Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Exclusion Criteria

• •1. Patient is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female patients of child-bearing potential), or intends to become pregnant during the study or is not using effective methods to prevent pregnancy.
• •2. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
• •3. Keloid scars, hypertrophic scars or a history of abnormal healing.
• •4. Thrombophlebitis.
• •5. Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
• •6. Tissue ischemia in the area to be treated.
• •7. Hypertension or abnormally high blood pressure.
• •8. High cholesterol.
• •9. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
• •10. Diabetes.
• •11. Epilepsy.
• •12. Tuberculosis.
• •13. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
• •14. Endocrine syndromes or thyroid hyperfunction.
• •15. Any type of hemorrhagic (bleeding) status.
• •16. Active skin infection, any infection in the treated area within the last 30 days or skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria, dermographism).
• •17. Hepatic or renal insufficiency.
• •18. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
• •19. Malignancy in the area to be treated.
• •20. Laminectomy in the area to be treated. 5.2. Withdrawal and Replacement of Subjects