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Section 8: Tite Treatment Information
8.1 Indications for Use
The EvolveX System with the Tite Applicator units is indicated for the
temporary relief of minor muscle aches and pain, temporary relief of
muscle spasm, and temporary improvement of local blood circulation.
8.2 Contraindications
▪ Pacemaker or internal defibrillator, or any other metallic or electronic
implant anywhere in the body. The Applicator should be used at least
1cm away from cochlear implants in the ear.
▪ Permanent implant in the treated area such as metal plates, screws and
metal piercing, silicone implants or an injected chemical substance,
unless deep enough in the periosteal plane.
▪ Intra-dermal or superficial sub-dermal areas that have been injected
with HA/collagen/fat injections or other augmentation methods with
bio-material during last 6 months.
▪ Current or history of skin cancer, or current condition of any other type
of cancer, or pre-malignant moles.
▪ Severe concurrent conditions, such as cardiac disorders, sensory
disturbances, epilepsy, uncontrolled hypertension, and liver or kidney
diseases.
▪ Pregnancy and nursing.
▪ Impaired immune system due to immunosuppressive diseases such as
AIDS and HIV, autoimmune disorders or use of immunosuppressive
medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent
Herpes Simplex in the treatment area, may be treated only following a
prophylactic regimen.
▪ Poorly controlled endocrine disorders, such as diabetes or thyroid
dysfunction and hormonal virilization.
▪ Any active condition in the treatment area, such as sores, psoriasis,
eczema, and rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as
very dry and fragile skin.
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