Valkee 2 Manual de usuario
CONTENTS
1. WELCOME 35
1.1. Intended use 36
1.2. Safety information 37
1.3. Product description 40
1.4. Light and health 41
2. USE OF THE DEVICE 42
2.1. Basic use 42
2.2. Suggested use 43
2.3. Charging 44
2.4. Adjustment of the light settings 45
2.5. Troubleshooting 47
2.6. Maintenance and service 47
3. DISPOSAL 48
4. WARRANTY AND LEGAL INFORMATION 48
5. TECHNICAL INFORMATION 50
1. WELCOME
Thank you for purchasing
the Valkee®bright light headset!
Your Valkee sales package contains the
following accessories and materials:
• A USB cable
• Abagofsiliconettings
• Instructions for use (quick
guide, user guide and technical
information)
This user guide contains im-
portant information about the
appropriate use of your Valkee
device. 35
Read all safety information and instruc-
tions for use carefully before using the
device.
KEEP THE USER GUIDE FOR
FUTURE REFERENCE.
Visit www.valkee.com/support now to:
• Register your device,tobenetfully
from Valkee user support
• Learn more about your device
Please send us your feedback at
book at facebook.com/ValkeeCompany.
1.1. INTENDED USE
The Valkee 2 bright light headset is intended
forusetotreatsymptomsofseasonalaective
disorder. It can also be used to promote adjust-
ment to ambient time, and aid in improving your
energy level, reaction time, and attention.
Fortreatmentofsymptomsofseasonalaec-
tive disorder, the device is considered a Class
II(a) medical device under Directive 93/42/EEC
and has been CE marked and clinically tested.
For promoting adjustment to ambient time, and
aiding in improving your energy level, reaction
time, and attention, the device is not considered
aClassII(a)medicaldeviceasdenedinDirec-
tive 93/42/EEC.
36
1.2. SAFETY INFORMATION
IMPORTANT NOTE: Use the device only as
instructed by Valkee, to avoid potential per-
sonal injury or damage to the device. Read
all warnings and cautions before using the
device.
The device has CE Class II(a) medi-
caldevicecerticationandhasbeen
clinically tested. The device meets the re-
quirements of the Medical Device Directive
93/42/EEC.
CONTRAINDICATIONS: The device is not in-
tended for children or for use during preg-
nancy.
The device may not be suitable for indi-
viduals who are on photo-sensitising medi-
cationsorwhosuerfrombipolardisorder.
Sideeectsofuseofthedevicearerare
when the instructions for appropriate use
are followed. The most common side ef-
fects are temporary headache on the rst
days of usage, insomnia, restlessness, and
decreased quality of sleep or sleeplessness
during the early morning hours.
WARNINGS: Consult your physician
and have your current medication
reviewed before using the device, if:
• You have low blood pressure 37
(hypotension)
• You have an ear infection
• Yousuerfrom,orhavesueredfrom,
depression
• You have bipolar disorder
• You are hypersensitive to light (e.g.
because of epilepsy)
• You are taking:
• e.g. certain antibiotics or herbal
compounds such as hypericin
• antidepressants (e.g., neuroleptics or
monoamine oxidase inhibitors,
or psychotropic drugs)
• anti-malarial tablets
DO NOT use the device while performing
tasks that require unrestricted hearing, to
avoid hazards due to restriction in hearing
capability caused by the earplugs.
DO NOT look directly into the light-emitting
earplugs, to avoid eye irritation or damage.
DO NOT use excessive force to insert the ear-
plugs, to avoid damaging your ear canals.
KEEP THE DEVICE and its parts out of the
reach of children. The small parts could pre-
sent a choking hazard.
IF THE DEVICE becomes damaged or degrad-
ed in any way or does not work, do not oper-
38
ate it. Contact Valkee for service assistance.
DO NOT share earplugs to avoid personal
hygiene risks.
DO NOT overuse the device. This helps avoid
nausea, headache and sleep disturbances.
Noclinicaldataareavailableonsideeects
of multiple dosing.
MAKE SURE that neither the device nor any
of its cables can catch on anything when you
are using the device, to eliminate the pos-
sibility of strangulation.
CAUTIONS: For safe operation, keep
the device away from water. If liq-
uid has somehow entered the system or
its parts, immediately stop using the device
and contact Valkee for service assistance.
The device contains an integrated, re-
chargeable lithium-ion battery. Do not incin-
erate, disassemble, or expose to extreme
temperatures, because the battery could
overheat,causingreorbursting.
Otherelectricalequipmentmayaectthis
device; Use the device in accordance with
the guidelines for electromagnetic compati-
bility (EMC) as described in the EMC informa-
tionleaetcontainedinthesalespackage.
Nomodicationofthisdeviceisallowed.
Contact Valkee for service assistance.
39
40
1.3. PRODUCT
DESCRIPTION
A. Valkee main unit
B. Ledset earplugs
C. Siliconettingfor
the earplug
D. Poweron/obutton
E. USB connector for the
Ledset and charger cable
F. Indicator light for battery
power and charging
G. Indicator light for session
length and progress
A
B
C
D
F
G
E
SYMBOL KEY:
Follow the instructions for use
Serial number
European Declaration of
Conformity
Keep dry
Compliant with the Waste Electri-
cal and Electronic Equipment and
Restriction of the Use of Certain
Hazardous Substances in Electrical
and Electronic Equipment (WEEE) recycling
directives (2012/19/EU and 2006/66/EC)
S/N
41
1.4. LIGHT AND HEALTH
Our daily functioning varies in line with the 24
hours of the day. This circadian (from circa =
about, dies = day) variation is caused by our
internal biological clock, which gets its timing
cues from the external light-dark cycle. A well-
synchronized biological clock helps regulate
our mood, sleep, energy, appetite and diges-
tion and helps ensure our well-being. Some-
times our internal clock gets out of sync with
the external world, – for example, because of
long-distance travel or working night shifts. This
can cause various health-related problems.
Many factors in day-to-day life diminish the
ability of our internal biological clock to syn-
chronise us properly with our external environ-
ment. We no longer work regularly from dawn
to dusk: many people work irregular hours or
must follow shift-work schedules, or travel ex-
tensively across several time zones. Also, mod-
ern electric lighting allows activities to extend
well into the night.
These factors can be balanced through ex-
posure to bright light that is timed with the in-
dividual’s needs in mind. For more information
about how to use the device to improve your
well-being, visit www.valkee.com/support.
Keep dry
42
2. USE OF THE DEVICE 2.1. BASIC USE
The device emits UV-free, blue-enriched white
light through the ear canals to the light-sensitive
regionsofthebrain.Mostpeoplebenetfrom
the default bright light settings of the device
(see ”Technical Information”) when applied in
the morning.
Good timing of exposure to Valkee bright
light is essential for reaching the best results.
The best time to use your device depends on
theintendedpurposeofuse.Themosteec-
tive bright-light time also varies with the indivi-
dual,soyouwillndthebestbright-lighttime
(morning/midday/evening) by experimenting.
Yourdeviceisreadyforuse.Beforetherstuse,
selectthesiliconettingsthatbestmatchyour
ears and put them on the earplugs. Then con-
nect the Ledset with the main unit. For illustra-
tions, see the quick guide .
To use your device daily:
1. Place the earplugs carefully in your ear
canals.
2. Startthesessionbybrieypressingand
then releasing the power button.
3. Recharge the device if it does not start and
repeat steps 1 and 2.
43
2.2. SUGGESTED USE
GENERAL WELL-BEING: To help improve your
mood and cognitive performance, boost your
daily energy levels and increase your general
well-being, use the device whenever you feel
youcouldbenetfromitinthecourse of the
day.
To alleviate typical symptoms of SEASONAL AF-
FECTIVE DISORDER, such as depression, anxiety,
irritability, loss of interest in activities you usually
ndenjoyable, feelingofworthlessness, hope-
lessness, oversleeping, loss of energy, social
4. Enjoy the Valkee bright light until the
deviceswitchesoautomaticallyafter12
minutes (by default).
5. Clean the earplugs regularly.
NOTE: You can interrupt the session by pressing
the power button again. If you turn on the de-
vice again within 10 seconds, you can resume
the session from the point of interruption.
NOTE: If you press the power button to start the
devicewithoutrstconnectingtheLedset,the
device gives an error signal (four beeps and four
ashes).
44
withdrawal, decreased physical activity, fatigue,
cravings for foods that are high in carbohydra-
tes, and weight gain, use the device on a regular
basis in the morning within two hours after
waking up at the same time each day.
If your seasonal mood swings are more severe
andyouaresueringfromdepression,orifyou
currently are on medication for depression,
consult your physician and use light therapy
only under supervision.
2.3. CHARGING
It is recommended to use the charger sold
or otherwise provided by Valkee for your
device. Other chargers or power sources
may exceed the limits of IEC 60601-1.
However, the device can also be charged
with many mobile-phone chargers or
smartphone micro-USB chargers or from
a computer’s USB port without damage to
the device.
If you have a problem with charging, see
the ‘Troubleshooting’ section.
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