Related Manuals for OPTOCEUTICS EVY LIGHT
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 (revision 1.6) English Technical Identifier: Neurostimulation System (NSS) 1.0 (patent pending)
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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.
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Page 5: Introduction
EVY LIGHT is a non-invasive light-based brain stimulation device for activating gamma ® brainwaves developed by OptoCeutics ApS. In the United States of America, EVY LIGHT carries ® the general wellness device designation, following the FDA guidelines. In the European Union, EVY LIGHT is classified as a class I medical device under the Medical Device Regulation 2017/745. - 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 ®...
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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! •...
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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 Technical Symbols Safety Device Maintenance/ Introduction Operation General Notes Disposal Information Data Explained 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. Technical Symbols Safety...
- 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 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 aid your eyes. However, it is better to find a comfortable use where you will use EVY LIGHT ®...
- 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. Technical Symbols...
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Page 20: Maintenance & Troubleshooting
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 ApS at +1 (209) 213-2250 within the USA, or +45 50 20 60 71 within the EU, and also at info@optoceutics.com via email. - Page 21 Environmental conditions Storage temperature: -5ºC to +45ºC (+23ºF to +113ºF) Storage relative humidity: <90%, without water vapor condensation Operation temperature: 5ºC to +35ºC (+41ºF 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 at + 1 (209) 213-2250 within the USA, or +45 50 20 60 71 within the EU, and also at info@optoceutics.com via email.
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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 Lighting Elements Only visible light from 410 nm Light Wavelengths to 710 nm. No ultra-violet. No infra-red. Nominal 2800 cd/m2 (<10.000 cd/m2 in all use cases) Lighting 220 lux at setting 1 (at 50 cm) Brightness 280 lux at setting 2 (at 50 cm) 340 lux at setting 3 (at 50 cm) 380 lux at setting 4 (at 50 cm) 2402 to2480 MHz (Wi-Fi)
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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...
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Page 27: General Notes
The intention is for the user to keep the instructions for use for a period corresponding to the expected service life of the device. If the User Manual is lost, you can download a PDF version from our website at https://optoceutics.com/evy-light/ or request a copy via email at info@optoceutics.com. - Page 28 Do not attempt to open the device or attempt to repair the device yourself. This could result in serious injuries. If you need to have the device repaired, contact OptoCeutics at +1 (209) 213-2250 within the USA, or +45 50 20 60 71 within the EU, and also at info@optoceutics.com via email.
- Page 29 Declaration of conformity OptoCeutics ApS hereby guarantees that this product complies with the European Medical Device Regulation 2017/745 and RED Directive 2014/53/EU. Please contact the specified service address or website to obtain further information, such as the CE Declaration of Conformity.
- Page 30 Notes on electromagnetic compatibility The device complies with the EU Medical Device Regulation (under the scope of home light equipment including healthcare environment) and 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. Technical Symbols...
- 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...