Optomed HALO User Manual
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Optomed HALO User Manual

Automated portable retinal camera
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Automated Portable Retinal Camera
User Manual
Reading through accompanying documents is a mandatory
action before using this equipment
810-C2701-131 Rev. D

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Summary of Contents for Optomed HALO

  • Page 1 Automated Portable Retinal Camera User Manual Reading through accompanying documents is a mandatory action before using this equipment 810-C2701-131 Rev. D...

  • Page 2: Table Of Contents

    Automated Portable Retinal Camera (Optomed HALO) User Manual Content 1 Introduction Outline Intended use Indication for Use Proper instrument use 2 Safety information Displays for safety use Symbols and labels Protective packing symbols Product labels Service life Cybersecurity information Cybersecurity functions...
  • Page 3 Automated Portable Retinal Camera (Optomed HALO) User Manual Remove the buckles Take off the Optomed Halo machine Setup machine and relative cables Connect the external laptop Remove lens cover Page 2 Ver. D...

  • Page 4: Introduction

    1.1 Outline The Automated Portable Retinal Camera Optomed Halo is an auto 3D tracking, fast and easy to carry retinal imaging system. Optomed Halo is designed to provide images of the eye as an aid to clinicians in the diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal diseases.

  • Page 5: Proper Instrument Use

    User Manual 1.4 Proper instrument use 1. Optomed Halo is a medical device; it must be operated by properly trained and qualified person(s) only. The operation should be supervised by a physician. If abnormal behavior is observed due to EM disturbances, please relocate the device accordingly.

  • Page 6: Safety Information

    Automated Portable Retinal Camera (Optomed HALO) User Manual 2 Safety information 2.1 Displays for safety use Display Meaning “WARNING” indicates the presence of a hazard WARNING that could result in severe personal injury. “CAUTION” indicates the presence of a hazard CAUTION that could result in minor injury.
  • Page 7 VOIDS the Warranty completely. Optomed Halo is not intended for home use and WARNING may not be stored or operated in environment conditions other than those prescribed. (see...
  • Page 8 The patient cannot touch any electrical device WARNING that is not powered by Optomed Halo with any part of his or her body while being examined. In addition, the Optomed Halo operator must not attempt to touch the patient and any electrical device that is not powered by Optomed Halo at the same time while examining the patient.
  • Page 9 This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments. CAUTION Distance between Optomed Halo and wall not less than 22cm CAUTION To ensure cleanliness, replace the chinrest paper whenever changing patients.

  • Page 10: Symbols And Labels

    Automated Portable Retinal Camera (Optomed HALO) User Manual 2.2 Symbols and labels Presence of electrical shock hazard. Note: Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the instrument. Do not remove the instrument cover or parts.

  • Page 11: Protective Packing Symbols

    Automated Portable Retinal Camera (Optomed HALO) User Manual 2.3 Protective packing symbols The protective packing symbols specify the handling requirements and the transport and storage conditions. Fragile, Handle with care Keep dry This end up Relative Humidity Temperature Do not stack...
  • Page 12 Product compliance 93/42/EEC/M5 Medical Device Directive Indicates this equipment contains Type B applied parts The Optomed Halo is classified as follows: Class I Equipment – Protection against electrical shock. Type B – Degree of protection against electric shock of applied part (chin and forehead rests).
  • Page 13 Guidance and manufacturer’s declaration – electromagnetic emissions The Optomed Halo is intended for use in the electromagnetic environment specified below. The customer or the user of the Optomed Halo should assure that it is used in such an environment. Electromagnetic environment – guidance...
  • Page 14 Manufacturer’s declaration-electromagnetic immunity The Optomed Halo is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Optomed Halo should assure that it is used in such an environment. Electromagnetic Immunity test...
  • Page 15 Manufacturer’s declaration-electromagnetic immunity The Optomed Halo is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Optomed Halo should assure that it is used in such and environment. Immunity test...
  • Page 16 RF communications equipment and the Optomed Halo The Optomed Halo is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the Optomed Halo can help prevent electromagnetic interference by...
  • Page 17 ENCLOSURE PORT IMMUNITY The Optomed Halo is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Optomed Halo should assure that it is used in such an environment. Compliance LEVEL...

  • Page 18: Product Labels

    User Manual 2.4 Product labels Optomed Halo system labels (samples only): 2.5 Service life The service life of Optomed Halo is five years if specified inspections and maintenance are done. 2.6 Cybersecurity information 2.6.1 Objective The purpose of this section is to summarize the cybersecurity controls of the Optomed Halo system.

  • Page 19: Cybersecurity Functions

    • The laptop or PC is limited to install Windows 10 operation system and is dedicated for Optomed Halo, for the risk of viruses and other malwares, users must install and enable...

  • Page 20: Data Back Up

    Automated Portable Retinal Camera (Optomed HALO) User Manual 2.8 Data back up • To avoid the loss of patient data due to damage to the storage device of the user's PC, it is recommended that the user should regularly back up the data.

  • Page 21: Instrument Description

    Automated Portable Retinal Camera (Optomed HALO) User Manual 3 Instrument description Introduction Forehead rest Ocular lens Power switch (Back side) Base Chinrest (motorized) Page 20 Ver. D...

  • Page 22: Standard Accessories

    Automated Portable Retinal Camera (Optomed HALO) User Manual D-Sub I/O AC power in D-Sub I/O Power switch USB to external laptop or tablet or PC 3.2 Standard accessories Q’ty Item Description User manual 1 pc. USB cable 1 pc. AC power cord 1 pc.

  • Page 23: Log In And Introduction Of User Interface

    Automated Portable Retinal Camera (Optomed HALO) User Manual Log in and introduction of user interface ◼ Log in Username Password ⚫ Username: Input the user name. ⚫ Password: Input the password. ◼ Default account: ⚫ Username: camera ⚫ Password: 00000000 Page 22 Ver.
  • Page 24 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Modify account After logging in, go to the settings page to modify the username and password. Username Password Confirm Password Account ⚫ Username: Change username when needed. ⚫ Password: Change password when needed.
  • Page 25 Automated Portable Retinal Camera (Optomed HALO) User Manual If the password inputs are not same, please check them again. If the password inputs are same, below dialog is displayed. Page 24 Ver. D...
  • Page 26 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Change password every six months Password is requested to be changed every six months. ⚫ Old password: Input the old password. ⚫ New password: Input the new password. ⚫ Confirm new password: Input the password again.
  • Page 27 Automated Portable Retinal Camera (Optomed HALO) User Manual Below graph shows error occurs. Click Change button if no error occurs. Page 26 Ver. D...
  • Page 28 Automated Portable Retinal Camera (Optomed HALO) User Manual Below error message means input password is incorrect. Below graph shows new password is changed successfully. Page 27 Ver. D...
  • Page 29 Automated Portable Retinal Camera (Optomed HALO) User Manual Three tabs are displayed on screen after logging in and describe in below sections. Capture Image Patient management Review captured image Page 28 Ver. D...

  • Page 30: Patient Management

    Automated Portable Retinal Camera (Optomed HALO) User Manual 4.1 Patient management Select patient, add patient and modify patient information Information Delete / Edit Settings Quick Search Search Patient List Pati Recent Images ◼ Patient list: Displays all the patients associated with the search result.
  • Page 31 Automated Portable Retinal Camera (Optomed HALO) User Manual ⚫ The columns with * mark are mandatory before adding new patient to database. ⚫ By clicking , the new patient information is saved to the database. The main screen will then return to the main Patient Information window and the newly added patient is listed under the patient list window.
  • Page 32 Automated Portable Retinal Camera (Optomed HALO) User Manual ⚫ Settings : Click to show settings of Optomed Halo program ⚫ Packing: Enabling auto packing, the camera head moves to packing position before Optomed Halo shutting down. ⚫ Export: Enabling auto export, the captured image will be copied to specific path automatically where the user set ⚫...
  • Page 33 The target folder for backup file Process progress NOTE: The file system of target drive should be NTFS ⚫ Restore: Restore the database of Optomed Halo by backup file Step1. Choose the target folder where the backup file is saved Page 32 Ver. D...
  • Page 34 Automated Portable Retinal Camera (Optomed HALO) User Manual Step2. Choose the backup file from the list and click the “RESTORE” button to restore the database of Optomed Halo Backup file list ⚫ Language: Multi-language selection Page 33 Ver. D...

  • Page 35: Capture Image

    Automated Portable Retinal Camera (Optomed HALO) User Manual ⚫ About: Display software version of Optomed Halo 4.2 Capture image Main window for image capture X/Y Control Patient Name or Patient ID Capture Mode Control Fixation Diopter Control Setting Lighting Control...
  • Page 36 ◼ Advanced: Display settings of Optomed Halo program ⚫ Semi auto mode: User needs to switch eye manually. ⚫ Full auto mode: The Optomed Halo will switch to another eye automatically. ⚫ Enable manual mode helper: It can help to find suitable working distance and do capture processes automatically if enable it.
  • Page 37 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Diopter control: Display diopter setting panel and provide empty lens (default), - lens and + lens ◼ Lighting control: Display lighting setting panel and provides viewing and flash LED level ◼ Dilate selection: The captured image will save with this setting.
  • Page 38 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Click the montage button and select fixation LEDs. ◼ Click the SET button. ◼ Click the OK to start montage capture Page 37 Ver. D...
  • Page 39 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Click CONTINUE button for next shot. 4.2.3 Manual alignment and manual capture ◼ Click mode selection button to manual mode ◼ Adjust chinrest by and table to suitable position. ◼ Click pupil position on screen or press buttons to align the camera.
  • Page 40 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Approach to the pupil by buttons until split bar is visible ◼ Align split bar by (Click on the button, the fixation mask plate will be removed. User can see the live retina video. ) Page 39 Ver.
  • Page 41 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Enter the pupil by buttons until two spots are appeared ◼ Use buttons to align two spots and click button to capture Page 40 Ver. D...
  • Page 42 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Click on the button, the operation tips will be shown. Page 41 Ver. D...
  • Page 43 Automated Portable Retinal Camera (Optomed HALO) User Manual 4.2.4 Cornea capture mode ◼ Add forehead adaptor to forehead rest ( refer to item 7.1 forehead rest installation) ◼ Click the button and then select the cornea capture mode. ◼ Adjust Chinrest with and table to suitable position.
  • Page 44 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Click to capture 4.2.5 Send DICOM Image When the selected patient which is found from DICOM server, the DICOM sending widnow is displayed before user leaves the Capture Image page. User can choose images and send them to DICOM server.
  • Page 45 Automated Portable Retinal Camera (Optomed HALO) User Manual 4.2.6 Review captured image Display the Visit List classified by capture date, and the capture time is also displayed with each image. Operator can review images in this window on a particular date.
  • Page 46 Automated Portable Retinal Camera (Optomed HALO) User Manual Selected Image Montage Printer Compare Export Delete Cancel Select ◼ Image delete ⚫ Click on button, warning dialog will show. Click yes to delete selected image. Be careful, Deleted image cannot restore! ◼...
  • Page 47 Automated Portable Retinal Camera (Optomed HALO) User Manual Date List Switch Close Deselect ⚫ Click button, the visit date list of selected patient will show. Visit Date List Click on image to assign it to candidate list Candidate List Start Montage ⚫...
  • Page 48 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Image export ⚫ Click on button, warning dialog will be shown and then choose the destination folder, image compression format. The Export ID means the file name should be included patient ID.
  • Page 49 Automated Portable Retinal Camera (Optomed HALO) User Manual ◼ Image comparison ⚫ Click on button, comparison dialog will be shown Date List Switch Close Reset Redfree ⚫ Date list switch: Click button, the visit date list of selected patient will be shown.
  • Page 50 Automated Portable Retinal Camera (Optomed HALO) User Manual Click on image to assign it to left or right frame Visit date list Left frame Right frame ⚫ Reset: Click button, all image settings are reset to default ⚫ Redfree: Click button to show the redfree image ◼...
  • Page 51 Automated Portable Retinal Camera (Optomed HALO) User Manual Preview Selected printer Image Browse Copy count Selected paper Comment Perform print Close printer dialog ⚫ Select two images and click on button, printer dialog will show. Click the PRINT to print selected images.
  • Page 52 Automated Portable Retinal Camera (Optomed HALO) User Manual 4.2.7 Photo viewer ◼ Click image of Image List, the Photo Viewer will show. The Photo Viewer includes below functions. Image Information Close Contrast Brightness Negative Red Free RGB Separation CD Ratio...
  • Page 53 Automated Portable Retinal Camera (Optomed HALO) User Manual Level up Level down ⚫ Brightness: Adjust the selected image. The button is brightness level up and the button is brightness level down. Level up Level down ⚫ Negative: To do negative process for selected image ⚫...
  • Page 54 Automated Portable Retinal Camera (Optomed HALO) User Manual Step3. Tap the border of disc until the blue line fit it. Step4. Click the CD ratio button and click the button. Step5. Tap the border of cup until the yellow line fit it.
  • Page 55 Automated Portable Retinal Camera (Optomed HALO) User Manual ⚫ Reset: Reset all measurement, scaling ratio, image position and processing level etc… Back/Next: Choose the next or previous image The estimate CD ratio is obtained manually by operator and it is for reference only.

  • Page 56: Specifications

    Automated Portable Retinal Camera (Optomed HALO) User Manual 5 Specifications 5.1 Product specification Function Value/Type Remark Fundus image Non-mydriatic, color image Field of view 45 degrees Illumination for retina White LED Strobe mode with flashing image (Capture) illumination. Cornea Image (Capture) White LED...

  • Page 57: Environmental Conditions

    Note-2: Spec of external laptop or PC, the laptop or PC is dedicated for Optomed Halo and for the risk of viruses and other malwares, users must install and enable window defender and anti-virus software and follow the suggestion of third- party software (including Windows defender and virus updates) to update it.

  • Page 58: Electric Rating

    Automated Portable Retinal Camera (Optomed HALO) User Manual 3) Transport conditions: • Temperature: -40–70°C • Relative humidity:10–95%RH • Vibration, sinusoidal: 10–500Hz, 0.5g • Shock:1/2 Sine Wave, 6 msec, 30G peak (packaged) • Bump: 1/2 Sine Wave, 6 msec,10G peak (packaged) 5.3 Electric rating...

  • Page 59: Maintenance

    Automated Portable Retinal Camera (Optomed HALO) User Manual 6 Maintenance 6.1 Lens cleaning It is recommended to regularly clean the ocular lens of the Optomed Halo on weekly basis or when needed. 6.1.1 Material required for ocular lens: a) Diluted Acetone or Lens cleaning solution b) Lens cleaning paper 6.1.2 Method:...

  • Page 60: Software Installation

    Automated Portable Retinal Camera (Optomed HALO) User Manual 7 Software installation Step 1. Copy the Optomed Halo installation package file to Windows desktop. Step 2. Perform the Optomed Halo installation package, below installation dialog will be shown. Click here Page 59...
  • Page 61 Automated Portable Retinal Camera (Optomed HALO) User Manual Step 3. Click the “Install” button and wait for installation Step 4. Perform the Optomed Halo program. Page 60 Ver. D...

  • Page 62: Installation And Setup With External Laptop

    Automated Portable Retinal Camera (Optomed HALO) User Manual 8 Installation and setup with external laptop (Need to be executed by trained person or qualified agency). 8.1 Place carton box on the floor. 8.2 Remove the buckles Page 61 Ver. D...
  • Page 63 Automated Portable Retinal Camera (Optomed HALO) User Manual 8.3 Take off the Optomed Halo machine 8.4 Setup machine and relative cables 8.5 Connect the external laptop Page 62 Ver. D...
  • Page 64 Automated Portable Retinal Camera (Optomed HALO) User Manual 8.6 Remove lens cover Page 63 Ver. D...

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