Section 6 - Treatment Information; Indications For Use; Contraindications - InMode System with BodyFX Handpiece Operator's Manual

Section 6 - Treatment Information

Indications for Use

InMode System with the BodyFX Handpiece is intended for the treatment of the
following medical conditions using non thermal RF combined with massage:
 Relief of' minor muscle aches and pain, relief of muscle spasm, temporary
improvement of local blood circulation.
 Temporary reduction in the appearance of cellulite.
 Temporary improvement of circumferential reduction and body contouring.

Contraindications

Contraindications in the use of the System include:
 Pacemaker or internal defibrillator, or any other active electrical implant anywhere in
the body.
 Permanent implant in the treated area such as metal plates and screws, silicone
implants or an injected chemical substance, unless deep enough in the periostal plane.
 Current or history of cancer, or current condition of any other type of cancer, or pre-
malignant moles.
 Severe concurrent conditions, such as cardiac disorders, 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.
 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.
 History of bleeding coagulopathies, or use of anticoagulants in the last 10 days.
 Any surgery in treated area within 3 months prior to treatment.
 Use of Isotretinoin (Accutane
InMode BodyFX Operator Manual
®
) within 6 months prior to treatment.
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