Phelcom Eyer User Manual
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Phelcom Eyer User Manual

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Summary of Contents for Phelcom Eyer

  • Page 3: Table Of Contents

    Creating patients 3.2.4.1. Patients 3.2.4.1.1. Creating patient profiles through Eyer ® 3.2.4.1.2. Patient personal information 3.2.4.1.2.1. Info 3.2.4.1.2.2. Removing a patient profile through Eyer ® 3.2.4.1.2.3. Exams 3.2.4.1.2.4. Creating exams through Eyer ® 3.2.4.1.2.5. Image capture screen 3.2.4.1.2.6. Captured images 3.2.4.1.2.6.1.
  • Page 4 3.2.4.1.2.9. Removing exams through Eyer ® 3.2.4.1.2.10. Creating and editing diagnosis through Eyer ® 3.2.4.1.2.11. Sending files by email 3.2.4.1.2.12. Device printer setup 3.2.4.2. Exams 3.2.4.3. Options 3.2.4.3.1. Clinic 3.2.4.3.2. System 3.2.4.3.2.1. Logs 3.2.4.3.2.2. Defaults 3.2.4.3.2.3. Advanced Resources 3.2.4.3.2.4. Language 3.2.4.3.2.5.
  • Page 5 Electromagnetic Safety Standards 13.1. Supplier declaration and guidelines - Electromagnetic emissions 13.2. Supplier declaration and guidelines - Electromagnetic immunity 13.3. Recommended minimum separation distances from mobile RF communication devices to Eyer ® 13.4. Radio frequency interference Biocompatibility Glossary and symbols Cybersecurity Information 16.1.

  • Page 6: Compliance

    Compliance Phelcom Technologies developed this device according to worldwide quality standards, prioritizing patient and operator safety, electromagnetic compatibility and friendly operational flow, thus making Eyer ® Retinal Camera safe, reliable and robust, meeting the most varied demands of fundus imaging for diagnosis and screening purposes.

  • Page 7: Indication For Use

    ● Never disassemble the device, since it may damage optical and electronic parts, as well as fragile mechanisms. ● Contact Phelcom technical support in case there are any problems related to the device. ● Device must be used either in clinical/hospital locations or on-field itinerary campaigns with a trained operator.

  • Page 8: Contraindications And Limitations

    field of view is 45 degrees allowing a detailed diagnosis. The operation of Eyer ® Retinal Camera can be learned quickly, and even an inexperienced camera operator can capture images with sufficient quality for quick screening purposes. Eyer ® Retinal Camera provides versatility for diagnosing different patient groups that are not able to sit in front of desk-top fundus cameras (e.g., supine patients,...

  • Page 9: Introduction

    In case of any information, doubt, suggestion, or complaint about device components, please contact Phelcom. Always count on the technical staff to help and guide you, maximizing device usefulness. 2.2.

  • Page 10: Setup And Electrical Connections

    Before first use, qualified and supplier-authorized technicians must install smartphone and application to assure the device works perfectly. Contact Phelcom for further information on initial setup. Phelcom staff may also provide remote access to make maintenance and application troubleshooting possible. Eyer ®...
  • Page 11 Figure 1 displays the device in its accessory base. Figure 1: Device on its accessory base. Eyer ® application setup for smartphones works as the steps described in section 2.2. Minimum requirements of the smartphone follow specified in Table 1. Table 1: Minimum requirements for smartphone.
  • Page 12 Charge source USB - C fast charging Battery 3400mAh Water resistance IP 68 rating Dimensions 149.9 x 70.4 x 7.8mm Weight 157 g According to minimum requirements, the most adequate smartphones available on market are Samsung Galaxy S10.

  • Page 13: Eyer

    Device and application details and operation flow are presented below: 3.1. Device features Figure 2, figure 3, figure 4, figure 5 and figure 6 present the feature list below: 1. Eyer ® Retinal Camera with integrated smartphone 2. Protective lens cap 3. Eyecap 4.

  • Page 14: Operation

    The Eyer® operation is divided into two options: The user can create an account or make quick captures without being logged in. See section 3.2.2 to create the...

  • Page 15: Application

    3.2. Application The Eyer® application is simple and functional. It allows patient registration, conducting and organizing exams, making reports, and editing information. Captured information and exams can be safely synchronized by SMB/CIFS, DICOM, FTP or Local Folder connections allowing the visualization of the data and exams outside Eyer®...
  • Page 16 Figure 8: Device start screen with top Figure 9: Quick Access Tools android bar Figure 10: Wi-Fi details Figure 11: Quick access apps...
  • Page 17 Access application by an icon on the central screen, figure 8. Figure 12 depicts the program loading screen. Figure 12: Initial system loading screen A screen for USB device permission displays at the end of the process, use it as default and click “OK”, figure 13 and 14. Select the language, figure 15, and the terms of use and privacy policy display, figure 16.

  • Page 18: Eyer Account Creation

    Figure 16: Accept Terms of Use 3.2.2. Eyer Account Creation After accepting the terms and conditions of use, the user must create their account on Eyer ® . Follow the instructions as shown in the figures below. Figure 17: Click on Create account.
  • Page 19 Figure 17 - Create Account Figure 18 - User Info...
  • Page 20 Figure 19 - Login info Figure 20 - Account Verification Figure 20: A verification code was sent to the user’s email. Put this code in the requested field, as shown above, and confirm. Figure 21 below shows the email that the user will receive to fill in the previous figure 20.

  • Page 21: Quick Captures

    Figure 22 - login with email and password 3.2.3. Quick captures If the user intends to make a quick capture, just to visualize the photo, you can use the basic capture screen. The user must click on “Capture” as in Figure 23: Figure 23 - Capture option to Quick Capture Figure 24 - Screen available for Quick capture...
  • Page 22 The screen available for Quick Capture, as shown in Figure 24, is the Basic Capture Screen. Below is an explanation of the functions: ● PRO: Navigates to full screen, with all available control options. ● HDR: Image combination with different exposures to increase the dynamic range.
  • Page 23 Figure 27 - Import images screen Figure 28 - Import exams screen Figure 29 - Desired images Figure 30 - Patients screen...

  • Page 24: Creating Patients

    Figure 31 - Info screen Figure 32 - Gallery screen 3.2.4. Creating patients After login, a screen displays, figure 25. It enables accessing all system functions: patients, exams, and options. Click the synchronization icon , figure 25, to check transfer status, figure 33.

  • Page 25: Patients

    Access option 1, “Patients”, in the main screen, figure 25, to register, visualize, alter information, as well as carry out exams and diagnostics through patient information. 3.2.4.1.1. Creating patient profiles through Eyer ® Selecting icon 1, figure 25, displays a screen as in figure 34. Here, a list of registered patient names displays.
  • Page 26 Figure 34: Opening screen for the “PATIENTS” Figure 35: Screen for creating patient profile option, figure 25...

  • Page 27: Patient Personal Information

    Info Each patient registration form, figure 37, is accessible through the screen depicted by figure 34, or automatically, after creating a new patient profile (section 3.2.1.1.1 Creating patient profiles through Eyer ). First provided ® information is compiled in the “info” tab, with the following functions:...

  • Page 28: Removing A Patient Profile Through Eyer

    ® Figure 37: Patient registration form in “info” tab. 3.2.4.1.2.2. Removing patient profile through Eyer ® Select icon 3, figure 37, to remove a patient form. Click the “remove” option in checkbox, figure 38. Do not select “remove remote” to remove the capture...

  • Page 29: Exams

    Figure 39: Remove patient profile Figure 40: Remove patient profile ® ® from Eyer from Eyer and configured servers 3.2.4.1.2.3. Exams Figure 41 depicts each patient registration form, which contains the tab “exams”. It displays a list with exams sorted by date, hour, status (closed or open) and possible images or reports in the exam.

  • Page 30: Creating Exams Through Eyer

    3.2.4.1.2.4. Creating exams through Eyer ® Select icon in “info” or “exams” tab, figure 41, and the screen in figure 42 displays. “Info” contains patient’s name, date, and time of exam (click in any section field to edit), a field to write notes and a selector switch for patients with mydriasis.
  • Page 31 Patient will see a white light flash. There is no image capture at this point, but the device will adjust focus of the examined eye. Remove Eyer ® from the patient's...
  • Page 32 with eye drops. Segment Selection RETINA - Indicates image capturing of the posterior segment. ANTERIOR - Indicates image capturing of the anterior segment. This function has fixed parameters. It is only necessary to select the eye to be examined, figure 43. Exams image gallery Image capture Manual focus...
  • Page 33 adjustment if they are white or bright color Increase contrast and definition of Clear eyes and standard details in clear MEDIUM 100% retina structures such as the optic nerve head Ideal for taking the first image capture and HIGH 100% Standard setting checking the need for...
  • Page 34 Function PRO The function PRO navigates to full screen, with all available control options. See figure 45. Function HDR This function is the image combination with different exposures to increase the dynamic range. AUTOSHOT Function Automatic capture. The condition for using the “Autoshot” function is that the positioning is done correctly.
  • Page 35 Figure 46: List of patient exams. Figure 47: Patient progression.
  • Page 36 Figure 48: Expand exam images. Figure 49: Expand exam images and generate progression.
  • Page 37 Figure 50: Confirm creation. Figure 51: Wait for progression. The chosen images will be displayed in contrast, with the darkest regions being common areas of the selected images. In “shape of the cutout”, Figure 52 - item 1, it is possible to select whether the format will be square or circular. Place the square that surrounds the image, , in the region you want to cut and confirm with the symbol , Figure 52 - item 2.
  • Page 38 Figure 53. In “Data”, Figure 54, it is possible to: 1. Consult the options for this exam; 2. View the exam used; 3. Create a diagnostic report as in 3.2.1.1.2.10 Create and edit diagnosis through Eyer®.
  • Page 39 Figure 53: Selection area. Figure 54: Selection area. In the exam options, Figure 54 - item 1, it is possible, in Figure 55: 1. Share an exam; 2. Transfer to a previously registered server. To consult a previously performed progression, access the patient's exams and click on the “Patient Progression”...

  • Page 40: Captured Images

    Figure 55: Sharing area. Figure 56: Patient exams with progression. 3.2.4.1.2.6. Captured images Select the tab “Gallery”, figure 42, to view captured images, figure 57. Click the icon , figure 57 to share images, send manually via DICOM/FTP/SMB; click the icon, figure 57, to create panoramic images, texture or 3D effect and/or remove images in bulk.
  • Page 41 Figure 57: Images captured during exam Figure 58: Checkbox for images Figure 59: Screen for sending image via DICOM/FTP...
  • Page 42 1. Share: Sends images to external platforms. Click and hold on the images to select until a blue square frame shows around them. Click the icon , then “share” and choose how to send the file. Figure 60: Share images 2. Transfer: Screen which presents a summary of exams and images to send, with success and failure statistics and the available server list, figure 59.
  • Page 43 3. Panoramic: Set of compiled images, created from the selection of two or more fixation targets. Variety of fixation targets equals a wider analysis area. Click and hold over targeted images, then a blue square frame shows around them. Click , then panoramic.
  • Page 44 Figure 62: Generate texture 5. 3D Effect: dynamic image that enables better viewing of the optic nerve. Click and hold over targeted images, then a blue square frame shows around them. Click , then 3D effect. Confirm generation and wait. Figure 63: Generate 3D effect...
  • Page 45 6. Select low quality images Click and hold over targeted images, then a blue square frame shows around them. Click , then Select quality images. Confirm generation and wait.
  • Page 46 Figure 64: Select low quality images 7. Delete images: Permanently delete an image or set of images. Check section 3.2.1.1.2.8. Removing Images through Eyer ® to delete a magnified image. Click and hold over targeted images to remove, click the icon , then “Delete images”, then “yes”.

  • Page 47: Synchronization Failure

    Figure 65: Delete images 3.2.4.1.2.6.1. Synchronization failure In case of exam synchronization failure, the symbol , figure 66, displays. Click the icon to check the cause. “Synchronization Status”, figure 67, displays pointing server and send errors. Touch the message in red and check synchronization details for further information, figure 61.
  • Page 48 Figure 66: Synchronization failure Figure 67: Synchronization details Figure 68: Synchronization status...

  • Page 49: Image Analysis And Editing Through Eyer

    3.2.4.1.2.7. Image analysis editing through Eyer ® Click the capture of interest to analyze images via device. A screen with expanded view displays, figure 69. Use icon to edit. Figure 69: capture expanded image 3.2.4.1.2.7.1. Cropping Select icon to crop an image and...

  • Page 50: Image Measurement

    3.2.4.1.2.7.2. Image Measurement Click the icon to measure images. Rectangular and elliptical shapes are available, figure 71. Click the icon complete. Figure 71: Image measures screen...

  • Page 51: Image Rotation

    3.2.4.1.2.7.3. Image Rotation Select the icon and drag the scale towards the aimed direction to rotate an image, figure 72. After completing, select the icon Figure 72: Image rotation screen 3.2.4.1.2.7.4. Levels Drag the icon scale bar to adjust image brightness level or icon adjust contrast, figure 73.

  • Page 52: Isnt Function

    3.2.4.1.2.7.5. ISNT Function The user must click on the CDR (Cup Disc Ratio) button to open the ISNT (Inferior-Superior-Nasal-Temporal) function, figure 74. Figure 74: CDR (Cup Disc Ratio Button) First, the user must select the intended region and a graph will be generated below, as shown in Figure 75.
  • Page 53 The user can use the closed padlock tool to fix one region or another. It is possible to analyze this through figures 76 to 80. To delete the generated graph, the user must click on the button highlighted in the figure 73.

  • Page 54: Removing Images Through Eyer

    Removing exams through Eyer ® In the patient exams list, figure 46, slide leftwards and select “remove”, figure 81. Do not activate “remove remote”, figure 82, to delete the exam only from Eyer ® and not from other configured servers. Activate it to delete from all servers, figure 83.
  • Page 55 Figure 81: Removing exam Figure 82: Removing exam in Eyer ® Figure 83: Removing exam in Eyer ® configured servers...

  • Page 56: Creating And Editing Diagnosis Through Eyer

    3.2.4.1.2.10. Creating and editing diagnosis through Eyer ® After image capture, “Info” tab, figure 42, enables the field “diagnosis” to insert technical reports, figure 84. Icon creates a diagnosis. Figure 84: Creating diagnosis for present exam When a diagnosis is created, the screen portrayed in figure 85 opens in the...
  • Page 57 All images will be selected in the “images” tab, figure 86. To prevent specific captures from appearing in the report, press it until the blue frame does outline Repeat procedure with 3D effect imaging. Press to complete the report. Figure 86: Registered images to select technical report Report file will display below the diagnosis field, figure 87:...

  • Page 58: Sending Files By Email

    Screen portrayed in figure 88 displays when icon (generate report) is selected. The icons represent: Search text in file Send file, open with, download, print or report a bug, figure 89 Figure 88: Application-generated report Figure 89: File options 3.2.4.1.2.11. Sending files by email Access “Send file”, figure 90, then choose “Gmail”...

  • Page 59: Device Printer Setup

    Figure 90: Sending files by email 3.2.4.1.2.12. Device printer setup Access “open with”, figure 90, choose the local printer application, figure 91, and follow the instructions. A Wi-Fi printer is required and must be turned on to show in the available printers list. Figure 91: Print PDF 3.2.4.2.
  • Page 60 the date and choose the date to check or edit. Exams are organized in ascending chronological order. “Open” status means the exam was created but not completed; “closed” status indicates the exam is completed. The icons represent: ● search patientf ●...

  • Page 61: Options

    3.2.4.3. Options Option 3 on the application start screen refers “options” button, figure 25, which enables visualizing information on the clinic, system, device, and servers, figure 93. Figure 93:” Options” tag available functions. 3.2.4.3.1. Clinic Option 1. “Clinic”, figure 93, displays information on the accessed clinic, figure 94.

  • Page 62: System

    3.2.4.3.2. System Option 2. “System”, figure 93, displays options to visualize system logs, default settings and language, as well as terms and conditions, figure 95. Figure 95: System screen 3.2.4.3.2.1. Logs Function 1. “Logs”, figure 95, presents options to control the registry, which is used diagnose system...

  • Page 63: Defaults

    3.2.4.3.2.2. Defaults Access option 2, figure 95, to visualize device default settings. A screen as in figure 97 displays. Click the icon to change defaults, figure 98. Figure 97: Device default settings Figure 98: Edit device defaults 1. Illumination intensity: Sets image lighting level - default lighting level for image capture screen is 3 2.

  • Page 64: Advanced Resources

    1. Archive data time (days): determines, in days, how long the information remains available in the device. 3.2.4.3.2.3. Advanced Resources Figure 95, option 3, depicts the advanced resources in the Eyer ® : Autoshot, Evaluate Capture Quality. Figure 99: Advanced resources disabled...

  • Page 65: Language

    3.2.4.3.2.4. Language Figure 95, option 4, depicts where to Eyer ® language: Portuguese (Brazil), English (US), Spanish, and Japanese, figure 101. Figure 101: Device language selection 3.2.4.3.2.5. Terms and conditions of use Terms of Use and Privacy Policy are displayed to the user at his/her first access to the device, for authorization and acceptance, item 3.2.1 Device start screen and...

  • Page 66: Device

    Figure 102: Terms of Use Figure 103: Privacy Policy 3.2.4.3.3. Device The option “device” contains information on the device, item 3, figure 93. When selected, there are three available options: 1. Calibration, 2. About, 3. User Manual, figure 104. Figure 104: Technical information on the device...

  • Page 67: Calibration

    3.2.4.3.3.1. Calibration Click option “Calibration”, figure 104, to proceed to the screen as in figure 105. ● Direct the device towards a flat and clear surface. ● Activate “start” button, figure 105, and wait for the device to make technical adjustments. Note: In case the camera image is not in a symmetric circle, adjust manually.

  • Page 68: User Manual

    Figure 106: Device information 3.2.4.3.3.3. User Manual Access the user manual through the application “Manual”, figure 11, section 3 or option 3, “Manual”, figure 104. 3.2.4.3.4. Servers Option 4. “Servers”, enables accessing available servers, figure 107. Select button , figure 107, to add a new server. Select the server type to synchronize, figure 108, and fulfill information as described in item 3.2.1.3.4.1 Common server setup.

  • Page 69: Common Server Setup

    Figure 107: Servers list Figure 108: Option to create servers 3.2.4.3.4.1. Common server setup Any type of server requires defining information, figure 109: 1. Action: Defines server action behavior, figure 110: a. Primary: Main communication server, all the information will obligatorily be synchronized with this server b.

  • Page 70: Dicom Servers Setup

    Figure 109: Common server setup Figure 110: Synchronization action options 3.2.4.3.4.2. DICOM servers setup server information exam storage (Archive AE) or worklist server information, figure 111, to use DICOM servers. 1. AE Title: Application identification in the system 2. AET: Server identifier 3. IP: Server IP 4.

  • Page 71: Ftp Server Setup

    3.2.4.3.4.3. FTP server setup Fill information in as in figure 112 to use FTP servers. 1. Server address 2. Server port 3. Username 4. Password 5. File format transferred (DCM or JPG). Figure 112: FTP server setup...

  • Page 72: Smb/Cifs Server Setup

    3.2.4.3.4.4. SMB/CIFS server setup Fill information in as in figure 113 to use SMB/CIFS servers: Server address 2. Shared folder name 3. Domain 4. When activated, transfer will authentication 5. Username 6. Password 7. File format transferred (DCM or JPG). Figure 113: SMB/CIFS server setup...

  • Page 73: Local Folder

    Diverse fields are filled in for that standard, as the TAGS that follow below: ● PatientID → Built from the clinic medical record number, with a prefix defined in the field “DICOM Prefix” in Eyer® systems screen. Example: For a clinic registered with a CNS medical record, a DICOM file with PatientID value “phelcom_cnsPaciente”...
  • Page 74 ● PupilDilated → Dilated Pupil “YES” ou “NO” ● ImageLaterality → Exam laterality “R” (right) or “L” (left) ● Manufacturer → Fixed value “Phelcom Technologies” ● ManufacturerModelName → Fixed value “Eyer” ● deviceSerialNumber → Serial number of the device used in the exam ●...
  • Page 75 3.2.5. Shutdown procedure After the operator performs the exams, he must finish the operation by pressing the button and confirm by Selection “YES”. Figure 117 - Finish the operation The Application will enter the home screen and recommends if for short periods between exams, leave the equipment on standby, quickly pressing the right-side button of the smartphone leaving it on the reset screen.
  • Page 76 Figure 118 - Turn off the equipment...

  • Page 77: Carrying Out Exams

    Carrying out exams 4.1. Posterior segment Provided the knowledge on handling Eyer ® integrated systems, access the image capture screen, figure 43, then follow steps below to capture images. ● Adjust device parameters according to section 3.2.1.1.2.5 Image capture screen ● Stay in front of the patient ●...
  • Page 78 Captured image displays for a few seconds then is immediately stored in gallery, figure 120, enabling capture screen for new photos. Figure 120: Example of Posterior segment capture...

  • Page 79: Anterior Segment

    The other fingers rest on the patient’s head until the capture is complete ● Hold Eyer with the right hand ® ● Ask the patient to open both eyes wide and cover the eye that...
  • Page 80 It is not possible for the user or operator to carry out maintenance in this device. Manufacturer recommends regular preventive maintenance inspections made by Phelcom. Inspection must be done every year to help detect eventual damage, increase device safety, and lengthen its service life.

  • Page 81: Packing, Storage, Transportation, Site Selection, Operation, And Environmental Conditions

    ● Conform to the safety labels affixed to device package. ● Avoid impacts (shock, falls, etc.) that may cause mechanical, optical and/or electronic damage, resulting in loss of calibration made by Phelcom. ● Location for storage, transport and operation must have controlled environmental conditions.

  • Page 82: Accompanying Parts And Accessories

    Accompanying parts and accessories Following parts and accessories compose the device, figure 122: Figure 122: Equipment parts and accessories 7.1. Accessories 1. Eyer Retinal Camera 2. Dock station (Charging station) 3. Eyecap 4. Lens Protector 5. Storage case 6. Cleaning cloth 7. Allen wrench 8.

  • Page 83: Disposal

    2002/96/CE, through recycling companies or licensed solid waste disposal in the country of operation. Disposal of device or parts does not need to be sent to the factory. Consult Phelcom local authorized supplier before disposal. Users are responsible for disposal of Eyer ®...

  • Page 84: Cables And Connections

    ● Smartphone charge: Plug a charger connected to the power grid, figure 125, in the Eyer ® USB-C port, figure 126. ● Accessory base charge: Install the power cable at the bottom of the accessory base, figure 127, and plug Eyer ® to charge, figure 128. Figure 125: Eyer ®...
  • Page 85 Figure 127: Cable connected at the bottom of ® Figure 128: Eyer positioned for accessory base the accessory base charge Power grid isolation is possible through the smartphone charger while the battery charges. Always use the original charger in good conditions.

  • Page 86: Technical Data

    Resolution Camera resolution 12 MP Image resolution 1600 x 1600 px Chart 1 shows a graphic about Eyer emission spectrum for retinal and anterior ® segment imaging and Chart 2 shows a graphic about Eyer ® emission spectrum in the preview mode.

  • Page 87: Electrical Characteristics

    Chart 1: Eyer® emission spectrum for retinal and anterior segment imaging Chart 2: Eyer® emission spectrum in the preview mode 10.2. Electrical characteristics Patient exposure to any energy related risk coming from the power grid is prevented by a software lock that unable exam procedures while charging. Table 3 presents...
  • Page 88 Table 3 - Eyer® mobile device specifications Protection against electrical shock Class 2 equipment Degree of protection against BF type equipment electrical shock Degree of protection against harmful Console: Unprotected (IPX0) water penetration Sterilization: not applicable Sterilization or Disinfection methods Disinfection: use a clean cloth...

  • Page 89: Warning

    Warning You have acquired a high technology device made by a Brazilian company. That means you can access us after sales service through the contacts in the last page of this Guide.

  • Page 90: Troubleshoot Guide

    This chapter presents some operational issues the device may present in use. User can check for technical specifications in table 4 that will serve to correct simpler issues or to facilitate contact with Phelcom technical support. Table 4 - Technical specifications for operational issues...

  • Page 91: 12.1 Remote Support

    Once a secure connection is established, Phelcom will enable screen sharing on this device and initiate support along with the user. The Eyer application by default does not allow screen capture, that is, for remote access to be able to view the application screen, it is necessary to release it based on the user's consent.
  • Page 92 by the user. During the service, the customer can follow all the procedures performed on the equipment.

  • Page 93: Electromagnetic Safety Standards

    Phelcom. If the performance of Eyer Retinal Camera is lost or degraded due to electromagnetic disturbances, it may cause unexpected or adverse operation of this device.

  • Page 94: Supplier Declaration And Guidelines - Electromagnetic Emissions

    Replacement cables may only be purchased at Phelcom. the use of Accessories, any converters or cables which are not specified in this user manual or have not been purchased as spare parts from Phelcom can result in increased emissions or reduced immunity of the device.

  • Page 95: Supplier Declaration And Guidelines - Electromagnetic Immunity

    13.2. Supplier declaration and guidelines - Electromagnetic immunity Eyer® maintains basic safety and performance when used in the electromagnetic environment specifies tables 6 and table 7. The customer or the user of the device should ensure that it is used in such an environment.
  • Page 96 3 Vrms 150 KHz to communication equipment must 150 KHz to 80 Conducted RF 80 MHz not be used near any Eyer part, IEC 61000-4-6 & 6 Vrms including cables, within a shorter & 6 Vrms ISM separation distance than...

  • Page 97: Devices To Eyer

    Interference may occur around the equipment marked with the following symbol: 13.3. Recommended minimum separation distances from mobile communication devices to Eyer ® Eyer ® maintains basic safety and essential performance when used in an...
  • Page 98 RF disturbances are controlled. The customer or the user of Eyer Retinal Camera can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) Eyer Retinal Camera recommended in table 8, according to the maximum output power of the communications equipment.

  • Page 99: Radio Frequency Interference

    13.4. Radio frequency interference Eyer® follows the regulation IEC 60601-1-2:2014, following all applicable requirements regarding electromagnetic compatibility, provided that local environmental limitations are met.

  • Page 100: Biocompatibility

    Biocompatibility Phelcom declares that the material used in the applied part of the device Eyer ® certified by ISO 10993-1 - Biological evaluation of healthcare products, thus offering no risk regarding its use. The Eyecap accessory is manufactured by Phelcom Technologies and has a use by date of 5 years.

  • Page 101: Glossary And Symbols

    Glossary and symbols This section presents all the symbols related to device safety and their meanings, table 9, as well as the labels on its protective package. Table 9: Labels, markings, and symbols MARKING SYMBOL MARKING SYMBOL Fragile; handle Operator's manual with care Keep away from Class II equipment rain...
  • Page 102 Waste electrical Type BF Applied and electronic Part disposal Federal law restricts this device to sale by or General warning on the order of a sign physician or licensed practitioner...

  • Page 103: Cybersecurity Information

    Cybersecurity Information 16.1. Objective The purpose of this section is to summarize the cybersecurity controls of the Eyer ® Retinal Camera system. 16.2. System overview The Eyer ® Retinal Camera system has the following interface that are critical for cybersecurity: ●...

  • Page 104: Data Backup

    ● The Eyer device can be configured to synchronize all exam data with external servers. The following transmission types are supported: DICOM, FTP and SMB/CIFS. Data transmission is encrypted by default. The configuration of the connection parameters must be informed by the user.

  • Page 105: Cybersecurity Events Notification

    Eyer configuration on the factory process, the responsibility of it is from the user. All sensitive information from the Eyer application is stored in encrypted form in a protected area. Other apps cannot access this information. Phelcom Technologies recommends the use of parental control to all Eyer equipment users upon receipt of the product, allowing new applications to be installed only through the use of a PIN.
  • Page 106 Phelcom is not responsible for personal injuries, lesions or wounds resulting from device misuse. Phelcom legal liability refers to this device and its use is limited to the purchase value paid by the Customer. In case the commercial relation to Phelcom is not a purchase and sale agreement, the applicable warranty and responsibility terms shall mandatorily be defined in...
  • Page 107 São Carlos - SP - Brazil - ZIP Code: 13.562-405 Phone: +55 (16) 3413-3088 support@phelcom.com DESIGNATED MARKETING AUTHORIZATION HOLDER (DMAH) Allm Inc 1-12-1 道玄坂, 渋谷区 東京都, 日本 Phone: Email: PHELCOM EYER ® - NM-STD USER MANUAL - REVIEW 11 02/17/2023...

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