Ulthera DeepSEE DS 4 - 4.5, Instructions For Use Manual

Page: 9 / 72

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 active 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.
Warning: 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.