Idiomas disponibles
Idiomas disponibles
Ulthera, Inc.
Sterile anesthetic introduction system, containing a syringe with associated 1-way valves for IV bag use.
The system should have a minimum syringe volume of 10 ml with an accuracy of +/- 5%, with a male
luer connection on the outflow tubing set.
Additional Necessary Equipment
®
The Cellfina
System should be used with a commercially available suction pump with footswitch attachment and
accessory suction tubing/isolation canister. The negative pressure from the suction pump is used only with the
Vacuum Handpiece for the acquisition of the tissue and there is no active fluid removal or subcutaneous use of
vacuum pressure. The suction pump should have adjustable pressure with an accurate gauge (+/- 10%), be
rated for a differential negative pressure of 60 kPa and minimum of 30 liters per minute of flow. The connector
from the suction tubing to the Vacuum Handpiece of the Cellfina
DIRECTIONS FOR USE
Description of Procedure
See the
Preparing the Treatment Area:
1)
Prepare the treatment area using sterile technique similar to any other aseptic or sterile procedure.
2)
Additional commercially available supplies are recommended: Sterile Gauze, Surgical Tape, Disposable
Undergarments, and Compressive Garments (for use post treatment).
Ensure that all required ancillary equipment is available and in working condition per the manufacturer's
3)
instructions.
WARNING
if there is any evidence of damage.
Verify that device is within its "Use By Date." Do not use product if it is beyond its "Use By Date."
4)
5)
Using sterile technique, open the Cellfina
the Device elements onto the sterile area or tray.
1007270IFU Rev D
Cellfina
for patient preparation steps
Prior to use, inspect packaging for damage or breach of sterile barrier. Do not use product
®
System
®
System is a ¼" barb.
®
Disposable Kit Outer Tray and place the Inner Tray containing
User Manual
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