instructions for use indications for use contraindications
Contents
1. 9 4069 fax 480 619 4071 www ultherapy com ulthera e 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 e There are no user serviceable or replaceable parts inside the Cellfina System Motor Module or Power Supply Do not open housings under any circumstances ADDITIONAL WARNINGS Additional boxed warnings are provided within the Directions for Use Section of the IFU for specific procedural steps PRECAUTIONS e The Cellfina System should only be used by physicians who have read and understood the User Manual e To protect sterility after opening the blade and needle should remain covered prior to use RISKS Potential adverse events are those typically associated with anesthesia infiltration liposuction Subcision and other methods of body sculpting including e Abscess e Hematoma e Red Spots from needle e Anetoderma e Hemosiderosis punctures e Anxiety nervousness e Hyperpigmentation e Redness erythema or rash apprehension e Hypopigmentation e Scarring or keloid formation e Blanching generalized e Induration fibrosis e Sensations of heat or cold whiteness e Infection e Seroma e Blurred or double vision e Inflammation generalized e Skin necrosis e Bleeding redness e Skin surface convexity e Dizziness drowsiness e Nausea vomiting depression or other confusion e Numbness tingling or sensitivity irregularity e2. Ecchymosis bruising change e Soreness or discomfort pain e Fluid accumulation e Petechiae or purpura vacuum e Tinnitus swelling edema acquisition marks e Toxic allergic or other e Fluid extravasation reaction from the injected anesthetic COMPLAINTS AND ADVERSE EVENTS No serious adverse events were observed during the clinical study evaluation of the Cellfina System Ulthera follows MDR Medical Device Reporting rules for handling complaints and adverse events Should an adverse event be suspected or reported contact Ulthera Inc at 1 877 ULTHERA NOTE This document is for web purposes only It has been condensed from its original version For additional information contact 1 877 ULTHERA 1004297A Ulthera Inc 1840 S Stapley Drive Suite 200 Mesa AZ 85204 tel 480 619 4069 fax 480 619 4071 www ultherapy com
3. s part of the Cellfina System are for single use only 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 e Do not operate the Cellfina System Motor Module and Power Supply where aerosol spray products flammable anesthetics or oxygen administering equipment is used e 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 e Make sure the Cellfina System Motor Module and Power Supply and your hands are completely dry before plugging in the AC Power Cable e 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 e To avoid electrical shock never clean the Cellfina System Motor Module and Power Supply with the power supply plugged in or the Motor Module powered on e 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 e Do not sterilize any of the Cellfina System Motor Module and Power Supply Ulthera Inc 1840S Stapley Drive Suite 200 Mesa AZ 85204 tel 480 61
4. ulthera cel system INSTRUCTIONS FOR USE INDICATIONS FOR USE The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 1 year of observation CAUTION Federal law restricts this device to use by or on the order of a physician CONTRAINDICATIONS The System should not be used on patients who have or who are e Coagulant disorders e On anticoagulant medications e Uncontrolled hypertension e Diabetic e Phlebitis and vasculitis e Tumors e Excessive obesity e Pregnant e Vascular fragility e Had recent surgery 6 e Skin infections open lesions e Varicose veins in the area of weeks treatment WARNINGS e 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 e The safety and effectiveness of the Cellfina System has been evaluated in the buttocks and thighs of adult 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 e The safety and effectiveness of more than one treatment with the Cellfina System has not been established e The sterile products provided a
Download Pdf Manuals
Related Search