Secret DUO

Indications for Use: Secret DUO 1540 nm is indicated for dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. Secret DUO RFMN is FDA cleared for dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Contraindications: Patients using a pacemaker or another implantable metal medical device; Patients with an unknown skin disease; Pregnant women; Patients who have a piercing on the treatment area; Patients with a hemostatic disorder; Patients who are receiving treatment for skin cancer or have a history of cancer; Patients who have symptoms such as sores, psoriasis, eczema, or a rash on the treatment area; Patients who are sensitive to hot sensation or who have any type of suspected lesions on the treatment area; Patients who have any immunosuppressive disease such as AIDS and HIV or any immune system disorder due to the use of immunosuppressants. Treat only known benign lesions. (Do not treat dysplastic nevus or suspected pigmented lesions) Treatment should not be performed on an area of skin with a tattoo or permanent make-up. Special caution should be exercised for the following patients during treatment. Patients who have received a Botox/collagen/fat dissolving injection or augmentation through the injection of a substance into the treatment area in the last six months; Patients who have thin skin due to multiple laser or RF treatments; Patients with a medical history of repeated conditions on the treatment area caused by heat stimulation, such as herpes simplex: Such patients should receive prophylaxis before treatment. Patients with a skin disease, keloids, abnormal wound healing, or very dry, delicate skin; Patients who have undergone face lift surgery or eyelid surgery in the last year; Patients who have undergone facial dermabrasion, facial resurfacing, or deep chemical peeling in the last three months (if the face is to be treated); Patients who have received light, laser or RF treatment on the treatment area in the last month; Patients using nonsteroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofencontaining agents) a week prior to and after each treatment session; Patients who have undergone surgery on the treatment area in the last three months or where the surgery wound has not completely healed; Patients who have been exposed to UV rays or used a tanning bad or tanning cream in the last two weeks; Patients with a known sensitivity or allergy to metals (e.g., chromium, nickel, and other metals contained in the needle); Patients who have other health problems as determined by a physicianTreat only known benign lesions. (Do not treat dysplastic nevus or suspected pigmented lesions); Treatment should not be performed on an area of skin with a tattoo or permanent make-up. Special caution should be exercised for the following patients during treatment. Patients who have received a Botox/collagen/fat dissolving injection or augmentation through the injection of a substance into the treatment area in the last six months; Patients who have thin skin due to multiple laser or RF treatments; Patients with a medical history of repeated conditions on the treatment area caused by heat stimulation, such as herpes simplex: Such patients should receive prophylaxis before treatment. Patients with a skin disease, keloids, abnormal wound healing, or very dry, delicate skin; Patients who have undergone face lift surgery or eyelid surgery in the last year; Patients who have undergone facial dermabrasion, facial resurfacing, or deep chemical peeling in the last three months (if the face is to be treated);Patients who have received light, laser or RF treatment on the treatment area in the last month; Patients using nonsteroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofencontaining agents) a week prior to and after each treatment session; Patients who have undergone surgery on the treatment area in the last three months or where the surgery wound has not completely healed. Patients who have been exposed to UV rays or used a tanning bad or tanning cream in the last two weeks.

Important Safety Information: The following adverse effects can occur when treating with the Secret DUO: (i) Laser Treatment — Pigmentation change; Temporary pain; Erythema; Edema. (ii) RF Treatment — Discomfort; Pain; Swelling; Redness; Skin color changes; Milia; Acne; Wounds; Contact/Allergic dermatitis or Skin sensitivity; Infection; Scarring; Treatment Pattern; Petechiae; Dilated pores; Allergy; Sun exposure, tanning beds, artificial tanning may increase risk of side effects and adverse events.

Warnings: Adverse effects can occur when treating with the Secret DUO System for all indications. 1) Laser treatment: Pigmentation change (Dark skin patient), Temporary pain (recommend anesthesia cream),Erythema, and Edema. 2) RF treatment: DISCOMFORT/PAIN – Some discomfort and/ or pain may be experienced during treatment. A topical anesthetic will be applied to your skin before treatment. Other forms of anesthesia,
or pain management, may also be used. SWELLING – Swelling (edema) of the treated area is common and may occur. This usually resolves in a few days. REDNESS – Redness (erythema) of the treated area is common and may occur. The erythema typically resolves in about two weeks. SKIN COLOR CHANGES – During the healing process, there is a possibility that the treated area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent. You should avoid sun exposure after the treatment and use sunblock. MILIA/ACNE – Ointments that occlude hair follicles, sweat ducts, or sebaceous ducts may lead to milia/acne formation. This is more common in patients with a history of cystic acne or oily skin. WOUNDS – Treatment can result in burning, blistering, or bleeding of the treated areas. It is important that you not pick or scratch the sites as this may lead to permanent scars or promote an infection. If any of these occur, please call our office. CONTACT/ALLERGIC DERMATITIS OR SKIN SENSITIVITY – Potential increased sensitivity, irritation/itching or allergic reaction of the skin due to skin surface disruption. INFECTION – Infection is a possibility whenever the skin surface is disrupted which can lead to scarring. Proper wound care and keeping the treated area clean are important. If signs of infection develop, such as pain, heat, blisters, or surrounding redness, please call our office. SCARRING – Scarring is a rare occurrence, but it is a possibility if the skin surface is disrupted. To minimize the chances of scarring, it is IMPORTANT that you follow all post-treatment instructions provided by your healthcare staff. TREATMENT PATTERN – A persistent spot size pattern may be apparent on the treated skin and usually resolves with time. In rare cases, it may be permanent. PETECHIAE – May appear for several weeks after healing and clear without treatment. DIALATED PORES – Collagen contraction that occurs as part of the resurfacing process may also contract the skin between the pores, which widens the existing pores. This occurrence, though rare, is permanent. SUN EXPOSURE / TANNING BEDS / ARTIFICIAL TANNING – May increase risk of side effects and adverse events. ALLERGY – There is a risk of an allergic reaction to the topical anesthetic or the metal needles.

Precautions: Before treatment, make sure to check the patient’s skin condition and disinfect the area to be treated. Precautions: Before treatment, make sure to check the patient’s skin condition and disinfect the area to be treated to remove any foreign substances. Before treatment, inform the patient of any matters they must be aware of before, during and after treatment and ensure that the patient understands the risk of an unintended adverse event. Treat only known benign lesions. (Do not treat dysplastic nevus or suspected pigmented lesions) Treatment should not be performed on an area of skin with a tattoo or permanent make-up. Special caution should be exercised for the following patients during treatment. Patients who have received a Botox/collagen/fat dissolving injection or augmentation through the injection of a substance into the treatment area in the last six months; Patients who have thin skin due to multiple laser or RF treatments; Patients with a medical history of repeated conditions on the treatment area caused by heat stimulation, such as herpes simplex: Such patients should receive prophylaxis before treatment; Patients with a skin disease, keloids, abnormal wound healing, or very dry, delicate skin; Patients who have undergone face lift surgery or eyelid surgery in the last year; Patients who have undergone facial dermabrasion, facial resurfacing, or deep chemical peeling in the last three months (if the face is to be treated); Patients who have received light, laser or RF treatment on the treatment area in the last month; Patients using nonsteroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofencontaining agents) a week prior to and after each treatment session: Patients who have undergone surgery on the treatment area in the last three months or where the surgery wound has not completely healed; Patients who have been exposed to UV rays or used a tanning bad or tanning cream in the last two weeks; Patients with a known sensitivity or allergy to metals (e.g., chromium, nickel, and other metals contained in the needle); Patients who have other health problems as determined by a physician. Refer to the Operator Manual to view the laser safety labels of the product.