Vacuum -Assisted Tissue Capture And; Guidance; Anesthesia Introduction - Ulthera Cellfina CM1 Instrucciones De Uso Del Sistema

Ulthera, Inc.
Vacuum-Assisted Tissue Capture and Guidance
®
The Cellfina System Vacuum Handpiece (Figure 2) has a body and a removable lid which provides two depths,
6 and 10 mm, for the recess into which the tissue is drawn. The depth is visibly marked on the lid. The opening
for the anesthetic delivery needle and release blade (used later) is sealed with an elastomeric septum. The
vacuum line from the commercially available suction pump with footswitch attachment is attached to the
Handpiece where illustrated. The same Handpiece is used for both the infusion of the anesthetic solution and
subcutaneous release by way of interchangeable Guidance Platforms as described below.

Anesthesia Introduction

The infusion needle and guidance of the Cellfina
guided in the subcutaneous space at the exact depth of the intended release utilizing the Vacuum Handpiece
and associated anesthesia needle Guidance Platform. These components should be used with a manual
syringe and tubing set containing 1 way valves and labeled for the purposes of local anesthesia infiltration.
WARNING
The Anesthesia Handle contains a needle which may come loose during shipping.
standard sharps protocol when handling. Needle should be firmly attached to Handle prior to use.
The target volume per application of the Vacuum Handpiece is 24 ml. Use the kit according to the following
steps with the Cellfina
1) Prepare the anesthetic solution (IV bag) per standard treating physician direction.
2) Prepare the syringe set per the product instructions for use. This syringe set may be obtained through
Ulthera, Inc.
3) The Anesthesia Needle is pre-connected to the Handle but not tightly secured. Remove the Anesthesia
Needle Assembly and press the needle firmly onto the handle luer.
extension line to the female luer on the Anesthesia Needle Assembly.
CAUTION
the handle may result in the user dropping the needle, requiring the use of an additional sterile kit.
4) Insert the spike into the IV bag containing the anesthesia solution and open the roller clamp.
5) Remove the needle cover and ensure that needle hub is secure to Anesthesia Handle and the holes are
horizontal.
6) Retract and depress the syringe plunger to fill the syringe with the fluid by repeating the process until all the
air is purged from the system and needle.
7) Verify the desired depth of delivery or invert the Vacuum Handpiece lid to switch between the 6 and 10 mm
depth settings. Note: the 6 mm configuration is recommended, unless connection or overlapping of released
sites will result. Place Vacuum Handpiece over the desired treatment area.
8) Turn on vacuum to the Handpiece by means of the footswitch and set the vacuum pressure gauge to
approximately 40kPa.
9) Visually confirm that the tissue is uniformly elevated into the vacuum recess. Insertion of the Anesthesia
Needle for this site should proceed only if the circle of contact is coincident with, or distal to, the rectangular
release reference mark on the Vacuum Handpiece lid (see Illustration below). If not, increase vacuum level
or release vacuum and reposition.
WARNING
with sufficient margin for safe release of the areas illustrated. Do not operate without proper vacuum
acquisition of the treatment area.
1007270IFU Rev D
Cellfina
®
System.
The needle comes pre-connected but not tightly secured. Failure to secure the needle to
The skin must be elevated up against the underside of the Vacuum Handpiece lid
®
System
®
System (Figure 1) utilizes a 22G multi-hole needle which is
User Manual
Connect the male luer from the
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Use