Smoothskin bare fit IPL User manual

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IPL USER GUIDE
10 minutes and voilà!

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ENGLISH Page 4
FRANÇAIS Page 32
NEDERLANDS Paginanummer 60
TÜRK SayfaNumarası 89

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CONTENTS
WELCOME TO
SMOOTHSKIN BARE 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 BARE FIT SYSTEM 5
2. HOW DOES SMOOTHSKIN BARE FIT WORK 6
3. IMPORTANT SAFETY INFORMATION 7
4. POTENTIAL RISKS, SIDE EFFECTS AND SKIN
REACTIONS 15
5. BENEFITS OF USING THE SMOOTHSKIN
BARE FIT 17
6. WHAT IS THE INTENDED USE OF
SMOOTHSKIN BARE FIT 19
7. YOUR SUITABILITY 19
8. HOW TO USE SMOOTHSKIN BARE FIT 20
9. THE SKIN CONTACT SENSOR 24
10. THE PRECISION HEAD 25
11. CLEANING, MAINTENANCE AND STORAGE 27
12. TRAVELLING WITH SMOOTHSKIN BARE FIT 27
13. TROUBLESHOOTING 28
14. WARRANTY 28
15. LABELS AND SYMBOLS 29
16. TECHINCAL SPECIFICATIONS 30

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Package Contents
Inside the packaging of the SmoothSkin Fit you will find the following:
• Handset and Power Supply
• Mains Power Cable
• Precision Head
• User Manual
1. THE SMOOTHSKIN BARE FIT SYSTEM
Precision Head
Skin Tone Sensor
Activation Button
Umbilical Cable
Power Supply
Power Cable
Treatment Window

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2. HOW DOES SMOOTHSKIN BARE FIT WORK
HOW DOES IPL WORK
SmoothSkin Bare Fit is designed to help break the hair cycle. Light energy is transferred through the
skin’s surface and is absorbed by melanin present in the hair shaft. That light energy is converted to
heat energy (below the surface of the skin), which stops the hairs from growing back. Now you can
look forward to seeing the treated hairs naturally fall out over the course of a few days to 1-2 weeks.
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SHAVE FLASH PREVENTS REGROWTH

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3. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DO NOT use SmoothSkin Bare 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 Bare Fit will be
prevented.
DO NOT use SmoothSkin Bare 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 Bare Fit. Wait 1
week until sunburn or tan disappears before using SmoothSkin Bare Fit.

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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 Bare 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 Bare 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 areas
may cause discomfort/pain or injure (burn, discolour or scar) your skin.
DO NOT use SmoothSkin Bare 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 Bare Fit if you are pregnant, lactating, as this device has not been
tested with these individuals.
DO NOT use SmoothSkin Bare Fit on dark brown or black spots such as birthmarks, moles or
warts in the area you wish to treat. Using SmoothSkin Bare 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.

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DO NOT use SmoothSkin Bare 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 Bare Fit if you are under the age of 18 as this device has not been
tested on these individuals.
WARNINGS
EYE SAFETY
SmoothSkin Bare 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 snesor (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.

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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.
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 Bare Fit, as this may expose you to dangerous electrical
components.
DO NOT use if SmoothSkin Bare 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 Bare Fit becomes wet, it should not be used.
DO NOT use if SmoothSkin Bare Fit becomes uncomfortably hot to touch. This may
indicate that the unit is damaged.

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DO NOT use a power supply or other component, other than those provided for use with
SmoothSkin Bare Fit. This may damage the unit and cause it to stop working.
DO NOT attempt to activate (flash) SmoothSkin Bare Fit onto any surface other than skin.
WARNING: no modification of this equipment is allowed.
DO NOT position SmoothSkin Bare 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 Bare 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 Bare Fit on

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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.
SmoothSkin Bare Fit should not be used over any fillers or botox.
SmoothSkin Bare 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, choking from the removable front.
SmoothSkin Bare Fit should be kept out of reach of pets and pests which could damage the
device. Potential risks include reduced function and electrocution.
SmoothSkin Bare 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.

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The SmoothSkin Bare 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 Bare Fit if the filter is cracked or missing.
Ensure that SmoothSkin Bare 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.
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.

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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 Bare Fit on any area where you may want hair to grow back.
DO NOT use your SmoothSkin Bare Fit device on man's face, jaw, or neck. The hair in a man's
beard area is too dense, and using SmoothSkin Bare Fit device in these areas may result in skin
injury.
SmoothSkin Bare Fit is not recommended for use on red, grey, white or blonde hair. SmoothSkin
Bare Fit is not eective on these hair colours.

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4. POTENTIAL RISKS, SIDE EFFECTS AND SKIN
REACTIONS
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
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.
Use of the SmoothSkin Bare Fit could result in side eects. The table below lists the known skin reactions that may
occur following treatment with the SmoothSkin Bare 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.
In a clinical trial of 50 subjects, each subject received 12 weekly treatments. The recorded eects
were:
• Itchiness – 3 subjects experienced mild itchiness after treatment.
• Slight Redness – This was reported by 2 subjects.
• Mild Stinging Sensation – 5 subjects reported mild discomfort following treatment.
• In-growing Hair – 1 subject reported experiencing an in-growing hair following treatment.
• Follicle Redness – 1 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 BARE FIT
The SmoothSkin Bare Fit 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 Bare 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 the SmoothSkin Bare 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;
• 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 the SmoothSkin Bare Fit;
• Each subject received 12 weekly treatments to their chosen body location. A typical treatment
consisted of shaving the site then applying the SmoothSkin Bare 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;

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• 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;
SmoothSkin Bare Fit
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 the SmoothSkin Bare Fit to their friends.

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6. WHAT IS THE INTENDED USE OF SMOOTHSKIN
BARE FIT
INTENDED USE
SmoothSkin Bare Fit is intended for the permanent reduction in unwanted hair.
7. YOUR SUITABILITY
BODY AREAS
SmoothSkin Bare Fit is suitable for use on body hair and female facial
hair below the cheekline.
SKIN COLOUR
SmoothSkin Bare Fit is suitable for use on light, medium and dark skin
tones up to and including skin tone 5. SmoothSkin Bare Fit incorporates
a Skin Tone Sensor that measures the colour of your skin and will
prevent use if your skin tone is too dark.
HAIR COLOUR
SmoothSkin Bare Fit is suitable for use on naturally black or brown hair.
It may not be as eective on white, grey, blonde or red hair.

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Always perform a patch test on each new treatment area
Observe for adverse
events
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24 HOURS
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8. HOW TO USE SMOOTHSKIN BARE FIT
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 as this may cause injury.
This also prevents debris from covering the front of your device.
Cleanse the treatment area and pat dry. Remember, don’t use any gels or creams with this device!
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 Bare Fit. 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.