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TRUSCULPT OPERATOR MANUAL
D1395, REV. K, 02/18
Expected Transient Events and Possible Adverse Effects
Radio frequency treatment may cause the following side effects (in alphabetical order): bleeding,
bruising, burns, blisters, crusting, discomfort and pain, infection, lumps, numbness, redness, scabs,
scarring, skin color changes, swelling, tenderness. It is important that if you develop blisters and scabs,
you not pick or scratch the area as this may cause an infection. If the area does become infected, you
may need to take oral antibiotics (i.e., drug that kills bacteria and other germs). There is a risk of scarring
if the area becomes infected and is not properly taken care of.
Treatment Precautions
The truSculpt should only be operated by qualified personnel who have received appropriate training.
The following safety precautions are recommended:
WARNING
For patients with cardiac pacemakers or other active implants, a
possible hazard exists because interference with the action of the
pacemaker may occur, or the pacemaker may be damaged. In case
of doubt, approved qualified advice should be obtained.
WARNING
Ensure that there is a minimum of 1 cm thickness of soft tissue in
the treatment area to allow for current delivered through the skin to
disperse.
WARNING
Do not treat on the neck over the trachea or thyroid cartilage.
CAUTION
Evaluate patients for predisposing medical problems that may be
aggravated by the stress of RF energy.
CAUTION
Excessive doses of RF energy may cause damage to tissue.
Periosteal pain is an indication of excess intensity; if it occurs,
reduce the treatment duration or exposure.
CAUTION
Apparent low power output or failure of the system to function
correctly at normal operating settings may indicate faulty application
of the return electrode or poor contact in its connections. In this
case, the application of the return electrode and its connections
should be checked before selecting a higher output power.
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