OPTOCEUTICS EVY LIGHT User manual

User Manual
EN
Read before use
E V Y LIGHT
®
Ba n ebr y dende hjer n e stimuler i n g

English
Technical Identifier: Neurostimulation System (NSS) 1.0
(patent pending)
User Manual (revision 1.6)

Contents
Introduction..................................................................................................................................
Safety Information...................................................................................................................
Device Description..................................................................................................................
Operation........................................................................................................................................
Maintenance & Troubleshooting..................................................................................
Technical Data.............................................................................................................................
Symbols Explained...................................................................................................................
General Notes...............................................................................................................................
Disposal............................................................................................................................................
3
6
10
11
18
21
23
25
33

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. If the situation persists, consult your physician.
Read this User Manual completely before use of EVY LIGHT®.
PLEASE NOTE:
If any serious incident has occurred with the device, please report this to OptoCeutics
and the competent authority within your country. OptoCeutics can be contacted
at [phone] within the USA, or [phone] within the EU, and also at
[e-mail] via email.

What is EVY LIGHT® ?
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.
Thank you for getting your EVY LIGHT® and becoming a pioneer in brain stimulation
for the activation of gamma brainwaves.
Kind regards,
The OptoCeutics Team
03
Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
Introduction
Maintenance/
Troubleshooting

Intended use of EVY LIGHT®
The device is intended for 40 Hz brain stimulation and activation of gamma brainwaves.
It is intended to be used in conjunction with a healthy lifestyle to promote mental acuity. The
device does not have any medical indication for any specific patient population. It is intended
but not limited to residential use.
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.
Instead of flashing 40 times per second between the light being on and off,
EVY LIGHT®alternates between two different combinations of colors that together form a
nearly continuous light, we call it Invisible Spectral Flicker.
(The effect can be seen if you try to record a video of the light.)
Read more at www.optoceutics.com
04 Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
Maintenance/
Troubleshooting

Inside the package:
EVY LIGHT®Power Supply User Manual
E V Y LIGHT
®
Ban ebr y dende hjer n e stimuler i n g
05
Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
Maintenance/
Troubleshooting

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:
• You are highly sensitive to light (photophobia)
• You have a history of migraines
• You suffer from any neurological conditions
• You have any eye disease (glaucoma, retinitis, retinopathy, or macular degeneration)
• You suffer from bipolar disorder, as it could provoke manic episodes
06
Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
Safety Information
Maintenance/
Troubleshooting

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:
Measures to avoid, minimize or alleviate these adverse reactions:
• Stop using the device for a few days to make the reactions disappear and then try again.
• Always use the device in a normally-lit room.
• Follow the instructions for use with special attention to the user’s distance to the device
and the time of day.
• Consult a physician if the reaction does not dissipate after a few days.
• Irritability
• Headache
• Nausea
• Early wakening / trouble falling asleep
• Dry eyes or eye strain
• Light sensitivity
• Nervousness or anxiety
• Sleepiness or drowsiness
• Numbness
• Dizziness or disorientation
• Temporary change in color and brightness
perception, slower vision readjustment
07
Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
Maintenance/
Troubleshooting

08
Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
• If you experience any epileptic seizure-like events related to the use of the equipment, immediately stop its use
and seek advice from your physician.
• If you experience a migraine, feel nausea, headaches, or other discomforts, immediately stop the ongoing
session. If the situation persists, consult your physician.
• This equipment is not intended for use by children. Children should be supervised to ensure that they do not
play with the packaging and equipment to avoid the risk of suffocation, fire, and burns.
• EVY LIGHT® is not intended for use by persons with reduced physical, sensory, or mental capabilities, or lack of
experience and knowledge unless they have been given supervision or instruction concerning the use of EVY
LIGHT®to avoid the risk of fire or burns.
• 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.
WARNING!
• KEEP DRY! Water and electricity are a dangerous combination! To avoid the risk of electrocution:
»do not use this equipment in wet surroundings (e.g. in the bathroom, near a shower or a
swimming pool);
»do not let the water run into the equipment.
Maintenance/
Troubleshooting