Treatment Guidelines

Transcription

1 Treatment Guidelines Cutera Inc. World Headquarters 3240 Bayshore Boulevard, Brisbane, CA USA Tel: Fax: D1544 Rev E, May

2 The following information is supplemental to the excel HR Operator Manual. Refer to the Operator Manual for detailed information, including important cautions and warnings, prior to using the laser system. USING THESE TREATMENT GUIDELINES These treatment guidelines are based on physician feedback and are provided as a guide only. They are not designed to be a substitute for clinical training. The excel HR should only be operated by qualified practitioners who have received appropriate training and have thoroughly reviewed the Operator Manual that shipped with the system. When using the laser, always observe laser-tissue interaction and clinical endpoints to determine appropriate settings. INDICATIONS FOR USE The 755 nm and 1064 nm wavelengths are indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9 and 12 months after the end of a treatment regime. The Cutera excel HR is also cleared for the treatment of: Benign pigmented lesions Benign cutaneous lesions Benign vascular lesions Wrinkles Refer to the Operator Manual for a complete list of indications for use. CONTRAINDICATIONS Pregnant patients Patients undergoing treatment for skin cancer Refer to the Operator Manual for a complete list of contraindications, warnings, and precautions. WARNINGS Do not treat over dysplastic nevi or questionable pigmented lesions. o Online Melanoma resources include and Do not treat over or close to: o tattoos or permanent make-up o metal or electronic implants 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. PRECAUTIONS Do not treat patients who have taken Accutane in the past 6 months. Anticoagulants may increase the risk of purpura or bruising. Gold therapy may cause blue-gray discoloration. Vitiligo may cause de-pigmentation. Pre-treatment with an antiviral may be indicated for patients with herpes. Use caution when treating patients with a history of keloids or hypertrophic scarring. Patients with hormone disorders (e.g., Polycystic Ovarian Syndrome) may not see effective hair reduction. Do not treat over open wounds. Only treat over known benign lesions. EXPECTED TRANSIENT EVENTS AND POSSIBLE ADVERSE EFFECTS Erythema, edema and purpura may occur following treatment and typically resolve with time. Hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting or blistering may occur, some of which may result in scarring. Temporary or permanent gray hair (leukotrichia) may develop. Undesired hair loss in hair-bearing areas may result from treatment of vascular and benign pigmented lesions. D1544 Rev E, May

3 Sun exposure/tanning beds/artificial tanning may increase the risk of unwanted side effects and adverse events. Red rash/bumps may occur. Hemosiderin staining may occur. Textural changes/cutaneous indentations may occur. Darker skin types have an increased risk of complications and/or pigmentary issues. PATIENT ASSESSMENT Obtain a complete medical history and signed informed consent prior to treatment. Determine skin type to help guide treatment parameter selection. AVOIDING COMPLICATIONS Use extreme caution when treating near the eye. o Always treat outside the orbital rim of the eye aiming the beam away from the orbit. o Always use patient eye protection. o Point the treatment window away from the eye and apply to the skin outside of the orbital rim. Sun exposure, tanning beds, and artificial tanning may increase the risk of side effects and adverse events. o Patients should avoid sun exposure, including tanning beds, and artificial tanning (spray tans, tanning lotions, etc.) for at least 4 weeks prior to treatment. o Patients should have no residual sun tan (sun/tanning booth) prior to treatment. o Sun tan may be faded, but keep in mind that any residual tan is a target for the laser. Remove all traces of make-up prior to treatment. Keep top side of sapphire window clear of gel; wipe periodically with 4x4 gauze if necessary. o Excessive top side gel may affect laser beam output, possibly leading to adverse events. Pre and post cooling can help reduce the risk of complications. Reaction to treating over fillers and toxins is unknown. Reaction to treating over superficial cosmetic implants or threads is unknown. Patients should avoid treatments that may irritate the skin (depilatories, harsh chemicals, etc.) for 1-2 weeks prior to treatment. Pigmented lesions may darken. Allow these to slough off naturally. SAFETY EYEWEAR Safety eyewear appropriate for 755 nm and 1064 nm must be worn by ALL people in treatment room. The laser ships with opaque stainless steel patient goggles as well as operator goggles. Check the wavelength and optical density (OD 755 nm and OD 1064 nm) marked on all operator goggles. Apply wet gauze over the eye lid when using metal eye shields. CAUTION: Metal eye shields may increase in heat and burn the patient if a protective layer of gauze is not used. Operator Goggles Patient Goggles D1544 Rev E, May

4 EXCEL HR USER INTERFACE Fluence is the energy measured in J/cm 2. The lighter the chromophore or target, the more energy (fluence) is needed. Press the Up/Down arrows to adjust. 2. Pulse Duration is the length of each pulse measured in milliseconds (ms). Pulse duration is automatically set to 3 ms when using the 755 nm wavelength but is adjustable when using the 1064 nm wavelength. 3. Repetition Rate is the number of pulses per second measured in Hz with foot pedal depressed. Press the Up/Down arrows to adjust. 4. Temperature can be adjusted to 4 C, 8 C, 12 C, 16 C, or 20 C. 5. Memory Button saves 2 different settings per wavelength for common indications. 6. Number of Pulses is displayed. Press the reset button to reset. 7. Spot Size is adjustable: 5 18 mm for the 755 nm wavelengths; 3 18 mm for the 1064 nm wavelength. 8. Standby Button is the yellow icon that is selected to go into Standby Mode. The handpiece cannot be fired when in Standby Mode. Screen background is yellow when in Standby Mode. 9. Ready Button is the green icon that is selected to go into Ready Mode to begin treatment. Press the foot pedal to start the pulse after the flute sound indicates system is ready. Screen background is green when in Ready Mode. NOTE: Treatment parameters are interrelated. Therefore, not all parameter combinations are simultaneously available. If you attempt to select a treatment setting that is not available, the system emits a distinct audible tone. Changing one or more of the other parameters may enable you to select the desired treatment setting. D1544 Rev E, May

5 HANDPIECE CARE It is very important to ensure that the handpiece is inspected and cleaned throughout the treatment to prevent any damage to the treatment window or handpiece electrical components. Inspect the handpiece to ensure the treatment window and metal surfaces are free of debris and ejected hair prior to and during treatment. If performing treatment with gel, wipe the bottom of the handpiece every 50 pulses (including both the treatment window and copper cooling plate) with a gauze to remove excess gel, ejected hair or debris. To prevent gel from getting into the crevice of the handpiece, wipe the gel from back to front of the bottom of the handpiece. Any excessive gel on the handpiece can leach into the cracks and compromise the integrity of the handpiece. o Use only a thin layer of gel on the skin. o Do NOT handle the handpiece with gel covered gloves. Clean handpiece of any gel PRIOR to placing handpiece into the handpiece holster on the excel HR system. Inspect sapphire window prior to and during treatment HOLSTER CARE Wipe gel from bottom of HP to the front of the handpiece after each row of pulses. Ensure that no excess gel is on gloves or gauze when handling the handpiece. Clean the handpiece holster daily to prevent accumulation of gel and debris. Place handpiece in system front pocket when cleaning holster. Clean holster with germicidal sani-wipe using a tongue depressor or gloved hand to clean inside holster. o Bottle brush soaked in water and mild detergent may also be used if necessary. Do not drip any water onto system. o Do not remove handpiece holster from system when cleaning. Clean handpiece holster daily. Place handpiece in front pocket when cleaning holster. Clean inside of holster with Germicidal Sani-Cloth wipe. D1544 Rev E, May

6 HAIR REMOVAL PROCESS The purpose of the treatment is to selectively treat the hair follicle without causing thermal damage to the surrounding tissue. o The sapphire window provides epidermal cooling and protection. Permanent hair reduction is achieved by using heat to disable the hair follicle and prevent re-growth. o The bulb and bulge of the hair follicle, which are responsible for hair re-growth, are targeted by the excel HR laser. o Because the bulb and bulge of the hair follicle must be present, do not pluck or wax targeted hair in between treatment sessions. The excel HR laser targets the melanin in the hair bulb and bulge; therefore, hair must be brown or black. o The excel HR laser does not target and cannot be absorbed by white, gray, or red hair. TREATMENT INTERVALS Only the hair follicle in the anagen growth phase can be effectively targeted and disabled. Each hair goes through the 3 growth phases independently of the neighboring hairs, so not all hairs will be in the same phase at the same time. Therefore, multiple treatments are required to achieve sufficient reduction in hair growth. Treatment Interval recommendations are a general guideline only and are a compilation of intervals used by successful operators. o Facial hair: 6-8 week intervals between treatments o Body hair: 8-10 week intervals between treatments o Back or Leg hair: week intervals between treatments Hormones, diseases, medication, and other factors can affect the treatment outcome. Treatments that are spaced too closely together may appear to be more successful within the first few treatments. However, more treatment sessions may be required for the desired final outcome, because a smaller percentage of regrown hairs may be available as targets. Patients should be assessed before each treatment to determine treatment intervals and settings. o Hair may grow back lighter and finer, and settings may need to be adjusted to target this new hair. If the patient returns for treatment and there is minimal hair, it may be in a transitional or resting phase. o Wait until hair is actively growing to resume treatment cycle. Facial skin has significantly more hair follicles per cm² than the body, which is why you can see results within the first three to four treatments with shorter interval times. When in doubt, it is better to space the treatments farther apart than closer together. D1544 Rev E, May

7 PREPARING THE PATIENT FOR HAIR REMOVAL TREATMENT Clean the skin by removing all make-up and/or topical anesthetic. Ensure that the treatment area is clean shaven. Take photographs prior to the initial treatment for future reference. Topical anesthetic is optional and must be removed before treatment. o CAUTION: Toxicity may result from overuse. Consult the product labeling for any anesthetic used. Ensure that ALL people in the treatment room are wearing safety eyewear. SELECTING TREATMENT PARAMETERS FOR HAIR REMOVAL TREATMENT The following parameters are provided as a guide only. Perform and observe test spots prior to treatment. Potential adverse reactions may take hours to appear. Pigmentation changes for darker skin type patients may develop up to several weeks following treatment. o Test spot fluence settings are determined by evaluating skin type and, for hair removal procedures, hair color, thickness, and density. o Treatment settings should be selected based on test spot clinical response. o Perform test spots on the same area as being treated. o Deliver single pulses to assess clinical response and potential adverse reactions. o Deliver 3 to 4 adjacent pulses to assess skin s reaction to bulk heating. Start with conservative settings, and observe laser-tissue interaction and clinical endpoints to determine appropriate settings for each patient. Fluence and/or pulse duration adjustments should be performed gradually. o 1064 nm Adjust by 5 J/cm² or 5 ms at a time, while watching for epidermal response. Adjust only one parameter (fluence OR pulse duration) at a time. Shortening the pulse duration by 5 ms is more aggressive than increasing the fluence. o 755 nm Adjust 1 J/cm² at a time, while watching for epidermal response. Patients should be re-assessed prior to each treatment to determine sun exposure and hair density and coarseness. o Parameters may need to be adjusted. Mild to moderate erythema and/or perifollicular edema are desired endpoints. o IMPORTANT: Clinical endpoints are not always required for an effective treatment. It is possible for a treatment to be effective without seeing these reactions. If treated area darkens or develops significant erythema or edema, the fluence should be decreased or the pulse duration should be increased. Repetition rate should be adjusted according to patient comfort, skin type, hair density, and user experience. o Single pulses or low repetition rate are recommended on areas where additional cooling is desired (such as higher energy settings, sun exposed areas, coarse/dense hair, darker skin, curved or bony areas, etc.). o Higher repetition rates are only recommended for experienced practitioners and only when treating larger treatment areas that allow for easy handpiece motion. o If using a higher repetition rate, the fluence may need to be lowered. CAUTION: When treating darker skin types, additional pre-cooling and lower repetition rates or single pulse modes are recommended to maximize epidermal protection. Re-evaluate the patient prior to each treatment to determine sun exposure and treatment target. o Parameters may need to be decreased if increased melanin content due to sun exposure is observed. Treatment ranges are wide due to significant variations in patient response. CAUTION: Sun-exposed areas have a higher risk of adverse events. CAUTION: Do not use clinical settings taken from other 755 nm or 1064 nm laser guideline documents. Technology and performance differences can significantly effect clinical response. o Excel HR contact cooling technology provides refractive index matching improving energy coupling into skin. Skin compression from the contact handpiece also blanches the skin and reduces the distance to the hair target reducing losses. o These effects, for the same displayed settings, result in excel HR achieving higher effective intradermal fluence than seen with other cooling technologies. o As a result, the same levels of efficacy will be achieved with lower system settings. o If equivalent displayed settings are selected, the higher effective intradermal fluence will result in higher follicular and perifollicular temperatures which can improve efficacy but may increase treatment sensations. D1544 Rev E, May

8 SELECTING HAIR REMOVAL TREATMENT PARAMETERS Skin Type 755 nm is preferred for lighter skin types and lighter or fine hair nm is preferred for darker skin types or darker, coarser hair. CAUTION: When treating darker skin types, additional pre-cooling and lower repetition rates or single pulses are recommended to maximize epidermal protection. Hair Color and Thickness For darker, coarser hair, use lower fluence and longer pulse duration. For lighter, finer hair, use higher fluence and shorter pulse duration. Hair Density For dense hair, extended pre-cooling, lower fluence, lower repetition rates, and less overlap are recommended. Parameters may need to be adjusted as density decreases, skin type permitting. o Use caution when transitioning from lower density areas to higher density areas such as men s necks approaching the hairline and the bikini line. Actinic Bronzing Patients Actinic bronzing is chronic tan-like pigmentation damage resulting from long-term sun exposure. Patients with actinic bronzing are at higher risk for crusting and other adverse events. Patients with actinic bronzing should be treated as though they are one skin type darker than their underlying ethnicity would suggest. o For example, treat a skin type II patient with skin type III settings. D1544 Rev E, May

9 HAIR REMOVAL TREATMENT GUIDELINES The following parameters are provided as a guide only and are based on practitioner feedback. Start at the lowest fluence and observe laser-tissue interaction and clinical endpoints to determine appropriate settings. NOTE If no endpoint is seen and a higher fluence is desired but not available on spot size, decrease the spot size until the desired fluence setting is available. 755 nm Wavelength Skin Type Temperature Pulse Duration Spot Size Fluence 10 mm J/cm² 12 mm J/cm² I - II 4 3 ms 14 mm J/cm² 16 mm J/cm² 18 mm 9 20 J/cm² 10 mm J/cm² 12 mm J/cm² III 4 3 ms 14 mm J/cm² 16 mm J/cm² 18 mm 9 15 J/cm² 10 mm J/cm² 12 mm J/cm² IV 4 3 ms 14 mm 9 17 J/cm² 16 mm 8-15 J/cm² 18 mm 7 13 J/cm² 10 mm J/cm² 12 mm 9 15 J/cm² V * 4 3 ms 14 mm 8 13 J/cm² 16 mm 7 11 J/cm² 18 mm 6-9 J/cm² * Treating Skin Type V patients with the 755 nm Wavelength. The 1064 nm wavelength is recommended for all Skin Type V treatments. Use caution if considering 755 nm treatment for Skin Type V patients. o Should only be treated by experienced practitioners. o Do not treat patients with recent sun exposure or chronic tan. D1544 Rev E, May

10 1064 nm Wavelength Skin Type Temperature Pulse Duration Spot Size Fluence ms 10 mm J/cm² 12 mm J/cm² I - II 4 14 mm J/cm² ms 16 mm J/cm² 18 mm 755nm recommended for 18mm ms 10 mm J/cm² 12 mm J/cm² III 4 14 mm J/cm² ms 16 mm J/cm² 18 mm J/cm² 10 mm J/cm² 12 mm J/cm² IV ms 14 mm J/cm2 16 mm J/cm2 18 mm J/cm² 10 mm J/cm² 12 mm J/cm² V ms 14 mm J/cm2 16 mm J/cm2 18 mm J/cm² 10 mm J/cm² 12 mm J/cm² VI ms 14 mm J/cm2 16 mm J/cm2 18 mm J/cm² Adjusting parameters for 1064 nm treatments when treating coarse or fine hair Coarse Hair o Longer pulse durations are recommended. Fine Hair o Shorter pulse durations recommended. o Higher fluence or 755nm wavelength may be required to achieve the desired clinical endpoint. D1544 Rev E, May

11 HAIR REMOVAL TREATMENT STEPS Perform and observe test spots prior to treatment. Potential adverse reactions may take hours to appear. Pigmentation changes for darker skin type patients may develop up to several weeks following treatment. Large areas may be easier to treat if divided into smaller grids. o Mark with a white eyeliner pencil. o Use only WHITE pencil as it will not be absorbed by laser light. o Because eyeliner pencil components are not standardized, test the pencil before using on patients. Apply a thin layer of clear gel (such as ultrasound or aloe vera gel) for increased epidermal protection, for easy gliding of the handpiece, and to determine placement of adjacent rows. To prevent fogging of the treatment window, place one drop of the Anti-fog drops provided with the system on top of the window prior to each treatment or when window develops condensation. Mark treatment area with white eyeliner pencil Sapphire window must be in full contact with skin during treatment. o Pay particular attention when treating rounded/bony areas. Pulses should be spaced with 10-20% overlap. o Use a maximum of 10% overlap on darker skin. Pull handpiece back after each pulse to provide pre-cooling to each treatment spot with the copper backplate. Consider precooling for patients with darker skin or areas of dense hair. Precool area with sapphire window, depress the foot pedal to fire a pulse, then glide handpiece to next treatment area and repeat. o If using a repetition rate, keep foot pedal depressed as the laser Ensure handpiece has full contact with skin fires each pulse. Ensure that handpiece has complete contact with skin during each pulse. Do not stack pulses ( double-pulse ) or retreat an area within a single visit. Common endpoints are mild to moderate erythema and/or perifollicular edema, which may be delayed. However, these endpoints are not required for a successful treatment. o If desired clinical endpoint is not achieved, consider increasing fluence or shortening the pulse duration. Always observe the epidermis during the treatment, watching for signs of damage (blanching or gray coloration). o If damage is seen, stop the treatment and apply a cool compress and evaluate the area for possible complications and wound care. Typical 10% - 20% overlap of pulses Be extra cautious when treating delicate or highly sensitive areas (knuckles, genitalia, ears, upper lip, etc.). o Provide extra cooling with handpiece and/or frozen gel pack. o Thinner skin is more easily damaged. o Insert damp cotton ball inside ear canal when treating the ear. o Pull skin away from testes to treat. o When treating near the mouth, a moist gauze can be placed between the lips and teeth to protect teeth from discomfort. HAIR REMOVAL POST-TREATMENT CARE Avoid sun exposure, and use a broad spectrum (UVA/UVB) sunscreen. Perifollicular edema is a common endpoint Avoid heat (hot tubs, saunas, etc.) for 1-2 days. Avoid skin irritants (products containing tretinoin, retinol, benzoyl peroxide, glycolic/salicylic acids, astringents, etc.) for a few days post-treatment. Do not wax or pluck between treatments. Redness and perifollicular edema are common and will resolve with time. Bruising and swelling are uncommon but may occur and will resolve with time. Hair may take up to two weeks to fall out. D1544 Rev E, May

12 BENIGN PIGMENTED LESION TREATMENT GUIDELINES 755 NM WAVELENGTH The following parameters are provided as a guide only and are based on practitioner feedback. Start at the lowest fluence and observe laser-tissue interaction and clinical endpoints to determine appropriate settings. Indication Skin Type Spot Size Fluence Temperature Gel (mm) ( C) Light Pigment I III J/cm² J/cm² C C Optional Optional Dark Pigment I - IV J/cm² J/cm² 12 C 12 C Optional Optional Seborrheic Keratosis * May only be lightened and often re-occurs. I III J/cm² 20 C NO TREATMENT PRECAUTIONS Avoid treating surrounding skin with actinic bronzing or chronic tan. Reduce fluence when treating: o darker skin types o sun exposed areas (such as chest and arms) or actinic bronzing o over bony areas o on the body Extreme caution should be used when treating near the eye. o Always treat outside the orbital rim of the eye aiming the beam away from the orbit. o Patient eye protection is required to avoid ocular damage. o The laser beam should ALWAYS be pointed away from the eye and only applied to the skin outside of the orbital rim. o Distance from the orbit can often be increased by pulling the skin away from the eye for treatment. Do not treat over or close to tattoos or permanent make-up. Possible hair loss may occur. Implants: o Reaction to metal implants is unknown. o Pacemaker - stay at least 6 inches away from implant. o Reaction to fillers is unknown. D1544 Rev E, May

13 GENERAL TREATMENT TECHNIQUES Inspect the handpiece to ensure that the sapphire window is free of debris or ejected hair prior to and during treatment. o For treatments using gel, wipe the bottom of the handpiece with a gauze every 50 pulses. o For treatments where no gel is used, it is important to inspect the treatment sapphire window frequently and wipe the bottom of the handpiece every 5 pulses. If gel is recommended, apply a thin layer of ultrasound gel to the treatment area to improve epidermal contact during treatment. Ensure that the handpiece is in full contact with the skin during treatment. o Pay particular attention when treating rounded/bony areas. Treat the pigmented lesion only and not the surrounding area. o If spot size is larger than the targeted pigment, select setting that won t harm surrounding skin. If the desired clinical endpoint is not achieved, adjust the settings accordingly. Always observe the epidermis during the treatment, watching for signs of damage (e.g., epidermal separation, frosting or gray coloration). o If damage is observed, stop the treatment, cool the skin and evaluate the area for possible complications and wound care. Treating Seborrheic Keratosis o May only be lightened and often re-occurs. o Use caution and less aggressive settings when treating flatter Seborrheic Keratosis. Use extreme caution when treating near the eyes. Use caution when treating unusual areas (scalp hair, knuckles, men s genitalia, ears, inside nose, etc.). o Consider extended pre-cooling with the handpiece or a frozen gel pack. Do not double-pulse or retreat an area within a single visit. When treating near the mouth, rolled-up gauze can be placed between the lips and teeth to protect teeth from discomfort. Treatment endpoint is a slight darkening of the lesion. o A subtle color change is sufficient. o It is important to achieve a color change over the full diameter of the lesion. o Localized erythema and/or edema may develop up to 15 min after treatment. 1 2 treatments are recommended, spaced 4 weeks apart. Re-assess the treatment area prior to subsequent treatments, and adjust the parameters accordingly. BENIGN PIGMENTED LESION POST-TREATMENT CARE Cold compresses or chilled gel-packs may be applied post treatment. Avoid sun exposure and apply sunscreen to the treated area. Treated lentigines will darken after treatment. Crusting forms within a few days and typically slough within 1-3 weeks. Retreatment of lentigines is not recommended prior to 4-6 weeks. BENIGN PIGMENTED LESION POSSIBLE REACTIONS Normal Reactions: o Erythema usually resolves within 2-4 hours. o Edema usually resolves within 24 hours. o Bruising usually resolves within 7-10 days. Pigmented lesions will darken after treatment. Crusting may form and last 1-3 weeks before flaking off. Cold gel packs or cool compresses should be applied to a suspected burn. If a blister develops, treat as a wound. D1544 Rev E, May

14 DIFFUSE PIGMENT TREATMENT GUIDELINES 755 NM WAVELENGTH The following parameters are provided as a guide only and are based on practitioner feedback. Start at the lowest fluence and observe laser-tissue interaction and clinical endpoints to determine appropriate settings. Skin Spot Fluence Repetition Temp. Gel Handpiece Position & Type Size Rate Overlap Non- Contact Technique Full Contact Technique 1-2 cm Above the Skin I III 18 mm J/cm² Hz 20 C No 10% Overlap No epidermal cooling provided with this technique, may be more uncomfortable. Endpoint will be erythema and slight edema over the treatment area with darkening of the pigmented lesions. The endpoint can be delayed, so start with conservative settings. Full Contact with Skin I IV 14 mm J/cm² Hz 8-16 C Yes 10-20% Overlap 8 C recommended for actinic bronzing and C recommended for medium to light lesions. Use less overlap and lower fluence with darker skin types or actinic bronzing. Use higher fluence with lighter skin types. Endpoint will be erythema and slight edema over the treatment area with darkening of the pigmented lesions within 5-10 minutes. Microcrusting is expected 1-2 days post-treatment. TREATMENT PRECAUTIONS Reduce fluence when treating: o Actinic bronzing o Darker skin types o Sun exposed areas (such as chest and arms) or actinic bronzing o Over bony areas o On the body Extreme caution should be used when treating near the eye. o Always treat outside the orbital rim of the eye aiming the beam away from the orbit. o Patient eye protection is required to avoid ocular damage. o The laser beam should ALWAYS be pointed away from the eye and only applied to the skin outside of the orbital rim. o Distance from the orbit can often be increased by pulling the skin away from the eye for treatment. Do not treat over or close to tattoos or permanent make-up. Possible hair loss may occur. Implants: o Reaction to metal implants is unknown. o Pacemaker - stay at least 6 inches away from implant. o Reaction to fillers is unknown. D1544 Rev E, May

15 GENERAL TREATMENT TECHNIQUES Inspect the handpiece to ensure that the sapphire window is free of debris or ejected hair prior to and during treatment. o For treatments using gel, wipe the bottom of the handpiece with a gauze every 50 pulses. If gel is recommended, apply a thin layer of ultrasound gel to the treatment area to improve epidermal contact during treatment. o If handpiece is in contact with the skin during treatment, pay particular attention when treating rounded/bony areas. If the desired clinical endpoint is not achieved, adjust the settings accordingly. Always observe the epidermis during the treatment, watching for signs of damage (e.g., epidermal separation, frosting or gray coloration). o If damage is observed, stop the treatment, cool the skin and evaluate the area for possible complications and wound care. Use extreme caution when treating near the eyes. 1 2 treatments are recommended, spaced 4-6 weeks apart. Re-assess the treatment area prior to subsequent treatments, and adjust the parameters accordingly. DIFFUSE PIGMENT POST-TREATMENT CARE Cold compresses or chilled gel-packs may be applied post treatment. Avoid sun exposure and apply sunscreen to the treated area. Treated lentigines will darken after treatment. Crusting forms within a few days and typically slough within 1-3 weeks. Retreatment is not recommended prior to 4-6 weeks. DIFFUSE PIGMENT POSSIBLE REACTIONS Normal Reactions: o Erythema usually resolves within 2-4 hours. o Edema usually resolves within 24 hours. o Bruising usually resolves within 7-10 days. Pigmented lesions will darken after treatment. Crusting may form and last 1-3 weeks before flaking off. Cold gel packs or cool compresses should be applied to a suspected burn. If a blister develops, treat as a wound. D1544 Rev E, May

16 SELECTING VASCULAR LESION TREATMENT PARAMETERS 1064 NM WAVELENGTH Select treatment parameters in the order listed below. Always start with the least aggressive settings for a specific vessel. Observe laser-tissue interaction and clinical response to determine appropriate settings for each patient. 1. Spot Size measured in millimeters (mm), based on treatment type and vessel depth. For superficial linear vessels, use smaller spot size. For deeper linear vessels, use larger spot size. For area treatments/diffuse redness, use larger spot size. 2. Fluence measured in J/cm 2, based on the vessel size, depth, and skin type. For smaller vessels, use higher fluence. For larger vessels, use lower fluence. For deeper vessels, use higher fluence (energy dissipates to the surrounding tissue). For darker skin types or tan skin, use lower fluence. 3. Pulse Duration measured in milliseconds (ms), based on vessel size and color. For smaller diameter, lighter vessels, use shorter pulse duration. For larger diameter, darker vessels, use longer pulse duration. For darker skin types or tan skin, use longer pulse duration. Pulse durations shorter than 10 ms increase the likelihood of purpura when treating vascular lesions. 4. Window Temperature measured in o Celsius. There are 5 options: 4 C, 8 C, 12 C, 16 C or 20 C. For vascular indications, 4 C or 8 C is advised for increased epidermal protection and patient comfort. For larger, darker vessels and vascular birthmarks (more hemoglobin), use 4 C. 5. Repetition Rate measured in Hz. Number of pulses per second with foot pedal depressed. For increased epidermal safety, use single pulses (0.0 Hz) with pre and post cooling. 6. Contact Cooling Sapphire window provides pre, parallel and post cooling. Pre-cooling protects the epidermis by reducing initial skin temperature. Parallel cooling during the laser pulse protects epidermis while laser is firing. Post-cooling extracts heat from tissue to help prevent epidermal injury. Longer pre and post cooling is recommended when heating larger, darker vessels. Linear vessels Superficial vessels Spot Size - + Area treatments Deeper vessels Larger vessels Fluence - + Smaller vessels Smaller vessels Pulse Duration - + Larger vessels Darker skin types Tan skin D1544 Rev E, May

17 VASCULAR LESION TREATMENT GUIDELINES 1064 NM WAVELENGTH The following parameters are provided as a guide only and are based on practitioner feedback. Start at the lowest setting and observe laser-tissue interaction and clinical endpoints to determine appropriate settings. Settings below are for skin types I-V only. Use lower fluence and longer pulse duration for darker skin types and higher fluence and shorter pulse duration for lighter skin types Indication Example Picture Temp Spot Size Fluence Pulse Width Skin Type Facial Telangiectasia 8 o 8 o 3 mm 5 mm J/cm² J/cm² ms ms I V Fine Leg Telangiectasia < 0.5 mm diameter Purple/Blue Facial Telangiectasia 8 o 8 o 3 mm J/cm² ms I V 5 mm J/cm² ms 8 o 5 mm J/cm² ms I V Periorbital Blue Veins** 8 o 5 mm J/cm² ms I V Red Spider Leg Veins 1-2 mm 8 o 8 o 3 mm 5mm J/cm² J/cm² ms ms I V Purple Spider Leg Veins 1 2 mm 8 o 5 mm 7 mm J/cm² J/cm² ms ms I V Reticular Leg Veins 2-4 mm Cherry or Spider Angioma 8 o 7 mm J/cm² ms I V 8 o 8 o 3 mm (<2 mm) 5 mm (>2mm) J/cm² J/cm² 8 30 ms ms I V Venous Lake 8 o 5 mm J/cm² ms I - V 8 o 5 mm J/cm² TREATMENT PRECAUTIONS When treating skin types IV-V, use a lower fluence and a longer pulse duration in addition to longer precooling. Test pulses are always recommended. Observe laser-tissue interaction before proceeding. WARNING: The red diode aiming beam in the sapphire window should be in full contact with the skin before, during, and after the laser pulse. o Pay close attention when treating over the nose or curved areas to ensure full contact with the window where the red aiming beam is present. o Consider using smaller spot size if you cannot ensure full contact with the sapphire window. Extreme caution should be used when treating near the eye. o Always treat outside the orbital rim of the eye aiming the beam away from the orbit. o Patient eye protection is required to avoid ocular damage. D1544 Rev E, May,

18 o The laser beam should ALWAYS be pointed away from the eye and only applied to the skin outside of the orbital rim. o Distance from the orbit can often be increased by pulling the skin away from the eye for treatment. Do not treat over or close to tattoos or permanent make-up. Possible hair loss may occur. The Nd:YAG may affect a tooth if exposed. o Moist gauze may be placed between the lips and teeth. Implants: o Reaction to metal implants is unknown. o Pacemaker - stay at least 6 inches away from implant. o Reaction to fillers is unknown. GENERAL TREATMENT TECHNIQUES Inspect the handpiece to ensure that the sapphire window is free of debris prior to and during treatment. Apply a thin layer of ultrasound gel to the treatment area if indicated to aid gliding of the handpiece and to improve epidermal contact during treatment. Ensure that the handpiece is in full contact with the skin during treatment. o Pay particular attention when treating rounded/bony areas. Pre-cooling the skin is required to help prevent epidermal damage. o Ensure each pulse receives both pre and post cooling. o Length of pre and post cooling time required will vary according to size, color, and depth of vessel. Larger, darker vessels require longer pre and post cooling. Do not stack pulses or double pulse. o For smaller vessels, place treatment pulses adjacent to one another without overlap. o For larger vessels, leave space between pulses. Vessel rupture and extravasation may occur with more aggressive settings. o Cool and compress the area; purpura may develop. Telangiectasia prior to pulse o Lengthen the pulse width and/or reduce the fluence on subsequent pulses. Endpoints will vary based on type, size, color, volume, pressure, and location of vein. o Common endpoints are color change, vein disappearance, or constriction. o If the clinical endpoint is not reached, shorten the pulse duration. If clinical endpoint still not reached, then increase the fluence. o The endpoint may not be evident or may be very subtle when treating larger reticular leg veins. Always observe the epidermis during the treatment, watching for signs of damage (e.g., epidermal separation, frosting or gray coloration). o If damage is observed, stop the treatment, cool the skin and evaluate the area for possible complications and wound care. Use extreme caution when treating near the eye. Telangiectasia endpoint example o Only experienced practitioners should treat periorbital vessels. o Always use patient eye protection. o Always point the laser beam away from the eye, and never treat near or within the orbital rim. When treating near the mouth, rolled-up gauze can be placed between the lips and teeth to protect teeth from discomfort. Re-assess the treatment area prior to subsequent treatments, and adjust the parameters accordingly. D1544 Rev E, May,

19 VASCULAR LESIONS POST-TREATMENT CARE Cold compresses or chilled gel-packs may be applied post treatment. Avoid sun exposure and apply sunscreen to the treated area. Retreatment of vessels is not recommended prior to 4-6 weeks. Larger reticular vessels may take longer to resolve and should not be re-treated prior to 2-3 months. Compression stockings following leg vein treatments are optional. VASCULAR LESIONS POSSIBLE REACTIONS Normal Reactions: o Erythema usually resolves within 2-4 hours o Edema usually resolves within 24 hours o Bruising usually resolves within 7-10 days o Urticarial (hive-like) reaction (smaller vessels) usually resolves within several hours Linear crusting may occur when treating leg veins and should be allowed to slough off naturally. Hemosiderin staining is uncommon but may occur (more commonly in leg veins) and usually resolves over time (3-6 months). Cold gel packs or cool compresses should be applied to a suspected burn. If a blister develops, treat as a wound. D1544 Rev E, May,

20 ACNE TREATMENT GUIDELINES 1064NM WAVELENGTH The following parameters are for the treatment of mild to moderate inflammatory acne. These parameters are provided as a guide only for skin type I-III on the face. Treatment protocols have not been developed for skin types IV-VI or off the face treatments. Observe laser-tissue interaction and clinical endpoints to determine appropriate settings. Indication Mild to Moderate Inflammatory Acne Treatment Location Skin Type Temperature Spot Size Fluence Pulse Duration Repetition Rate Face I - III 4 o 10 mm J/cm² ms 0 1 Hz TREATMENT TECHNIQUE ACNE: 1064 NM WITH COOLVIEW HANDPIECE WARNING: The red diode aiming beam in the sapphire window should be in full contact with the skin before, during, and after the laser pulse. o Pay close attention when treating over the nose or curved areas to ensure full contact with the sapphire window where the red aiming beam is present. WARNING: Do not treat patients who have taken Accutane (isotretinoin capsule) in the past 6 months. Technique: o Apply a thin layer of clear gel (such as ultrasound gel) for increased epidermal protection and patient comfort and seat the sapphire window gently on the skin. o Ensure that no large bubbles are present under the aiming beam. o Do not apply too much pressure on the skin. o Pre-cool area with sapphire window, depress the foot pedal to fire a pulse, then glide handpiece to next treatment area and repeat. o Ensure that handpiece has complete contact with skin during each pulse. Always observe the epidermis during the treatment, watching for signs of damage (blanching or gray coloration). o If damage is seen, stop the treatment and apply a cool compress and evaluate the area for possible complications and wound care. Treat the individual lesions and surrounding area. This is not a full global treatment so surrounding area should be limited to affected areas only. o Overlap pulses by no more than 10 20%. o Only 1 pass recommended. Treat to endpoint of mild erythema. Treating off the face is not recommended. As with other 1064nm treatments, hair reduction in treatment area is a possible reaction to treatment. Common treatment intervals are every 2-4 weeks. Number of treatments varies by patient. POST TREATMENT CARE ACNE Cold compresses or chilled gel packs may be applied post treatment. If a blister develops, treat as a wound. Avoid sun exposure and use a broad spectrum (UVA/UVB) sunscreen to minimize the risk of PIH (Post Inflammatory Hyperpigmentation). Bruising, redness, and swelling are common and resolve with time. Avoid heat (hot tubs, saunas, etc.) for 1-2 days post-treatment. Avoid skin irritants (i.e., products containing tretinoin, retinol, benzoyl peroxide, glycolic/salicylic acids, astringents, etc.) a few days post-treatment. o Request that the patient contact your office with any concerns, such as blistering, excessive redness/swelling, etc. D1544 Rev E, May,

21 LASER GENESIS TREATMENT GUIDELINES 1064 NM WAVELENGTH These parameters are provided as a guide only for skin types I-VI. Observe laser-tissue interaction and clinical endpoints to determine appropriate settings. Laser Genesis is recommended for scar revision, diffuse redness, fine line and wrinkles. Area Large Area (face or neck or chest) Small Area (toes or fingers) Spot Size Skin Type Fluence Pulse Duration Repetition Rate Temp # of Pulses # of Tx 8 mm I VI 4 7 J/cm ms 7 10 Hz 20 C 6,000 8, Treatment Intervals 2 3 weeks 8 mm I VI 6 7 J/cm ms 2 3 Hz 20 C Based on area weeks Scars 8 mm I VI 4 5 J/cm ms 5 7 Hz 20 C Based on area weeks Do NOT use topical anesthetic. o Patient feedback is important. Start with low fluence and slow repetition rate to observe laser-tissue interaction. o Adjust fluence and/or repetition rate to patient tolerance. Sensitive areas, darker skin types, and areas of dense hair or recent sun exposure may require lower fluences or lower repetition rates. To create heat to target the microvasculature, divide the face into multiple regions (see example on right). o Divide the forehead in half. o Do NOT treat upper lids. o Divide the cheeks into 2-3 sections. o The vermillion border may be treated, but ensure that there is no tattoo or permanent makeup in the area. Place moist gauze between lips and teeth to protect enamel. Hold the handpiece 1-2 cm from the skin s surface. o Handpiece should not be touching the skin during treatment. o Move handpiece continuously in an even zig-zag motion. o Adjust speed according to the patient s tolerance. o Treat each region to point of discomfort and erythema (see example right). o Then move to adjacent regions using multiple passes. Dark skin, scars or hot spots may need short break during treatment. o Pause treatment or use a frozen gel pack or wet 4x4 between passes to cool the skin. Treating a Scar: o Check with surgeon before starting treatment on fresh scars. o Always include the tissue surrounding the scar observing for erythema of the scar as endpoint. o Scar will absorb more energy than surrounding skin. o Do not rely on heat in surrounding skin as an endpoint. o Decreased or no sensation of the scar tissue increases the risk of a burn. o Treat in a zig-zag movement across the scar. o Do not treat linearly. o Pause occasionally or use a frozen gel pack between passes. o Several treatments may be required. Use extreme caution when treating near the eye. o Always use patient eye protection. o Always point the laser beam away from the eye, and never treat near or within the orbital rim. D1544 Rev E, May,

22 POST-TREATMENT CARE Avoid sun exposure, and use a broad spectrum (UVA/UVB) sunscreen to prevent further sun damage. If a blister develops, treat as a wound. Bruising, redness, and swelling may occur and resolve with time. Urticarial reaction (hive-like/bug-bite look) may occur and usually resolves in 1-2 days. Avoid heat (hot tubs, saunas, etc.) for 1-2 days. Avoid skin irritants (products containing tretinoin, retinol, benzoyl peroxide, glycolic/salicylic acids, astringents, etc.) for a few days post-treatment. D1544 Rev E, May,

23 SKIN TYPE CLASSIFICATION QUESTIONNAIRE SCORE What is the natural color of your hair? Sandy red Blond Chestnut, dark blond Dark brown Black What is the eye color? Light blue, Gray, Green Blue, Gray, Green Brown Dark Brown Brownish Black What is the color of sun unexposed skin areas? How many freckles on unexposed skin areas? Reddish Very pale Pale with beige tint Light brown Dark brown Many Several Few Incidental None What happens when you are in the sun TOO long without sunblock? Painful redness, blistering, peeling Blistering followed by peeling Burns, sometimes followed by peeling Rarely burns Never had a problem How well do you turn brown? Hardly or not at all Light color tan Reasonable tan Tan very easily Turn dark very quickly Do you turn brown within one day of sun exposure? Never Seldom Sometimes Often Always How does your face respond to the sun? Very sensitive Sensitive Normal Very resistant Never had a problem When did you last expose yourself to the sun or artificial sun treatments? More than 3 months ago 2-3 month ago 1-2 months ago Less than 1 month ago Less than 2 weeks ago Do you expose the area to be treated to the sun? Never Hardly ever Sometimes Often Always TOTAL points = Skin type I points = Skin type II points = Skin type III points = Skin type IV points = Skin type V & VI D1544 Rev E, May,