1. Manuals
  2. Brands
  3. CenterVue Manuals
  4. Medical Equipment
  5. Icare DRSplus
  6. User manual

CenterVue Icare DRSplus User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
DRSplus
User manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Icare DRSplus and is the answer not in the manual?

Questions and answers

Related Manuals for CenterVue Icare DRSplus

Summary of Contents for CenterVue Icare DRSplus

  • Page 1 DRSplus User manual...

  • Page 3: Manual Information

    May 24 , 2023 Revision number: 13 Software Version: 2.2 Reference device: DRSplus (REF: AXSDRME100) Copyright © 2023 CenterVue Spa. All rights reserved. CenterVue S.p.A. Via San Marco 9h, 35129 Padova – ITALY www.icare-world.com iCare DRSplus User Manual - EN...

  • Page 4: Table Of Contents

    CONTENTS INTRODUCTION ......................8 LABELS, SYMBOLS AND DEFINITIONS ..............9 ......................... 9 ABELS ................10 YMBOLS USED ON THE DEVICE .............. 10 THER SYMBOLS FOUND IN THIS MANUAL ....................... 11 EFINITIONS DEVICE DESCRIPTION ....................12 SAFETY INFORMATION ..................... 15 FIRST USAGE ......................17 ................
  • Page 5 7.2.4 Exposure ....................... 39 7.2.5 Retinal fields ....................40 ..............42 UTOMATIC ACQUISITION OF IMAGES ....................44 ANUAL MODE ................47 XTERNAL EYE EXAMINATION ....................47 TEREO MODALITY REVIEW THE PATIENT VISITS .................. 48 ....................49 MAGE REVIEW ................52 OMPARISON OF TWO EXAMS 8.2.1 Side-by-side Image review ................
  • Page 6 DEVICE SETTINGS ....................79 12.1 ......................79 CCOUNT 12.2 ....................... 80 SERS 12.3 ......................83 ETWORK 12.4 ....................85 ATE AND TIME 12.5 ......................... 86 12.5.1 Fixations ......................86 12.5.2 Default imaging modality ................87 12.5.3 Default exposure value .................. 87 12.6 .....................
  • Page 7 13.8 ......................127 THER 13.8.1 Demo dataset ....................127 13.8.2 Optical head position ................... 127 POWER OFF......................128 CLEANING ......................129 MAINTENANCE ..................... 130 ELECTROMAGNETIC COMPATIBILITY ............... 131 17.1 EMC D IEC 60601-1-2 ....131 ANUFACTURERS ECLARATION ACCORDING TO 17.2 –...

  • Page 8: Introduction

    1. Introduction Congratulations for choosing DRSplus and its confocal retinal imaging capabilities. DRSplus is a fundus imaging device, based on a confocal scanning imaging system, which uses infrared and visible light to obtain confocal images of the retina. DRSplus works with DRSplus Software, and it operates as a standalone unit. DRSplus is intended for the acquisition of retinal images with or without a mydriatic agent and their review.

  • Page 9: Labels, Symbols And Definitions

    2. Labels, Symbols and Definitions 2.1 Labels Device information such as device model, serial number, manufacturing date and UDI barcode are reported in the label located on the back side of the display, as shown in Fig. 1: please do not remove it.

  • Page 10: Symbols Used On The Device

    2.2 Symbols used on the device The meaning of the symbols adopted in the device label and on the device back panel is as follows: Symbol Explanation Information about the Manufacturer. Manufacturing date (year-month). DRSplus identifier (catalogue number–product code). DRSplus is a Medical Device. DRSplus Serial number.

  • Page 11: Definitions

    2.4 Definitions Word Explanation Device The synonym of DRSplus used in this User Manual. Any image retinal acquisition session performed using the DRSplus Exam for a certain patient on a certain date. External eye The examination mode involving the acquisition of images of the examination ocular surface instead of the retina.

  • Page 12: Device Description

    3. Device description DRSplus consists of: • 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.
  • Page 13 Headrest Touch screen Patient side End-user side Back panel (with shell) Fig. 7 – DRSplus Power supply connector USB ports Ethernet port DisplayPort Device power status Power button Fig. 8 – Back Panel iCare DRSplus User Manual - EN...
  • Page 14 DRSplus can be optionally equipped with: • External fixation target (Fig. 9); • Prismatic goggles for stereo view (Fig. 10); see §7.6 to have more details on the stereo view functionality. Fig. 9 – External fixation target Fig. 10 – Prismatic stereoscopic goggles For a list of all components included with DRSplus, please see the Content List documents in the device package DRSplus User Manual - EN iCare...

  • Page 15: Safety Information

    4. Safety Information The following precautions and warnings are important to use the device in safety: • Do not use DRSplus if the covers or other parts of the device have been removed. • Avoid all contact with water: risk of fire or electric shock. •...
  • Page 16 When in operation, DRSplus contains Personal Data. The following precautions for the End-users and the Responsible Organization are important to control the risks related to network interfaces, data protection and cybersecurity. • It is the end user’s responsibility to keep and maintain an updated copy of the data generated by DRSplus through regular use of the backup facility, thus preventing the risk of accidental loss of data.

  • Page 17: First Usage

    5. First usage This section explains how to set up DRSplus for use. 5.1 Preparation of the device Carefully read chapter 4 before proceeding to the device operation. To prepare DRSplus for the first usage: • Take the device out of its shipping box and place it onto a suitable table; •...

  • Page 18: Configuration Wizard

    Fig. 12 – Back panel with cables protection shell 5.2 Configuration wizard Turn on the device by pressing the power switch button: upon the first power-on of the device, the Configuration Wizard will appear (Fig. 13). Use the button located near the top-right corner of the screen to temporarily skip the Configuration Wizard and go straight to the login screen.
  • Page 19 Select the country in which you use the device. Fig. 14 - Country selection Read and approve the End-user License Agreement (EULA) (Fig. 15). The EULA language changes according to the selected Country. Different types of EULA are defined for EU and EFTA, USA or Other Countries. You must approve the EULA to continue the configuration and use the DRSplus.
  • Page 20 Fig. 16 - Language selection Set the current time zone (Fig. 17). An initial time zone is suggested according to the selected country. Fig. 17 – Time zone Set the current date and time and configure their format (Fig. 18). Fig.
  • Page 21 Create the local Administrator account by selecting username and password (Fig. 19). The username must contain at least 4 characters . The password must contain at least 6 characters. You can select the interface Language for such a user. Fig. 19 – Administrator account creation Optionally create an Operator account (Fig.
  • Page 22 Fig. 21 - Online services configuration Save the configuration (Fig. 22) Fig. 22 - Save configuration Wait for the device configuration (Fig. 23). Fig. 23 - Device configuration DRSplus User Manual - EN iCare...

  • Page 23: Login Screen

    Start using the device (Fig. 24) Fig. 24 - End of the Configuration Wizard 5.3 Login Screen Turn on the device by pressing the power switch button (Fig. 8). When the boot is completed, the Login Screen will be shown (Fig. 25). Fig.

  • Page 24: Preparation Of The Patient

    5.4 Preparation of the patient This paragraph is dedicated to patient preparation before taking retinal images with DRSplus. There are no specific restrictions based on the type of patients that can be examined with DRSplus. The acquisition of retinal images 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.

  • Page 25: Acquisition Of Retinal Images

    5.5 Acquisition of retinal images After the login, the Patient List Screen will appear as in Fig. 26. Fig. 26 - Patient List screen Push the new patient button to open the New patient Screen (see Fig. 27). Fig. 27 - New Patient screen Fill in the mandatory and optional fields and SAVE the new patient.
  • Page 26 Fig. 28 - Exam Configuration screen Push START EXAM to acquire the retinal images according to the default options shown on the screen. Alternatively, configure any of the following parameters • the fields you want to acquire by pushing the related locations on the reference image; •...

  • Page 27: Review Of The Acquired Exam

    5.6 Review of the acquired exam After the acquisition, the Patient details Screen appears (see Fig. 29). Fig. 29 - Patient details screen From this screen, you can immediately review the exam with all the acquired retinal images. Function Command New exam (§8.2.2) New mosaic (§8.4) Export patient (§9)

  • Page 28: Patient Database

    6. Patient database Upon the login, the Patient List Screen appears, as shown in (Fig. 30). You will find the patients sorted from the last updated data. This is the entry point for each activity of the DRSplus: you can insert, review, export, delete patients from this Screen. Fig.

  • Page 29: Insert A New Patient

    Fig. 31 - Search functionality In the settings, activate Privacy Mode (see §6.6 for details) to hide patients’ Surname and Name. They will be replaced by the first letters followed by asterisks. On the right side of the screen, the following buttons appear: Function Command New patient (§6.1)
  • Page 30 Fig. 32 - New patient Screen Type on the keyboard to fill Surname, First name, Patient ID and Notes. Use the numeric pad or push the calendar icon to insert the Birth date. Push MALE, FEMALE, OTHER to select the Gender. Press SAVE to save the new patient or CANCEL to cancel the operation. To browse back to the Patient List, press the Patients icon located on the top left side of the screen Whenever patient data are similar to those of an existing patient, the Duplicate record pop-up...

  • Page 31: Select Patients

    6.2 Select patients Press Select, or keep pressing the patient’s info, to activate the Select functionality. Fig. 34 - Select functionality A box appears at the left of each patients’ thumbnail (see Fig. 34). After ticking at least one box, you can Export or Delete the selected patients. Click Cancel to close the selection. Function Command Merge (§6.6)

  • Page 32: Export Patients

    Alternatively, open the Patient details screen (see §8), press the ellipsis and then the Delete button. Press CONFIRM to delete the patient, CANCEL to return to the Patient List Screen, where your selection remains active. 6.4 Export patients Select the patients to export and click the Export button on the right panel. The Export Screen will appear (see Fig.

  • Page 33: Patient Merge

    Fig. 37 – Edit Patient Panel If the edited patient data are similar to those of already existing patients, the Duplicate Patient Panel will warn you about a possible duplication (see Fig. 38). Press MERGE WITH THIS RECORD to merge the edited patient with an existing one. Press OPEN THIS RECORD to exit the Duplicate Patient Panel box and open the related Patient details Screen.

  • Page 34: Privacy Mode

    Select which patient you want to keep by clicking the patient’s box. The highlighted patient receives the data of the non-highlighted one (see Fig. 40). Fig. 40 – Merge patients Panel, selected patient Click CANCEL to abort the operation, click PROCEED to merge the patients. To complete the merge, which is an irreversible operation, click CONFIRM on the Merge patients pop-up.
  • Page 35 Press the privacy mode ON button to hide the patients' information. iCare DRSplus User Manual - EN...

  • Page 36: Acquisition Of Retinal Images

    7. Acquisition of retinal images This section explains how to acquire high-quality retinal images using DRSplus. 7.1 Start of the acquisition To start the acquisition process, open the Patient List Screen and then you can: • select an existing patient; •...

  • Page 37: Insert A New Patient

    7.1.2 Insert a new patient press the New patient button to add to create a new patient (see §6.1). Fill in the data and SAVE. Push the new exam button to access the Exam Configuration Screen. 7.1.3 Fast exam Push the Fast exam button in the Patient List Screen to directly start an examination and postpone the insertion of the patient data.

  • Page 38: Eye Selection

    Fig. 44 - Exam mode selection Select the Automatic mode to make DRSplus automatically perform the examination according to the exam settings (§7.3). Select the Manual mode to directly control the movement of the device in front of the eye, adjust the focus and select the fields and the imaging modality (§7.4).

  • Page 39: Exposure

    The IR functionality is not available for devices with a serial number starting with K. 7.2.4 Exposure The control of the Exposure is available for the TrueColor images. Find the default Exposure percentage value in the Exposure box. The default value is 100%. Use the Exposure slider to decrease or increase the exposure level to get a darker or brighter image, respectively.

  • Page 40: Retinal Fields

    7.2.5 Retinal fields Find the default acquisition fields marked by a white-filled circle in the retina map (see as an example Fig. 49). In the example, CENTRAL and CENTRAL NASAL are selected, 3D and INFERIOR NASAL are deselected. Every selected field corresponds to a specific position of the internal green fixation target.
  • Page 41 • The configuration of many fields ends in different portions of the retina being acquired. Such fields can be stitched together using the Mosaic feature (See §8.4). • Use the live view on the top left box to visualize the position of the patient’s pupil.

  • Page 42: Automatic Acquisition Of Images

    7.3 Automatic acquisition of images After you click START EXAM, DRSplus automatically: • Aligns the frontal lens toward the patient’s pupil; • Performs the autofocus of the retina to correct spherical errors; • Flashes the patient’s retina and acquires one or more images according to the number of selected fields;...
  • Page 43 Information Position on the screen top left corner of the image box Current image acquisition information (OD or OS; TrueColor or Infrared; progressive image number for the exam) Live image of the retina, acquired using infrared light At the center of the screen Position of the internal fixation target for the patient Green dot Top right text...

  • Page 44: Manual Mode

    7.4 Manual mode Press the Manual Mode button to be able to manually adjust the automatic control of the device. Fig. 51 - Manual mode configuration Screen The Manual mode configuration Screen will appear (see Fig. 51). Select OD to acquire the right eye, OS for the left eye. Push START EXAM The Manual mode Screen appears.
  • Page 45 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.
  • Page 46 Information Position on the screen Disable Alignment to manually control the alignment. Move the XY cursor up, down, left or right to move the optical head consequently. Move Z upwards or downwards to approach or recede from the patient’s eye. Push Autofocus to activate the autofocusing procedure.

  • Page 47: External Eye Examination

    7.5 External eye examination Set External Eye modality to automatically acquire a TrueColor image of the external surface of the eye (see Fig. 53). Fig. 53 – Image of the external surface of the eye 7.6 Stereo modality Select the 3D modality to automatically acquire a couple of TrueColor retinal images using either the nasal or central fixation target.

  • Page 48: Review The Patient Visits

    8. Review the patient visits Click on a patient’s data to enter the Patient details Screen, as in Fig. 54 Fig. 54 - Patient details screen On the left side, you find the patients’ information and the thumbnails of each visit with the date and the number of acquired images.

  • Page 49: Image Review

    Touch the ellipsis (⁝) button on the right of the visit date box to export (see §6.4) or delete the visit. Function Command New exam (§8.2.2) New mosaic Export patient (§9) Select (§6.2) 3D Stereo review retake Table 6 - Available functions of the Patient details The Export queue button shows the status of the Export.
  • Page 50 Fig. 55 - Image review The top left corner shows the information of the acquisition conditions: • Eye and image modality • Field/Mosaic/External Eye • Visit date and acquisition time • Estimated pupil size • Filter settings (only in case of a filtered image) •...
  • Page 51 Function Command all patient items comparison of two images (§8.2) 3D stereo review Show the images acquired with the 3D modality for a stereo review (see §7.6) export export the current view of the image. See §9 for more information. filters Table 7 - Available functions of the Image Review iCare...

  • Page 52: Comparison Of Two Exams

    8.2 Comparison of two exams To compare the currently shown exam with another one: • push the all patient items button to open a panel on the Image Review screen, as in Fig. 57. Fig. 57 - All patient items screen •...

  • Page 53: Visual Flickering Of 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 visualize a single patient image. Press flicker to activate the flickering review modality. (§8.2.2) Flicker is available on images of the same eye.

  • Page 54: Image Adjustment

    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.

  • Page 55: Mosaic Creation

    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 channel- filtered image. Click RESET any time to restore the image at the original acquisition condition.
  • Page 56 Press the CREATE MOSAIC button to start the stitching, press CANCEL to abort the Mosaic and return to the Patient details Screen. Once you have pushed CREATE MOSAIC, DRSplus will generate the mosaic automatically and will save it as a new image, available in the Patient Details screen. Fig.

  • Page 57: Stereo Review

    images are stitched together. These artefacts can be easily recognized by looking at the original images. 8.5 Stereo review Press 3D Stereo review to open the Stereo Review Screen (see Fig. 64) Fig. 64 - Stereo Review Screen Two zoomed regions of the two views appear on the screen. Wear the prismatic goggles (refer to Fig.

  • Page 58: Exporting Images

    9. Exporting images DRSplus offers extreme flexibility in exporting images. From the Export Screen, in detail, you can: • simultaneously export all images of one or more patients (§6.4, 8.2); • export or print a single image (§8.1); • configure (§12.8) one or more destinations, including USB and network drives; •...
  • Page 59 Paper Size: A4, A5, letter Number of images per page: 1, 2, 4 Enable Anonymize patient data to export all the patients with masked information: Disable Anonymize patient data to export the patients with their information. See the PDF preview on the right side of the screen. You can scroll through all the generated pages.

  • Page 60: Export A Zoomed Image

    Fig. 66 - Error during export 9.1 Export a zoomed image When you zoom on an image during the review (see §8.1) and you want to export the zoomed view, click the EXPORT button and the Export Cropped View Screen appears. Fig.

  • Page 61: Review Exported Images

    9.2 Review exported images Review the exported images on your device. See an example of an exported pdf report in Fig. 68, where two images per page have been exported. The headings contain the patient data and notes. Fig. 68 — Example of pdf report of an exam iCare DRSplus User Manual - EN...
  • Page 62 The following figure shows the Pdf report of an anonymized export of a cropped, filtered image. Fig. 69 - PDF report of a cropped, filtered image The width of the image corresponds to the zoomed view of the image at the moment of export. The information on the color channel filter is indicated in the top right box of the header.
  • Page 63 • Date of birth (DD/MM/YYYY, if present) -> 01/01/YYYY • Gender -> Gender The patient ID is removed. You can always retrieve the patient’s visits starting from an anonymized export. Input the complete UUID in the search box of the Patient List Screen, as shown in Fig. 70. Fig.

  • Page 64: Remote Viewer

    10. Remote Viewer Remotely review the whole patient database and all the images stored into DRSplus memory employing any standard PC connected in the same Local Area Network of the DRSplus. In the Remote Viewer, you retrieve all the same screens and functionalities available in the local interface, plus some additional features.

  • Page 65: Remote Exam

    • The Remote Viewer requires a standard Web Browser and does not require any additional third-party software to be installed in the remote computer. • The Remote Viewer is tested on the latest release of the following browsers Google Chrome, Mozilla Firefox, Microsoft...
  • Page 66 The Remote Activation Code will be shown on the display of the DRSplus. Fig. 71 – Remote Activation Code showed on DRSplus display Insert the Remote Activation Code on the remote exam interface. The Remote Exam activation code is requested only the first time the operator starts an exam from a Remote Viewer station.

  • Page 67: Export And Print From Browser

    10.3 Export and print from browser Fig. 73 – Remote viewer export From the Remote Viewer, in the Export Panel, you can download it on your PC or print through a printer connected with your PC. Select Download to browser and then push DOWNLOAD TO BROWSER to export the selection on your PC.
  • Page 68 Click on the first point of the disc or of the Click on the corresponding end-point. cup. Locate the starting point of the second Locate the corresponding end-point. segment. The Cup to disc ratio is always calculated as a value lower than 1, independently from the order of design of the segments.

  • Page 69: Shortcuts

    The cup to disc ratio is reported on the top left side of the image (see Fig. 74). Note that you can anytime edit the selected points and the CDR will correspondingly be updated. 10.4.2 Shortcuts Fig. 75 – Shortcuts in the remote Image Review Screen In the Image Review Screen of the Remote viewer push the question mark to discover the Keyboard shortcuts.

  • Page 70: Device Controls

    11. Device controls 11.1 Navigation Bar Upon the login, the Navigation Bar shown in Fig. 77 appears on all the screens. Find the date and time at the right of the Navigation Bar. Fig. 77 – Navigation Bar The Navigation Bar functionalities follow: Function Command Menu...

  • Page 71: Dashboard

    Function Command Speakers volume Set the volume of the audio notifications. Control center Open the Control center Screen including Configuration (§11.2) and Utilities tools (§12.11.2) Table 9 - Navigation bar options 11.2 Dashboard To access the Dashboard Screen, click the Dashboard button on the Navigation Bar. Fig.
  • Page 72 Click the Dashboard icon in the Navigation Bar to view the last notifications Fig. 79 – Examples of toasts for warning and error categories Click HIDE ALL to close the toast. In this case, the notification is marked as viewed. In case of critical errors, the notification is displayed as a blocking pop-up like the following: Fig.

  • Page 73: Control Center

    Fig. 81 – Notifications list Panel After a critical notification, the dashboard icon remains highlighted. From this panel, all the notifications can be marked as viewed. 11.3 Control Center To access the Control center Screen, click on the Control center icon in the Navigation Bar.

  • Page 74: Maintenance

    11.4 Maintenance The Maintenance Screen contains two logs viewers, the System and the Audit logs (see Fig. 83), which are useful for service purposes. To access the Maintenance Screen, click the MAINTENANCE button on the Control center Screen. Fig. 83 – Maintenance Panel 11.4.1 System logs The System Logs Screen shows the logs generated by either the operating system or the application software.
  • Page 75 Warning: message informing about situations that might have an adverse performance implication. Error: messages that inform about serious errors that anyway might allow the application to continue running. Critical: messages that inform about severe errors that can cause the application to terminate.

  • Page 76: Audit Logs

    Fig. 85 – System Logs Record Details Dialog 11.4.2 Audit logs The Audit logs Screen shows the activities performed on the device’s interface (see Fig. 86). Fig. 86 – Audit Logs Panel For each activity, the Status code shows the operation result, which can be either or error.

  • Page 77: About Screen

    Input a specific text in the Search field and then press SEARCH to find it. Press RESET to restore the default view. Click on a specific record, to open a pop-up showing the related details (see Fig. 87). Push CLOSE to revert to the Audit logs Screen. Fig.
  • Page 78 Fig. 88 – About Screen, About and Storage Fig. 89 - About Screen, Device usage DRSplus User Manual - EN iCare...

  • Page 79: Device Settings

    12. Device Settings To access the Settings Screen, click the Settings button in the Control center Screen. The menu on the left allows access to various configuration panels, described below. Some configuration panels are accessible or restricted, according to the user level. Fig.

  • Page 80: Users

    12.2 Users The Settings|Users Screen (Fig. 92) manages (creation, modification and deletion) the user accounts. It is accessible only by the Administrator. Fig. 92 - Settings|Users Screen • The username must contain at least 4 characters • The password must contain at least 6 characters For each user can be also generated the WebAPI token.
  • Page 81 Fig. 94 - Edit the user Panel You can change the Username, the Roles, the Language, Enable or Disable the Remote Exam Functionality and De-activate the user. Click SAVE to save the changes, click CANCEL to abort the editing operation. Click RESET PASSWORD to open the Reset user password panel (Fig.
  • Page 82 Fig. 96 - Creation of a custom role Panel The two preset users Administrator and Operator have the permissions indicated in the next table. Permission admin operator Anonymized patient data view Patient data view Patient data edit Exam parameters configuration Exam execution and mosaic composition Patient data export on a pre-configured destination Patient data download and export to a USB drive...

  • Page 83: Network

    Permission admin operator Licence revocation Security and device access configuration Table 10 – Permissions of the admin and operator users. 12.3 Network Open the Settings/Network Screen (Fig. 97) to configure the network connection. Specify the primary network interface between Ethernet and Wi-Fi. Fig.
  • Page 84 Press the ellipsis (⁝) at the right of the Wi-Fi box. Click CONFIGURE to edit the Wi-Fi properties, DISCONNECT to remove the device from the current Wi-Fi network, RADIO ON/RADIO OFF to enable or disable the Wi-Fi. Push SEARCH WI-FI NETWORKS to scan for available Wi-Fi networks.

  • Page 85: Date And Time

    Function Command Disconnect the device from the current Wi-Fi network Scan for available Wi-Fi networks Table 11 - Available functionalities To check the network connection status, click on the icon in the top bar (Fig. 101). Fig. 101 – Example of wired and Wi-Fi network connection status 12.4 Date and time Access the Settings|Date and time Screen (Fig.

  • Page 86: Exam

    Fig. 103 - Select a time zone Panel In the Date and time format section, set your preferred formats. To provide the date and time to the device via an NTP server, push the CONFIGURE button in the Local NTP server section and insert the NTP server address. 12.5 Exam Access the Settings|Exam Screen (Fig.

  • Page 87: Default Imaging Modality

    12.5.2 Default imaging modality It appears only if the IR imaging modality is enabled. DRSplus devices with a serial number starting with K don’t have the IR functionality (see §2.1 for the label position). Fig. 105 – Settings|Exam Screen Imaging modality and exposure Possible options are: •...

  • Page 88: Device Access

    Fig. 106 – Settings|Patient data Screen Imaging modality and exposure Set the Mandatory patient fields to fill when creating or editing a patient record. At least one field among Surname, First name, and patient ID must be selected. An error message appears if you attempt to disable all the possible mandatory fields. The Privacy mode setting allows enabling the privacy mode.
  • Page 89 Fig. 107 - Settings|Device access Screen For the Local Interface, select the inactivity time on the dropdown menu after which the device will log out the user. Activate or deactivate a screensaver when the inactivity time has expired. To resume work, you have to log in again. For the Remote Viewer, select the communication protocol.

  • Page 90: Webapi

    for security reasons to keep the Periodically check for online software updates always enabled. 12.7.1 WebAPI WebAPI are HTTP/HTTPS REST APIs that allow integration of the device with third- parties software. WebAPIs allow: • Patient data retrieve and management: o Retrieve of a patient list (and search) o Retrieve of visits list o Retrieve of single patient record o Retrieve of patient visits and images...
  • Page 91 Fig. 109 - Settings|Export Screen, Network Export destination section Push ADD NETWORK DESTINATION to open the Add new network export destination Panel and define the shared folder. Fig. 110 - Add new network export destination panel Insert the Server IP or hostname and the Shared folder, optionally fill the other fields. You can enable or disable the destination and the automatic export of completed exams.
  • Page 92 Fig. 111 - Settings|Export Screen, the Export path settings section Separately customize the PATIENT FOLDER NAME, the FILE NAME and the FILE NAME SEPARATOR. Default Filename formats are: Single-image file name The default file name is composed as follows: [Surname]_[FirstName]_[PatientID]_[Eye]_[Field]_[ImageType]_[ImageDate]_[ExportingDate ]_[ExportingDateMicroseconds].[FileExtension] Example: Doe_John_ABC123_OD_central_color_2020-09-23_175010_2020-11-...
  • Page 93 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]...

  • Page 94: Printers

    12.9 Printers Access the Settings|Printers Screen (Fig. 113) to configure the printing subsystem. Fig. 113 - Settings|Printers Screen The Configured printers section shows the already set printers. Click on the ellipsis at the right of this box to REMOVE or CONFIGURE the printer. Click CONFIGURE PRINTERS to add, edit and remove printers.

  • Page 95: Add Printer - Local Printer

    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 o In this section will be shown the printers available on the network, if correctly detected.
  • Page 96 Fig. 116 – “Printer Identification” panel pre-set with automatic detection information In this panel can be set the Name, that is used in printer selection dialogue during images printing, a Description, the location of the printer (in this case can be Local Printer) and a check box to set if this printer can be shared in the network with other devices.
  • Page 97 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 shown (Fig. 118). Fig. 118 – “Default Options Setting” panel, Banners tab Fig. 119 – “Default Options Setting” panel, Policies tab The Set Default Options doesn’t influence the selection of the paper format set in Print Configuration pop-up shown in §9.

  • Page 98: Add Printer - Network Printer

    In this panel, three tabs are present: General, Banners and Policies. With the General tab, the Paper Size, Media Type and Ink can be set. The Default Options Setting panel depends on the printer’s characteristics. In the case of a multifunction printer, a panel like Fig.

  • Page 99: Add Printer - Other Network Printers

    indicating that this is a network printer and the Location indicating the physical position of the printer are suggested. The following panel is the Printer model selection panel shown in Fig. 117, and it can be configured as explained in §12.9.1. Also, in this case, press the Add Printer button to see the Set Default Options for the selected printer (Fig.
  • Page 100 Internet Printing Protocol (IPP) For this protocol the device URIs have the following structures: http://ip-address-or-hostname:port-number/printers/name/.printer ipp://ip-address/ipp/print ipp://ip-address-or-hostname/printers/name ipps://ip-address/ipp/print ipps://ip-address:443/ipp/print ipps://ip-address-or-hostname/printers/name The protocol supports many options, which are summarized in the following table. IPP URI Options Option Description contimeout=seconds Specifies the number of seconds to wait for the connection to the printer to complete (default 1 week or 604800 seconds).

  • Page 101: Find New Printers

    Option Description format=f Specifies that the print data is a plain text file. format=o Specifies that the print data is a PostScript file. format=p Specifies that the print data is a plain text file that should be “pretty” printed with a header and footer. mode=stream Specifies that the backend should stream print data to the printer and not wait for confirmation that the job has been successfully...
  • Page 102 Fig. 124 – “Printers” panel Touching the name of the printer, a panel showing two sections is shown. The first section presents the main information of the printer, with two buttons: • Maintenance • Administration The second section lists all the jobs for this printer, with the possibility to show all jobs or just the completed jobs and to search in the list with the dedicated buttons (Fig.
  • Page 103 o With this command, the procedure to clean the print heads is launched in the printer (this command can be present or not depending on the printer model) • Cancel all jobs o Cancel all jobs running and waiting Fig. 127 – Administration Activities list Pushing the Administration button, a list of activities that can be done on the printer is shown.

  • Page 104: Dicom Functionality

    12.10 DICOM Functionality Access the Settings|DICOM Screen (Fig. 129) to set the DICOM configuration. Fig. 129 - Settings|DICOM Screen DICOM is an international standard for distributing and viewing medical images and related information. DRSplus supports DICOM communication as specified in the DICOM Conformance Statement document .

  • Page 105: Icare Cloud

    Domain Protocol Port *.icare-world.cloud HTTPS *.eu-north-1.amazonaws.com HTTPS api.centervue.net HTTPS *.cloudfront.net HTTPS Please note that at this stage we do not support connecting to our services using an HTTP Proxy. The ILLUME functionalities are available only under license. Please refer to your local Authorized Distributor for detailed information about the ILLUME product and license.

  • Page 106: Icare Cloud Registration

    12.11.1 iCare cloud Registration Click the START THE ICARE CLOUD REGISTRATION button to start the registration of the device. Fig. 131 - Registration PIN Screen Push the START THE REGISTRATION button to confirm, push CANCEL to abort. Register the device on the ILLUME platform using the Registration PIN showed on the device (Fig.

  • Page 107: Icare Cloud De-Registration

    Fig. 134 Export queue When the iCare cloud service is registered, a new icon appears on the Topbar of the screen. 12.11.2 iCare Cloud de-registration The device can be associated to a unique account. Before connecting the device to another iCare Cloud account, you shall de-register the device.

  • Page 108: Utilities

    Access the Utilities|Assistance Screen (Fig. 136) to open a Remote Assistance (R.A.) session or to export diagnostic data for technical troubleshooting purposes. 13.1.1 Remote assistance The Remote Assistance allows an iCare/CenterVue operator to connect to the device. Remote Assistance always requires an internet connection. DRSplus User Manual - EN...
  • Page 109 Fig. 136 – Utilities|Assistance Screen Push OPEN REMOTE ASSISTANCE to open the Authorize remote assistance by your own action pop-up (see Fig. 137). Fig. 137 –Authorize remote assistance by your own action pop-up Push OPEN REMOTE ASSISTANCE to open the Authorize remote assistance by your own action pop-up.

  • Page 110: Log Export

    13.1.2 Log Export In the Log Export section, you can extract diagnostic data of the device for service purposes. UPLOAD DEVICE LOGS exports diagnostic data to an iCare/CenterVue server. It requires an internet connection. Push UPLOAD DEVICE LOGS to open the Upload diagnostic or statistic data pop-up (see Fig.
  • Page 111 Fig. 140 – Upload Device Logs pop-up Touch the box of the USB DISK you want to use to highlight it (see Fig. 141) and then push SELECT THIS DRIVE to start the logs export. Fig. 141 – Upload Device Logs pop-up, USB DISK selected A pop-up informs you that the export is in progress.

  • Page 112: Backup

    13.2 Backup Access the Utilities|Backup Screen (Fig. 142) to backup the patient data stored in the onboard disk. Data can be backed up on a remote Network backup through an IP connection or into an external, USB backup through a connected memory device (flash memory or disk). Fig.
  • Page 113 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.
  • Page 114 Fig. 144 - USB disks pop-up Select the USB DISK to use for the backup. Push CANCEL to abort the operation, push SELECT THIS DRIVE to complete the set-up. The first time you configure an automatic Backup on a valid location (Network of USB), a backup automatically starts, as you can see in the Backup progress pop-up (Fig.
  • Page 115 When the backup is completed, a pop-up appears. Click CLOSE to revert to the Utilities|Backup Screen, in which you will find the information about the date and time of the Last performed backup (see Fig. 147). Fig. 147 – Utilities|Backup Screen, Last performed backup You can find here the Network path, the Disk status, the date and time of the last performed backup, the backup size and the Password protected option.

  • Page 116: Restore

    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.
  • Page 117 Fig. 149 - Search on a network disk panel Manually insert the address of the restore position. Click CANCEL to abort the operation, click SCAN THIS DISK to proceed Click RESTORE THIS BACKUP to start the restore process. The Confirm the restore pop-up appears (Fig. 150). Fig.

  • Page 118: Storage

    13.4 Storage The Utilities|Storage Screen (Fig. 151) allows resetting the device and configuring a threshold for the data storage memory. Only an Administrator account has the permission to modify the configurations. Fig. 151 – Utilities|Storage Screen Click RESET PATIENT DATA to delete all the patients and exams data from the device.
  • Page 119 Fig. 153 – Factory reset pop-up To enable the Factory reset, insert the Administrator password. Alternatively, select to put the device in the Shipment position, or to Reboot the device after the reset. Click CANCEL to abort the operation, click FACTORY RESET to proceed. The factory reset does not alter or erase the installed licences.
  • Page 120 (Fig. 157) and the image acquisition is disabled. Fig. 157 - Disk full pop-up Push CLOSE to close the pop-up. After closing the pop-up, the error message remains at the bottom of the Utilities|Storage Screen. Contact the iCare/CenterVue service for troubleshooting. DRSplus User Manual - EN...

  • Page 121: Licenses

    Fig. 158 - Utilities|Licenses Screen DRSplus will automatically download any assigned license when connected to the iCare/CenterVue License Server. A suitable network configuration and internet connection are required. Push SYNC LICENSE STATUS to immediately synchronize the status of the device licences from the iCare/CenterVue server.
  • Page 122 Fig. 160 – License revoked pop-up The revoke of a license is an irreversible operation. To activate a revoked functionality, ask the iCare/CenterVue service for a new valid license. To retrieve the list of the revoked licenses of the device, toggle the HIDE/SHOW REVOKED LICENSES at the bottom of the Utilities|Licenses Screen.

  • Page 123: Update

    13.7 Online updates Push CHECK ONLINE FOR UPDATES. The Search for online software updates pop-up appears (see Fig. 163). Push CHECK ONLINE FOR UPDATES to allow the connection to the iCare/CenterVue servers or click CANCEL to abort the operation. iCare...

  • Page 124: Usb Updates

    Fig. 163 - Search for online software updates pop-up When an update is found, in the Online Software Updates panel push DOWNLOAD THE SOFTWARE UPDATE to receive the update or click CLOSE to abort the operation (see Fig. 164). Fig. 164 - Online software updates panel Wait for the download, then push VIEW AND INSTALL THE DOWNLOADED UPDATE to proceed, or push CLOSE to abort the operation.
  • Page 125 Fig. 165 - Utilities|Update Screen, 1 update found In the Utilities|Update Screen, push INSTALL THIS UPDATE. Fig. 166 - Installation confirmation pop-up In the Confirm the software update installation pop-up (see Fig. 166), click CONFIRM to proceed with the installation or click CANCEL to abort the operation. The Software update appears (Fig.
  • Page 126 Fig. 168 – Device Updated screen DRSplus User Manual - EN iCare...

  • Page 127: Other

    13.8 Other The Utilities|Other Screen (Fig. 169) provides a few utilities that can be used to • Enable or disable the “demo” dataset • Move the optical head to positions that are suitable for cleaning the lens, shipping or waiting for performing the exam. Fig.

  • Page 128: Power Off

    14. Power off You can turn off the device only via software in the local interface. The remote connection does not show the POWER OFF button. Push the Menu button in the Navigation Bar. Push Power off The Power off pop-up appears. Fig.

  • Page 129: Cleaning

    15. Cleaning This paragraph explains how to clean the device. The device must be powered off, and the power cord shall be disconnected. The front lens should be cleaned using a small hand pump air blower to blow away dust. If the lens is very dirty, due to the presence of fingerprints or other impurities, the front lens should be cleaned using photographic cleaning paper or very clean microfiber cloth and a suitable lens cleaning fluid.

  • Page 130: Maintenance

    16. Maintenance All maintenance operations must be carried out exclusively by personnel authorized by the Manufacturer. Maintenance frequency recommended by the Manufacturer: • Safety electric tests (according to IEC 60601-1): once a year. • Comprehensive system verification: every two years. Please refers to your local Authorized Distributor or Authorized Service Center for service contracts and warranty extensions.

  • Page 131: Electromagnetic Compatibility

    17. Electromagnetic Compatibility DRSplus complies with the requirements of Class A as defined by the IEC 60601-1-2 standards. DRSplus has been tested and found to comply with the limits for medical devices contained in IEC60601-1-2. These limits are intended to provide reasonable protection against harmful interference in a typical medical installation.

  • Page 132: Guidance And Manufacturer Declaration

    IEC 60601-1-2 EMISSION TEST Test Test Requirements Compliance Electromagnetic environment - Guidance Result Class A or B DRSplus uses RF energy for its internal function. Therefore, its RF emissions are very Group low and not likely to cause any interference in CISPR CISPR 11, 14-1, 32 or ISO 7137 nearby electronic equipment.

  • Page 133: I Secifications

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of DRSplus, including cables specified by the manufacturer (CenterVue). Otherwise, degradation of the performance of this equipment could result.

  • Page 134: Fcc (Usa) And

    Operating Range Wi-Fi Open Space (300 m) / Indoor (100 m) (The transmission speed may vary according to the environment) BT: 10m~20m (depending on environment and NB model) Authentication WPA and WPA2 Encryption 64-bit and 128-bit WEP, AES-CCMP, TKIP 17.5 FCC (USA) and IC (Canada) radio certification DRSplus contains a radio module that complies with the regulations of Canada and the USA and in particular with Part 15 of FCC regulation.

  • Page 135: Technical Specifications

    18. Technical Specifications Technical specifications are reported in the next table Fundus Imaging Features Field of view: 45° (H) x 40° (V) as captured with a single exposure Mosaic (up to 9 fields): 83° Light sources: White LED (420-675 nm) Infrared LED (825‐870 nm) Imaging modalities: TrueColor, Infrared, Red-Free*, Blue*, Red*, Stereo**, Mosaic**...

  • Page 136: Disposal

    19. Disposal DRSplus is made of different materials, such as plastics, aluminium, electronic parts. In the case of DRSplus disposal, please separate the various materials and follow the laws and regulations regarding disposal or recycling for each material effective in your own country. 19.1 Separate collection for electrical and electronic equipment The European Directive 2012/19/EU establishes separate collection for Waste of Electrical and Electronic Equipment (WEEE).

  • Page 137: External Fixation Target Usage

    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.
  • Page 138 Fig. 172 – External Fixation Target positioning DRSplus User Manual - EN iCare...

  • Page 139: External Display Setup

    External Display Setup DRSplus can be connected to an external monitor using the DisplayPort socket placed at the back of the device. When an external monitor is plugged in, DRSplus will mirror the onboard display. Important Native DisplayPort links are usually found in monitors, but they are rarely available on TV sets. Requirements •...
  • Page 140 Via San Marco 9h, 35129 Padova – ITALY Ph.: +39 049 5018399 Fax: +39 049 5018398 info@icare-world.com 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.

Table of Contents