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OPTOCEUTICS EVY LIGHT User Manual

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E V Y
L I G H T
B
l e r i n g
a n e b r y d e n d e h j e r n e s t i m u
User Manual
EN
Read before use

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Summary of Contents for OPTOCEUTICS EVY LIGHT

  • Page 1 ® E V Y L I G H T l e r i n g a n e b r y d e n d e h j e r n e s t i m u User Manual Read before use...
  • Page 2 User Manual (version 2.0) English Technical Identifier: Neurostimulation System (NSS) 2.0 (patent pending)

  • Page 3: Table Of Contents

    Contents Introduction..........................Safety Information........................Device Description........................Operation............................Maintenance & Troubleshooting.................. Technical Data..........................Symbols Explained........................General Notes..........................Disposal............................
  • Page 4 Read this User Manual completely before use of EVY LIGHT ® WARNING! If you experience any epileptic seizure-like events related to the use of EVY LIGHT ® immediately stop its use and seek advice from your physician. WARNING! If you experience a migraine, feel nausea, headaches, or other discomforts, immediately stop the ongoing session.

  • Page 5: Introduction

    OptoCeutics ApS. EVY LIGHT is an electronic equipment with LED technology providing its intended performance and safety. EVY LIGHT is made to adhere to the published guidelines by FDA for Low Risk General Wellness Products. EVY LIGHT is made in compliance with the safety regulations of the European Union.
  • Page 6 What is Invisible Spectral Flicker? OptoCeutics has invented a way to make 40 Hz flashing lights more comfortable. Traditional 40 Hz flashing lights can be disturbing, highly uncomfortable to use, and may induce side effects such as nausea and headaches, especially if used for extended periods.
  • Page 7 L I G H T ® a n e b r y d e n d e h j e r n e s t i m u l e r i n g EVY LIGHT Power Supply User Manual ®...

  • Page 8: Safety Information

    Safety Information CONTRAINDICATIONS No matter your reason for using the device, we recommend not exceeding the intended daily use of 1 hour. Do not use the device if: • You suffer from photosensitive epilepsy (PSE) Consult your physician before use if: •...
  • Page 9 POSSIBLE REACTIONS The possible adverse reactions to using EVY LIGHT are relatively mild and only temporary. ® They may include but are not limited to the following: • Irritability • Nervousness or anxiety • Headache • Sleepiness or drowsiness • Nausea •...
  • Page 10 ® • If the mains power cord becomes damaged, STOP its use to avoid the risk of electric shock and contact OptoCeutics or qualified personnel for replacing the cord. • KEEP DRY! Water and electricity are a dangerous combination! To avoid the risk of electrocution: »...
  • Page 11 • If the wall socket used to power the equipment has poor connections, the plug becomes hot. Make sure you plug the equipment into a properly installed wall socket to avoid the risk of fire and burns. • Do not leave the equipment unattended when it is switched on to avoid the risk of fire or burns. CAUTION! •...

  • Page 12: Device Description

    Device Description 1. Power Socket & Status Light 4. Focus Point 2. On / Off Button 5. Time Indicators 3. Light Panel 6. Usage Tracker Safety Technical Symbols Device Maintenance/ Introduction Operation General Notes Disposal Data Explained Information Description Troubleshooting...

  • Page 13: Operation

    Operation QUICK START GUIDE Connect the device to power. 2. Place yourself comfortably within arm’s reach of the device. 3. Press the front button to start a session. 4. Read our guidelines for effective and comfortable use. 5. How to track your usage (optional). Detailed stepwise description on the following pages.
  • Page 14 1. Connect the device to power Connect the power supply to a power outlet and connect the power plug to the device power socket (1). A white status light around the power socket turns on, indicating that the device is plugged in and powered. Safety Technical Symbols...
  • Page 15 2. Place yourself comfortably within arm’s reach of the device You should place yourself within a distance of 50-100 cm (2-3 feet) of your device, corresponding roughly to an arm’s reach. The device should be placed in front of you, so the light has access to your eyes. 50-100 cm 2-3 feet Incorrect use...
  • Page 16 3. Press the front button to turn the light ON and OFF The front button (2) can be used to turn the device on and off. A full stimulation session is 60 min, and the device will automatically turn off afterward. At any time, you can press the front button again to stop the session and press it again to resume it.
  • Page 17 4. Follow these guidelines for use You receive gamma brain stimulation the moment the light from EVY LIGHT reaches your eyes. ® The amount of brain stimulation can vary depending on how it is used but, generally, the following applies: •...
  • Page 18 Disclaimer The highest brain response is seen when looking directly into the light. If you wish to look directly into the light, the focus point (4) can be used to rest your eyes. However, the above methods can be used to prevent eye strain and achieve consistent use.
  • Page 19 Usage tracking is NOT enabled by default. PLEASE NOTE: The camera data is not shared, and the image is only stored temporarily for gaze direction analysis. See the included flyer on how to install and use the INSIGHT App, or contact OptoCeutics support. Safety Technical...

  • Page 20: Maintenance

    Do not attempt to open or repair the device. This can result in serious injuries and will void the warranty. If defects or malfunctions are observed, contact OptoCeutics. The contact information can be found on the back of the user manual.
  • Page 21 Environmental conditions Storage temperature: -5ºC to +45ºC (+23 to +113ºF) Storage relative humidity: <90%, without water vapor condensation Operation temperature: 5ºC to +35ºC (+41 to +95ºF) Operating relative humidity: 15% to 90%, without water vapor condensation Cleaning of the device Keep the light panel free of occlusions, heavy dust, stains, etc.
  • Page 22 Try plugging the power cable out and plugging it back in. Ensure that there is light in the status light. If any problem with the device is persistent, please contact OptoCeutics for a possible repair/ replacement. The contact information can be found on the back of the user manual.

  • Page 23: Technical Data

    Technical Data Technical Data*** EVY LIGHT Power Adapter AC/DC ® Dimension** 300 x 198 x 130 mm ( 12 x 8 x 5 in ) 79 x 54 x 33 mm ( 3.1 x 2.1 x 1.3 in ) Space Clearance...
  • Page 24 Ingress Protection Class IP 20 (keep dry) IP 22 *EVY LIGHT is not a medical device, however, it is verified against the Home Light Therapy Equipment standard specified for medical devices **Dimensions and weight are approximate ***Subject to changes Safety...

  • Page 25: Symbols Explained

    Symbols Explained Symbol Meaning Symbol Meaning Device emits radio-frequency Read the manual before using the device electromagnetic energy Warning notice indicating a risk of severe injury or damage Keep dry (IP20) to health Warning Caution notice indicating a risk of minor injury or damage General warning sign to the device Caution...
  • Page 26 Serial number Lot number Name and address of Manufacturing date manufacturer (solid icon) (outline icon) QR device Unique Device CE mark Identifier - Production Identifier Electronics, do not throw away, must not be disposed of with Polarity indication unsorted household waste but must be collected separately Temperature range Relative humidity range...

  • Page 27: General Notes

    , which is manufactured by OptoCeutics ® ApS. Intended user In the European Union and the United States of America, EVY LIGHT carries the general ® wellness device designation, following the FDA guidelines. The device does not have a medical purpose and, hence, no intended medical indication.
  • Page 28 Customer service Feel free to contact OptoCeutics if you have any questions. The contact information can be found on the back of the user manual. Warranty A 2-year right to make a complaint is granted following the Danish Sale of Goods Act. The right of complaint applies to defects in material and / or fabrication.
  • Page 29 The formal DoC letter can be requested at any time by a request to info@optoceutics.com. Even though EVY LIGHT is not a medical device, this device meets the high safety standards that are applied to medical grade equipment. In this way we can deliver the best assurances to our customers.
  • Page 30 Notes on electromagnetic compatibility The device complies with the European standard EN 60601-1-2 (following CISPR 11 Group 1 Class B, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000- 4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11) and is subject to particular precautions about electromagnetic compatibility.
  • Page 31 FCC legal notice Class B digital device for use in a residential environment notwithstanding use in commercial, business, and industrial environments. Examples of such devices include, but are not limited to, personal computers, calculators, and similar electronic devices that are marketed for use by the general public.
  • Page 32 If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •...
  • Page 33 RF exposure requirements. Following these instructions satisfies the FCC radio-frequency exposure guidelines for an uncontrolled environment. CAUTION! Any changes or modifications to the equipment not expressly approved by OptoCeutics could void the user’s authority to operate the equipment. Safety Technical...
  • Page 34 0.33 m and 1 m distance as the users should be able to reach out and turn on/off the equipment by themselves. You can request the full text of the EU Declaration of Conformity by contacting OptoCeutics ApS via email at info@optoceutics.com.
  • Page 35 Disposal Electrical and electronic equipment (EEE) contains materials, components, and substances that can be dangerous and harmful to human health and the environment when the waste of electrical and electronic equipment (WEEE) is not disposed of properly. Products marked with the crossed-out wheeled bin below are electrical and electronic equipment.
  • Page 36 CVR nr: 39769689 OptoCeutics ApS www.optoceutics.com Gl. Kongevej 1, 4. tv. info@optoceutics.com 1610 Copenhagen +45 50 20 60 71 Denmark +1 (209) 213-2250...