The Natural Face LIft Company FaceLite 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 at [email protected] if you have any
comments about the faceLITE™ LED system or this User Guide.
faceLITE™ 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. faceLITE from the Natural Face Lift Company™
As we age skin becomes thinner and drier and develops sags and
wrinkles due to the loss of collagen and elastic tissue. Aging skin is
also much more susceptible to the development of brown spots and
pigmentation. The skins dermis can lose from 20-80% of its thickness
during the aging process.
faceLITE 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 stimulate collagen and elastin production cells
and to improve blood flow and tissue oxygenation through a process
called photobiomodulation. These effects help skin cells absorb topical
skincare products more effectively and helps rebuild the damage
caused by the aging process.
faceLITE has been designed to deliver light directly to the skin,
ensuring that the maximum amount of light hits its cellular targets and
is not wasted.
1.1. Intended use
The faceLITE™ LED system emits light in the red and near infra-red
(NIR) region of the light spectrum and is indicated for the treatment of
cosmetic indications including facial wrinkles.
2.0. Device Description
The faceLITE consists of
1. Silicon flexible face mask
2. Controller
3. Power supply and country specific adaptors
4. USB C to USB A connector
5. Head straps
6. Carry bag
Contents
Section header Page number
1.0. faceLITE from the Natural Face Lift Company™ 5
1.1. Intended use 5
2.0. Device Description 5
3.0. Contraindications, Warnings and Precautions 6
4.0. Risks and Benefits 8
4.1. Known Risks 8
4.2. Known Benefits 8
5.0. First Time Setup. 8
5.1. Unpacking and Charging your faceLITE 8
5.2. Sensitization test 9
6.0. Using faceLITE Device 9
6.1. Treatment Recommendations 9
6.2. Wearing the faceLITE LED system 9
6.3. Carrying out a treatment 10
7.0. Care and Maintenance 10
7.1. Cleaning the faceLITE LED system 10
7.2. Disposal 10
7.3. Troubleshooting 11
8.0. Labelling 11
9.0. Warranty 14
1
2
4
3
5

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faceLITE 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 facial wrinkles.
The system consists of a flexible silicon mask that contains light
emitting diodes (LEDs) and a controller. The LEDs generate the light.
The mask is worn on the face and is held in place by an adjustable
Velcro strap.
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 faceLITE cannot be operated while
charging.
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 faceLITE 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 facial wrinkles through a non-thermal mechanism
called Photobiomodulation.
3.0. Contraindications, Warnings and Precautions
Contraindications
• DO NOT use faceLITE LED system to treat any other conditions
apart from those listed in the indications for use. The faceLITE
LED system has not been tested for any other conditions than
those listed, and the risk is unknown.
• DO NOT use faceLITE LED system if you are pregnant, planning
on becoming pregnant or breastfeeding. The faceLITE 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 faceLITE LED system if you suffer from Lupus
erythematosus, photosensitive eczema or Albinism. If you
use the faceLITE LED system to treat Lupus erythematosus,
photosensitive eczema or Albinism you may cause a severe skin
reaction.
• DO NOT use faceLITE LED system if you suffer from any
photosensitive disorder (sensitization to light). If you use the
faceLITE LED system and you suffer from a photosensitive
disorder you may cause a severe skin reaction.
• DO NOT use faceLITE LED system if you are taking any
medication that can cause photosensitivity. If you use the
faceLITE 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).
Warnings
• Before using the faceLITE you must carry out a sensitization test
(see section 5.2-page 9). DO NOT use the faceLITE if you are
sensitive to faceLITE.
• DO NOT use the faceLITE system in any way that is not exactly
as specified in these instructions for use. Use of the faceLITE 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 faceLITE immediately if it feels hot
or your skin feels uncomfortably warm.
• Only use faceLITE with the proprietary hydrogel mask
recommended and supplied with the device. Other masks are
available but have not been tested with the faceLITE system.
• DO NOT use the faceLITE 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 faceLITE without removing these
products, you may cause a skin reaction, or you may reduce the
effect of the treatment.
• NEVER use faceLITE near water or where water can be spilt onto
the equipment. DO NOT use the faceLITE if you think it has come
into contact with water.
• Keep the faceLITE away from HOT surfaces.
• DO NOT attempt to modify the faceLITE in any way. Modifying
the faceLITE will void your warranty. Modifying the faceLITE
could cause an electric shock when the system is used again. The
system contains no serviceable parts.
• DO NOT use the faceLITE if the mask, controller, charging plug
or cord are damaged in anyway.

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General Safety
The faceLITE 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 faceLITE 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 head strap provided.
• The faceLITE system cannot be used in charging mode.
• Before each use, with the device switched off, clean the facemask.
All surfaces of the faceLITE system may be cleaned by following
the cleaning instructions in Section 7.1 - page 10.
• Do NOT use any other cleansing products other than those
stated in the cleaning instructions. Use of other cleansing
products may damage the faceLITE
• Store the faceLITE at room temperature in dry conditions, away
from direct sunlight.
4.0. Risks and Benefits
4.1. Known Risks
• Immediately after treatment skin may appear red.
Skin should return to normal within 1-2 hours.
• Temporary headaches immediately following the light
treatment. Headaches can be treated with an appropriate
pain killer and rehydration.
4.2. Known Benefits
• People who have undergone a course of 12 faceLITE
LED treatments report a reduction in fine facial lines and
improvements in texture and pigmentation.
5.0. First Time Setup.
5.1. Unpacking and Charging your faceLITE
The faceLITE system uses a Lithium ion polymer battery. When in
the charging mode the faceLITE will not illuminate.
• Before use it is important to fully charge the faceLITE
battery.
• Unpack the faceLITE device and check off the parts
described in Section 2 page 5.
• To charge faceLITE 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 faceLITE battery is fully charged when the
three indicator LED’s on the control unit stay illuminated.
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 faceLITE over your inner arm.
2. Switch ON the controller and allow the faceLITE 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 the skin on
your inner arm appears red and/or itchy then faceLITE is
unsuitable for you. Return the device to the retailer within
14 days of purchase.
6.0. Using faceLITE 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 faceLITE LED system
• faceLITE comes with an adjustable Velcro strap that allows
you to comfortably wear the mask.
• To fit the mask, thread the straps through the inlet holes on
either side of the mask.
• Loop the straps around your head and secure firmly.
• Adjust if necessary.

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6.3. Carrying out a treatment
1. Cleanse and exfoliate skin to remove any traces of skincare
2. Apply the hydrogel mask (use at least once a week).
3. Place faceLITE device on the face, 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 moisturiser and
sunscreen.
5. Clean the mask using a water-based wipe or a damp clean
cloth. Ensure that the device is NOT connected to the
mains when cleaning.
6. Repeat 3 – 5 times a week for four weeks.
7.0. Care and Maintenance
• Store the faceLITE LED system at room temperature in dry
conditions. Use the carry bag provided.
• Avoid storing the faceLITE LED system in dusty conditions, in
direct sunlight or in damp and humid conditions.
• The faceLITE LED system contains no serviceable parts.
• Before each use, with the device switched off, clean the facemask
following the cleaning instructions below.
7.1. Cleaning the faceLITE LED system
DO NOT use any other cleansing products as these may damage
the plastics.
• Clean the transparent (Face side) of the mask and rear with
a water based wipe or damp clean cloth. Stubborn stains
can be removed by wiping gently with 70% alcohol.
7.2. Disposal
DO NOT dispose of any part of the faceLITE at a domestic waste
facility.
The faceLITE 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 faceLITE.
Not charged Plug in the controller
to the charger
making sure that
the connectors are
attached and leave
charging until the
three indicator LED’s
on the controller
remain lit and do
NOT flash.
No red or infra-red
light from faceLITE.
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
Device is faulty Return to your
supplier
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 faceLITE
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

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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
• Weight: 600g (controller and face mask)
• LEDs: Red: 630nm+/-10nm. NIR: 830nm+/-17.5nm
• Total Device Dimensions:
• Facemask:- 406mm max (w) x 196mm max (h)
• 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 faceLITE 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.
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 faceLITE 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 faceLITE 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.
This symbol means keep dry
This symbol indicates the serial number of the device.
This symbol refers to the catalogue number for the faceLITE
mask.
This symbol refers to the batch code of the faceLITE mask.
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.
SN
REF
LOT
CN

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This symbol means the upper and lower operating
temperatures that the faceLITE can be safely used at.
This symbol means the upper and lower operating humidity
that the faceLITE can be safely used at.
This symbol means that the cardboard packaging that the
faceLITE came in can be recycled.
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 your provider.
• 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 faceLITE 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 faceLITE
system.
The faceLITE 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