Optomed AURORA AEYE User Manual
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Optomed AURORA AEYE User Manual

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  • Page 1 USER MANUAL...
  • Page 2 Optomed Aurora AEYE Camera User manual of Optomed Aurora AEYE ophthalmic camera Contact information: Manufacturer Optomed Oyj (Plc) Yrttipellontie 1, FI-90230 Oulu, Finland Tel: +358 20 741 3380 info@optomed.com www.optomed.com Optomed USA, Inc Royal Centre One 11675 Great Oaks Way, Ste 110...
  • Page 3 Optomed Aurora AEYE - User Manual...

  • Page 4: Table Of Contents

    3.4 Start up and camera software set up ................23 4. Imaging with Optomed Aurora AEYE ..............25 4.1 Overview of Aurora AEYE study ..................25 4.2 Image capture during Aurora AEYE study with Retinal Module ........ 28 4.2.1. Image analysis........................30 4.2.2. Image saving and transfer ....................32 4.3 Other study ..........................32...
  • Page 5 A.1 Connecting to Cloud ......................72 A.2 Wireless connections settings ..................... 73 A.3 AEYE-DS Service via Cloud ....................75 A.4 Optomed Aurora AEYE Client PC software (only for transferring images to PC) ..76 Optomed Aurora AEYE - User Manual...

  • Page 6: Safety

    Safety The information in this manual applies to the Optomed Aurora AEYE ophthalmic camera. The specifications in this manual are subject to change without prior notice due to continuing product development. The latest version of this manual can be downloaded at www.optomed.com/us/ auroraaeye where you can also find more material.
  • Page 7 Power supply designed primarily for indoor use only according to IEC 60471 Plug socket for power supply (Positive polarity) Voltage and current Disposal specification Disposal in accordance with WEE and/or in accordance with local disposal and recycling laws Optomed Aurora AEYE - User Manual...
  • Page 8 (digits 3-4) of the manufacture. Global trade item number Reference number GS1 Unique Device Identification Keep away from water Fragile Handle with care. Do not use hand hooks Keep out of direct sunlight Optomed Aurora AEYE - User Manual...

  • Page 9: Intended Use

    Atmospheric pressure limitations 1.2 Intended use Optomed Aurora AEYE Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye. Optomed Aurora AEYE Camera with Retinal Module is intended to capture digital images and video of the fundus of the human eye.
  • Page 10 Optomed Aurora AEYE Camera provides versatility for diagnosing different patient groups that are not able to sit in front of a desktop fundus camera (e.g. supine patients, wheelchair patients). Due to the small size and portability Optomed Aurora AEYE Camera can also be used for homecare visits and remote screening services.

  • Page 11: Contraindications And Limitations

    WARNING! Optomed Aurora AEYE is classified as Group 2 based on standard ISO 15004-2:2007. 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.

  • Page 12: Precautions

    1.4 Precautions WARNING! Optomed Aurora AEYE is not suitable for use in explosion risk areas or in the presence of flammable anesthetics. WARNING! Place the PC and Charging Station outside the patient environment at a distance of at least 1.5 meters from the patient.
  • Page 13 For more information, go to www.P65Warning.ca.gov CAUTION! Optomed Aurora AEYE is intended for use inside, in normal room temperature and normal humidity. Do not use the device in an environment where there is a possibility of water condensation on or inside the device.
  • Page 14 CAUTION! If there are breaks in device covers or other visual defects, contact Optomed Customer Service or an Optomed-certified service facility. CAUTION! Repair and maintenance work may only be performed by authorized specialists. Contact Optomed Customer Service or an Optomed-certified service facility for repairs and maintenance work on the device.

  • Page 15: Device Overview

    Device overview Optomed Aurora AEYE Camera is a modular ophthalmic camera that is designed for use in a medical environment. It is intended to capture digital images and video of the human fundus of the eye and surface of the eye for documentation, screening, and consultation. The camera is used with interchangeable optics modules: Retinal Module and Anterior Module.
  • Page 16 Charging Station. Charging Station is a dual charger used for charging the battery inside the camera and the spare battery. Optomed Aurora AEYE Portal is a web application which enables registering to the service, administrating background information used to run the service, administrating Cloud service connecting Optomed Aurora AEYE Camera and AEYE-DS Service provider, and viewing information such as AI result.

  • Page 17: Getting Started

    Getting started 3.1 Part list and unpacking The Optomed Aurora AEYE carrying case contains the following items: Device 1. Optomed Aurora AEYE Camera 2. Retinal Module 3. Anterior Module Accessories 4. Charging Station 5. USB Cable 6. Power Supply 7. Eye Cup (2 pcs) 8.

  • Page 18: Preparations

    Place Charging Station (4) on a table outside the patient environment at a distance of at least 1.5 meters from the patient. Connect the Power Supply (6) cable to Charging Station and to the wall outlet. No need to connect USB cable to the PC since Aurora AEYE study uses wireless data transfer.
  • Page 19 When the battery is fully charged, all indicator LEDs are lit. When charging for the first time, charge the battery until full (at least 4 hours). In daily use, place the camera to Charging Station for charging whenever it is not used. Optomed Aurora AEYE - User Manual...
  • Page 20 Charging Station connectors. If Optomed Aurora AEYE Camera is not used for more than two minutes, the device enters power save mode. It wakes up from power save mode by using any control button. The camera will power off if not used in 10 minutes.

  • Page 21: Controls And Display Icons

    3.3 Controls and display icons Battery level Study Fixation target WLAN indicator Brightness level Cloud indicator Focus mode Client indicator Power button Back button Optoroller Battery charging indicator LED Shutter button Eject button Optomed Aurora AEYE - User Manual...
  • Page 22 Optomed Aurora AEYE Camera is powered on and off by pressing the power button for few seconds. Powering on switches the lights on and turning off in turn opens a notification about powering off. Opening the Quick menu is done by pressing Optoroller, which is also used for navigating in the menu together with back button.

  • Page 23: Start Up And Camera Software Set Up

    Both Retinal Module and Anterior Module are attached to Optomed Aurora AEYE Camera by connecting firmly the bayonet legs of the optics module to the bayonet holes of the camera. Optics modules are detached by pressing the eject button on the top of the camera.
  • Page 24 Optoroller Cloud; for configuration of AEYE-DS Service and Optomed Aurora AEYE Portal. Username and password are the same as for Optomed Aurora AEYE Portal. In case the camera does not guide you to Cloud menu, choose Settings > Camera > Connections > Cloud.

  • Page 25: Imaging With Optomed Aurora Aeye

    When Optomed Aurora AEYE Camera is powered on, select the user, and enter the passcode followed by a press of back button to log in. With Aurora AEYE study, the user is guided to take a macula centered image of both eyes and then send images to AEYE-DS analysis.
  • Page 26 A notification is shown if some imaging settings are automatically changed according to recommendations for Aurora AEYE study. These include a capture mode (still), a fixation target (macula centered), a focus (auto), an exposure (auto), an IR image (off), additional images (none), and capture settings in image (off).
  • Page 27 Images are saved automatically to Archive menu in camera • If Cloud connection is not available and the images cannot be sent to AEYE-DS Service, they can be analyzed later from Archive (Save option on image preview screen) Optomed Aurora AEYE - User Manual...

  • Page 28: Image Capture During Aurora Aeye Study With Retinal Module

    Camera shows the AI analysis result which is also sent to Optomed Aurora AEYE Portal • It is possible to get the result in addition by email by enabling the option in Optomed Aurora AEYE Portal Failed analysis with a red...
  • Page 29 Brightness can be changed to manual mode while in Live view by rotating or pressing Optoroller and choosing proper value for it in case image quality is not sufficient. If image is underexposed and dark, increase brightness level. If overexposed and washed out, reduce Optomed Aurora AEYE - User Manual...

  • Page 30: Image Analysis

    - continue the study to capture the next image of the sequence User can exit the Aurora AEYE study by pressing back button for few seconds and selecting Leave. All images captured in the study will be saved to Archive. Later user may use AEYE-DS analysis service from Archive if a good quality image of both eyes is available for the AEYE-DS.
  • Page 31 Archive. You can try sending the images again from Archive for AI analysis.” If the study is closed before finishing the two-image sequence, the image(s) are saved to Archive but they cannot be sent to AI analysis. The study must be repeated for the patient. Optomed Aurora AEYE - User Manual...

  • Page 32: Image Saving And Transfer

    When study is ready and user selects Close by pressing Optoroller, user is asked if they want to start new Aurora AEYE study. If Yes, new Aurora AEYE study is created for a new patient; if No, camera goes back to Live view and creates an anonymous study. Images captured in Live view are saved to the active anonymous study.

  • Page 33: Other Study Menu

    Retinal Module; to capture fundus images and video • Anterior Module; to capture images and video of the surface of the eye and surrounding areas Optomed Aurora AEYE Camera has two capture modes in optics-specific settings menu, Settings > Optics > Capture Mode •...

  • Page 34: Imaging Settings For Other Study

    The middle fixation target is automatically on, and it provides a macula centered image. Change the fixation target from the Quick menu. Anterior module has four focus windows for user to guide camera on which area of subject to Optomed Aurora AEYE - User Manual...

  • Page 35: Retinal Module

    Aim help is red, retina is not fully in view. b) Aim help circle turns green when retina is in full view and focusing starts. c) Green rectangle indicates that focusing is ready thus shutter button can be pressed. d) Red rectangle indicates that focusing has failed. Focusing starts again. Optomed Aurora AEYE - User Manual...

  • Page 36: Anterior Module

    Ask patient to look in different directions so that different areas can be imaged. Capturing still images: • Autofocus: Automatic focusing begins when the dual action shutter button is pressed halfway down. After successful focusing, an image is captured when the dual action shutter Optomed Aurora AEYE - User Manual...

  • Page 37: After Imaging

    If the image quality analysis is enabled, the results are shown in the top right corner of the image. Occasionally artifacts may occur in images. If the imaging distance is not optimal the light may Optomed Aurora AEYE - User Manual...
  • Page 38 Central reflection is caused by internal reflection of the light source of the objective lens. Normally it is not seen but if there are stains or dust on the objective lens the reflection may be stronger. Instructions for cleaning can be found in chapter 6.3. Optomed Aurora AEYE - User Manual...

  • Page 39: Image Saving And Transfer

    PC via USB. Writing to the memory card from PC is disabled by default. When the memory card or image counter is full, Optomed Aurora AEYE Camera will display a message with request to erase the study memory. First copy the images to a safe location and then select Erase study memory from the Camera settings to erase images and videos taken by all users from the camera memory card.

  • Page 40: Features

    Client connection Active study folder number (in Aurora AEYE study or anonymous Other study) or patient initials (in Other study) Fixation target; filled dot indicates the fixation target for current imaging Brightness; AE for automatic exposure or a number of manually chosen value Focus;...

  • Page 41: Quick Menu

    (both eyes) image (left eye) BRIGHTNESS In auto exposure mode, Optomed Aurora AEYE Camera calculates the optimal image brightness (exposure) value automatically for imaging. Automatic brightness is on by default. The brightness can be adjusted in manual mode from 0 to 10, and the default value is 5. It is also possible to reduce the brightness setting below 1, to 0.8, 0.6, 0.4 and 0.2, or set brightness to zero,...
  • Page 42 STUDIES In Studies menu it is possible to create a new study for images (Other study), select Aurora AEYE study for two-image sequence, or browse studies from Archive. Other study A new patient study is recommended for each patient. Select the Other study item by pressing Optoroller.
  • Page 43 When study is ready and user selects Close by pressing Optoroller, user is asked if they want to start new Aurora AEYE study. If Yes, Aurora AEYE study starts from beginning with new patient, if No, camera goes back to Live view.
  • Page 44 AI results, or analyze it (only Aurora AEYE study) if not already done. Then select the desired image from the selected study by rotating and pressing the Optoroller. When the image is shown, the image can be zoomed by pressing Optoroller.

  • Page 45: Settings

    15 times in a row. Admin user may reset the passcode to enable new login. LOGOUT User can log out from the camera by selecting Logout with Optoroller. Optomed Aurora AEYE - User Manual...

  • Page 46: Advanced Optics Settings

    Users can be added manually or by loading a user list from PC via USB connection by copying a userlist.txt file to camera (Aurora AEYE drive) and lifting the camera from Charging Station (USB write protection must be set off).
  • Page 47 In addition to default imaging mode, there is an alternative additional imaging mode in Optomed Aurora AEYE: Red free. In Red free setting the camera saves a red reduced image in addition to the original image. To save only the original image, choose None.
  • Page 48 Uniformity: If there is a reflection in the upper part of the image, the imaging distance is too short, and if the reflection is in the lower part of the image, the imaging distance is too long. Optomed Aurora AEYE - User Manual...
  • Page 49 First select vertical or horizontal adjusting by using Optoroller. Move the image to the middle of the screen by rotating Optoroller. NOTE! There is no need to change the centering in normal use. Optomed Aurora AEYE - User Manual...

  • Page 50: Optics Settings For Anterior Module

    Autofocus: image is captured after focusing when the dual action shutter button is kept pressed halfway down CAPTURE MODE There are two capture modes in Optomed Aurora AEYE: still imaging and video recording. To choose capture mode, use Optoroller. 5.3.4. Camera settings...

  • Page 51: Connections

    DATE & TIME To change the date and time settings, press Optoroller. Select Daylight saving time, if applicable, and Time zone. Optomed Aurora AEYE uses nine time zones: Atlantic Standard Time (AST), Eastern Standard Time (EST), Central Standard Time (CST), Mountain Standard Time (MST), Pacific Standard Time (PST), Alaskan Standard Time (AKST), Hawaii-Aleutian Standard Time (HST), Samoa standard time (SST), and Chamorro Standard Time (CHST).

  • Page 52: Advanced Camera Settings

    The network mode is the only option to connect the camera to AEYE-DS Service in Aurora AEYE study. Wireless data transfer after Other study can be done either with network mode or access point.
  • Page 53 (Device ID), press Optoroller. START QUERY Choose the start query; Aurora AEYE study, Study (Other study), None, or Erase (Erase study memory). The camera prompts the start query after powering on the device. When the Erase query is chosen, the camera will ask whether all images and videos should be deleted.

  • Page 54: Other Information

    °C (+95 °F) or fall below -20 °C (-4 °F). Please note that electromagnetic compatibility information and recommended separation distances between portable and mobile RF communications equipment and Optomed Aurora AEYE are given in Chapter 6.8. Protection against harmful ingress of water or particulate matter is defined as IPX0 (Equipment not protected against the ingress of water).

  • Page 55: Error Messages

    6.2 Error messages Optomed Aurora AEYE will display error messages to indicate error situations. An error message is always displayed with an explanatory message providing information about possible actions. ERROR MESSAGE POSSIBLE ACTION Optics failure # Please detach the optics module, place it back, and restart the camera.
  • Page 56 - Camera not active: Cloud service is not purchased, or starting date is not chosen - Login failed: either username or password was incorrect If the device behaves abnormally, Optomed Aurora AEYE Camera can be forced to shut down by pressing the power and back buttons simultaneously for seven seconds or longer.

  • Page 57: Cleaning

    6.3 Cleaning Optomed Aurora AEYE has been tested to verify that it is compatible with the approved disinfectant agents. Clean and disinfect device parts on a routine basis according to your facility’s protocols and standards or local regulations. Optomed Aurora AEYE is a precision optics instrument that should be handled with care.
  • Page 58 Use of ammonia-based cleaners on the liquid crystal display (LCD) may cause damage to the display. If a replacement for eye cup or additional disposable eye cups (E-safe Disposable Eye Cups) are needed, please contact Optomed Customer Service. The eye cup should be replaced when: • Discolored •...

  • Page 59: Service And Repair

    Use only lightly moistened cleaning cloth. Optomed Aurora AEYE has been tested to verify these instructions as being capable of preparing Optomed Aurora AEYE for re-use. You must ensure that cleaning and disinfection as actually performed by your personnel, with your equipment and materials, achieves the desired results.

  • Page 60: Disposal

    Optomed Aurora AEYE Camera has a rechargeable Li-ion battery that is charged when the camera is placed on Charging Station, which is connected to the mains. Charging Station can also be used as an external battery charger for the spare battery included in sales case. The battery pack is specially designed and manufactured for this device.

  • Page 61: Technical Description

    6.7 Technical description CAUTION! Only use the USB cable, battery and power supply provided in the sales package. If you need replacement to the USB cable, battery, or power supply, please contact Optomed Customer Service. CAUTION! The development, production, and maintenance of this device, together with associated risks, are based on an expected device lifetime of five years.
  • Page 62 Li-ion cell with integrated safety circuit Usage time: Approximately 2 h Device lifetime: Approximately five years OPTICS FOR RETINAL IMAGING Model: Retinal Module Dimensions: 69 (w) x 74 (h) x 160 (d) mm Weight: 324 g Optomed Aurora AEYE - User Manual...
  • Page 63 Spectral output at working distance: White and Infrared LED when operated in continuous mode OPTICS FOR ANTERIOR IMAGING Model: Anterior Module Dimensions: 71 (w) x 80 (h) x 78 (d) mm Weight: 105 g Optomed Aurora AEYE - User Manual...
  • Page 64 CINCON TRG10R090 Input: 100-240 V, ~0.4 A, 47-63 Hz Output: 9 V, 1.1 A, 10 W Type2: XP Power ACM12US09 Input: 100-240 V, 0.5 A, 50-60 Hz Output: 9 V, 1.33 A, 12 W Optomed Aurora AEYE - User Manual...
  • Page 65 Eye cup for Anterior Module: Liquid silicone rubber Reusable, free from latex, PVC, and DEHP MEMORY STICK Memory stick including Optomed Aurora AEYE Client PC Software, and Instructions for use. CLEANING CLOTH Cleaning cloth for cleaning lens, windows, and display. INTELLECTUAL PROPERTY RIGHT INFORMATION Windows 8.1, Windows 10, and Windows 11 are trademarks of Microsoft Corporation.

  • Page 66: Electromagnetic Compatibility

    Optomed. If the performance of Optomed Aurora AEYE is lost or degraded due to electromagnetic disturbances, it may cause unexpected or adverse operation of the device. If a malfunction cannot be rectified, please contact Optomed Customer Service.
  • Page 67 8 ф angles; typical commercial or hospital environment. at 8 ф angles; interruptions, 0% 1 cycle; If the user of the Optomed Aurora AEYE 0% 1 cycle; and voltage requires continued operation during power variations on 70% UT for...
  • Page 68 If the measured field strength in the location in which the Optomed Aurora AEYE is used exceeds the applicable RF compliance level above, Optomed Aurora AEYE should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Optomed Aurora AEYE.
  • Page 69 MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS Optomed Aurora AEYE maintains basic safety and performance when used in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT –...

  • Page 70: Compliance

    • Optomed Aurora AEYE is not intended to be sterilized • Optomed Aurora AEYE is not intended for use in an oxygen rich environment • Optomed Aurora AEYE is classified for continuous operation Optomed Aurora AEYE complies with FDA 21 CFR 886.1120 and ISO 13485:2016 standard.
  • Page 71 Group 2 Group 2 2:2007 IEC 62471:2006 Exempt Group Exempt Group ANSI Z80.36- Group 2 Group 2 2016 This declaration shall be rendered invalid if changes are made to the product without the manufacturer’s authorization. Optomed Aurora AEYE - User Manual...

  • Page 72: Appendix - Wireless Local Area Network (Wlan), Client, And Cloud

    - Network; select available wireless network from the list - Enter network password - Select Connect Set up Date & Time Set up Cloud connection; username and password are the same as for Optomed Aurora AEYE Portal • Enter Cloud username; fill in your email address •...

  • Page 73: Wireless Connections Settings

    (a) or Access Point mode (b) can be used, but not at the same time. The network mode is the only option to connect the camera to AEYE-DS Service in Aurora AEYE study. Wireless data transfer after Other study can be done either with network mode or Access Point.
  • Page 74 In case there are slowness or other issues with wireless communication between the camera and the PC, the images will transfer slowly. You can follow the progress of the transfer from Optomed Aurora AEYE Client PC software. Client PC software will inform, if the wireless communication between the camera and the PC fails and images cannot be transferred.

  • Page 75: Aeye-Ds Service Via Cloud

    The AI-algorithm grades the fundus images within minutes and the results are then sent back to Optomed Aurora AEYE Camera and to Optomed Aurora AEYE Portal as well as by email if chosen in Portal. AEYE-DS supports only diabetic retinopathy (DR) screening results.

  • Page 76: Optomed Aurora Aeye Client Pc Software (Only For Transferring Images To Pc)

    A.4 Optomed Aurora AEYE Client PC software (only for transferring images to PC) Optomed Aurora AEYE Client PC software enables WLAN connectivity from PC or another client device to Optomed Aurora AEYE Camera. With Client software you can wirelessly connect PC or other...
  • Page 77 Notes Optomed Aurora AEYE - User Manual...
  • Page 78 https://www.optomed.com/us...

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