Device
Exam
External eye
examination
Field
Fixation
Fixation target
Local interface
Picture
Pupil
Remote viewer
Retina
Stereo exam
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Explanation
The synonym of DRSplus used in this User Manual.
Any image retinal acquisition session performed using the DRSplus
for a certain patient on a certain date.
The examination mode involving the acquisition of images of the
ocular surface instead of the retina.
A portion of the retina visible in a specific image.
The ability of a patient to fix his/her view on a specific point, for
example, the internal fixation target of the DRSplus.
A 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.
The application on the DRSplus device.
The synonym of the image acquired by DRSplus.
The aperture 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.
The web application running on an external PC.
The inner layer of the eyeball. It is the main area of interest in the
images acquired by DRSplus.
The 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.
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3. Device description
DRSplus consists of:
12
•
The device (with a lens cap for shipping only) (Fig. 2);
•
Cables protection shell (Fig. 3);
•
Device stand (Fig. 4);
•
Headrest with silicone cushion (Fig. 5);
•
External power supply (Fig. 6) which includes a country-specific power cable.
Fig. 2 – DRSplus device
Fig. 3 – Cables protection shell
Fig. 5 – Headrest
Fig. 6 – External power supply
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Fig. 4 – Device stand
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Headrest
Touch
screen
Patient side
End-user side
Back panel
(with shell)
Fig. 7 – DRSplus
Power supply
connector
USB ports
Ethernet port
DisplayPort
LED
Device power
status
Power
button
Fig. 8 – Back Panel
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DRSplus can be optionally equipped3 with:
•
External fixation target (Fig. 9);
•
Prismatic goggles for stereo view (Fig. 10); see §7.6 to have more details on the stereo
view functionality.
Fig. 9 – External fixation target
Fig. 10 – Prismatic stereoscopic goggles
3 For a list of all components included with DRSplus, please see the Content List documents in the device package
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4. Safety Information
The following precautions and warnings are important to use the device in safety:
•
Do not use DRSplus if the covers or other parts of the device have been removed.
•
Avoid all contact with water: risk of fire or electric shock.
•
Stand clear from moving parts during operation
•
Do not open DRSplus: this could lead to electric shocks or damage to the device.
•
DRSplus is supplied with an earth ground using a protection conductor contained inside the
power supply cable. Before turning on the device, make sure the power supply socket is
correctly grounded to avoid the risk of electric shock
•
DRSplus power supply must be connected to a socket with a circuit breaker.
•
The use of other cables and accessories on DRSplus than ones provided by the
Manufacturer may negatively affect EMC performances.
•
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 60950-1. Any operator who connects
external devices to DRSplus creates a new Medical Electrical System as defined by IEC
60601-1 and is therefore responsible for 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.
•
DRSplus must be used in a room with an electrical system that complies with applicable
healthcare environment safety regulations.
•
DRSplus must NOT be used in an oxygen-rich environment or presence of flammable
anaesthetics.
•
DRSplus must be placed in a room that 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 device
cannot be guaranteed if these conditions are not met.
•
DRSplus needs to be operated in a semi-dark environment, to ease the natural dilation of
the patient’s pupil.
•
DRSplus needs to be operated in the following environmental conditions:
o Temperature: +10 °C to +35 °C (50 °F to 95 °F)
o Humidity (max): 90% not condensing
•
DRSplus needs to be stored in the following environmental conditions:
o Temperature: -10 °C to +55 °C (14 °F to 131 °F)
o Humidity (max): 95% not condensing
•
Only technicians authorized by the Manufacturer may service DRSplus. The Manufacturer
cannot be held responsible for the device safety should DRSplus be opened, repairs carried
out (included using of not the Manufacturer’s genuine parts), third-parties software installed,
or parts replaced by an unauthorized person.
The following precautions are important for are important to use the device correctly:
•
The clinical interpretation of the images acquired by DRSplus is restricted to licensed eye
care practitioners. The process of making a diagnosis using DRSplus results is the
responsibility of the eye care practitioner.
•
Device-specific training is required: it is recommended for the End-user (operator) to
carefully read this User Manual to be informed and trained before use.
•
Use the device in dim light, or at least away from direct light to facilitate the natural dilation
of the pupil.
•
Provide explanations to patients before placing them in front of the device (see §5.4)
•
The minimum pupil diameter required to obtain good quality images is 2.5 mm.
•
DRSplus works in a non-mydriatic condition for patients with a minimum pupil size of 2.5
mm: the decision to use the mydriatic agent on a patient's pupil eye of under the
responsibility of the eye care practitioner.
•
Report any serious incident to the Manufacturer and to the competent authority of the
Member State in which the user and/or patient is established.
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When in operation, DRSplus contains Personal Data. The following precautions for the End-users
and the Responsible Organization are important to control the risks related to network interfaces,
data protection and cybersecurity.
•
It is the end user’s responsibility to keep and maintain an updated copy of the data
generated by DRSplus through regular use of the backup facility, thus preventing the risk of
accidental loss of data.
•
DRSplus offers a Wired Network Connection (via Ethernet cable), used to connect to a
Remote Viewer (accessible with device credentials) and to store and/or backup data on a
Remote Shared Folder (accessible with infrastructure credentials). When setting your
credentials in the device, it is strongly recommended to use complex passwords; refer to
your infrastructure’s policies to create an effective password. If your infrastructure does not
enforce any password policy, we recommend the following:
o a strong password must be at least 8 characters long;
o it should not contain any of your personal information, like your real name,
username or your company name;
o it must be different from your previously used passwords;
o it should not contain any word spelt completely;
o a strong password should contain different types of characters, including
uppercase letters, lowercase letters, numbers and characters;
o don’t write down your password on notes;
o don’t share your password with other people;
o change your password from time to time.
•
The Remote Viewer browser runs on your PC/Laptop and allows you to locally download
exams reports and patient’s images; reports and images stored in the Remote Shared
Folder can be available also on your PC/Laptop. It is strongly recommended to protect your
computer by:
o applying physical security measures (locks, security alarms, monitoring, etc.) to
prevent unauthorized persons from accessing your computer that stores patients’
personal data files;
o using full disk encryption (Bitlocker) with a strong password to render data
unreadable even if an unauthorized person were to gain access to your computer;
o using firewall and antivirus software to prevent intrusion and to detect infected files
that might compromise the security of your computer, and thereby enable
unauthorized file access;
o installing security patches and updates in a timely manner;
o protect access to your Windows account with a strong password (see the indication
above);
o log off or power off when leaving your computer unattended.
•
DICOM files usually include very sensitive information about the patient (name, age, ID
number, birth date, weight, etc.) and contain the medical images, which itself is of an
extremely sensitive nature. Special care must be taken to ensure that this information stays
private and is not susceptible to unauthorized access. Before taking any further actions,
make sure that you are authorized to view and store specific DICOM files on your machine.
•
When saving, exporting, or sending DICOM files, please remember that the DICOM protocol
does not encrypt patients’ data; for this reason, it is strongly recommended to delete the
DICOM files from your computer when they are no longer necessary.
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5. First usage
This section explains how to set up DRSplus for use.
5.1 Preparation of the device
Carefully read chapter 4 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 device on the device stand and firmly secure it with the screw;
•
Install the headrest (included in the package) on the device (see Fig. 11);
•
Connect the power supply to the back panel, and the wall socket;
•
(Optional) Connect a printer to one of the USB ports located in the back panel of the
device;
•
Install the cable's protective shell.
Fig. 11 – Headrest
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Fig. 12 – Back panel with cables protection shell
5.2 Configuration wizard
Turn on the device by pressing the power switch button: upon the first power-on of the device,
the Configuration Wizard will appear (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,
1.
Press the START button. In any of the wizard steps, it is possible to browse back to
the previous step by pressing the PREVIOUS button.
Fig. 13 – Beginning of the Configuration Wizard
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2.
Select the country in which you use the device.
Fig. 14 - Country selection
3.
Read and approve the End-user License Agreement (EULA) (Fig. 15).
The EULA language changes according to the selected Country. Different types of EULA are
defined for EU and EFTA, USA or Other Countries.
You must approve the EULA to continue the configuration and use the DRSplus.
Fig. 15 End-user License Agreement
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Set the language. A language is initially suggested according to the selected country
(Fig. 16).
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Fig. 16 - Language selection
5.
Set the current time zone (Fig. 17). An initial time zone is suggested according to the
selected country.
Fig. 17 – Time zone
6.
Set the current date and time and configure their format (Fig. 18).
Fig. 18 –Date and time selection
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7.
Create the local Administrator account by selecting username and password (Fig.
19). The username must contain at least 4 characters4. The password must contain at
least 6 characters. You can select the interface Language for such a user.
Fig. 19 – Administrator account creation
8.
Optionally create an Operator account (Fig. 20) by following the same rules and
constraints described for the Administration account.
Fig. 20 – Creation of user accounts
Tick the box Use the administrator account also as the device operator to use a unique
account. To create different accounts, refer to §12.2.
9.
Select the Online services configuration (Fig. 21). Select among the options. It is
strongly recommended to enable the Periodically check for online software updates
option to receive the security updates.
4 Moreover, “service” and “production” cannot be used as usernames.
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Fig. 21 - Online services configuration
10.
Save the configuration (Fig. 22)
Fig. 22 - Save configuration
11.
Wait for the device configuration (Fig. 23).
Fig. 23 - Device configuration
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12.
Start using the device (Fig. 24)
Fig. 24 - End of the Configuration Wizard
5.3 Login Screen
Turn on the device by pressing the power switch button (Fig. 8). When the boot is completed,
the Login Screen will be shown (Fig. 25).
Fig. 25 – Login screen.
Select the desired user from the dropdown menu, input the user password and press LOGIN.
DRSplus can now be operated.
To modify the password, see §12.1.
The Service button is used for service activities only.
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5.4 Preparation of the patient
This paragraph is dedicated to patient preparation before taking retinal images with DRSplus.
There are no specific restrictions based on the type of patients that can be examined with
DRSplus. The acquisition of retinal images5 with DRSplus does not involve any risk, because
DRSplus will never touch the patient’s eye and the only effect perceived by the patient is a
flashlight when the device acquires a retinal image.
If the patient does not fixate correctly and steadily the green light during the exam, the images
acquired may relate to portions of the retina that are not what is expected.
Provide to the patient the following instructions and explanations about the
device operation before placing the patient on the device:
1.
Please find a comfortable position, keeping the forehead well placed on
the device headrest;
2.
Once you have found a good position, please do not move and do not
talk;
3.
Open your eyes wide;
4.
Please keep looking forward while the device moves. The movement is
necessary to the device to find your eye;
5.
When a small light appears, please look at such light and avoid blinking
5 DRSplus works in a non-mydriatic condition for patients with minimum pupil size of 2.5 mm: the decision to use
the mydriatic agent on patient's pupil eye of under the responsibility of the eye care practitioner.
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5.5 Acquisition of retinal images
After the login, the Patient List Screen will appear as in Fig. 26.
Fig. 26 - Patient List screen
Push the new patient button to open the New patient Screen (see Fig. 27).
Fig. 27 - New Patient screen
Fill in the mandatory and optional fields and SAVE the new patient.
Push the new exam button to access the Exam Configuration Screen (see Fig.
28).
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Fig. 28 - Exam Configuration screen
Push START EXAM to acquire the retinal images according to the default options shown on
the screen.
Alternatively, configure any of the following parameters
•
the fields you want to acquire by pushing the related locations on the reference image;
•
the exam mode (automatic, manual);
•
the eye (left, eye, both);
•
the imaging modality (TrueColor, IR, both).
Use the live view on the top-left corner to visualize the position of the
patient’s pupil. To ensure the correctness of the image acquisitions, make
sure that the pupil falls inside the two yellow lines before starting the exam.
Select automatic to make the device automatically align on the eye and perform the exam.
Select manual to manually control the alignment, the focusing and the acquisition of the
images.
Push START EXAM to conduct the examination.
The device emits a brief sequence of sounds immediately before acquiring an image, and a
confirmation sound after its successful acquisition.
During the exam acquisition, press STOP EXAM if you need to interrupt the acquisition. All
the already acquired images will be saved.
For more information about the exam configuration and execution, refer to §7.
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5.6 Review of the acquired exam
After the acquisition, the Patient details Screen appears (see Fig. 29).
Fig. 29 - Patient details screen
From this screen, you can immediately review the exam with all the acquired retinal images.
Function
Command
New exam (§8.2.2)
New mosaic (§8.4)
Export patient (§9)
Select (§6.2)
retake
Table 1 - Available functions of the Patient details
You can acquire a New exam, create a New mosaic, Export the patient or Select items.
To retake an image, click the retake button on its bottom right corner. The image will be
acquired with the same conditions as the previous one.
Press DRSplus to access the Patient List.
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6. Patient database
Upon the login, the Patient List Screen appears, as shown in (Fig. 30). You will find the patients
sorted from the last updated data. This is the entry point for each activity of the DRSplus: you
can insert, review, export, delete patients from this Screen.
Fig. 30 – Patient List Screen
On the left side of the screen, you will find the patients’ information:
•
Thumbnails of the last left and right acquired images;
•
Surname and Name;
•
Patient ID;
•
Gender and Date of Birth;
•
Notes.
On the right side, you will find the following exam information:
•
Date of the last examination made with DRSplus;
•
The number of acquired retinal images.
Use one finger to scroll the list back and forth.
Press on a patient’s box to access the Patient details Screen
and review the exams (see 6.6).
Use the search box above the patient list to retrieve a given patient or group of patients whose
data contains the text you input. (see Fig. 31). This functionality is especially useful when you
need to select and export a specific group of patients.
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Fig. 31 - Search functionality
In the settings, activate Privacy Mode (see §6.6 for details) to hide patients’
Surname and Name. They will be replaced by the first letters followed by
asterisks.
On the right side of the screen, the following buttons appear:
Function
Command
New patient (§6.1)
Fast exam (§7.1.3)
Select (§6.2)
Table 2 - Available functions of the Patient List
6.1 Insert a New Patient
Push New patient to insert data of a new patient in the New patient Screen (see Fig. 32).
Enter the Mandatory fields, that are marked by (*).6 You can either fill or leave blank the
additional fields.
6 For more information about the mandatory fields, refer to §12.6.
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Fig. 32 - New patient Screen
Type on the keyboard to fill Surname, First name, Patient ID and Notes. Use the numeric pad
or push the calendar icon to insert the Birth date. Push MALE, FEMALE, OTHER to select
the Gender. Press SAVE to save the new patient or CANCEL to cancel the operation.
To browse back to the Patient List, press the Patients icon
located on the top left side of the screen
Whenever patient data are similar to those of an existing patient, the Duplicate record pop-up
(Fig. 33) appears to warn about a possible duplication. Press OPEN THIS RECORD to use
the existing patient, SAVE ANYWAY to create a new patient or CANCEL to cancel the
operation.
Fig. 33 – Duplicate record pop-up
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6.2 Select patients
Press Select, or keep pressing the patient’s info, to activate the Select functionality.
Fig. 34 - Select functionality
A box appears at the left of each patients’ thumbnail (see Fig. 34). After ticking at least one
box, you can Export or Delete the selected patients. Click Cancel to close the selection.
Function
Command
Merge (§6.6)
Select two patients to enable the Merge button.
Export (§6.4)
Delete (§6.3)
Cancel
Table 3 - Available options of the Select screen
6.3 Delete patients
Select the patients to delete and click the Delete button on the right panel.
Fig. 35 – Deletion Confirmation Pop-up
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Alternatively, open the Patient details screen (see §8), press the ellipsis and then
the Delete button.
Press CONFIRM to delete the patient, CANCEL to return to the Patient List Screen, where
your selection remains active.
6.4 Export patients
Select the patients to export and click the Export button on the right panel.
The Export Screen will appear (see Fig. 36).
Fig. 36 - Export screen
Connect a USB drive or configure an Export destination.
Select the export destination among the possible options.
Configure the export options and click EXPORT TO USB DISK to begin the export, or
CANCEL to skip and revert to the previous screen.
Refer to §9 for more information about the export functionality.
6.5 Editing an existing patient
To modify the information of an existing patient, open the Patient details
Screen (see §88), press the ellipsis at the right of the patient’s name and
then the EDIT PATIENT button.
This will open the Edit Patient Panel (Fig. 37).
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Fig. 37 – Edit Patient Panel
If the edited patient data are similar to those of already existing patients, the Duplicate Patient
Panel will warn you about a possible duplication (see Fig. 38).
Press MERGE WITH THIS RECORD to merge the edited patient with an existing one.
Press OPEN THIS RECORD to exit the Duplicate Patient Panel box and open the related
Patient details Screen.
Press SAVE ANYWAY to create a new patient or CANCEL to cancel the operation.
Fig. 38 – Duplicate Patient Panel
6.6 Patient Merge
To merge two patients, select two patients and click the Merge button on the right
panel. The Merge patients Panel appears (Fig. 39).
Fig. 39 – Merge patients Panel
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Select which patient you want to keep by clicking the patient’s box. The highlighted patient
receives the data of the non-highlighted one (see Fig. 40).
Fig. 40 – Merge patients Panel, selected patient
Click CANCEL to abort the operation, click PROCEED to merge the patients.
To complete the merge, which is an irreversible operation, click
CONFIRM on the Merge patients pop-up.
At the end of the operation, a pop-up warns you that the operation
is completed. Click OPEN THE PATIENT’S PAGE to view the
Patient details Screen of the merged patient.
6.7 Privacy mode
Activate the Privacy Mode in the Settings|Patient data Screen (see §12.6) to hide the Surname
and Name of the patients. They will be replaced by their first letters followed by asterisks (see
Fig. 41).
Fig. 41 - Patients database in privacy mode
Press the privacy mode OFF button to unhide the patients' information.
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Press the privacy mode ON button to hide the patients' information.
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7. Acquisition of retinal images
This section explains how to acquire high-quality retinal images using DRSplus.
7.1 Start of the acquisition
To start the acquisition process, open the Patient List Screen and then you can:
•
select an existing patient;
•
create a new patient (§6.1);
•
start a Fast Exam (§7.1.3).
7.1.1 Select an existing patient
Fig. 42 – Patient List Screen
Scroll the Patient List screen, or enter the initial characters of
the patient’s name, surname or code in the search box to
retrieve an existing patient.
Press on the patient’s data to open the Patient details Screen.
Push the new exam button to access the Exam Configuration
Screen.
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7.1.2 Insert a new patient
press the New patient button to add to create a new patient (see §6.1). Fill in the
data and SAVE.
Push the new exam button to access the Exam Configuration Screen.
7.1.3 Fast exam
Push the Fast exam button in the Patient List Screen to directly start an
examination and postpone the insertion of the patient data.
The application automatically creates a patient, whose Surname temporarily is “Patient” and
First name is the visit date and time.
After the acquisition of the images, the Patient Detail Screen will be shown, where you can
edit any of the patient information and fill all the mandatory fields.
7.2 Configuration of Exam Parameters
Enter the Exam Configuration Screen (see Fig. 43)
Fig. 43 - Exam configuration screen
Push the START EXAM button to acquire the exam according to the default configuration.
Refer to §12.5.2 for more information regarding the default configuration.
You can modify the default exam parameters to change the acquisition.
7.2.1 Exam mode
Find the default Exam mode option in the Exam mode box. To
change it, push the Exam mode button.
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Fig. 44 - Exam mode selection
Select the Automatic mode to make DRSplus automatically perform the examination
according to the exam settings (§7.3).
Select the Manual mode to directly control the movement of the device in front of the eye,
adjust the focus and select the fields and the imaging modality (§7.4).
7.2.2 Eye selection
The Eye box shows the default option. To change it, press the
Eye button.
Fig. 45 - Eye selection
Select OD for the right eye, OU for both eyes or OS for the left eye.
7.2.3 Imaging modality
The Imaging modality box shows the default option. Push
imaging modality to override the default.
Fig. 46 - Imaging modality selection
Select Infrared to acquire only an Infrared retinal image, TrueColor for a color retinal image,
Infrared TrueColor for both.
In the Settings|Exam Screen (§12.5), a default imaging modality can be set and will be used
for each exam. The modality set in the Exam configuration overrides the modality defined in
the Settings|Exam Screen.
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The IR functionality is not available for devices with a serial number starting
with K.
7.2.4 Exposure
The control of the Exposure is available for the TrueColor images.
Find the default Exposure percentage value in the Exposure box. The default value is 100%.
Use the Exposure slider to decrease or increase the exposure level to get a darker or brighter
image, respectively.
Fig. 47 – Exposure slider
When you change the exposure value, the image information shows (see the red box in Fig.
48) the value of exposure you have selected in the exam.
Fig. 48 - Image information
In the Settings|Exam Screen (§12.5), a default value can be set that will be used for each
acquisition. The value set in the Exam Configuration screen overrides the value defined in the
Settings screen. This value doesn’t influence external eye acquisition.
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7.2.5 Retinal fields
Find the default acquisition fields marked by a white-filled circle in the retina map (see as an
example Fig. 49). In the example, CENTRAL and CENTRAL NASAL are selected, 3D and
INFERIOR NASAL are deselected.
Every selected field corresponds to a specific position of the internal green
fixation target.
Fig. 49 - Example of the field configuration
Select the fields you want to acquire (see Fig. 43):
•
CENTRAL: centered on the foveal pit;
•
3D = acquire a couple of retinal images for stereo review (see §7.6);
•
NASAL: centered approx. 19° nasally to the foveal pit;
•
TEMPORAL: centered approx. 19° temporally to the foveal pit;
•
CENTRAL-NASAL: centered approx. 7° nasally to the foveal pit;
•
SUPERIOR: centered approx. 19° superiorly to the foveal pit;
•
INFERIOR: centered approx. 19° inferiorly to the foveal pit;
•
SUPERIOR-TEMPORAL: centered approx. 12° superiorly and 7° temporally to the
foveal pit;
•
SUPERIOR-NASAL: centered approx. 12° superiorly and 7° nasally to the foveal pit;
•
INFERIOR-TEMPORAL: centered approx. 12° inferiorly and 7° temporally to the foveal
pit;
•
INFERIOR-NASAL: centered approx. 12° inferiorly and 7° nasally to the foveal pit;
•
EXTERNAL EYE = acquire an image of the external eye surface (see §7.5).
The device will acquire the fields in the order in which they are selected during the exam
configuration.
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•
The configuration of many fields ends in different portions of the
retina being acquired. Such fields can be stitched together using the
Mosaic feature7 (See §8.4).
•
Use the live view on the top left box to visualize the position of the
patient’s pupil. To ensure the correctness and speed of the image
acquisition, make sure that the pupil falls inside the two yellow lines
before starting the exam.
When the patient is ready and the acquisition is configured, press the START EXAM button
to begin the image acquisition procedure.
7 Mosaic feature is available under license only: please refer to your local
Authorized Distributor for detailed
information.
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7.3 Automatic acquisition of images
After you click START EXAM, DRSplus automatically:
•
Aligns the frontal lens toward the patient’s pupil;
•
Performs the autofocus of the retina to correct spherical errors;
•
Flashes the patient’s retina and acquires one or more images according to the number
of selected fields;
•
Saves the images in the local storage for a later review.
Information
Position on the screen
Top left text
Patient data
Under the patient’s data
Exam phase (aligning, focusing, waiting, waiting for picture)
Graphics:
Position of the eye on the headrest
Estimated pupil size.
The yellow box indicates that the pupil size is below the
minimum suggested value.
When the eye blinks or when the patient is away, a red box
indicates that the eye is not found.
Under the graphics of the
eye position
Under the estimated pupil
size
Acquisition status of every set field for the current examination
(in progress, processing, completed)
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Information
Position on the screen
top left corner of the
image box
Current image acquisition information (OD or OS; TrueColor
or Infrared; progressive image number for the exam)
Live image of the retina, acquired using infrared light
Position of the internal fixation target for the patient
At the center of the screen
Green dot
Top right text
The retinal field under acquisition, including useful instructions
for the patient.
Table 4 - Information shown during the acquisition process
Fig. 50 – Running examination screen in automatic mode
The acquisition process can be interrupted at any moment by clicking the STOP
EXAM button. Being the acquisition fully automated, this is the only available
control.
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7.4 Manual mode
Press the Manual Mode button to be able to manually adjust the automatic control of the
device.
Fig. 51 - Manual mode configuration Screen
The Manual mode configuration Screen will appear (see Fig. 51).
Select OD to acquire the right eye, OS for the left eye.
Push START EXAM
The Manual mode Screen appears. (see
Fig. 52 - Manual mode Screen
You can exploit the device automatism and then manually refine the position of the optical
head, the focusing condition, the exposure and the fixation position. You can then acquire as
many images as you deserve by pushing the TrueColor or the Infrared buttons.
Push STOP EXAM to save the images and revert to the Patient details Screen for reviewing
the exam.
A detailed description of the screen and the controls follows in the next table.
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Information
Position on the screen
Top left text
Patient data
Under the patient’s data
Exam phase (aligning, focusing, waiting, waiting for picture)
Graphics:
Position of the eye on the headrest
Estimated pupil size.
The yellow box indicates that the pupil size is below the
minimum suggested value.
When the eye blinks or when the patient is away, a red box
indicates that the eye is not found.
Under the graphics of the
eye position
Under the estimated pupil
size
Acquisition status of every set field for the current examination
(in progress, processing, completed)
Eye selection
The currently selected eye is marked with a brighter color.
Push OD / OS to switch eyes.
Autoexposure
Push the Autoexposure button to get darker or brighter
images, as explained in §7.3. A change of the Exposure
value affects only TrueColor images.
Activate Alignment to enable the Auto-alignment
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Information
Position on the screen
Disable Alignment to manually control the alignment.
Move the XY cursor up, down, left or right to move the optical
head consequently.
Move Z upwards or downwards to approach or recede from
the patient’s eye.
Push Autofocus to activate the autofocusing procedure.
Move the slider close to the Autofocus button to manually
change the diopter corrections.
Find the actual Diopter correction value at the right of the
Focusing slider.
Push TrueColor to acquire a color fundus image
Push Infrared to acquire an Infrared fundus image
Find the position of the internal fixation target
Green dot
Push any Circle in the retinal image to move the fixation
accordingly
Top right text
See the retinal field under acquisition, including useful
instructions for the patient.
Table 5 - Information and controls of the Manual mode Screen
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7.5 External eye examination
Set External Eye modality to automatically acquire a TrueColor image of the external surface
of the eye (see Fig. 53).
Fig. 53 – Image of the external surface of the eye
7.6 Stereo modality
Select the 3D modality to automatically acquire a couple of TrueColor retinal images using
either the nasal or central fixation target.
The two acquisitions differ just by a small transverse displacement of the fixation to create the
stereoscopic effect. See the stereo images using the prismatic stereoscopic goggles (see Fig.
10).
The stereo modality is available only for color images and under license8.
If the imaging modality is set to Infrared, the 3D option is disabled.
8 Stereo modality is available under license only: please refer to your local
Authorized Distributor for detailed
information
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8. Review the patient visits
Click on a patient’s data to enter the Patient details Screen, as in Fig. 54
Fig. 54 - Patient details screen
On the left side, you find the patients’ information and the thumbnails of each visit with the
date and the number of acquired images. Exams are grouped by visit date.
Press a visit thumbnail to bring on top of the screen the corresponding exams.
Each image preview contains:
•
Acquired eye: OS/OD for left and right eye, respectively
•
Image modality: TrueColor, Infrared, Channel (see 8.2.2)
•
Field: Field type, Mosaic, External Eye
•
Visit date
•
Image acquisition time
•
Estimated pupil size
If an image is part of a stereo modality, a 3D rounded button
appears on the top right corner of the image.
Touch the ellipsis (⁝) button on the right of the patient information
box to edit the patient data (see §6.5) or delete the patient (see
§6.3).
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Touch the ellipsis (⁝) button on the right of the visit date box to
export (see §6.4) or delete the visit.
Function
Command
New exam (§8.2.2)
New mosaic
Export patient (§9)
Select (§6.2)
3D Stereo review
retake
Table 6 - Available functions of the Patient details
The Export queue button shows the status of the Export.
This button appears only when the selected patient has
items in the network export queue or when the PACS
DICOM server is configured. Refer to §12.10 for more
information.
8.1 Image review
Click on an image to open the Image Review Screen (see Fig. 55).
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Fig. 55 - Image review
The top left corner shows the information of the acquisition conditions:
•
Eye and image modality
•
Field/Mosaic/External Eye
•
Visit date and acquisition time
•
Estimated pupil size
•
Filter settings (only in case of a filtered image)
•
Exposure value (only in case of a modified exposure)
•
Estimated diopter correction
Double-click or use two fingers to zoom the image in and out (see Fig. 56). Drag the image
with a finger to navigate around the image.
Fig. 56 - Zoomed region
Use the left and right arrows to switch to a following or previous image,
respectively. The navigation spans across all the patient visits.
Press the close button to exit the Image Review Screen and revert to the
Patient details screen.
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Function
Command
all patient items
comparison of two images (§8.2)
3D stereo review
Show the images acquired with the 3D modality for a stereo
review (see §7.6)
export
export the current view of the image. See §9 for more
information.
filters
Table 7 - Available functions of the Image Review
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8.2 Comparison of two exams
To compare the currently shown exam with another one:
•
push the all patient items button to open a panel on the Image Review screen, as in
Fig. 57.
Fig. 57 - All patient items screen
•
Select an exam and press the ellipsis
to open the menu.
8.2.1 Side-by-side Image review
Click COMPARE to review side-by-side any couple of patient’s images (see Fig. 58)
Fig. 58 - Side-by-side comparison
The box on the top left corner of each image contains the information of the image acquisition,
as in the review panel.
Double-click on a picture to zoom in, press-and-drag to pan the zoomed picture. Activate the
sync items to apply the same operations to both images, deactivate the sync items to
independently operate on the two images.
Press switch items to swap the images.
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Press sync items to synchronously zoom and pan the two images.
Press unsync items to independently zoom and pan the two images.
Press close compare to interrupt the side-by-side view and visualize a single
patient image.
Press flicker to activate the flickering review modality. (§8.2.2)
Flicker is available on images of the same eye. Flickering is not available for
Mosaics.
Press the filters button on the bottom right side of an image to independently filter
that image.
Press export to export the current view of the two images (see §9).
8.2.2 Visual flickering of the images
Click FLICKER to alternatively visualize the two images superimposed on the Flicker Screen
(see Fig. 59). They will be automatically registered to overlap the retinal features and ease
your reviewing analysis.
Fig. 59 - Flickering review of the images
The top left corner shows the information of the two images: imaging modality, fixation, exam
date. A grey line informs you what image is currently shown.
Press play to start the flickering and use the slider to slow down or increase the toggling
frequency.
At any moment, with the flickering active or in pause, you can zoom, pan and de-zoom the
images.
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Function
Command
play
Press play to start flickering
pause
Press pause to stop the flickering
next frame
Press next frame to toggle the images.
Press along the slider or drag the circle to change the toggling
frequency, that is shown in the box
close flickering
Press close flickering to revert to the Image Review.
Table 8 - Available options of the Flicker
8.3 Image adjustment
Press the filters button to adjust the image parameters.
The Filters Panel will appear (see Fig. 60).
Fig. 60 - Filters panel
You can modify the Brightness, Contrast, and Gamma of the image. See the preview in the
top-right thumbnail while you are sliding the control and view the effect on the full image when
you release it.
Select RGB to apply a filter to the TrueColor image. The image adjustment applied to the
image remains after closing the filtering option. You can RESET the image filters at any time.
Move the Channel slider to mix BLUE and GREEN or GREEN and
channels.
Select one of BLUE, GREEN or RED channels to selectively filter a
single color channel.
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Click the export button to export the currently filtered image.
Click SAVE NEW IMAGE to a filtered image to save it in the Patient
details. SAVE NEW IMAGE applies only to a TrueColor channelfiltered image.
Click RESET any time to restore the image at the original acquisition
condition.
8.4 Mosaic creation
DRSplus includes a special software algorithm that stitches together two or more photos of a
retina to obtain an image with a wider field of view, called mosaic (Fig. 63).
The mosaic function is available only under license.
To create a mosaic, in the Patient details Screen:
Click the New mosaic button to open the Mosaic Composition Screen (see Fig.
61).
Fig. 61 - Mosaic Composition Screen
If you need, filter the images by pushing TrueColor or Infrared, OD or OS on top of the
images.
Select the fields you want to stitch together. While you select the fields, the device will
automatically enable the additional stitchable fields and disable all the remaining ones.
Mark the field you want to address as a central field by pushing the mark as
central field button on the top right corner of the image.
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Press the CREATE MOSAIC button to start the stitching, press CANCEL to abort the Mosaic
and return to the Patient details Screen.
Once you have pushed CREATE MOSAIC, DRSplus will generate the mosaic automatically
and will save it as a new image, available in the Patient Details screen.
Fig. 62 – Mosaic elaboration in-progress
Fig. 63 – Final mosaic
The central field is automatically detected by the device, but you can
manually mark another field as central in case of unstable patient fixation or
external fixation.
Mark the field you want to address as a central field by
pushing the mark as central field button on the top
right corner of the image.
A maximum of 9 images can be stitched together into a mosaic.
DRSplus cannot be used to acquire images, during a mosaic creation. The
creation of a mosaic with 9 images takes about a minute.
A mosaic of retinal images can show visual artefacts (e.g. duplicated
retinal vessels or non-contiguous retinal vessels) in the areas where two
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images are stitched together. These artefacts can be easily recognized by
looking at the original images.
8.5 Stereo review
Press 3D Stereo review to open the Stereo Review Screen (see Fig. 64)
Fig. 64 - Stereo Review Screen
Two zoomed regions of the two views appear on the screen. Wear the prismatic goggles (refer
to Fig. 10) and move forward or backwards until you see a single 3D retinal image.
If you see elevations instead of cavities, press the switch items button.
Use a finger to pan the image. Use two fingers to increase or reduce the magnification. Doubleclick on the screen to zoom in or zoom out.
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9. Exporting images
DRSplus offers extreme flexibility in exporting images. From the Export Screen, in detail, you
can:
•
simultaneously export all images of one or more patients (§6.4, 8.2);
•
export or print a single image (§8.1);
•
configure (§12.8) one or more destinations, including USB and network drives;
•
Print all the images of a single patient.
❖
Fig. 65 – Export Screen
Connect one or more destinations.
Select the export destination (USB disks, Network disks,
Printers).
Printing is available for a single patient only.
Select one or more of the following Export formats: JPEG, PDF,
DICOM. Light grey buttons are enabled, dark grey buttons are
disabled.
For printing, only the PDF option is available.
Customize the PDF options:
Layout: Portrait or Landscape
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Paper Size: A4, A5, letter
Number of images per page: 1, 2, 4
Enable Anonymize patient data to export all the patients with
masked information:
Disable Anonymize patient data to export the patients with their
information.
See the PDF preview on the right side of the screen. You can
scroll through all the generated pages.
Click EXPORT to proceed, or click CANCEL to abort the Export. For printing, click SEND TO
PRINTER.
See the progress of the export activity and its completion in the pop-up. Click CANCEL to
interrupt the export or wait until the export is completed. Click CLOSE to return to the previous
Screen.
In case of completion with errors (e. g.: for lack of space), a pop-up indicates the error. Click
CANCEL to close the pop-up and interrupt the export. Select different support or empty the
currently selected one to complete the export operation.
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Fig. 66 - Error during export
9.1 Export a zoomed image
When you zoom on an image during the review (see §8.1) and you want to export the zoomed
view, click the EXPORT button and the Export Cropped View Screen appears.
Fig. 67 – Export Cropped View Export Cropped View Screen
Enable Current crop to export the magnified, cropped image, as
shown in the preview.
Disable Current crop to export the whole image, as shown in the
preview.
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9.2 Review exported images
Review the exported images on your device. See an example of an exported pdf report in Fig.
68, where two images per page have been exported. The headings contain the patient data
and notes.
Fig. 68 — Example of pdf report of an exam
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The following figure shows the Pdf report of an anonymized export of a cropped, filtered image.
Fig. 69 - PDF report of a cropped, filtered image
The width of the image corresponds to the zoomed view of the image at the moment of export.
The information on the color channel filter is indicated in the top right box of the header.
You can see in the top left corner that patient’s data are replaced as follows:
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•
Patient’s Surname -> Anonymous
•
Patient’s Name -> Universally Unique Identifier (UUID)
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•
Date of birth (DD/MM/YYYY, if present) -> 01/01/YYYY
•
Gender -> Gender
The patient ID is removed.
You can always retrieve the patient’s visits starting from an anonymized export. Input the
complete UUID in the search box of the Patient List Screen, as shown in Fig. 70.
Fig. 70 - Search via UUID
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10. Remote Viewer
Remotely review the whole patient database and all the images stored into DRSplus memory
employing any standard PC connected in the same Local Area Network of the DRSplus.
In the Remote Viewer, you retrieve all the same screens and functionalities available in the
local interface, plus some additional features.
In the Remote Viewer Navigation Bar, the MENU does not show the
Power off button.
10.1 Remote viewer enabling
To enable the Remote Viewer:
DRSplus must be connected to the Local Area Network using an Ethernet or Wireless
connection (Fig. 8). 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
(§12.3).
Remote Viewer access (HTTP or HTTPS) must be enabled in the Settings|Device access
Screen (§12.7)
By default, the remote viewer is disabled.
Once the connection is up and running, open a browser in the remote PC and insert the
address of the device:
http://DRSplus-nnnnnnn
or
http://DRSplus-nnnnnnn.local
into the address bar. Here: nnnnnnn are the 7 characters that compose the serial number of
the DRSplus, as reported in the device label.
The Remote Viewer functionality is available only under license9. The license
can be provided as a single license or a 5-licenses pack. Every single license
will give access to DRSplus from one remote station at a time, while the 5
licenses pack will give access to the device from 5 remote stations at a time.
9 Remote Viewer functionality is available under license only: please refer to your local Authorized Distributor for
detailed information.
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•
•
•
•
•
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 is tested on the latest release of the following
browsers10: Google Chrome, Mozilla Firefox, Microsoft Edge
(Chromium-based), Apple Safari
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 the period
specified in the Settings|Device access menu (§12.7). To continue using
the Remote Viewer, a new login is required.
The use of the HTTP protocol exposes to higher cybersecurity
vulnerabilities.
10.2 Remote exam
From the Remote Viewer, the configuration and execution of a new exam are permitted only
after Remote Exam activation.
DRSplus Remote Exam functionality11 through DRSplus Remote Viewer provides the
capability of executing a patient remote acquisition with DRSplus.
DRSplus Remote Exam functionality is intended for extending the distance normally present
between the patient and the medical examiner.
This feature requires the user to be in the same room as the patient, with a clear view of the
patient and of DRSplus to set up and control the exam.
If your medical office does not allow for a clear view of the patient and DRSplus, it is suggested
to set up a video conferencing call between two tablets or other capable devices (not provided
by the Manufacturer) using the integrated or third-party video conference app.
Note that some patients may have difficulty following a remote exam set-up: patients that may
have a poor fixation or a very small pupil, need a standard imaging approach. In those cases,
remember to protect yourself and the patient against the spread of pathogens.
For Remote Exam activation for a specific user, see §12.2.
From the computer, log in with the proper use of the Remote Viewer.
Select or Create a New Patient and start a New Exam.
A pop-up appears and the Remote Activation Code is requested.
10 As of February 2023.
11 The Remote Exam Feature Viewer functionality is available under license only and needs as a pre-requisite a
Remote Viewer license installed: please refer to your local Authorized Distributor for detailed information.
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The Remote Activation Code will be shown on the display of the DRSplus.
Fig. 71 – Remote Activation Code showed on DRSplus display
Insert the Remote Activation Code on the remote exam interface.
The Remote Exam activation code is requested only the first time the operator starts an exam
from a Remote Viewer station. The code will not be requested again for the same operator
account and the same review station. The code is requested once more after 4 hours of
inactivity.
Fig. 72 – Remote Activation Code fill on Remote Viewer Interface
Conduct the exam steps the same way as if you are next to the patient.
Verify the seat of the patients and instruct them to place their foreheads in the proper position.
Use the eye position view to make sure that the patient is well aligned.
Perform the acquisition sequence just as you would normally, instructing the patient remotely
when the acquisition has begun.
During the exam, it is always possible to control and stop the exam from the display of the
DRSplus. When the exam has been completed, you can review the images and download the
report directly from the remote viewer.
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10.3 Export and print from browser
Fig. 73 – Remote viewer export
From the Remote Viewer, in the Export Panel, you can download it on your PC or print through
a printer connected with your PC.
Select Download to browser and then push DOWNLOAD TO
BROWSER to export the selection on your PC.
Select Send to printer and then OPEN PRINT WINDOW to open
the printing interface of your browser.
10.4 Remote Image review
10.4.1 Cup to disc
From the Remote Viewer, you can use the cup to disc function.
Push the cup to disc button to activate the measurement function.
Fig. 74 –Image Review Screen, cup to disc
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Click on the first point of the disc or of the Click on the corresponding end-point.
cup.
Locate the starting point of the second Locate the corresponding end-point.
segment.
The Cup to disc ratio is always calculated as a value lower than 1, independently from the
order of design of the segments.
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The cup to disc ratio is reported on the top left side of the image (see Fig. 74). Note that you
can anytime edit the selected points and the CDR will correspondingly be updated.
10.4.2 Shortcuts
Fig. 75 – Shortcuts in the remote Image Review Screen
In the Image Review Screen of the Remote viewer push the question mark to discover the
Keyboard shortcuts.
10.5 Privacy mode
Fig. 76 - Patients list in privacy mode
In the Remote Viewer, hover a patient box with the cursor to make the Surname and the First
Name fully visible.
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11. Device controls
11.1 Navigation Bar
Upon the login, the Navigation Bar shown in Fig. 77 appears on all the screens. Find the date
and time at the right of the Navigation Bar.
Fig. 77 – Navigation Bar
The Navigation Bar functionalities follow:
Function
Command
Menu
Browse the main device management options: preferences,
Control center, Dashboard, Logout, Power off.
The Power off button does not appear in the Remote Viewer.
Open the Patient List
Open the Dashboard
Show the Remote assistance information
This icon appears when you request remote assistance.
View the USB disks connected for images export, if any. This
icon disappears if no USB device is plugged-in.
Connectivity
View the current status of ethernet and wireless connections.
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Function
Command
Speakers volume
Set the volume of the audio notifications.
Control center
Open the Control center Screen including Configuration
(§11.2) and Utilities tools (§12.11.2)
Table 9 - Navigation bar options
11.2 Dashboard
To access the Dashboard Screen, click the Dashboard button on the Navigation Bar.
Fig. 78 –Dashboard Screen
The Dashboard contains a comprehensive review of the Notifications (§11.2.1), the storage
on the device and the Network disks, the About (§11.5) Screen and the statistics of usage, to
show at a glance all the information regarding the device operativity.
11.2.1 Notifications
The Notifications are all the information regarding an event, a warning or an error.
Within its operation activity, the device can generate notifications that are displayed to the
operator through pop-ups and toasts. When such an event happens, the color of the
Dashboard icon changes and becomes grey for an event, orange for a warning or red for an
error. A number on the top right of the icon tells how many unseen notifications are present.
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Click the Dashboard icon in the Navigation Bar to view the last notifications
Fig. 79 – Examples of toasts for warning and error categories
Click HIDE ALL to close the toast. In this case, the notification is marked as viewed.
In case of critical errors, the notification is displayed as a blocking pop-up like the following:
Fig. 80 – Example of a critical error blocking pop-up
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Fig. 81 – Notifications list Panel
After a critical notification, the dashboard icon remains highlighted.
From this panel, all the notifications can be marked as viewed.
11.3 Control Center
To access the Control center Screen, click on the Control center icon in the
Navigation Bar.
Fig. 82 – Control Center Screen
From the Control Center you can access the following Screens:
•
Settings (§12)
•
Utilities (§12.11.2)
•
Maintenance (§11.4)
•
About (§11.5).
The first three screens will be described in dedicated paragraphs.
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11.4 Maintenance
The Maintenance Screen contains two logs viewers, the System and the Audit logs (see Fig.
83), which are useful for service purposes.
To access the Maintenance Screen, click the MAINTENANCE button on the Control
center Screen.
Fig. 83 – Maintenance Panel
11.4.1 System logs
The System Logs Screen shows the logs generated by either the operating system or the
application software. They are divided into the following categories:
Fig. 84 – System logs Screen
Notice: messages informing that a run-time event, such as startup or shutdown, has
occurred.
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Warning: message informing about situations that might have an adverse performance
implication.
Error: messages that inform about serious errors that anyway might allow the application to
continue running.
Critical: messages that inform about severe errors that can cause the application to
terminate.
By default, messages appear in chronological order (the newest at the top of the list) grouped
in pages.
Use the arrows to change the page.
Press Search on to change the grouping option.
Select among: Local time, Level, App name, Tag, Log message and Error
code.
Press SEARCH to refresh the page according to your selection.
Input a specific text in the Search field and then press SEARCH to find it.
Press RESET to restore the default view.
Click on a specific record to open a pop-up showing the related details (see Fig. 85). Push
CLOSE to revert to the System Logs Screen.
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Fig. 85 – System Logs Record Details Dialog
11.4.2 Audit logs
The Audit logs Screen shows the activities performed on the device’s interface (see Fig. 86).
Fig. 86 – Audit Logs Panel
For each activity, the Status code shows the operation result, which can be either ok or error.
By default, messages appear in chronological order (the newest at the top of the list) grouped
in pages.
Use the arrows to change the page.
Press Search on to change the grouping option.
Select among: Start time, Username, Command and Error code.
Press SEARCH to refresh the page according to your selection.
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Input a specific text in the Search field and then press SEARCH to find it.
Press RESET to restore the default view.
Click on a specific record, to open a pop-up showing the related details (see Fig. 87). Push
CLOSE to revert to the Audit logs Screen.
Fig. 87 – Audit Logs Record Details Dialog
11.5 About Screen
The About Screen contains general information regarding the device.
To access the About Screen, click the ABOUT button on the Control center Screen.
The About Screen shows:
•
The installed software version
•
The device serial number
•
The status of the End User Licence Agreement (EULA)
•
The size and amount of free space for Data and System disks
•
The Device Usage, in terms of Patients records, Item records and graphical information
of the number of exams performed in the last 180 days.
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Fig. 88 – About Screen, About and Storage
Fig. 89 - About Screen, Device usage
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12. Device Settings
To access the Settings Screen, click the Settings button in the Control center Screen.
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.
Fig. 90 – Settings Screen
12.1 Account
The Settings|Account Screen (Fig. 91) allows users to change their passwords.
Fig. 91 – Settings|Account Screen
You must know the current password to be able to change it.
You can change the interface language of the current user via a dropdown menu. Supported
languages are English, Spanish, Italian, French, German, Portuguese, Japanese, Chinese,
Korean, Russian, Czech, Swedish and Finnish.
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12.2 Users
The Settings|Users Screen (Fig. 92) manages (creation, modification and deletion) the user
accounts. It is accessible only by the Administrator.
Fig. 92 - Settings|Users Screen
•
•
The username must contain at least 4 characters
The password must contain at least 6 characters
For each user can be also generated the WebAPI token.
Push the CREATE NEW USER button to create a new user.
In the Create new user Panel (Fig. 93), define Username and Password, Roles, Language
and enable or disable the Remote Exam functionality (see §10.2). Click SAVE to maintain the
changes, click CANCEL to abort the creation of the new user.
Fig. 93 – Create New User
To modify an existing user, press the ellipsis (⁝) at the right of the
user’s box.
Click EDIT to open the Edit the user Panel (Fig. 94).
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Fig. 94 - Edit the user Panel
You can change the Username, the Roles, the Language, Enable or Disable the Remote Exam
Functionality and De-activate the user. Click SAVE to save the changes, click CANCEL to
abort the editing operation.
Click RESET PASSWORD to open the Reset user password panel (Fig. 95).
Fig. 95 - Reset user password Panel
You can modify the new password. Click CONFIRM to save the new password, click CANCEL
to abort the operation.
Push the CREATE A CUSTOM ROLE button to create a new role
with limited permissions.
Select a name to describe the custom role in the Custom role description box. Enable or
disable the permissions, according to your needs. Click SAVE to create the role, click
CANCEL to abort.
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Fig. 96 - Creation of a custom role Panel
The two preset users Administrator and Operator have the permissions indicated in the next
table.
Permission
admin
operator
Anonymized patient data view
Patient data view
Patient data edit
Exam parameters configuration
Exam execution and mosaic composition
Patient data export on a pre-configured destination
Patient data download and export to a USB drive
Patient data backup execution
Open and close of remote assistance
Networking configuration
Licence installation
Enable and disable demo images
Date and time configuration
Device logs and events registry navigation
Configure export parameters and destinations
Patient data parameters configuration
Patient data backup configuration
Patient data restore execution
Device factory reset
Software update installation
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Permission
admin
operator
Licence revocation
Security and device access configuration
Table 10 – Permissions of the admin and operator users.
12.3 Network
Open the Settings/Network Screen (Fig. 97) to configure the network connection. Specify the
primary network interface between Ethernet and Wi-Fi.
Fig. 97 – Settings/Network Screen
Press the ellipsis (⁝) at the right of the Ethernet box and then
CONFIGURE.
DHCP auto / manual settings can be configured. In this latter case, the IP address and DNS
must be configured manually.
Fig. 98 – Ethernet connection settings
Wi-Fi connection
The network parameters can be configured as per the Ethernet.
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Press the ellipsis (⁝) at the right of the Wi-Fi box. Click CONFIGURE to edit
the Wi-Fi properties, DISCONNECT to remove the device from the current
Wi-Fi network, RADIO ON/RADIO OFF to enable or disable the Wi-Fi.
Push SEARCH WI-FI NETWORKS to scan for available Wi-Fi
networks.
Select the network primary interface between Ethernet and Wi-Fi.
Push RESET NETWORK to revert to the factory defaults.
Push PING TEST to verify the connection status in the Ping panel (Fig. 99).
Fig. 99 – Ping Panel
Enter the Address and push PING TEST to verify. Click RESET to interrupt the test, click
CLOSE to revert to the Settings/Network panel.
In the Wi-Fi access point section,
Push ENABLE to allow a direct Wi-Fi connection to the device. You will receive a temporary
access point password in a pop-up, as shown in Fig. 100.
Fig. 100 – Access point Panel
Function
Command
Enable/disable the Wi-Fi interface from the Wi-Fi ellipsis.
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Function
Command
Disconnect the device from the current Wi-Fi network
Scan for available Wi-Fi networks
Table 11 - Available functionalities
To check the network connection status, click on the icon in the
top bar (Fig. 101).
Fig. 101 – Example of wired and Wi-Fi network connection status
12.4 Date and time
Access the Settings|Date and time Screen (Fig. 102) to configure the date and time formats.
Fig. 102 – Settings|Date and time panel
In the Date and time configuration section, select between Automatic (requires Internet
connection) or Manual date and time settings.
In the Time zone section, click on the currently selected one to set a time zone from the Select
a time zone panel.
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Fig. 103 - Select a time zone Panel
In the Date and time format section, set your preferred formats.
To provide the date and time to the device via an NTP server, push the CONFIGURE button
in the Local NTP server section and insert the NTP server address.
12.5 Exam
Access the Settings|Exam Screen (Fig. 104) to select the exam default configurations for the
Exam Configuration Screen.
Fig. 104 – Settings|Exam Screen fixations
You will be able to override any of the preset configurations before starting the exam, as
explained in §7.2.
12.5.1 Fixations
Select between
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•
Last used: last used fixation configuration becomes preset for the next exam;
•
Preset: in the interface, touch the fixation positions you want to preset for all the exams.
The list of the selected fixation is shown in the Preset fixations box, as well as in the
configuration’s picture.
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12.5.2 Default imaging modality
It appears only if the IR imaging modality is enabled.
DRSplus devices with a serial number starting with K don’t have the IR
functionality (see §2.1 for the label position).
Fig. 105 – Settings|Exam Screen Imaging modality and exposure
Possible options are:
•
last used modality: last used imaging modality will be preset for the next exam;
•
Infrared: the default imaging modality is Infrared only;
•
TrueColor: the default imaging modality is TrueColor only. This option is the initial
default;
•
Infrared, TrueColor: the default imaging modality is to acquire both Infrared and
TrueColor images.
12.5.3 Default exposure value
Set the value (percentage) which defines the brightness of the TrueColor acquired image.
12.6 Patient data
Access the Settings|Patient data Screen to configure the patient data management options
(Fig. 106).
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Fig. 106 – Settings|Patient data Screen Imaging modality and exposure
Set the Mandatory patient fields to fill when creating or editing a patient record. At least one
field among Surname, First name, and patient ID must be selected.
An error message appears if you attempt to disable all the possible mandatory fields.
The Privacy mode setting allows enabling the privacy mode. As explained in section 6.7, if the
Privacy Mode is activated, the Surname and Name of the patients are replaced by the initials
followed by asterisks.
The Duplication alerts setting offers two options to prevent records duplication:
•
Prevent the creation of multiple patients with the same patient ID by clicking on the
upper box.
•
Display a warning whenever a created or edited patient record is similar to an existing
one with the inferior box.
12.7 Device Access
The Settings|Device access Screen (Fig. 107) allows you to configure the security options of
the Remote Viewer, including the communication protocol and the session duration.
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Fig. 107 - Settings|Device access Screen
For the Local Interface, select the inactivity time on the dropdown menu after which the device
will log out the user. Activate or deactivate a screensaver when the inactivity time has expired.
To resume work, you have to log in again.
For the Remote Viewer, select the communication protocol.
Select Disabled to temporary disable the Remote Viewer for the device.
Select the HTTP and or the HTTPS protocol for the remote connection.
When you enable the “HTTPS” protocol, the device will use a self-signed HTTPS certificate.
On your browser, accept the certificate once to dismiss the standard warning issued by all
browsers.
Specify the inactivity time for the session running on the Remote Viewer.
Fig. 108 - Settings|Device access Screen
As an additional security option, you can disable the login from a given IP address for 10
minutes after 10 attempts with invalid credentials.
For WebAPI functionality refer to DRSplus WebAPI Manual.
The Online services customize the communication options between the device and the icare
servers. Enable or disable them according to your preferences. It is strongly recommended
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for security reasons to keep the Periodically check for online software updates always
enabled.
12.7.1 WebAPI
WebAPI are HTTP/HTTPS REST APIs that allow integration of the device with thirdparties software.
WebAPIs allow:
•
Patient data retrieve and management:
o Retrieve of a patient list (and search)
o Retrieve of visits list
o Retrieve of single patient record
o Retrieve of patient visits and images
o Patient creation
o Patient editing
o Patient deletion
o Visit deletion
•
Image data retrieve and management:
o Image filters management
o Download of images in JPG, DICOM or PDF formats
o Image deletion
For WebAPI functionality refer to DRSplus WebAPI Manual.
The webAPI functionalities are available only under license.
12.8 Export
Open the Settings|Export Screen (Fig. 109) to configure the parameters of the export function.
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Fig. 109 - Settings|Export Screen, Network Export destination section
Push ADD NETWORK DESTINATION to open the Add new network export destination Panel
and define the shared folder.
Fig. 110 - Add new network export destination panel
Insert the Server IP or hostname and the Shared folder, optionally fill the other fields. You can
enable or disable the destination and the automatic export of completed exams.
Push CHECK CONFIGURATION to verify the connection, SAVE to complete the
configuration, CANCEL to abort.
Press the ellipsis at the right of the Destination box to SHOW STATUS of
the network and PING, EDIT to modify the network parameters, REMOVE
the network and see the EXPORT QUEUE status.
In the Export path settings section, select how to group the exported data (with or without a
patient folder, with or without a visit folder).
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Fig. 111 - Settings|Export Screen, the Export path settings section
Separately customize the PATIENT FOLDER NAME, the FILE NAME and the FILE NAME
SEPARATOR.
Default Filename formats are:
Single-image file name
The default file name is composed as follows:
[Surname]_[FirstName]_[PatientID]_[Eye]_[Field]_[ImageType]_[ImageDate]_[ExportingDate
]_[ExportingDateMicroseconds].[FileExtension]
Example:
Doe_John_ABC123_OD_central_color_2020-09-23_175010_2020-1102_143741_264527.jpg
Where:
•
Surname: the patient surname, as in the surname field.
•
FirstName: the patient's first name, as in the given name field.
•
PatientID: the patient ID, as in the patient id field.
•
Eye: Side of the Eye. Possible values: OD, OS.
•
Field: Index representing the field acquired:
o
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central, nasal, temporal, superior, inferior, central_nasal, superior_nasal,
inferior_nasal, superior_temporal, inferior_temporal, external, anterior_eye,
stereo1, stereo2
•
ImageType: Type of image acquired, color or infrared
•
ImageDate: Image acquisition date and time. Formatted as per-user configuration
(i.e.: mm-dd-yyyy_hhiiss AM/PM)
•
ExportingDate: Exporting Date/Time of the image, same format as ImageDate
•
ExportingDateMicroseconds: Microseconds of the ExportingDate
•
FileExtension: File extension, according to the selected format. Possible values: .jpg
for JPEG images, .pdf for PDF files, .dcm for DICOM files.
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Multi-image default filename
When more than one image is to be included in a single file (this is the case for multi-image
PDF reports) the file name is stripped of the image parameters while all patient parameters
are preserved. The trailing elements of the file name show the number of images included in
the exported file:
[Surname]_[FirstName]_[PatientID]_[ItemsNumber]images_[ExportingDate]_[ExportingDateMicroseconds].[FileExtension]
Example:
Rossi_Mario_ABC123_4-images_11-04-2019_121315_981247.pdf
Fig. 112 - Settings|Export Screen, PDF report header section
Select the language for the PDF report from the PDF report language
dropdown menu. By default, the PDF report language is the language
selected during the initial configuration (see Fig. 16).
You can customize the PDF report by adding an image (JPEG, PNG and SVG formats are
accepted) and some text. The image size must be smaller than 2.0 MB and the text must not
exceed 5 rows.
Enable JPEG acquisition metadata to store the metadata of the exam in the JPEG comment
section. This information may be useful for troubleshooting purposes if requested by the
assistance personnel. Setting this option to "disabled" will improve JPEG export
performances.
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12.9 Printers
Access the Settings|Printers Screen (Fig. 113) to configure the printing subsystem.
Fig. 113 - Settings|Printers Screen
The Configured printers section shows the already set printers. Click on the ellipsis at the
right of this box to REMOVE or CONFIGURE the printer.
Click CONFIGURE PRINTERS to add, edit and remove printers.
You can access two main panels selectable using tabs:
•
Administration (Fig. 114)
•
Printers (Fig. 124 – “Printers” panel)
In the Administration Panel is possible to
•
Add a printer
•
Find new printers
•
Manage Printers
Fig. 114 - Administration panel
Press the Add Printer button in the Administration Panel shown in Fig. 114: after a while, the
panel Add Printer appears. In this panel there are three sections:
•
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o
•
Discovered Network Printers
o
•
In this section printers connected directly via USB will be shown, if correctly
detected. In this example, the printer Epson Stylus SX440 has been detected
automatically by the system once connected to one of the USB ports.
In this section will be shown the printers available on the network, if correctly
detected.
Other Network Printers
o
In this section network printers not automatically detected can be configured
manually
Fig. 115 – “Add Printer” panel
In the Printers panel, the printers configured for the device are listed and can be managed.
WiFi Direct connection with printers is not available.
12.9.1 Add Printer – Local Printer
Selecting the radio button related to the local printer automatically detected, in this case,
Epson Stylus SX440, and pressing Continue, the panel for printer identification is shown (Fig.
116).
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Fig. 116 – “Printer Identification” panel pre-set with automatic detection information
In this panel can be set the Name, that is used in printer selection dialogue during images
printing, a Description, the location of the printer (in this case can be Local Printer) and a check
box to set if this printer can be shared in the network with other devices.
Pressing Continue the panel with the selection of the model of the printer is shown. Scrolling
the Model section, the correct model of printer in use can be selected. In case a “.ppd” file is
available, which is a file that serves as a driver for a PostScript printer, it can be uploaded
using the Choose File button.
Fig. 117 – “Printer Model Selection” panel
In case the producer of the printer is not shown automatically, it can be selected in the Make
section, scrolling the list, as shown in the following figure.
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Once the printer model has been selected, pushing the Add Printer button the configuration is
saved and the Set Default Options for the selected printer is shown12 (Fig. 118).
Fig. 118 – “Default Options Setting” panel, Banners tab
Fig. 119 – “Default Options Setting” panel, Policies tab
12 The Set Default Options doesn’t influence the selection of the paper format set in Print Configuration pop-up
shown in §9.
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In this panel, three tabs are present: General, Banners and Policies.
With the General tab, the Paper Size, Media Type and Ink can be set.
The Default Options Setting panel depends on the printer’s characteristics. In the case of a
multifunction printer, a panel like Fig. 120 can be presented.
Fig. 120 – Set Default Options for a multifunction printer
With the Banners tab, it is possible to select starting or ending banners from a top-down list
(classified, confidential, …).
With the tab Policies, the rules for each operation can be configured, like abort the job or retry
in case of error. In this tab, the access control can be defined.
Pushing the Set Default Options the configuration procedure is completed and the printer can
be found in the printer selection list when trying to print an image.
12.9.2 Add Printer – Network Printer
In case a printer connected to the network can be detected, the system shows it in the Add
Printer panel, Discovered Network Printers section (Fig. 121).
Fig. 121 – “Network Printers Selection” panel
Selecting the desired network printer, in this case, Epson Stylus SX440, and pressing
Continue, the same printer identification panel shown in Fig. 116 appears. In this case, a name
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indicating that this is a network printer and the Location indicating the physical position of the
printer are suggested.
The following panel is the Printer model selection panel shown in Fig. 117, and it can be
configured as explained in §12.9.1. Also, in this case, press the Add Printer button to see the
Set Default Options for the selected printer (Fig. 118) as in §12.9.1.
12.9.3 Add Printer – Other Network Printers
In case the network printer has not been automatically detected, it can be configured manually.
The printer can be configured using one of three TCP/IP-based protocols:
❖ AppSocket
❖ Internet Printing Protocol
❖ Line Printer Daemon.
Printers are referred by using a Uniform Resource Identifier (URI) which is an addressing
technology for identifying resources on the Internet or a private intranet.
Selecting the protocol in the list and pressing Continue, the printer address can be set in the
following window (Fig. 122).
Fig. 122 – URI Printer Configuration
AppSocket Protocol
The AppSocket protocol is the simplest and fastest network protocol used for printers.
Device URIs for the printer have the following structures:
socket://ip-address
socket://ip-address/?contimeout=30
socket://ip-address/?waiteof=false
socket://ip-address/?contimeout=30&waiteof=false
socket://ip-address:port-number/?...
The “contimeout” option controls the number of seconds that the backend will wait to obtain a
connection to the printer. The default is 1 week or 604800 seconds.
The “waiteof” option controls whether the socket backend waits for the printer to complete the
printing of the job. The default is to wait (waiteof=true). Add waiteof=false to the URI to tell the
backend not to wait.
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Internet Printing Protocol (IPP)
For this protocol the device URIs have the following structures:
http://ip-address-or-hostname:port-number/printers/name/.printer
ipp://ip-address/ipp/print
ipp://ip-address-or-hostname/printers/name
ipps://ip-address/ipp/print
ipps://ip-address:443/ipp/print
ipps://ip-address-or-hostname/printers/name
The protocol supports many options, which are summarized in the following table.
IPP URI Options
Option
contimeout=seconds
encryption=always
encryption=ifrequested
encryption=never
encryption=required
version=1.0
version=1.1
version=2.1
waitjob=false
waitprinter=false
Description
Specifies the number of seconds to wait for the connection to
the printer to complete (default 1 week or 604800 seconds).
Specifies that the connection to the IPP printer should be
encrypted using SSL.
Specifies that the connection to the IPP printer should only be
encrypted if the printer requests it.
Specifies that the connection to the IPP printer should not be
encrypted.
Specifies that the connection to the IPP printer should be
encrypted using TLS.
Specifies that version 1.0 of the IPP protocol should be used
instead of the default version 2.0.
Specifies that version 1.1 of the IPP protocol should be used
instead of the default version 2.0.
Specifies that version 2.1 of the IPP protocol should be used
instead of the default version 2.0.
Specifies that the IPP backend should not wait for the job to
complete.
Specifies that the IPP backend should not wait for the printer to
become idle before sending the print job.
Line Printer Daemon (LPD) Protocol
LPD is the original network printing protocol.
Device URIs for the printer have the following structures:
lpd://ip-address/queue
lpd://ip-address/queue?format=l
lpd://ip-address/queue?format=l&reserve=rfc1179
The following table summarizes the options supported.
Option
banner=on
contimeout=seconds
100
Description
Specifies that a banner page should be printed by the printer.
Specifies the number of seconds to wait for the connection to
the printer to complete (default 1 week or 604800 seconds).
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Option
format=f
format=o
format=p
mode=stream
order=data,control
reserve=none
reserve=rfc1179
sanitize_title=no
sanitize_title=yes
timeout=seconds
Description
Specifies that the print data is a plain text file.
Specifies that the print data is a PostScript file.
Specifies that the print data is a plain text file that should be
“pretty” printed with a header and footer.
Specifies that the backend should stream print data to the printer
and not wait for confirmation that the job has been successfully
printed.
Specifies that the print data files should be sent before the
control file.
Specifies that the backend should not reserve a source port.
Specifies that the backend should reserve a source port from
721 to 731 as required by RFC 1179.
Specifies that the job title string should not be restricted to ASCII
alphanumeric and space characters.
Specifies that the job title string should be restricted to ASCII
alphanumeric and space characters.
Specifies the number of seconds to wait for LPD commands to
complete (default 5 minutes or 300 seconds).
12.9.4 Find New Printers
Pushing the Find Printers button in the Administration panel, the Available Printers panel is
shown (Fig. 123).
Fig. 123 – “Available Printers” panel
If the desired printer is listed, push the Add This Printer button: the Printer Identification panel,
Printer Model selection panel and Default Options Setting panel are shown in sequence as
explained in §12.9.1, to configure it.
12.9.5 Printers panel
In the Printers panel, all the configured printers are listed (Fig. 124).
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Fig. 124 – “Printers” panel
Touching the name of the printer, a panel showing two sections is shown. The first section
presents the main information of the printer, with two buttons:
•
Maintenance
•
Administration
The second section lists all the jobs for this printer, with the possibility to show all jobs or just
the completed jobs and to search in the list with the dedicated buttons (Fig. 125).
Fig. 125 – “Printer” panel
Pushing the Maintenance button, a list of activities that can be done on the printer is shown.
Fig. 126 – Maintenance Activities list
•
Print test page
o
•
102
With this command, a test page is sent to the printer to check the
communication and printing capability
Clean Print Heads
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o
•
With this command, the procedure to clean the print heads is launched in the
printer (this command can be present or not depending on the printer model)
Cancel all jobs
o
Cancel all jobs running and waiting
Fig. 127 – Administration Activities list
Pushing the Administration button, a list of activities that can be done on the printer is shown.
•
Modify printer
o
•
Delete printer
o
•
The Configuration of the printer can be modified
The printer can be deleted, after confirmation (Fig. 128)
Set default options
o
Can modify the Default Options using the panel in Fig. 118 and Fig. 120
Fig. 128 – “Delete Printer” panel
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12.10 DICOM Functionality
Access the Settings|DICOM Screen (Fig. 129) to set the DICOM configuration.
Fig. 129 - Settings|DICOM Screen
DICOM is an international standard for distributing and viewing medical images and related
information. DRSplus supports DICOM13 communication as specified in the DICOM
Conformance Statement document14. For more information, refer to DRSplus DICOM User
Manual.
13 The DICOM Feature for DRSplus is available under license only: please refer to your local Authorized Distributor
for detailed information.
14 Please refer to your local Authorized Distributor for the DRSplus DICOM conformance statement.
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12.11 iCare Cloud
Access the Settings|ICARE CLOUD Screen (Fig. 130) to set the iCare Cloud Interface.
Fig. 130 - Settings|ICARE CLOUDScreen
The iCare Cloud Interface is a service that allows a DRSplus to connect to the iCare Cloud
platform. It enables the connection to ILLUME platform15.
Verify that
1. the device is connected to the Network, via Ethernet of WiFi.
2. the device reaches the following domains and their relative sub-domains via https:
Domain
*.icare-world.cloud
*.eu-north-1.amazonaws.com
api.centervue.net
*.cloudfront.net
Protocol
Port
HTTPS
HTTPS
HTTPS
HTTPS
443
443
443
443
Please note that at this stage we do not support connecting to our services using an HTTP
Proxy.
The ILLUME functionalities are available only under license.
15
Please refer to your local Authorized Distributor for detailed information about the ILLUME product and license.
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12.11.1
iCare cloud Registration
Click the START THE ICARE CLOUD REGISTRATION button to start the registration of the
device.
Fig. 131 - Registration PIN Screen
Push the START THE REGISTRATION button to confirm, push CANCEL to abort.
Register the device on the ILLUME platform using the Registration PIN showed on the device
(Fig. 131).
Fig. 132 Registration panel on the ILLUME platform
Push CLOSE on the Registration PIN screen to go back to the ICARE CLOUD screen.
Fig. 133 Registered
Push VIEW THE UPLOAD QUEUE to open the iCare cloud upload queue window.
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Fig. 134 Export queue
When the iCare cloud service is registered, a new icon appears on the Topbar of the
screen.
12.11.2
iCare Cloud de-registration
The device can be associated to a unique account. Before connecting the device to another
iCare Cloud account, you shall de-register the device.
Push CANCEL THE ICARE CLOUD REGISTRATION to de-register the device from the
ILLUME account. Push CONFIRM to deactivate the connection, push CANCEL to abort the
operation.
12.11.3
iCare cloud status icon
If the iCare Cloud Service is enabled on the device, the iCare Cloud icon on the top bar of the
screen shows the status of the service.
The device is registered to a cloud account, and all the items in the cloud queue
have been synced.
The device is processing the upload queue and sending the pending items to the
cloud.
The device is unable to contact the cloud server. No item is pending upload.
The device is unable to contact the cloud server. At least one item is pending
upload.
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13. Utilities
The Utilities Screen contains a set of functionalities to keep the device updated, manage the
data backup and ask for assistance (see Fig. 135).
Fig. 135 - Utilities Screen
To access the system Utilities Screen, click the UTILITIES button on the Control
center Screen.
13.1 Assistance
Access the Utilities|Assistance Screen (Fig. 136) to open a Remote Assistance (R.A.) session
or to export diagnostic data for technical troubleshooting purposes.
13.1.1 Remote assistance
The Remote Assistance allows an iCare/CenterVue operator to connect to the device.
Remote Assistance always requires an internet connection.
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Fig. 136 – Utilities|Assistance Screen
Push OPEN REMOTE ASSISTANCE to open the Authorize remote
assistance by your own action pop-up (see Fig. 137).
Fig. 137 –Authorize remote assistance by your own action pop-up
Push OPEN REMOTE ASSISTANCE to open the Authorize remote
assistance by your own action pop-up.
A pop-up warns you that Remote assistance is available and shows
the Authorization code. Click OK to close the pop-up.
Communicate the Authorization Code to the remote operator for allowing him to connect to
the device.
Only after the remote operator has confirmed that the assistance activity is completed, you
can close the R.A.
Push CLOSE REMOTE ASSISTANCE to open the Close remote
assistance pop-up (see Fig. 138).
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Fig. 138 - Close remote assistance pop-up
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.
13.1.2 Log Export
In the Log Export section, you can extract diagnostic data of the device for service purposes.
UPLOAD DEVICE LOGS exports diagnostic data to an iCare/CenterVue server. It requires
an internet connection.
Push UPLOAD DEVICE LOGS to open the Upload diagnostic or
statistic data pop-up (see Fig. 139).
Fig. 139 – Upload Device Logs pop-up
Push UPLOAD DEVICE LOGS to start the
EXPORT DEVICE LOGS saves the diagnostic data of the device into a connected USB
storage device. Connect a USB storage device in the rear of DRSplus (see Fig. 12).
Push EXPORT DEVICE LOGS to select the USB disks (see Fig.
139).
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Fig. 140 – Upload Device Logs pop-up
Touch the box of the USB DISK you want to use to highlight it (see Fig. 141) and then push
SELECT THIS DRIVE to start the logs export.
Fig. 141 – Upload Device Logs pop-up, USB DISK selected
A pop-up informs you that the export is in progress. Wait until it is
completed, or push CLOSE to abort the operation.
When the export is completed, the pop-up informs you about the
name of the export file DRSplus-<SerialNumber>_<Date and time>.tar.gz.
Push CLOSE to return to the Utilities|Assistance Screen.
Extract the USB storage data, plug it into a PC. Open the https://service.icareworld.com/upload/ link in a browser and upload the file through the form you will find.
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13.2 Backup
Access the Utilities|Backup Screen (Fig. 142) to backup the patient data stored in the onboard
disk. Data can be backed up on a remote Network backup through an IP connection or into
an external, USB backup through a connected memory device (flash memory or disk).
Fig. 142 – Utilities|Backup Screen
Only the Administrator user can create a backup configuration. The Operator user can only
execute an already-configured backup job.
From the Backup Schedule dropdown menu, you can configure the automatic backup.
Select Never to perform the backup manually.
Select Daily to enable the automatic backup once a day. Configure
the time from the hours and minutes dropdown menus.
Select Weekly to enable the backup once a week. Configure the
backup Day from the dropdown menu. Configure the time from the
hours and minutes dropdown menus.
To set up a network backup, push the ADD A NETWORK
DESTINATION button. The Add new network backup destination
panel appears.
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Fig. 143 – Add new network backup destination panel
Configure the mandatory parameters.
To encrypt the backup data, enable Backup password protection. Be careful to avoid losing
the backup password.
Once the password is set, the backup can be performed by any user without knowing the
password, but the backup can be restored only with the backup password. Without the
password, the data cannot be restored, not even by iCare/CenterVue service personnel.
PASSWORD-PROTECTED BACKUPS CAN NOT BE RESTORED OR
RECOVERED IF THE PASSWORD IS LOST.
Click CANCEL to abort the operation, CHECK CONFIGURATION to test the added backup
network destination, SAVE to complete the configuration and revert to the Utilities|Backup
Screen.
To set up backup on a USB storage device, push the ADD A USB
DESTINATION button. The USB disks pop-up appears.
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Fig. 144 - USB disks pop-up
Select the USB DISK to use for the backup. Push CANCEL to abort the operation, push
SELECT THIS DRIVE to complete the set-up.
The first time you configure an automatic Backup on a valid location (Network of USB), a
backup automatically starts, as you can see in the Backup progress pop-up (Fig. 145).
Fig. 145 - Backup progress pop-up
Click STOP THE BACKUP to abort the operation. To complete the backup, you can either
wait until the end of the process or click CLOSE. When you click CLOSE, you will revert to
the Utilities|Backup Screen while the backup operation will continue (see Fig. 146).
Fig. 146 – Utilities|Backup Screen, Backup progress
When the backup is completed, the
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When the backup is completed, a pop-up appears. Click CLOSE to
revert to the Utilities|Backup Screen, in which you will find the
information about the date and time of the Last performed backup
(see Fig. 147).
Fig. 147 – Utilities|Backup Screen, Last performed backup
You can find here the Network path, the Disk status, the date and time of the last performed
backup, the backup size and the Password protected option.
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 end user’s responsibility to keep an updated backup of the data
generated by 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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Click on the ellipsis at the right of the Network destination. In the
menu, click SHOW STATUS to check the Network disk status, EDIT
to Edit the network backup destination, REMOVE to Remove the
backup destination or START to manually start a backup operation.
Click on the ellipsis at the right of the USB destination. In the menu,
click EDIT to Edit the USB backup destination and add a backup
password, or click START to manually start a backup operation.
13.3 Restore
The Utilities|Restore Screen (Fig. 148) provides the utility to restore from a backup. The
Screen 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.
DRSplus can restore backup images made with the DRS. Only backup images created by
DRS devices running software 2.5.0 or greater can be imported into DRSplus.
Fig. 148 – Utilities|Restore Screen
Click SEARCH AGAIN to scan the available restore sources.
Click SEARCH ON A NETWORK DISK to open the Search on a
network disk panel (Fig. 149).
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Fig. 149 - Search on a network disk panel
Manually insert the address of the restore position. Click CANCEL to abort the operation, click
SCAN THIS DISK to proceed
Click RESTORE THIS BACKUP to start the restore process. The
Confirm the restore pop-up appears (Fig. 150).
Fig. 150 - Confirm the restore pop-up
Alternatively, select to Import only the patients list or Import the patients list and all exams.
Click CANCEL to abort the operation, click START THE RESTORE to complete it. The box of
the encryption password appears when a password has been previously set for the backup
(see §13.2). Input the backup password to proceed.
When the restore starts, a pop-up appears. You can CLOSE the
pop-up to revert to the Utilities|Restore Screen while the restore is
in progress. Click STOP THE RESTORE to interrupt the process.
A pop-up appears at the end of the restore process. Click CLOSE
to revert to the Utilities|Restore Screen.
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13.4 Storage
The Utilities|Storage Screen (Fig. 151) allows resetting the device and configuring a threshold
for the data storage memory. Only an Administrator account has the permission to modify
the configurations.
Fig. 151 – Utilities|Storage Screen
Click RESET PATIENT DATA to delete all the patients and exams
data from the device. The Reset patient data pop-up appears (Fig.
152).
Fig. 152 - Reset patient data pop-up
Enter the Administrator password. Click DELETE PATIENT DATA to proceed with the reset,
click CANCEL to abort. The reset is an irreversible process.
A pop-up warns you that the reset is in progress. At the completion,
the pop-up is automatically closed and you will return to the
Utilities|Storage Screen.
Click FACTORY RESET to bring back the device to the factory
configuration. The Factory reset pop-up appears (Fig. 153).
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Fig. 153 – Factory reset pop-up
To enable the Factory reset, insert the Administrator password. Alternatively, select to put the
device in the Shipment position, or to Reboot the device after the reset. Click CANCEL to
abort the operation, click FACTORY RESET to proceed. The factory reset does not alter or
erase the installed licences.
Click ENABLE WELCOME PAGE to bring back the device to the
factory configuration. The Enable welcome page pop-up appears
(Fig. 154).
Fig. 154 – Enable welcome page pop-up
At the reboot, the acceptance of the End-user Licence Agreement and the online services will
be again requested. Alternatively, select to bring the device in the shipment position or simply
reboot the device.
The Data storage disk section provides information about the Data disk usage inside the
device (see Fig. 155).
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Fig. 155 - Data storage disk
In the Low space threshold, select with the slider the threshold of free space under which a
warning pop-up appears (Fig. 156).
Fig. 156 - Disk space running low pop-up
The warning remains at the bottom of the Utilities|Storage Screen.
When the remaining memory does not allow acquiring additional exams, a Disk full pop-up
appears (Fig. 157) and the image acquisition is disabled.
Fig. 157 - Disk full pop-up
Push CLOSE to close the pop-up. After closing the pop-up, the error message remains at the
bottom of the Utilities|Storage Screen. Contact the iCare/CenterVue service for
troubleshooting.
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13.5 Licenses
Access the Utilities|Licenses Screen (Fig. 158) 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
one16.
Fig. 158 - Utilities|Licenses Screen
DRSplus will automatically download any assigned license when connected to the
iCare/CenterVue License Server. A suitable network configuration and internet connection are
required.
Push SYNC LICENSE STATUS to immediately synchronize the
status of the device licences from the iCare/CenterVue server. At
the right of the button, the information about the last synchronization
appears (see Fig. 158).
Click ACTIVATE LICENSE to manually activate a license. In the
Activate licence pop-up (Fig. 159). Insert the license code and push
ACTIVATE, or click CANCEL to abort the operation.
Fig. 159 – Activate License pop-up
Possible licenses are:
16 Please refer to your local Authorized Distributor for requiring licenses
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•
Remote viewer 1 client;
•
Remote viewer 5 clients;
•
Remote exam;
•
Mosaic;
•
Stereo acquisition;
•
DICOM workflow;
•
WebAPI.
To remove a license, click on the ellipsis at the right of the licence
box, and then push REVOKE. The Revoke the license pop-up
appears.
Insert the administrator password and push CONFIRM to remove
the license, or click CANCEL to abort the operation. When you
proceed with the revocation, the License revoked pop-up appears
(Fig. 160).
Fig. 160 – License revoked pop-up
The revoke of a license is an irreversible operation. To activate a revoked functionality, ask
the iCare/CenterVue service for a new valid license.
To retrieve the list of the revoked licenses of the device, toggle the
HIDE/SHOW REVOKED LICENSES at the bottom of the
Utilities|Licenses Screen.
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Fig. 161 - Utilities|Licenses Screen, license revoked
13.6 Update
Access the Utilities|Update Screen (Fig. 162) to install software updates and upgrades.
Access to this panel is limited to the Administrator user.
Software updates can be obtained either online or through a USB flash drive All your
configurations will be maintained during a software update.
Fig. 162 - Utilities|Update Screen
13.7 Online updates
Push CHECK ONLINE FOR UPDATES. The Search for online
software updates pop-up appears (see Fig. 163).
Push CHECK ONLINE FOR UPDATES to allow the connection to the iCare/CenterVue
servers or click CANCEL to abort the operation.
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Fig. 163 - Search for online software updates pop-up
When an update is found, in the Online Software Updates panel push DOWNLOAD THE
SOFTWARE UPDATE to receive the update or click CLOSE to abort the operation (see Fig.
164).
Fig. 164 - Online software updates panel
Wait for the download, then push VIEW AND INSTALL THE
DOWNLOADED UPDATE to proceed, or push CLOSE to abort the
operation.
In the Utilities|Update Screen, push INSTALL THIS UPDATE.
The Screen will now show the update file in the 1 update found box, as shown in Fig. 165.
13.7.1 USB updates
Save the installation package on the top folder of a USB flash memory. Plug the USB drive
into one of the three USB ports. The device will detect the installation package automatically,
and the 1 update found box will appear, as in Fig. 165.
13.7.2 Installation of the updates
The procedure is the same for the online and the USB updates.
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Fig. 165 - Utilities|Update Screen, 1 update found
In the Utilities|Update Screen, push INSTALL THIS UPDATE.
Fig. 166 - Installation confirmation pop-up
In the Confirm the software update installation pop-up (see Fig. 166), click CONFIRM to
proceed with the installation or click CANCEL to abort the operation.
The Software update appears (Fig. 167). Wait until the end of the update or click CANCEL
INSTALLATION to abort the operation.
Fig. 167 - Software update Screen
At the end of the update, the Device Updated Screen appears (Fig. 168). Push START to
verify the setup configuration described in §5.2 and start using the device.
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Fig. 168 – Device Updated screen
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13.8 Other
The Utilities|Other Screen (Fig. 169) 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
waiting for performing the exam.
Fig. 169 - Utilities|Other Screen
13.8.1 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.
13.8.2 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.
Before 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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14. Power off
You can turn off the device only via software in the local interface. The remote connection
does not show the POWER OFF button.
Push the Menu button in the Navigation Bar.
Push Power off
The Power off pop-up appears.
Fig. 170 - Power off pop-up
Click SCREENSAVER to close the current session and pause the device. The Screensaver
Screen appears (Fig. 171). Push anywhere on the Screen to open the Login Screen (§5.3).
Fig. 171 - Screensaver Screen
Click POWER OFF to turn off the device.
Click RESTART to restart the device.
Click CANCEL to close the Power off pop-up.
Wait a few seconds after the onboard display goes dark before removing the
power cord or switching off the power source (for example, by turning the main
switch on the electric table).
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15. Cleaning
This paragraph explains how to clean the device. The device must be powered off, and the
power cord shall be disconnected.
The front lens should be cleaned using a small hand pump air blower to blow away dust.
If the lens is very dirty, due to the presence of fingerprints or other impurities, the front lens
should be cleaned using photographic cleaning paper or 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 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 silicone cushion is the only part in direct contact with the patient: it is
recommended to sanitize it with a disinfecting wipe after each use and dry it before reuse.
Take care not to sprinkle parts not belonging to the patient rest. The headrest silicone 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 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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16. Maintenance
All maintenance operations must be carried out exclusively by personnel
authorized by the Manufacturer.
Maintenance17 frequency recommended by the Manufacturer:
17
•
Safety electric tests (according to IEC 60601-1): once a year.
•
Comprehensive system verification: every two years.
Please refers to your local Authorized Distributor or Authorized Service Center for service contracts and warranty extensions.
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17. Electromagnetic Compatibility
DRSplus complies with the requirements of Class A as defined by the IEC 60601-1-2
standards.
DRSplus has been tested and found to comply with the limits for medical devices contained
in IEC60601-1-2. These limits are intended to provide reasonable protection against harmful
interference in a typical medical installation. DRSplus 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 device 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.
DRSplus 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.
17.1 Manufacturers EMC Declaration according to IEC 60601-1-2
The following tables provide specific information regarding the compliance of the DRSplus.
DRSplus is intended for use in the electromagnetic environment specified in the below tables.
The customer or the End-user of DRSplus should ensure that it is used in such an environment.
Other cables and accessories not provided with the devices may negatively affect EMC
performance.
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IEC 60601-1-2 EMISSION TEST
Test
Test Requirements
Compliance
Electromagnetic environment - Guidance
B
Yes
DRSplus uses RF energy for its internal
1
Yes
function. Therefore, its RF emissions are very
Result
Class A or B
Group
CISPR 11, 14-1, 32 or ISO 7137
CISPR
low and not likely to cause any interference in
Yes
11
nearby electronic equipment.
DRSplus
Conducted RF emissions
CISPR
11
Class B
Yes
Radiated RF emissions
CISPR
11
Class B
Yes
Disturbance Power (if applicable)
N/A
N/A
Harmonic Distortion IEC 61000-3-2
(Class A, B, C, D)
Class A
Yes
is
suitable
for
use
in
all
establishments, including domestic and those
directly connected to the public low-voltage
supply network that supplies buildings used for
domestic purposes, providing the following
warning is heeded:
DRSplus is intended for use by healthcare
professionals only. DRSplus may cause radio
Voltage Fluctuations and Flicker IEC
61000-3-3
interference or may disrupt the operation of
Passed
nearby equipment. It may be necessary to take
Yes
mitigation measures, such as re-orientating or
re-locating DRSplus or shielding the location.
Table 12 – Electromagnetic Emissions
17.2 Guidance and manufacturer declaration – electromagnetic immunity
IEC 60601-1-2 ELECTROMAGNETIC IMMUNITY
Test Requirements
Test Result
Compliance
Electrostatic Discharges
Passed
Yes
Radiated RF EM Fields
and Proximity Wireless field
Professional Healthcare
Facility Environment
Yes
(IEC 60601-1-2)
Electrical Fast Transients and bursts
Passed
Yes
Surges Conducted Disturbances,
induced by RF fields
Passed
Yes
Voltage Dips and Interruptions
Passed
Yes
Passed
Yes
Rated Power-frequency Magnetic
Field
Table 13 – Electromagnetic Immunity (IEC 60601-1-2:2014) of the DRSplus
17.3 Immunity pass criteria
IMMUNITY
Function
IMMUNITY pass criteria
System functioning – main unit
During the applied testing stimulus, temporary cessation
or interruption of any intended operation is acceptable
Table 14 – Electromagnetic Immunity (IEC 60601-1-2) criteria
DRSplus is indicated for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the end-user of DRSplus can help prevent
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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.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of DRSplus,
including cables specified by the manufacturer (CenterVue). Otherwise, degradation of the
performance of this equipment could result.
Separation distance according to frequency of transmitter
Rated maximum output power
150 kHz to 80 MHz
d = 1.17√P
of transmitter
80 MHz to 800 MHz
d = 1.17√P
800MHz to 2.5 GHz
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.
Table 15 – Recommended Separation Distances
17.4 Wi-Fi secifications
Wi-Fi specifications
Model Name
AW-CB161H
Main Chipset
RTL8821AE
Product Description
IEEE 802.11 a/b/g/n/ac Wi-Fi with Bluetooth 4.0 class I Combo
Radio ON/OFF Control
Supported in both hardware and software
IEEE WLAN Standard
IEEE 802.11abgn, 802.11ac, 802.11d, 802.11e, 802.11i, 802.11h,
802.11w
Frequency Range
Wi-Fi: 2.4 GHz ISM Bands 2.412-2.472 GHz, 2.484 GHz /
•
5.15-5.25 GHz (FCC UNII-low band) for US/Canada, Japan and
Europe
•
5.25-5.35 GHz (FCC UNII-middle band) for US/Canada and
Europe
•
5.47-5.725 GHz for Europe
•
5.725-5.825 GHz (FCC UNII-high band) for US/Canada
BT: 2402MHz~2483MHz
Host Interface
Operation Voltage
iCare
Wi-Fi PCI-E , BT : USB
3.3V +/-9%
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Operating Range
Wi-Fi Open Space (300 m) / Indoor (100 m)
(The transmission speed may vary according to the environment)
BT: 10m~20m (depending on environment and NB model)
Authentication
Encryption
WPA and WPA2
64-bit and 128-bit WEP, AES-CCMP, TKIP
17.5 FCC (USA) and IC (Canada) radio certification
DRSplus contains a radio module that complies with the regulations of Canada and the USA
and in particular with Part 15 of FCC regulation.
•
FCC ID: TX2-RTL8821AE
•
IC ID: 6317A- RTL8821AE
•
CMIIT ID: 2013AJ7899
Changes or modifications not expressly approved by the party responsible for compliance
could void the 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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18. Technical Specifications
Technical specifications are reported in the next table18.
Fundus Imaging Features
Field of view:
Mosaic (up to 9 fields):
Light sources:
Imaging modalities:
45° (H) x 40° (V) as captured with a single exposure
83°
White LED (420-675 nm)
Infrared LED (825‐870 nm)
TrueColor, Infrared, Red-Free*, Blue*, Red*, Stereo**, Mosaic**
Autofocus adjustment
range:
-15 D to +15 D
Automatic operation:
Auto-alignment, Auto-focus, Auto-exposure, Auto-capture
Minimum pupil size:
Non-mydriatic 2.5 mm
Minimum Working
distance:
Pixel pitch on the retina:
25 mm
4.3 micron
Image size:
10 Megapixels
Resolution:
77 pixel/degree
Fixation target:
Dynamic Programmable
Internal Target:
External Eye:
Internal / External**
Central, Nasal, Temporal, Central-Nasal, Superior, Inferior, Superior-Temporal,
Superior-Nasal, Inferior-Temporal, Inferior-Nasal
Yes
Other features and characteristics
Display:
Integrated 10.1” (1280 x 800) Color, Capacitive, Multi-touch
Hard Drive:
SSD ≥ 480 GB
Interfaces
USB port 2.0 x 3, Gigabit Ethernet Port x 1
Export / Import:
Remote Viewer**:
Acoustic emission:
Size:
jpeg, pdf, DICOM**, Web API**
Up to a maximum of 5 remote stations
<80 dBA
300 mm x 450 mm x 650 mm / 11.8” x 17.7” x 25.6”
Weight:
11 Kg (24.3 lbs)
Device Power supply and
consumption:
Voltage 12V DC
External power supply:
Power Consumption 60W
Input: Related voltage 100-240V ~ Frequency 50-60 Hz 2A
Output: 12.0V DC 5.42A
Class and type of applied
part:
IP classification:
Class I, Type B (according to IEC 60601‐1).
IPX0 (according to the degree of protection provided by the enclosure to harmful
penetration of particulate matter or water).
* digital filters
**optional
18
Specifications are subject to change without notice for improvement, as a result of ongoing technical
development.
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19. Disposal
DRSplus is made of different materials, such as plastics, aluminium, electronic parts. In the
case of DRSplus disposal, please separate the various materials and follow the laws and
regulations regarding disposal or recycling for each material effective in your own country.
19.1 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 an authorized company
can recycle the WEEE. Please refer to the public administration about the
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 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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External Fixation Target Usage
The External Fixation Target consists of an orange LED light, whose position can be adjusted
through a flexible tube.
To install this component, insert the double pin of the External Fixation Target into the
corresponding mount on the Headrest: note that the button on the base of the External Fixation
Target should be orientated towards the operator (i.e. towards the display).
Double pin
Headrest mount
Once the part is installed, the position of the fixation light can be adjusted as desired by flexing
the tube (Fig. 172).
The base of the External Fixation Target includes the power button, a green LED indicator, a
Micro-USB port and an internal battery.
Press the button to power on the Fixation Light: it will automatically power off after 10 minutes.
To charge the internal battery, use a standard USB charger, connected to the Micro-USB port:
the green LED indicator will turn on when the External Fixation Target is charging.
Since the External Fixation Target is battery powered, no electrical connection with DRSplus
is required.
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Fig. 172 – External Fixation Target positioning
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External Display Setup
DRSplus can be connected to an external monitor using the DisplayPort socket placed at the
back of the device.
When an external monitor is plugged in, DRSplus will mirror the onboard display.
Important
Native DisplayPort links are usually found in monitors, but they are rarely available on TV sets.
Requirements
•
The external display must support “DisplayPort 1.0” standard
•
The external display must support 1920x1080 resolution
DRSplus can be connected to a TV set via HDMI using an active converter.
Passive converters are not supported.
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CenterVue S.p.A.
Via San Marco 9h, 35129 Padova – ITALY
Ph.: +39 049 5018399
Fax: +39 049 5018398
[email protected]
www.icare-world.com
iCare is a registered trademark of iCARE FINLAND OY. CENTERVUE S.P.A., iCARE
FINLAND OY and iCARE USA INC. are parts of REVENIO GROUP and represent the brand
iCare.
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