Smoothskin GOLD User manual

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USER GUIDE powered by

WELCOME TO
SMOOTHSKIN GOLD
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1. Introduction To
SMOOTHSKIN GOLD

Welcome to an unparalleled
beauty experience with your new
SMOOTHSKIN GOLD Intense
Pulsed Light (IPL) hair removal
system.
For further information, please
visit the beauty room at www.
smoothskin.co.uk/us/ where you
can join our unique SMOOTHSKIN
‘support programme’ for helpful
tips and expert advice throughout
your treatment regime.
Inside the packaging of the
SMOOTHSKIN GOLD you will find
the following:
• Handset
• Power Supply
• Mains Power Cable
• User Manual
• Quick Start Guide
• Carry Bag
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2.
How Does
SMOOTHSKIN GOLD
Work

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The SMOOTHSKIN GOLD is designed
to help break the cycle of hair
growth. Light energy is transferred
through the skin’s surface and is
absorbed by melanin present in the
hair shaft. The absorbed light energy
is converted to heat energy (below
the surface of the skin), which
disables the hair follicle. Treated hairs
naturally fall out over the course of a
few days to 1-2 weeks.
Hair growth is cyclical and follows 3
distinct and consecutive phases. IPL
treatment is only eective when hairs
are in a particular phase (the Anagen
– growth phase). Not all hairs are
in the same phase at any one time.
This is why you should follow the
recommended treatment regimen of
12 weekly treatments.

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What to Expect
Immediately post treatment, you
should not see any significant side
eects from treatment (Refer to
section 4 for more information on
side eects).
In the first few weeks following the
initial treatments, you will still see
some hairs growing. These are
likely to be hairs that were missed
during treatment i.e. they were lying
dormant and not in their growth
phase (Anagen) during treatment;
when IPL is most eective.
Around 6 weeks into the 12 week
treatment programme you should
see a reduction in hair growth.
However, many hairs may still not
have been treated in their growth
phase. It is important to continue
the weekly treatments.
After the 12 week programme, you
should see a significant reduction in
hairs within the treated area. Any
remaining hairs should be finer
and lighter in colour. Continued
monthly treatments, or treatments
as required, should maintain the
reduction in unwanted hair.

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3.
Important Safety
Information

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DO NOT USE SMOOTHSKIN GOLD if you have very dark skin. The
Skin Tone Sensors located near the output window of the device will
determine the tone of your skin. If the Skin Tone Sensors determine
your skin is too dark for safe use, operation of the SMOOTHSKIN
GOLD will be prevented.
DO NOT USE SMOOTHSKIN GOLD if your skin has been artificially
or naturally tanned or is burned from sun overexposure. Your skin
may be extra sensitive following sun exposure and particularly
susceptible to burning, blistering, discolouring or scarring if you use
the SMOOTHSKIN GOLD. Wait 7 days until sunburn or tan disappears
before using the SMOOTHSKIN GOLD
DO NOT expose treated areas to the sun. Wait at least 7 days after
treatment before exposing treated skin to direct sunlight. Your skin
may be extra sensitive following SMOOTHSKIN GOLD treatment
and particularly susceptible to sunburn. Apply sunscreen (SPF 15 or
greater) to the treated area or cover the treated area with suitable
clothing.
Contraindications

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DO NOT USE SMOOTHSKIN GOLD directly on the nipples, genitals
or around the anus. These areas may have a darker skin colour and/
or greater hair density. Using the device in these areas may cause
discomfort/pain or injure (burn, discolour or scar) your skin.
DO NOT USE SMOOTHSKIN GOLD if you have a history of skin
cancer or pre-cancerous lesions (e.g. nevi or a large number of
moles)
DO NOT USE SMOOTHSKIN GOLD if you are pregnant or lactating,
as this device has not been tested with these individuals.
DO NOT USE SMOOTHSKIN GOLD on dark brown or black spots
such as birthmarks, moles or warts in the area you wish to treat.
Using the SMOOTHKIN GOLD may injure your skin or make existing
conditions worse. You may experience side eects such as burns,
blisters and skin colour changes or scarring.
DO NOT USE SMOOTHSKIN GOLD if you have any skin condition in
the treatment area, including psoriasis, vitiligo, eczema, acne, herpes
simplex or active infections or wounds.
DO NOT USE SMOOTHSKIN GOLD if you are under the age of 18 as
this device has not been tested on these individuals.

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The SMOOTHSKIN GOLD emits flashes of Intense Pulsed Light.
Direct exposure is potentially harmful to your eyes. Take care to
follow the safety precautions below.
The handset can only be activated (flashed) if both Skin Tone
Sensors (either side of the treatment window) detect a valid Skin
Tone reading. However:
DO NOT look directly into the treatment window of the handset
when the system has electrical power and is switched on
DO NOT attempt to activate (flash) the system towards the eye
DO NOT treat areas around the eye (eyebrows or eyelashes)
ONLY attempt to activate (flash) the system when the front of
the handset is in good contact with the area you wish to treat.
 WE RECOMMEND you look away from the handset when firing
onto your skin.
Warnings
EYE SAFETY

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ELECTRICAL AND SAFETY
As with any electrical device, certain precautions must be taken in
order to ensure your safety.
DO NOT try to open the SMOOTHSKIN GOLD, as this may expose
you to dangerous electrical components.
DO NOT USE if SMOOTHSKIN GOLD is damaged; for example,
cracked handset, cable damage (internal wires visible), cracked or
broken glass on the handset, etc.. This may result in injury.
DO NOT USE near bathtubs, showers, basins or other vessels
containing water. If SMOOTHSKIN GOLD becomes wet, it should not
be used.
DO NOT USE if the SMOOTHSKIN GOLD becomes uncomfortably hot
to touch. This may indicate that the unit is damaged.
DO NOT USE a power supply or other component, other than those
provided for use with SMOOTHSKIN GOLD. This may damage the unit
and cause it to stop working.
DO NOT attempt to activate (flash) the SMOOTHSKIN GOLD onto
any surface other than skin.
WARNING no modification of this equipment is allowed.

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DO NOT USE if you have had a skin peel treatment on the area you
wish to treat. Please wait 30 days after a skin peel before treating
with the SMOOTHSKIN GOLD. Treating tanned skin with Intense
Pulse Light (IPL) may result in permanent Hyper (darkening) or Hypo
(lightening) of the treated skin.
DO NOT USE If you have a known sensitivity to sunlight
(photosensitivity) or are taking medication that makes the skin more
sensitive and causes photosensitivity, e.g. Retin A, Accutane and/
or other topical retinoids. Always check the instruction leaflet that
comes with your medicinal product, to see if photosensitivity is listed
as a side eect. Use of the SMOOTHSKIN GOLD on photosensitive
skin could result in skin damage such as swelling or blisters.
The SMOOTHSKIN GOLD should be kept out of the reach of children
under 18 years of age. Children should not use, play with, maintain
or clean the device. There are a number of potential risks – exposure
to the light output causing burns or eye damage, electrocution,
strangulation from the cables, choking on the Removable Front
The SMOOTHSKIN GOLD is not intended for use by persons with
reduced physical, sensory or mental capabilities. Unless they have
been given supervision or instruction concerning safe and proper use
of the device by a person responsible for their safety.
GENERAL SAFETY

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Hair removal by lasers or intense pulse light sources can cause
increased hair growth in some individuals. Based upon currently
available data, the highest risk groups for this response are females
of Mediterranean, Middle Eastern, and South Asian heritage treated
on the face and neck.
DO NOT USE the SMOOTHSKIN GOLD on any area where you
may want hair to grow back.
The SMOOTHSKIN GOLD IS NOT recommended for use on the
male beard as results may be permanent.
SMOOTHSKIN GOLD IS NOT recommended for use on red, grey
or blonde hair. The SMOOTHSKIN GOLD IS NOT eective on
these hair colours.
The SMOOTHSKIN GOLD Glass Filter is
a critical component that will get hot
during use.
DO NOT touch the Filter during or
directly after use. Regularly inspect the
filter for damage.
DO NOT use SMOOTHSKIN GOLD if the
filter is cracked or missing.
SKIN TONE SENSORS
PRECAUTIONS

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4.
POTENTIAL RISKS, SIDE
EFFECTS AND SKIN
REACTIONS

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Use of the SMOOTHSKIN GOLD could result in side eects.
The table below lists the known skin reactions that may occur following treatment with the
SMOOTHSKIN GOLD.
POSSIBLE SIDE EFFECTS HOW TO ASSESS AND REACT
Mild pain / discomfort in the area being
treated
This is expected and is normal for all IPL
treatments. You can keep on using the
device as instructed, and the pain should
diminish with continued use.
Warm feeling or tingling sensations during
treatment, which typically disappear after a
few seconds to a minute and decrease with
continued use.
This is expected and is normal for all IPL
treatments. You can keep on using the
device as instructed.
Itchiness in the treatment area This is quite common for IPL treatments,
and should subside after a short period. You
can keep on using the device as instructed.
Do not scratch the area.
Skin redness during or after treatment
which disappears within minutes.
This is expected and is normal for all IPL
treatments. You can keep on using the
device as instructed once skin redness has
disappeared.
Skin redness which does not disappear
within minutes and lasts 24-48 hour
Stop using the device immediately and
consult your physician before using it again.
Pain or discomfort that is intense during
treatment or persists after a treatment.
Stop using the device immediately and
consult your physician before using it again.
IN VERY RARE CASES HOW TO ASSESS AND REACT
Swelling and redness that does not
disappear within two to three days
Stop using the device immediately and
consult your physician before using it again.
Temporary changes in skin colour
(lightening or darkening).
If your skin colour changes, stop using
the device immediately and consult your
physician.
Blistering or burning of the skin. Stop using the device immediately and
consult your physician before using it again.
Apply a cold pack to the area. Treat with
antiseptic or burn cream.

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Use of the SMOOTHSKIN GOLD could result in side eects.
The table below lists the known skin reactions that may occur following treatment with the
SMOOTHSKIN GOLD.
In a clinical trial of 50 subjects, each subject received 12 weekly treatments. The
recorded eects were:
ITCHINESS – Four subjects experienced mild itchiness after treatment.
SLIGHT REDNESS – This was reported by 1 subject.
MILD STINGING SENSATION – Five subjects reported mild discomfort following
treatment.
IN-GROWING HAIR – One subject reported experiencing an in-growing hair
following treatment.
FOLLICLE REDNESS – One subject reported a red spot at the treatment site
following treatment.
In all cases, the treated skin returned to normal within 7 days.
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5 .
Benefits of Using
SMOOTHSKIN GOLD
SMOOTHSKIN GOLD is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and ecacy of the SMOOTHSKIN
GOLD. The key features of the clinical trial were:
• All treatments were performed by non-medically trained operators at a single location
using devices identical to the SMOOTHSKIN GOLD provided in this package;
• All subjects were required to complete questionnaires related to their general health and
those who could not be treated, e.g. those who had one or more of the contraindications
as listed in Section 3 of this User Manual were excluded. In addition, all subjects were
required to provide Informed Consent as per international clinical trial requirements;
• A total of 53 female subjects, aged between 19 and 45 years old, commenced the trial;