Hair Remval Treatment Guidelines Cutera Inc. Wrld Headquarters 3240 Bayshre Bulevard, Brisbane, CA 94005 USA Tel: +1 415 657 5500 Fax: +1 415 330 2444 www.cutera.cm Octber 2010, 19-400-5989 Rev. D
The Cutera, Inc. ClGlide Nd:YAG 1064nm Lasers are FDA-cleared fr: Hair remval Permanent hair reductin Treatment f all skin types, including tanned skin Treatment f pseudfllicultis barbae (PFB) PREREQUISITE Review Operatr Manual and Clinical CD with Laser Physics, Safety and Maintenance presentatins prir t perating the laser. LASER HAIR REMOVAL PROCESS: The purpse f the treatment is t selectively treat the hair fllicle withut causing thermal damage t the surrunding tissue. Laser light is absrbed by melanin, which is the target (chrmphre) in hair. The light is cnverted t heat. Heat damages the bulge and bulb, disabling the hair structure. D nt pluck r wax during the treatment sessin as this remves the target Hair must be brwn r black. Laser light is nt absrbed by white, gray, red r light-blnd hair. Hair has three grwing cycles which are all present at the same time. The length f hair grwth cycles vary fr different bdy parts. Anagen Phase Active phase f hair grwth when laser hair remval is effective. Hair cntains an abundance f melanin and cells are rapidly dividing. Length f this stage is variable accrding t bdy part. Catagen Transitinal phase last abut 2-3 weeks. 3% f all hairs are in this phase. Telgen Resting phase - hair falls ut in preparatin fr the develpment f new hair. Length f this stage is variable accrding t bdy part. Lcatin Resting Hairs, % Grwth Time Telgen Anagen Telgen Anagen Head Scalp 13 85 3-4 m 2-6 yr Eyebrws 90 10 3 m 4-8 wk Ear 85 15 3 m 4-8 wk Cheeks 30-50 50-70 N/A N/A Beard r chin 30 70 10 wk 1yr Mustache r upper 35 65 6wk 16wk lip Bdy Axillae 70 30 3 m 4m Trunk N/A N/A N/A N/A Pubic area 70 30 3m 4 m Arms 80 20 18 wk 13 wk Thighs 80 20 24 wk 16 wk Breasts 70 30 N/A N/A Octber 2010, 19-400-5989 Rev. D
PATIENT ASSESSMENT Cntraindicatins: Pregnancy and Skin Cancer Obtain a medical histry and signed cnsent. Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale Patient Cnsideratins including but nt limited t are belw. Current Medicatins (bth rutine and ccasinal use) Accutane d nt treat if taken in the last 6 mnths Gld Therapy may cause blue-gray disclratin Phtsensitizing drugs (Tetracyclines, etc) may have t adjust treatment parameters accrding t clinical respnse frm the test are(s) Anticagulants may increase risk f purpura r bruising Vitilig heat frm the treatment culd induce a flare-up Herpes pre-treatment with an antiviral may be indicated Wund infectins Hrmnal influence may require cntinual maintenance PCOS, male trs, etc Histry f cagulpathies Histry f kelid r hypertrphic scarring Diabetes may impede wund healing D nt treat dysplastic nevi r questinable pigmented lesins. Online Melanma resurces include (www.aad.rg), (www.cancer.rg) Aviding Cmplicatins: Always treat utside the rbital rim f the eye aiming the beam away frm the rbit D nt treat ver r clse t tatts r permanent make-up N self-tanners fr at least 2-4 weeks prir t treatment All traces f make-up must be remved The Nd:YAG can crack a tth if teeth are expsed. Mist gauze may be placed between the lips and teeth. Implants Avid metal implants in thin skinned areas; clavicle, jaw, rbit Ask abut surgical implants and threads D nt treat ver Pacemaker implant Reactin t fillers unknwn Ensure the cpper tip is in full cntact with the skin during the entire treatment. Ice shuld NEVER be applied t a suspected burn as it may cause unwanted side effects. Frzen gel packs r cl cmpresses can be used. Octber 2010, 19-400-5989 Rev. D
TREATMENT PARAMETERS The fllwing parameters are prvided as a guide and are based n practitiner feedback. Fluence is the energy measured in J/cm2. Pulse Width r Duratin is the length f each laser pulse measured in millisecnds (ms). Repetitin Rate is the number f pulses per secnd measured in Hz. Selecting Parameters Start with cnservative settings fr early treatments Observe laser-tissue interactin and clinical respnse t determine apprpriate settings fr each patient Re-evaluate patient prir t each treatment t determine sun expsure Parameters may need t be decreased as sun expsure increases melanin cntent Fitzpatrick Skin Type Fluence Pulse Duratin Spt Size I-II 50-65 J/cm² 10-20 ms 10 mm III 45-60 J/cm² 15-25 ms 10 mm IV 40-55 J/cm² 15-30 ms 10 mm V 35-50 J/cm² 25-35 ms 10 mm VI 20-45 J/cm² 30-60 ms 10 mm Fluence and Pulse Duratin are determined by skin type, hair clr, hair thickness and hair density. 1. Determine Skin Type a. Use Fitzpatrick Skin typing chart prvided t determine apprpriate settings b. Cautin - when treating darker skin types, additinal pre-cling and slw repetitin rate (Hz) are required t prtect the epidermis. 2. Determine Hair Clr a. Darker Hair Clr = Lwer Fluence, Lnger Pulse Duratin b. Lighter Hair Clr = Higher Fluence, Shrter Pulse Duratin 3. Determine Hair Thickness a. Carse Hair = Lwer Fluence, Lnger Pulse Duratin b. Finer Hair = Higher Fluence, Shrter Pulse Duratin 4. Determine Hair Density a. Dense Hair = Lwer Fluence, Lnger Pulse Duratin. i. Dense hair requires lnger pre-cling and slwer repetitin rate ii. Hair density shuld decrease with subsequent treatments 1. Parameters may need t be adjusted as density decreases, skin type permitting Octber 2010, 19-400-5989 Rev. D
OPERATING THE SYSTEM The laser system shuld nly be perated by qualified practitiners wh have received apprpriate training and have thrughly read the peratr manual. Select the 10 mm spt size by rtating the ring n the handpiece Select apprpriate parameters. The last used parameters will be displayed when restarting the laser. Navigatin nly prvides the range f treatment parameters n the screen. The peratr is required t chse the crrect parameters. Cnsult peratr manual fr Navigatin infrmatin. Laser shuld be placed in standby when nt actively in use Fluence Pulse Width Repetitin Rate Standby Mde Display Screen fr ClGlide Ready Mde Display Screen fr Xe PREPPING THE PATIENT Clean skin remving all make-up and/r tpical anesthetic. Pre-treatment phtgraphs shuld be taken prir t the initial treatment fr future reference. Shave the treatment area prir t each treatment. A white eyeliner pencil can be used t divide the treatment area int smaller grids. Dark skin and/r areas with dense hair may be pre-cled with frzen gel packs fr epidermal cling and t increase patient cmfrt. Safety eyewear must be wrn by ALL peple in the treatment rm. Check the wavelength and ptical density ( 6.1 @ 1064 nm) marked n all peratr gggles Operatr Gggles Patient Gggles Octber 2010, 19-400-5989 Rev. D
TREATMENT TECHNIQUE Treatment f a test area is recmmended bserving tissue reactin. Ptential adverse reactins may take 24-48 hurs t appear. Apply a thin layer f clear gel (such as ultrasund gel) fr increased epidermal prtectin and easy gliding f the handpiece t determine placement f adjacent rws. Place the cpper cling prtin f handpiece n the treatment area t pre-cl the skin. The epidermis must be pre-cled with the back f the handpiece t prevent epidermal damage Pull the handpiece back at least 1 full spt size t deliver the laser pulse. Glide the handpiece in the same directin t deliver subsequent laser pulses. Ensure that the cling prtin f the handpiece remains in cntact with the skin at all times, especially ver curves. Laser pulses shuld nly be delivered t areas that have been pre-cled. Darker skin r areas f dense hair will require lnger pre-cling. Pulses shuld be spaced with a 10-20% verlap between adjacent pulses. Avid verlap n darker skin D nt stack pulses r retreat an area within a single visit. Repetitin Rate shuld be adjusted accrding t patient cmfrt, skin type, hair density and user experience. Lw r n Repetitin Rate is recmmended fr dark skin and n curved areas (jaw). Watch fr signs f damage (blanching r gray clratin). If damage is seen, stp the treatment and apply a cl cmpress. Evaluate area fr pssible cmplicatins and wund care. POST-OPERATIVE CARE Erythema and perifllicular edema are cmmn but nt required fr a successful treatment. Hair may take up t 2 weeks t fall ut. Avid heat fr 24 hurs ht tubs, saunas, etc. If a blister r crusting develps, treat as a wund. D nt ice a suspected burn D nt wax r pluck between treatments. Hair remval requires a series f treatments. The number f treatments depends n bdy lcatin and type f hair. Average number f treatments is 5-8. Average treatment interval is 6-12 weeks depending n the bdy part. The laser will nly target hair in the active grwth phase and there is n advantage t scheduling visits clser tgether Back, Trs, Legs may have better utcme with lnger treatment intervals Octber 2010, 19-400-5989 Rev. D
LASER CARE Turn the unit ff r place in standby. Disinfect the entire handpiece and crd between patients with a germicidal dispsable wipe, such as Sani- Clth. The laser windw must be cleaned after each treatment t avid damage. Use a small amunt f ptical grade acetne and a wden cttn tipped applicatr t clean the windw. D nt use Q-Tips as they cntain an adhesive that disslves when in cntact with acetne. The windw will need t be cleaned peridically during the treatment if hair is ejected. If the windw is damaged, a replacement must be purchased. Clean the bttm f the laser (air intake) See the peratr manual r the System Maintenance Presentatin fr additinal infrmatin n care f the laser. Octber 2010, 19-400-5989 Rev. D
Fitzpatrick Classificatin Questinnaire SCORE 0 1 2 3 4 What is the natural clr f yur hair? Sandy red Blnd Chestnut, dark blnd Dark brwn Black What is the eye clr? Light blue, Gray, Green Blue, Gray, Green Blue Dark Brwn Brwnish Black What is the clr f sun unexpsed skin areas? Reddish Very pale Pale with beige tint Light brwn Dark brwn Hw many freckles n unexpsed skin areas? What happens when yu are in the sun TOO lng withut sunblck? Many Several Few Incidental Nne Painful redness, blistering, peeling Blistering fllwed by peeling Burns, smetimes fllwed by peeling Rarely burns Never had a prblem Hw well d yu turn brwn? Hardly r nt at all Light clr tan Reasnable tan Tan very easily Turn dark very quickly D yu turn brwn within ne day f sun expsure? Hw des yur face respnd t the sun? When did yu last expse yurself t the sun r artificial sun treatments? D yu expse the area t be treated t the sun? Never Seldm Smetimes Often Always Very sensitive Sensitive Nrmal Mre than 3 mnths ag 2-3 mnth ag 1-2 mnths ag Very resistant Less than 1 mnth ag Never had a prblem Less than 2 weeks ag Never Hardly ever Smetimes Often Always TOTAL 00-07 pints = Skin type I 08-16 pints = Skin type II 17-25 pints = Skin type III 25-30 pints = Skin type IV 30-40 pints = Skin type V & VI Octber 2010, 19-400-5989 Rev. D