TempSure FIRM
Contraindications

• 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 when using Smart Handpieces.
• The patient is unable to wear the Ocular Shields when required.
• The patient has medical conditions with potentially decreased function of the peripheral nervous tissue, such as but not limited to diabetes or multiple sclerosis.
• Aesthetic application in women who are pregnant and/or breastfeeding.
• If the patient has a metal implant that interferes with the transmission of energy to the electrical field, they are not eligible for any RF treatment.

Discuss treatment consideration with practitioner when the following criteria is met:

• If the patient 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.
• Do not use the TempSure Generator with patients that have electronic implants without first consulting a qualified professional. The TempSure Generator has not been tested in conjunction with: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices, and may interfere with the functionality of the device and/or damage the electronic implant.
• The patient is allergic to adhesives, gold, or corn.
• If the patient has an unhealthy expectation of the results – this is not plastic surgery and all patients should be fully informed of the treatment’s expected results.
• The patient has nerve insensitivity to heat in the treatment area, or in the neutral pad placement area.
• The patient 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 patient has used Accutane (Isotretinoin) less than 12 months prior to treatment.
• If the patient is prone to fever blisters, they should receive a prophylactic antiviral medication regimen prior to treatment.
• If the patient has high levels of dyschromia, photo damaged skin, or any lesions that have not been evaluated.
• The patient has applied fillers to the area to be treated less than four weeks prior to treatment.
• The patient has used Retinoid in the last seven days in the area to be treated.
• The patient has used a Glycolic Acid peel in the last two to three months in the treatment area to be treated.
• Use caution when treating patients with melasma, as heat may increase symptoms.
• Use caution when treating areas that have tattoos, permanent makeup, and permanent brows.
• The patient has active cystic acne in the areas to be treated.

*Treatment using the TempSure is unstudied and unknown for the following populations: pregnant patients and patients with autoimmune diseases, diabetes, herpes simplex, and patients with recently applied fillers or neurotoxins to the treatment area.