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Ulthera, Inc.
®
Use the Cellfina
System for Subcutaneous Release according to the following steps:
1)
Ensure anesthetic solution has had sufficient time to diffuse and take effect.
2)
Insert the blade assembly onto the Motor Module.
3)
Remove the anesthesia Guidance Platform and replace with either of the desired release area platforms
(see Figure 2).
4)
Place Vacuum Handpiece over the desired treatment area.
5)
Turn on vacuum to the Handpiece by means of the footswitch and set the vacuum pressure gauge to
approximately 40kPa.
6)
Visually confirm that the tissue is sufficiently elevated up against the underside of the Vacuum
Handpiece lid such that the circle of contact is coincident with, or distal to, the rectangular release
reference mark (see Illustration above). If not, increase vacuum level or release vacuum and reposition.
WARNING
Vacuum Handpiece lid with sufficient margin for safe release of the areas
illustrated. Do not operate without proper vacuum acquisition of the treatment
area.
WARNING
sharps precautions and handle with care once the blade cover has been
removed.
WARNING
Discard the Microblade Assembly immediately if there any signs of damage;
including, but not limited to, bent blades, damaged blades, or bent blade shafts.
DO NOT attempt to straighten either the blade or the blade shaft.
WARNING
ensure it is fully connected.
7)
Remove blade cover from the Micro-Blade Assembly. Insert the Module into the platform Guidance
Track such the Guide Pin is within the guide pin entry and the tip of the blade is in front of the septum
entry of the Handpiece base.
8)
Advance the Module through the Skin Insertion Track section (See Figure 5) until the Guide Pin comes
to a stop on the proximal arc of the Guidance Track and the blade pierces the dermis.
1007270IFU Rev D
®
Cellfina
System
The skin must be elevated up against the underside of the
The Microblade Assembly contains a sharp blade. Use standard
Visually inspect the Microblade Assembly prior to and during use.
Visually inspect the Motor module to power supply connection to
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