Procedure Protocol

Pellev Wrinkle Reduction System

Pellev Procedure Protocol

The Pellev Wrinkle Reduction System is currently FDA cleared for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes IIV. Please be aware of the following warnings and precautions. Refer to all instructions provided with the products for detailed information. WARNINGS High frequency surgical equipment should be used only by persons having adequate training and familiarity with high frequency surgical equipment and related techniques. A thorough understanding of the use of high frequency surgical equipment is essential to avoid shock and burn hazards to both patient and medical personnel and dam age to the device or other medical equipment. Consult medical literature relative to related techniques, complications, and hazards prior to use of high frequency surgical equipment. Never increase the power settings without first checking both the active electrode and the neutral plate. Corneal Eye Shields (plastic, non-conductive) must be used for any radiofrequency surgical procedure involving the eyelid and the immediate surrounding areas. Treatment of wrinkles is dependent upon ongoing patient feedback. Local, oral and systemic anesthetic agents must not be used prior to or during wrinkle treatment. Patients with nerve insensitivity to heat anywhere in the treatment area should not be treated for wrinkles. Treatment of patients with nerve insensitivity may lead to patient burns or injury. Use only with Ellman accessories including Ellman handpieces, neutral plates, cables, electrodes and gels. When using an active electrode near a metal (conductive) accessory, ensure the electrode does not come into contact with the metal accessory. Electrical contacts must be completely dry prior to connection with other electrical equipment and instruments. Use of damaged equipment or wet contacts may cause electrical burns to the patient, staff, or doctor. Do not use dry heat as product damage may occur. PRECAUTIONS Treatment of Wrinkles Removing the tip from the skin when activated or touching the skin after activating the tip may result in the patient feeling an electric shock similar to a static discharge in a dry environment. Do not treat wrinkles on cut, wounded or infected skin. All jewelry and makeup, including lotions, eyeliner and eyeshadow should be removed from the treatment area. Only Pellev Treatment Gel should be applied to the surface of the patients skin prior to or during the treatment. Remove beard stubble thoroughly prior to treatment. Treatment of wrinkles using the Pellev Wrinkle Reductrion System is unstudied and unknown for the following populations: pregnant patients, patients with autoimmune disease, diabetes, herpes simplex, and patients with recently applied fillers to the treatment area. Device is fragile and may be damaged if dropped. Confirm that the ElectrodeTip moves freely prior to each use.

ADVERSE REACTIONS OBSERVED WITH TREATMENT OF WRINKLES Mild discomfort during treatment may be experienced by the patient. Typically the discomfort is temporary during the procedure and localized within the treatment area. Adjust power setting to maintain acceptable levels of patient discomfort. Mild swelling (edema) and redness may occur. Initial studies indicate that these typically resolve within 2 to 24 hours. CLINICAL DATA Six month follow-up on patients treated with the Ellman wrinkle treatment handpieces demonstrates that this system is associated with statistically significant improvements in mild to moderate facial wrinkles (p<0.01) at all time points compared to pretreatment baseline. Extended data analysis conducted on the raw data published by Rusciani et al in the Journal of Drugs in Dermatology included ninety-three consecutive patients with mild to moderate facial wrinkles who were treated with the Ellman Surgitron Dual RF and Ellman wrinkle treatment handpieces. Each patient received a single treatment and was followed for six months post treatment. Evaluation photographs were scored by three independent evaluators, blinded to time interval post treatment, per the following scale 0: Less than 25% improvement 1: 25 - 50% improvement 2: 51 75% improvement 3: Greater than 75% improvement

The correlation between the three independent evaluators was statistically significant (p < 0.01) with 90.3% of patients receiving an average score of 1.0 or higher at 30 days, 88.2% at 90 days, and 87.1% at 180 days. The mean score across all patients and evaluators is shown below.
Pellev TREATMENT RESPONSE RATE
% of Patients Showing Improvement
100 80 60 40 20 0 30 Days 90 Days 180 Days 90.3% 88.2% 87.1%

Pellev Treatment Response Rate

Percentage of patients showing improvement of mild to moderate facial wrinkles across 93 patients vs. time post treatment There were no serious adverse affects. Two patients experienced small abrasions that healed in 3 days. Three patients experienced mild asymmetries.
1

Rusciani, A. et al. Nonsurgical Tightening of Skin Laxity: A New Radiofrequency Approach. Journal of Drugs in Dermatology. April 2007. Pgs. 377-382.

PELLEV WRINKLE TREATMENT HANDPIECES The Pellev Wrinkle Treatment Handpieces are used for the treatment of facial wrinkles. Because the three dimensional physical geometry of each persons face is different, Ellman offers handpieces with four different sized tips. The different handpieces provide the physician with the ability to customize the treatment for each patient. Smaller handpieces are designed to for use in confined, delicate areas of the face or where there are geometrical areas that would be more difficult to reach with the larger handpieces. The larger handpieces are designed to treat larger areas of the face where the physician can more easily contact all the tissue with the flat surface of the larger electrodes. Ellman provides the following recommendations; however, physicians may have individual preferences. GlideSafe Wrinkle Treatment Handpieces*

P275HPD

7.5mm handpieces are optimized to treat tightly confined areas, such as near the eyes, where larger handpieces may not contact all tissue intended to be treated.

P210HPD

10mm handpieces may be used similarly to the 7.5mm handpiece, but in slightly less confined areas such as crow's feet, perioral, and the chin.

P215HPD

15mm handpieces are designed for large unconfined areas, such as the forehead or the cheeks near the nose, mouth and chin.

P220HPD

20mm handpieces may be used on larger unconfined areas such as the forehead or large areas of the cheek.

NOTE: Please see Instructions For Use provided with GlideSafe Handpieces for more information.

*GlideSafe handpieces Patent Pending

PROCEDURAL INSTRUCTIONS Set up the system with a Pellev Wrinkle Treatment Handpiece. The Pellev S5 generator should be in the Pelleve/CUT mode for all wrinkle treatments. The power settings for the treatment should be based on verbal feedback from the patient. If the patient experiences discomfort from the treatment, immediately turn the setting on the generator down to a comfortable setting. The recommended initial power setting for most patients should be:
Handpiece Size 7.5mm 10mm 15mm 20mm Recommended Initial Setting 5 15 20 25

The patient is typically relaxing in a treatment chair or on a treatment table with the user positioned close to the patients head. The Neutral Plate is placed under the patients shoulders or back, but always making full skin contact. Pellev Treatment Gel is applied to the skin in the treatment area. The gel should be applied as an even layer. The handpiece should only be activated once placed on the gel coated skin. The gel should be applied liberally throughout the procedure. After application of gel to the treatment area, the handpiece is placed on the skin and is activated by pressing either the yellow CUT foot pedal connected to the generator or the fingerswitch paddle on the handpiece. The handpiece must be in contact with the skin prior to the activation of the generator and the generator must be deactivated prior to removing the handpiece from the skin. The audible solid tone sound is the signal that the generator is active. Note: alarm will sound if generator is constantly activated for 55 seconds prompting user to release, pause and reactivate. The activated handpiece, in contact with the skin, is continuously moved in small circular overlapping patterns (2-5 cm diameter) in the gel-coated treatment area for 3 to 5 minutes. It is important to have the patients feedback on the temperature of the treatment. If the patient feels that the temperature is too hot, turn the setting on the generator down by approximately 10% and continue treatment while assesing how the patient feels. The treatment should be warm to the patient but without a burning sensation or pain. If the temperature is slightly warm then slowly turn up the settings until the patient feels warm and the physician can see contraction or firming of the skin. The ideal skin temperature should be approximately 3942 C during treatment as measured with an infrared thermometer. Additional treatment passes may be performed until desired tissue effect is achieved. Optional: An ice pack or cooling roller may be applied to the skin for approximately 10-15 seconds to relieve and cool the skin after treating an area. The skin may redden or darken slightly during the treatment. Mild swelling (edema) and redness may occur. Initial studies indicate these typically resolve within 2 to 24 hours. A regimen to moisturize and soothe skin for one week post-treatment is recommended.

THERE ARE FOUR VARIABLES THAT AFFECT THE AMOUNT OF HEAT DELIVERED TO THE TISSUE. Handpiece size Generator setting Velocity of hand movement Size of the area treated

Suggested Generator Setting Ranges*

100
Pellev S5 Generator Setting

90 80 70 60 50 40 30 20 10 0
5 10 8 25 15 40 25 60

7.5

10 15 GlideSafe Handpiece Size (mm)

20

*NOTE: Settings may need to be adjusted higher or lower depending on patient feed back and type of area being treated. e.g. Eyes and forehead may have thinner tissue, may be more sensitive and may require lower settings; the cheek area may require higher settings.

GlideSafe Handpieces
7.5mm 10mm 15mm 20mm More More Faster More More Treat Larger Unconned Areas Periorbital Glabellar Periorbital Glabellar Perioral Forehead Cheeks Jawline Perioral Forehead Cheeks Jawline

Tip Surface Area Skin Contact Procedure Time Patient Turn-Over Uniformity of Treatment Applications Ideal Areas For Use

Less Less Slower Less Less Treat Tightly Conned Areas

e Skin
UNTREATED SKIN

HOW PELLEV WORKS

Pellev Handpiece Delivers Energy

Untreated Skin

Collagen Synthesis Begins

Collagen Remodeling Occurs

39 C to 42 C

2-6 weeks Post-Treatment

 2011 Ellman International, Inc. All Rights Reserved. ellman International, Inc. 3333 Royal Avenue, Oceanside, N.Y. 11572-3625 U.S.A. (800) 835-5355 Fax: (516) 267-6435 www.ellman.com www.pelleve.com
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