Subcutaneous Release - Ulthera Cellfina CM1 Instrucciones De Uso Del Sistema

Ulthera, Inc.
10) With reference to Figure 3, place the Anesthesia Handle on platform such that the guide pin is in the guide
pin entry and the needle is in front of the elastomeric septum entry in the base of the Vacuum Handpiece.
Slowly push the Anesthesia Handle forward until it hits the stop in the insert.
11) Verify that the needle tip has penetrated the skin. If the tip of the needle has not fully-penetrated the outer
surface of the dermis, then the user should remove the needle and reposition the Handpiece in an attempt to
achieve improved tissue-capture.
12) Choose one of the 4 lateral Guidance Tracks by moving the Anesthesia Handle to that track. Advance
Handle along Guidance Track until it stops.
13) Depress the syringe plunger to deliver the desired fluid bolus. Once inserted, the needle can be retracted
within the track (the needle does not exit the subcutaneous space) and moved to subsequent lateral tracks
and the syringe used to infuse the other areas with the solution.
14) Retract the syringe plunger to refill as necessary. Once a target site has been properly infused, remove the
needle by moving the handle guide pin into the entry/exit region. Repeat process for subsequent sites until
the areas of intended release have been properly infiltrated.
15) Allow anesthetic to take effect per physician direction.
It is recommended that all sites to be treated are anesthetized first and then subsequently released to allow
for sufficient dwell time of the anesthesia. Anesthesia chosen and doses used are at the discretion of the
treating physician.
After the anesthetic has taken effect, the same Vacuum Handpiece is used for the subcutaneous release
part of the procedure by replacing the anesthetic Guidance Platform with the preferred release Guidance
Platform (see Figures 1 and 3) and used as described below.

Subcutaneous Release

Subcutaneous release is accomplished through the mechanical action of a single-use reciprocated Micro-Blade
Assembly (Figure 5) attached to the reusable Motor Module which is moved by the user through a fixed path in
the Guidance Platform (Figures 1 and 4). The sterile Micro-Blade Assembly is snapped onto the Motor Module
and the Module placed in the Platform such that the Guide Pin fits in the entry point to the Guidance Track Insert
(see Figure 4). Prior to powering on the Motor Module, the Module is advanced in through the Skin Insertion
Section of the Guidance Track and the blade tip pierces the skin, bringing the blade to the target depth. Once
the Module is in the forward position on the Insertion Section of the Track, the Motor Module is turned on, and
the Guidance Track followed to create the subcutaneous release. There are 2 different release area Guidance
Platforms (Figure 2). Partial completion of the arcs in the Rectangle Platform as illustrated below can be
effectively used to release areas smaller than the complete rectangle area for smaller, isolated depressions.
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Cellfina System User Manual
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