Patient Safety - Ulthera DeepSEE DS 4 - 4.5 Instructions For Use Manual

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
o Herpes Simplex
o Autoimmune Disease
o Diabetes
o Epilepsy
o Bell's Palsy

2.4. Patient Safety

W arning: Ulthera should not be used on a patient's eyes or in a location
or technique where ultrasound energy can reach the eye.
W arning: 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.
Ulthera, Inc.
healing
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