Treatment Guidelines June 2013, D0028 Rev. F

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1 Treatment Guidelines June 2013, D0028 Rev. F Cutera Inc. Wrld Headquarters 3240 Bayshre Bulevard, Brisbane, CA USA Tel: Fax: June 2010, D0028 Rev. F

2 Laser Genesis is a delivery mde fr Nd:YAG (1064nm) lasers with a patented pulse structure designed fr safe and effective treatment n all skin types and tanned skin. It can be safely used n all bdy parts (excluding the eye and surrunding area). Cmmn indicatins include: Treatment f Wrinkles Rsacea / Diffuse Redness Scar Reductin: including reductin in hypertrphic and kelid scars Pikilderma f Civatte PREREQUISITE The Laser Genesis handpiece shuld nly be perated by qualified practitiners wh have received apprpriate training and have thrughly read the laser system peratr manual (shipped with laser) PATIENT ASSESSMENT This is a medical device. It is imprtant t btain a cmplete medical histry and signed infrmed cnsent. Cnsult the Operatr Manual fr additinal infrmatin, including expected transient events and pssible adverse events. Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale Cntraindicatins: Pregnancy and patients underging treatment fr skin cancer 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 Anticagulants may increase risk f purpura r bruising Vitilig may cause de-pigmentatin Herpes pre-treatment with an antiviral may be indicated Open wunds Diabetes may impede wund healing Neurpathies decreased sensatin r numbness Treatment area shuld be evaluated fr numbness r decreased sensatin Histry f kelid r hypertrphic scarring Tan skin and darker skin types have an increased risk f cmplicatins and/r pigmentary issues. Parameters may need t be adjusted t help prevent adverse events. N self-tanners, spray tans, etc. fr at least 2-4 weeks prir t treatment D nt treat questinable skin lesins. These shuld be evaluated by a specialist prir t treatment. Online Melanma resurces include ( ( 2

3 Aviding Cmplicatins Tpical anesthetics shuld nt be used as patient feedback is required Darker skin types have an increased risk f cmplicatins and/r pigmentary issues 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 All traces f make-up must be remved Pssible hair lss may ccur N self-tanners fr at least 2-4 weeks prir t treatment. The Nd:YAG may harm a tth if 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 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. 3

4 SELECTING TREATMENT PARAMETERS Always start with the least aggressive settings. Observe laser-tissue interactin and clinical respnse t determine apprpriate settings fr each patient. Adjustments shuld be made based n epidermal respnse. Size Large Area (face, neck, r chest) Small Area (including scars) Skin Type Recmmended Treatment Guidelines Fluence Pulse Duratin Repetitin Rate I-IV J/cm ms 7 10 Hz 4-6 V-VI 8-14 J/cm ms 5 8 Hz 4-6 # Tx # f Pulses 8,000 12,000 I-IV J/cm ms 4 8 Hz ,000 V-VI 8-12 J/cm ms 4 8 Hz 1-6 Depending n the size f the area Start with lw fluence and slw repetitin rate t bserve laser-tissue interactin. Adjust t patient tlerance Darker skin types, bny areas, r areas with a higher cncentratin f target, dense hair r recent sun expsure may require less pulses, lwer fluences and/r slwer repetitin rates 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 5mm 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 Display Screen fr Vantage Fluence Pulse Width Repetitin Rate Standby Mde Ready Mde Display Screen fr Xe 4

5 PREPARING 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. Treatment f a test area shuld be perfrmed and bserved prir t the treatment. Tpical anesthetic shuld nt be used as patient feedback is required Safety eyewear must be wrn by ALL peple in the treatment rm. Check the wavelength and ptical density 1064nm) marked n all peratr gggles. TREATMENT TECHNIQUE Operatr Gggles Patient Gggles Gel is nt used Tpical anesthetics shuld nt be used as patient feedback is required T imprve treatment unifrmity and utcmes, divide the face int multiple regins (example shwn). Frehead divide in half Pericular D NOT treat upper lids Cheeks divide int 2-3 sectins Periral areas Hld the handpiece apprximately 1-2 cm (abut inch) frm the skin s surface, The handpiece shuld be cntinuusly mved in a zig-zag mtin with even distributin f pulses Mvement shuld be cntrlled and speed adjusted accrding t the patient s tlerance Treat each regin t pint f discmfrt and erythema (example shwn), then mve t adjacent regins using multiple passes The laser emits a distinct water drp sund every 100 and 1,000 pulses. Music plays every 5,000 pulses. Dark skin, scars r ht spts may need cling r a shrt break during treatment Scars Check with surgen befre starting treatment n fresh scars Always include the tissue surrunding the scar bserving fr erythema f the scar as endpint Scar will absrb mre energy than surrunding skin D nt rely n heat in surrunding skin as an endpint Decreased sensatin f scar increases risk f burn Several treatments may be necessary Extreme cautin shuld be used when treating near the eye. Patient eye prtectin is required t avid cular damage. The laser beam shuld ALWAYS be pinted away frm the eye and nly applied t the skin utside f the rbital rim. Distance frm the rbit can ften be increased by pulling the skin away frm the eye fr treatment. POST-TREATMENT CARE Erythema is cmmn and reslves with time. If a blister r crusting develps, treat as a wund. 5

6 Fitzpatrick Classificatin Questinnaire SCORE 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? Many Several Few Incidental Nne What happens when yu are in the sun TOO lng withut sunblck? 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? Never Seldm Smetimes Often Always Hw des yur face respnd t the sun? Very sensitive Sensitive Nrmal Very resistant Never had a prblem When did yu last expse yurself t the sun r artificial sun treatments? Mre than 3 mnths ag 2-3 mnth ag 1-2 mnths ag Less than 1 mnth ag Less than 2 weeks ag D yu expse the area t be treated t the sun? Never Hardly ever Smetimes Often Always TOTAL pints = Skin type I pints = Skin type II pints = Skin type III pints = Skin type IV pints = Skin type V & VI 6

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