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11

Pigment Changes

Silk’n™ targets the hair shaft, in particular the pigmented cells in the hair follicle and the hair follicle itself. Nevertheless there is risk of temporary 
hyperpigmentation (increased pigment or brown discoloration) or hypopigmentation (whitening) to the surrounding skin.  This risk of changes in skin 
pigmentation is higher for people with darker skin tones. 
Usually discoloration or changes to skin pigment are temporary and permanent hyperpigmentation or hypopigmentation rarely occur.

Excessive Redness and Swelling

In rare cases treated skin may become very red and swollen.  This is more common in sensitive areas of the body. The redness and swelling should subside within 
2 to 7 days and should be treated with frequent applications of ice. Gentle cleansing is OK, but one should avoid exposure to sun.

Infection

Infection of the skin is exceedingly rare but is still a possible risk following a skin burn or wound caused by Silk’n™.

Bruising

Very rarely, use of Silk’n™ may cause blue-purple bruising that can last 5 to 10 days.  As the bruising fades, there may be a rust-brown discoloration 
of the skin (hyperpigmentation) that can be permanent.

3.1.   How does light remove hair?

Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. In order to achieve 
such thermal effect the hair shaft needs to selectively absorb light energy and transform it into heat. This selectivity is achieved when optical energy that 
is delivered to the tissue is mostly absorbed by hair shaft pigment, while the skin and the surrounding tissue stays cool. Melanin is the pigment in the 
hair shaft that is responsible for the absorption of the light, which generates the heat that eventually disables hair growth.  Therefore the more melanin 
present in the hair (i.e. the darker the hair) the more light that can be absorbed and the more effective light can be at removing hair.

 After Silk’n™ Application

During Silk’n™ pulse

 Before Silk’n

™ 

Application

3. Long Term Hair Removal the Silk’n

TM  

Way

3.2.  How does the hair growth cycle impact light-based hair removal?

Every hair in our body goes through the three phases of the hair growth cycle: Anagen, Catagen and Telogen.  These phases have an important impact 
on how the process of light-based hair removal works.
Anagen is the hair growth phase while Catagen and Telogen, both are resting phases.
The time it takes to complete a full hair growth cycle varies from person to person and the location of the hair on the body, but is typically 18-24 months. 

Содержание Silk'n

Страница 1: ...1 INSTRUCTIONS FOR USE ...

Страница 2: ...or neck Do not use Silk n on tanned skin or after recent sun exposure Such use can cause serious burns or skin injury Do not use Silk n on naturally dark skin Please read all warnings and safety precautions before use and strictly follow them when using Silk n Note Silk n may not be effective on naturally white and light hair Not Safe ...

Страница 3: ...be reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Home Skinovations Ltd Data is subject to change without notification Home Skinovations Ltd has patents and pending patent applications trademarks copyrights or other intellectual property rights covering subject matter in this document The furnishing of this d...

Страница 4: ...tions How to use Silk n Safely p 8 2 5 Reducing the risk of injury p 9 2 6 Possible Side Effects using Silk n p 10 3 LongTerm Hair Removal the Silk n Way p 11 3 1 How does light remove hair p 11 3 2 How does the hair growth cycle impact light based hair removal p 11 3 3 What is different about Home Pulsed Light technology in Silk n p 12 3 4 Plan your Silk n hair removal for best results p 12 Table...

Страница 5: ...with Silk n p 15 4 6 After treating with Silk n p 15 5 Maintenance of Silk n p 16 5 1 Cleaning Silk n p 16 5 2 Replacing the Lamp Cartridge p 16 6 Troubleshooting p 17 6 1 My Silk n does not start p 17 6 2 A light pulse is not emitted when I press the Pulse Switch p 17 7 Customer Service p 17 8 Frequently Asked Questions p 18 9 Specifications p 19 10 Labeling p 20 EC Declaration of Conformity p 22...

Страница 6: ...ibutes to your overall safety Silk n protects your eyes The Silk n APPLICATOR has a built in safety feature for eye protection It has been designed so that a light pulse can not be emitted when the APPLICATOR is facing open air The safety switch is activated only when the APPLICATOR TIP is in full contact with the tissue and pressed Silk n protects your skin The 2X3cm OPTICAL LENS through which pu...

Страница 7: ...ose which don t seem to tan quickly The presence of large quantities of Melanin exposes the skin to higher risk when using Silk n Using Silk n on skin that has been recently exposed to sunlight can result in adverse effects such as burns blisters and skin color changes hyper or hypo pigmentation Using Silk n to remove facial hair may cause serious eye injury and may stimulate facial hair growth DO...

Страница 8: ...sing lactating If you were exposed to strong sunlight or an artificial tanning machine during the past 28 days If you have a tattoo or permanent makeup on the area to be treated If you have dark brown or black spots such as large freckles birth marks moles or warts on the area to be treated If you have eczema psoriasis lesions open wounds or active infections such as cold sore in the area to be tr...

Страница 9: ...ion Remove the Silk n APPLICATOR from the skin if either the skin or the APPLICATOR is too hot Never use flammable liquids such as alcohol including perfumes sanitizers or other applications containing alcohol or acetone to clean the skin before using Silk n Use of Silk n may cause temporary pigmentation changes See Possible Side Effects below Keep this device out of the reach of children Do not u...

Страница 10: ...d means that either you should not continue to use Silk n because you are unable to tolerate the hair removal application or that the energy level setting is too high Skin Redness Your skin may become red right after using Silk n or within 24 hours of using Silk n Redness generally clears up within 24 hours See your doctor if redness does not go away within 2 to 3 days Increased Sensitivity of the...

Страница 11: ...t remove hair Light based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth In order to achieve such thermal effect the hair shaft needs to selectively absorb light energy and transform it into heat This selectivity is achieved when optical energy that is delivered to the tissue is mostly absorbed by hair shaft pigment while th...

Страница 12: ...al plan during a full hair growth cycle The first 3 4 hair removal sessions with Silk n will be approximately two weeks apart Hair removal sessions 5 7 with Silk n will be approximately four weeks apart After that you will typically use Silk n again from time to time if and when needed until long term results are achieved Typical maintenance with Silk n after achieving long term hair removal Due t...

Страница 13: ... Indicator Lights Energy Level Settings Buttons Energy Level Indicator Lights Ready Indicator Lights Audio ON OFF switch Cartridge 90 Usage Indicator Light Cartridge 100 Usage Indicator Light SystemWarning Indicator Light 1 6 5 4 2 8 7 9 11 12 15 14 3 13 10 4 2 Package contents Upon opening the Silk n package you will find the following parts Silk n BASE UNIT and APPLICATOR An AC cord A second DIS...

Страница 14: ...ses at the lowest energy level and the next 200 pulses at up to level 3 To cancel these safety settings press and hold the and ENERGY LEVEL SETTING BUTTONS simultaneously until you hear 2 consecutive beep sounds To restore these safety settings press and hold the and ENERGY LEVEL SETTING BUTTONS simultaneously until you hear 3 consecutive beep sounds 4 Using firm pressure apply the APPLICATOR TIP ...

Страница 15: ...of HPL light is activated it is normal to hear a subtle pop sound simultaneously with the flash of light Moderate Pressure of the APPLICATOR This is necessary and helpful for placement of adjacent pulses of light and is part of the unique safety feature of Silk n A Sensation of Warmth and Tingling During each pulse of light it is normal to feel a mild sensation of warmth and tingling from the ligh...

Страница 16: ...0 USAGE INDICATOR LIGHT on the CONTROL PANEL will be activated indicating that the DISPOSABLE LAMP CARTRIDGE should soon be replaced Once all 750 pulses in a DISPOSABLE LAMP CARTRIDGE have been used the CARTRIDGE 100 USAGE INDICATOR LIGHT will be activated indicating that further pulses can not be emitted In order to continue the hair removal session it will now be necessary to replace the DISPOSA...

Страница 17: ... n does not start Make sure the power cord is properly connected to the Silk n device Make sure the power cord is plugged into an electrical outlet on the wall 6 Troubleshooting Do not attempt to open or repair your Silk n device Only authorized Silk n repair centers are permitted to perform repairs Opening Silk n may expose you to dangerous electrical components and to pulsed light energy either ...

Страница 18: ... unwanted hair by selectively addressing hair pigment Varied quantities of pigment also exist in the surrounding tissue of skin The quantity of pigment in a particular person s skin which is manifested by their skin complexion determines the degree of risk they are exposed to using Silk n Treating dark skin with Silk n can result in adverse effects such as burns blisters and skin color changes hyp...

Страница 19: ... Silk n after unprotected exposure to the sun However if there is ever any uncertainty about sun exposure please contact your physician or Home Skinovations customer support 17 Should I do anything before using Silk n Before any Silk n session it is important to avoid sun exposure on the treated area for at least four weeks A high level UV Sun Screen SPF 50 will help as will clothing covering the ...

Страница 20: ...20 10 Labeling ...

Страница 21: ...ectronic Equipment CE Mark Follow operating instructions This device comply with Part 15 of the FCC Federal Communications Commission Rules Degree of protection against ingress water ordinary This device is not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide ...

Страница 22: ...rmitywiththeessentialrequirementsofCouncilDirective 89 336 EEC and 73 23 EEC amended by Directives 93 68 EEC This declaration is based on the full compliance of the products with the following European standards EN 61000 3 2 2000 A2 2005 EN 61000 3 3 1995 A1 2001 EN 55014 1 2000 A2 2002 EN55014 2 1997 A1 2001 EN 60335 1 2002 A1 2004 A12 2006 EN 60335 2 23 2003 EN 60335 2 27 2003 EN 50364 2001 Elec...

Страница 23: ...RAEL Tel 972 4 9097470 Fax 972 4 9097471 Dr Amir Waldman VP Regulatory Clinical Affairs Yokneam February 4 2008 Gabi Lavi General Manager Yokneam February 4 2008 Authorized Representative Home Skinovations GMBH Dr Kurt Huber Str 6 D 82031 Grunwald GERMANY Tel 49 89 64919530 Fax 49 89 64919531 ...

Страница 24: ...m Silk n is a physician recommended and innovative light based device for hair removal in the privacy of your home Safe easy to use and cost effective Silk n achieves marked clinical results while offering personal convenience Silk n utilizes the highly sophisticated and new Home Pulsed Light HPL technology developed by Home Skinovations Ltd ...

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