Equipment Use And Care; Ergonomic Safety; Medical Ultrasound Safety - Ulthera DeepSEE DS 4 - 4.5 Instructions For Use Manual

To avoid a burn hazard, remove the transducer from the patient before
performing HF electrosurgical procedures.

4.2. Equipment Use and Care

Caution: Failure to observe these precautions may void the warranty.
The Ulthera handpiece connectors must be kept clean and dry. Do not use
the transducer if the connectors have been immersed in liquid. See the
instructions for cleaning the transducer.
Every effort has been made to make the transducers as rugged as possible;
however, they may be permanently damaged if dropped onto a hard
surface or if the membrane is punctured. Transducers damaged in this
manner are not covered by the warranty.
The Ulthera System has no user-serviceable components. Do not attempt to
open the control unit enclosure or transducers. Contact Ulthera, Inc. if service
is required.
W hen not in use by trained personnel, the Ulthera System Access Key should
be removed from the system to help prevent unauthorized use. Keep the
Ulthera System Access Key in a designated place accessible only to
authorized and trained personnel.

4.3. Ergonomic Safety

W arning: Ultrasound scanning has been associated with repetitive
motion injuries such as carpal tunnel syndrome. To reduce chances of
such injury, maintain a balanced, comfortable posture while scanning,
avoid gripping the handpiece too tightly, and keep hands and arms in
a comfortable position while using.

4.4. Medical Ultrasound Safety

W arning: Use this system only if you are trained and qualified to do so.
The Ulthera System has a fixed, non-adjustable output power level for
imaging, well below the limits set by FDA guidelines. However, ultrasound
exposure times should be limited to the shortest amount of time needed to
complete the treatment. The ALARA principle (As Low As Reasonably
Achievable) can be followed by minimizing the examination time. (See
explanation of ALARA in the Technical Information Manual).
If the system displays unusual / inconsistent behavior, discontinue use and
contact Ulthera, Inc.
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