SMOOTHSKIN CM12-1955-01 IPL Laser Smart Permanent Hair Removal User Manual

SMOOTH SKIN CM12-1955-01 IPL Laser Smart Permanent Hair Removal

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.

THE SMOOTHSKIN PURE MINI SYSTEM

Package Contents
Inside the packaging of the SmoothSkin Pure Mini, you will find the following:

•  Handset and Power Supply
•  Mains Power Cable
•  Precision Head
•  User Manual

HOW DOES SMOOTH SKIN PURE MINI WORK
HOW DOES IPL WORK
SmoothSkin Pure Mini is designed to help break the hair cycle. Light energy is transferred through the skin’s surface and is absorbed by the melanin present in the hair shaft. That light energy is converted to heat energy (below the surface of the skin), which reduces the hairs 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.

WHAT TO EXPECT
Immediately post-treatment, you should not see any significant side effects from treatment (Refer to section 4 for more information on side effects). 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 effective. Around 4 weeks into the 12-week treatment program 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 program, you should see a significant reduction in hairs within the treated area. Any remaining hairs should be finer and lighter in color. Continued treatments as required, should maintain the reduction in unwanted hair.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

DO NOT use SmoothSkin Pure Mini 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, the operation of SmoothSkin Pure Mini will be prevented. DO NOT use SmoothSkin Pure Mini 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, discoloring or scarring if you use SmoothSkin Pure Mini. Wait 1 week until sunburn or tan disappears before using SmoothSkin Pure Mini.

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 Mini 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 Mini directly on the nipples, genitals or around the anus. These areas may have a darker skin color and/or greater hair density. Using the device in these areas may cause discomfort/pain or injure (burn, discolor or scar) your skin. DO NOT use SmoothSkin Pure Mini 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 Mini if you are pregnant, or lactating, as this device has not been tested with these individuals. DO NOT use SmoothSkin Pure Mini on dark brown or black spots such as birthmarks, moles or warts in the area you wish to treat. Using SmoothSkin Pure Mini may injure your skin or make existing conditions worse. You may experience side effects such as burns, blisters and skin color changes or scarring. DO NOT use SmoothSkin Pure Mini 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 Mini if you are under the age of 18 as this device has not been tested on these individuals.

WARNINGS
EYE SAFETY
SmoothSkin Pure Mini 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, and 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 leave the equipment unattended when it is switched on to avoid the risk of fire or burns. DO NOT try to open SmoothSkin Pure Mini, as this may expose you to dangerous electrical components.

DO NOT use if SmoothSkin Pure Mini is damaged; for example, cracked Handsets, 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 Mini becomes wet, it should not be used. WARNING: Water and electricity are a dangerous combination! To avoid the risk of electrocution,

•  do not use this equipment in wet surroundings (e.g. in the bathroom or near a shower or swimming pool);
•  do not let the water run into the appliance

DO NOT use if SmoothSkin Pure Mini becomes uncomfortably hot to the 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 Mini. This may damage the unit and cause it to stop working.

DO NOT attempt to activate (flash) SmoothSkin Pure Mini onto any surface other than the skin.

WARNING: no modification of this equipment is allowed. Pure Mini cannot be serviced.

DO NOT position SmoothSkin Pure Mini so that it is difficult to disconnect from the mains supply.

WARNING: If the wall socket used to power the equipment has poor connections, the plug of the equipment becomes hot. Make sure you plug the equipment into a properly installed wall socket to avoid the risk of fire and burns.

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 Mini. 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 makeup.

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 effect. Use of SmoothSkin Pure Mini 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.SmoothSkin Pure Mini should not be used over any fillers or botox. SmoothSkin Pure Mini 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, and strangulation from the cables.

SmoothSkin Pure Mini should be kept out of reach of pets and pests which could damage the device. Potential risks include reduced function and electrocution. SmoothSkin Pure Mini is not intended for use by persons with reduced physical, sensory or mental capabilities, or lack of experience and knowledge. Unless they have been given supervision or instruction concerning use of the equipment to avoid the risk of fire or burns. The SmoothSkin Pure Mini 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 Mini if the filter is cracked or missing. Ensure that the SmoothSkin Pure Mini 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.
DO NOT use on areas that have recently received local anesthesia.

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 Mini on any area where you may want hair to grow back. DO NOT use your SmoothSkin Pure Mini device on a man’s face, jaw, or neck. The hair in a man’s beard area is too dense, and using the SmoothSkin Pure Mini device in these areas may result in skin injury.
SmoothSkin Pure Mini is not recommended for use on red, grey, white or blonde hair. SmoothSkin Pure Mini is not effective on these hair colors.
CAUTION: Do not subject the equipment to heavy shocks to avoid risk of damage to the lamp.
CAUTION: Always unplug the appliance after use and in case of a power failure to avoid risk of damage to the equipment.

POTENTIAL RISKS, SIDE EFFECTS AND SKIN REACTIONS
Use of the SmoothSkin Pure Mini could result in side effects. The table below lists the known skin reactions that may occur following treatment with the SmoothSkin Pure Mini.

In a clinical trial of 50 subjects, each subject received 12 weekly treatments. The recorded effects were:

• Itchiness – 3 subjects experienced mild itchiness after treatment.
• Slight Redness – This was reported by 2 subjects.
• In-growing Hair – 1 subject reported experiencing 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.

BENEFITS OF USING SMOOTH SKIN PURE MINI
The SmoothSkin Pure Mini is indicated for the permanent reduction of unwanted hair. A clinical trial was performed to assess both the safety and efficacy of the SmoothSkin Pure Mini. 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 Pure Mini 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 Pure Mini;

Each subject received 12 weekly treatments to their chosen body location. A typical treatment consisted of shaving the site and then applying the SmoothSkin Pure Mini following the same process as outlined in Section 8, Step 3 of this user manual; Hair counts were used to measuring 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 difference 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;

The incidence of side effects 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 Pure Mini to their friends.

WHAT IS THE INTENDED USE OF SMOOTHSKIN PURE MINI
INTENDED USE
SmoothSkin Pure Mini is intended for the permanent reduction in unwanted hair.

INDICATIONS FOR USE
The SmoothSkin Pure Mini Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

YOUR SUITABILITY

BODY AREAS
SmoothSkin Pure Mini is suitable for use on body hair and female facial hair below the cheek line.

SKIN COLOUR
SmoothSkin Pure Mini is suitable for use on light, medium and dark skin tones up to and including skin tone 5.

SmoothSkin Pure Mini incorporates a Skin Tone Sensor that measures the color of your skin and will prevent use if your skin tone is too dark.

HAIR COLOUR
SmoothSkin Pure Mini is suitable for use on naturally black or brown hair. It may not be as effective on white, grey, blonde or red hair.

HOW TO USE SMOOTHSKIN PURE MINI
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 Pure Mini.

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.

STEP 3: TREATING WITH SMOOTH SKIN PURE MINI

• Plug the power supply into an electrical outlet using the provided power cable. You will see a sweep of white lights as the device switches on and the fan will start up.
  STANDBY MODE TIMEOUT
  When the unit is left “inactive” i.e. no buttons are pushed for 10 minutes then the unit will revert to STANDBY mode. To return to the READY mode for treatment, press the activation button.

•  Press the handset firmly against the area to be treated ensuring the skin tones sensor is in contact with the skin. If the skin tone sensor does not detect a valid skin tone, then the handset cannot be activated. When the skin tone sensor measures a valid skin tone, the lights around the activation button will illuminate WHITE to indicate the device is ready to flash.

• Press the activation button. The device will flash, and a warm sensation should be felt.

• Move the handset to the next area to be treated and repeat. The device needs to recharge between flashes. This will only take about 0.6 seconds.

• Ensure that the entire area receives treatment, and treat any stubborn areas (such as underarms) with multiple passes (running your device over the same area a maximum of 3 times).

WARNING: Make sure not to cover the vents on the device whilst treating, as this can lead to the device overheating. SmoothSkin Pure Mini is an extremely fast and powerful device, allowing you to complete a whole-body treatment in under 10 minutes.

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, and press and 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.

STEP 4: YOUR SMOOTHSKIN PURE MINI TREATMENT SCHEDULE
SmoothSkin Pure Mini should be used once a week until the desired results are achieved.

STEP 5: SWITCHING OFF THE SMOOTH SKIN PURE MINI
When the treatment is finished, SmoothSkin Pure Mini should be unplugged from the electrical outlet. Refer to section 13 for details of how best to look after your SmoothSkin Pure Mini.

THE SKIN TONE SENSOR

The skin tone sensor measures the color of your skin and sets the correct level of output power needed. If your skin is too dark for treatment with SmoothSkin Pure Mini, the skin tone sensor will detect this and prevent the unit from operating. A RED light will be shown in the power bar if your skin is too dark. The status of the skin tone sensor can be seen on the power bars located underneath the activation button on top 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.

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

This full contact with your skin ensures you get the best results, as all the light energy emitted from the device reaches the treatment area.

THE SKIN CONTACT SENSOR
SmoothSkin Pure Mini is fitted with a skin contact sensor that checks your skin contact before each flash, making sure the device is safe to operate! This makes the device compliant with the most stringent safety regulations.The skin contact sensor also ensures you get the best results from your device. The sensor must be in full contact with the treatment area in order for the device to flash. This full contact with your skin means that all the light energy emitted from the device reaches the treatment area to deliver the best results. If the device is not in full contact with the treatment area, the device will not flash and you will see a RED light. Try adjusting the positioning or twisting the device to ensure full contact is achieved. For tricky areas such as fingers and toes, we could recommend introducing the precision head

SMOOTHSKIN PURE MINI MODES
You can treat your body using either of the SmoothSkin Pure Mini comfort modes

Power Mode is the highest power setting of the device. Power Mode will deliver the best results, as it is using the maximum power output possible for your unique skin tone. This mode works particularly well on stubborn areas where the hair tends to be denser, such as underarms and bikini line.

Gentle Mode can be used if you find Power Mode uncomfortable or a little too painful. Operating the device in Gentle Mode will reduce the power output.
Power Mode is the default setting when your device is switched on. You can move into Gentle Mode by pressing the feather button, and which is indicated by a single blue light.
When in any of these modes, you can also choose whether to use Glide Method or Stamp Method.

The stamp 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. The glide 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.

THE PRECISION HEAD
SmoothSkin Pure Mini comes with a detachable precision head that is perfect for smaller, difficult-to-reach areas (like the upper lip, fingers, and toes). This has the benefit of giving you even more flexibility during each treatment. Using the precision head will slow your device down a little, so we only recommend using it when needed, to ensure you get the fastest treatment possible. The precision head simply attaches on to the front of your device via an internal magnet inside the front of the main device. This magnet holds the head in place whilst you treat the area. Simply unclip or re-attach depending on what area you’re treating.

If the precision head is damaged or missing any parts (e.g. magnet or reflector), then DO NOT use. If the precision head becomes uncomfortably hot during use, then stop treatment until it has cooled down. Follow all EYE SAFETY warnings (Section 3) when the precision head is fitted. Follow the cleaning instructions (Section 13) for the precision head.

CLEANING, MAINTENANCE, STORAGE

After treatment, always switch off SmoothSkin Pure Mini by unplugging it from 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. If necessary, the reflector and skin tone sensor can be carefully cleaned by using a slightly damp cotton bud. Store SmoothSkin Pure Mini in a cool, dry place. Make sure that the treatment window and skin tone sensor 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 – and visit the website for support details.

TRAVELLING WITH SMOOTHSKIN PURE MINI
The power supply unit of the SmoothSkin Pure Mini 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 Pure Mini will operate as normal.

TROUBLESHOOTING

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 effect on the value or operation of the appliance. The warranty becomes void if repairs are undertaken by unauthorized persons and if original SmoothSkin Pure Mini parts are not used. To obtain service within the warranty period, please visit our website: www.smoothskin.com

LABELS AND SYMBOLS
SmoothSkin Pure Mini is marked with the following symbols:

FCC Statement

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/ TV technician for help.

TECHNICAL SPECIFICATIONS

The SmoothSkin Pure Mini is a filtered broadband Intense Pulsed Light system intended for home use with the following technical specifications:

• Repetition Rate: Manually pulsed every 0.45 to 0.65 seconds. Continuous operation
•  Max Optical Output: 3 – 4J/cm2
•  Pulse Length: 0.5-1.0msec FWHM
•  Wavelength: 510-1100nm (Effective range)
• Power Line Input: 100–240V~, 50/60Hz,1.7-0.91A
•  Operating temperature: Between 5°C and 40°C
• Operating humidity: Up to 93%R.H. noncondensing
•  Operating Pressures: 700hPa to 1060hPa
•  Treatment area (spot size): 3 cm2 (30mm x 10mm)

The area directly around the treatment window is classified as the Applied Part and can reach a maximum temperature of 52degC. Ensure SmoothSkin Pure Mini is used as directed in Section 8. Transport and Storage Conditions:

• Temperature: -25°C to +70°C
• Humidity: Up to 93%R.H. noncondensing
• Pressures: 500hPa to 1060hPa

If the device has been stored at temperatures outside of the stated operating range, then please allow at least 30 minutes before use to allow the device to acclimatize. SmoothSkin Pure Mini has unlimited flashes and is intended for a single user. The Minimum expected service life is 10 years when following the recommended regimen.SmoothSkin Pure Mini complies with the latest EMC Standards and Amendments applicable to Household and Medical Devices. These are: EN 55014-1:2017, EN 55014-2:2015, EN 61000-3-2:2014, EN 61000-3-3:2013, EN/IEC 60601-1-2:2014 (Ed 4.0), FCC CRF 47 Part 15B 15.107 and 15.109, IECS-003 Issue 6.0

Safety
SmoothSkin Pure Mini complies with the latest Safety Standards and Amendments applicable to Household and Medical Devices. These are: IEC 60335-1:2010, IEC 60601-1-11:2015, IEC 60601-1:2005, IEC 60601-2-57:2011, IEC 60601-1-6:2010, IEC 62366-1:2015, IEC 62304:2006, C22.2 No 60601-1:2008 and 2014, IEC 60601-2-83:2019, IEC 60335-2-113:2016, ANSI/AAMI ES 60601-1:2015 + AMS IEC 60601-2-83 Additions SmoothSkin Pure Mini is classified as Risk Group Exempt for all hazards
Spectral Irradiance:

CE marking certifies that this appliance conforms to the following EU Directives:

•  Low Voltage Directive 2014/35/EU
•  Electromagnetic Compatibility Directive 2014/30/EU
•  Energy-Related Product Directive 2009/125/EC
•  Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS 2015/863/EU and subsequent updates

For further details contact CyDen Ltd

DISPOSAL (end of life)
This product is a medical device. 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.

References

• SmoothSkin | THE WORLD’S MOST SOPHISTICATED PERMANENT HAIR REMOVAL TECHNOLOGY

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