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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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;

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• Three subjects left the trial during the treatment period for personal reasons. No subjects
left the trial due to problems associated with the use of the SMOOTHSKIN GOLD;

• Each subject received 12 weekly treatments to their chosen body location. A
typical treatment consisted of shaving the site then applying the SMOOTHSKIN GOLD
following the same process as outlined in Section 7, Step 3 of this user manual;

• Hair counts were used to measure the change in the amount of hair 6 months after the last
treatment and 12 months after the last treatment. The hairs in the treatment sites were
counted via high resolution photography and the dierence in hair counts was calculated
as a percentage change;

• When used as directed, the clinical trial participants showed on average 44% less
hair 6 months after their last treatment and 36% less hair 12 months after their last
treatment when compared to hair counts taken before treatment (see table below).
Actual results did vary from person to person;

Number of Subjects at 6 Months Post Treatment 50

43.9%

Number of Subjects at 12 Months Post Treatment 33

36.0%

% of Subjects
areas at 12 months post-

months.

66.7%

SMOOTHSKIN GOLD

• The incidence of side eects during the clinical trial was minimal (as outlined in
Section 4 above) and the majority of subjects (48 out of 50) would recommend the
SMOOTHSKIN GOLD to their friends.

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6.
What is the
Intended Use of
SMOOTHSKIN GOLD

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SKIN COLOUR

The SMOOTHSKIN GOLD is intended
for use on light, medium and dark skin
tones up to and including skin tone 5.
The SMOOTHSKIN GOLD incorporates
two Skin Tone Sensors that measure the
colour of your skin and will prevent use
if your skin tone is too dark.

HAIR COLOUR

The SMOOTHSKIN GOLD is intended for
use on naturally black or brown hair. It
is not as eective on white, grey, blonde
or red hair.

USE

The SMOOTHSKIN GOLD is intended
for the permanent reduction in
unwanted hair.

BODY AREAS

SMOOTHSKIN GOLD is intended to
be used on body hair below the neck,
including arms, underarms, bikini line,
stomach and legs.

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7.
How to Use
SMOOTHSKIN GOLD

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WARNING:

FOLLOW EACH STEP IN THE TREATMENT PROCESS ENSURING YOU COMPLETE ALL
ASPECTS OF EACH STEP BEFORE PROGRESSING TO THE NEXT.

STEP 1: PREPARE the area to be treated

Remove all visible hair by shaving. Make sure there is no hair remaining above
the surface of the skin to ensure optimal treatment and prevent debris from
covering the front of the SMOOTHSKIN GOLD.

Ensure you DO NOT wax, epilate or pluck the hair in the treatment area, as this
will remove the hair shaft that absorbs the light energy during treatment.
Cleanse the treatment area and pat dry

STEP 2: Doing a TEST PATCH

Before your first treatment on each new body area, we recommend you test
your skin in that area for a reaction to SMOOTHSKIN GOLD. The patch test area
should be approximately 3cm x 2cm in size (equivalent to 2 flashes applied to
the skin side by side). Follow Step 3 to treat the area.

Wait 24 hours following the patch test, to ensure your skin is suitable for treatment and

there is no adverse reaction to the light energy. If there is no reaction after 24 hours, you

may treat the area around the patch test. The ‘patch tested area’ should NOT be

re-treated for at least 1 week.

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STEP 3: Treating with SMOOTHSKIN GOLD

a) Insert the Power Supply into the base of the handset.

b) Plug the Power Supply into an electrical outlet. The Standby/Ready Button

will illuminate BLUE to indicate STANDBY mode. In this mode the device
cannot be fired.

c) Press the Standby/Ready Button once, the light will change from BLUE to
WHITE to indicate the handset is READY for use.

STANDBY MODE Timeout

When the unit is left “inactive” i.e. no buttons are pushed for 3 minutes then the unit

will revert to STANDBY mode. This is indicated by the Standby/Ready button changing

to a BLUE light. Press the button once to return to READY mode for treatment

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d) Press the Handset firmly against the area to be treated ensuring both
Skin Tone Sensors are in contact – the SMOOTHSKIN GOLD will not operate
if only one Skin Tone Sensor is in contact with skin. Once both Skin Tone
Sensors measure a valid skin tone, the pre-set output power is displayed on
the Power Bars.

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WHAT THE SKIN TONE SENSORS DO

The Skin Tone Sensors measure the
colour of your skin and set the correct
level of output power needed. If your
skin is too dark for treatment with the
SMOOTHSKIN GOLD, the Skin Tone
Sensors will detect this and prevent
the unit from operating. RED lights will
be shown in the Power Bar if your skin
is too dark.

The status of the Skin Tone Sensors
can be seen on the Power Bars located
on both sides of the handset. If a valid
skin tone is detected, the Power Bars
will illuminate WHITE. The number of
lights illuminated will be dependent
upon your exact skin tone.

Less lights : Darker skin and Lower Power Setting
More lights : Lighter skin and Higher Power Setting

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The amount of light energy delivered for each of the device settings
(depending on skin colour) is shown in the table below.

e) Press the ACTIVATION BUTTON. The device will flash, and a warm sensation
should be felt.

NUMBER OF POWER BAR

LIGHTS ILLUMINATED

ENERGY

(J/cm)

10 6.00

9 5.78

8 5.56

7 5.33

6 5.11

5 4.89

4 4.67

3 4.44

2 4.22

1 4.00

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GENTLE MODE

If you find the treatment uncomfortable or a little too painful, pressing the
‘GENTLE Mode’ button will reduce the power output.
Press the GENTLE Mode button once and it will illuminate WHITE to indicate it is
activated. You will notice less Power Bar indicators illuminated when applied to
your skin.
To de-activate GENTLE Mode, press the button again. The button will not be
illuminated and the device will return to its standard power settings.

Using GENTLE mode reduces the output energy by 0.9J/cm2

f) Move the Handset to the next area to be treated and repeat. The device
needs to recharge between flashes. This will take between 1-2 seconds.
Whilst recharging, the Standby/Ready button will flash WHITE, and the
lamp will not flash.

g) Ensure that the ENTIRE AREA receives treatment, but DO NOT overlap
treatment pulses.

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TREATMENT METHOD – STAMP OR GLIDE?

STAMP METHOD

This method is recommended for small areas such as the underarm and
bikini line. Place the handset on the skin, press & release the activation
button. Remove from the skin before carefully re-applying to the next
treatment area.

GLIDE METHOD

This method is recommended for larger areas such as legs. Place the
handset on the skin, hold down the activation button (press down
continuously), then glide the handset along the skin between flashes. Try to
move the handset at a steady speed that gives full coverage without overlap
or missed areas.

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STEP 4: Your SMOOTHSKIN GOLD Treatment Schedule

For optimal results, SMOOTHSKIN GOLD should be used once per week to ensure
all hair follicles are treated.

Step 5: Switching O the SMOOTHSKIN GOLD

When the treatment is finished, SMOOTHSKIN GOLD should be unplugged from the
Power Supply, and the electrical outlet.

Refer to section 8 for details of how best to look after your SMOOTHSKIN GOLD

After the initial treatment phase (12 weekly treatments), to maintain results we
recommend SMOOTHSKIN GOLD is used once a month, or as required

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8.

Cleaning ,

Maintenance

and Storage

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After treatment, always switch o SMOOTHSKIN GOLD by unplugging the
power supply from SMOOTHSKIN GOLD and the electrical outlet.

After use, the Handset, Skin Tone Sensors and Treatment Window should be
inspected for damage and wiped down with a dry, lint free cloth.

WARNING: The glass filter can get hot during use. DO NOT touch or clean
the filter for at least 5 minutes after use to allow it to cool down.

NEVER use water or other cleaning fluids, as these can damage the device
leading to a potential safety hazard.

To ensure maximum performance of your SMOOTHSKIN GOLD, it is particularly
important to keep the Removable Front and Reflector free from dirt, hair or
other debris.

To aid in the cleaning of this part, the front section is removable from the
Handset. Once removed, it can be cleaned with a slightly damp cloth. Always
ensure the Removable Front is completely dry before re-fitting to the Handset.

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Store SMOOTHSKIN GOLD in a cool, dry place. Make sure that the Treatment
Window and Skin Tone Sensors on the handset are protected from damage.

Regularly check the device (including cords) for visible signs of damage. In case
of damage or cracks, stop using the device.

Grip sides of Front section
and pull away from Handset

Once cleaned, replace ensuring
the Front section is fully
inserted

The Front section will only fit
one way. Do not force it.

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9.
Travelling with
SMOOTHSKIN GOLD

The power supply unit of the SMOOTHSKIN GOLD is universal and will work with
all commonly encountered mains supplies.

Providing you have a suitable adaptor for the mains power cable plug, the
SMOOTHSKIN GOLD will operate as normal.

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10.

Troubleshooting

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PROBLEM SOLUTION

The Power Bar indicators on the side of the
handset do not light up when placed against
your skin.

Make sure the power supply is plugged in.
Make sure the Handset is in READY mode
(press the Standby/Ready button once)
Ensure that both Skin Sensors (either side of
the Treatment Window) are pressed against
the skin.

Whilst pressed against your skin, the first
Power Bar indicator on the side of the
handset is illuminated RED, and SMOOTHSKIN
GOLD will not work.

The Area you are trying to treat is too dark
for treatment.
SMOOTHSKIN GOLD includes intelligent Skin
Tone Sensors that automatically detect your
skin tone and select the optimal treatment
setting. Due to the nature of Intense Pulsed
Light technology, SMOOTHSKIN GOLD is not
for everyone and cannot treat very dark skin.

The first Power Bar indicator on the side of
the handset is flashing RED continuously and
SMOOTHSKIN GOLD will not work.

The Removable Front is missing or incorrectly
fitted. Try re-fitting to the handset.

All the Power Bar indicators are flashing
continuously, and SMOOTHSKIN GOLD will
not work.

The SMOOTHSKIN GOLD has fired 120,000
shots and can no longer be used (end of life).

The Power Bar indicators on the side of the
handset are on or are flashing in an unfamiliar
pattern including a red LED indicator light.

SMOOTHSKIN GOLD will display any error
messages through combinations of lights
on Power Bars on the sides of the handset.
This indicates that there is a fault with the
device. Stop using the device and contact the
helpline.

The SMOOTHSKIN GOLD handset, treatment
window, power supply or cable are damaged,
broken, cracked or appear defective.

DO NOT USE.
If you are in any doubt about the safety of
SMOOTHSKIN GOLD or suspect it is damaged
in any way, it must not be used, and you
should contact the helpline.

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11. Warranty

We grant a 2 year warranty on the product starting on the date of purchase.
Within the warranty period, we will check faults in materials or workmanship free
of charge and replace the complete device, at our discretion.

This warranty extends to every country where this device is supplied by CyDen
or its appointed distributor.

This warranty does not cover damage due to improper use, normal wear or use
as well as defects that have a negligible eect on operation of the appliance.
The flash bulb is considered a wearable part of the device and is therefore
not covered under the warranty. The warranty becomes void if repairs are
undertaken by unauthorized persons and if original SMOOTHSKIN GOLD parts
are not used.

To obtain service within the warranty period, please visit our website:
www.smoothskin.co.uk/us/support or call the helpline on 866.813.4926

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12. Labels and Symbols

24V 2.5A

+

-

6027..

Type BF Applied Part

Direct current
Conection polarity

Class II equipment

Follow instructions for use

Keep Dry

WEEE symbol

European Conformity Marking

Only use with Power Supply 6027

MET

US

NRTL Certification marking

ACMA compliance marking

SMOOTHSKIN GOLD is marked with the following symbols.

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13. Technical Specifications

The SMOOTHSKIN GOLD is a filtered broadband Intense Pulsed Light system with
the following technical specifications:

Repetition Rate: Manually pulsed every 1-2 seconds (dependent
on treatment setting), Continuous operation
Max Optical Output: 6J/cm
Pulse Length: 2.6msec FWHM
Power Line Input: 100–240V~, 50/60Hz,1.3-0.55A
Operating temperature: Between 5°C and 40°C
Operating humidity: Up to 93%R.H. non condensing
Operating Pressures: 700hPa to 1060hPa
Treatment area (spot size): 3 cm2 (30mm x 10mm)

Transport Conditions:
Temperature: -25 degrees c to +70 degreesC
Humidity: Up to 93%R.H. non condensing
Pressures: 500hPa to 1060hPa

SMOOTHSKIN GOLD includes 120,000 flashes and is intended for a single user.

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SMOOTHSKIN GOLD complies with the standards IEC 60601-1-2:2007, EN55014­1:2006, EN55014-2:1997, EN61000-3-2:2006, EN61000-3-3:2008, IEC62087:2011,
IEC62301:2011 and IEC60335-2-23:2003 for Electromagnetic (EMC) Immunity
and Emissions. Therefore, it is suitable for use in environments with similarly
controlled devices.

SMOOTHSKIN GOLD complies with the medical standards ANSI/AAMI ES60601­1:2005/A2:2010, CSA C22.2 No. 60601-1:08, IEC 60601-1:2005 + CORR. 1 (2006)
+ CORR.2 (2007), EN 60601-1:2006/A11:2011, IEC 60601-1-11 (First Edition): 2010,
IEC 60601- 2-57 (First Edition): 2011.

DISPOSAL (END OF LIFE)
In order to minimize hazards to health and the environment and ensure that
materials can be recycled, this product should be disposed of at a separate
collection facility for waste electrical and electronic equipment.
The WEEE symbol marked on the product is there to remind you.

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14. Support

You can reach SMOOTHSKIN in numerous ways. If you are
unable to call our Helpline in working hours then we provide
online support.

You can reach us via our SMOOTHSKIN web page
(www.smoothskin.co.uk/us/support)

For all support queries please call the helpline on 866.813.4926

MANUFACTURER:

CyDen Ltd
Technium 2
Kings Rd
Swansea
SA1 8PJ

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SUPPORT

You can reach SMOOTHSKIN in numerous ways.

If you are unable to call our Helpline in working hours:

866.813.4926 then we provide online support.

You can reach us via our SMOOTHSKIN web page at:
www.smoothskin.co.uk/us/support

CM12-1043-01