TREATMENT GUIDELINES September 2012 D0592 Rev. B Cutera 3240 Bayshore Boulevard Brisbane California 94005 PH: 415.657.5500 www.cutera.com
Pearl Treatment Guidelines The following guidelines are based on practitioner feedback for treatments with the Pearl laser system on patients with Fitzpatrick skin types I-IV. Additional treatment information is discussed in the Pearl Clinical Training CD included with the system. The Pearl laser system should only be operated by qualified practitioners who have received appropriate training and have thoroughly read the operator manual. Consult the Operator Manual for additional information, including contraindications, expected transient events and possible adverse effects. PATIENT CARE CONSIDERATIONS: It is important to be aware that patients are more susceptible to irritation or infection following procedures that disrupt the surface of the skin. If this occurs, it is important to properly diagnose and treat these conditions in order to avoid delayed wound healing, scarring, or spread of an infection. Treatment for these conditions often requires prescriptive medications. During the first 3 or 4 days after treatment, the skin will be more susceptible to irritation which can lead to contact dermatitis. As this can be triggered by substances that do not normally irritate the skin, it is important for the patient to avoid putting anything in contact with their skin other than those items specifically recommended for post-treatment care, and to always thoroughly wash their hands prior to touching their face. It is possible for a treatment to reactivate the herpes simplex virus in the treated area and potentially lead to scarring. Because not all carriers of the herpes simplex virus are aware that they have the virus, many physicians provide prophylactic oral antiviral medications to all patients prior to receiving an ablative treatment. However, it has been shown that prophylactic treatment does not completely eliminate the incidence of herpes reactivation. Because of this, it is also important to watch for, and treat, any post-treatment reactivation. The skin is also more susceptible to bacterial and fungal infections after disruption from an ablative procedure. The probability of these infections occurring can be reduced by good post-treatment skin care following the treatment, such as regular cleansing, vinegar (acetic acid) soaks (1 teaspoon per 2 cups of water), and minimizing contact with the facial skin. As a result of these concerns, it is important to instruct the patient on proper post-treatment skin care and to have them contact the treating office if they experience any suspect symptoms such as increased pain, drainage, increased itching, severe redness or fever, the appearance of a cold sore, blister, or a similar tingling sensation, or any other sign that healing is not proceeding normally. This information is intended to provide awareness of these issues, but is in no way complete. Additional information on possible irritation and infection following ablative laser treatments, and their care, is contained in the medical literature. One such source is the chapter entitled Complications in Laser and Light Surgery by Tina S. Alster and Elizabeth L. Tanzi, in the book Laser and Lights, Volume 2, edited by David J. Goldberg, of the series Procedures in Cosmetic Dermatology, edited by Jeffrey S. Dover. This book was published in 2005 by Elsevier Saunders. September 2012, D0592 Rev. B Pearl Treatment Guidelines Page 2 of 4
SUPPLIES & MATERIALS Smoke Evacuator o Change the tubing and filters as per the manufacturer s recommendations Laser plume masks - filters to 0.1μm (optional) Isopropyl Alcohol Gauze pads Tongue depressors Gloves Topical anesthetic O Additional forms of pain management may also be used to assist in patient comfort Occlusive ointment (e.g. plain Vaseline or Aquaphor ointment) Safety eyewear must be worn by ALL people in the treatment room o The patient should be given the solid, light blocking eyewear provided by Cutera. o Operator Goggles - Optical Density (OD) of 2.5 or greater at 2790 nm PRE-TREATMENT: Conduct a patient consultation complete with medical history prior to treatment. The beard area should be closely shaven prior to treatment as the hair will absorb the laser energy, decreasing efficacy. Clean the skin, including removal of all make-up and other skin care products. Pre-operative photographs should be taken with consistent technique (patient positioning, camera settings, and lighting) prior to the initial treatment for general reference. Printed pre-operative photos can also be used to compare and duplicate the same patient position when taking follow-up photos. Pigmented lesions should be evaluated for potential skin cancer warning signs prior to treatment. If these are present, the lesion should not be treated unless diagnosed as benign. Apply a topical anesthetic (such as LMX, 4-5% lidocaine) for a minimum of 30 minutes. CAUTION: Toxicity may result with the overuse of topical anesthesia. Consult the manufacturer s labeling. Thoroughly remove all of the anesthetic after the desired amount of time. Wipe the skin with a medical grade acetone to remove any residual anesthetic (alcohol may be used, but is not as efficient). Allow the skin to dry before treating with the laser. Any residual anesthetic will absorb light and may cause irregular results. September 2012, D0592 Rev. B Pearl Treatment Guidelines Page 3 of 4
PEARL TREATMENT PARAMETERS: Specific parameters are provided as a guide only. Patient response will vary. Treatment Area Skin Fluence Pulse Overlap % # Passes Type Duration Face (down to jawline) I-III 2 3.5 J 0.4 msec 20 % 1 3 Face (down to jawline) IV 1.5 2.5 J 0.4 msec 10 % 1 Off face I-III 1.5 2.5 J 0.4 msec 10 % 1 Treatments off the face (below the jawline) may have an increased risk of unwanted side effects as the skin may be thinner and does not heal as well. Patients with darker skin may have an increased risk of postinflammatory hyperpigmentation following treatment. Increasing fluence and number of passes may increase the risk of Post inflammatory hyperpigmentation. These treatments, if undertaken, should be performed with caution. 1. Fluence determines the total depth of tissue that is removed with the treatment. This includes both the immediately ablated tissue and the coagulated tissue that will subsequently slough off. While this will vary from person to person, a fluence of 1.5 J/cm 2 has been found to remove approximately 50% of the epidermis and a fluence of 3.5 J/cm 2 has been found to remove approximately 100% of the epidermis. Higher settings will result in a deeper treatment, but could prolong the post treatment erythema. 2. Pulse duration can be modified from the nominal value of 0.4 ms. It is expected that increasing the pulse duration will reduce the amount of tissue that is ablated and increase the amount of tissue that is coagulated, whereas reducing the pulse duration is expected to have the opposite effect. 3. Delay determines the time between the delivery of scan sequences if the footswitch is maintained in the down position. Delay times of 1 to 2 seconds are typically used, with longer delay times for larger patterns. Delay can be reduced below 1 second for single pulse mode if desired. 4. Scan Pattern and Overlap determine the location of the delivery of the 6 mm diameter pulses and selection options will be discussed under Recommended Technique. While the scan pattern is varied during treatment, overlap can remain fixed. The overlap setting specifies the overlap of pulses within a scan pattern. The 20% setting is used to eliminate any untreated skin within a scan pattern. This setting can be reduced if desired. A setting of 0% would place each round pulse within a scan pattern adjacent to each other and result in very small areas of untreated skin within the pattern. September 2012, D0592 Rev. B Pearl Treatment Guidelines Page 4 of 4
RECOMMENDED TECHNIQUE: All people in the treatment room should have safety eyewear and, other than the patient, laser plume masks (0.1 um filter). The smoke evacuator hose should be attached to the snorkel handpiece and suction set high enough to capture the airborne particles and prevent plume odor. A large scan pattern (e.g. 5x5 or 4x4) is initially used to rapidly treat the majority of the face. After this is done, smaller areas will remain. These can be treated by using a smaller scan pattern as appropriate (e.g. 2x2 or linear). Finally, the smallest untreated areas can be filled in with the single spot setting. Hold the handpiece perpendicular to the skin with the stand-off in contact with the skin. The standoff indicates the optimal distance from the laser to the skin being treated. The aiming beam will indicate the area to be treated. A small test pattern (such as 2 x 2) can be delivered on a tongue depressor to verify laser performance and familiarize the patient with the sound of the laser prior to treatment. Depress and hold the foot pedal down while holding the handpiece still until the scan pattern is complete. The skin should exhibit a white ash appearance in the treated area. This may fade into a uniform erythema as the treatment progresses. Once the scan is complete, move the handpiece to the next treatment location. Using the aiming beam as a guide, place the scan pattern adjacent to any previous scans without overlap, and repeat. Higher fluences and additional passes will result in a deeper treatment, increasing the risk of adverse effects. Avoid treating over the eyebrow as the hair will singe. It is important that the natural dressing is left intact. Do not attempt to wipe this layer off. Do not treat over areas with tattoos or permanent make-up. POST-TREATMENT: Immediately after treatment, apply an occlusive ointment such as plain Vaseline or Aquaphor ointment. Some patients experience a burning sensation immediately after treatment. This usually resolves a few minutes after the application of the occlusive ointment. Erythema is a normal reaction to treatment and will usually persist for a few days or more, with deeper treatments resulting in longer lasting erythema. Swelling may occur in some patients. While this is temporary, sleeping with the head elevated may help to minimize this effect. The coagulated skin will slough off at 3 to 4 days after treatment for most patients. Provide the patient with a post-treatment instruction sheet for proper post-treatment care. An example set of post-treatment instructions is provided on the Pearl Clinical Training CD or on the Cutera.com/education web site. Also refer to the information in the Patient Care Considerations section of these treatment guidelines. If repeat treatments are performed, the recommended treatment interval is 4 weeks or longer. Between each patient, the entire hand piece, including the circular clamp that holds the stand-off in place and the umbilical cord, must be cleaned thoroughly using germicidal wipes that are antibacterial, antifungal, antiviral (e.g. SaniCloth or PDI). September 2012, D0592 Rev. B Pearl Treatment Guidelines Page 5 of 4
The smoke evacuator snorkel can be detached from the handpiece and cleaned with 1 part bleach & 10 parts water in the following manner; 1) Place the soiled snorkel in a small wash basin containing 1:10 solution of bleach and water ensuring it can be completely submerged. 2) Using a small, non-abrasive, flexible brush or pipe cleaner to gently scrub the inner wall of the snorkel. 3) Using a sponge or gauze pad gently clean the exterior of the snorkel. 4) After cleaning, rinse the inner and outer surfaces of the snorkel thoroughly with water. 5) Air-dry the entire piece by gently shaking it. NOTE: Cleaning procedure should be clearly understood before proceeding using manufacturer s recommendations. In addition the operator should follow any and all internal procedures regarding the handling of bio hazardous material and the use of personal protection equipment. NOTE: To loosen dried-on debris, you may also pour the 1:10 solution through the inner snorkel or submerge and soak the snorkel in the solution for approximately 10 minutes. CAUTION: Do not use harsh chemicals that may damage the snorkel, such as acetone Replace smoke evacuator filters and tubing per manufacturer s recommendations and guidelines September 2012, D0592 Rev. B Pearl Treatment Guidelines Page 6 of 4
Fitzpatrick Classification Questionnaire SCORE 0 1 2 3 4 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 Blue Dark Brown Brownish Black What is the color of sun unexposed skin areas? How many freckles on unexposed skin areas? What happens when you are in the sun TOO long without sunblock? How well do you turn brown? Do you turn brown within one day of sun exposure? How does your face respond to the sun? When did you last expose yourself to the sun or artificial sun treatments? Do you expose the area to be treated to the sun? TOTAL Reddish Very pale Pale with beige tint Light brown Dark brown Many Several Few Incidental None Painful redness, blistering, peeling Hardly or not at all Blistering followed by peeling Light color tan Burns, sometimes followed by peeling Reasonable tan Rarely burns Tan very easily Never had a problem Turn dark very quickly Never Seldom Sometimes Often Always Very sensitive More than 3 months Sensitive 2-3 month Normal 1-2 months Very resistant Less than 1 month Never had a problem Less than 2 weeks Never Hardly ever Sometimes Often Always 00-07 points = Skin type I 08-16 points = Skin type II 17-25 points = Skin type III 25-30 points = Skin type IV 30-40 points = Skin type V & VI September 2012, D0592 Rev. B Pearl Treatment Guidelines Page 7 of 4