TempSure™ Vitalia Indications and Safety Information

Like all medical procedures, not all patients are suitable for TempSure Vitalia. Practices may elect to have patients sign a consent form that they are aware of the indications and potential side effects. This is an elective procedure and not covered by insurance or eligible for flexible spending account reimbursement.

Indications

• The 18mm handpiece provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

Contraindications

• As with any procedure, it is the physician’s responsibility to determine whether the TempSure-RF Generator is an appropriate treatment option for the patient.  Should the patient meet any of these Contraindications they should not receive treatment.
• The patient has a cut, wound, or infected skin on the area to be treated.
• The patient is on local, oral, or systemic anesthetic agents.
• The patient is unable to wear the Ocular Shields when required.
• If the client has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment. Consult with the health care manager before turning off a client’s electronic device.
• The client has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client’s cardiologist must be consulted prior to treatment.
• The client is allergic to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the neutral pad site and an over the counter solution may be used to treat the area.
• The client is allergic to gold, such as the metallic covering of the TempSure handpieces.
• If the client is allergic to corn, such as the corn derivative ingredient in Parker Aquasonic Gel.
• If the client has an unhealthy expectation of the results – this is not plastic surgery and all clients should be fully informed of the treatment’s expected results.
• If the neutral pad would need to be placed on a client that has a metal plate, rod, or any metal implant that could conduct heat from the Smart Handpiece or surgical handpiece.
• The client has nerve insensitivity to heat in the treatment area.
• The client has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated – this treatment will be ineffective.
• The client has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
• Studies of the use of the RF generator on clients that have any of the following conditions is unknown:
  • pregnant
  • autoimmune disease
  • diabetic
  • herpes simplex

NOTE: A qualified practitioner is solely responsible for evaluating each subject’s suitability to undergo a RF procedure and for informing about any risks involved with the procedure, pre-and postoperative care, and any other relevant information. Like all medical procedures, not all patients are suitable for the procedure. Physicians and patients should discuss the procedure and review the risks and benefits of this procedure.