Juvashape Ultra Informed Consent Form

The Alma V-Shape Ultra system is an FDA approved radio frequency (RF) & ultrasound (US) based device. The RF system is indicated for the non-invasive treatment of wrinkles and rhytids, to tighten and tone the skin anywhere on the body or face, and for the temporary reduction of cellulite.  When volumetric heating is applied to the area being treated, collagen bonds in the tissue are broken down and then new collagen production is stimulated.  The RF system is also used off label to reduce fat deposits anywhere on the body or face. If the device is being used for fat reduction, heat will liquefy fat cells and the body's lymphatic system will naturally process it and flush it from the body through urine and feces. Best results with the RF system are typically seen after 2 to 10 treatments and 3-6 months after the last treatment.  The US system is indicated to deliver selective US energy that can disrupt subcutaneous adipose tissue to provide a non-invasive approach to achieve a desired aesthetic effect anywhere on the body or face. The US energy will cause the fat cell membranes to breakdown and permanently destroyed and the body’s lymphatic system naturally will process the broken down fat cells and flush it out from the body through urine and feces. Best results with the US system are typically seen after 2 to 4 treatments and 2-4 weeks after the last treatment. 

I understand that clinical results may vary depending on individual factors including but not limited to medical history, prior liposuction of area being treated, skin type, compliance with pre/post care instructions and individual response to treatment. I understand that for purposes of fat/cellulite reduction, I must maintain good dietary habits, have sufficient intake of water and participate in light physical activity as well as comply with other items outlined in pre/post care instructions for best results. I understand that there is no guarantee of results or assurance that I will be satisfied with my results. 

Contraindications For The RF Treatment Include:

Systemic high blood pressure (systolic pressure >140mm/Hg and diastolic pressure > 95mmHg)
Glaucoma
Pregnancy or IVF procedure
Skin conditions / irritated skin
Phlebitis and blood-clotting
Cancer
Hormonal therapy existing or history of any skin malignancy
Active collagen or vascular disease
Recent (less than 6 months) use of Isotretinoin (Accutane)
Implantable pacemaker or automatic defibrillator/ cardioverter (AICD)
Large dental metallic prosthetic implants
Multi systemic diseases (diabetes, hypertension, coronary artery disease, renal insufficiency etc.)

I am aware of the following risks of the RF system, which include but are not limited to:

Mild to moderate discomfort or stinging feeling. Many patients describe an intense heating sensation especially with an aggressive treatment.
Redness and/or swelling of the skin lasting up to 24 hours.
Dry skin may occur at the first 12 hours post-treatment. Usually it will resolve spontaneously within 48 hours. Lubrication with moisturizing cream can be helpful.
Increased Urination/Bowel Movements up to several days following treatments if fat/cellulite reduction is being performed.
Nausea or Flu-Like Symptoms as the body tries to process liquefied fat, if fat/cellulite reduction is being performed. 
Though rare, I am aware the following may also be considered risks of the RF system not limited to:

Burns- A burn in the treated area, although highly unlikely, may occur. If a burn does occur, they will typically heal over time without issue with conventional treatment. However, it is possible, although extremely rare, that the burn will lead to scarring or pigment changes in the skin. 
Contraindications For The US Treatment Include:

Undiagnosed somatic pain.
Cancer
Active tuberculosis.
Psoriasis
Decreased circulation.
Infection
Pregnancy
Central nervous system tissue.
Plastic components.
Pacemakers
Thrombophlebitis
Uncontrolled bleeding or blood-thinning medication (Coumadin).
Reproductive organs.
Heart disease
Abdominal wall hernias.
Diabetes
Hepatitis
HIV positivity
History of exposure to highly fat-soluble compounds.
I am aware of the following risks of the US system, which include but are not limited to:

Mild to moderate discomfort or stinging feeling. Many patients describe an intense heating sensation especially with an aggressive treatment.
Redness and/or swelling of the skin lasting up to 24 hours.
Dry skin may occur at the first 12 hours post-treatment. Usually it will resolve spontaneously within 48 hours. Lubrication with moisturizing cream can be helpful.
 Urination/Bowel Movements up to several days following treatments if fat/cellulite reduction is being performed.
Nausea or Flu-Like Symptoms as the body tries to process liquefied fat, if fat/cellulite reduction is being performed. 

Though rare, I am aware the following may also be considered risks of the US system not limited to:

Burns- A burn in the treated area, although highly unlikely, may occur. If a burn does occur, they will typically heal over time without issue with conventional treatment. However, it is possible, although extremely rare, that the burn will lead to scarring or pigment changes in the skin. 

I understand that these treatments may involve risks of complication from both known and unknown causes, and I freely assume those risks. Prior to receiving treatment, I have been candid in revealing any condition or habits that may have a bearing on this procedure including but not limited to medical history, medications, supplements, skin care regimen, diet & exercise regimen, water intake, etc. 

 

What to Expect During the Treatment

An Alma V-Shape Ultra treatment of the body or face can take 15min to 60min per treatment area. The areas to be treated will be marked on your skin.  The Alma V-Shape Ultra treatment heads will be placed on each treatment area moved in a circular motion until the treatment is complete.

You cannot have any lotions, cream or oils applied to the skin area to be treated. Please before coming in for treatment, do not any apply lotions, creams or oils to the treatment area.

During the treatment, some patients experience discomfort, pain, cold, prickling, tingling or warmth. To maximize your comfort, please be vocal with your practitioner of your constant tolerance to the treatment.

Most patients can return to their normal daily activities after each treatment.

 

I consent and authorize Timeless Beauty Aesthetics my practitioner, who has been trained in the Alma V-Shape Ultra system, to perform the treatment on me. I agree to pay for this treatment. I understand that I have the right to refuse or stop treatment at any time, but that no refunds will be provided once treatments are performed (including and even if I am dissatisfied with my result after completion of the treatment series). 

I certify that I have read this entire informed consent and that I understand and agree to the information provided in this form as well as the information provided in the Pre/Post Care form. Timeless Beauty Aesthetics has explained the nature of my condition, the nature of the procedure, alternative treatments, and the benefits to be reasonably expected compared with alternative approaches. I have been given the opportunity to ask questions. This document is a written confirmation of these discussions. 

I agree that this consent supersedes any previous verbal or written disclosures. This consent is valid for all of my Alma V-Shape Ultra treatments in the future as well.