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Optomed AURORA User Manual

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USER MANUAL

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Summary of Contents for Optomed AURORA

  • Page 1 USER MANUAL...
  • Page 3 Optomed Aurora User manual for Optomed Aurora ophthalmic camera Contact information: Manufacturer Optomed Oyj (Plc) Yrttipellontie 1, FI-90230 Oulu Finland info@optomed.com www.optomed.com Optomed USA, Inc Royal Centre One 11675 Great Oaks Way, Ste 110 Alpharetta, GA 30022 Tel: (844) 4-SIGHT-1...

  • Page 5: Table Of Contents

    Getting started Part list and unpacking Preparations Features Quick menu User settings Camera settings Optics settings for Optomed Aurora Retinal Module Optics settings for Optomed Aurora Anterior Module Imaging with Optomed Aurora Retinal Module Anterior Module After imaging Important information...

  • Page 6: Safety

    1. Safety The information in this manual applies to the Optomed Aurora 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 where you can also find more training materials.
  • Page 7 The eye cup which is in physical contact with the patient, is electrically isolated and protected against electric shock. Class II power supply For indoor use only Power supply designed primarily for indoor use only according to IEC 60417 Plug socket for power supply (Positive polarity) Voltage and current Optomed Aurora...
  • Page 8 Serial number The first four digits of the serial number indicates the week (digits 1-2) and year (digits 3-4) of the manufacture. Global trade item number Reference number GS1 Unique Device Identification Keep away from water Optomed Aurora...
  • Page 9 Fragile Handle with care. Do not use hand hooks Keep out of direct sunlight Number of units packed Temperature limitations Humidity limitations Atmospheric pressure limitations Medical device The device is a medical device as defined in MDR 2017/745. Optomed Aurora...

  • Page 10: Intended Use

    Optomed Aurora provides versatility for diagnosing different patient groups that are not able to sit in front of desktop fundus camera (e.g. supine patients, wheelchair patients). Due to the small size and portability Optomed Aurora can also be used for homecare visits and remote screening camps.
  • Page 11 • 67 min video recording / eye / day for Optomed Aurora Retinal Module • 37 min video recording with white light / eye / day for Optomed Aurora Anterior Module • 5 min video recording with blue light / eye / day for Optomed Aurora Anterior Module The risk of retinal injury at an exposure of 2.2 J/cm2 is not high, but because some...

  • Page 12: Precautions

    Unconscious or anesthetized patients may be difficult to image as the patient cannot fixate on a target led. 1.4 Precautions WARNING! Optomed Aurora is not suitable for use in explosion risk areas or in the presence of flammable anesthetics. WARNING! Place the PC and Optomed Aurora Charging Station outside the patient environment (at a distance of at least 1.5 meters from the patient).
  • Page 13 Only use accessories and battery provided by Optomed with this product. CAUTION! Only use USB cable and the power source provided by Optomed with this product. If you need replacement USB cable or power source, please contact customer service or your local distributor. USB cable must be connected only to the USB port of a PC that complies with the IEC 60950 standard.

  • Page 14: Device Overview

    2. Device overview Optomed Aurora 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 fundus of the eye and surface of the eye for documentation, screening and consultation. Optomed Aurora Camera is used with interchangeable optics modules Optomed Aurora Retinal Module and Optomed Aurora Anterior Module.
  • Page 15 Patient Battery level WLAN indicator Fixation target Brightness level Diopter value Power button Back button Optoroller Battery charging indicator LED Dual action shutter Eject button Optomed Aurora...

  • Page 16: Controls And Display Icons

    Back button Images are captured by pressing the dual action shutter. If the performance of Optomed Aurora Camera is abnormal, it can be forced to shut down by pressing the power and back buttons simultaneously for seven seconds or longer.

  • Page 17: Getting Started

    10. Cleaning Cloth 11. User Manual and other material Open the sales packaging. Remove Optomed Aurora and accessories from the sales package and check that all parts are present and undamaged. Packaging materials should be retained for future relocation or repair.
  • Page 18 Avoid touching the camera lens with bayonet legs in order to prevent scratches. To detach the optics module, press the eject button on the top of the camera and take the camera and optics module apart. Place the eye cup (7) on the optics ring of Optomed Aurora Retinal Module (2).
  • Page 19 Optomed Aurora Charging Station can be used as an external charger for the spare battery. Set the spare battery (8) connectors to the Charging Station (4) connectors and put the spare battery in place. The spare battery charging indicator LED on Charging Station blinks when the battery is being charged, and is lit when the spare battery is fully charged.
  • Page 20 If Optomed Aurora Camera is not used for more than two minutes, the device will go into power save mode. It is powered on from power save mode by using any control button. Optomed Aurora Camera will power off if not used for 10 minutes.

  • Page 21: Features

    Optoroller and press Optoroller to confirm the settings. For Optomed Aurora Anterior Module, it is possible to change the imaging LED between white and blue. When the desired LED is selected, the imaging light brightness can be adjusted manually from 0 to 10 in a similar way as described above.
  • Page 22 Optoroller left or right. Confirm the language by pressing Optoroller. A patient list or a worklist can be uploaded to Optomed Aurora via Optomed Cloud, Sync software, image viewer or as a text document patlist.txt. Update worklist icon is shown in Patient menu when Cloud service with worklist download is enabled.

  • Page 23: User Settings

    TARGET LEDS FOR OPTOMED AURORA RETINAL MODULE Optomed Aurora Retinal Module has nine internal fixation targets for the patient to fixate on during imaging. The middle fixation target is on by default and it provides a macula centred image. To change the fixation target, select the target LEDs item, then turn Optoroller left or right to choose the suitable LED and press Optoroller to set the fixation target.

  • Page 24: Change Passcode

    Admin, and 4.3 Camera settings and Erase image memory. LANGUAGE There are ten language options in Optomed Aurora: English (default), Finnish, German, French, Italian, Portuguese, Spanish, Russian, Japanese and Chinese . To change language, press Optoroller, then turn left or right to choose the desired language and set the language by pressing Optoroller.

  • Page 25: Advanced Camera Settings

    WIRELESS Optomed Aurora has a WLAN module that enables wireless connection to a PC. To change wireless settings, press Optoroller. Appendix A provides instructions for wireless settings. It is recommended to use a password- protected Wi-Fi network.

  • Page 26: Optics Settings For Optomed Aurora Retinal Module

    Cloud service can be enabled or disabled. The choice affects the contents of Patient and Wireless menus. When Cloud service is enabled, Optomed Aurora can be connected to Optomed Cloud that provides AI-based screening for various eye diseases, patient list upload and download, and image storage services.
  • Page 27 • Autofocus: image is captured after focusing when the dual action shutter is kept pressed halfway down CAPTURE MODE There are two capture modes in Optomed Aurora: still imaging and video recording. To choose capture mode, use Optoroller. ADDITIONAL IMAGE In addition to color image, there are two alternative imaging modes in Optomed Aurora: Red-free and Low-red.

  • Page 28: Image Quality Analysis

    Instructions for cleaning can be found in chapter 6.3 Sharpness: If the image is out of focus, check the patient’s refractive error and adjust the manual focus accordingly or use autofocus. Optomed Aurora...

  • Page 29: Optics Settings For Optomed Aurora Anterior Module

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

  • Page 30: Imaging With Optomed Aurora

    In autofocus mode, the camera finds correct focus automatically. • For Optomed Aurora Retinal Module , use auto focus when the refractive error is not known or manually chosen diopter value yields blurred images. Manual focus is adjusted according to the patient’s refractive error.

  • Page 31: Retinal Module

    Aurora Anterior Module to focus the image on different areas during autofocus imaging. The right focus window is selected by default. Change the focus window from the quick menu. Create a new study for each patient from the Patient menu .

  • Page 32: Anterior Module

    It is recommended that both the patient and the examiner are seated during imaging with Optomed Aurora Anterior Module. Place the eye cup of Optomed Anterior Module around the patient’s eye. Stabilize the camera by supporting the optics module on your thumb and place your fingers on the patient’s forehead.

  • Page 33: After Imaging

    In addition, eyelids, eyelashes and iris may partly block the retinal view and make the imaging more challenging. More detailed information about artifacts and image quality analysis can be found in Chapter 4.4 Optics settings for Optomed Aurora Retinal Module and Image Quality Analysis.
  • Page 34 PC. Writing to the memory card from PC is disabled by default. When the Optomed Aurora Camera is not used, it may be stored on Optomed Aurora Charging Station. Storing the device on Charging Station is not harmful for the battery.

  • Page 35: Important Information

    NOTE! Avoid subjecting the device to vibration or shock. 6.2 Error messages Optomed Aurora 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 and restart the camera.
  • Page 36 This indicates that there is a problem with the optics module. Please reattach the optics module. Autofocus calibration needed Optomed Aurora needs to be calibrated. Please hold the camera horizontally and press Optoroller to calibrate. Memory erasing failed This indicates that there is a problem with memory erasing.

  • Page 37: Cleaning

    If the device behaves abnormally, Optomed Aurora Camera can be forced to shut down by pressing the power and back buttons simultaneously for seven seconds or longer. The manufacturer of Optomed Aurora will provide software updates as needed throughout the lifecycle of Optomed Aurora to continue to guarantee its safety and effectiveness.
  • Page 38 NOTE! Ensure that no moisture penetrates the system during cleaning and disinfection. Optomed Aurora has been tested to verify these instructions as being capable of preparing Optomed Aurora 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 39: Service And Repair

    There are no other maintenance procedures that can be carried out by the user. All other servicing and repairs must be carried out by Optomed or Optomed-authorized service facilities and service personnel. Optomed will make available work instructions to repair those parts of medical electrical equipment that Optomed has designated as repairable by service personnel.

  • Page 40: Disposal

    For further information on disposal of this product, please contact your Optomed representative. This will guarantee that no hazardous substances enter the environment and that valuable raw materials are recycled.

  • Page 41: Technical Description

    NOTE! The device should not be reused anymore, if the power supply cable has become frayed, pinched, or exposed. Optomed Aurora...
  • Page 42 Li-ion cell with integrated safety circuit Usage time: Approximately 2 h Device life time: Approximately five years OPTICS FOR RETINAL IMAGING Model: Optomed Aurora Retinal Module Dimensions: 69 (w) x 74 (h) x 160 (d) mm Weight: 324 g Optomed Aurora...
  • Page 43 (for emmetropic eye with 17 mm focal length) Spectral output at working distance:   White and Infrared LED when operated in continuous mode OPTICS FOR ANTERIOR IMAGING Model: Optomed Aurora Anterior Module Dimensions: 71 (w) x 80 (h) x 78 (d) mm Weight: 105 g Illumination:...

  • Page 44: Charging Station

    Spectral output at working distance: White LED when operated in continuous mode Blue LED when operated in continuous mode CHARGING STATION Model: Optomed Aurora Charging Station Dimensions: 107 (w) x 147 (h) x 300 (d) mm Weight: 683 g Switching power supply...

  • Page 45: Memory Stick

    Liquid silicone rubber Anterior Module: Reusable, free from latex, PVC, and DEHP MEMORY STICK Memory stick including Optomed Client PC Software, Training video, and Instructions for use. CLEANING CLOTH Cleaning cloth for cleaning lens and display. INTELLECTUAL PROPERTY RIGHT INFORMATION Windows 8.1, Windows 10, and Windows 11 are trademarks of Microsoft Corporation.

  • Page 46: Electromagnetic Compatibility

    Optomed. If the performance of Optomed Aurora 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 customer service or your local distributor.
  • Page 47 Mains power quality should be that of a short at 8 ф angles; 8 ф angles; typical commercial or hospital environment. interruptions If the user of the Optomed Aurora requires 0% 1 cycle; 0% 1 cycle; and voltage continued operation during power mains 70% U...
  • Page 48 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Optomed Aurora is used exceeds the applicable RF compliance level above, Optomed Aurora should be observed to verify normal operation.

  • Page 49: Separation Distances

    RF disturbances are controlled. The customer or the user of Optomed Aurora can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Optomed Aurora as recommended below, according to the maximum output power of the communications equipment. Rated maximum...

  • Page 50: Compliance

    • Protection against harmful ingress of water or particulate matter is classified as IPX0. • Optomed Aurora is not intended to be sterilized. • Optomed Aurora is not intended for use in an oxygen rich environment. • Optomed Aurora is classified for continuous operation.

  • Page 51: Warranty

    SUBMITTING A CLAIM Any claim under this warranty must be submitted in writing before the end of warranty period to Optomed Oyj (Plc). The claim must include a written description of the failure to the device. WARRANTY DOES NOT COVER...

  • Page 52: A Appendix - Wlan

    Access point mode is used when there is no wireless network available. In access point mode Optomed Aurora Camera sets up a camera-specific access point to which the PC can connect. First set access point on in camera menu. Then connect PC to the created access point by selecting it from PC's Network list.

  • Page 53: Connection Details

    If a communication error occurs, check that both Optomed Aurora and the PC are connected to the same network (Network mode) or the PC is connected to Optomed Aurora’s access point (access point mode). You may also try to disconnect and reconnect both Optomed Aurora and Client PC software.

  • Page 54: Optomed Client Pc Software

    The PC software Optomed Client enables WLAN connectivity from PC or other client device to Optomed Aurora Camera. With Optomed Client software you can wirelessly connect PC or other client device to Aurora Camera and define the image destination folder into which images will be transferred.
  • Page 55 Site ID, Server address, Server port and Application Entity title to be able to link Optomed Aurora to Cloud and the remote server. These parameters and Cloud login information can be acquired from orders@optomed.com. Note that Optomed Aurora needs to be connected to network before connecting to Cloud.
  • Page 56 In Cloud settings you can set Site ID, Server address, Server port and Application Entity title. NOTE! Optomed Aurora's Date & Time must be set correctly in order to connect to Optomed Cloud. Date & Time settings are found in Advanced Camera settings.
  • Page 57 Image quality is too low for analysis. Possible reasons include image artifacts such as reflections, blurriness, Ungradable inappropriate brightness, or eyelids and eyelashes blocking the view. Take another image and try again. If pupil diameter is too small, dilation may be needed. Optomed Aurora...

  • Page 58: Notes

    Notes Optomed Aurora...
  • Page 59 Optomed Aurora...
  • Page 60 www.optomed.com...