Ulthera, Inc. Page 9
The Ulthera System has not been evaluated for use in patients on an
anticoagulant treatment plan.
It is recommended that the following areas should be avoided during
treatment:
• Thyroid gland, thyroid cartilage and trachea
• Major vessels
• Breast tissue or breast implants
The Ulthera System has not been evaluated for use in the following patient
populations:
• Pregnant or breast feeding women
• Children
• Those with the following disease states
o A hemorrhagic disorder or hemostatic dysfunction
o An a cti ve systemic or local skin disease that may alter wound
healing
o Herpes Simplex
o Autoimmune Disease
o Diabetes
o Epilepsy
o Bell’s Palsy
2.4. Patient Safety
Warning: Ulthera should not be used on a patient’s eyes or in a location
or technique where ultrasound energy can reach the eye.
Warning: Use this system only if you are trained and qualified to do so.
W arning: If any problems occur during system operation, take
immediate action(s): lift the transducer off the patient’s skin, press the
See pushbutton on handle to discontinue treatment in progress, and/or
press the red emergency Stop button to completely halt system
operation.
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