iCare EIDON Fundus Imaging System User Manual
Icare EIDON is a fundus imaging device based on a confocal scanning system, offering TrueColor Confocal images. It's designed to capture images of the human retina, with or without mydriatic agents, providing high image fidelity, resolution, contrast, and quality, even in the presence of media opacities. The device is ideal for healthcare professionals in ophthalmology for diagnosing and monitoring various retinal conditions.
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EIDON Family User Manual MANUAL INFORMATION The information in this document is subject to change without prior notice and it is correct at revision date. Devices configuration can change as products improvements are incorporated and this manual may not exactly depict your device: please contact the local distributor if you have any questions about differences. The original language of this User Manual is English. Should a conflict situation arise concerning a translated document, the English language version shall prevail. Date of release: Revision number: Software Version: Reference devices: February 06th, 2023 27 4.1 EIDON Family devices [models: EIDON (REF: AMFUNME001), EIDON AF (REF: AIFLUME001) and EIDON FA (REF: AIFLAME001)] Copyright © 2023 CenterVue Spa. All rights reserved. CenterVue S.p.A. Via San Marco 9h, 35129 Padova – ITALY www.icare-world.com CONTENTS 1. INTRODUCTION ......................................................................................................................................... 6 2. EIDON Family devices ................................................................................................................................ 7 2.1 Devices description ............................................................................................................................ 7 2.2 The EIDON Custom Control Interface ................................................................................................ 9 3. LABELS, SYMBOLS AND DEFINITIONS ................................................................................................. 10 3.1 Labels ............................................................................................................................................... 10 3.2 Symbols used on the device ............................................................................................................ 11 3.3 Other symbols found in this manual ................................................................................................. 11 3.4 Definitions ......................................................................................................................................... 12 4. SAFETY INFORMATION .......................................................................................................................... 13 5. FIRST USAGE ........................................................................................................................................... 16 5.1 Preparation of the device ................................................................................................................. 16 5.2 Assembling the EIDON Custom Control Interface and 3D Joystick supports.................................. 16 5.3 Assembling the EIDON Family External Fixation Target ................................................................. 17 5.4 Removing the front lens cap ............................................................................................................ 17 5.5 Turning on the Device ...................................................................................................................... 18 5.6 Unlock function ................................................................................................................................. 19 6. PREPARING THE PATIENT ..................................................................................................................... 20 7. PERFORMING THE EXAM ....................................................................................................................... 21 7.1 Adding a new patient ........................................................................................................................ 22 7.2 Deleting patients ............................................................................................................................... 22 7.3 Searching for an existing patient ...................................................................................................... 23 7.4 Patient Merge ................................................................................................................................... 23 7.5 Selecting an existing patient ............................................................................................................ 24 7.6 Setting up exam parameters ............................................................................................................ 24 7.7 Selecting the field(s) to be captured ................................................................................................. 26 7.8 Exposure Value ................................................................................................................................ 26 7.9 Automatic mode ............................................................................................................................... 26 7.9.1 Single field ................................................................................................................................... 28 7.9.2 Multiple fields............................................................................................................................... 28 7.9.3 Smart mosaic .............................................................................................................................. 28 7.9.4 Stereo .......................................................................................................................................... 29 7.10 7.10.1 Manual fixation ....................................................................................................................... 30 7.10.2 Manual Fixation and Focus .................................................................................................... 32 7.10.3 Full Manual ............................................................................................................................. 32 7.11 iCare Manual mode .................................................................................................................................... 29 Fluorescein Angiography Imaging (FA) ............................................................................................ 33 7.11.1 Patient preparation ................................................................................................................. 33 7.11.2 Pre-injection phase ................................................................................................................ 34 7.11.3 Post-injection phase ............................................................................................................... 36 7.11.4 Resuming an active FA session ............................................................................................. 37 7.11.5 Active FA sessions list ........................................................................................................... 38 7.11.6 Terminating an active FA session .......................................................................................... 38 EIDON Family - User Manual EN Page 3 of 88 7.12 Ultra-Widefield Imaging modality ..................................................................................................... 39 7.13 Image retake .................................................................................................................................... 41 8. REVIEWING IMAGES ............................................................................................................................... 42 8.1 Patient list ......................................................................................................................................... 42 8.2 Patient Record .................................................................................................................................. 42 8.3 Single image review ......................................................................................................................... 44 8.4 3D Stereo Review ............................................................................................................................ 45 8.5 Mosaic .............................................................................................................................................. 46 8.6 Compare Images .............................................................................................................................. 47 8.7 HypoAF Boost .................................................................................................................................. 49 8.8 Video review ..................................................................................................................................... 49 8.9 Export functions ................................................................................................................................ 50 8.10 Printout ............................................................................................................................................. 50 9. REMOTE VIEWER .................................................................................................................................... 52 9.1 Setting up the Remote Viewer ......................................................................................................... 52 9.2 Using the Remote Viewer ................................................................................................................ 52 9.3 Patient List ........................................................................................................................................ 52 9.4 Patient Record .................................................................................................................................. 53 9.5 Single Image review ......................................................................................................................... 55 9.6 3D Stereo Review ............................................................................................................................ 55 9.7 Mosaic .............................................................................................................................................. 56 9.8 Compare Images .............................................................................................................................. 57 9.9 Flickering view .................................................................................................................................. 58 9.10 Cup-to-disc evaluation...................................................................................................................... 59 9.11 HypoAF Boost .................................................................................................................................. 60 9.12 Video Review ................................................................................................................................... 60 9.13 Export Functions .............................................................................................................................. 61 10. DICOM ....................................................................................................................................................... 62 11. LDAP ......................................................................................................................................................... 62 12. INFORMATION CENTER .......................................................................................................................... 62 12.1 Backup status ................................................................................................................................... 62 12.2 Shared folder status ......................................................................................................................... 62 12.3 Data storage status .......................................................................................................................... 63 12.4 About tab .......................................................................................................................................... 63 13. SETTINGS ................................................................................................................................................. 64 13.1 Launching the Configurator .............................................................................................................. 64 13.2 Device lock reset procedure ............................................................................................................. 64 13.3 Date and time ................................................................................................................................... 64 13.4 Password change ............................................................................................................................. 64 13.5 Exam parameters ............................................................................................................................. 65 13.6 Remote Viewer ................................................................................................................................. 65 13.7 Network configuration....................................................................................................................... 66 13.8 Backup ............................................................................................................................................. 67 13.8.1 Page 4 of 88 Device tab .............................................................................................................................. 67 EIDON Family - User Manual EN iCare 13.8.2 Schedule tab .......................................................................................................................... 69 13.8.3 Execute tab ............................................................................................................................ 69 13.9 Restore ............................................................................................................................................. 70 13.10 Shared folder configuration .............................................................................................................. 71 13.10.1 Status ..................................................................................................................................... 71 13.10.2 Mode ...................................................................................................................................... 71 13.10.3 Destination ............................................................................................................................. 71 13.10.4 File type .................................................................................................................................. 71 13.10.5 Filenames ............................................................................................................................... 72 13.10.6 Shared Folder Configuration examples ................................................................................. 73 13.11 Custom Printout ................................................................................................................................ 74 13.12 Custom control interface setting ....................................................................................................... 74 13.13 Printer setup ..................................................................................................................................... 75 13.13.1 Infrastructure Mode ................................................................................................................ 75 13.13.2 Wi-Fi Direct Mode .................................................................................................................. 75 14. DEVICE SHUTDOWN ............................................................................................................................... 76 15. TECHNICAL SPECIFICATIONS ............................................................................................................... 77 16. CLEANING ................................................................................................................................................ 79 17. TROUBLESHOOTING .............................................................................................................................. 80 18. ELECTROMAGNETIC COMPATIBILITY .................................................................................................. 81 18.1 Manufacturers EMC Declaration to IEC 60601-1-2 ......................................................................... 81 18.2 Guidance and manufacturers declaration – Electromagnetic Immunity EIDON Family devices ..... 82 18.3 Immunity pass criteria ...................................................................................................................... 82 18.4 Wi-Fi Specifications .......................................................................................................................... 83 19. INFORMATION ABOUT THE OPTICAL RADIATION HAZARD............................................................... 84 19.1 Information required by ISO 15004-2 valid for EIDON FA model only ............................................ 84 19.2 Information required by ANSI Z80.36 for EIDON FA model only ..................................................... 85 20. DISPOSAL ................................................................................................................................................. 86 iCare EIDON Family - User Manual EN Page 5 of 88 1. INTRODUCTION Congratulations for choosing one of the EIDON Family devices (EIDON, EIDON AF, EIDON FA) and its confocal retinal imaging capabilities. EIDON Family devices (EIDON, EIDON AF, EIDON FA) are fundus imaging devices which are based on confocal scanning imaging system. The intended end-users are heath care professionals with training in the ophthalmology field (or equivalent). EIDON Family devices are intended for taking images of a human retina with or without1 the use of a mydriatic agent. In particular, EIDON Family imaging modalities depend on the chosen device model as follow: • infrared light to obtain infrared-reflectance images (Fig. 1) (available for all EIDON models); • white light to obtain color and red-free images (Fig. 2) (available for all EIDON models); • blue light to obtain autofluorescence images (Fig. 3) (available for EIDON AF and EIDON FA); • blue light to obtain fluorescein angiography images (Fig. 4) (available for EIDON FA only). Fig. 1 – IR retinal reflectance image Fig. 2 – Color retinal image Fig. 3 – Autofluorescence retinal image Fig. 4 – Fluorescence angiography retinal image The clinical interpretation of the images acquired by the EIDON Family devices is restricted to licensed eye-care practitioners: the process of making a diagnosis is the responsibility of the eye care practitioner. Each device integrates a EIDON Custom Control Interface with multi-touch display, a 3D joystick and an external power supply. All EIDON Family devices work with the same EIDON Family software and they operate as standalone units. Federal laws (US) restrict these devices to sale by or on the order of a physician or a properly licensed practitioner. COLOR CONFOCAL IMAGING SLO systems are superior to conventional fundus cameras in many ways, as they exploit a confocal imaging principle which limits the backscattered light effect from deeper layers and provides enhanced image quality, in terms of contrast and resolution. Another advantage of SLO systems is that they operate with smaller pupils than non-confocal imaging systems. However, SLO systems do not provide color images, as they employ monochromatic laser sources, resulting in black and white or pseudo-color images. EIDON Family devices are based on a confocal system that uses white LED light instead of monochromatic lasers, hence it provides TrueColor Confocal images and offers high image fidelity, no need for dilation, high resolution and contrast, high quality even in presence of media opacities. 1 EIDON Family devices work 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. Page 6 of 88 EIDON Family - User Manual EN iCare 2. EIDON Family devices 2.1 Devices description Device Logo (EIDON or EIDON AF or EIDON FA) Head rest (contacting part) Chin rest (contacting part) Patient side EIDON Custom Control Interface with multi-touch display Connectors panel Fig. 5 – EIDON FA as representative example of the EIDON Family devices The main parts2 of each EIDON Family device consists of: • Device (EIDON or EIDON AF or EIDON FA); • EIDON Custom Control Interface with multi-touch display; • External Power supply3; • 3D Joystick4; • EIDON UWF Module5. USB ports LED Device power status EIDON Custom Control Interface port Power button Power supply connector Fig. 6 – Detail of connectors panel Ethernet port 2 For a list of all components included with EIDON Family devices, please see the Content List documents in the device package It is a EIDON device component, model MDS-150AAS12-BA manufactured by Delta Electronics. It features 100-240 VAC, 50-60 Hz and a consumption of 80 W. 4 It is a EIDON device component, model 3DX-700059 manufactured by 3DConnexion. It features the possibility to adjust focus by using the left (focus +) and right (focus -) buttons of the joystick, using the retinal image as feedback. 5 It is not a EIDON device component but an EIDON family accessory (sold as an EIDON Family’s optional and shipped with a dedicated box). The EIDON UWF Module is manufactured by CenterVue and it features the possibility to increase the EIDON field of view (see EIDON UWF Module User Manual for details) when mounted on the EIDON frontal lens. The EIDON UWFL module is available only under license: to request license, please refer to your local distributor. 3 iCare EIDON Family - User Manual EN Page 7 of 88 Page 8 of 88 EIDON Family - User Manual EN iCare 2.2 The EIDON Custom Control Interface The EIDON Custom Control Interface with color multi-touch display (see Fig. 7) is an integral part of the EIDON Family device that cannot operate without it. The EIDON Custom Control Interface must be connected to EIDON device using the supplied cable6. The Mini-HDMI-to-HDMI adapter allows the user to connect the Custom control Interface to an external monitor in order to display the image on a larger screen. Patient data and images are not stored on the EIDON Custom Control Interface Fig. 7 – EIDON Custom Control Interface with multi-touch display supplied with each EIDON Family device The EIDON Custom Control Interface with multi-touch display must be used only together with EIDON Family device and in accordance with the instructions provided in this User Manual. Use of the EIDON Custom Control Interface for other purposes than the one intended by the Manufacturer, as well as any modifications or misuses are exclusively under end-user responsibility. 6 EIDON Custom Control Interface with multi-touch display is equipped with a custom cable permanently connected to the same EIDON Custom Control Interface. iCare EIDON Family - User Manual EN Page 9 of 88 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 labels fixed on the right side of each device as shown in the following figure from EIDON FA which is a representative example for EIDON Family devices: please do not remove them. Serial number Prod. date UDI barcode Fig. 8 – Device and warning labels7 on a EIDON FA model as representative example of the EIDON Product Family devices 7 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. Page 10 of 88 EIDON Family - User Manual EN iCare 3.2 Symbols used on the device The meaning of the symbols adopted in the device labels is as follows: Symbol Explanation Information about the Manufacturer. Manufacturing date (year-month). Device identifier (catalogue number–product code). EIDON / EIDON AF / EIDON FA is a Medical Device. EIDON / EIDON AF / EIDON FA Serial number. UDI number. Electrical and electronic waste is destined for separate recycling. Refer to the User Manual. CE mark: the device complies with the essential requirements of the European Medical Devices Directive 93/42/EEC. Type B Applied Part. Non-ionizing radiation - ME EQUIPMENT that includes RF transmitters. Direct current. Warning, read carefully. No serviceable parts inside. Internal inspection is allowed to authorized personnel only. Warning, read carefully. Stand clear from moving parts while in operation. 3.3 Other symbols found in this manual The meaning of the additional symbols adopted in this User Manual is as follows: Symbol Explanation Important Information. General Warning, read carefully. iCare EIDON Family - User Manual EN Page 11 of 88 3.4 Definitions The meaning of the specific words adopted in this User Manual are as follows: Word Explanation EIDON Family devices’ owner (it can be different from EIDON Family devices’ Customer end-user) Device/s The synonym of EIDON Family device/s used in this User Manual. Any retinal image acquisition session performed using the EIDON Family Exam device for a certain patient on a certain date. External eye The examination mode involving the acquisition of images of the ocular examination surface instead of the retina. Field A portion of the retina visible in a specific image. The ability of a patient to fix his/her view on a specific point, for example the Fixation internal fixation target or the external fixation target. A small bright green circle visible when looking into the front lens of the EIDON Fixation target Family device, used to move the gaze of the patient and capture different fields. Operator EIDON Family devices’ end-user The synonym of the image acquired by EIDON Family device used in this User Picture Manual The aperture located in the center of the iris, of variable diameter, which allows Pupil 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. The inner layer of the eyeball. It is the main area of interest in the images Retina acquired by EIDON Family devices. The examination mode that involves the acquisition of two images of the retina Stereo exam taken from different angles, providing a three-dimensional view using suitable prismatic glasses. Page 12 of 88 EIDON Family - User Manual EN iCare 4. SAFETY INFORMATION The following precautions and warnings are important to use the devices in safety: • Do not use EIDON Family devices 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 EIDON Family devices: this could lead to electric shocks or damage to the device. • EIDON Family devices are supplied with an earth ground by means of a protection conductor contained inside the power supply cable. Before turning on the system, make sure the power supply socket is correctly grounded to avoid the risk of electric shock. • EIDON Family devices power supply must be connected to a socket with a circuit breaker. • The use of other cables and accessories on EIDON Family devices than ones provided by Manufacturer may negatively affect EMC performances. • External device/s connected to EIDON Family devices, into the patient environment, must comply with IEC 60601-1. Those device/s that do not comply/complies with the IEC 606011 must be kept out of the patient environment and must comply with IEC 60950-1. Any enduser who connects external devices EIDON Family device creates a new Medical Electrical System as defined by IEC 60601-1 and is therefore responsible of the conformity of such system with the requirements defined in clause 16 of IEC 60601-1. Please contact the local distributor for any additional information. • EIDON Family devices must be used in a room with an electrical system that complies with applicable healthcare environment safety regulations. • EIDON Family devices must NOT be used in an oxygen-rich environment or presence of flammable anaesthetics. • EIDON Family devices must be used 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. • EIDON Family devices need to be operated in a semi-dark environment, to ease the natural dilation of the patient’s pupil. • EIDON Family devices needs to be operated in the following environmental conditions: o Temperature: +10 °C to +40°C (50°F to 104° F) o Humidity (max): 90% not condensing • EIDON Family devices needs to be stored in the following environmental conditions: o Temperature: -10 °C to +60°C (14° F to 140° F) o Humidity (max): 95% not condensing • Only technicians authorized by Manufacturer may service EIDON Family devices. Manufacturer cannot be held responsible for the devices safety should EIDON Family devices be opened, repairs carried out (included using of not Manufacturer’s genuine parts), third-parties software installed, or parts replaced by an unauthorized person. • In case an unexpected hardware condition occurs during use, an error message may appear (see for example Fig. 9) and the device may become temporarily locked. It is possible to reset this condition by letting the device re-initialize: refer to par. 13.2 for the complete procedure. If the error persists, please contact an Authorized Service Center. The following precautions are important to use the device correctly: • The clinical interpretation of the images acquired by EIDON Family is restricted to licensed eye care practitioners. The process of making a diagnosis using EIDON Family devices results is the responsibility of the eye care practitioner. • Device-specific training is required: it is recommended for the end-user (operator) to carefully read this User Manual to be informed and trained before use. • Use the device in dim light, or at least away from direct light to facilitate the natural dilation of the pupil. • Provide explanations to patients before placing them in front of the device: refer to par. 6. • The minimum pupil diameter required to obtain good quality images is 2.5 mm. iCare EIDON Family - User Manual EN Page 13 of 88 • • EIDON Family devices work 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 Manufacturer and to the competent authority of the Member State in which the user and/or patient is established. When in operation, EIDON Family devices contain 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 EIDON Family devices through regular use of the backup facility, thus preventing the risk of accidental loss of data. • The Custom Control interface offers Wi-Fi connection (used for remote printing): it is strongly recommended to connect only to trusted networks protected by an encryption system, like for example WPA2, and refrain from connecting to unsecured Wi-Fi networks. • Device offers a Wired Network Connection (via Ethernet cable), used to connect to a Remote Viewer (accessible with device credentials) and to store and/or backup data on a Remote Shared Folder (accessible with infrastructure credentials). When setting your credentials in the device, it is strongly recommended to use complex passwords; refer to your infrastructure’s policies to create an effective password. If your infrastructure does not enforce any password policy, we recommend the following: o a strong password must be at least 8 characters long; o it should not contain any of your personal information, like your real name, username or your company name; o it must be different from your previously used passwords; o it should not contain any word spelled completely; o a strong password should contain different types of characters, including uppercase letters, lowercase letters, numbers and characters; o don’t write down your password on notes; o don’t share your password with other people; o change your password from time to time. • The Remote Viewer browser runs on your PC/Laptop and allows to locally download exams reports and patient’s images; reports and images stored in the Remote Shared Folder can be available also in your PC/Laptop. It is strongly recommended to protect your computer by: o applying physical security measures (locks, security alarms, monitoring, etc.) to prevent unauthorized persons from accessing your computer that stores patients’ personal data files; o using full disk encryption (Bitlocker) with a strong password to render data unreadable even if an unauthorized person were to gain access to your computer; o using firewall and antivirus software to prevent intrusion and to detect infected files that might compromise the security of your computer, and thereby enable unauthorized file access; o installing security patches and updates in a timely manner; o protect access to your Windows account with a strong password (see indication above); o log off or power off when leaving your computer unattended. • DICOM files usually include very sensitive information about the patient (name, age, ID number, birth date, weight, etc.) and contain the medical images, which itself is of an extremely sensitive nature. Special care must be taken to ensure that this information stays private and is not susceptible to unauthorized access. Before taking any further actions, make sure that you are authorized to view and store specific DICOM files on your machine. • When saving, exporting, or sending DICOM files, please remember that the DICOM protocol does not encrypt patients’ personal data; for this reason, it is strongly Page 14 of 88 EIDON Family - User Manual EN iCare recommended to delete the DICOM files from your computer when they are no longer necessary. Fig. 9 - Example of error message iCare EIDON Family - User Manual EN Page 15 of 88 5. FIRST USAGE 5.1 Preparation of the device We recommend reading carefully and thoroughly par.4 before proceeding with first use. To make EIDON family device functional for the first use: • extract the device from its box; • place it on a suitable electrical table8; • mount the headrest on the metal support (see Fig. 10); • place the EIDON Custom Control Interface and the 3D Joystick on their supports, screw it with the dedicated screws (par. 5.2); • connect the power supply provided with the unit to the power inlet (see Fig. 6); • mount the EIDON Family External Fixation Target (see par. 5.3); • plug the power supply to the wall socket. Fig. 10 – Headrest mounted on metal support 5.2 Assembling the EIDON Custom Control Interface and 3D Joystick supports Fasten the Custom Control Interface to is support bracket using the two dedicated screws. For the 3D Joystick, first fasten its support bracket to the device and then place the 3D Joystick on it. The 3D Joystick should be placed close to the EIDON Custom Control Interface. Both supports need to be fixed with screws to the bottom of the device according with the schematic showed on Fig. 13. Connect the Custom Control Interface to the proper socket and the 3D Joystick to one of the USB ports (see Fig. 6). Fig. 11 – EIDON Custom Control Interface and 3D Joystick mounted on the left side of the device Fig. 12 – Support bracket for EIDON Custom Control Interface (left) and for 3D Joystick (right) Mounting the support bracket on the back of the device will make access to USB ports difficult: in such case, use a USB extension cable9 to make one of the USB ports readily accessible. 8 9 It is not provided with the device. For a list of all components included with EIDON family device, see Content List in the device package It is provided with the device. For a list of all components included with EIDON family device, see Content List in the device package Page 16 of 88 EIDON Family - User Manual EN iCare Fig. 13 – Device bottom with holes for Custom control Interface and 3D Joystick supports RED positions for both Custom Control Interface and 3D Joystick, Blue only for 3D Joystick. 5.3 Assembling the EIDON Family External Fixation Target The EIDON Family External Fixation Target10 is an external light that can be used for all EIDON Family devices. Fasten the external fixation target to the headrest using the supplied screws (see Fig. 14); connect it to one of the device USB ports to power it on (see Fig. 6). Do not use EIDON Family External Fixation Target in combination with the accessory EIDON UWF Module since collision may occur Fig. 14 – EIDON Family External Fixation Target 5.4 Removing the front lens cap Unscrew the device’s front lens cap to remove it, before turning on the device. 10 It is provided with the device. For a list of all components included with EIDON family device, see Content List in the device package iCare EIDON Family - User Manual EN Page 17 of 88 5.5 Turning on the Device Turn on the device by pressing the power button (see Fig. 6), the device will emit a single beep, the LED Power Status will power on and the Custom control Interface will power on. Then wait for the boot process to complete, until the Login screen appears (see Fig. 15). All the next screens from EIDON FA are representative for the EIDON Family Software used for all EIDON Family devices: EIDON Family Software will show the related name of the specific EIDON Family model used. During the power-on, the LED Power Status performs a red/green/blue cycle to test its LEDs functioning. In addition, the following information are important to understand device messages emitted from the color LED Power Status (see Fig. 6): • steady green light means “power on” • Fast flashing red light means “Reboot” • Fast flashing red/green light means “Reboot – Over Voltage Protection/Under Voltage Protection” • Single red flashlight means “start of error code reporting” • Single white flashlight means “start of version code reporting” • Flashing blue light (code reporting) is proportional at tens in the numerical code • Flashing green light (code reporting) is proportional at units in the numerical code Fig. 15 – Login screen of a EIDON FA as an example From the drop-down menu you can select your user profile choosing between Doctor or Admin: - Doctor User have only the access to perform exam (par. 7) and review images (par. 8). - Admin User have the access to the Doctor User function and the device’s setting (par. 12). Type the password11 and click on Login button. If login is successful, the Home screen opens (see Fig. 16). The session is automatically closed after 10 minutes of inactivity, which means that the user has to perform the login again. To modify the login password, see par. 13.4. To modify the standby time please, see par. 13.12. 11 Please ask an authorized iCare/CenterVue representative for the factory password Page 18 of 88 EIDON Family - User Manual EN iCare Fig. 16 – Home screen 5.6 Unlock function When unlock button appears insert password to exit the standby to come back to the latest used page. iCare EIDON Family - User Manual EN Page 19 of 88 6. PREPARING THE PATIENT This paragraph explains how to prepare a patient for the exam. The acquisition of retinal images 12 with EIDON Family devices does not involve any risk, because EIDON Family devices 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. EIDON Family devices are non-mydriatic12 devices (minimum pupil diameter 2.5 mm), so there is no need to dilate the pupil’s patient, except when fluorescein angiography is being performed. For preparation of the patient for this modality please refer to par. 7.11. EIDON Family devices compensate for a patient’s spherical refractive error in the range -12 to +15 diopters: testing a patient presenting a spherical error out of the above range may result in poor quality images. EIDON Family devices do not compensate for a patient’s astigmatism. There are no specific restrictions based on the type of patients that can be examined. The patient may wear spectacles or contact lenses while being examined, although this may occasionally cause reflection artifacts in the retinal image. Patient contacting parts are indicated in Fig. 5. Before starting the exam, the operator should check the following: • patient should sit in a comfortable position, with the forehead and chin in firm contact with the rests; • height of table and chair should be adjusted so that the patient can comfortably place her/his chin on the corresponding rest; • the patient’s head should be vertical (not tilted forward/backward); • chin rest should be positioned so that the patient’s eye is aligned to the mark found on the left side of the metal frame (see Fig. 17). If this is not the case the chin rest height needs to be adjusted (see par. 7.6). Fig. 17 – Sketch of the eye mark on the metal frame Before the exam, the operator should inform the patient about the following: • EIDON Family devices will take photos of the fundus of the eyes; • the exam is non-invasive, in particular the system will never touch your eye and you will only see a flash of light when a photo is taken; • find a comfortable position, keeping the chin and forehead firmly pressed against the rests; • at the beginning of each exam, the device will move around to find your pupil: this is absolutely normal; • always keep your eyes wide open, so that eyelids do not interfere; • when the exam starts, look straight in front of you and when a small green, circular spot appears anywhere, look at it; • do not move, nor speak during the exam: • try to not blink when instructed. 12 EIDON Family devices work 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. Page 20 of 88 EIDON Family - User Manual EN iCare 7. PERFORMING THE EXAM This paragraph explains how to operate EIDON Family Software to perform the image acquisition process. Once the Device has been turned on (see par. 5.5), click on the device’ name button (EIDON or EIDON AF or EIDON FA) to open the Patient List screen (see Fig. 18). The New exam button in each Patient record is a shortcut that links to the Exam configuration screen, bypassing the Patient screen. Fig. 18 – Patient list screen as an example from EIDON FA device The different columns in the list indicate respectively (left to right): • presence and number of images (represented by the retinal images) stored for a certain patient (right and left eye); • patient’s Surname and Name, Patient ID, Birth date, patient gender; • date of last exam, formatted as month/day/year; • for EIDON FA only, if an FA session is open, instead of New exam button will appear the Resume FA button that allow to resume the FA session already in progress. The following commands are available on the upper part of the Patient List screen: Position on the Information screen Active sessions: Only available on EIDON FA, shows the FA session already active (see par. 7.11.5). Search: Search for an existing patient (see par. 7.3). Refresh: Refresh of the patient list. New Patient: Create a new patient (see par. 7.1) Information Center: Show relevant information about the device (see par. 12) iCare EIDON Family - User Manual EN Page 21 of 88 7.1 Adding a new patient To create a record for a new patient, click on and the Patient Editing screen will open (see Fig. 19). Type the First Name and Surname (mandatory fields), optionally select the date of birth, gender, patient notes and a code of your choice to identify the patient (patient ID). Then click Save button to save or Cancel button to abort. When the operator enters a new patient with same Name and Surname, or same Patient ID of and already created patient, a warning message will inform that another patient with the same data already exist in the database. Fig. 19 – Patient editing screen 7.2 Deleting patients From the Patient List screen, press and hold the patient to be deleted: the EIDON Family Software enters a patient multi-selection mode. Select other patients to perform a simultaneous delete, then press the icon. Fig. 20 – Multi selection for patient deleting. Page 22 of 88 EIDON Family - User Manual EN iCare 7.3 Searching for an existing patient To search for an existing patient, click on and type the initial letters of the patient you are looking for. This function will search on Surname, Name, Patient ID and Notes fields. To exit the search, click on to hide the keyboard and then on . 7.4 Patient Merge Patient merge function allows to select and unify two patients by selecting the records to be merged. Following the instruction (see Fig. 21 and Fig. 22): • Select the duplicated patient (e.g., merge of Smith Jon with Smith John) • Select the patient’s personal data you want to keep (e.g., Keep data of Patient 2) • Press Proceed to confirm the operation • Once the merge is completed the Patient will result as the sum previous two patients images. Fig. 21 – Selection of patients for Patient Merge Fig. 22 – Selection of patient to keep. Images will be transferred from Patient 1 to Patient 2 iCare EIDON Family - User Manual EN Page 23 of 88 7.5 Selecting an existing patient To select a specific patient in the Patient list, click on it. The list is sorted by the date and time of the last exam and can be scrolled up and down. Once a patient has been selected, the Patient Record screen opens (see Fig. 23) and provides information on the selected patient (See par. 8 for additional details). Click on New Exam button to start a new exam for the selected patient. Fig. 23 – Patient Record screen 7.6 Setting up exam parameters When the New Exam button is clicked, the New Exam screen opens (see Fig. 24). This screen allows to set the exam parameters and trigger the acquisition process. Fig. 24 – New Exam screen Page 24 of 88 EIDON Family - User Manual EN iCare The following commands are available: Position on the screen Information Edit patient’s personal data Select the Exam Mode: - Automatic (see par. 7.9), - FA (only available on EIDON FA see par. 7.11). Manuals mode (see par. 7.10) Select the Eye(s) to be captured: - OD: Right eye - OU: Both eyes OS: Left eye. Select the Acquisition Modality: - Single Field (see par. 7.9.1) - Multiple fields (see par. 7.9.2) - SmartMosaics (see par. 7.9.3) - Stereo (see par.7.9.4) Adjust the height of the chin-rest: UP or DOWN Exposure value: Adjust the exposure value (see par. 7.8) UWF Status button: Available only with the EIDON UWF Module activated (see par. 7.12) Start Button: Start the acquisition process Fields Selection map: To select the field(s) to be acquired (see par. 7.7). Go back to the Patient Record screen iCare EIDON Family - User Manual EN Page 25 of 88 7.7 Selecting the field(s) to be captured The following fields can be selected: • Central: centered on the foveal pit; • Central-Nasal: centered 5° nasally to the foveal pit; • Nasal: centered approx. 20° nasally to the foveal pit; • Temporal: centered approx. 20° temporally to the foveal pit; • Superior-Temporal: centered approx. 12° superiorly and 12° temporally to the foveal pit; • Inferior: centered approx. 20° inferiorly to the foveal pit; • Superior: centered approx. 20° superiorly to the foveal pit. • Superior-nasal: centered approx. 12° superiorly and 12° nasally to the foveal pit • Inferior-nasal: centered approx. 12° inferiorly and 12° nasally to the foveal pit; • Inferior-Temporal: centered approx. 12° inferiorly and 12° temporally to the foveal pit. 7.8 Exposure Value The exposure is the total amount of light reaching the retina of the patient. In order to have images with the right brightness value, the exposure is automatically adjusted by EIDON Family Software every time the retinal images are acquired. Some kinds of retinas, due to their reflecting properties, require an adjustment of the default target brightness, i.e. they need to be more or less exposed. With the Exposure Value slider, it is possible to modify the target brightness of the acquired images. See the par. 13.5 to adjust the default exposure value. 7.9 Automatic mode In this Exam Mode, EIDON Family Software will automatically perform all steps involved in the exam process, namely: a. align the instrument to the selected eye; b. set the fixation target to the location corresponding to the desired field; c. perform auto-focusing, while maintaining alignment; d. capture image of the selected field(s); e. repeat steps b., c and d. for any additional fields or move to next eye and repeat a. through e. The following information are available on screen during the automatic exam process (see Fig. 25): A. Patient name and surname B. Live view from IR pupil cameras and an evaluation of the current pupil size; C. Eye currently being captured; D. Field currently being captured and the indication of where the patient should look; E. Current step of the exam process; Page 26 of 88 EIDON Family - User Manual EN iCare Fig. 25 – Exam screen in auto mode during auto-alignment The following commands are available during the automatic exam process: Position on the screen Information Adjust the height of the chin-rest: UP or DOWN Reset Alignment: Alignment process Restart the Stop the acquisition process and go back to the exam Patient Record screen EYE OD or OS OD OS FIELD GAZE DIRECTION Central Straight Superior Up Inferior Down Nasal Left Central nasal Left Temporal Right Superior temporal Up, right Superior-nasal Up, left Inferior-nasal Down, left Inferior-temporal Down, right Nasal Right Central nasal Right Temporal Left Superior temporal Up, left Superior-nasal Up, right Inferior-nasal Down, right Inferior-Temporal Down, left Table 1 – Gaze directions corresponding to the various fields If the auto alignment fails, the EIDON Family Software will give the option to switch to full manual mode. iCare EIDON Family - User Manual EN Page 27 of 88 Fig. 26 – Eye not found during alignment phase in automatic mode exam EYE NOT FOUND: Make sure patient’s head is not tilted, eye is open wide EYE TOO FAR LEFT: Make sure patient’s head is well centered in front rest and not tilted EYE TOO FAR RIGHT: Make sure patient’s head is well centered in front rest and not tilted EYE TOO LOW: Please raise the chin rest until alignment process restarts EYE TOO HIGH: Please lower the chin rest until alignment process restarts PATIENT TOO FAR: Make sure patient’s head is not tilted, or detached from front rest Table 2 – EIDON Family Software hints during auto-alignment 7.9.1 Single field Allows, in combination with the Field Selection map on the center of the screen, to select which field (1) will be captured. 7.9.2 Multiple fields Allows, in combination with the Field Selection map, to select which fields (2 to 10) will be captured. 7.9.3 Smart mosaic Allows to acquire automatically 3 or 5 fields as multiple fields acquisition modality of color images and directly proceed with the Mosaic creation. The operator can select between the following types of smart mosaic: • Horizontal: automatic acquisition of Central, Nasal and Temporal fields. • Vertical: automatic acquisition of Central, Superior and Inferior fields. • Full: automatic acquisition of Central, Superior, Inferior, Nasal and Temporal fields. After the fields’ acquisition, the EIDON Family Software will ask to select the fields to be retaken before the mosaic elaboration. Page 28 of 88 EIDON Family - User Manual EN iCare Fig. 27 – Image retake after horizontal smart mosaic acquisition Select the fields to be retaken then press the Retake button to acquire new retinal images: the new retinal image acquired will replace the old retinal images. If the Continue button is pressed, the EIDON Family Software will generate a retinal mosaic image. Fig. 28 – Example of full smart mosaic Typically, the generation of a 3-fields mosaic image takes around 20 seconds, while a 5-fields mosaic takes up to 1 minute. Mosaic images are permanently stored on the local memory and can be reviewed at any time as individual fields. 7.9.4 Stereo Stereo functionality in automatic mode is available for nasal and central fixation target to acquire stereo images of ONH and Macula respectively. If a Stereo exam is selected, two slightly offset images of the selected field will be captured with automatic alignment and focus. A delay between the acquisitions is applied in order to let the pupil recover. To review stereo retinal images, please use specific prismatic stereoscopic goggles, such as those provided with EIDON Family Devices. The retake function for stereo retinal images is disabled. 7.10 Manual mode Partial or full override of automated controls is possible by selecting one of the manual mode options in the New Exam screen. This paragraph explains how the different available options work. iCare EIDON Family - User Manual EN Page 29 of 88 Fig. 29 – Manual mode options (FA option available only in the EIDON FA) 7.10.1 Manual fixation In this Exam Mode, the EIDON Family software allows the operator to manually adjust the fixation target and acquire images in the different modality. The device will automatically perform the following steps: a. align the instrument to the selected eye; b. perform auto-focusing, while maintaining alignment; The following commands are available on screen: Main Tab on the screen Position on the screen Information Adjust the height of the chinrest: UP or DOWN Reset Alignment: Restart the Alignment process Stop the acquisition process and go back to the exam Patient Record screen Internal fixation: Allows the standard selection of fixation that appeared superimposed to the live infrared image retina. Manual fixation: Allows the operator to move freely the fixation on the live infrared image, using the white semitransparent circle. External fixation: Allows the operator to use the external fixation powering off the internal fixation. 3D switch: Allows to switch between standard and 3D acquisition. IR: Acquire a fundus infrared image No Tab COLOR: Acquire a fundus color image Page 30 of 88 EIDON Family - User Manual EN iCare FAF: Acquire a fundus Autofluorescence image Exposure value: Adjust the exposure value Stop the acquisition process and go back to the exam Patient Record screen In order to help the Patient, during the Fixation positioning, which could be both Internal or Manual, it appears a green dot that is the position of the fixation target from the patient point of view. Fig. 30 – Exam screen in manual mode with displaced fixation target iCare EIDON Family - User Manual EN Page 31 of 88 7.10.2 Manual Fixation and Focus In this Exam Mode, the EIDON Family software allows the operator to manually adjust the fixation target, set the focus position and acquire images in the different modality. The device will automatically align the instrument to the selected eye and maintaining the alignment. The following commands are available on screen in addition to the ones explained in the previous par. 7.10.1 : Main Tab on the screen Position on the screen Information Manual Focus Adjustment: Allows the manual focus adjustment, by moving the vertical slider or pressing “+” or “-“ Buttons. Autofocus: Allows to perform the automatic focus adjustment. Fast Autofocus: Allows to perform a short automatic focus adjustment, on the range of ±2 Diopters from the current focusing position. 7.10.3 Full Manual This option requires use of the 3D Joystick provided with the EIDON Family devices. In this Exam Mode, the EIDON Family software allows the operator to manually align the instrument to the selected eye, adjust the fixation target, set the focus position and acquire images in the different modality. The device will perform a preliminary alignment to the patient’s eye, so that part of the retina is visible on the screen and then the operator can adjust the position using the 3D Joystick as explained on the Fig. 31. Using the 3D Joystick for alignment in the vertical and horizontal directions, bring the retinal reflection to the center of the infrared retina live image. Once the retina is centered, rotate the 3D Joystick clockwise to move the optical head towards the patient until the retina is fully framed. Once you reach a proper distance adjust focusing as explained for the manual focusing option. Once alignment and focusing are satisfactory proceed as explained for the manual fixation option for displacing the fixation target and capturing images. Fig. 31 – 3D Joystick, top view If at any time while focusing or when displacing the fixation target, the retinal image disappears from view, rotate the Joystick counter-clockwise to “zoom out” and re-center as explained above. Page 32 of 88 EIDON Family - User Manual EN iCare Fig. 32 – Exam screen in manual mode when approaching eye 7.11 Fluorescein Angiography Imaging (FA) Only EIDON FA model includes additional EIDON Family Software features that allow fluorescein angiography images and videos acquisition, following intravenous injection of fluorescein. The decision on whether to perform fluorescein angiography must be made by end-user. It is end-user’s responsibility to be properly skilled to perform such procedure, which is outside the scope of this User Manual and of the products. Any fluorescein angiography session involves the following steps: - Patient preparation; - Pre-injection phase; - Fluorescein injection / recording of early, intermediate and late phase. It is outside the scope of this User Manual and of the products providing specific about injection of fluorescein sodium to perform angiography, in particular the type and dosage of the fluorescein dye, as well as the injection device (syringe) and administration method shall be decided by the prescribing clinicals and are independent on EIDON FA. 7.11.1 Patient preparation In addition to what has been described at par. 6, the preparation for a fluorescein angiography session involves explaining the entire procedure to the patient, dilating the patient’s pupil and, after the pre-injection phase, administering an intravenous injection of fluorescein. Pharmacological dilation is required during fluorescein angiography exams in order to guarantee that the pupil of the patient remains above the minimum allowed for good quality imaging during the whole exam (2.5 mm in diameter). After administration of a mydriatic agent, patient's pupils are dilated, therefore patients may experience glaring or blurred vision. Instruct the patient to be careful when they walk or move around and refrain from driving. iCare EIDON Family - User Manual EN Page 33 of 88 7.11.2 Pre-injection phase To start a new FA session, select the FA option in the Exam Mode options (see Fig. 33) and select the target eye. Fig. 33 – FA mode, selection in the new exam screen Click on the START button to start the exam: EIDON Family Software will enter the pre-injection phase (see Fig. 34). Fig. 34 – FA modality, pre-injection phase The device aligns and focuses using the focus position calculated in the last retinal image acquired in the same day. If no retinal image was acquired yet, the device performs automatic focusing. The following commands are available at this time: Main Tab on the screen Position on the screen Information Adjust the height of the chinrest: UP or DOWN Reset Alignment: Restart the Alignment process Stop the acquisition process and go back to the exam Patient Record screen Internal fixation: Allows the standard selection of fixation that appeared superimposed to the live infrared image retina. Page 34 of 88 EIDON Family - User Manual EN iCare Manual fixation: Allows the operator to move freely the fixation on the live infrared image, using the white semitransparent circle. External fixation: Allows the operator to use the external fixation powering off the internal one. Manual Focus Adjustment: Allows the manual focus adjustment, by moving the vertical slider or pressing “+” or “-“ Buttons. Autofocus: Allows to perform the automatic focus adjustment. Fast Autofocus: Allows to perform a short automatic focus adjustment, on the range of ±2 Diopters from the current focusing position. Switch eye: Align to the contralateral eye, then autofocus. If the patient has no focusing information for the new eye, the device performs autofocus. Inject: Start the FA session. The timer and the blue light are activated for the post injection phase. 3D switch: Allows to switch between standard and 3D acquisition. IR: Acquire a fundus infrared image No Tab COLOR: Acquire a fundus color image FAF: Acquire a fundus Autofluorescence image Exposure value: Adjust the exposure value Stop Exam: Interrupt the FA session and go back to the patient screen: This allows to resume session later. iCare EIDON Family - User Manual EN Page 35 of 88 The light used for FA is a pulsed blue flash, with a 5 Hz repetition frequency. Each pulse of the flash has a certain duration, which can be adjusted. Reducing flash duration will make the exam more comfortable to the patient, but the images may become noisier. It is recommended to perform at least one acquisition per eye before every FA session: in this way EIDON FA records the eyes position and focus. During the FA session, these positions and focuses are taken as a starting point for alignment and focusing operations, to speed up the switching between eyes. For more information see Post-injection phase. A preview of the retinal image just acquired will be shown in the bottom left part of the retinal image. Click on it to enlarge it. 7.11.3 Post-injection phase As soon as the Inject button is pressed the device switch to the FA acquisition The time elapsed since the injection is prominently displayed at the top of the screen (see Fig. 35). Fig. 35 – FA mode, post-injection phase The following commands are available on screen in addition to the ones explained in the previous par. 7.11.2: Main Tab on the screen Position on the screen Information Live IR: Allows to switch the light source to IR and enable the IR, Color and AF Imaging Modalities, in the case that the operator need to acquire these images during FA session. Live FA: Allows to switch to the FA acquisition, to see the live FA view. It’s the standard during the Early phase or for the Video acquisition. Live IR for FA: Allows to switch the light source to IR, but the device remains ready for FA acquisition (this may result in a blurred IR image). This in mainly to reduce the stress for the patient. Page 36 of 88 EIDON Family - User Manual EN iCare Flash duration: Allows to adjust the FA flash duration between 5, 10 or 15 ms. Reset timer: Allows to reset the inject timer and revert to preinjection phase Rec: Allows to Start FA video capture13. Recording stops automatically after 35 seconds. The actual start of the video recording precedes by 5 seconds the click of this button Stop Rec: Stops FA video capture before its automatic termination No Tab FA: Acquire a Fundus Fluorescein Angiography image Stereo FA: Acquire a pair of stereo Fundus Fluorescein Angiography images 7.11.4 Resuming an active FA session Active FA sessions are kept on hold, with the timer running, and can be resumed at any time. To do that, go back to the Patient List screen (see Fig. 18), identify and select the patient for whom you want to resume the FA session and click on Resume FA session button (see Fig. 36). Fig. 36 – Patient Record screen for patient with an active FA session 13 Image resolution 1840 x 1644 @ 5 fps iCare EIDON Family - User Manual EN Page 37 of 88 7.11.5 Active FA sessions list The Patient List screen (see Fig. 18) includes a column that indicates which patients have an active FA session. The list of all active FA sessions is available in a swipe-in side panel that can be opened in the patients list or patient details pages. The panel can also be opened by clicking the icon on the top-left corner of the screen. The panel is also available during image acquisition although in that case the Close FA session buttons are not available. Fig. 37 – FA session tab 7.11.6 Terminating an active FA session To terminate an active FA session, open the swipe-in panel listing the active FA sessions and click “Close FA session” button. Page 38 of 88 EIDON Family - User Manual EN iCare 7.12 Ultra-Widefield Imaging modality The EIDON UWF Module14 is compatible with all the EIDON Family devices imaging modalities (color, infrared, autofluorescence imaging and fluorescein angiography) and is intended for extending the field of view of EIDON Family devices15. Fig. 38 – Color retinal image with Ultra-Widefield Modality Fig. 39 – IR retinal image with Ultra-Widefield Modality Fig. 40 – Autofluorescence retinal image with Ultra-Widefield Modality Fig. 41 – Fluorescence angiography retinal image with Ultra-Widefield Modality Please refers to the EIDON UWF Module User Manual for: • Instruction for preparing the patient for exam with EIDON UWF Module; • Instruction for first installation and for mounting and removing the EIDON Ultra-Widefield Lens; • Warning and precaution information including details about the Optical radiation hazard • Other information (disposal, cleaning, labelling, technical specifications…). 14 It is an optional accessory to EIDON Family devices: please, refers to your local distributor for further details and information about this product. 15 Please, refer to EIDON UWF Manual User Manual for further details and information (technical specification included). iCare EIDON Family - User Manual EN Page 39 of 88 On EIDON Custom Control Interface, press New Exam and chose the desired imaging mode with the button UWF ON // UWF OFF (see Fig. 42). Fig. 42 – UWF ON and UWF OFF button To perform an Ultra-Widefield (UWF) acquisition, mount the EIDON UWF Module and switch status button to UWF ON: exam will progress as usual. To return to standard acquisition modality, remove the EIDON UWFL and switch the status button to UWF OFF. During acquisition, a tag (see Fig.43) is always visible to inform the operator on the current selected imaging mode. Fig. 43 – EIDON UWF Tag The EIDON Family Software preserve the last chosen modality (UWF ON or UWF OFF, see Fig. 42): verify that the current acquisition modality is the desired one, by looking at the UWF Status on the top of the screen (see Fig. 43). Review of retinal image acquired with EIDON UWF Module is made as per standard images review used on EIDON Family device without the EIDON UWF Module installed: please, refers to par. 8 for further details and information. Page 40 of 88 EIDON Family - User Manual EN iCare 7.13 Image retake It is possible to retake every retinal image acquired in automatic mode during the current day, except for FA and stereo retinal images. To retake a retinal image, press the retake icon on the bottom right thumbnail corner: the exposure information panel will appear to set exposure value if necessary before pressing start exam button. By clicking on this button, an automatic exam starts, with the same parameters as the retinal image to be retaken (same eye, same field). After the acquisition, the software will ask to keep the old retinal image, replace it with the new one or keep both. Fig. 44 – Image ready to be retaken Fig. 45 – Image retaken choose which retinal image to keep iCare EIDON Family - User Manual EN Page 41 of 88 8. REVIEWING IMAGES This paragraph explains how to navigate on the EIDON Family Software to review and manage from the Custom control interface the images acquired. 8.1 Patient list Once the Device has been turned on, click on the device’ name button (EIDON or EIDON AF or EIDON FA) to open the Patient List screen (see Fig. 46). Fig. 46 – Patient list screen The different columns in the list indicate respectively (left to right): • presence and number of images (represented by the retinal images) stored for a certain patient (right and left eye); • patient’s Surname and Name, Patient ID, Birth date, patient gender; • date of last exam, formatted as month/day/year; • for EIDON FA only, if an FA session is open, instead of New exam button will appear the Resume FA button that allow to resume the FA session already in progress. Further information about the Patient List screen is available at par. 7. 8.2 Patient Record The Patient Record screen (see Fig. 23) presents all patients’ related information and a thumbnail view of all retinal images captured at any selected date. The following commands are available for the review and manage of the patient: Position on the screen Information Active FA session List: Shows the list of the Active FA sessions (See par. 7.11.5) Export Button: Allows to export the images to: • USB (if an USB drive is connected) • Remote shared folder (if it is properly set) When both USB and RSF are active a Pop-up appears asking the user to choose the desired export destination (see par. 8.9). Delete: Used to permanently delete all data pertaining to the current patient. To delete individual retinal images, select the thumbnail by pressing and holding on it, click on other thumbnails (if needed), then press the delete button Page 42 of 88 EIDON Family - User Manual EN iCare Edit patient data: Used to add or modify a patient’s data Edit patient data: Used to add or modify a patient’s data Visit list: Allows to select different Patient Visit. New Mosaic: Allows to create a new mosaic (see par. 8.5) Select: Allows to select multiple images in order to delete, export or create a PDF report. Back: Allows to return to the Patient List screen. Each thumbnail displays the following information: • examined eye (OD/OS); • imaging modality (IR, Color, FAF or FA) • time and date at which the image was acquired; • field information (not available when image is acquired in manual mode); • 3D logo, when the image has been acquired in stereo mode; • player icon, when the “image” is actually a fluorescein angiography video; • retake logo, when it is possible to retake the image. Fig. 47 – Example of thumbnail with 3D logo iCare Fig. 48 – Example of thumbnail with retake logo EIDON Family - User Manual EN Page 43 of 88 8.3 Single image review To review any of the available images click on the corresponding thumbnail: this will open the Exam review screen (see Fig. 49). EIDON Family Device acquires and stores TrueColor images. Nevertheless, the operator can adjust the acquired retinal image according to his own preferences. Every adjustment to the image is reversible because the original image will never be altered. It is possible to filter the color component of the image (Blue, Green and Red). Images can be modified in brightness, contrast and gamma by moving the related slider. In addition, for color images, it is possible to enhance the red component of the retinal images by applying one of the Red, Red+, Red++ color filters: press the button with the name of current setting (True Color in Fig. 49) to select the desired filter. Red color enhancement can be used together with brightness, contrast and gamma: the adjustments will be applied to every exported image, thumbnail and printout, except for the images stored in the internal shared folder (see par. 8.9). From the Configurator, it is possible to change the default settings for brightness, contrast, gamma and red enhancement filters: see the par. 13.5 for more information. To revert to the default settings (i.e. the settings seen in Configurator) press the Restore defaults button. The red-free retinal image is available by selecting the Green channel Fig. 49 – Exam review screen, color image The following commands and information are available: Position on the screen Click on the retinal image Information Allows to open a full screen view, also allowing zoom and pan Patient and image information RGB filters: Allows to display individual color channels (for color images) and the IR image (if available). Page 44 of 88 EIDON Family - User Manual EN iCare Image Adjustment: Allows to adjust the image acquired. Every parameter will be stored internally but the correction does not alter the original image Export: Allows to export your data. The button open the export menu where operator can choose the format Export Details Allows to: - Export image to.. : export a jpg image to USB or shared folder(par. 8.9). - Create report: Create a PDF report Export DICOM object to shared folder Export image to.. : Allows to export the jpg image to USB or shared folder. This menu shows only the export properly configured (Shared folder and USB) 3D: Allows to open the 3D viewer when the image is part of a stereo acquisition. Back: Allows to return to the Patient Record screen 8.4 3D Stereo Review When the retinal image is part of a stereo pair, a logo will be shown at the top of the review window: when clicking on this logo, the 3D reviewing window will be opened. Fig. 50 – 3D review window Wear the prismatic stereoscopic goggles16, and move forward or backward to the retinal image until you see a single 3D retinal image. If you see elevations instead of cavities, press the corner of the screen. 16 logo on the top right It is provided with the device. For a list of all components included with EIDON family device, see Content List in the device package iCare EIDON Family - User Manual EN Page 45 of 88 8.5 Mosaic EIDON Family Software allows to merge multiple fields of the same retina, to obtain a wider retinal image. The new retinal image generated is called mosaic. Two to nine images can be used to generate a mosaic. A central field is always required. Fig. 51 – Example of a 3-fields mosaic image generated by EIDON Family device Clicking on the Mosaic button in the Patient Record screen, the Field selection screen opens (see Fig. 52). Select the retinal images to be composed into a mosaic; select the When all fields are selected, click on the Create Mosaic button. icon to identify the central field. Fig. 52 – Field selection screen Once mosaic generation is initiated, a dialog box on screen provides progress indications, including which field is being processed and the estimated time to complete. EIDON Family Device cannot be used while mosaic generation is in progress. The images resulting from the mosaic process may contain artifacts (such as duplicated or disconnected vessels) that are generated at the transition between two adjacent fields and that are not present in the original images. Such artifacts can be easily ruled out by comparing the mosaic image with the original single-field images. Only EIDON FA also allows to create mosaics of FA images. Page 46 of 88 EIDON Family - User Manual EN iCare FA images acquired at very different times from injection may present significant differences in fluorescein perfusion, especially during the early perfusion phase, which may prevent proper functioning of the algorithm. In general, a mosaic of FA images may be misleading as it mixes information captured at different times during a dynamic process (dye perfusion). 8.6 Compare Images To review or print a pair of images side by side, press and hold on the thumbnail of the first retinal image until the image is selected (highlighted border); do the same for the second image. Fig. 53 – Dual image selection To review the images, click the image review screen (see Fig. 54). button at the top-right corner of the screen: this will open the Dual To use image enhancement filters, click on the (see Fig. 55). icon and swipe the slider corresponding to , , If the images are taken from different eyes (left and right), the right eye will be displayed on the left, while the left will be shown on the right. Otherwise, the most recent image is displayed on the left. Fig. 54 – Dual image review screen. iCare EIDON Family - User Manual EN Page 47 of 88 Fig. 55 – Dual image review screen with image enhancements filters To export the two images, press from the dual image review screen: the two images will be saved in a landscape page, using the same page template as described in 8.10 Page 48 of 88 EIDON Family - User Manual EN iCare 8.7 HypoAF Boost EIDON AF and EIDON FA models include an additional feature called HypoAF Boost which enhances low autofluorescence signals on the retinal image. The HypoAF Boost can be applied only to autofluorescence images. Fig. 56 – Example of AF retinal image before (left) and after (right) the application of HypoAF Boost A secondary effect of the HypoAF Boost feature is a grainy image. Disabling the HypoAF Boost will restore the original AF image preserving the image quality. 8.8 Video review During FA sessions videos can be captured. In such case a video-camera icon appears as a thumbnail in the patient record screen. Click on the thumbnail to review the video (see Fig. 57). Fig. 57 – FA Video review screen The following commands are available: Position on the screen Information Play and Pause Step forward or backward by 10 seconds The video shows the information on acquisition, like the eye, date/time of injection and time from injection. iCare EIDON Family - User Manual EN Page 49 of 88 8.9 Export functions EIDON Family Software allows to export the patient images and videos to three different locations: • JPG images, videos and PDF printouts, to a USB storage connected to the back panel of the device. • JPG images and videos, to an internal folder called Local shared folder • JPG images, videos, PDF printouts and DICOM files, to a network folder called Remote Shared Folder (RSF) All of the information about the shared folder status are included in the Device Information Center screen. For additional information on the Device Information Center, see par. 12. For additional information on the shared folder and how to configure the export to shared folder (i.e. shared folder type, location, username, etc.) see par. 13.10. EIDON Family Software: press and hold on the thumbnail (first item only) to enter the selection mode for images and videos (highlighted border), choose other elements for export, then press on the export icon. When both USB key and RSF are active a Pop-up appears asking the user to choose the desired export destination. Exported images are identical to those stored in the device 8.10 Printout EIDON Family Software allows to create multi-images and multi-pages PDF printout presenting the following information: 1. Clinic information header (only if the header has been uploaded by the Configurator app. For additional information, see par 13.11) 2. Patient information (name, date of birth, age) 3. Patient notes 4. EIDON Family Device Software version and Device number Depending on the selection, the printout can include up to 9 retinal images per page. The interface allows to choose page orientation (portrait or landscape) and number of images per page (see Fig. 59). First Selected Image is displayed in the Top Left. he following selections are order to Right and Down. Each retinal image contains the following data: 1. Examined eye (OD, OS) 2. Exam information (date, time) 3. Pupil size 4. Gamma, contrast and brightness correction (when applied) 5. Filtering values of the R, G, B channels (when applied) 6. Captured field position (N.A. for retinal images acquired in manual mode) 7. Cup-to-disc (when applied) Page 50 of 88 EIDON Family - User Manual EN iCare Fig. 58 – Multi image printout with custom header Fig. 59 – Report Configuration window The following functions are available in this screen: Position on the screen Information Report preview: It allows to generate the preview of the Printout. Export report to remote shared folder: It allows to export the printout to the remote shared folder. Export report to USB: It allows to export the report to the USB drive. Functionality is available if USB is plugged otherwise the icon is greyed out Report Printing: It allows to print the report iCare EIDON Family - User Manual EN Page 51 of 88 9. REMOTE VIEWER17 The Remote Viewer is a browser-based software that allows the review of retinal images taken with EIDON Family Device on any computer connected to EIDON Family Device via a local area network. The Remote Viewer provides access to the patient list, individual patient records, single and dual image review screen and pdf printout. Compatible browsers include Google Chrome, Microsoft Edge, Mozilla Firefox and Apple Safari. To use the Remote Viewer, the device needs to be connected to the local area network via Ethernet connection. Remote viewer is available only for wired connections. 9.1 Setting up the Remote Viewer To enable the Remote Viewer, connect the device to the local network by plugging the network cable to the Ethernet port located on the back of the device (see Fig. 6) To start using the Remote Viewer a password must be set: to set (or change) the Remote Viewer password see par. 13.6. 9.2 Using the Remote Viewer Open the browser and type http://xxx-nnnnn.domain in the address bar, where: - xxx is the EIDON Family identification name: o EIDON = fun o EIDON AF = flu o EIDON FA = fla - nnnnn is the five digits’ serial number of the Device unit - domain is the local network domain name (or “.local”) This will open the Login screen. When you cannot retrieve the network domain name or if the network is using static IPs and not DHCP, you can retrieve the Device IP as follows: • launch the Configurator application (see par.13.1); • click on the “NETWORK” tab (see Fig. 78); • • • click on the icon of the “Wired” network; retrieve the IP (e.g. 10.0.0.19); type http://IP in the browser address bar (e.g. http://10.0.0.19) Type the password and press Login: this will open the Patient List screen (see Fig. 60), which resembles the corresponding screen in the EIDON Family on-board software. The Remote Viewer session is automatically closed after 20 minutes of inactivity. If needed, press F5 to update the data displayed. 9.3 Patient List Right and left eye image thumbnails are shown in the first columns, followed by the patient full name, patient code, gender and date of birth. The right-most column shows the date of the last exam and the number of images stored. Patients in the list are sorted by the date of their last exam. 17 Starting from EIDON Family manufactured Software v.4.0, the multiple concurrent access to the Remote Viewer on the EIDON Family devices is available under license. One Remote Viewer access is always included by default with the device: please, refer to your local distributor for detailed information. Page 52 of 88 EIDON Family - User Manual EN iCare Patient Search function is available in the top of the screen. From the top right side of the window, the New Patient button allows to add new patients to the device database. Click on the desired patient to enter the Patient Record screen. Click on Logout to exit the Remote Viewer. Fig. 60 – Patient List in Remote Viewer The following functions are available in this screen: Position on the screen Information Remote viewer Information. EIDON: Allows to return to the Patient list screen. Search: Allows to search for an existing patient. View selector: Allows to switch between grid and list view. New Patient: Allows to create a new patient. Select: Allows to select multiple patients. Export of selection: After Select multiple patients, allows to export the selected patient images (see par. 9.13). Delete of selection: After Select multiple patients, allows to delete them. 9.4 Patient Record This screen allows access to individual images as well as mosaic images. Click on the desired image to enter the Single Image review screen. iCare EIDON Family - User Manual EN Page 53 of 88 Fig. 61 – Patient Record screen in Remote Viewer The following functions are available in this screen: Position on the screen Information Remote viewer Information. EIDON: Allows to return to the Patient list screen. Patient Data. Edit Patient Data: Allows to edit or delete the patient. New Mosaic: Allows to create a new Mosaic (see par. 9.7). Export: allows to export or create a printout of the current visit images (see par. 9.13). Select: Allows to select multiple images. Export of selection: After select multiple images, allows to export or create a printout of them (see par. 9.13). Delete of selection: After Select multiple images, allows to delete them. Page 54 of 88 EIDON Family - User Manual EN iCare 9.5 Single Image review Fig. 62 – Single Image Review screen in Remote Viewer The following functions are available in this screen: Position on the screen Information Image Data Previous / Next: Allows to move between previous and next images. Close: Back to Patient Record Screen. Patient Data: Allows to open the patient panel on the side of the image. It shows Patient Data and the other images acquired for the same patient. Image options: Allows to compare or delete or flicker the selected image from the Patient data Panel Image Adjustment: Allows to adjust the image acquired. Every parameter will be stored internally but the correction does not alter the original image Export: Allows to export the image (see par.9.13) 3D Stereo Mode: Allows to access to the stereo mode window when image is part of stereo pairs (see par. 9.6) Cup-to-disc: Allows the evaluation (see par 9.10) Double click or Mouse wheel Mouse left-click and drag cup-to-disc ratio Zooms in or out Moves the image to frame different regions 9.6 3D Stereo Review By clicking on the 3D button, the software display the 3D Stereo Images. Zoom and Pan are available as per the Single Image Review Screen. For more information about the stereo feature, see par. 7.9.4 iCare EIDON Family - User Manual EN Page 55 of 88 Fig. 63 – 3D Stereo Review Image Screen The following functions are available in this screen: Position on the screen Information Switch: Allows to switch the two images Sync: Allows to Sync the zoom and pan of the two images Close compare: Allows to close the image 3D view, remaining on the single image view Close: Back to Patient Record Screen. Patient Data: Allows to open the patient panel on the side of the image. It shows Patient Data and the other images acquired for the same patient. Image options: Allows to compare or delete or flicker the selected image from the Patient data Panel Image Adjustment: Allows to adjust the selected image. Every parameter will be stored internally but the correction does not alter the original image Export: Allows to export and create the printout of the current view, the images will be exported on the printout with the same zoom and pan set in this window (see par.9.13) Flicker: Allow the flicker between the two images selected. Double click or Mouse wheel Mouse left-click and drag Zooms in or out Moves the image to frame different regions 9.7 Mosaic By clicking on the New Mosaic Button is possible to create a new mosaic. Page 56 of 88 EIDON Family - User Manual EN iCare Fig. 64 – Field selection screen in Remote viewer Select the retinal images to be composed into a mosaic; select the icon to identify the central field. When all fields are selected, click on the Create Mosaic button. Once mosaic generation is initiated, a dialog box on screen provides progress indications, including which field is being processed and the estimated time to complete. The images resulting from the mosaic process may contain artifacts (such as duplicated or disconnected vessels) that are generated at the transition between two adjacent fields and that are not present in the original images. Such artifacts can be easily ruled out by comparing the mosaic image with the original single-field images. Only EIDON FA also allows to create mosaics of FA images. FA images acquired at very different times from injection may present significant differences in fluorescein perfusion, especially during the early perfusion phase, which may prevent proper functioning of the algorithm. In general, a mosaic of FA images may be misleading as it mixes information captured at different times during a dynamic process (dye perfusion). 9.8 Compare Images This screen allows comparison of any pair of images of the same patient (color, infrared or AF images, left and right eye, same or different dates, same or different fields). This window allows also to compare two copies of the same image, e.g. to simultaneously see the original image versus the red-free version. When the two images are “synced”: zooming and panning will act on both images. Fig. 65 – Image selection for compare function, from the single review screen iCare EIDON Family - User Manual EN Page 57 of 88 Fig. 66 – Dual Image Review screen in Remote Viewer It is also possible to compare two identical images and zooming one or both to different details and export the selected view. The following functions are available in addition to the function described in the Single Image Review: Position on the screen Information Switch: Allows to switch the two images. Sync: Allows to Sync the zoom and pan of the two images. Close compare: Allows to close the image compare view, remaining on the single image view. Close: Back to Patient Record Screen. Patient Data: Allows to open the patient panel on the side of the image. It shows Patient Data and the other images acquired for the same patient. Export: Allows to export and create the printout of the current view, the images will be exported on the printout with the same zoom and pan set in this window (see par.9.13). Flicker: Allow the flicker between the two images selected. 9.9 Flickering view EIDON Family Software allows to overlap two images and manually or automatically toggling between them. This feature is called flickering and is accessible both from the Single Image review screen (click on the icon all patient items then click on settings an than on compare button or flickering button) or form the compare view (from the dedicated icon , see par. 9.8). During Flickering, patient details are listed and highlighted on right side of each image. Zooming and panning are available. The following functions are available in this screen: Position on the screen Information Close: Allows to to go back to the Single Image Screen. Play/pause flickering. Page 58 of 88 EIDON Family - User Manual EN iCare Next Frame: Allows to manually flicker between images. Animation speed: Allows to adjust the flicker frequency from 1 to 10Hz. Flickering is not available during the execution of an exam or the creation of a mosaic 9.10 Cup-to-disc evaluation The cup-to-disc ratio (CDR) is the ratio between the optic cup diameter and the neuroretinal rim diameter. To evaluate it, draw the two diameters: click over the retinal image to start the first segment drawing, then click to define the end. Do the same for the second diameter. The segments can be modified by clicking and dragging the segment endpoints. In the flickering review Screen are still available the Export and Filter functions. Fig. 67 – Cup-to-disc view The cup-to-disk ratio (CDR) in EIDON Family Device is a qualitative indication to be used as an aid for the detection of diseases: its accuracy depends on how the diameters are drawn by the operator. The clinical interpretation of the CDR obtained with EIDON Family device is the responsibility of the eye care practitioner. iCare EIDON Family - User Manual EN Page 59 of 88 9.11 HypoAF Boost HypoAF Boost is available in the 9.12 icon of AF images (for more info see par.8.7) Video Review Video Review is available in the EIDON FA model only. In the video review window, it is possible to view the video acquisitions and extract and save frames into the patient details screen. The video shows the information on acquisition, like the eye, date/time of injection and time since injection. Fig. 68 – Video review window The following functions are available in this screen: Position on the screen Information Play or pause the video. previous/next: Allows to move between previous and next video frame. Speed: Allows to adjust the speed of video reproduction. Video timer and frame navigation. Save the current frame of the video inside the device. Download the full video to the local computer. The “Extract and save” functionality is not working on videos acquired on EIDON FA with software version previous the v2.0.0 Browser required for video review: • Google Chrome • Microsoft Edge Otherwise, the video can be viewed from VLC players, by enabling the video HW acceleration feature from the VLC options. Page 60 of 88 EIDON Family - User Manual EN iCare 9.13 Export Functions By pressing the icon, the Remote Viewer allows to export the images to the Local computer. With this function is possible to download the selected images, create the pdf printout or send (both images or/and printout) to the local printer installed on the local computer. Fig. 69 – Export function in Remote Viewer The following functions are available in this screen: Position on the screen Information Destination: Allows to choose destination between - Download to Browser. Send to Printer. the export Export Format: Allows to choose the export format between Jpeg or/and PDF. PDF options: - Page orientation. - All images in one document or One document per image. Number of images per page. Allows to proceed with the action selected. Cancel: go back to the previous screen. iCare EIDON Family - User Manual EN Page 61 of 88 10. DICOM DICOM18 is a standard for distributing and viewing medical images and related information. EIDON Family Device supports full DICOM communication, as specified in the EIDON Family Device DICOM Conformance Statement19 document. This feature requires dedicated license. For information about DICOM modality worklist and C-Store, see the EIDON Family device DICOM User Manual. 11. LDAP LDAP (Lightweight Directory Access Protocol) is a software protocol provide a central place for authentication. LDAP is used in Microsoft's Active Directory, but can also be used in other tools such as Open LDAP, Red Hat Directory Servers and IBM Tivoli Directory Servers for example EIDON Family device supports the LDAP authentication, as specified in the EIDON family - LDAP User Manual document. This feature requires dedicated license. 12. INFORMATION CENTER The Information Center contains additional information on the EIDON Family device status. This window includes four tabs: • backup status (for further details, see par. 12.1); • shared folder status (for further details, see par. 12.2); • data storage (for further details, see par. 12.3); • about (for further details, see par. 12.4). 12.1 Backup status From the Backup tab, it is possible to see the status of the backup process, execute or stop a backup. This screen also includes information on the backup media and on the last backup. For more information on Backup and to see how to initialize a new media, see par. 13.8. Fig. 70 – Device Information Center – Backup status 12.2 Shared folder status From the Shared Folder tab, it is possible to monitor the status, the activity and errors of the Shared Folder export process. For more information on Shared Folder see par. 8.9. See par. 17 for information about possible error conditions during the export process. 18 The DICOM Feature for is available under license only: please refer to your local Authorized Distributor for detailed information 19 Please refer to your local Authorized Distributor for the EIDON Family device DICOM conformance statement. Page 62 of 88 EIDON Family - User Manual EN iCare Fig. 71 – Device Information Center – Shared folder status 12.3 Data storage status From the Data Storage tab, it is possible to see some information about the storage available in the internal disk (Local disk space). Fig. 72 – Device Information Center – Data Storage status 12.4 About tab The About tab contains the software release version. Additional information appears after pressing the Details button. Fig. 73 – Device Information Center – About tab iCare EIDON Family - User Manual EN Page 63 of 88 13. SETTINGS EIDON Family Software provides access to settings by means of a separate application called “Configurator”. The Configurator app is available only for the Admin user. 13.1 Launching the Configurator To access the Configurator: • Press the “back” icon at the bottom of the screen to go to the Home screen (see Fig. 16); • Press the logout icon; • Select “Admin” user from the drop-down menu; • Type the corresponding password and click login; • Click the App icon • Start the Configurator by clicking the icon 13.2 ; . Device lock reset procedure In case EIDON Family Software raises error codes ranging from “117” to “121”, or from “124” to “130”, entering a locked state, the Configurator can be used to reset this condition. In such cases a warning icon is shown on the top right bar of the Configurator. To reset the error condition, click on the warning icon: a confirmation message will appear. After clicking the OK button EIDON Family Device will re-initialize. Upon completion of the re-initialization procedure, it is possible to restart using EIDON Family Device normally. If the error condition keeps occurring, please contact an authorized service center. 13.3 Date and time To modify the device date and time, go to the “Date and time” tab on the Configurator: modify the time and date, then press apply. The device will be turned on after applying the date and time modifications. Fig. 74 – Configurator – Date time set 13.4 Password change Passwords for both the “Admin” and “Doctor” users can be changed in the “User Role” tab of the Configurator by clicking the pencil icon (see Fig. 75). Shut down and restart the device to make the new passwords effective. Page 64 of 88 EIDON Family - User Manual EN iCare • • • Always keep passwords in a safe place It is not possible to operate if the EIDON Family Device passwords are lost If both passwords are lost, or to reset the “Admin” password, contact your iCare/CenterVue Authorized Service Center for support. Fig. 75 – Configurator – USER ROLE screen 13.5 Exam parameters From the Exam parameters tab it is possible to: - Set the default value for exposure parameter when acquiring color images either in full-automatic or manual mode; - Set the default brightness, contrast, gamma and redness filter applied to the acquired color images; - Select the default imaging modality; - Enable the pupil size detection in full-automatic exams. When enabled, the pupil size shall be selected between 2.0 and 3.0mm and the maximum waiting time to reach the selected pupil size dimension can be chosen between 5 and 40s. These parameters will be applied starting from the next acquired retinal image. Fig. 76 – Configurator – EXAM PARAMETERS screen 13.6 Remote Viewer To set or change the password used to access the Remote Viewer click on the Remote viewer tab of the Configurator, type the new password and press Apply. It is also possible to set the Privacy mode that will hide the patient name and surname from the patient list of the remote viewer. iCare EIDON Family - User Manual EN Page 65 of 88 Fig. 77 – Configurator – REMOTE VIEWER screen 13.7 Network configuration EIDON Family Device supports either Ethernet connection or wireless connection. However, remote viewer, shared folder export, DICOM and service access are available only through wired network connection. The wireless connection is available only through the Custom Control Interface and is intended only for printing and service access. The Ethernet port is located on the back of the system (see Fig. 6). The Custom Control Interface Wi-Fi should be enabled to connect the EIDON Family Device to a wireless network. Click on the “Network” tab in the Configurator app to access the network configuration window. Fig. 78 – Configurator – NETWORK screen The wireless network parameters are set directly using the tablet’s Android Wi-Fi Settings panel, while the Ethernet network is configured by clicking on the icon, near the “Wired” label. Fig. 79 – Configurator –Network configuration screen Page 66 of 88 EIDON Family - User Manual EN iCare The EIDON Family Device wired interface supports either DHCP or static profiles: to use DHCP, switch ON the DHCP button. Otherwise, type the IP, Network Mask, Gateway and DNS: you may need to contact your system administrator to obtain these details. After configuration, press OK button to store the parameters. To switch between Ethernet and wireless connection, click on the Advanced button on the Network configuration window (Fig. 78): the following window appears. Fig. 80 – Primary Network settings The window shows the current configured network interface, called active interface, and allows to select the connection to be used as network connection. By pressing OK, the Custom control Interface prompts a message if the configured interface was modified. 13.8 Backup EIDON Family device allows the backup of data to a USB media or to a Network folder. The backup can be automatic (i.e., periodically scheduled) or manual. The backup is an incremental backup and will be saved in a subfolder called cv_backup: this means that EIDON Family Device will back up only the data added or modified since the last completed backup. EIDON Family Device supports backup to more than one device media but it is recommended to use a media formatted with the NTFS filesystem to avoid data loss. Moreover, the same device media can be used as backup for different EIDON devices. To access the Backup window, press Backup on the Configuration app. The backup configurator contains three screens: Device, Schedule, Execute. Although EIDON Family Device uses Solid State Drive (SSD) technology for data storage, performing periodic backups is critical for maintaining the safety of your data against unpredictable hardware failures. Manual modifications to the backup folders will damage the backup data. Use a media formatted with the NTFS filesystem. External media formatted with different filesystems might lead to data loss. 13.8.1 Device tab This screen allows to select the device used for backup. The backup can be performed to a USB media or to a network folder: select the desired backup device by clicking on USB or NETWORK at the top of the screen. iCare EIDON Family - User Manual EN Page 67 of 88 When all the parameters are defined for the selected device, press Apply to store the device parameters and move to the Schedule screen. Backup to USB Fig. 81 – Configurator – BACKUP screen – USB-media backup selected When the device is connected and ready for backup, the icon changes to green. The USB media used for backup should be formatted as NTFS, with enough free space to store the backup file. USB sticks are less reliable than USB disks: in case of backup to USB media, consider using USB disks instead of USB sticks. Backup to Network Fig. 82 – Configurator – BACKUP screen – Network backup selected The network parameters to be set are the following: • Server: network name or IP address of the remote host. • Folder: name of the shared folder in the server. The name shall include subfolder in the format FOLDER\SUBFOLDER or FOLDER/SUBFOLDER. • Username: if you’re not in a Windows Domain network, this field contains the user name used in the remote server; if you’re in a Windows Domain network, the format of this field is: DOMAIN\USERNAME • Password: this field contains the password used by the user in the remote server All these fields are mandatory. Empty passwords (i.e. guest accounts) are not supported. Page 68 of 88 EIDON Family - User Manual EN iCare If a Windows-based system is used as backup destination, the Username should be different from Guest, because of Windows Guest user restrictions. 13.8.2 Schedule tab Turn ON the Automatic backup button in the Schedule tab to allow periodic backup. At the scheduled time, EIDON Family Device will try to contact the selected media. If the media is not ready (e.g. network disk not available or USB not connected), EIDON Family Device will temporary suspend the backup procedure and will keep retrying for one hour. The backup will be performed regularly on the next scheduled occurrence even if the last backup attempt failed. Fig. 83 – Configurator – BACKUP screen – Schedule tab with automatic backup enabled The backup will be performed starting on the date set in the Starts on field with the frequency configured in the Execute every field. By pressing the Apply button, EIDON Family Device stores the backup configuration. 13.8.3 Execute tab This screen shows the backup status and allows to perform a manual backup. To perform a backup, press on the Execute button. Once the backup has started, EIDON Family Device can be used regularly except for the impossibility to delete images. Fig. 84 – Configurator – BACKUP screen – Execute tab iCare EIDON Family - User Manual EN Page 69 of 88 If a manual or automatic backup is in execution, this screen shows the progression status with an estimation of the remaining time. 13.9 Restore This feature allows to restore a backup from the selected media. The backup to be restored can come from the same EIDON Family Device or from another EIDON Family device with an exception20: the Restore window will show a list of available backups. To restore a database: Be sure that the USB media or the Network folder used as backup are available, then select the right device in the Device tab and press Apply. Fig. 85 – Configurator – RESTORE screen – Network folder selected Click Apply: the screen shows the list of available backups in the selected media. Fig. 86 – Configurator – RESTORE screen – List of available archives to be restored Tap on the backup to be restored to select the backup. The screen switches to the Execute tab. Press the Execute button: all the data contained in the backup media will be uploaded to the device. Wait until the message “Restore completed successfully” is displayed. The restore function will not erase the EIDON Family Device database: patient data will be appended. EIDON and EIDON AF cannot restore backups from EIDON FA, while EIDON FA can restore backups from EIDON and EIDON AF. 20 EIDON FA accepts restore also from EIDON and EIDON AF. It is not possible to restore EIDON FA backup on EIDON or EIDON AF device. Page 70 of 88 EIDON Family - User Manual EN iCare 13.10 Shared folder configuration Retinal images (and video for EIDON FA only) acquired by EIDON Family Software can be automatically copied to a folder, called shared folder. The Shared Folder configuration tab in the Configurator app allows to edit the export parameters. Press Apply when the modification process has been completed. 13.10.1 Status Switch to “Enabled” to activate data export to a shared folder and configure the relevant options, including server, destination folder, username and password. 13.10.2 Mode If the “Manual” option is selected, data is exported using the export icon located in the exam review screen (see par. 8.9). If “Auto” is selected, data is exported automatically to the selected shared folder upon acquisition and can also be exported manually. 13.10.3 Destination Both “Local” and “Remote” shared folders can be selected as the export destination: - Local shared folder is a folder located in the device; - Remote shared folder is a folder located in another computer connected to the EIDON Family Device through a network. Export to a remote destination requires an active network connection. Local shared folder No additional parameters can be defined for the local shared folder: the shared folder address will be shown at the top of the screen. Remote shared folder If the remote shared folder is selected, Server, Folder, Username and Password fields are required: for additional information on them, please see the chapter 13.8 (Backup configuration). When the administrator clicks on the apply button and a remote shared folder is selected, the device checks for the configuration and displays the check result. 13.10.4 File type If the local option is used, only one export format is available for images (JPEG) and one for video (MP4). Otherwise, JPEG, PDF and DICOM formats are available for images and it is possible to avoid video export. iCare EIDON Family - User Manual EN Page 71 of 88 13.10.5 Filenames The filename of a single exported image or video is as follows: Surname-FirstName-PatientID-ExamDate-SerialNumber-Eye-Field-ImageType-ImageDateExportingDate-Options.FileExtension where: • • • • • • • • • • • • • • • • Surname: the patient surname, as in the surname field. FirstName: the patient given name, as in the given name field. PatientID: the patient ID, as in the patient id field ExamDate: Date/Time of the exam in ISO8601 format: yyyy-mm-ddThh_mm_ssZ where yyyy mm dd are respectively year, month, and day, T is the separator between date and time, hh mm ss are respectively hours, minutes and seconds and Z indicates that the exported file time zone is UTC. SerialNumber: Device serial number, including a prefix eidon_. Eye: Side of the Eye. Possible values: right or left. Field: Index representing the field acquired. Possible values: 0 central, 1 central nasal, 3 nasal, 4 temporal, 5 superior, 6 inferior, 8 superior temporal and undefined in case of manual pictures. ImageType: Type of image acquired. Possible values: visible for color images, infrared for infrared images, af for AF images, fa for FA images, favideo for FA video, favideoframes for pictures extracted from FA videos. ImageDate: Acquisition Date/Time of the image, in the same format as exam date. ExportingDate: Exporting Date/Time of the image, formatted as yyyy-mm-dd_hhmmss, where yyyy mm dd are respectively year, month and day, hh mm ss are respectively hours, minutes and seconds. Options: this is an optional parameter: report if the exported file is a report (i.e. not an image). image if the exported file is an image. mosaic if the exported file is a mosaic. (null) in case of DICOM files. FileExtension: File extension, according to the selected format. Possible values: JPG for JPEG images, PDF for PDF files, dcm for DICOM files. Example: John-Smith-123456789-2020-10-16T13_47_11Z-eidon_00045-right-0-visible-2020-1016T13_46_48Z-2020-11-02_171549-image.jpg The filename of a dual exported image is as follows: Surname-GivenName-SerialNumber-dual-Eye1-Field1-ImageType1-ImageDate1-Eye2Field2-ImageType2-ImageDate2-Options.FileExtension with the same parameters as for the single image (1 and 2 identify respectively the left and the right image in the printout), except for the constant string dual and the extension (only pdf allowed). Page 72 of 88 EIDON Family - User Manual EN iCare 13.10.6 Shared Folder Configuration examples See Fig. 87 as an example of remote shared folder configured for network without domains, and Fig. 88 in the case of Windows Domain network. Fig. 87 – Configurator – SHARED FOLDER configuration example: automatic export of JPEG images and MP4 videos to a remote folder exported_data (subfolder of sharedfolder), located in the server REMOTE-PC, with John as server username Fig. 88 – Configurator – SHARED FOLDER configuration example, in Windows Domain Networks: automatic export of PDF printouts to a remote folder shared folder, located in the server with IP 10.0.0.5, with Lucas as domain username and MYDOMAIN as domain name iCare EIDON Family - User Manual EN Page 73 of 88 13.11 Custom Printout PDF reports can be customized with personal information: it is possible to add a custom logo and a custom text to the header. To add the logo, store a JPG or PNG image, up to 1024x1024 pixels, in a USB key. The retinal image filename must be custom_header_image.jpg in case a JPG image is used as logo, or custom_header_image.png in the case of a PNG image. To add custom information to the header, write a text up to 5 lines in a file named custom_header.txt, and store it in a USB key. The file extension (“.jpg”, “.png”, “.txt”) is added automatically by the software used to create the files. By default, Windows hides the “known extensions” (like “.png”, “.jpg” and “.txt”) therefore the file will have the correct extension even if you don’t see it. Do not add an extra extension otherwise the configurator will not recognize the file. Plug the USB key to the device when the configurator is in the Custom Printout tab: device recognizes the presence of the above files in the USB. If a custom header has been previously uploaded, the header is shown in the upper part of the screen. With “Remove current header” it is possible to remove the custom header from the printouts. If a USB key is plugged to the device and contains valid custom header files, the software will preview the custom header at the bottom of the window. Fig. 89 – Configurator – CUSTOM PRINTOUT configuration 13.12 Custom control interface setting From Home screen of Fig. 16 press to enter into the menu. Click on the Settings Icon to enter the menu and select the desired standby time for the Custom Control Interface Display. Extending the display standby time, the patient data will be more exposed to unwanted visualization. Page 74 of 88 EIDON Family - User Manual EN iCare 13.13 Printer setup EIDON Family Device supports wireless connection to most Android-compatible printers. Printing apps from the most common manufacturers come pre-installed into the EIDON Custom Control Interface. Before choosing a printer, please check if the model is included in the compatibility list issued by the printer Manufacturer for every app. Brand Mopria HP Samsung Lexmark Canon Epson Konica Minolta Description Multi-brand printer app HP Android ePrint Samsung Mobile Print App Lexmark Mobile Printing Canon Mobile Printing, Canon Easy-PhotoPrint, PIXMA/MAXIFY PrintingSolutions Epson iPrint, Seiko Epson Corporation Konica Minolta Printers, Page Scope Mobile Table 3 - Printing apps There are two possible network setups for printers, depending on whether a wireless Access Point (e.g., Wireless router) is available or not. 13.13.1 Infrastructure Mode In this configuration, both the EIDON Custom Control Interface and the printer are connected to an Access Point, such as a wireless router: the printer should be connected to the Access Point either by cable or wireless. Access Point (e.g. Wireless router) Fig. 90 - EIDON Family device’s connection to the printer via Access point (wireless) Access Point (e.g. Wireless router) Fig. 91- EIDON Family device’s connection to the printer via Access point (cable) 13.13.2 Wi-Fi Direct Mode The EIDON Family device connects directly to the printer via wireless (Wi-Fi Direct Mode), without the need of an Access Point: please note that, in order to set up this configuration, the printer must support Wi-Fi Direct. Wi-Fi Direct Fig. 92 – EIDON Family device’s connection to the printer via Wi-Fi Direct iCare EIDON Family - User Manual EN Page 75 of 88 14. DEVICE SHUTDOWN To shut down the device, go back to the Home screen and press the power off icon : device beeps twice then turns off. Is it also possible to press the on/off button on the rear connectors panel (see Fig. 6). The EIDON Custom Control Interface will shut down and power off automatically. Page 76 of 88 EIDON Family - User Manual EN iCare 15. TECHNICAL SPECIFICATIONS Fundus Imaging Features Field of view for Single image: 60°(H) x 55°(V) captured in a single exposure (external eye notation) 90°(H) x 85°(V) captured in a single exposure (center of the eye notation) 80°(H) x 75°(V) captured in a single exposure (external eye notation) – with EIDON UWFL21 120°(H) x 110°(V) captured in a single exposure (center of the eye notation) – with EIDON UWFL21 Field of Mosaic22 image: 110° (H) captured with 3 images horizontally (external eye notation) 160° (H) captured with 3 images horizontally (center of the eye notation) (three images) Sensor resolution: Light sources: 14 Mpixel (4608 x 3288 pixels) White LED (440-650 nm) - for all models Infrared LED (825‐870 nm) - for all models Blue LED (440-475 nm) - for EIDON AF and EIDON FA model only) Imaging modalities: Color, Infrared, RGB channel separation23 - for all models Autofluorescence - for EIDON AF and EIDON FA model only Fluoresceine Angiography Imaging - for EIDON FA model only Working distance: 28 mm 16 mm – with EIDON UWFL21 Resolution: 60 pixels / deg Optical resolution on retina: 15 µm Pixel pitch: 4.9 µm Minimum pupil size 2.5 mm FA Video resolution: 1840x1644 pixels (EIDON FA model only) FA Video acquisition rate: 5 fps (EIDON FA model only) Other features and characteristics Automatic operation: auto-alignment, auto-focus, auto-exposure, auto-capture, auto-mosaic Auto-focusing adjustment range: - 12 D to + 15 D Fixation targets: internal / external Dynamic programmable internal Fixation target: Central, Nasal, Temporal, Central-Nasal, Superior, Inferior, Superior-Temporal, Superior-Nasal, Inferior-Temporal, Inferior-Nasal EIDON Custom Control Interface: 10.1” multi-touch, color display custom control interface Wi-Fi connectivity: through EIDON Custom Control interface Hard disk: DICOM24: SSD, 480 Gb for - EIDON and EIDON AF models SSD, 2 TB - for EIDON FA model only Compatibility - DICOM version 3.0 21 Ultra-Widefield Imaging is avaible with the optional accessory EIDON UWF Module only. For futher information and technical specifications about the EIDON Family devices used with the EIDON UWF module, see EIDON UWF Module User Manual: please, refers to your local distributor for further and detailed information. 22 Up to nine retinal images. 23 Red-Free digital filters. 24 Available under additional license only: please refers to your local distributor for further and detailed information including for DICOM Conformance Statatement iCare EIDON Family - User Manual EN Page 77 of 88 Other features and characteristics Size: Weight: Power supply: Class and type of applied part: IP classification: Service life (lifetime): EIDON Family devices are equipped with: Accessory: 360 mm x 590 mm x 620 mm (14.2” x 23.2” x 24.4”) 25 kg (55 lb) Related voltage 100-240VAC Frequency 50-60 Hz Power Consumption 80W Class I, Type B (according to IEC 60601‐1). IPX0 (according to the degree of protection provided by the enclosure with respect to harmful penetration of particulate matter or water). The service life (lifetime) of the devices is five (5) years from the date of manufacturing. • • • • • • • • • • Support bracket for Control Interface with mounting kit for 3 different positioning 3D Joystick with support bracket Prismatic stereoscopic goggles Headrest and chin rest silicone cushion Dust cover EIDON Family front lens cap This User Manual EIDON Family External Fixation Target Mini-HDMI-to-HDMI adapter USB Extension cable EIDON UWF Module21 (Optionally equipped with EIDON Family devices) Specifications are subject to change without notice for improvement, as result of ongoing technical development. Page 78 of 88 EIDON Family - User Manual EN iCare 16. CLEANING This paragraph explains how to clean the device. The chin rest and the headrest should be wiped with an alcohol wipe before each use and allowed to dry prior to reuse. Fig. 93 – Removal of the chin rest silicone pad Gently pull up and slide the chin rest pad to avoid breaking the retaining peg. The front lens should be cleaned using a small hand pump air blower, to blow away dust. Only if really needed, for instance due to the presence of a fingerprint, the objective lens can be cleaned by means of photographic cleaning paper and a suitable lens cleaning fluid. The Custom control Interface display should be cleaned only with a cloth damped in water. When cleaning the rest of the device, the device must be off, and the power cord should be disconnected from mains. If needed, the external covers of the unit can be cleaned using a slightly damp cloth. iCare EIDON Family - User Manual EN Page 79 of 88 17. TROUBLESHOOTING Symptom 1. EIDON Family Device does not power on (no green LED) 2. System keeps failing alignment with message “Eye not found” Bluish artifacts as in this example appear in all newly acquired images 3. 4. Captured image is totally white 5. One or more dark areas appear in color and/or IR retinal images Possible cause(s) Solution Unit is not powered Plug the power supply into a properly working socket then press the power button for at least 2 seconds Front lens cap is in place Remove front lens cap Front lens or UWFL is dirty Clean the front lens or the UWFL Patient blinked capture during image Pupil is too small (< 2.5 mm) Repeat capture and ask patient not to blink Dark adapt patient. Otherwise dilate patient’s pupils. • • 6. Export to the remote shared folder fails with message “The selected host is not reachable” or “Timeout” • Network connection to the remote shared folder not working Write access to the selected remote folder not granted host computer is not reachable • • • Check that the network cable is correctly plugged Check that the local area network is available Check that the remote folder is shared with write permission Check that the computer hosting the shared folder is reachable 7. Export to the remote shared folder fails with message “Unknown error” The remote export folder was renamed after the export destination was configured Re-configure the export destination 8. Export to the remote shared folder fails with message “The shared disk is full.” The computer hosting the shared folder has a full hard disk Empty some space on the host computer or change the export destination to another computer Page 80 of 88 EIDON Family - User Manual EN iCare 18. ELECTROMAGNETIC COMPATIBILITY EIDON Family Devices have been tested and found to comply with the limits for medical devices contained in IEC 60601-1-2 and Medical Device Directive 93/42/EEC. These limits are intended to provide reasonable protection against harmful interference in a typical medical installation. EIDON Family Devices 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 EIDON Family Devices does cause harmful interference to other devices, which can be determined by turning the EIDON Family Devices 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. EIDON Family Devices need 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 these EIDON Family Devices 18.1 Manufacturers EMC Declaration to IEC 60601-1-2 The following tables provide specific information regarding compliance of EIDON Family Devices EIDON Family Device is intended for use in the electromagnetic environment specified in the below tables. The customer or the end-user of EIDON Family Device should ensure that it is used in such an environment. Other cables and accessories not provided with the devices may negatively affect EMC performance. IEC 60601-1-2 EMISSION TEST for EIDON and EIDON AF models Test Requirements Test Result Compliance Electromagnetic environment - Guidance Class A or B B Yes EIDON and EIDON AF uses RF energy for its internal function. Therefore, its RF emissions are Group 1 Yes very low and not likely to cause any interference CISPR 11, 14-1, 32 or ISO 7137 CISPR 11 Yes in nearby electronic equipment. CISPR 11 Conducted RF emissions Yes EIDON is suitable for use in all establishments, Class B including domestic and those directly connected to CISPR 11 Radiated RF emissions Yes the public low-voltage supply network that supplies Class B buildings used for domestic purposes, providing Disturbance Power (if applicable) N/A N/A the following warning is heeded: Harmonic Distortion IEC 61000-3-2 Class A Yes (Class A, B, C, D) EIDON and EIDON AF are intended for use by healthcare professionals only. EIDON and EIDON AF may cause radio interference or may Voltage Fluctuations and Flicker disrupt the operation of nearby equipment. It may be Passed Yes IEC61000-3-3 necessary to take mitigation measures, such as reorientating or re-locating EIDON /EIDON AF or shielding the location. Table 4 - Electromagnetic Emissions for EIDON and EIDON AF models 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 IEC61000-3-3 IEC 60601-1-2 EMISSION TEST for EIDON FA Test Result Compliance Electromagnetic environment - Guidance A Yes EIDON FA uses RF energy for its internal function. Therefore, its RF emissions are very low and not 1 Yes likely to cause any interference in nearby electronic CISPR 11 Yes equipment. CISPR 11 Yes Class A The EMISSIONS characteristics of EIDON CISPR 11 FA make it suitable for use in industrial areas and Yes Class A hospitals (CISPR 11 class A). If it is used in a N/A N/A residential environment (for which CISPR 11 class B is normally required), EIDON FA might not offer Class A Yes adequate protection to radio-frequency communication services. The user might need to Passed Yes take mitigation measures, such as relocating or reorienting the equipment Table 5 - Electromagnetic Emissions for EIDON FA model iCare EIDON Family - User Manual EN Page 81 of 88 18.2 Guidance and manufacturers declaration – Electromagnetic Immunity EIDON Family devices IEC 60601-1-2 ELECTROMAGNETIC IMMUNITY FOR EIDON Family devices Test Requirements Test Result Compliance Electrostatic Discharges Passed Yes Radiated RF EM Fields Professional Healthcare and Proximity Wireless field Facility Environment Yes (IEC 60601-1-2) Electrical Fast Transients and bursts Passed Yes Surges Conducted Disturbances, Passed Yes induced by RF fields Voltage Dips and Interruptions Passed Yes Rated Power-frequency Magnetic Field Passed Yes Table 6 - Electromagnetic Immunity (IEC 60601-1-2:2014) for EIDON Family Devices 18.3 Immunity pass criteria IMMUNITY Function System functioning – main unit System functioning – connection between Custom control Interface and main unit IMMUNITY pass criteria During the applied testing stimulus, temporary cessation or interruption of any intended operation is acceptable During the applied testing stimulus, temporary cessation or interruption of any intended operation is acceptable Table 7 - Electromagnetic Immunity (IEC 60601-1-2) EIDON Family devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the end-user of EIDON Family devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and EIDON Family devices 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 the EIDON Family devices, including cables specified by the manufacturer. 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 8 - Recommended Separation Distances Page 82 of 88 EIDON Family - User Manual EN iCare 18.4 Wi-Fi Specifications Model name: WL18MODGI (Texas Instruments Incorporated) Main Chipset: WL1807MODGIMOC (Texas Instruments Incorporated) Tx/Rx: Standard Conformance: Interface: Operation Voltage: Maximum RF Power: Security: 20- and 40-MHz SISO IEEE 802.11 b/g/n IEEE 802.11 a/n Dual-Band (2.4 and 5 GHz) 4-Bit SDIO Host Interface Support DC 1.8V ±8% According to EMF Exposure Evaluation Report: 2.4GHz Avg power: 17.5dbm (56.2mW) 5GHz Avg power: 19.5dbm (89.1mW) Hardware-based encryption-decryption using 64-, 128-, and 256-bit WEP, TKIP, or AES keys Requirements for Wi-Fi-protected access (WPA and WPA2.0) and IEEE Std 802.11i (includes hardware-accelerated Advanced Encryption Standard AES) FCC (USA) radio certification The EIDON Family devices contain a radio module that complies with regulations of the USA and Canada. FCC ID: ID-Z64-WL18DBMOD IC ID: 451I- WL18DBMOD These devices comply with part 15 of the FCC rules. Changes or modifications not expressly approved by the party responsible for compliance could void user’s authority to operate the equipment. Operation is subject to the following 2 conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. iCare EIDON Family - User Manual EN Page 83 of 88 19. INFORMATION ABOUT THE OPTICAL RADIATION HAZARD EIDON Family devices are a classified25 as: • EIDON and EIDON AF: class 1 • EIDON FA: class 2 according to ISO 15004-2 and ANSI Z80.36. 19.1 Information required by ISO 15004-2 valid for EIDON FA model only The light emitted from this instrument is potentially hazardous. The longer the duration of exposure and the greater the number of pulses, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum output will exceed the safety guideline after 46300 color images or 6666 autofluorescence images or 75 minutes of continued fluorescein angiography video or 6666 fluorescein angiography images or 8600 hours of continued green fixation light or 109793 hours of continued yellow fixation light. Patient exposure to light from the EIDON FA can be calculated as follows: • For color images the exposure for 1 photo is 0.0002157 𝐽⁄𝑐𝑚2 . • For autofluorescence image the exposure for 1 photo is 0.0015 𝐽⁄𝑐𝑚2 . • For illumination light during dynamic fluorescein angiography the exposure for 1 minute is 0.133 𝐽⁄𝑐𝑚2 . • For fluorescein angiography image the exposure for 1 photo is 0.0015 𝐽⁄𝑐𝑚2 . • For green fixation light the exposure for 1 minute is 0.00001938 𝐽⁄𝑐𝑚2 . • For yellow fixation light the exposure for 1 minute is 0.0000015 𝐽⁄𝑐𝑚2 . Since the exposure from all light sources is cumulative, and all imaging modalities, including fluorescein angiography, and the fixation light can be used in combination, the exposure given by each source shall be added in order not to exceed the safety guidelines. Therefore, calculation of total exposure is as follows: 𝑇𝑜𝑡𝑎𝑙 𝑒𝑥𝑝𝑜𝑠𝑢𝑟𝑒 = (𝑛𝑉𝐼𝑆 × 0.0002157) + (𝑛𝐴𝐹 × 0.0015) + (𝑛𝐹𝐴 × 0.0015) + (𝑡𝐹𝐴 × 0.133) + (𝑡𝐹𝐼𝑋𝑔𝑟𝑒𝑒𝑛 × 0.00001938) + (𝑡𝐹𝐼𝑋𝑦𝑒𝑙𝑙𝑜𝑤 × 0.0000015) < 10[𝐽⁄𝑐𝑚2 ] where: • 𝑛𝑉𝐼𝑆 is the number of color images captured during an exam, • 𝑛𝐴𝐹 is the number of autofluorescence images captured during an exam, • 𝑛𝐹𝐴 is the number of fluorescein angiography images captured during an exam, • 𝑡𝑉𝐼𝑆 is the time, in minutes, that the illumination light for fluorescein angiography is on, • 𝑡𝐹𝐼𝑋𝑔𝑟𝑒𝑒𝑛 is the time, in minutes, that the fixation light is on during all exams, • 𝑡𝐹𝐼𝑋𝑦𝑒𝑙𝑙𝑜𝑤 is the time, in minutes, that the fixation light is on during all exams. Example 1: if 100 color photos, 100 autofluorescence photos, 100 fluorescein angiography photos are captured, together with 60 minutes of continued fluorescein angiography illumination and 120 minutes of green fixation, the resulting exposure will be about 8.3 J/cm2, which is still below the safety guideline. Example 2: if 6 color photos, 4 autofluorescence photos and 50 fluorescein angiography photos are captured, together with 2 minutes of continued fluorescein angiography illumination and 20 minutes of green fixation, the resulting exposure is 0.35 J/cm2. 25 EIDON Family devices used with EIDON Ultra-Widefield Lens (EIDON UWFL) remain in the same class. Page 84 of 88 EIDON Family - User Manual EN iCare 19.2 Information required by ANSI Z80.36 for EIDON FA model only The light emitted from this instrument is potentially hazardous. The greater the number of pulses, the greater is the risk of ocular damage. Exposure to light from this instrument when it operates at maximum intensity will exceed the recommended maximum exposure (RME) of 2.2 𝐽⁄𝑐𝑚2 , unless additional action is taken by the user to minimize exposure, after 10185 color fundus images taken alone, 1467 autofluorescence images taken alone, 17 minutes for illumination light during FA exam operating alone, 1467 FA images taken alone, 1892 hours for green fixation used alone, 24154 hours for yellow fixation used alone. The risk of retinal injury at an exposure of 2.2 𝐽⁄𝑐𝑚2 is not high but, because some patients may be more susceptible than others, caution is advised if this radiant exposure value is exceeded. However, because of a significant risk of injury at exposures exceeding 10 𝐽⁄𝑐𝑚2 , the user should avoid exposures longer than 46300 color images or 6666 autofluorescence images or 75 minutes of continued fluorescein angiography video or 6666 fluorescein angiography images or 14467 hours of continued green fixation light or 8600 hours of continued yellow fixation light. Patient exposure to light from the EIDON FA can be calculated as follows: • For color images the exposure for 1 photo is 0.0002157 𝐽⁄𝑐𝑚2 . • For autofluorescence image the exposure for 1 photo is 0.0015 𝐽⁄𝑐𝑚2 . • For illumination light during dynamic fluorescein angiography the exposure for 1 minute is 0.133 𝐽⁄𝑐𝑚2 . • For fluorescein angiography image the exposure for 1 photo is 0.0015 𝐽⁄𝑐𝑚2 . • For green fixation light the exposure for 1 minute is 0.00001938 𝐽⁄𝑐𝑚2 . • For yellow fixation light the exposure for 1 minute is 0.0000015 𝐽⁄𝑐𝑚2 . Since the exposure from all light sources is cumulative and all the images type, the FA exam and the fixation can be used in combination, the exposure given by each source shall be summed in order not to exceed the safety guidelines in the following way: 𝑇𝑜𝑡𝑎𝑙 𝑒𝑥𝑝𝑜𝑠𝑢𝑟𝑒 = (𝑛𝑉𝐼𝑆 × 0.0002157) + (𝑛𝐴𝐹 × 0.0015) + (𝑛𝐹𝐴 × 0.0015) + (𝑡𝐹𝐴 × 0.133) + (𝑡𝐹𝐼𝑋𝑔𝑟𝑒𝑒𝑛 × 0.00001938) + (𝑡𝐹𝐼𝑋𝑦𝑒𝑙𝑙𝑜𝑤 × 0.0000015) < 10[𝐽⁄𝑐𝑚2 ] where: • 𝑛𝑉𝐼𝑆 is the number of color images captured during an exam, • 𝑛𝐴𝐹 is the number of autofluorescence images captured during an exam, • 𝑛𝐹𝐴 is the number of fluorescein angiography images captured during an exam, • 𝑡𝑉𝐼𝑆 is the time, in minutes, that the illumination light for fluorescein angiography is on, • 𝑡𝐹𝐼𝑋𝑔𝑟𝑒𝑒𝑛 is the time, in minutes, that the green fixation light is on during all exams, • 𝑡𝐹𝐼𝑋𝑦𝑒𝑙𝑙𝑜𝑤 is the time, in minutes, that the yellow fixation light is on during all exams. Example: if 100 color photos, 100 autofluorescence photos and 100 fluorescein angiography photos are performed in combination with 60 minutes of fluorescein angiography illumination light and 120 minutes of green fixation the exposure will be about 8,3 J/cm2. iCare EIDON Family - User Manual EN Page 85 of 88 20. DISPOSAL EIDON Family Device are made of different materials, such as plastics, aluminum, electronic parts. In case of device disposal, please separate the various materials and follow the laws and regulations regarding disposal or recycling for each material effective in your own country. Separate collection for electrical and electronic equipment The European Directive 2012/19/EU establishes separate collection for Waste of Electrical and Electronic Equipment (WEEE). Users of Electric and Electronic Equipment (EEE) must not dispose of WEEE as unsorted municipal waste but collect such WEEE separately. The available return and collection system is defined by the local public administration, or alternatively an authorized company can recycle the WEEE. Please refer to public administration about separate collection, if this information is not available, contact the equipment manufacturer. Users play a major role in contributing to the reuse, recycling and recovery of WEEE. The potentially dangerous substances contained in WEEE can pollute the environment and produce harmful effects on human health. Below is a list of specific hazards related to some substances, which may leach in the environment and in the water system. Lead: damages the nervous system of humans, affects the endocrine system, the cardiovascular system and kidneys. It accumulates and is very toxic for animals, plants and micro-organisms. Cadmium: accumulates with a half-life of 30 years and can damage the kidneys and cause cancer. Mercury: is easily accumulated in organisms and concentrates through the food chain. It has chronic effects and can cause brain damage. Chromium (Hexavalent): easily absorbed into cells with toxic effects. The results can be allergic reactions, asthma and it is considered to be genotoxic (damages the DNA). Especially dangerous when incinerated. Brominated Flame Retardants: widely used to reduce flammability (eg. cables, connectors and plastic cases). Page 86 of 88 EIDON Family - User Manual EN iCare 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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Key features
- Confocal imaging
- TrueColor images
- High resolution
- High contrast
- Non-mydriatic imaging
- Autofluorescence imaging
- Fluorescein angiography (EIDON FA only)
- Ultra-Widefield imaging (optional module)
- Remote Viewer access
- DICOM compatibility
Frequently asked questions
The EIDON can capture infrared reflectance, color, red-free, and autofluorescence images. The EIDON FA model also provides fluorescein angiography images.
No, the EIDON can operate in a non-mydriatic condition for patients with a minimum pupil size of 2.5 mm. However, the decision to use a mydriatic agent is under the responsibility of the eye care practitioner.
Confocal imaging provides enhanced image quality by limiting the backscattered light effect from deeper layers, resulting in better contrast and resolution. It can also operate with smaller pupils compared to non-confocal imaging systems.