EndyMed PRO Application Guide Guidelines for the EndyMed PRO User Page 1
Copyright EndyMed, 2010 All rights reserved. Document number: Rev. August, 2011 No part of this publication may be reproduced in any material form (including photocopying, or storing it in any medium by electronic means whether or not transiently or incidentally to some other use of this publication) without the prior written permission of the copyright owner, or under the terms of a license issued by the copyright owner. The information contained in this document is subject to change without notice. EndyMed is neither responsible for nor liable to anyone in connection with this document. Contact Information: EndyMed Medical Ltd. 7 Bareket St. North Industrial Park. P.O. Box 3582, Caesarea 30889, Israel Tel: 04-6309100 Fax: 04-6309101 European Authorized Representative Mr. Alfred Eckert Zum Klosterbruhl 32 D- 66636 Tholey, Germany Tel: +49-172-6831617 Fax: +49-6853-922762 Page 2
Table of Contents 1 INTRODUCTION... 4 1.1 DOCUMENT CONVENTIONS... 4 2 SAFETY... 5 2.1 INTENDED USE... 5 2.2 PATIENT SAFETY... 5 Contraindications... 5 Adverse Events... 6 Disclaimer... 7 3 PATIENT SELECTION AND EXPECTATIONS MANAGEMENT... 8 3.1 FACE AND BODY SKIN TIGHTENING... 8 3.2 FRACTIONAL SKIN RESURFACING... 8 4 THE ENDYMED PRO TIGHTENING/CONTOURING TREATMENT... 9 4.1 PREPARING FOR TREATMENT... 9 Marking the Treatment Area... 9 Measuring Body Circumference... 10 Before and After Pictures... 10 Positioning the Patient for the Procedure... 13 4.2 PERFORMING THE ENDYMED PRO TIGHTENING/CONTOURING TREATMENT... 17 5 THE ENDYMED PRO FRACTIONAL SKIN RESURFACING (FSR)... 18 5.1 PREPARING FOR TREATMENT... 18 Before and After Pictures... 18 Skin Preparation... 19 Marking the treatment Area Using the FSR Template... 19 5.2 PERFORMING THE ENDYMED PRO FSR TREATMENT... 20 6 CLINICAL EVENT REPORT... 21 6.1 CLINICAL EVENT FORM... 22 Page 3
1 INTRODUCTION 1.1 Document Conventions The following messages in this manual indicate for the reader to pay special attention to specific points: Warning A warning indicates precautions and instructions which, if not followed may result in serious body injury or death Caution A caution indicates instructions, or cautionary notes which, if not followed, may result in a damage to the equipment or to the quality of measurements Note Notes contain helpful information and tips Page 4
2 SAFETY Warning Personnel operating or maintaining the device are REQUIRED to read the User Manual and to become thoroughly familiar with all its safety requirements and operating procedures BEFORE attempting to use or operate the system. 2.1 Intended Use The EndyMed Pro Skin Treatment System is a non invasive device intended for use in dermatologic and general surgical procedures. 2.2 Patient Safety Contraindications Treatment with the device is contraindicated for patients with any of the following conditions. General contraindications: Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder. Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as Isotretinoin (Accutane) within the past two months. Pregnant or lactating Subjects. Subjects who suffer from autoimmune disorders or diabetes. Subjects using blood thinning medications. Subjects with clotting disorders. History of any kind of cancer Impaired immune system due to immunosuppressive diseases such as AIDS and HTV, or use of immunosuppressive medications. Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen containing agents) one week before and after each treatment session. Page 5
Local treatment area contraindications: Subjects with any implantable metal device in the treatment area. Subjects who have any form of suspicious lesion on the treatment area. Subjects with body piercing (in the treated area). Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash. Face lift or eyelid surgery within a year prior to treatment. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. Botox /collagen/fat injections or other methods of augmentation with injected material in the treated area within one month prior to treatment. Having received treatment with light, RF or other devices in the treated area within one month prior to treatment. Any surgical procedure in the treatment area within the last 3 months or before complete healing. Treating over tattoo or permanent makeup. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. Adverse Events The EndyMed PRO has proven to be safe when used properly. No significant adverse events have been reported in clinical trials or commercial use. As with other energy device minor adverse events such as prolonged redness or minor skin burns may rarely occur. Patients should be advised of the possibility of mild adverse events prior to treatment. Methods to reduce the occurrence of these events are discussed in detail in the sections: Positioning the Patient for the Procedure; Performing the EndyMed PRO Tightening/contouring Treatment and Performing the EndyMed PRO FSR Treatment of this Application Guide. Regulatory requirements mandate that unanticipated adverse events be reported. We therefore ask that providers notify EndyMed and record the details of certain adverse events. A mild degree of discomfort, or erythema (redness) lasting less than 24 hours, are known to occur and may be anticipated. Any other unintended effects, such as skin burns or blisters, should be documented and reported to EndyMed. For your convenience, a sample Adverse Event form is attached to this manual. The most commonly expected effects of the device are light and temporary erythema (redness) in the treatment area and small scabs that appear after using the FSR Handpiece. These scabs fall off within a few days after the treatment. These types of events do not require reporting. Page 6
Disclaimer The physician is responsible for defining the eligibility of a patient for treatment and defining the treatment area. The physician will perform a thorough history and physical examination and any additional testing he/she feels is needed to corroborate the health status of the prospective patient. The physician will rely on his/her medical expertise and judgment in determining treatment candidates. Criteria for determining authorized operators are restricted according to local regulations. Page 7
3 PATIENT SELECTION AND EXPECTATIONS MANAGEMENT 3.1 Face and Body Skin Tightening It is important to remember that the EndyMed PRO is intended for face and body reduction of wrinkles and skin tightening. The system does not provide general slimming or weight loss. Keeping this in mind will help you select patients who will have the best results and will also help you to gear their expectations. Setting clear expectations is the key to patient satisfaction. Patients who present with a large abdomen may have most of their fat in visceral (deep) deposits rather than subcutaneous deposits. These patients might derive less benefit from the EndyMed treatment, unless combined with another fat-reducing modality (liposuction, diet, and exercise). 3.2 Fractional Skin Resurfacing The EndyMed Pro Fractional Skin Resurfacing (FSR) System is a minimally invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. Doctors around the world have reported that the effect of the FSR treatment improves the appearance of wrinkles, enlarged pores, acne scars and overall texture and vitality of the skin. Experience has demonstrated that the FSR has improved the appearance of pigmentation in some cases; however, since RF energy is "color Blind" one should not expect a complete or any removal of any kind of pigmentation marks. Page 8
4 THE ENDYMED PRO TIGHTENING/CONTOURING TREATMENT 4.1 Preparing for treatment Marking the Treatment Area 1. When treating the body it is recommended to mark the treatment area in order to achieve optimal coverage. 2. To attain the best position for viewing the body accurately and reproducibly, ask the patient to stand up straight and look straight ahead. 3. Divide the treatment area into 10cmx10cm squares, using a skin marker (Figure 1). It is enough to mark the corners of the squares. If 10cmx10 cm squares are not possible because of the size of the treatment area (e.g., arms, knees) use rectangles of approximately the same area. Figure 1: Marking the Treatment Area During the treatment make sure that there is a full overlap of the treatment squares, so all the area is covered homogeneously. When treating the face there is no need to use skin marker. Treatment areas should be chosen in accordance to patient s needs. Page 9
Measuring Body Circumference For body contouring and body tightening measure the patient s body circumference in the relevant area. In order for the measurements to be reproducible, we recommend the following: The measurement tape should be parallel to the floor during the measurement. To assure that the measuring tape is parallel to the floor, mark several reference points around the treatment area and place the measuring tape in such a way that it is aligned with them. Always place the measuring tape either under or over the marked reference points. Note Consider using more than one reference line in large areas such as the abdomen and thighs. Consecutive measurements should be performed at the same height. To enable the operator to return to the same point at next treatment or at follow-up make a note in the patient file of the height of the measurement. Whenever possible, measure the circumference of each thigh separately to provide a more representative measure of the change resulting from the treatment. Before and After Pictures Photographs of the treated area should be taken before procedure and at each follow-up visit to assess the apparent changes in body contour qualitatively. It is important that the photographs are taken prior to the marking of the treatment area. In general, photographs should be taken at standardized distances, camera height, position and lighting. Tips for consistent photography: To provide an accurate record of pre- and post-operative patient appearances, the relative positions of patient and camera must be kept constant. Maintain constant lighting every time you photograph. Use the same lights (overhead or side lamps) and have the patient stand at the same position relative to the lights, to maintain similar shadows from photo to photo. If possible, always photograph on the same background. A dark wall or a dark (blue or black) cloth hung on the wall will bring greater attention to the body you are photographing and will accentuate the body contours. Page 10
Reduce all distracting items from the frame such as office furniture, body jewelry, clothing (other than undergarments), arms (have the patient stand with hands on their head to reduce distraction and for reproducible positioning), etc. Ideally, produce a floor marking that contains 45 rotating axes and a straight line denoting the camera axes. The patient will rotate on the 45 axes and the camera can move forwards and backwards on the camera axes according to the appropriate distance relevant to the body area of interest. Holding the camera, sit, stand or kneel at one of the positions marked along the camera axis. For greater stability, the camera may be mounted on a tripod. Camera height is adjusted to match the height of the target area, with the lens barrel always parallel to the floor. It is important not to tilt the camera up or down. Face Patient Preparation: Pull hair off face and behind ears (use headband or small clips that hold hair without pulling), remove jewelry and eyeglasses, remove heavy makeup, cover shirt collar with black drape. Patient Positioning: Seat patient on a stool adjusted to a comfortable height and placed in front of the camera. Patient should sit up straight. When turning for oblique and lateral views, patient should rotate entire body (shoulders and feet). Framing: Center ears vertically in all views. For frontal and oblique views, center entire head horizontally. For lateral views, place front of face 1/4 frame from edge (Figure 2). Figure 2: Framing the Face Page 11
Abdomen Patient Preparation: Remove gown completely. Patient should wear paper panties. The front portion of the underwear must be below the treatment area. Patient Positioning: Patient standing comfortably erect with arms folded above breasts. Feet should be aligned with the marking on the floor denoting photographic angle. Framing: Position infra-mammary fold at top of frame. Center the torso horizontally (Figure 3) Hips/Thighs Figure 3: Framing the Abdomen Patient Preparation: Remove gown completely. Patient should wear paper panties. Patient Positioning: Patient standing comfortably erect with arms folded above breasts. Feet should be at approximately shoulder width, aligned with the marking on the floor denoting photographic angle. Framing: Position the knees at bottom of frame. Center the hips horizontally. (Figure 4) Special Notes: The distal leg should not be visible in lateral views. Figure 4: Framing the Thighs Page 12
Positioning the Patient for the Procedure If the treatment table is height adjustable, change the height according to the treatment area. Treating the Face Place the patient in supine position. Ask the patient to fully turn their head so one cheek is almost parallel to the treatment table (Figure 5). Figure 5: Facial Treatment The cheek and temple are considered one treatment square. For peri-oral and peri-orbital areas that are very sensitive, reduce the power and use additional gel. Treating the Neck and Submental Areas Place the patient in supine position. Ask the patient to fully turn their head so the cheek does not interfere with the treatment. Figure 6: Neck Treatment For the submental area, extend the patient's head backwards. A small round pillow placed below the neck could be helpful to increase patient's comfort. Page 13
Treating the Arms Place the patient in supine position. The upper arm is divided into 3 longitudinal sections; Proximal, distal and lower, each is composed of a rectangle of approximately 100cm 2 area. Overlap of adjacent rectangles is recommended. The proximal part is treated with the arm lying on the treatment table and bent in a comfortable position (Figure 7). The distal part is treated with the arm bent on the chest. Use a pillow, if needed (Figure 7). The lower part is treated with the arm bent upwards towards the head (Figure 7). Figure 7: Treating the Arms Due to difference in fat and muscle thickness in different zones of the arm, adjust power level to fit appropriate temperature range of 40-42 C. Treating the Abdomen When the patient is standing straight, divide the abdomen into 10cmx10cm squares and mark them with skin markers: 2-3 squares for lower abdomen 1-2 squares for upper abdomen If skin laxity in the umbilical area is prominent, add an additional square around the umbilicus. Place the patient so that he / she are lying on the back with the legs extended. In this position, the abdomen is fully accessible and treatment can be easily performed (Figure 8). Figure 8: Treating the Abdomen Page 14
Treating the Flank Area Divide the entire flank to be treated into 10cmx10cm squares (or rectangles of equal area) while the patient is standing. Depending on the area to be treated, the patient should be positioned face down with the treatment area raised on a pillow. Figure 9: Treating the Flank Area Treating the External Thigh Area ("Saddlebag") Divide the entire area to be treated into 10cmx10cm squares (or rectangles of equal area) while the patient is standing. Position the patient face down, with the leg to be treated folded towards the chest ("frog leg" position). For patient comfort you may support the leg on a pillow (Figure 10). Figure 10: Treating the External Thigh Page 15
Treating the internal thigh area Divide the entire area to be treated into 10cmx10cm squares (or rectangles of equal area) while the patient is standing. Position the patient in supine position, with the leg to be treated folded (Figure 11). Figure 11: Treating the Internal Thigh Page 16
4.2 Performing the EndyMed PRO Tightening/contouring Treatment To perform the EndyMed PRO tightening/contouring procedure: After marking the squares in the region of treatment (See Marking the Treatment Area, page 9), lay the patient on the treatment bed and position them according to the treated area (See Positioning the Patient for Procedure, page 13). Perform the procedure according to the directions described in detail in the User Manual. You may also refer the EndyMed Training video. After completion of the treatment use a soft cloth, moistened with enzymatic detergent solution such as 0.5% ANIOSYME DD1, to clean the Handpiece. Use the enzymatic solution according to manufacturer's instructions. Use a soft cloth, moistened with water to remove detergent residuals, followed by a soft cloth, moistened with 70% Isopropyl alcohol, to disinfect the handpiece. Dry the handpiece with a clean towel. The tightening/contouring treatment protocol includes 6 treatments: 4 treatments at 1 week interval, followed by 2 treatments at 2 weeks interval (totally, approximately 2 months). Additional treatments may be given for maintenance or according to need. Page 17
5 THE ENDYMED PRO FRACTIONAL SKIN RESURFACING (FSR) The EndyMed PRO Fractional Skin Resurfacing (FSR) application may be used for treatment of generally sun-exposed body areas such as the face, neck, cleavage and hands and areas susceptible to acne scarring. The treatment is recommended for sun-damaged skin, improvement of skin texture, decreasing the appearance of wrinkles and treatment of acne scars. 5.1 Preparing for treatment Before and After Pictures Photograph the treated area before the procedure and at each follow-up visit to assess the apparent changes in body contour qualitatively. It is important that the photographs are taken prior to the marking of the treatment area. In general, photographs should be taken at standardized distances, camera height, position and lighting. Tips for consistent photography: If clinical photos are to provide an accurate record of pre- and post-operative patient appearances, the relative positions of patient and camera must be kept constant. Maintain constant lighting every time you photograph. Use the same lights (overhead or side lamps) and have the patient stand at the same position relative to the lights, to maintain similar shadows from photo to photo. If possible, always photograph on the same background. A dark wall or a dark (blue or black) cloth hung on the wall will bring greater attention to the body you are photographing and will accentuate the body contours. Try to eliminate all distracting items from the frame: office furniture, body jewelry, clothing (other than undergarments), arms (have the patient stand with hands on their head to reduce distraction and for reproducible positioning), etc. Ideally, produce a floor marking that contains 45 rotating axes and a straight line denoting the camera axes. The patient will rotate on the 45 axes and the camera can move forwards and Page 18
backwards on the camera axes according to the appropriate distance relevant to the body area of interest. Hold the camera and sit stand or kneel at one of the positions marked along the camera axis. For greater stability, the camera may be mounted to a tripod. Adjust the camera height to match the height of the target area, with the lens barrel always parallel to the floor. It is important not to tilt the camera up or down. Face Patient Preparation: Pull hair off face and behind ears (use headband or small clips that hold hair without pulling), remove jewelry and eyeglasses, remove makeup, cover shirt collar with black drape. Patient Positioning: Seat patient on a stool adjusted to a comfortable height and placed in front of the camera. Patient should sit up straight. When turning for oblique and lateral views, patient should rotate entire body (shoulders and feet). Framing: Center ears vertically in all views. For frontal and oblique views, center entire head horizontally. For lateral views, place front of face 1/4 frame from edge (See Figure 2). Skin Preparation 1. Wash the treatment area thoroughly with water and soap to remove lotion and makeup. Dry the skin using a paper towel. 2. Clean the skin thoroughly with 70% alcohol to dry it for better absorbance of anesthetic cream. 3. Apply Emla (or similar anesthetic cream) for 30-40 min. Occlude the area with a plastic wrap for better absorption of the anesthetic cream. 4. Clean the Emla residual gently with 70% alcohol and dry the skin. Marking the treatment Area Using the FSR Template The FSR Template enables easy positioning of the FSR Handpiece during treatment to ensure uniform coverage of treatment area. Follow the steps below. 1. Place the Template on the intended treatment area. 2. Use a light, oil-free make-up base and a small sponge to spread the make-up through the Template holes, creating a uniform matrix grid on the skin. Page 19
3. Position one corner of the lower edge of the FSR tip on one of the outside dots of the grid, so the surface of the tip covers the first area to be treated. Deliver pulse. 4. Lift the FSR Handpiece and position the same tip corner on the next grid dot so that the lower edge of the tip now covers the next area. Deliver pulse. 5. Repeat Step 4 for full and uniform coverage of treatment area. 5.2 Performing the EndyMed PRO FSR Treatment Perform the procedure according to the directions described in detail in the User Manual. You may also refer the EndyMed Training video. General Guidelines for power and pulse duration adjustments: To increase deep dermal heating with minimal increase in microablation: To increase extent of microablation: Increase pulse duration Increase power To increase both microablation and deep dermal heating: Increase both power and pulse duration Fine tuning: After first 2-3 pulses, inspect the skin for at least 5 minutes Skin Effect Patient's sensation Mild to moderate erythema and edema Mild to supportable discomfort Continue with same settings Skin Effect No erythema / edema Increase pulse duration by 10 msec Patient's sensation Skin Effect Patient's sensation Treatment not felt at all In case of severe edema or over bony areas (Jaw, Zigomatic arch, temples) High level of discomfort and try again. Increase power by 1 W and try again. Decrease pulse duration by 10 msec and try again. Decrease power by 1 W and try again. Page 20
6 CLINICAL EVENT REPORT Dear EndyMed customer, EndyMed is committed to the satisfaction of its customers, patients, and physicians alike. To this end, the attached form will help us ensure that all cases of adverse events are reported to the company. Based on our experience from clinical trials, there are minimal adverse events occurring from the use of EndyMed PRO system. EndyMed is dedicated to minimizing the number of adverse events, and your help in this matter is crucial. The attached Form assesses some of the parameters that might contribute to an adverse event. Please provide us with as much detail as possible on the particular procedure and the clinical event. EndyMed will analyze the reports and learn from you what factors may predispose to these mild adverse events. Thanking you in advance for your collaboration, With best regards, The Applications and Medical Affairs Teams Page 21
6.1 Clinical Event Form Date of the Event: / / dd mm yy Clinic Name: Address: Tel No.: Case Number: (to be filled in by EndyMed) Please describe the visible skin lesion. Use descriptive terms as much as possible (blister, redness, abrasion, etc.) Clinical Parameters Patient age years Patient gender Male Female Patient weight Patient height kg cm Known skin sensitivity or allergy? No Yes: Skin color Fair Olive Dark Area treated Application/Handpiece in use? Abdomen Flanks Thighs Face Other (specify): Was a Test Pulse performed? (FSR only) No Yes Did the patient have any implanted metal in the area? Power Used Pulse length used (FSR only) No W msec Yes: Page 22
Final skin temperature after the pulse/pulse series? º C Did the patient complain of discomfort or excessive heat? No Yes, discomfort Excessive heat Was there anything unusual during the treatment? Did the patient have previous liposuction in the area? No No Yes, specify: Yes, specify (including time of the procedure): Did the patient have recently another aesthetic treatment in the area? No Yes, specify (including time of the procedure): Occurrence of the event When did the event resolve? During treatment After treatment: hours/days Not resolved Resolved after: days Without scar With scar, describe: Please provide EndyMed with photographs of the area. Completed by Signature Date Page 23