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Idiomas disponibles
Idiomas disponibles
Ulthera, Inc.
If the areas are slow to improve, patients can be asked to perform firm massage with their fingertips for
a few minutes a day until resolved.
Supply and Conditions for Use
Sterile Components
®
The Cellfina
System Kit components are provided in an internal tray which has a clear plastic lid. This internal
tray is packaged within a Tyvek® sealed outer tray so that the inner tray can be removed and placed within the
sterile prep area. Each Cellfina
for the reusable Motor Module.
WARNING
Prior to use, inspect packaging for damage or breach of sterile packaging. Do not use
product if there is any evidence of damage or breach.
The sterile products have limited shelf life. The devices must be used on or before the "Use By Date" provided
on the package.
Motor Module and Power Supply
®
The Cellfina
System Motor Module and Power Supply (Figure 6) are reusable and packaged together. The
Motor Module connects to the Power Supply, which is part of the system, in only one orientation insuring proper
contact. Only use the Motor Module with the provided power supply. Use of a foreign power supply can lead to
malfunction and/or patient injury. Approved models and manufacturers are listed in the Specification section. The
Motor Module and Power Supply should be cleaned and disinfected prior to use. See Cleaning, Disinfecting and
Maintenance section. A sterile cover for the Motor Module is provided within the Cellfina
WARNING
Prior to use, inspect packaging and do not use product if there is any evidence of damage.
The Motor Module is verified for 50 procedures, in which each procedure is to be recorded on the Cellfina
Procedure Tracker. Do not use beyond this limit.
®
Cellfina
Procedure Tracker
®
The Cellfina
System Motor Module has been verified for a maximum of 50 procedures, and comes with a
®
"Cellfina
Procedure Tracker" booklet designed to track the use of the Motor Module. After each use, record the
date and initial that a procedure has been completed. Prior to the Motor Module reaching 50 uses, contact
Ulthera to order a replacement. Please maintain two (2) Motor Modules so a backup is available in case of a
Motor Module malfunction.
Storage
Store components at room temperature, in a clean, dry location. Avoid prolonged exposure to elevated temperature.
The Temperature, Humidity and Atmospheric Pressure conditions listed below are recommended.
Ambient temperature range of - 18° C to +60° C;
Relative humidity range of 15 % to 90 %, including condensation.
Atmospheric pressure range of 70 kPa to 106 kPa.
Additional Necessary Supplies
The following supplies are commercially available and are not included with the Cellfina
Local injectable anesthetic solution per prescribing physician direction.
Topical anesthetic, if desired (not utilized in previous clinical studies).
Sterile gauze and surgical tape.
Compressive garments (per physician direction).
1007270IFU Rev D
®
Cellfina
System
®
System Kit is sterilized by Ethylene Oxide gas (EO) and contains a sterile cover
User Manual
®
System Kit.
®
®
System:
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