Ismart Natural facelift decoLITE User manual

USER GUIDE

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Users of this device can obtain benefit from using it only if they read
and comprehend all information in the user manual.
You must follow all the instructions in the user manual.
Please feel free to contact us on our Customer Services email if you have any
comments about the décoLITE™ LED system or this User Guide.
décoLITE™ and the Natural facelift Company™ are trademarks of; iSMART
Developments Ltd, Registered office Fulford House Newbold Terrace,
LEAMINGTON SPA. CV32 4EA. United Kingdom
[email protected]
www.natural-facelift.com
The information in this document is proprietary to iSMART Development Ltd, and
supplied on the understanding that it shall be kept confidential to recipients and
that it shall not be reproduced and/or used for commercial purposes without the
written consent of iSMART Developments Ltd

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1.0. décoLITE from the Natural Face Lift Company™
As we age skin becomes thinner, drier and develops wrinkles due to the
loss of collagen and elastic tissue. The décolletage is one of the first
areas to show the signs of aging. It is often forgotten about in skin care
regimes and can be exposed the sun without regular use of SPF and
antiaging products people apply to the face.
décoLITE uses two proven wavelengths of light; 633nm, red light and
830nm or near infra-red light. These wavelengths have been shown
in clinical studies to increase collagen production and to reduce the
appearance of fine lines and wrinkles. These effects help skin cells
absorb topical skincare products more effectively and helps rebuild the
damage caused by the aging process. décoLITE has been designed
to deliver light directly to the skin, ensuring that the maximum amount
of light hits its cellular targets leaving the more delicate skin of the
décolletage and neck feeling softer, smoother and with a visible
improvement in skin tone and texture, lines and age spots.
1.1. Intended use
The décoLITE™ LED system emits light in the red and near infra-red (NIR)
region of the light spectrum and can be used to help reduce the signs of
aging.
It is also indicated for the alleviation of pain; increased blood flow and
temporary relaxation of muscle can provide pain relief.
2.0. Device Description
1. Silicone flexible décolletage and neck LED device
2. Controller
3. Power supply and country specific adaptors
4. Straps for adjustment of position of device
5. Carry bag
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2
4
3
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5
Contents
Section header Page number
1.0. décoLITE from the Natural Face Lift Company™ 5
1.1. Intended use 5
2.0. Device Description 5
3.0. Contraindications, Warnings and Precautions 7
4.0. Risks and Benefits 9
4.1. Potential Adverse Effects 9
4.2. Potential Benefits 9
5.0. First Time Setup. 9
5.1. Unpacking and Charging your décoLITE 9
5.2. Sensitization test 10
6.0. Using décoLITE Device 10
6.1. Treatment Recommendations 10
6.2. Wearing the décoLITE LED system 10
6.3. Carrying out a treatment 10
7.0. Care and Maintenance 11
7.1. Cleaning the décoLITE LED system 11
7.2. Disposal 11
7.3. Troubleshooting 11
8.0. Labelling 12
9.0. Warranty 15

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décoLITE is a home use wearable LED phototherapy device whose
purpose is to produce an even, cool, narrow-band of light for the
treatment of cosmetic indications including neck and décolletage,
fine lines and age spots
The system consists of a flexible silicone mask that contains light
emitting diodes (LEDs) and a controller. The LEDs generate the light.
The mask is worn on the neck and décolletage and is held in place
by an adjustable Velcro strap. Alternatively, it can be just worn on
the décolletage area for more coverage by using the longer strap
and adjusting the strap position to the holes positioned on the top
of the device.
USING SHORT STRAPS USING LONG STRAPS
USING SHORT STRAPS USING LONG STRAPS
The controller switches the LEDs ON/OFF and controls power to the
mask. The controller contains a rechargeable Lithium ion polymer
battery. The controller uses a visible display comprising of 3 micro LEDs
to show the user the battery charge status of the device.
The power supply is used to charge the Lithium battery and is
connected to a suitable mains outlet via a 2 or 3 pin input socket and
wall plug. The power cable is connected to the controller by a standard
micro USB A-C connector. The décoLITE cannot be operated while
charging. The controller should only be recharged without the device
plugged into the controller
The equipment is not used to make measurements of any sort, or to
draw any conclusions regarding the indication to treat. The equipment
does not require checks on the light output as the LEDs do not dim
with age to any practical extent.
The décoLITE Light emitting diode (LED) system emits light energy
in the red and near infra-red (NIR) region of the light spectrum and
is intended to treat neck and décolletage finelines and age spots
through a non-thermal mechanism called Photobiomodulation.
3.0. Contraindications, Warnings and Precautions
Contraindications
• DO NOT use décoLITE LED system to treat any other conditions
apart from those listed in the indications for use. The décoLITE
LED system has not been tested for any other conditions than
those listed, and the risk is unknown.
• DO NOT use décoLITE LED system if you are pregnant, planning
on becoming pregnant or breastfeeding. The décoLITE LED
system has NOT been tested on pregnant or breast-feeding
women and therefore the risk to the foetus, neonate or pregnant
women is unknown.
• DO NOT use the décoLITE LED mask if you suffer from light
induced headaches.
• DO NOT use the décoLITE LED mask if you suffer from any
genetic conditions of the eyes. The décoLITE LED system has
NOT been tested on subjects who suffer with genetic conditions
of the eyes and therefore the risks are unknown. If you are unsure
about any related eye condition and using the décoLITE contact
your ophthalmologist or eye doctor.
• DO NOT use décoLITE LED system if you suffer from Lupus
erythematosus, photosensitive eczema or Albinism. If you
use the décoLITE LED system to treat Lupus erythematosus,
photosensitive eczema or Albinism you may cause a severe
skin reaction.
• DO NOT use décoLITE LED system if you suffer from any
photosensitive disorder (sensitization to light). If you use the
décoLITE LED system and you suffer from a photosensitive
disorder you may cause a severe skin reaction.
• DO NOT use décoLITE LED system if you are taking any
medication that can cause photosensitivity. If you use the
décoLITE LED system and you are taking any medication that can
causes photosensitivity you may cause a severe skin reaction.
Photosensitivity is a common side effect of various medications.
These can include certain antibiotics, chemotherapy drugs, and
diuretics. If you are unsure about any medication you may be
taking consult your healthcare provider.
Other substances not listed above can also cause photosensitivity.
• Common examples of these substances are:
St John’s Wort, Coal tar, Deodorants, antibacterial soaps, artificial
sweeteners, naphthalene (mothballs), petroleum products,
brightening agents found in laundry detergent, and cadmium
sulphide (a chemical injected into the skin during tattooing).

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Warnings
• Before using the décoLITE you must carry out a sensitization test
(see section 5.2-page 10).
• DO NOT use the décoLITE if you are sensitive to faceLITE, our
facial led product
• DO NOT use the décoLITE system in any way that is not exactly
as specified in these instructions for use. Use of the décoLITE LED
system other than exactly as specified in these instructions for use
has not been tested and the risk is unknown.
• TURN OFF and REMOVE the décoLITE immediately if it feels hot
or your skin feels uncomfortably warm.
• Only use décoLITE with the proprietary hydrogel mask
recommended and supplied with the device. Other masks are
available but have not been tested with the décoLITE system.
• DO NOT use the décoLITE without first removing creams, lotions
or make-up BEFORE treatment. Some ingredients in these
products may cause light sensitization or may reduce the effect
of the treatment. If you use the décoLITE without removing these
products, you may cause a skin reaction, or you may reduce the
effect of the treatment.
• NEVER use the décoLITE near water or where water can be spilt
onto the equipment. DO NOT use the décoLITE if you think it has
come into contact with water.
• Keep the décoLITE away from HOT surfaces.
• DO NOT attempt to modify the décoLITE in any way. Modifying
the décoLITE will void your warranty. Modifying the décoLITE
could cause an electric shock when the system is used again. The
system contains no serviceable parts.
• DO NOT use the décoLITE if the mask, controller, charging plug
or cord are damaged in anyway.
General Safety
The décoLITE system is an electrical device, which under certain
circumstances could present an electrical shock hazard to the user.
Please read the accompanying user manual thoroughly and follow
directions stated in the manual to assure maximum safety during
operation.
Precautions
• The décoLITE strap contains a mixture of Polyester, nylon and
lycra. If you are allergic to any of these materials, you may not be
able to use the straps provided.
• The décoLITE system CANNOT be used in charging mode. Only
when the controller is unplugged from the mains.
• Before each use, with the device switched off, clean the device.
All surfaces of the décoLITE system may be cleaned by following
the cleaning instructions in Section 7.1 - page 11.
• DO NOT use any other cleansing products other than those
stated in the cleaning instructions. Use of other cleansing
products may damage the décoLITE.
• Store the décoLITE at room temperature in dry conditions, away
from direct sunlight.
4.0. Risks and Benefits
4.1. Potential Adverse Effects
• Immediately after treatment skin may appear red.
Skin should return to normal within 1-2 hours.
4.2. Potential Benefits
• People who have undergone a course of 12 décoLITE LED
treatments report a visible improvement in skin tone and
texture, lines and age spots.
5.0. First Time Setup.
5.1. Unpacking and Charging your décoLITE
The décoLITE system uses a Lithium ion polymer battery. When in
the charging mode the décoLITE will not illuminate.
• Before use it is important to fully charge the décoLITE
battery.
• Unpack the décoLITE device and check off the parts
described in Section 2 page 5.
• To charge décoLITE insert the micro USB cable into the
controller. Insert the USB connector into the USB port of the
power supply.
• Insert the power supply into a suitably grounded outlet and
switch on.
• The 3 LEDs in the control unit will start to flash to indicate
charging. The décoLITE battery is fully charged when the
three indicator LEDs on the control unit stay illuminated.

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5.2. Sensitization test
Before carrying out your first treatment you must carry out a
sensitization test. Follow the step by step guide below;
1. Place the décoLITE over your inner arm.
2. Switch ON the controller and allow the décoLITE to run
for its full 10-minute treatment program.
3. At any time if your skin feels HOT or uncomfortable
STOP using the device immediately.
4. After the treatment wait at least 6 hours. If your skin on
your inner arm is red or itchy then the décoLITE is unsuitable
for you. Return the device to the retailer within (14) days
of purchase.
6.0. Using décoLITE Device
6.1. Treatment Recommendations:
• For best results treat for 3-5 days a week for a minimum
of 4 weeks.
• Maintenance treatment should be carried out as required,
according to lifestyle and skin condition.
6.2. Wearing the décoLITE LED system
• décoLITE comes with an adjustable Velcro strap that allows
you to comfortably wear the device in two positions, around
the neck and décolletage or décolletage only
• To fit the mask, thread the shorter straps through the inlet
holes on either side of the device for neck and décolletage.
Alternatively, to treat a larger area of the décolletage put
the longer strap through the holes at the top of the device.
• Loop the straps around your neck and secure firmly.
• Adjust if necessary.
6.3. Carrying out a treatment
1. Cleanse and exfoliate neck and décolletage to remove any
traces of skincare
3. Place décoLITE on the neck and décolletage, secure with
the Velcro strap and switch on the controller. The device
switches off after a ten-minute treatment time. You may stop
the treatment at any time by pressing the ON/OFF button
on the controller.
4. Remove the mask, apply your normal skincare and
sunscreen.
5. Clean the mask using a water-based wipe or a damp clean
cloth. Ensure that the device is NOT being charged when
cleaning.
6. Repeat 3 – 5 times a week for four weeks.
7.0. Care and Maintenance
• Store décoLITE LED device at room temperature in dry
conditions. Use the carry bag provided.
• Avoid storing the décoLITE LED system in dusty conditions, in
direct sunlight or in damp and humid conditions.
• The décoLITE LED system contains no serviceable parts.
• Before each use, with the device switched off, clean the face
mask following the cleaning instructions below.
7.1. Cleaning the décoLITE LED system
Do NOT use any other cleansing products as these may
damage the plastics.
• Clean the transparent side (side in contact with the skin) of
the mask and the rear of the mask with a water-based wipe
or damp clean cloth. Place the mask on a clean dry surface
to air dry. Visually inspect the surfaces to ensure they are
clean. Stubborn stains can be removed by wiping gently
with 70% alcohol.
7.2. Disposal
DO NOT dispose of any part of the device at a domestic
waste facility.
The décoLITE controller contains a Lithium ion polymer battery.
For protection of the environment, please package and return
this unit to the manufacturer or their representative at the end
of its working life or safely dispose of the device following your
local guidelines.
7.3. Troubleshooting
Problem Possible Cause Action
No red or
infra-red light
from décoLITE
Not charged Plug in the controller to the
charger making sure that the
connectors are attached and
leave charging until the three
indicator LEDs on the controller
remain lit and do NOT flash
No red or
infra-red light
from décoLITE
Device
connected to
the mains
Unplug micro USB connector
from controller
LEDs do NOT
turn OFF after
10 minutes
Device is faulty Return to your supplier
LEDs flicker
during
treatment
décoLITE USB
is not fully
inserted into the
controller
Ensure the controller and
décoLITE are connected
correctly

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If the actions suggested fail to fix the problem, or the problem
reoccurs, and your device is within the warranty period please return to
your provider.
• DO NOT attempt to investigate any further.
• DO NOT attempt to modify the device in any way.
The décoLITE LED System has NO parts you can
repair yourself.
8.0. Labelling
The labelling supplied with the device contains the following
information:
• Date of manufacture
• Catalogue number and batch code
• Operating environment
Recycling
This symbol means that this product shall not be disposed of with
normal household waste (2012/19/EU).
This symbol means that this product contains a built-in
rechargeable battery which shall not be disposed of with normal
household waste (2006/66/EC).
We advise you to take your product to an official collection point to
have a professional remove the rechargeable battery. Follow your
country’s rules for the separate collection of electrical and electronic
products and rechargeable batteries. Correct disposal helps prevent
damage to the environment and human health.
Technical specification
• LEDs: Red: 630nm+/-10nm. NIR: 830nm+/-17.5nm
• Controller: 23mm max (dia) x 104mm (l)
• Program time: 10 minutes fixed
• Operating Temperature: 0°C to 40°C
• Storage and Transport Temperature: -5°C to 55°C
• Operating Humidity: 30% to 95% without condensation
• Storage and Transport Humidity: 20% to 85%
without condensation
• Mains Electrical Input from power adaptor:
100-240Vac/47-63Hz. 0.6A
• Electrical Output: 5V
Compliance
The décoLITE LED mask complies with the standard of basic safety
for medical devices EN60601-1:2006/A12:2014 and with the relevant
collateral and particular standards for non-laser light source medical
equipment for home use EN 60601-1-11:2015, EN 60601-2-57:2011,
and EN 60601-1-2:2015 and IEC 62471:2006 Photobiological Safety
of Lamps and Lamp Systems. EN 55014-1.2006+A1: 2009+A2 2011
Electro Magnetic Compatibility – requirements for household
appliances, electric tools and similar apparatus – Part 1 emissions.
EN 55014-2:2015 Electromagnetic compatibility- requirements for
household appliances electric tools ad similar apparatus – part 2:
immunity – product family standard.
Regarding electromagnetic compatibility (EMC) and electromagnetic
fields (EMF), the device should be kept away from radio frequency (RF)
equipment to avoid interference.
Explanation of symbols
There are several safety warning labels on the décoLITE and
associated packaging and in the user manual. Not following these
warnings may result in one or more of the following hazards:
electrical shock and/or fire.
This warning symbol on the device label is a warning to read
the enclosed documents before use and take all safety
precautions required.
This symbol on the device label means: Read the user manual
before you start using the device.
This symbol means: that the device is specified as applied part
type BF. B indicates that it is used on the Body and F indicates
that it is not connected to the mains voltage.
This symbol means: Conforms to certain EC Directives on
health, safety, and environmental protection standards.
CE stands for ‘Conformité Européenne’’.
This symbol means “Manufactured by” and provides the name
and address of the legal manufacturer.
This symbol indicates input for the power supply. This symbol
means that the device may only be charged with the adapter
that is supplied in the package. Usage of other adapters may
not be safe and could lead to electrical shock. The adapter has
the following electrical specification: 100-240Vac/47-63Hz. 0.6A.
Electrical Output; 5V.

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This symbol means keep dry
This symbol indicates the serial number of the device.
This symbol refers to the catalogue number for the device.
This symbol refers to the batch code of the device.
This symbol indicates the USB connector.
This symbol means that the device uses a Lithium ion Polymer
battery.
This symbol means made in China
This symbol means keep the device away from direct sunlight.
This symbol means the upper and lower operating
temperatures that the décoLITE can be safely used at.
This symbol means the upper and lower operating humidity
that the device can be safely used at.
This symbol means that the cardboard packaging that the
device came in can be recycled.
SN
REF
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9.0. Warranty
Under normal use this product is guaranteed for 2 years after its
original purchase date against manufacturing defects in materials
or workmanship.
This warranty extends only to the original purchaser. If the product
should become faulty within the warranty period, contact the
Customer Service Centre.
• iSMART Developments Ltd or its authorised distributor reserves
the right to repair a defective product.
• iSMART Developments Ltd or its authorised distributor reserves
the right to replace a defective product with the most compatible
product currently available.
• This warranty does not cover damage caused by the following:
• Accident, misuse, abuse or alteration
• Servicing by unauthorized persons
• Connection to incorrect power sources
• Use with unauthorized accessories
iSMART Developments Ltd or its authorised distributors shall not
be responsible for any incidental, special or consequential damages
resulting from the use of this product. All implied warranties, including
but not limited to implied warranties of fitness and merchantability are
limited in duration to one year from date of original purchase.
This warranty gives you specific legal rights, and you may also have
other rights that vary from country to country. Some countries do
not allow the exclusion or limitation of incidental or consequential
damages, or limitations on how long an implied warranty lasts, so some
of the above limitations and exclusions may not apply to you.
This warranty is given in lieu of all other warranties, written or oral,
whether expressed by affirmation, promise, description, drawing,
model or sample. Any and all warranties other than this one, whether
expressed or implied, including implied warranties of merchantability
and fitness for a particular purpose are hereby disclaimed.
Please register your warranty at
www.natural-facelift.com
If the product is defective within the warranty period, please contact
your provider.

Fulford House Newbold Terrace,
LEAMINGTON SPA.
CV32 4EA.
United Kingdom
According to MDD 93/42/EEC, the décoLITE LED mask is classified as a cosmetic
device within the European union. However, for purposes of safety we have conducted
additional testing so that you can be ensured of the safety and efficacy of the décoLITE
system.
The décoLITE system has been tested to or complies with the following standards;
EN 60601-1:2006/A12:2014. Medical electrical equipment. General requirements for basic
safety and essential performance.
EN 60601-1-2:2015 Medical electrical equipment. General requirements for basic
safety and essential performance. Collateral standard. Electromagnetic compatibility.
Requirements and tests
IEC 60601-1-6 2010 AMD12013 Medical Electrical Equipment – Part 1 General
Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.
IEC/EN60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements
for basic safety and essential performance -- Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used in the home healthcare
environment
IEC/EN 60601-2-57:2011 Medical electrical equipment. Particular requirements for the
basic safety and essential performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
EN 62471:2008 Photobiological Safety of Lamps and Lamp Systems
EN 62366-1:2015 Application of usability engineering to medical devices.
EN ISO 10993-1:2010-04 Biological evaluation of medical devices Part 1: Evaluation and
testing
EN ISO 15223-1:2017 Medical Devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
EN 55014-1.2006+A1: 2009+A2 2011 Electro Magnetic Compatibility – requirements for
household appliances, electric tools and similar apparatus – Part 1 emissions.
EN 55014-2:2015 Electromagnetic compatibility- requirements for household appliances
electric tools ad similar apparatus – part 2: immunity – product family standard.