Treatment Guide Version 2.0. Reform Your Youth. Micro and Macro Focused Ultrasound Non-surgical Lifting, Tightening & Contouring System

Transcription

1 Treatment Guide Version 2.0 Reform Your Youth Micro and Macro Focused Ultrasound Non-surgical Lifting, Tightening & Contouring System

2 Table of Contents Introduction 1. Introduction of the ULTRAFORMER III 2. ULTRAFORMER III Cartridges - L7-1.5 : 1.5mm - MF2 : 2.0mm - L7-3.0 : 3.0mm - L4-4.5 : 4.5mm - MF6 : 6.0mm - MF9 : 9.0mm - MF13 : 13.0mm Precautions for Treatment - Contraindications - Preferred Patient Selection - Potential Side Effects - Precautions - Patient Consultation - Pain Management - Avoiding Nerves Operational Guideline 1. Graphical User Interface (GUI) Treatment 1. Preparation for Treatment 2. Treatment Steps & Parameters

3 Introduction Introduction of the ULTRAFORMER III The ULTRAFORMER III is a completely non-invasive, face lifting and tightening, body tightening and contouring device that provides a customized treatment procedure for the entire face, neck, and body. Utilizing HIFU technology with Micro and Macro Focused cartridges, the ULTRAFORMER III focuses uniform ultrasound energy that induces thermal coagulation in the face and contraction in the body, excluding direct contact with or damage to the epidermis.

4 Introduction ULTRAFORMER III Cartridges Face & Body Cartridges MMFU-powered depth cartridges for facial lifting and tightening directly transfer ultrasound energy into the dermal and superficial muscular aponeurotic system (SMAS) layers of the face to stimulate collagen renewal. MMFU-powered depth cartridges for body tightening and contouring directly transfer ultrasound energy into the subcutaneous tissue, inducing contractions and to dispose of stubborn fat cells naturally through the body as waste. 4.5 mm 3.0 mm 6.0 mm 2.0 mm Face & Body Cartridges 9.0 mm 1.5 mm 13.0 mm

5 Precautions for Treatment Contraindications The ULTRAFORMER III is contraindicated for use in patients with: - Pregnancy or when breastfeeding - Open wounds or lesions on the treatment area - Severe or cystic acne on the treatment area - Metal stents/electrical implants in the treatment area - Bio-absorbable mechanical implants - Skin infections of any type - Hemorrhagic disorders or dysfunctions Precautions for Patient Determine whether treatment is appropriate for patients with the following conditions: - Anticoagulant therapy - Skin conditions caused by autoimmune diseases, skin cancer, and Herpes Simplex - Diabetes or epilepsy - Severe skin diseases - Decortication or heart disease - Hypersensitiveness or hypertrophic scars - Hemostatic dysfunctions Preferred Patient Selection Patients who comply with the following requirements are preferred for yielding greater results: - Mild-to-moderate skin with soft tissue laxity, where the skin begins to feel and look less firm - Patients with lowered brow lines, sagging skin, fine lines, and wrinkles - Crepey and wrinkled skin throughout the face and inner arm, décolleté, abdomen, inner thighs, knees, etc. Potential Side Effects Patients receiving the ULTRAFORMER III may react to normal responses which are mild and temporary as follows: - Edema (swelling) - Erythema (redness) - Tenderness - Bruising - Lumps - Scarring *The local doctor or practitioner should consult with the patient for any history of severe pain or mild discomfort undergoing topical, non-invasive treatments including the ULTRAFORMER III. Precautions for Procedure - Do not use the ULTRAFORMER III without completion of training by an authorized Classys representative - To prevent unauthorized use of the device, ensure access is limited strictly to trained and certified personnel only - To avoid possible injury during treatment, do not apply the ULTRAFORMER III hand-pieces near the patient s eyes - Avoid applying treatment on the thyroid gland, thyroid cartilage, and trachea - Avoid applying treatment directly on the breast tissue and major vessels - If any malfunctions or adverse events occur immediately stop the treatment procedure - Always apply ultrasound gel on target areas before proceeding with the ULTRAFORMER III treatment - Before conducting shots, check that the cartridge attached on the transducer is applied on the skin properly

6 Precautions for Treatment Precautions for System Safety - To avoid risk of electric shock, always inspect the cartridge hand-piece and cable before use. - Do not use a cable or cartridge that has been damaged or is leaking fluid. - Do not remove the covers attached to the Main Body or hand-piece. The ULTRAFORMER III contains no user serviceable components. If the system requires service, contact a local distributor or Classys representative. Modification of this equipment is not allowed. - Do not lean over the equipment obliquely and do not give physical external shock to the equipment as it may cause permanent system damage. - Do not use the equipment with anesthetic gases or flammable materials in the surrounding areas. *For additional information, refer to the ULTRAFORMER III Maintenance Guide. Patient Consultation To achieve safe and optimum results: - Check the patient s medical history. - Check for past surgical procedures performed on areas to be treated. - Assess patient concerns on each individual facial and body preference. - Consult with patients pain tolerance levels to determine if administration of pain medication is appropriate. - Coordinate custom treatments with the patient. Pain Management For patients who report higher pain sensitivity levels, recommend the following during procedure: - Local or topical anesthetics - Oral pain medication - Topical numbing cream *No further pain medication is necessary following treatment. Avoiding Nerves Nerve areas to avoid during treatment: - Supraorbital and temporal facial nerves - Marginal mandibular nerve - Navel - Posterior superior iliac spine (PSIS) - Popliteal fossa - Cubital tunnel - Pelvic nerves *If the patient experiences undue pain or a tingling sensation during the ULTRAFORMER III treatment, set treatment parameters to lower energy levels. DO NOT apply shots without making proper contact between the cartridge and skin. DO NOT press the shot button of the hand-piece without applying ultrasound gel onto treatment area.

7 Operational Guideline Graphical User Interface (GUI) The Graphical User Interface allows the user to adjust changes to system settings and the option to save existing parameter values SYMBOL Description 1 Used & remaining shot counts (Ex: 8000 shots used, remaining shots) 2 Cartridge information (Ex: MF6-6.0mm Cartridge) 3 Skin layer image 4 Current pitch setting displayed per Cartridge Adjustable by user

8 Operational Guideline Graphical User Interface (GUI) SYMBOL Description Current length setting displayed per Cartridge Adjustable by user Set preset values for M1 / M2 buttons Set preset values by pressing down on the M1 / M2 buttons for 3 seconds Current energy setting displayed Adjustable by user 8 Press button for single shot Press button for repeat shots 9 System preferences for volume Control & factory default setting 5 10 Records information of Cartridges and shots used until reset Count is reset when the System is turned off 11 System status: START/STANDBY button 12 Set shot alarm ㅁ Beeping sound occurs when shot value reaches limit 13 Total shots used

9 Treatment Preparation for Treatment Latex Gloves Ultrasound Gel Tissues 1. Clean the area to be treated with a soft cleanser. 2. Outline target areas according to treatment parameters. 3. Conduct a test shot to determine the level of the patient s pain toleration. 4. Ensure to always apply ultrasound gel on target areas before proceeding with treatment.

10 Treatment Treatment Steps & Parameters Body Upper Body Area Cartridge Energy Range of Pitch Shots 4.5mm J mm Décolleté 3.0mm J mm mm J mm mm J mm Arm 4.5mm J mm mm J mm mm J mm Axilla 4.5mm J mm mm J mm Do not apply treatment directly on the clavicle, breast tissue, or breast implant. 2. Avoid applying treatment on specific points which may trigger tingling sensations in the patient. 3. Conduct a pinch test to ensure the patient complies with the following: 6.0mm - depth of at least 1.2cm Abdominal Region Area Cartridge Energy Range of Pitch Shots 13.0mm J mm Abdomen 9.0mm J mm mm J mm mm J mm Flanks 9.0mm J mm mm J mm mm J mm Love Handles 9.0mm J mm mm J mm Do not apply treatment directly on the sensitive areas of the navel, posterior superior iliac spine (PSIS), or pelvis. 2. Conduct a pinch test to ensure the patient complies with the following: 6.0mm - depth of at least 1.2cm 9.0mm - depth of at least 1.8cm 13.0mm - depth of at least 2.5cm * The following are recommendations for treating the target areas for the body.

11 Treatment Treatment Steps & Parameters Body Lower Body Area Cartridge Energy Range of Pitch Shots 13.0mm J mm Inner Thigh 9.0mm J mm mm J mm mm J mm Outer Thigh 9.0mm J mm mm J mm mm J mm Knee 4.5mm J mm mm J mm mm J mm Lower Leg 4.5mm J mm mm J mm Do not apply treatment directly on the popliteal fossa where the tibial nerve is located. 2. Treatment is recommended for sagging skin located above the knees and fat or thick calves. 3. Conduct a pinch test to ensure the patient complies with the following: 6.0mm - depth of at least 1.2cm 9.0mm - depth of at least 1.8cm 13.0mm - depth of at least 2.5cm * The following are recommendations for treating the target areas for the body.

12 Treatment Treatment Steps & Parameters Face Submentum & Neck 4.5mm 3.0mm 1.5mm Cartridge Energy Range of Pitch Shots 4.5mm J mm mm J mm mm J mm Treatment on the submentum & neck is recommended for V-line contouring. 2. Do not apply excess pressure on the neck to prevent discomfort during procedure. 3. Do not apply treatment on the nerve regions. 4. When treating multiple layers, treat from deep to shallow in sequential order. Ex: 4.5mm 3.0mm 1.5mm * The following are recommendations for treating the target areas for the face.

13 Treatment Treatment Steps & Parameters Face Cheek 4.5mm 3.0mm 1.5mm 4.5mm 3.0mm Cartridge Energy Range of Pitch Shots 4.5mm J mm mm J mm mm J mm Treatment on the cheek with 3.0mm and 4.5mm Cartridges require each side to be treated with a horizontal and vertical treatment pattern. 2. The 1.5mm Cartridge is NOT used in a vertical treatment pattern for these treatment recommendations. The 1.5mm Cartridge is not limited to be used in only horizontal treatment patterns. 3. Do not apply treatment on the nerve regions. 4. When treating multiple layers, treat from deep to shallow in sequential order. Ex: 4.5mm 3.0mm 1.5mm * The following are recommendations for treating the target areas for the face.

14 Treatment Treatment Steps & Parameters Face Forehead & Periorbital 1.5mm Cartridge Energy Range of Pitch Shots 1.5mm J mm Do not apply treatment on the nerve regions. 2. When treating near the brow line, pull the skin tighter towards the forehead to reduce pain. 3. When treating the forehead only apply the 1.5mm as the skin layer is thin and may be sensitive. 4. Adjust the shot length between 10mm and 15mm as it is difficult for the transducer to make firm contact with both the periorbital region and forehead. * The following are recommendations for treating the target areas for the face.

15 Treatment Treatment Steps & Parameters Face Fine Lines & Wrinkles 2.0mm Area Forehead Around the Eyes Cartridge 2.0mm Energy Range of Pitch Shots J mm 100 Around the Mouth Adjust the shot length between 10mm and 15mm as it is difficult for the transducer to make firm contact with both the periorbital region and forehead. 2. Have patients close their eyes when treating the periorbital region. 3. When treating around the eyes, check for patient discomfort as the layer of skin is thinner than other regions. 4. When treating near the brow line, pull the skin tighter towards the forehead to reduce pain. 90 * The following are recommendations for treating the target areas for the face.

16 ULTRAFORMER III Treatment GUIDE Manufacturer CLASSYS Inc. 2F, Baekyoung Bldg., 546, Samseong-ro Gangnam-gu, Seoul, Rep. of Korea Tel Fax Website