Section 6: Treatment Information
6.1 Training Requirements
This manual is not intended to be a complete clinical guide to the use of the System. All
users should be trained prior to operating the BodyTite. Updated treatment protocols
and recommendations are presented in the Quick Reference Guide (QRG).
6.2 Indications for Use
The BodyTite system is intended for use in dermatological and general surgical
procedures for electrocoagulation and hemostasis.
6.3 Contraindications
▪ DO NOT USE in patients who have electronic implants such as cardiac pacemakers or
internal defibrillators without first consulting a qualified professional (e.g.,
cardiologist). A possible hazard exists because interference with the action of the
electronic implant may occur, or the implant may be damaged.
▪ The Handpiece should be used at least 1cm away from cochlear implants in the ear.
▪ Permanent implant in the treated area such as metal plates and screws, silicone
implants or an injected chemical substance, unless deep enough in the periosteal
plane.
▪ 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.
▪ Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and
hormonal virilization.
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