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Warning: Use this system only if you are trained and qualified to do so.
Warning: If any problems occur during system operation, ask immediate
action(s): lift the transducer off the patent’s skin, press the STOP button to
completely halt system operation.
2.5. Potential Side Effects
Side effects reported in the clinical evaluation of the RF system were mild and
transient in nature.These were limited to:
Erythema (redness): The treated area may exhibit erythema immediately following
Treatment. This typically resolves within a few hours of treatment.
Edema (swelling)rythema (redness): The treated area may exhibit erythema
immediately following Treatment. This typically resolves within a few hours of
treatment.
Pain: Momentary discomfort may be experienced during the procedure while
energy is being deposited. Post procedure discomfort or tenderness to the touch is
also possible.
Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels,
may occur occasionally and typically resolves within a few days of treatment.
Nerve Effects:
Transient local muscle weakness may result after treatment due to
inflammation of a motor nerve.
Transient numbness may result after treatment due to inflammation of a
Sensory nerve.
Transient pain, paresthesia and/or tingling may be experienced
No permanent injuries to facial nerves have been reported
Scarring: The possibility for scar formation ( which may respond to medical care)
May exist if incorrect treatment technique is used
3. System Overview&operation guide
3.1 Control Unit & Handpiece