Phelcom Eyer User Manual
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Phelcom Eyer User Manual

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  • Page 3: Table Of Contents

    3.2.4.1. 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. Synchronization failure 3.2.4.1.2.7.
  • Page 4 Exams 3.2.4.2. Options 3.2.4.3. 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. Terms and conditions of use 3.2.4.3.3. Device 3.2.4.3.3.1. Calibration 3.2.4.3.3.2. About 3.2.4.3.3.3. User Manual 3.2.4.3.4. Servers 3.2.4.3.4.1. Common server setup 3.2.4.3.4.2. DICOM servers setup 3.2.4.3.4.3.
  • Page 5 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. Objective 16.2. System overview 16.3. General principles 16.4. Cybersecurity functions 16.5. Data backup Term of Warranty...

  • Page 6: Compliance

    1. 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

    Camera digital images can be stored for follow-up or consultation purposes. The ® 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.

  • Page 8: Contraindications And Limitations

    (e.g., supine patients, wheelchair patients). Due to small size and portability Eyer ® Retinal Camera can also be used for homecare visits and remote screening camps. 1.6. Contraindications and limitations...

  • 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. Overview ®...

  • 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.
  • Page 11 ® 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. Operating System Android Nougat 9.0 Pie Screen 6.1-inch AMOLED 1440X3640 (~550 ppi)
  • 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

    4. Accessory base (Charging station) 5. Charger and USB cable 6. Compliant Smartphone 7. Optical body 8. Charging connection 9. Electronics compartment 10. Compliance seal and indelible label with basic information ® Figure 2: Eyer protective lens cap and Eyecap...

  • Page 14: Operation

    3.1.1. Operation After acquiring the Eyer®, the user must access the Eyer application and log in. Follow the next instructions for creating your account. All operation of the device is done through the application installed on the smartphone, which is used for commands, controls, visualization of operations and results, as well as access to external systems for sharing and storing images.

  • Page 15: Application

    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® application. For patient data synchronization consult the section 3.2.1.3.4 Servers for details.
  • 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.
  • Page 18 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 Figure 19 - Login info Figure 20 - Account Verification...
  • Page 20 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 Clinic name Username Figure 21 - Verification code in email...
  • Page 21 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 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. Figure 33 –...

  • Page 25: Patients

    3.2.4.1. 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. Creating patient profiles through Eyer ® 3.2.4.1.1. 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 Click to sort the profiles list and choose one option: recent, ascending or descending, figure 36. Figure 36: Filter to exhibit patient profiles...

  • Page 27: Patient Personal Information

    3.2.4.1.2.1. 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: 1.

  • Page 28: Removing A Patient Profile Through Eyer

    Removing patient 3.2.4.1.2.2. 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 ® from Eyer and keep it on your servers, figure 39.

  • Page 29: Exams

    Figure 41: Exams tab Creating exams 3.2.4.1.2.4. ® through Eyer Select icon in “info” or “exams” tab, figure 41, and the screen in figure 42 displays. “Info” tab contains the patient’s name, date, and time of exam (click in...

  • Page 30: Image Capture Screen

    Image capture screen 3.2.4.1.2.5. Select icon , figure 42, and a screen, figure 43, opens. Its icons are specified according to their functions. Figure 43: Image capture screen...
  • 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 face.
  • Page 32 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 Select the icon and drag the adjustment bar towards the aimed value to inform the...
  • Page 33 retina and definition of details in clear structures such as the optic nerve head Ideal for taking the first image capture and HIGH 100% Standard setting checking the need for adjustment Dark eyes or with opacity First adjust when in the anterior tissues of the photo is dark HIGH 120%...

  • Page 34: Captured Images

    10. Function HDR This function is the image combination with different exposures to increase the dynamic range. 11. AUTOSHOT Function Automatic capture. The condition for using the “Autoshot” function is that the positioning is done correctly. This function interacts with the user through the target displayed on the screen.
  • Page 35 Figure 47: Checkbox for images Figure 48: Screen for sending image via DICOM/FTP 1. Share: Sends images 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.
  • Page 36 2. Transfer: Screen which presents a summary of exams and images to send, with success and failure statistics and the available server list, figure 48. Click the icon , then “transfer”, figure 47, then select preferred server, figure 48. 3. Panoramic: Set of compiled images, created from the selection of two or more fixation targets.
  • Page 37 4. Texture: images with filters to assist identifying lesions. Click and hold over targeted images, then a blue square frame shows around them. Click , then texture. Confirm generation and wait.
  • Page 38 5. Stereo: 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 stereo. Confirm generation and wait. 6. Heatmap: Data visualization mode that highlights regions of retinal changes. Medical evaluation is required.
  • Page 39 7. 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 41 8. 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 42: Synchronization Failure

    Synchronization failure 3.2.4.1.2.6.1. In case of exam synchronization failure, the symbol , figure 49, displays. Click the icon to check the cause. “Synchronization Status”, figure 50, displays pointing server and send errors. Touch the message in red and check synchronization details for further information, figure 51. Figure 49: Synchronization failure Figure 50: Synchronization details Figure 51: Synchronization status...

  • Page 43: Image Analysis And Editing Through Eyer

    Image analysis 3.2.4.1.2.7. editing through Eyer ® Click the capture of interest to analyze images via device. A screen with expanded view displays, figure 52. Use icon to edit. Figure 52: capture expanded image Cropping 3.2.4.1.2.7.1. Select icon to crop an image and...

  • Page 44: Image Measurement

    Image Measurement 3.2.4.1.2.7.2. Click the icon to measure images. Rectangular and elliptical shapes are available, figure 54. Click the icon complete. Figure 54: Image measures screen Image Rotation 3.2.4.1.2.7.3. Select the icon and drag the scale towards the aimed direction to rotate an image, figure 55.

  • Page 45: Levels

    Levels 3.2.4.1.2.7.4. Drag the icon scale bar to adjust image brightness level or icon adjust contrast, figure 56. Select icon when complete. Figure 56: Image levels screen ISNT Function 3.2.4.1.2.7.5. The user must click on the CDR (Cup Disc Ratio) button to open the ISNT (Inferior- Superior-Nasal-Temporal) function, figure 57.
  • Page 46 First, the user must select the intended region and a graph will be generated below, as shown in Figure 58. Figure 58: ISNT Graph generated The user can use the closed padlock tool to fix one region or another. It is possible to analyze this through figures 59 to 62.
  • Page 47 Figure 59: Padlock Figure 60: Padlock Figure 61: Padlock demonstrate demonstrate demonstrate Figure 63: Delete option Figure 62: Padlock demonstrate...

  • Page 48: Removing Images Through Eyer

    Removing exams through Eyer 3.2.4.1.2.9. In the patient exams list, figure 54, slide leftwards and select “remove”, figure 64. Do not activate “remove remote”, figure 65, to delete the exam only from Eyer ® and not from other configured servers. Activate it to delete from all servers, figure 66.

  • Page 49: Creating And Editing Diagnosis Through Eyer

    ® ® Figure 65: Removing exam in Eyer Figure 66: Removing exam in Eyer configured servers Creating and editing 3.2.4.1.2.10. diagnosis through ® Eyer After image capture, “Info” tab, figure 42, enables the field “diagnosis” to insert technical reports, figure 67.
  • Page 50 When a diagnosis is created, the screen portrayed in figure 68 opens in the “info” tab. Include, in the editable field “Diagnostic Hypothesis”, the disease hypothesis in the field “ICD pattern” and, for non-catalogued diseases, use the field “other”. Figure 68: Diagnosis information input All images will be selected in the “images”...
  • Page 51 Report file will display below the diagnosis field, figure 70: 1. Send report to one of the configured servers 2. Edit report information 3. Generate file and 4. Delete diagnosis. Figure 70: Diagnosis linked to the exam Screen portrayed in figure 71 displays when icon (generate report) is selected.

  • Page 52: Sending Files By Email

    Figure 71: Application-generated report Figure 72: File options Sending files by email 3.2.4.1.2.11. Access “Send file”, figure 72, then choose “Gmail” option, regardless of the user’s email server, figure 73, and follow application instructions. Figure 73: Sending files by email...

  • Page 53: Device Printer Setup

    Device printer setup 3.2.4.1.2.12. Access “open with”, figure 72, choose the local printer application, figure 74, and follow the instructions. A Wi-Fi printer is required and must be turned on to show in the available printers list. Figure 74: Print PDF Exams 3.2.4.2.

  • Page 54: Options

    Figure 75: Exams on a specific date. Options 3.2.4.3. Option 3 on the application start screen refers to the “options” button, figure 25, which enables visualizing information on the clinic, system, device, and servers, figure 76. Figure 76:” Options” tag available functions.

  • Page 55: Clinic

    Clinic 3.2.4.3.1. Option 1. “Clinic”, figure 76, displays information on the accessed clinic, figure 77. Figure 77: Clinic information. System 3.2.4.3.2. Option 2. “System”, figure 76, displays options to visualize system logs, default settings and language, as well as terms and conditions, figure 78.

  • Page 56: Logs

    Logs 3.2.4.3.2.1. Function 1. “Logs”, figure 78, presents options to control the registry, which is used diagnose system issues, figure 79. ● Log level: Level internal application event registry ● Native log level: Level of internal application exam registry Figure 79: System logs. Defaults 3.2.4.3.2.2.

  • Page 57: Advanced Resources

    1. Archive data time (days): determines, in days, how long the information remains available in the device. Advanced Resources 3.2.4.3.2.3. Figure 78, option 3, depicts the advanced resources in the Eyer ® : Autoshot, Evaluate Capture Quality, Evaluate heatmap, Generate heatmap image on...

  • Page 58: Language

    Figure 82: Advanced resources disabled Figure 83: Advanced resources enabled Language 3.2.4.3.2.4. Figure 78, option 4, depicts where to ® Eyer language: Portuguese (Brazil), English (US) and Spanish, figure 84. Figure 84: Device language selection...

  • Page 59: Terms And Conditions Of Use

    Terms and conditions of use 3.2.4.3.2.5. 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 access, figure 16. Select option 5 to access again, figure 78, “Terms and conditions”, and the terms of use display, figure 85.

  • Page 60: Calibration

    Figure 87: Technical information on the device Calibration 3.2.4.3.3.1. Click the option 1. “Calibration”, figure 87, to proceed to the screen as in figure 88. ● Direct the device towards a flat and clear surface. ● Activate “start” button, figure 88, and wait for the device to make technical adjustments.

  • Page 61: User Manual

    1. Software version: Information on operation application version 2. Firmware version: Version of the software on device frame 3. Serial number: Individual and non-transferable serial number 4. Device number: Device identification number Figure 89: Device information User Manual 3.2.4.3.3.3. Access the user manual through the application “Manual”, figure 11, section 3 or option 3, “Manual”, figure 87.

  • Page 62: Common Server Setup

    Figure 90: Servers list Figure 91: Option to create servers Common server setup 3.2.4.3.4.1. Any type of server requires defining information, figure 92: 1. Action: Defines server action behavior, figure 93: a. Primary: Main communication server, all the information will obligatorily be synchronized with this server b.

  • Page 63: Dicom Servers Setup

    Figure 92: Common server setup Figure 93: Synchronization action options DICOM servers setup 3.2.4.3.4.2. Add server information for exam storage (Archive worklist server information, figure 94, to use DICOM servers. 1. AE Title: Application identification in the system 2. AET: Server identifier 3.

  • Page 64: Ftp Server Setup

    FTP server setup 3.2.4.3.4.3. Fill information in as in figure 95 to use FTP servers. 1. Server address 2. Server port 3. Username 4. Password 5. File format transferred (DCM or JPG). Figure 95: FTP server setup...

  • Page 65: Smb/Cifs Server Setup

    SMB/CIFS server setup 3.2.4.3.4.4. Fill information in as in figure 96 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 96: SMB/CIFS server setup...

  • Page 66: Local Folder

    DICOM file information 3.2.4.3.4.6. ® Every Eyer exam can be converted to DICOM standard, generating a .dcm file. 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 field “DICOM...
  • Page 67 ● 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 68 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 100 - 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 69 Figure 101 - Turn off the equipment...

  • Page 70: Carrying Out Exams

    4. 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 ●...
  • Page 71 It is recommended to warn the patient about this. There are no known contraindications to carrying out fundus examination with Eyer. Nevertheless, the operator must evaluate if the skin of the eye area touched by the equipment is intact and clean. It is also necessary to evaluate if patient’s possible specific...

  • Page 72: Anterior Segment

    Figure 104: Captured image in anterior segment 5. Maintenance, handling and sanitizing Read this manual carefully to carry out maintenance and clean Eyer properly. Corrosive chemicals and other abrasives are not advisable. ● Do not clean the device on its accessory base.
  • Page 73 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 74: 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 75: Accompanying Parts And Accessories

    7. Accompanying parts and accessories Following parts and accessories compose the device, figure 105: Figure 105: 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.

  • Page 76: 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 77: Cables And Connections

    ● Smartphone charge: Plug a charger connected to the power grid, figure 108, in the Eyer ® USB-C port, figure 109. ● Accessory base charge: Install the power cable at the bottom of the accessory base, figure 110, and plug Eyer ® to charge, figure 111. ® Figure 108: Eyer connected to charger Figure 109: Eyer®...
  • Page 78 ® Figure 110: Cable connected at the bottom of Figure 111: 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 79: Technical Data

    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 80: 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 81 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...

  • Page 82: Warning

    11.Warning Phelcom is not responsible for the device in case it is disassembled and/or modified by unauthorized people. No modification is allowed for this device. If the device is used in another way than specified in this User Manual, its warranty will automatically void.

  • Page 83: 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. If the issue listed persists even after trying to solve it as described, technical support service is recommended.
  • Page 84 Low quality of examination images patient’s eye. Read this User Manual carefully and follow suggested instructions and recommendations. Check if the correct Eyer App, in its updated version, is selected. Application does not work Reinstall the Eyer App. Click on “forgot password” to generate a new password.

  • Page 85: 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. If a malfunction cannot be rectified, please contact your location distributor or Phelcom customer service.

  • Page 86: Supplier Declaration And Guidelines - Electromagnetic Emissions

    Otherwise, degradation of the performance of this equipment could result. 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 87: 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 88 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 89: Devices To Eyer

    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...

  • Page 90: Radio Frequency Interference

    NOTE 2 - These guidelines may not be applied to all situations. Electromagnetic propagation is affected by the absorption and reflection of structures, objects, and people. NOTE 3 - Portable and mobile RF communication equipment may affect Eyer®. 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 91 The device cannot be used in environments with atypically high electromagnetic fields such as an MRI room or close to CT, diathermy, RFID, and electromagnetic security systems such as metal detectors. In the case that there exist RF emitters (e.g., RFID), which might not be visible, the device can potentially be exposed to fields from these RF emitters without the user's awareness causing equipment malfunction.

  • Page 92: Biocompatibility

    14.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 93: Glossary And Symbols

    15.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...
  • Page 94 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 95: Cybersecurity Information

    16.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 96: Data Backup

    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 specific agreement.
  • Page 97 Passarini Regulatory Affairs of America LLC 201, South Biscayne Boulevard Suite 1200 - Miami Center Building Miami, FL US 33131 Phone: 886 2641043 Ext Fax: 866 2641043 Email: usagent@rapassarini.com.br PHELCOM EYER ® - NM-STD USER MANUAL - REVIEW 8 12/15/2022...

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