Indications For Use; Contraindications; Warnings - Ulthera Cellfina CM1 Instrucciones De Uso Del Sistema

Ulthera, Inc.

INDICATIONS FOR USE

Cellfina is intended for long-term reduction of cellulite, up to three years, by precise release of targeted structural
tissue (fibrous septae).

CONTRAINDICATIONS

The System should not be used on patients who have (or who are):

Coagulant disorders

Diabetic

Excessive obesity

Had recent surgery (6
weeks)

WARNINGS


Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or
attendants and may have an adverse effect on procedural outcomes.

The safety and effectiveness of the Cellfina
females between the ages of 25 and 55, with a body mass index (BMI) between 18 and 35, and with
moderate to severe cellulite. Safety and effectiveness in other anatomical areas or in patients outside of
these criteria has not been established.

The safety and effectiveness of more than one treatment with the Cellfina
established.

The sterile products provided as part of the Cellfina
cleaning and disinfection instructions, reference CLEANING, DISINFECTION, AND MAINTENANCE). Do
not re-use or re-sterilize. Re-sterilization of the device or components may result in a risk of device
malfunction and/or contamination due to residual fluids/tissue in the device.

Do not operate the Cellfina
flammable anesthetics, or oxygen administering equipment is used.

®
The Cellfina System Motor Module and Power Supply are intended for indoor, dry area use only. Do not
allow to be exposed to liquids. Never immerse any of the components in any liquid, or place the product
where it can fall or be pulled into liquid.

Make sure the Cellfina
plugging in the AC Power Cable.

Avoid using around alcohol or other flammable solutions. If alcohol is used to clean any component, assure
that the product is dry and the area ventilated of fumes before plugging in.

To avoid electrical shock, never clean the Cellfina
supply plugged in or the Motor Module powered on.

The Anesthesia Delivery Needle and Micro-Blade Assembly contain sharp areas – handle with extreme
caution and dispose of in appropriate sharps containers per standard practice.

Do not sterilize any of the Cellfina

Prior to use, inspect packaging for damage or breach of sterile packaging seals. Do not use product if there
is any evidence of damage or breach.

There are no user serviceable or replaceable parts inside the Cellfina
Supply. Do not open housings under any circumstances.

Inspect the Motor Module before use. Do not use the Motor Module if it is damaged or has cracks in the
housing.

No modification of this equipment is allowed.

The Motor Module is verified for treatment of up to 50 procedures.
1007270IFU Rev D
®
Cellfina System

On anticoagulant medications

Phlebitis and vasculitis

Pregnant

Skin infections/ open lesions
®
System has been evaluated in the buttocks and thighs of adult
®
System Motor Module and Power Supply where aerosol (spray) products,
®
System Motor Module and Power Supply and your hands are completely dry before
®
System components.




®
System are for single use only (for motor module
®
System Motor Module and Power Supply with the power
®
User Manual
Uncontrolled hypertension
Tumors
Vascular fragility
Varicose veins (in the area of
treatment)
®
System has not been
System Motor Module or Power
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