Title: PICO Operator Manual, Rev 510K Author: Hagopian Ara Subject: 850-7012-000 Created Date: 20200407190443Z
The SculpSure delivers laser energy to heat the deep layer of fat. The heat that is created damages the fat cells. The damaged fat cells are then ...
INFORMED CONSENT FORM: SCULPSURE® BODY TREATMENT The SculpSure® delivers laser energy to heat the deep layer of fat. The heat that is created damages the fat cells. The damaged fat cells are then eliminated by the body through your lymphatic system. During the laser delivery the applicators cool the skin throughout the entire treatment. The cooling protects your skin while the energy heats your fat layer. When the treatment begins, it will feel warm, and over time the heat sensation will increase to short periods of intense deep heat. You may also experience some cramping, tingling, prickling or squeezing sensations deep in the fat layer. These sensations are normal and expected. These sensations indicate that the laser is effectively targeting and damaging the fat layer. For body areas (non-submental), the SculpSure is eye safe. There is no need to wear protective eyewear. Your skin may be slightly pink to red immediately after treatment. This may last for hours up to days. Following the SculpSure® treatment you may experience swelling and tenderness that lasts approximately two to three (2 3) weeks but may last longer. You may also experience tissue firmness or nodules. Nodules can last for days to several months, depending on the size of the nodule. This side effect typically resolves on its own. While uncommon, some nodules may be permanent. The treated areas should be massaged two (2) times a day for several minutes. For flank and abdomen treatments there are no lifestyle restrictions following your SculpSure treatment. For inner or outer thigh treatment it is recommended to avoid crossing your legs until any tenderness has resolved. Staying well hydrated and engaging in light physical activity helps mobilize the disrupted fat for processing through the lymphatic system. We encourage you to drink at least 8 (eight) glasses of water a day and take a daily walk or continue your regular exercise routine. You may use cold gel packs or Tylenol according to package instructions to help ease tenderness. I understand that the practice of medicine is not an exact science and no results have been guaranteed. I acknowledge that the results may not meet my expectations. I certify that no guarantees have been made by anyone regarding the procedure(s) that I have requested and authorized. Yes No Initials: ________ I have been informed that firmness, hardness, nodules, redness, tenderness, swelling, pain, and bruising, are the most common side effects. Other less common side effects which can occur are itching, skin contour irregularities, dimpling, hyperpigmentation/hypopigmentation, asymmetry, necrosis, changes in skin laxity, numbness, blister or burn. Rare occurrences of fainting or dizziness have been noted during and/or after the treatment. Yes No Initials: ________ I consent to photographs and digital images being taken and used for medical education, training, professional publications or sales and marketing purposes. No photographs or digital images revealing my identity will be used without my written consent. If my identity is not revealed, these photographs and digital images may be used, shared, and displayed publicly for such stated purposes without my permission. Yes No Initials: ________ Before and after treatment instructions have been discussed with me. The procedure, potential benefits and risks, and alternative treatment options have been explained to my satisfaction. Yes No Initials: ________ I CERTIFY THAT I HAVE READ, FULLY UNDERSTOOD AND RECEIVED A COPY OF THE ABOVE CONSENT AND THAT I HAVE RECEIVED CLEAR EXPLANATIONS REGARDING THE PROVIDED INFORMATION. Client*: Date Witness: Date * Parent or legal guardian if patient is under age 18 or unable to authorize consent.Acrobat PDFMaker 15 for Word