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Contraindications in the use of the EvolveX System in EMS-TENS mode
include:
▪ Active electrical implant/device in any region of the body, including
pacemaker or internal defibrillator.
▪ Permanent implant in the treated area such as metal plates, screws or
silicon, metal piercing or other.
▪ 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 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.
▪ 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, open lacerations, abrasions or lesions, infection in
the area to be treated.
▪ History of skin disorders, keloids, abnormal wound healing, as well as
very dry and fragile skin.
▪ History of bleeding coagulopathies or use of anticoagulants except for
low-dose aspirin.
▪ Impaired immune system due to immunosuppressive diseases such as
AIDS and HIV or use of immunosuppressive medications.
▪ Any surgical procedure in the treatment area within the last 12 months
or before complete healing.
▪ (Accutane) within last 6 months.
▪ Having received treatment with light, laser, RF, or other devices in the
treated area within 2-3 weeks for non-ablative procedures, and 6-12
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