Smoothskin PURE FIT User manual

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IPL USER GUIDE

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ENGLISH Page 4
ไทย เลขหน้า 42
BAHASA INDONESIA Halaman 81
TING VIT S trang 125

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Welcome to SMOOTHSKIN PURE FIT
Congratulations! You’ve opened up a world of unparalleled beauty, smoothness and
convenience. Come and join in the conversation at www.smoothskin.com where you can
find expert advice and support throughout your treatment.
1. THE SMOOTHSKIN PURE FIT SYSTEM 5
2. HOW DOES SMOOTHSKIN PURE FIT WORK 6
3. IMPORTANT SAFETY INFORMATION 8
4. POTENTIAL RISKS, SIDE EFFECTS AND
SKIN REACTIONS 15
5. BENEFITS OF USING SMOOTHSKIN PURE FIT 17
6. WHAT IS THE INTENDED USE OF
SMOOTHSKIN PURE FIT 20
7. YOUR SUITABILITY 20
8. HOW TO USE SMOOTHSKIN PURE FIT 21
9. THE SKIN TONE SENSOR 25
10. THE SKIN CONTACT SENSOR 28
11. SMOOTHSKIN PURE FIT MODES 30
12. THE PRECISION HEAD 32
13. CLEANING, MAINTENANCE, STORAGE 34
14. TRAVELLING WITH SMOOTHSKIN PURE FIT 34
15. TROUBLESHOOTING 35
16. WARRANTY 36
17. LABELS AND SYMBOLS 37
18. TECHNICAL SPECIFICATIONS 39

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1. THE SMOOTHSKIN PURE FIT SYSTEM
PACKAGE CONTENTS
Inside the packaging of SmoothSkin Pure Fit you will find the following:
• Handset and Base Unit
• Power Cable
• Precision Head
• User Manual
Skin Tone
Sensor
Activation
Button
Mode Button
Power Bars Base Unit
Power
Cable
Treatment Window
Precision
Head

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SmoothSkin Pure Fit 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.
2. HOW DOES SMOOTHSKIN PURE FIT WORK
SHAVE FLASH PREVENTS REGROWTH

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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
CONTRAINDICATIONS
DO NOT use SmoothSkin Pure Fit if you have very dark skin. The skin tone sensor located near the
output window of the device will determine the tone of your skin. If the skin tone sensor determines
that your skin is too dark for safe use, operation of SmoothSkin Pure Fit will be prevented.
DO NOT use SmoothSkin Pure Fit 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 SmoothSkin
Pure Fit. Wait 1 week until sunburn or tan disappears before using SmoothSkin Pure Fit.
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 Pure Fit
treatment and particularly susceptible to sunburn. Apply sunscreen (SPF 15 or greater) to the
treated area or cover the treated area with suitable clothing.
DO NOT use SmoothSkin Pure Fit 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

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areas may cause discomfort/pain or injure (burn, discolour or scar) your skin.
DO NOT se SmoothSkin Pure Fit if you have a history of skin cancer or pre-cancerous lesions
(e.g. nevi or a large number of moles).
DO NOT use on blisters and scars.
DO NOT use SmoothSkin Pure Fit if you are pregnant, lactating, as this device has not been
tested with these individuals.
DO NOT use SmoothSkin Pure Fit on dark brown or black spots such as birthmarks, moles or
warts in the area you wish to treat. Using SmoothSkin Pure Fit 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 Pure Fit 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 Pure Fit if you are under the age of 18 as this device has not been
tested on these individuals.

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WARNINGS
EYE SAFETY
SmoothSkin Pure Fit emits flashes of intense pulsed light. Direct exposure is potentially harmful to
your eyes. Take care to follow the safety precautions below.
WARNING: Possible eye injury (Potentially leading to loss of vision) or skin injury if instructions are
not followed. Read and follow the instructions.
The handset can only be activated (flashed) if the skin tone sensor (next to the treatment window)
detects a valid skin tone reading and is in full contact with the treatment area. 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). Misuse can lead to eye damage,
protect eye from exposure. DO NOT use the appliance over the eye lids or close to the eye. 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.

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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 SmoothSkin Pure Fit, as this may
expose you to dangerous electrical components.
DO NOT use if SmoothSkin Pure Fit 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 Pure Fit becomes wet, it should not be used.
DO NOT use if SmoothSkin Pure Fit 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 Pure Fit. This may damage the unit and cause it to stop working.
DO NOT attempt to activate (flash) SmoothSkin Pure Fit onto any surface other than skin.
Glass filter

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WARNING no modification of this equipment is allowed.
DO NOT position SmoothSkin Pure Fit so that it is dicult to disconnect from the mains supply.
GENERAL SAFETY
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 SmoothSkin Pure Fit.
Treating tanned skin with Intense Pulsed Light (IPL) may result in permanent Hyperpigmentation
(Darkening) or Hypopigmentation (lightening) of the treated skin.
DO NOT use on areas where you have tattoos or permanent make up.
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 SmoothSkin Pure Fit on
photosensitive skin could result in skin damage such as swelling or blisters. Seek medical advice
prior to application of the appliance as use may harm the skin. This appliance is not intended for
the treatment of medical conditions. Medical advice should be sought to address, for example,
moles, skin rash, itchy skin, skin fungus or infection, skin bumps, or skin tags.

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SmoothSkin Pure Fit should not be used over any fillers or botox.
SmoothSkin Pure Fit 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.
SmoothSkin Pure Fit should be kept out of reach of pets and pests which could damage the
device. Potential risks include reduced function and electrocution.
SmoothSkin Pure Fit 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.
SmoothSkin Pure Fit 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 Pure Fit if the filter is cracked or missing.
Ensure that SmoothSkin Pure Fit treatment window is clean and free from debris. Any debris on
or around the treatment window during operation may result in temporary skin changes such as
redness or swelling.

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WARNING: Damage of the skin may occur after prolonged or repeated surface application on
one site. Avoid over-usage which included excessive passes, stacking of pulses and/or increased
frequency of use.
WARNING: Do not override the safety mechanisms inherent to the device.
DO NOT exceed the usage specified in the treatment regime.
PRECAUTIONS
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 SmoothSkin Pure Fit on any area where you may want hair to grow back.
DO NOT use SmoothSkin Pure Fit device on man's face, jaw, or neck. The hair in a man's beard
area is too dense and using SmoothSkin Pure Fit device in these areas may result in skin injury.
SmoothSkin Pure Fit is not recommended for use on red, grey, white or blonde hair. SmoothSkin
Pure Fit is not eective on these hair colours.

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SIDE EFFECT HOW TO ASSESS & 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.
4. POTENTIAL RISKS, SIDE EFFECTS
AND SKIN REACTIONS
Use of SmoothSkin Pure Fit could result in side eects. The table below lists the known skin reactions
that may occur following treatment with SmoothSkin Pure Fit.

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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, scarring 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.
SIDE EFFECT HOW TO ASSESS & REACT
Skin redness which does not disappear within minutes
and lasts 24-48 hours.
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 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.

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• 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.
5. BENEFITS OF USING SMOOTHSKIN PURE
SmoothSkin Pure Fit is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and ecacy of SmoothSkin Pure Fit. 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 SmoothSkin Pure Fit 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;

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A total of 53 female subjects, aged between 19 and 45 years old, commenced the trial;
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 SmoothSkin Pure Fit;
Each subject received 12 weekly treatments to their chosen body location. A typical treatment consisted
of shaving the site then applying SmoothSkin Pure Fit following the same process as outlined in Section
8, 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;

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SMOOTHSKIN PURE
Number of Subjects at 6 Months Post Treatment. 50
Hair Reduction at 6 Months Post Treatment. 43.9%
Number of Subjects at 12 Months Post Treatment. 33
Hair Reduction at 12 Months Post Treatment. 36.0%
% of Subjects met success (>30% hair reduction) on all
body areas at 12 months post-treatment. Subject Success is
defined as greater than 30% hair reduction at all treatment
sites at 12 months.
66.7%
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 SmoothSkin Pure Fit to their friends.

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6. WHAT IS THE INTENDED USE OF SMOOTHSKIN
PURE FIT
INTENDED USE
SmoothSkin Pure Fit is intended for the permanent reduction in unwanted hair.
7. YOUR SUITABILITY
BODY AREAS
SmoothSkin Pure Fit is suitable for use on body hair and female facial hair below the cheek line.
SKIN COLOUR
SmoothSkin Pure Fit is suitable for use on light, medium and dark skin tones, up to and including
skin tone 5.