iCare DRSplus Fundus Imaging System User Manual

DRSplus
Instructions for Use
DOCUMENT 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 these Instructions for Use is English. Should a conflict situation
arise concerning a translated document, the English language version shall prevail.
Date of release: July 09th, 2024
Revision number: 14.01
Software Version: 3.0
Reference device: DRSplus (REF: AXSDRME100)
Copyright © 2024 CENTERVUE S.P.A. All rights reserved.
CENTERVUE S.P.A.
Via San Marco 9h, 35129 Padova – ITALY
www.icare-world.com
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CONTENTS
1.
GENERAL INFORMATION ........................................................................................... 7
1.1
INTENDED PURPOSE.............................................................................................. 7
1.2
INDICATIONS FOR USE ........................................................................................... 7
1.3
INDICATIONS FOR USE (US FDA) ........................................................................... 7
1.4
CLINICAL BENEFIT ................................................................................................. 7
1.5
CONTRAINDICATIONS ............................................................................................. 7
1.6
OPHTHALMIC DEVICES COMPLIANCE ...................................................................... 7
1.7
OPTICAL SAFETY................................................................................................... 7
1.8
ROHS COMPLIANCE .............................................................................................. 8
1.9
ELECTRICAL SAFETY ............................................................................................. 8
1.10
REPORTING SERIOUS INCIDENTS (ONLY FOR EU) .................................................... 8
1.11
ESSENTIAL PERFORMANCE .................................................................................... 8
1.12
USE ENVIRONMENT ............................................................................................... 8
1.13
PATIENT PROFILE .................................................................................................. 8
1.14
INTENDED USER .................................................................................................... 9
1.15
PRINCIPLE OF OPERATION...................................................................................... 9
1.16
CONTENT OF THE DEVICE PACKAGING..................................................................... 9
2.
INTRODUCTION ......................................................................................................... 11
3.
LABELS, SYMBOLS AND DEFINITIONS ................................................................... 12
3.1
LABELS............................................................................................................... 12
3.2
SYMBOLS USED ON THE DEVICE ........................................................................... 13
3.3
OTHER SYMBOLS FOUND IN THE DEVICE PACKAGING .............................................. 14
3.4
OTHER SYMBOLS FOUND IN THIS MANUAL.............................................................. 14
3.5
DEFINITIONS ....................................................................................................... 15
4.
DEVICE DESCRIPTION .............................................................................................. 16
5.
SAFETY AND SECURITY INFORMATION ................................................................. 19
5.1
SAFETY INFORMATION ......................................................................................... 19
5.2
SECURITY INFORMATION ...................................................................................... 21
6.
FIRST USAGE ............................................................................................................. 22
6.1
PREPARATION OF THE DEVICE .............................................................................. 22
6.2
CONFIGURATION WIZARD ..................................................................................... 23
6.3
LOGIN SCREEN ................................................................................................... 28
6.4
PREPARATION OF THE PATIENT ............................................................................ 28
6.5
ACQUISITION OF RETINAL IMAGES ......................................................................... 30
6.6
REVIEW OF THE ACQUIRED EXAM.......................................................................... 32
7.
PATIENT DATABASE ................................................................................................. 33
7.1
INSERT A NEW PATIENT ....................................................................................... 34
7.2
SELECT PATIENTS ............................................................................................... 36
7.3
DELETE PATIENTS ............................................................................................... 36
7.4
EXPORT PATIENTS ............................................................................................... 37
7.5
EDITING AN EXISTING PATIENT .............................................................................. 37
7.6
PATIENT MERGE ................................................................................................. 38
7.7
PRIVACY MODE ................................................................................................... 39
8.
ACQUISITION OF RETINAL IMAGES ........................................................................ 40
8.1
START OF THE ACQUISITION ................................................................................. 40
8.1.1
Select an existing patient ............................................................................... 40
8.1.2
Insert a new patient........................................................................................ 40
8.1.3
Fast exam ...................................................................................................... 41
8.1.4
New exam for patient ..................................................................................... 41
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8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.2.5
8.3
8.4
8.5
8.6
9.
CONFIGURATION OF EXAM PARAMETERS .............................................................. 41
Exam mode ................................................................................................... 41
Eye selection ................................................................................................. 42
Imaging modality............................................................................................ 42
Exposure ....................................................................................................... 43
Retinal fields .................................................................................................. 44
AUTOMATIC ACQUISITION OF IMAGES .................................................................... 45
MANUAL MODE .................................................................................................... 47
EXTERNAL EYE EXAMINATION ............................................................................... 50
STEREO MODALITY .............................................................................................. 50
REVIEW THE PATIENT VISITS .................................................................................. 51
9.1
IMAGE REVIEW .................................................................................................... 53
9.2
IMAGE ADJUSTMENT ............................................................................................ 55
9.3
COMPARISON OF TWO EXAMS .............................................................................. 55
9.3.1
Side-by-side Image review ............................................................................. 57
9.3.2
Visual flickering of the images ........................................................................ 58
9.4
MOSAIC CREATION .............................................................................................. 59
9.5
STEREO REVIEW ................................................................................................. 61
10. EXPORTING IMAGES ................................................................................................. 62
10.1
EXPORT A ZOOMED IMAGE ................................................................................... 64
10.2
REVIEW EXPORTED IMAGES ................................................................................. 65
11. REMOTE VIEWER ...................................................................................................... 67
11.1
REMOTE VIEWER ENABLING ................................................................................. 67
11.2
REMOTE EXAM .................................................................................................... 68
11.3
EXPORT AND PRINT FROM THE BROWSER .............................................................. 70
11.4
REMOTE IMAGE REVIEW....................................................................................... 70
11.4.1 Cup to disc..................................................................................................... 70
11.4.2 Shortcuts ....................................................................................................... 72
11.5
PRIVACY MODE ................................................................................................... 72
12. DEVICE CONTROLS................................................................................................... 73
12.1
NAVIGATION BAR ................................................................................................ 73
12.2
DASHBOARD ....................................................................................................... 74
12.2.1 Notifications ................................................................................................... 74
12.3
CONTROL CENTER .............................................................................................. 76
12.4
MAINTENANCE .................................................................................................... 76
12.4.1 System logs ................................................................................................... 77
12.4.2 Audit logs ....................................................................................................... 78
12.5
ABOUT SCREEN .................................................................................................. 80
12.5.1 Manuals ......................................................................................................... 81
13. DEVICE SETTINGS ..................................................................................................... 82
13.1
ACCOUNT ........................................................................................................... 82
13.2
USERS ............................................................................................................... 83
13.3
NETWORK ........................................................................................................... 86
13.4
DATE AND TIME ................................................................................................... 88
13.5
EXAM ................................................................................................................. 89
13.5.1 Fixations ........................................................................................................ 89
13.5.2 Default imaging modality ................................................................................ 90
13.5.3 Default exposure value .................................................................................. 90
13.6
PATIENT DATA ..................................................................................................... 90
13.7
DEVICE ACCESS.................................................................................................. 91
13.7.1 WebAPI ......................................................................................................... 92
13.8
EXPORT.............................................................................................................. 93
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13.9
PRINTERS ........................................................................................................... 96
13.9.1 Add Printer – Local Printer ............................................................................. 97
13.9.2 Add Printer – Network Printer ...................................................................... 100
13.9.3 Add Printer – Other Network Printers ........................................................... 101
13.9.4 Find New Printers ........................................................................................ 103
13.9.5 Printers panel............................................................................................... 103
13.10 DICOM FUNCTIONALITY .................................................................................... 106
13.11 ICARE CLOUD ................................................................................................... 107
13.11.1
iCare Cloud Registration .......................................................................... 108
13.11.2
iCare Cloud options .................................................................................. 108
13.11.3
iCare Cloud status icon ............................................................................ 109
13.11.4
iCare Cloud de-registration....................................................................... 110
13.12 CONNECTIONS .................................................................................................. 110
14. UTILITIES .................................................................................................................. 111
14.1
ASSISTANCE ..................................................................................................... 111
14.1.1 Remote assistance ...................................................................................... 111
14.1.2 Log Export ................................................................................................... 113
14.2
BACKUP............................................................................................................ 115
14.3
RESTORE ......................................................................................................... 119
14.4
STORAGE ......................................................................................................... 121
14.5
LICENSES ......................................................................................................... 124
14.6
UPDATE ............................................................................................................ 126
14.7
ONLINE UPDATES .............................................................................................. 126
14.7.1 USB updates................................................................................................ 127
14.7.2 Installation of the updates ............................................................................ 127
14.8
OTHER ............................................................................................................. 129
14.8.1 Demo dataset .............................................................................................. 129
14.8.2 Optical head position ................................................................................... 129
15. POWER OFF ............................................................................................................. 130
16. CLEANING AND DISINFECTION.............................................................................. 131
17. MAINTENANCE ........................................................................................................ 132
18. ELECTROMAGNETIC COMPATIBILITY .................................................................. 133
18.1
MANUFACTURERS EMC DECLARATION ACCORDING TO IEC 60601-1-2 ................ 133
18.2
GUIDANCE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY ... 134
18.3
IMMUNITY PASS CRITERIA................................................................................... 134
18.4
WI-FI SECIFICATIONS ......................................................................................... 135
18.5
FCC (USA) AND IC (CANADA) RADIO CERTIFICATION .......................................... 135
19. TECHNICAL SPECIFICATIONS ............................................................................... 136
20. DISPOSAL ................................................................................................................ 137
20.1
SEPARATE COLLECTION OF ELECTRICAL AND ELECTRONIC EQUIPMENT ................. 137
21. LOG OF DOCUMENT CHANGES ............................................................................. 138
EXTERNAL FIXATION TARGET USAGE ............................................ 139
EXTERNAL DISPLAY SETUP ............................................................. 140
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1. General Information
1.1 Intended Purpose
DRSplus is an ophthalmology assessment and diagnosis instrument intended for the
acquisition of retinal images with or without a mydriatic agent and for their review.
1.2 Indications for Use
DRSplus is indicated to provide retinal images used for the diagnosis and monitoring of several
retinal pathologies.
There are no surgical or treatment decisions made solely on retinal images obtained by the
devices.
The clinical interpretation of the exams acquired by DRSplus is restricted to eyecare
professionals with training in the ophthalmology field (or equivalent) who retain the
responsibility of the diagnosis.
1.3 Indications for Use (US FDA)
DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared retinal
imaging with or without the use of a mydriatic agent.
1.4 Clinical Benefit
DRSplus does not claim any clinical benefits, i.e. a positive impact on the health of an
individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome,
as it does not provide any diagnostic outcome but provides information for the diagnosis.
The performance of the DRSplus – expressed as the ability of the device to achieve its
intended purpose – is to capture, display and store various images to aid in diagnosing and
monitoring a multitude of retinal diseases.
1.5 Contraindications
No contraindications nor side-effects have been found for fundus photography. There exist
rare and discomforts limited in their timespan, as temporary glare, watery eyes, during and/or
after the acquisition of the fundus image.
1.6 Ophthalmic Devices Compliance
DRSplus is compliant with ISO 10940:2009 and ISO 15004-1:2020.
1.7 Optical Safety
According to ISO 15004-2:2007 and ANSI Z80.36, DRSplus devices are classified as Group
1 – Ophthalmic instruments for which no potential light hazard exists.
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1.8 RoHS Compliance
The product is RoHS-compliant according to Directive 2011/65/EU and Directive
2015/863/EU.
1.9 Electrical Safety
The devices are compliant with IEC 60601-1:2005+AMD1:2012+AMD2:2020. The devices are
classified as Class I, type B applied part.
1.10 Reporting Serious Incidents (only for EU)
Report any serious incident related to the device, the operator, the patient, or anyone else to
CENTERVUE S.P.A. and to the Competent Authority of the Country/State in which the user
and/or patient is established.
1.11 Essential Performance
The clinical performance of the DRSplus is to capture, display and store images to aid in the
diagnosis and monitoring of diseases and disorders occurring in the retina. Since there are no
surgical or treatment decisions made solely on data obtained by the device, it was determined
that DRSplus has no Essential Performance as defined in the IEC 60601-1 standard.
1.12 Use Environment
DRSplus is intended for use in
• professional healthcare facility environment:
•
o
Ophthalmic & Optometrist Offices
o
Ophthalmology Clinics
o
Hospitals
o
Research laboratories
o
Medical offices
optical shops
The devices are suitable for use in domestic and home healthcare environments. Consult
complete information about electromagnetic environment requirements in section §18 of this
document.
1.13 Patient Profile
DRSplus can be used on any adult subject able to remain seated upright, to place the forehead
on the forehead rest, alone or with the aid of another person. The decision to use the DRSplus
on a vulnerable patient is under the responsibility of the eye care practitioner. The patient is
not required to interact with the device, apart from keeping the eyelid open and staring at the
fixation target. The patient population is NOT intended to be the end user of the device.
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1.14 Intended user
The primary intended users of DRSplus are healthcare care professionals. The device is not
intended for lay users.
User profile
ROLE
Context of use
Characteristics
Operator user
Operating as per the
medical intend purpose:
Image acquisition and
review
Demographic trait: Healthcare professional with training in
ophthalmology or equivalent:
•
Opticians
•
Ophthalmic photographers
•
Optometrists
•
Ophthalmologists
•
Clinical researchers
•
Medical assistants.
Required knowledge, skills and abilities:
•
Experience with using medical imaging systems that
have an embedded computer and software user
interface
•
Basic computer knowledge
•
Qualified and experienced personnel, familiarized with
the contents of the instructions for use.
Cleaning and disinfection
Troubleshooting
Admin user
Configuration and set up
Demographic trait: System administrator.
Required knowledge, skills and abilities:
•
Experience with desktop-based camera
•
Knowledge of operating systems, IT networks, user
administration, and backup management
•
Qualified and experienced personnel, familiarized with
the contents of the instructions for use.
1.15 Principle of operation
The acquisition of the retinal images is achieved by confocal illumination of the eye fundus by
means of a scanning line, and simultaneous acquisition of the same portion of the illuminated
retina. The device is able to compensate for eye movements by tracking in real-time the
position of the pupil and adapting its position and focus accordingly.
1.16 Content of the device packaging
The device is provided with:
Parts
Lens cap (for shipping only)
Cables protection shell
Device Stand
Headrest with silicon cushion
External power supply
Country-specific power cable
USB extension cable
Packing straps
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Documents
Unpacking, packing and setup manual
Leaflet and/or Instructions for Use
Climatic Preconditioning
Electrical Test Report
Optionals
External fixation light
Prismatic goggles
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2. 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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3. Labels, Symbols and Definitions
3.1 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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3.2 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, yyyy-mm).
DRSplus identifier (catalogue number – product code).
Indication of Medical Device.
DRSplus Serial number.
UDI number
Electrical and electronic waste is destined for separate recycling.
Please refer to the electronic Instructions For Use (eIFU)
This instruction manual must be read
Read this instruction manual before starting work or before operating
equipment or machinery
CE mark: the device complies with the general safety and performance
requirements of the Regulation (EU) 2017/745. CE mark is followed by the
Notified Body identifier.
Type B Applied Part.
Non-ionizing radiation - ME EQUIPMENT that includes RF transmitters.
Device consumption
Power supply
Direct current.
Power button. See the device back panel (Fig. 8).
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3.3 Other symbols found in the device packaging
The meaning of the symbols adopted in the device packaging is as follows:
Symbol
Explanation
Information about the Manufacturer.
Fragile. Handle with care.
Kilogram stacking limit because of the nature of the device package.
The Acceptable upper relative humidity for storage and transport.
The maximum and minimum temperature limits for storage and transport.
Correct the upright position of the transport package.
Device package shall be kept away from rain and be kept in dry conditions.
Stacking limit by number. Items shall not be vertically stacked beyond the
specified number. The bottom package is not included in the stack.
3.4 Other symbols found in this manual
The meaning of the additional symbols adopted in the Instructions for Use is as follows:
Symbol
Explanation
Important Information.
General Warning, read carefully.
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3.5 Definitions
Word
Explanation
Device
The synonym of DRSplus used in this User Manual.
Exam
Any image retinal acquisition session performed using the DRSplus for a
certain patient on a certain date.
External eye
examination
The examination mode involving the acquisition of images of the ocular
surface instead of the retina.
Field
A portion of the retina visible in a specific image.
Fixation
The ability of a patient to fix his/her view on a specific point, for example, the
internal fixation target of the DRSplus.
Fixation target
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.
Local interface
The application on the DRSplus device.
Picture
The synonym of the image acquired by DRSplus.
Pupil
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.
Remote viewer
The web application running on an external PC.
Retina
The inner layer of the eyeball. It is the main area of interest in the images
acquired by DRSplus.
Stereo exam
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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4. Device description
DRSplus consists of:
•
•
•
•
•
16
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
DRSplus Instructions for Use - EN
Fig. 4 – Device stand
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Headrest
Touchscreen
display
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 §8.6 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, refer to 1.16
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5. Safety and security information
5.1 Safety information
Although great care and diligence have been taken during the design and development of this
device to reduce as far as possible all risks related to the use of the devices, it is important to
read and understand the following precautions to further mitigate all residual risks.
The following precautions and warnings are important to use the devices safely:
• The device is for professional use only
• The device needs to be installed and put into service by the Authorized Service Center
• 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.
• No serviceable parts inside. Internal inspection is allowed to authorized personnel only.
• Do not use the device when there are visible signs of materials degradation.
• 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
CENTERVUE S.P.A. may negatively affect EMC performances
• The power cord shall be properly maintained during use. In case of damage, contact
CENTERVUE S.P.A. for the replacement.
• It is recommended to power off the device according to instructions of section §15;
removing the power cable could result in data loss.
• External device/s connected to DRSplus, into the patient environment, must comply with
IEC 60601-1. That/those device/s that does/do not comply with the IEC 60601-1 must be
kept out of the patient environment and must comply with IEC 60950-1. Any end-user 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 used and must be placed in a room that is not exposed to adverse
chemical-physical conditions, such as the presence of sulphur, 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% non-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% non-condensing
• Only technicians authorized by CENTERVUE S.P.A. may service DRSplus. CENTERVUE
S.P.A. cannot be held responsible for the device's safety should DRSplus be opened,
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•
•
repairs carried out (including using of not CENTERVUE S.P.A.’s genuine parts), third-party
software installed, or parts replaced by an unauthorized person.
Risks can arise in relation to the biological contamination caused by the environment the
device is operated into, and by the user and the patients. Follow the cleaning and
disinfection instructions provided below in this document.
The device is not supplied sterile, nor is intended to be sterilized before or after use;
nevertheless, the risks connected to the biocompatibility of the parts that come into contact
with the patient are in relation to severe consequences, including allergic reactions.
Contact materials used in DRSplus are biocompatible and safe for contact with intact skin
for limited exposure.
The following precautions 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 not required: it is recommended for the end-user (operator) to
carefully read these Instructions for Use 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: refer to §6.4.
• 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 is under the
responsibility of the eye care practitioner.
• Report any serious incident to CENTERVUE S.P.A. and to the competent authority of the
Member State in which the user and/or patient is established.
Fig. 11 – Error popup
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5.2 Security Information
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.
•
•
•
•
•
•
•
•
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When in operation DRSplus contains Personal Data. Transfer data using secure
infrastructures to avoid compromising patient privacy.
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.
To protect your devices against unauthorized access and manipulation, make sure that
only authorized personnel have physical access to the device.
The device offers a Wired Network Connection (via Ethernet cable) and a Wireless
Connection. It is the responsibility of the IT department of your organization to maintain
proper security practices.
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 for example:
o use a password at least 8 characters long;
o avoid using any of your personal information, like your real name, username
or your company name;
o select a password different from your previously used passwords;
o avoid using any word spelled completely;
o use a password containing 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 exam reports and patient images; reports and images stored in the Remote
Shared Folder can be available also on your PC/Laptop. Refer to your infrastructure’s
policies to protect your equipment with complex passwords, updated browsers and
other security policies, as an example:
o apply physical security measures (locks, security alarms, monitoring, etc.) to
prevent unauthorized persons from accessing your computer that stores
patients’ personal data files;
o use full disk encryption (for example Bitlocker) with a strong password to
render data unreadable even if an unauthorized person were to gain access to
your computer;
o use 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 install security patches and updates in a timely manner;
o protect access to your Windows account with a strong password (see
indications above);
o log off or power off when leaving your computer unattended.
When sending DICOM files to a configured PACS or receiving data from a Worklist
server, please remember that the DICOM protocol does not encrypt patients’ personal
data: It is the responsibility of the IT department of your organization to maintain proper
security practices for the IT infrastructure.
Precautions for the security of your devices must be maintained at the State of the Art.
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6. First usage
This section explains how to set up DRSplus for use.
6.1 Preparation of the device
Carefully read Chapter 5 before proceeding to the device operation.
To prepare DRSplus for the first usage:
•
•
•
•
•
•
Take the device out of its shipping box and place it on 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. 12);
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. 12 – Headrest
Fig. 13 – Back panel with the cables protection shell
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6.2 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. 14).
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 can be
resumed anytime afterwards.
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. 14 – Beginning of the Configuration Wizard
2.
Select the country in which you use the device.
Fig. 15 - Country selection
3.
Read and approve the End-user License Agreement (EULA) (Fig. 16). 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.
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Fig. 16 End-user License Agreement
4.
Set the language. A language is suggested according to the selected country (Fig. 17).
Fig. 17 - Language selection
5.
Set the current time zone (Fig. 18). An initial time zone is suggested according to the
selected country.
Fig. 18 – Time zone
6.
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Set the current date and time and configure their format (Fig. 19).
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Fig. 19 –Date and time selection
7.
Create the local Administrator account by selecting username and password (Fig.
20). 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. 20 – Administrator account creation
8.
Optionally create an Operator account (Fig. 21) by following the same rules and
constraints described for the Administration account. Tick the box Use the
administrator account also as the device operator to use a unique account. To create
different accounts, refer to §13.2.
4 Moreover, “service” and “production” cannot be used as usernames.
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Fig. 21 – Creation of user accounts
9.
Select the Online services configuration (Fig. 22). Select among the options. It is
strongly recommended to enable the Periodically check for online software updates
option to receive the security updates.
Fig. 22 - Online services configuration
10.
Save the configuration (Fig. 23).
Fig. 23 - Save configuration
11.
26
Wait for the device configuration (Fig. 24).
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Fig. 24 - Device configuration
12.
See an overview of the basic functions of the device and the improvement introduced
by the actual software version (Fig. 25). Click NEXT to go through the different pages,
click SKIP to proceed with the configuration.
Fig. 25 - What's new
13.
Start using the device (Fig. 26)
Fig. 26 - End of the Configuration Wizard
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6.3 Login Screen
Turn on the device by pressing the power switch button (Fig. 8). When the boot is completed,
the Login Screen will appear (Fig. 27).
Fig. 27 – 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 §13.1.
Push the Dashboard button to access the basic information of the device and
consult the Instructions for Use (see §12.2).
The Service button is used for service activities only.
6.4 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 on the green light during the exam, the
images acquired may relate to portions of the retina that are not as expected.
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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Provide the patient with the following instructions and explanations about the
device's 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 for the device to find your eye;
5.
When a small light appears, please look at such light and avoid blinking.
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6.5 Acquisition of retinal images
After the login, the Patient List Screen will appear as in Fig. 28.
Fig. 28 - Patient List screen
Push the new patient button to open the New patient Screen (see Fig. 29).
Push the Fast exam button to access the Exam Configuration Screen (see Fig.
30).
Fig. 29 - New Patient screen
Fill in the mandatory and optional fields and SAVE the new patient.
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Fig. 30 - Exam Configuration screen
Push START 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, right, 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 blue 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 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 §8.
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6.6 Review of the acquired exam
After the acquisition, the Patient details Screen appears (see Fig. 31).
Fig. 31 - Patient details screen
From this screen, you can immediately review the exam with all the acquired retinal images.
Function
Command
New exam (§9.3.2)
New mosaic (§9.4)
Export patient (§10)
Flicker (§9.3.2)
Compare (§9.3.1)
Select (§7.2)
Retake
Table 1 - Available functions of the Patient details
You can acquire a New exam, create a New mosaic, Compare or Flicker two images,
Export the patient or Select items.
To retake an image, click the retake button in the bottom right corner. The image will be
acquired with the same conditions as the previous one. Press Patients to access the Patient
List.
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7. Patient database
Upon login, the Patient List Screen appears, as shown in (Fig. 32). 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, merge, and delete patients from this Screen.
Fig. 32 – Patient List Screen
On the left side of the screen, you will find the patients’ information:
• 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 New exam to directly start the acquisition for the relative patient
(see §8.1.4)
Press on a patient’s box to access the Patient details Screen and review
the exams (see §7.6).
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. 33). This functionality is especially useful when you
need to select and export a specific group of patients.
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Fig. 33 - Search functionality
In the settings, activate Privacy Mode (see §7.6 for details) to hide patients’
Surname and Name. They will be replaced by their first letters followed by
asterisks.
On the right side of the screen, the following buttons appear:
Function
Command
New patient (§7.1)
Fast exam (§8.1.3)
Select (§7.2)
New exam (§8.1.4)
Table 2 - Available functions of the Patient List
7.1 Insert a New Patient
Push New patient to insert data of a new patient in the New patient Screen (see Fig. 34).
Enter the Mandatory fields, that are marked by (*).6 You can either fill in or leave blank the
additional fields.
6 For more information about the mandatory fields, refer to §13.6.
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Fig. 34 - New patient Screen
Type on the keyboard to fill in 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. 35) 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. 35 – Duplicate record pop-up
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7.2 Select patients
Press Select, or keep pressing the patient’s info, to activate the Select functionality.
Fig. 36 - Select functionality
A box appears at the left of each patient’s thumbnail (see Fig. 36). After ticking at least one
box, you can Merge, Export or Delete the selected patients. Click Cancel to close the
selection.
Function
Command
Merge (§7.6)
Select two patients to enable the Merge button.
Export (§7.4)
Delete (§7.3)
Cancel
Table 3 - Available options of the Select screen
7.3 Delete patients
Select the patients to delete and click the Delete button on the right panel.
Fig. 37 – Deletion Confirmation Pop-up
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Alternatively, open the Patient details screen (see §9), press the ellipsis and then
the Delete button.
Press CONFIRM to delete the patient or CANCEL to return to the Patient List Screen, where
your selection remains active.
7.4 Export patients
Select the patients to export and click the Export button on the right panel.
The Export Screen will appear (see Fig. 38).
Fig. 38 - 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 §10 for more information about the export functionality.
7.5 Editing an existing patient
To modify the information of an existing patient, open the Patient details
Screen (see §9), 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. 39).
Fig. 39 – 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. 40).
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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. 40 – Duplicate Patient Panel
7.6 Patient Merge
To merge two patients, from the Select screen (Fig. 36) select two patients and
click the Merge button on the right panel. The Merge patients Panel appears (Fig.
41).
Fig. 41 – Merge patients Panel
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. 42).
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Fig. 42 – Merge patients Panel, selected patient
Click CANCEL to abort the operation, or 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.
7.7 Privacy mode
Activate the Privacy Mode in the Settings|Patient data Screen (see §13.6) to hide the Surname
and Name of the patients. They will be replaced by their first letters followed by asterisks (see
Fig. 43).
Fig. 43 - Patients database in privacy mode
Press the privacy mode ON/OFF button to hide/unhide the patients'
information.
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8. Acquisition of retinal images
This section explains how to acquire high-quality retinal images using DRSplus.
8.1 Start of the acquisition
To start the acquisition process, open the Patient List Screen and then you can:
•
•
•
•
select an existing patient (§8.1.1);
insert a new patient (§8.1.2);
start a Fast Exam (§8.1.3);
start an exam for an existing patient (§8.1.4).
8.1.1 Select an existing patient
Fig. 44 – 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.
8.1.2 Insert a new patient
Press the New patient button to create a new patient record (see §7.1).
Fill in the data and SAVE.
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Push the New exam button to access the Exam Configuration Screen and
configure the exam (see §8.2).
8.1.3 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 in all the mandatory fields.
8.1.4 New exam for patient
Push the New exam button in the Patient List Screen to directly start
an examination for the selected patient.
8.2 Configuration of Exam Parameters
Enter the Exam Configuration Screen (see Fig. 45)
Fig. 45 – Exam configuration screen
Push the START button to acquire the exam according to the default configuration. Refer to
§13.5.2 for more information regarding the default configuration.
You can modify the default exam parameters to change the acquisition.
8.2.1 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. 46 – Exam mode selection
Select the Automatic mode to make DRSplus automatically perform the examination
according to the exam settings (§8.3).
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 (§8.4).
8.2.2 Eye selection
The Eye box shows the default option. To change it, press the
Eye button.
Fig. 47 – Eye selection
Select OD for the right eye, OU for both eyes or OS for the left eye.
8.2.3 Imaging modality
The Imaging modality box shows the default option. Push
imaging modality to override the default.
Fig. 48 – 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 (§13.5), a default imaging modality can be set and will be used
for each exam. Select a different modality in the Exam Configuration Screen to override the
default modality previously defined.
The IR functionality is not available for devices with a serial number starting
with K.
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8.2.4 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. 49 – Exposure slider
When you change the exposure value, the image information shows (see the red box in Fig.
50) the value of exposure you have selected in the exam.
Fig. 50 – Image information
In the Settings|Exam Screen (§13.5), 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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8.2.5 Retinal fields
Find the default acquisition fields marked by a white-filled circle in the retina map (see as an
example Fig. 51). In the example, CENTRAL and CENTRAL NASAL are selected, and 3D
and INFERIOR NASAL are deselected.
Every selected field corresponds to a specific position of the internal green
fixation target.
Fig. 51 – Example of the field configuration
Select the fields you want to acquire (see Fig. 45):
• CENTRAL: centered on the foveal pit;
•
3D: a couple of retinal images for stereo review (see §8.6);
•
NASAL: centered about 19° nasally to the foveal pit;
•
TEMPORAL: centered about 19° temporally to the foveal pit;
•
CENTRAL-NASAL: centered about 7° nasally to the foveal pit;
•
SUPERIOR: centered about 19° superiorly to the foveal pit;
•
INFERIOR: centered about 19° inferiorly to the foveal pit;
•
SUPERIOR-TEMPORAL: centered about 12° superiorly and 7° temporally to the
foveal pit;
•
SUPERIOR-NASAL: centered about 12° superiorly and 7° nasally to the foveal pit;
•
INFERIOR-TEMPORAL: centered about 12° inferiorly and 7° temporally to the foveal
pit;
•
INFERIOR-NASAL: centered about 12° inferiorly and 7° nasally to the foveal pit;
•
EXTERNAL EYE: image of the external eye surface (see §8.5).
The device will acquire the fields in the order in which they are selected during the exam
configuration.
When the patient is ready and the acquisition is configured, press the START button to begin
the image acquisition procedure.
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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 §9.4).
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 blue lines
before starting the exam.
8.3 Automatic acquisition of images
After you click START, 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)
top left corner of the image box
Current image acquisition information (OD or OS;
TrueColor or Infrared; progressive image number for the
exam)
Graphics
Position of the eye on the headrest
7 Mosaic feature is available under license only: please refer to your local
Authorized Distributor for detailed
information.
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Information
Position on the screen
Under the graphics of the eye
position
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 estimated pupil size
Acquisition status of every set field for the current
examination (in progress, processing, completed)
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. 52 – 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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8.4 Manual mode
Press the Manual Mode button to be able to manually adjust the automatic control of the
device.
Fig. 53 – Manual mode configuration Screen
The Manual mode configuration Screen will appear (see Fig. 53).
Select OD to start the acquisition from the right eye, OS for the left eye.
Push START.
The Manual mode Screen appears. (see Fig. 54).
Fig. 54 – 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
Under the graphics of the
eye position
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 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 blue color.
Push OD / OS to switch eyes.
Autoexposure
Push the Exposure button to get darker or brighter images,
as explained in §8.3. A change in the Exposure value affects
only TrueColor retinal images.
Activate Autoalign to enable the Auto-alignment
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Information
Position on the screen
Disable Autoalign or enable Joystick 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 Joystick to make the XY and Z controls disappear. The
auto-alignment remains disabled.
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
Push any Circle in the retinal image to move the fixation
accordingly
See your selected fixation field
Find the position of the internal fixation target from the
patient’s point of view
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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8.5 External eye examination
Set External Eye modality to automatically acquire a TrueColor image of the
external surface of the eye (see Fig. 55).
Fig. 55 – Image of the external surface of the eye
8.6 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.
To review a stereo images acquisition see §9.5
8 Stereo modality is available under license only: please refer to your local
Authorized Distributor for detailed
information.
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9. Review the patient visits
Click on a patient’s data to enter the Patient details Screen, as in Fig. 56.
Fig. 56 – Patient details screen
On the left side, you find the patients’ information for each visit. 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 §9.3.2)
• 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 §7.5) or delete the patient (see
§7.3).
Touch the ellipsis (⁝) button on the right of the visit date box to
export (see §7.4) or delete the visit.
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Function
Command
New exam (§8.2)
New mosaic (§9.4)
Export patient (§10)
Flicker (§9.3.2)
Compare (§9.3.1)
Select (§7.2)
3D Stereo review (§9.5)
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 §13.10 for more
information.
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9.1 Image review
Click on an image to open the Image Review Screen (see Fig. 57).
Fig. 57 – Image review
The top left corner shows the information on 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. 58). Drag the image
with a finger to navigate around the image.
Fig. 58 – 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
open sidebar
Open the image adjustment screen (§9.2) and the comparison
tools (§9.3)
3D stereo review
Show the images acquired with the 3D modality for a stereo
review (see §8.6)
export
Export the current view of the image. See §10 for more
information.
Table 7 – Available functions of the Image Review
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9.2 Image adjustment
Press the open sidebar button to adjust the image parameters.
The Filters Panel will appear (see Fig. 59).
Press the close sidebar button to close the panel and see the image full-screen
Fig. 59 – Filters panel
You can modify the Brightness, Contrast, and Gamma of the image. Move the Slider to view
the effect on the full image.
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
RED channels
Select one of the BLUE, GREEN or RED channels to selectively
filter a single color channel.
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 at any time to restore the image at the original
acquisition condition.
9.3 Comparison of two exams
To compare the currently shown exam with another one:
• Push the open sidebar button on the Image Review Screen to open the Sidebar panel,
and select the VISITS tab, as in Fig. 60.
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Fig. 60 – sidebar items screen
• Select an exam and press the ellipsis
to open the menu.
To compare two images from the Patient details screen:
Fig. 61 – Patient details screen
Press the FLICKER button to select the images to be flickered.
Flicker is available on images of the same eye. Flickering is not available for
Mosaics.
Press the COMPARE button to select the images to be compared.
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9.3.1 Side-by-side Image review
Click COMPARE to review any couple of patient images side-by-side (see Fig. 62).
Fig. 62 – Side-by-side comparison
The box on the corner of each image contains the information on the image acquisition, as in
the Image 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 and
deactivate the sync items to independently operate on the two images.
Press switch items to swap the images.
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 revert to the
previous Screen.
Press flicker to activate the flickering review modality. (§9.3.2)
Flicker is available on images of the same eye. Flickering is not available
for Mosaics.
Press the open sidebar button on the bottom left and right side of the
screen to independently filter the left or right image, respectively.
Press the close sidebar button to close the Sidebar panel.
Press export to export the current view of the two images (see §10).
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9.3.2 Visual flickering of the images
Click FLICKER to alternatively visualize the two images superimposed on the Flicker Screen
(see Fig. 63). The second image will be automatically registered on the first to overlap the
retinal features and ease your reviewing analysis. The first image acts as a reference and only
the overlapping part of the second image appears.
Fig. 63 – Flickering review of the images
The top left corner shows the information on the two images: imaging modality, fixation, and
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.
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
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9.4 Mosaic creation
DRSplus includes a special software algorithm, called mosaic, that stitches together two or
more photos of a retina to obtain an image with a wider field of view (Fig. 66).
The mosaic function is available only under license.
To create a mosaic, open the Patient details Screen.
Click the New mosaic button to open the Mosaic Composition
Screen (see Fig. 64).
Fig. 64 – Mosaic Composition Screen
If you need to, 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.
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.
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Fig. 65 – Mosaic elaboration in-progress
Fig. 66 – 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
images are stitched together. These artefacts can be easily recognized by
looking at the original images.
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9.5 Stereo review
Press 3D Stereo review to open the Stereo Review Screen (see Fig. 67).
Fig. 67 – 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 backward 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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10. 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 (§7.4, 9.2);
export or print a single image (§9.1);
configure (§13.8) one or more destinations, including USB and network drives;
Print all the images of a single patient.
Fig. 68 – 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, and dark grey buttons
are disabled. For printing, only the PDF option is available.
Customize the PDF options as follows
Layout: Portrait or Landscape
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Paper Size: A4, A5, letter
Number of images per page: 1, 2, 4, 6, 9
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 (see Fig. 69). Click
CANCEL to interrupt the export or wait until the export is completed. Click CLOSE to return
to the previous Screen.
Fig. 69 – Export progress pop-up
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. 70 – Error during export
10.1 Export a zoomed image
When you zoom on an image during the review (see §9.1) and you want to export the zoomed
view, click the EXPORT button and the Export Cropped View Screen appears.
Fig. 71 – 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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10.2 Review exported images
Review the exported images on your device. See an example of an exported PDF report in
Fig. 72, where two images per page have been exported. The headings contain the patient
data and notes.
Fig. 72 — Example of pdf report of an exam
The following figure shows the PDF report of an anonymized export 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 bottom left box of the
report. The header contains an example of a custom logo and text. To customize your header,
see §13.8.
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Fig. 73 – PDF report of a cropped, filtered image
You can see in the top left corner that patient’s data are replaced as follows:
• Patient’s Surname -> Anonymous
•
Patient’s Name -> Universally Unique Identifier (UUID)
•
Date of birth and age (DD/MM/YYYY, if present) (YY) -> 01/01/YYYY (YY)
•
Gender -> Gender
•
Operator
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. 74.
Fig. 74 – Search via UUID
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11. Remote Viewer
Remotely review the whole patient database and all the images stored in DRSplus memory
employing any standard PC connected to 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.
11.1 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 (§13.3).
Remote Viewer access (HTTP or HTTPS) must be enabled in the Settings|Device access
Screen (§13.7)
By default, the remote viewer is disabled.
Once the connection is up and running, open a browser on 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-license pack. Every single license will
give access to DRSplus from one remote station at a time, while the 5-license
pack will give access to the device from 5 remote stations at a time.
•
The Remote Viewer requires a standard Web Browser and does not
require any additional third-party software to be installed in the remote
computer.
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 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 to the local user
interface.
Every Remote Viewer session is automatically closed after the period
specified in the Settings|Device access menu (§13.7). To continue using
the Remote Viewer, a new login is required.
The use of the HTTP protocol exposes to higher cybersecurity
vulnerabilities.
11.2 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 who 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 §13.2.
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.
The Remote Activation Code will be shown on the display of the DRSplus.
10 As of February 2024.
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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Fig. 75 – 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. 76 – 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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11.3 Export and print from the browser
Fig. 77 – Remote viewer export
From the Remote Viewer, in the Export Panel, you can download it on your PC or print it
through a printer connected to 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.
11.4 Remote Image review
11.4.1 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. 78 –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 disc ratio is always calculated as a value lower than 1, independently from the
order of design of the segments.
The cup to disc ratio is reported on the top left side of the image (see Fig. 78). Note that you
can anytime edit the selected points and the CDR will correspondingly be updated.
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11.4.2 Shortcuts
Fig. 79 – 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.
11.5 Privacy mode
Fig. 80 – 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.
Press the privacy mode ON/OFF button to hide/unhide the patients’
information.
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12. Device controls
12.1 Navigation Bar
Upon login, the Navigation Bar shown in Fig. 81 appears on all the screens.
Fig. 81 – Navigation Bar
The Navigation Bar functionalities follow:
Function
Command
Menu
Browse the main device management options: preferences,
Control center, Dashboard, Logout, and Power off.
The Power off button does not appear in the Remote Viewer.
Control center
Open the Control center Screen including Configuration
(§12.2) and Utilities tools (§13.11.3)
Open the Dashboard
Patients
Go back to the patient detail or patient screen
Open the Patient List
Show the Remote assistance information
This icon appears when you request remote assistance.
Show the iCare Cloud services status (see §13.11.3)
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Function
Command
Show the DICOM automatic delete policy status
Announcements
Show the announcements published by iCare server, like
online software updates or availability of new features.
View the USB disks connected for image export, if any. This
icon disappears if no USB device is plugged in.
Connectivity
View the current status of ethernet and wireless connections.
Speakers volume
Set the volume of the audio notifications.
Date and time
View the date and time of the DRSplus
Table 9 – Navigation bar options
12.2 Dashboard
To access the Dashboard Screen, click the Dashboard button on the Navigation Bar.
Fig. 82 –Dashboard Screen
The Dashboard contains a comprehensive review of the Notifications (§12.2.1), the storage
on the device, the configured services like Backup destinations, Network disks and iCare
Cloud, the Info of the device, the Manuals, and the usage statistics, to show at a glance all the
information regarding the device operativity. For details refer to the About Screen (§12.5).
12.2.1 Notifications
The Notifications are all the information regarding an event, a warning or an error.
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Within its operation activity, the device can generate notifications that are displayed to the
operator through pop-ups and toasts (see Fig. 83). 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.
Click the Dashboard icon in the Navigation Bar to view the last notifications
Fig. 83 – 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. 84 – Example of a critical error blocking pop-up
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Fig. 85 – Notifications list Panel
After a critical notification, the dashboard icon remains highlighted.
From this panel, all the notifications can be marked as viewed.
12.3 Control Center
To access the Control center Screen, click on the Control center icon in the
Navigation Bar.
Fig. 86 – Control Center Screen
From the Control Center, you can access the following Screens:
• Settings (§12.5.1)
• Utilities (§14)
• Maintenance (§12.4)
• About (§12.5).
The first three screens will be described in dedicated paragraphs.
12.4 Maintenance
The Maintenance Screen contains two logs viewers, the System and the Audit logs (see Fig.
87), which are useful for service purposes.
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To access the Maintenance Screen, click the MAINTENANCE button on the Control
center Screen.
Fig. 87 – Maintenance Panel
12.4.1 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. 88 – System logs Screen
Notice: messages informing that a run-time event, such as startup or shutdown, has
occurred.
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.
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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. 89). Push
CLOSE to revert to the System Logs Screen.
Fig. 89 – System Logs Record Details Dialog
12.4.2 Audit logs
The Audit logs Screen shows the activities performed on the device’s interface (see Fig. 90).
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Fig. 90 – 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.
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. 91). Push
CLOSE to revert to the Audit logs Screen.
Fig. 91 – Audit Logs Record Details Dialog
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12.5 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 Info section containing the installed software version, the device’s serial number
and the status of the End User Licence Agreement (EULA). Push the button to review
the EULA on the language of the Country configured on the Configuration Wizard
Screen (see §6.2)
• The Storage section with the size and the amount of free space for the Data disk and
the System disk
• The Manuals section containing all the available Manuals (see §12.5.1)
• The Device Usage, in terms of Patient records, Item records and graphical information
of the number of exams performed in the last 180 days.
Fig. 92 – About Screen, About and Storage
Fig. 93 – About Screen, Device usage
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12.5.1 Manuals
The Manuals tab contains the Instructions for Use of the DRSplus. The Instructions for Use
are available in the following languages: English, Italian, French, German, Spanish,
Portuguese, Czech, Danish, Estonian, Greek, Hungarian, Lithuanian, Romanian, Slovak,
Norwegian, Swedish, Finnish, Latvian.
Push DRSplus User Manual to make the Instructions for Use appear on the screen in the
language corresponding to the Country selected during the Wizard. If your device has DICOM
or WebAPI active licences, their Manuals will be available in the About Screen (see Fig. 93).
Push SELECT A LANGUAGE (see Fig. 94) to change the language of the Instructions for
Use, push CLOSE to close the Manual.
Fig. 94 – Manuals screen
Push Bookmarks to navigate the Manual Headings.
Push Fit to width / Fit to page to adjust the zoom of the Manual to
the width or to the height of the screen, respectively
Push Zoom in / Zoom out to adjust the increase or decrease the
zoom of the Manual, respectively.
The Manuals section is not available if during the configuration Wizard
you have selected China as Country.
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13. 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. 95 – Settings Screen
13.1 Account
The Settings|Account Screen (Fig. 96) allows users to change their passwords.
Fig. 96 – 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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13.2 Users
The Settings|Users Screen (Fig. 97) manages (creation, modification and deletion) the user
accounts. It is accessible only by the Administrator.
Fig. 97 – 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. 98), define Username and Password, Roles, and Language
and enable or disable the Remote Exam functionality (see §11.2). Click SAVE to maintain the
changes, click CANCEL to abort the creation of the new user.
Fig. 98 – 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. 99).
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Fig. 99 – Edit the user Panel
You can change the Username, the Roles, and the Language, Enable or Disable the Remote
Exam Functionality and Deactivate the user.
If a WebAPI license is active, you can generate an access token (refer to the DRSplus webAPI
Manual for more information).
Click SAVE to save the changes, click CANCEL to abort the editing operation.
Click RESET PASSWORD to open the Reset user password Panel (Fig. 100).
Fig. 100 - 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. 101 - 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 the remote assistance
Networking configuration
Licenses 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
Licenses revocation
Security and device access configuration
Device configuration restore
Table 10 – Permissions of the admin and operator users.
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13.3 Network
Open the Settings/Network Screen (Fig. 102) to configure the network connection. Specify the
primary network interface between Ethernet and Wi-Fi.
Fig. 102 – 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. 103 – Ethernet connection settings
Wi-Fi connection
The network parameters can be configured as per the Ethernet. DRSplus supports the Wi-Fi
authentication with WPA1/WPA2, WPA2 802.1X, WEP standard protocols.
Press the ellipsis (⁝) at the right of the Wi-Fi box. Click CONFIGURE to edit
the standard 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,
ADVANCED to edit the advanced Wi-Fi properties (see Fig. 104)
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Fig. 104 - Advanced Wi-Fi panel
Push SEARCH WI-FI NETWORKS to scan for available Wi-Fi
networks.
Wi-Fi network that use a protocol WPA1 and WEP are considered unsecure
connections. A warning will appear if you select one of those protocols.
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. 105).
Fig. 105 – 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.
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Function
Command
Enable/disable the Wi-Fi interface from the Wi-Fi ellipsis (⁝).
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. 106).
Fig. 106 – Example of wired and Wi-Fi network connection status
13.4 Date and time
Access the Settings|Date and time Screen (Fig. 107) to configure the date and time formats.
Fig. 107 – Settings|Date and time panel
In the Date and time configuration section, select between Automatic (requires Internet
connection) or Manual date and time settings.
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In the Time zone section, click on the currently selected one to set a time zone from the Select
a time zone panel.
Fig. 108 - 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.
13.5 Exam
Access the Settings|Exam Screen (Fig. 109) to select the exam default configurations for the
Exam Configuration Screen. You will be able to override any of the preset configurations
before starting the exam, as explained in §8.2.
Fig. 109 – Settings|Exam Screen fixations
13.5.1 Fixations
Select between:
• 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 fixations is shown in the Preset fixations box, as well as in the
configuration’s picture.
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13.5.2 Default imaging modality
It appears only if the IR imaging modality is enabled.
Fig. 110 – 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.
13.5.3 Default exposure value
Set the value (percentage) which defines the brightness of the TrueColor acquired image.
13.6 Patient data
Access the Settings|Patient data Screen to configure the patient data management options
(Fig. 111).
Fig. 111 – Settings|Patient data Screen Imaging modality and exposure
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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 7.7, 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 record 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.
13.7 Device Access
The Settings|Device access Screen (Fig. 112) allows you to configure the security options of
the Remote Viewer, including the communication protocol and the session duration.
Fig. 112 - 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 temporarily 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.
You can however upload a custom certificate instead of the default one: to install it, store it
into a USB device and plug it into the device, then press SELECT FROM USB and select the
proper file.To remove an installed custome certificate, press the REMOVE button to uninstall
it and revert back to the default device certificate.
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A custom certificate must fulfill the following conditions to be installed on the
Device:
• It must be an SSL certificate generated in PEM format
• The private key must not be protected by a passphrase
• It must contain the private key within the certificate file, like in the example file
below:
-----BEGIN RSA PRIVATE KEY----MIIEogIBAAKCAQEAvmKAUWO/Z0YJu8PMqOOOn1zTp9xHsJp4IRyytS9eMsTIJdxR
[...]
sfJw7OZ5bFPCBU+OfSEs24W4W/0Zad8xBveLSMt1jO45sfOPATI=
-----END RSA PRIVATE KEY---------BEGIN CERTIFICATE----MIIDlTCCAn2gAwIBAgIJAM9S1YMXAf/RMA0GCSqGSIb3DQEBCwUAMGExCzAJBgNV
[...]
3F5jTQf4s6+C
-----END CERTIFICATE-----
Specify the inactivity time for the session running on the Remote Viewer.
Fig. 113 - 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.
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
for security reasons to keep the Periodically check for online software updates always
enabled.
13.7.1 WebAPI
WebAPI are HTTP/HTTPS REST APIs that allow integration of the device with third-party
software.
WebAPIs allow:
• Patient data retrieval and management:
o Retrieval of a patient list (and search)
o Retrieval of visits list
o Retrieval of single patient record
o Retrieval of patient visits and images
o Patient creation
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o Patient editing
o Patient deletion
o Visit deletion
• Image data retrieval 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.
13.8 Export
Open the Settings|Export Screen (Fig. 114) to configure the parameters of the export function.
Fig. 114 - 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. 115 - Add new network export destination panel
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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).
Fig. 116 - 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 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)
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•
•
•
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.
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. 117 - 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. 17).
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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13.9 Printers
Access the Settings|Printers Screen (Fig. 118) to configure the printing subsystem.
Fig. 118 - 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. 119)
• Printers (Fig. 129 – “Printers” panel)
In the Administration Panel is possible to
•
•
•
Add a printer
Find new printers
Manage Printers
Fig. 119 - Administration panel
Press the Add Printer button in the Administration Panel shown in Fig. 119: after a while, the
panel Add Printer appears. In this panel, there are three sections:
• Local 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.
• Discovered Network Printers
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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
o
•
Fig. 120 – “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.
13.9.1 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.
121).
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Fig. 121 – “Printer Identification” panel pre-set with automatic detection information
In this panel can be set the Name, which is used in printer selection dialogue during image
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. 122 – “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. 123).
Fig. 123 – “Default Options Setting” panel, Banners tab
Fig. 124 – “Default Options Setting” panel, Policies tab
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.
12 The Set Default Options doesn’t influence the selection of the paper format set in Print Configuration pop-up
shown in §10.
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The Default Options Setting panel depends on the printer’s characteristics. In the case of a
multifunction printer, a panel like Fig. 125 can be presented.
Fig. 125 – 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.
13.9.2 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. 126).
Fig. 126 – “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. 121 appears. In this case, a name
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. 122, and it can be
configured as explained in §13.9.1. Also, in this case, press the Add Printer button to see the
Set Default Options for the selected printer (Fig. 123) as in §13.9.1.
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13.9.3 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. 127).
Fig. 127 – 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.
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
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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
format=f
format=o
format=p
mode=stream
order=data,control
reserve=none
reserve=rfc1179
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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).
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.
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Option
sanitize_title=no
sanitize_title=yes
timeout=seconds
Description
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).
13.9.4 Find New Printers
Pushing the Find Printers button in the Administration panel, the Available Printers panel is
shown (Fig. 128).
Fig. 128 – “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 §13.9.1, to configure it.
13.9.5 Printers panel
In the Printers panel, all the configured printers are listed (Fig. 129).
Fig. 129 – “Printers” panel
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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. 130).
Fig. 130 – “Printer” panel
Pushing the Maintenance button, a list of activities that can be done on the printer is shown.
Fig. 131 – Maintenance Activities list
•
Print test page
•
With this command, a test page is sent to the printer to check the
communication and printing capability
Clean Print Heads
•
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
o
o
Cancel all jobs running and waiting
Fig. 132 – Administration Activities list
Pushing the Administration button, a list of activities that can be done on the printer is shown.
• Modify printer
•
o The Configuration of the printer can be modified
Delete printer
o
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The printer can be deleted, after confirmation (Fig. 133)
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•
Set default options
o
Can modify the Default Options using the panel in Fig. 123 and Fig. 125
Fig. 133 – “Delete Printer” panel
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13.10 DICOM Functionality
Access the Settings|DICOM Screen (Fig. 134) to set the DICOM configuration.
Fig. 134 - Settings|DICOM Screen
DICOM is an international standard for distributing and viewing medical images and related
information. DRSplus supports DICOM13 and DICOMweb14 communications as specified in
the DICOM Conformance Statement document15. 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 The DICOMweb Feature for DRSplus is available under license only: please refer to your local Authorized
Distributor for detailed information.
15 Please refer to your local Authorized Distributor for the DRSplus DICOM conformance statement.
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13.11 iCare Cloud
Access the Settings|ICARE CLOUD Screen (Fig. 135) to set the iCare Cloud Interface.
Fig. 135 - Settings|ICARE CLOUD Screen
The iCare Cloud Interface is a service that allows a DRSplus to connect to the iCare Cloud
platforms. It enables the connection to iCare ILLUME and iCare ALTIUS platforms16.
Verify that
1. the device is connected to the Network, via Ethernet or 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 iCare ILLUME and iCare ALTIUS functionalities are available only under
license.
16
Please refer to your local Authorized Distributor for detailed information about the ILLUME product and license.
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13.11.1
iCare Cloud Registration
Click the START THE ICARE CLOUD REGISTRATION button to start the registration of the
device.
Fig. 136 - Registration PIN Screen
Push the START THE REGISTRATION button to confirm, push CANCEL to abort.
Register the device on the iCare ILLUME or iCare ALTIUS platforms using the Registration
PIN shown on the device (Fig. 136).
Fig. 137 Registration panel on the ILLUME platform
Push CLOSE on the Registration PIN screen to go back to the ICARE CLOUD screen.
When the iCare Cloud service is registered, a new icon appears on the Topbar of the
screen (see §12.1)
13.11.2
iCare Cloud options
When the iCare Cloud services are enabled, the ICARE CLOUD shows the name of the iCare
Cloud account connected, the upload status, the number of exams uploaded, and the status
of the service (see Fig. 138).
Function
Command
Push START UPLOADER to start the upload of the exams to
the iCare cloud service
Push PAUSE UPLOADER to stop the upload of the exams to
the iCare cloud service.
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Function
Command
Push VIEW THE UPLOAD QUEUE to open the iCare cloud
upload queue window (See Fig. 139).
Push UPLOAD HISTORICAL EXAMS to upload the exams
acquired before the activation of the iCare Cloud service
(available only for iCare ALTIUS).
Fig. 138 Registered
Fig. 139 Export queue
13.11.3
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 upload process is paused. The new exams will be in the queue and will be
uploaded as soon as the operator starts the upload.
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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.
13.11.4
iCare Cloud de-registration
The device can be associated with 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 iCare
Cloud account. Push CONFIRM to deactivate the connection, push CANCEL to abort the
operation.
13.12 Connections
Access the Settings|Connections Screen (Fig. 140) to configure the external connection
services.
Fig. 140 – Settings|Connections Screen
The connection Screen is a comprehensive way to see and edit the connection of the device
to third-party internet services. For OAuth 2.0 and DICOMweb refer to DRSplus DICOM
Manual.
The Connections tab appears when a DICOMweb license is active on the
device.
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14. Utilities
The Utilities Screen contains a set of functionalities to keep the device updated, manage the
data backup and ask for assistance (see Fig. 141).
Fig. 141 - Utilities Screen
To access the system Utilities Screen, click the UTILITIES button on the Control
center Screen.
14.1 Assistance
Access the Utilities|Assistance Screen (Fig. 142) to open a Remote Assistance (R.A.) session
or to export diagnostic data for technical troubleshooting purposes.
14.1.1 Remote assistance
The Remote Assistance allows an iCare/CenterVue operator to connect to the device.
Fig. 142 – Utilities|Assistance Screen
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Push OPEN REMOTE ASSISTANCE to open the Authorize remote
assistance by your own action pop-up (see Fig. 143).
Fig. 143 –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. 144).
Fig. 144 - Close remote assistance pop-up
Remote Assistance always requires an internet connection.
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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.
14.1.2 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. 145).
Fig. 145 – Upload Device Logs pop-up
Push UPLOAD DEVICE LOGS to start the logs transfer.
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. 13).
Push EXPORT DEVICE LOGS to select the USB disks (see Fig. 145).
Fig. 146 – Upload Device Logs pop-up
Touch the box of the USB DISK you want to use to highlight it (see Fig. 147) and then push
SELECT THIS DRIVE to start the logs export.
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Fig. 147 – 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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14.2 Backup
Access the Utilities|Backup Screen (Fig. 148) 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. 148 – 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. 149 – 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.
Fig. 150 - 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. 151).
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Fig. 151 - 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. 152).
Fig. 152 – Utilities|Backup Screen, Backup progress
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. 153).
Fig. 153 – 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.
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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
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.
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14.3 Restore
The Utilities|Restore Screen (Fig. 154) 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. 154 – 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. 155).
Fig. 155 - 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. 156).
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Fig. 156 - 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 §14.2). 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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14.4 Storage
The Utilities|Storage Screen (Fig. 157) 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. 157 – Utilities|Storage Screen
Click RESET PATIENT DATA to delete all patients and exams data
from the device. The Reset patient data pop-up appears (Fig. 158).
Fig. 158 - 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. 159).
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Fig. 159 – 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
welcome page. The Enable welcome page pop-up appears (Fig. 160).
Fig. 160 – 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 to 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. 161).
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Fig. 161 - 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. 162).
Fig. 162 - 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. 163) and the image acquisition is disabled.
Fig. 163 - Disk full pop-up
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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.
14.5 Licenses
Access the Utilities|Licenses Screen (Fig. 164) to manage optional licenses. It shows the
installed licenses on the device and allows to either revoke a license or to install a new one17.
Fig. 164 - 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. 164).
Click ACTIVATE LICENSE to manually activate a license. In the
Activate licence pop-up (Fig. 165). Insert the license code and push
ACTIVATE, or click CANCEL to abort the operation.
Fig. 165 – Activate License pop-up
17 Please refer to your local Authorized Distributor for requiring licenses
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Possible licenses are:
Remote viewer 1 client
Remote viewer 5 clients
Remote exam
Mosaic
Stereo acquisition
DICOM workflow
DICOMweb 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. 166).
Fig. 166 – 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.
Fig. 167 - Utilities|Licenses Screen, license revoked
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14.6 Update
Access the Utilities|Update Screen (Fig. 168) to install software updates and upgrades. The
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 preserved.
Fig. 168 - Utilities|Update Screen
14.7 Online updates
Push CHECK ONLINE FOR UPDATES. The Search for online
software updates pop-up appears (see Fig. 169).
Push CHECK ONLINE FOR UPDATES to allow the connection to the iCare/CenterVue
servers or click CANCEL to abort the operation.
Fig. 169 - 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 (see Fig. 170).
Fig. 170 - Online software updates panel
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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. 171.
14.7.1 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. 171.
14.7.2 Installation of the updates
The procedure is the same for the online and the USB updates.
Fig. 171 - Utilities|Update Screen, 1 update found
In the Utilities|Update Screen, push INSTALL THIS UPDATE.
Fig. 172 - Installation confirmation pop-up
In the Confirm the software update installation pop-up (see Fig. 172), click CONFIRM to
proceed with the installation or click CANCEL to abort the operation.
The Software update appears (Fig. 173). Wait until the end of the update or click CANCEL
INSTALLATION to abort the operation.
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Fig. 173 - Software update Screen
At the end of the update, the Device Updated Screen appears (Fig. 174). Push START to
verify the setup configuration described in §6.2 and start using the device.
Fig. 174 – Device Updated screen
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14.8 Other
The Utilities|Other Screen (Fig. 175) 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. 175 - Utilities|Other Screen
14.8.1 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.
14.8.2 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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15. 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. 176 - Power off pop-up
Click SCREENSAVER to close the current session and pause the device. The Screensaver
Screen appears (Fig. 177). Push anywhere on the Screen to open the Login Screen (§6.3).
Fig. 177 - 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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16. Cleaning and disinfection
This section explains how to clean and disinfect the device.
The cleaning process is described as follows:
1. Clean the Touchscreen display and the device’s exteriors: use a clean lint-free
microfiber tissue dampened with small amount of water (i.e. tap-water).
2. Clean the headrest silicone cushion with a clean lint-free microfiber tissue dampened
with small amount of water after each use. The cushion can also be removed and
washed with water and/or a mild hand detergent.
3. Clean the other possible contact parts of the device with the user or patient (e.g. plastic
covers, display and any optional components) using the a clean lint-free microfiber
tissue dampened with small amount of water or a mild hand detergent.
4. Clean the front lens (only if really needed) using a clean lint-free microfiber tissue or
photographic cleaning paper dampened with a standard lens cleaning solution. Start
from the center of the lens, wipe it with a circular movement, very slowly, only for one
complete rotation. The exiting movement (i.e. moving away from the lens) has to be
made radially, towards the border. Do not reuse the same wiping cloth area after one
pass.
5. Allow all surfaces to dry before starting another exam.
The disinfection process should be done after each use and is described as follows:
1. Clean the headrest silicone cushion with a disinfecting wipe with 70% isopropyl alcohol
(IPA).
2. Disinfect all the other contact parts using a disinfecting wipe with 70% IPA (or a soft
clean disposable tissue damped with 70% IPA solution): plastic covers, frame and back
panel of the touchscreen display, and optional components if present.
3. Clean the front lens: use a disinfecting wipe with 70% IPA (or a soft clean disposable
tissue damped with 70% IPA solution). Starting from the centre of the lens, wipe it with
a circular movement, very slowly, only for one complete rotation. The exiting movement
(i.e. moving away from the lens) has to be made radially, towards the border. Do not
reuse the same wipe area after one pass.
4. Allow all surfaces to dry before starting a new exam.
Do not reuse the same area of the wiping tissue after one pass.
Do not use disinfectant wipes containing bleach.
Do not allow the liquid from the disinfecting wipe to sit or pool on the area being
disinfected for a long amount of time.
Do not use rough towels or cloths to dry the area.
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17. Maintenance
The Manufacturer recommends the periodic maintenance of the device once a year. Only
properly qualified Authorized Service Technicians can perform maintenance activities18 (for
example cable checking, motor greasing, SW updates). Contact the Authorized Service
Center for the maintenance.
To clean the front lens in case of dirt, refer to §16. To check the disk space, refer to §14.4, to
check for Software updates, refer to §14.7.
18
DRSplus has no user serviceable internal parts. Only technicians authorized by CENTERVUE S.P.A may perform maintenance
or repair procedures other than those described in these Instructions for Use.
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18. Electromagnetic Compatibility
DRSplus complies with the requirements of Class B 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.
18.1 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.
Test Requirements
Class A or B
Group
CISPR 11, 14-1, 32 or ISO 7137
Conducted RF emissions
Radiated RF emissions
Disturbance Power (if applicable)
Harmonic Distortion IEC 61000-3-2
(Class A, B, C, D)
Voltage Fluctuations and Flicker IEC
61000-3-3
IEC 60601-1-2 EMISSION TEST
Test
Compliance
Electromagnetic environment - Guidance
Result
B
Yes
DRSplus uses RF energy for its internal
function. Therefore, its RF emissions are very
1
Yes
low and not likely to cause any interference in
CISPR
Yes
nearby electronic equipment.
11
DRSplus is suitable for use in all
CISPR
establishments, including domestic and those
Yes
11
directly connected to the public low-voltage
Class B
supply network that supplies buildings used for
CISPR
domestic purposes, providing the following
11
Yes
warning is heeded:
Class B
N/A
N/A
DRSplus is intended for use by healthcare
Class A
Yes
Passed
Yes
professionals only. DRSplus may cause radio
interference or may disrupt the operation of
nearby equipment. It may be necessary to take
mitigation measures, such as re-orientating or
re-locating DRSplus or shielding the location.
Table 12 – Electromagnetic Emissions
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18.2 Guidance and manufacturer declaration – electromagnetic immunity
IEC 60601-1-2 ELECTROMAGNETIC IMMUNITY
Test Requirements
Test Result
Electrostatic Discharges
Passed
Radiated RF EM Fields
Professional Healthcare
Facility Environment
and Proximity Wireless field
(IEC 60601-1-2)
Electrical Fast Transients and bursts
Passed
Surges Conducted Disturbances,
Passed
induced by RF fields
Voltage Dips and Interruptions
Passed
Rated Power-frequency Magnetic
Passed
Field
Compliance
Yes
Yes
Yes
Yes
Yes
Yes
Table 13 – Electromagnetic Immunity (IEC 60601-1-2:2014) of the DRSplus
18.3 Immunity pass criteria
IMMUNITY
Function
System functioning – main unit
IMMUNITY pass criteria
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
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 S.P.A.). Otherwise, degradation
of the performance of this equipment could result.
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800MHz to 2.5 GHz
d = 1.17√P
d = 1.17√P
d = 1.17√P
0,01
0.12
0.12
0.12
0,1
0.37
0.37
0.37
1
1.17
1.17
1.17
10
3.70
3.70
3.70
100
11.70
11.70
11.70
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
power rating of the transmitter in (W) according to the transmitter manufacturer.
NOTE 1: At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflections from structures, objects and people.
Rated maximum output power
of transmitter
Table 15 – Recommended Separation Distances
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18.4 Wi-Fi specifications
Wi-Fi specifications
Model Name
Main Chipset
Product Description
Radio ON/OFF Control
IEEE WLAN Standard
Frequency Range
Host Interface
Operation Voltage
Operating Range
Authentication
Encryption
AW-CB161H
RTL8821AE
IEEE 802.11 a/b/g/n/ac Wi-Fi with Bluetooth 4.0 class I Combo
Supported in both hardware and software
IEEE 802.11abgn, 802.11ac, 802.11d, 802.11e, 802.11i, 802.11h, 802.11w
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
Wi-Fi PCI-E , BT : USB
3.3V +/-9%
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)
WEP, WPA, WPA2, WPA2 802.1X
64-bit and 128-bit WEP, AES-CCMP, TKIP
18.5 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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19. Technical Specifications
Technical specifications are reported in the next table19.
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:
Hard Drive:
Interfaces
Export / Import:
Remote Viewer**:
Acoustic emission:
Size:
Weight:
Device Power supply and
consumption:
External power supply:
Class and type of applied
part:
IP classification:
Integrated 10.1” (1280 x 800) Color, Capacitive, Multi-touch
SSD ≥ 480 GB
USB port 2.0 x 3, Gigabit Ethernet Port x 1
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”
11 Kg (24.3 lbs)
Voltage 12V DC
Device Power Consumption 25W 25VA
Input: Related voltage 100-240V ~ Frequency 50-60 Hz 2A
Output: 12.0V DC 5.42A
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
19
Specifications are subject to change without notice for improvement, as a result of ongoing technical
development.
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20. Disposal
DRSplus is made of different materials, such as plastics, aluminium, and 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.
20.1 Separate collection of electrical and electronic equipment
The European Directive 2012/19/EU establishes separate collections 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, and affects the endocrine system, the
cardiovascular system and the 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, and 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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21. Log of Document Changes
IFU version
14.01
14
138
Description
Fixed Minor Bugs
Change of the UI appearance, introduction of
DICOMweb, introduction of the support to WPA2
802.1x authentication, introduction of the
electronic Instructions for Use
IFU Release date
Software
version
09-07-2024
3.0.1
24-02-2024
3.0.0
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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. 178). 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.
Fig. 178 – 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 on 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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