OPTOCEUTICS EVY LIGHT User manual

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

EN
(Patent pending)
Technical Identifier: Neurostimulation System (NSS) 1.0
User Manual (revision 1.3)

Contents
Introduction..................................................................................................................................
Safety Information...................................................................................................................
Device Description..................................................................................................................
Operation........................................................................................................................................
Maintenance & Troubleshooting..................................................................................
Technical Data.............................................................................................................................
Symbols Explained...................................................................................................................
GeneralNotes...............................................................................................................................
Disposal............................................................................................................................................
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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. 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 in relation to the device, please report this to
Optoceutics and the competent authority within your country. OptoCeutics can be
contacted at [phone] or via email at [e-mail].

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
gamma brainwaves. EVY LIGHT ®is a class I medical device under MDR Regulation
2017/745.
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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 neurostimulation and brainwave entrainment.
What is Invisible Spectral Flicker?
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 ®
alternates between two different combinations of colors that together form a nearly
continuous light, we call it Invisible Spectral Flicker.
(The effect can be clearly seen if you try to record a video of the light.)
Read more at www.OptoCeutics.com
04 Introduction
Operation
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Information
Symbols
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Inside the package:
EVY LIGHT ®Power supply User manual
EV Y LIGHT
®
Ban ebr y dende hjer n e stimuler i n g
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Introduction
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Safety
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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:
• 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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Safety Information
Maintenance/
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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:
Measures to avoid, minimise 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 eye
• Light sensitivity
• Nervousness or anxiety
• Sleepiness or Drowsiness
• Numbness
• Dizziness or disorientation
• Eye strain
• Temporary change in color and brightness
perception, slower vision readjustment
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• If you experience any epileptic seizure-like events related to use of the device, immediately stop its use and
seek advice from your physician.
• If you experience migraine, feels nausea, headaches or other discomfort, 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 use of
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.
WARNING!
• KEEP DRY! Water and electricity are a dangerous combination! To avoid risk of electrocution:
»do not use this equipment in wet surroundings (e.g. in the bathroom, near a shower or
swimming pool);
»do not let water run into the appliance.
Maintenance/
Troubleshooting

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• Before use, make sure that all packaging material is removed and that there is no visible damage to the
device or accessories.
• Using the device close to your bedtime can disturb your circadian rhythm and shall be avoided.
• Do not subject the equipment to heavy shocks to avoid risk of damage to the lamp.
• Always unplug the appliance after use and in case of a power failure to avoid risk of damage to the
equipment.
• Do not attempt to repair or modify the device. The electronics and LEDs are not replaceable.
• Do not use the appliance outdoors or near heated surfaces or heat sources.
• Do not pull the mains cable from the socket by the cord.
• Connect the device 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. Start / Stop button
3. Light Panel
4. Focus point
5. Time indicators
6. Eye tracker / Ambient light sensor
2 1
4
3
6
5
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QUICK START GUIDE
1. 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).
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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
Incorrect use Correct use
50-100 cm
< 50 cm
am
Time of the day
It is recommended to use the device in the morning and until late afternoon.
Avoid using the device close to your bedtime. It is recommended not to undergo brain stimulation
less than 4 hours before going to bed , otherwise it may disturb your sleep.
You should place yourself within arm’s reach of your device or within a distance of 50 - 100 cm.
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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). By doing that, you get the stimulation as intended.
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PLEASE NOTE:
Sunglasses, special lenses or shaded windows, will affect your intended stimulation session.
In these instances, you may experience that the light flickers more than usual.
Maintenance/
Troubleshooting

Duration
The intended session time is 60 minutes continuously, but if that is not possible, it may be split
into, e.g. two times 30 minutes, using the start/stop button (2) (using Pause/resume button).
60
minutes
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.
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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.
If the session is not resumed within 4 hours, the device automatically resets the session.
Likewise, the session is reset when the power is removed from the device.
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5. Data collection (optional):
EVY LIGHT ®is able to collect data from your usage. This is used to give you an estimate of the quality and
amount of your brain stimulation, and can be viewed in the 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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Re-use
The expected service life for the device is 5000 hours of normal use.
The daily expected operating time is 60 minutes (1 hour).
Repairs
Please do not attempt to open the device or attempt to repair the device yourself. This
could result in serious injuries or irreversible damage to the device. Failure to observe
this mandate shall void the warranty. If defects or malfunctions are observed, contact
OptoCeutics ApS at: [phone] or via email at [e-mail].
Environmental conditions
Storage temperature: -5ºC to +45ºC
Storage relative humidity: <90%, non-condensing
Operation tamperature: 5ºC to +35ºC
Operating relative humidity: 15% to 90%, non-condensing
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