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 1.3) 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 use of EVY LIGHT ® immediately stop its use and seek advice from your physician. WARNING! If you experience migraine, feels nausea, headaches or other discomfort, immediately stop the ongoing session.
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Page 5: Introduction
Introduction Thank you for getting your EVY LIGHT and becoming a pioneer in brain stimulation ® for activation of gamma brain waves. Kind regards, The OptoCeutics Team What is EVY LIGHT ® EVY LIGHT is a non-invasive light-based neurostimulation device for activation of ®... - Page 6 40 Hz flashing lights can be disturbing, irksome to use and may induce side effects such as nausea and headaches, especially if used for extended periods. Instead of flashing with 40 Hz between the light being ON and OFF, EVY LIGHT ®...
- 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 epilepsy with photosensitive seizure (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 not limited to the following: • Irritability • Nervousness or anxiety • Headache • Sleepiness or Drowsiness • Nausea •...
- Page 10 EVY LIGHT to avoid the risk of fire or burns. ® • If the mains cord is damaged, you shall have it replaced by OptoCeutics or similarly qualified persons in order to avoid risk of electrocution. • KEEP DRY! Water and electricity are a dangerous combination! To avoid 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. Start / Stop button 5. Time indicators 3. Light Panel 6. Eye tracker / Ambient light sensor Safety Technical Symbols Device Maintenance/ Introduction Operation General Notes Disposal Data Explained Information Description... -
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 Start/Stop button to start a session. 4. Stop/Pause the session by pressing the button. 5. Data collection (optional). Detailed stepwise description on the following pages. Safety Technical Symbols... - 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 arm’s reach of your device or within a distance of 50 - 100 cm. 50-100 cm < 50 cm Incorrect use Correct use Time of the day It is recommended to use the device in the morning and until late afternoon.
- Page 16 3. Press the button to start a session Press the start/stop button (2) on the front of the device. The light panel (3) turns ON and the session begins. You should either look directly at the light on the focus point (4) or near the device (within 20 cm away from the edges of the device).
- Page 17 Tracking your session duration with the time indicators There are four time indicators on the front of the device (5). Each indicator represents a 15 minutes interval. A blinking indicator shows the undergoing quarter. After 60 minutes all time indicators will be turned on. See illustration below.
- Page 18 4. Stop/Pause session At any time, you can press the start/stop button (2) in the front to stop/pause the session, or press again to resume it. This is only recommended if you need to take a break or are unable to continue. There is no risk if the session is not complete, other than that the full effect will not be gained.
- Page 19 INSIGHT App (see enclosed installation pamphlet). EVY LIGHT ® only shares data with OptoCeutics if it is set up with the INSIGHT App. The data collected is anonymised and sent via your Wifi connection to the INSIGHT App (No images are stored or transferred).
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Page 20: Maintenance
Failure to observe this mandate shall void the warranty. If defects or malfunctions are observed, contact OptoCeutics ApS at: +45 50 20 60 71 or via email at info@optoceutics.com. Environmental conditions Storage temperature: -5ºC to +45ºC... - Page 21 Storage Please store your device at room temperature in a dry place. If you stored the device at the minimal or maximal storage temperatures, please wait 15 minutes before you use it to allow it to reach normal operating temperature. Cleaning of the device Keep the light screen free of occlusions, heavy dust, stains, etc.
- Page 22 Otherwise, Try plugging the power cable out and plugging it back in. If any problem with the device is persistent, please contact Optoceutics for a possible repair/replacement at: +45 50 20 60 71 or via email at info@optoceutics.com...
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Page 23: Technical Data
Technical Data Technical data EVY LIGHT Power adapter AC/DC ® Dimension 300 mm x 198 mm x 130 mm 79 x 54 x 33 mm Space clearance 350 mm x 250 mm x 200 mm (during use) (W x H x D) 1.10 kg (1.40 kg including AC/DC power... - Page 24 Lighting elements Only visible light from 410 nm Light wavelengths to 710 nm. No ultra-violet. No infra-red. Nominal 2700 cd/m2 (<10.000 cd/m in all use cases) Approx. 6000 lux at surface Lighting Approx. 1500 lux at 20 cm Brightness Approx. 500 lux at 50 cm Approx.
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Page 25: Symbols Explained
Symbols Explained Symbol Meaning Symbol Meaning Read the manual before Device emits electromagnetic using the device radiation Warning notice indicating a risk of severe injury or Keep dry (IP20) damage to health Warning Caution notice indicating a risk of minor injury or General warning sign damage to the device Caution... - Page 26 Serial number Lot number Name and address of Manufacturing date manufacturer (solid icon) (outline icon) CE mark QR device UDI-PI Do not throw away Polarity indication Temperature range Relative humidity range specifications specifications for storage (on for storage (on package) package) or use (on device) Indicates that the item Manufacturer’s logo...
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Page 27: General Notes
General Notes This document is related to and applies to EVY LIGHT (technical identifier: NSS 1.0), ® which is manufactured by OptoCeutics ApS. Intended user As a MDR Class I Device, the NSS does not have a medical purpose and therefore no in- tended medical indication. - 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 +45 50 20 60 71 or via email at info@optoceutics.com Declaration of conformity OptoCeutics ApS hereby guarantee that this product complies with the European Medical Device Regulation 2017/745 and RED Directive 2014/53/EU.
- Page 29 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 (in accordance with 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 with regard to electromagnetic compatibility.
- Page 30 1 m distance as the user should be able to reach out and turn on/off the device by him/herself. You can request the full text of the EU Declaration of Conformity by contacting OptoCeutics ApS via email at info@optoceutics.com. Notes on software licences Please visit www.optoceutics.com/software-licenses for a complete list of licenses. Safety Technical Symbols Device...
- Page 31 Disposal Electrical and electronic equipment (EEE) contains materials, components, and sub- stances 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 elec- tronic equipment.
- Page 32 OptoCeutics ApS CVR nr: 39769689 Gl. Kongevej 1, 4. tv. www.optoceutics.com 1610 Copenhagen info@optoceutics.com Denmark +45 50 20 60 71...