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
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10
11
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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 +1 (209) 213-2250 within the USA, or +45 50 20 60 71 within the EU, and also at
info@optoceutics.com 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
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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

09
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Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
• Before use, make sure that all packaging material is removed and that there is no visible damage to the
equipment or accessories.
• Using the equipment close to your bedtime may alter or disturb your sleep.
• Do not subject the equipment to heavy shocks to avoid the risk of damage to the equipment.
• Always unplug the equipment after use and in case of a power failure to avoid the risk of damage to the
equipment.
• Do not attempt to repair or modify the equipment. The electronics and LEDs are not replaceable.
• Do not use the equipment outdoors or near heated surfaces or heat sources.
• Do not pull the mains cable from the socket by the cord.
• Connect the equipment only to the main voltage listed on the technical data or power adapter.
CAUTION!
• 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.
Maintenance/
Troubleshooting

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

QUICK START GUIDE
1. 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).
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Detailed stepwise description on the following pages.
Operation
Maintenance/
Troubleshooting

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.
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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.
Incorrect use Correct use
50-100 cm
2-3 feet
< 50 cm
< 8 inches
am
Time of the day
It is recommended to use the device in a period between morning and late afternoon.
Using the device the last 4 hours before going to bed may alter or disturb your sleep.
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Disposal
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General Notes
Device
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Maintenance/
Troubleshooting

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.
There is no risk if the session is not completed, other than that the full effect may not be gained.
If the session is not resumed within 4 hours, the device starts counting from the beginning again.
Likewise, the device counts from the beginning again if the power is removed.
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General Notes
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PLEASE NOTE:
Sunglasses or special lenses can affect your intended stimulation session.
In these instances, you may experience that the light flickers more than usual.
Maintenance/
Troubleshooting

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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:
• The device should be used 1 hour a day, but it can be split up into shorter intervals, e.g. 2 x 30 minutes.
• The device should be within 2-3 ft (50-100 cm) and the light should be within your field of view.
• You don’t have to stare directly at the light, and you can use the device in connection with other activities
(see examples below).
Try using EVY LIGHT®while eating, working,
reading, listening to music, or watching TV.
Please visit
optoceutics.com
to get more
suggestions on how to form good and
lasting habits.

16
Introduction
Operation
Disposal
Safety
Information
Symbols
Explained
General Notes
Device
Description
Technical
Data
Maintenance/
Troubleshooting
PLEASE NOTE:
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®
consistently. The above methods can be used to prevent eye strain and achieve consistent use.
Front Indicators
There are four indicators on the front of the device (5).
For each 15 min the light has been turned on, one indicator will light up. After 60 min all four indicators will light
up for about 1 min before the light turns off completely.
Brightness Control
You can change the brightness of the device
by pressing and holding the front button for 2
seconds. The front indicators will start blinking
and indicate which of the four different brightness
settings you have chosen.
One indicator blinks for the lowest brightness, and
four indicators blink for the highest brightness. Lowest
2 seconds Highest

5. How to track your usage (optional):
You can enable usage tracking on EVY LIGHT®, by connecting the device to the INSIGHT app.
When enabled the camera tracks whether a person is in front of the device and the gaze direction,
so you know whether EVY LIGHT®has been used correctly and for how long.
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.
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PLEASE NOTE:
If you press the front button for about 6 seconds or more, it will go into pairing mode
(for connecting to the INSIGHT App), and the two outer front indicators will light up.
Completion of pairing is signified by the two inner indicators pulsing briefly.

Reuse
The expected service life for the device is 5 000 hours of normal use.
The daily expected operating time is 60 minutes (1 hour).
Repairs
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.
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.
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Maintenance
Maintenance/
Troubleshooting
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