2 nd Generation HIFU. Specification

Transcription

1 2 nd Generation HIFU You can treat skins and care obesity with one equipment. It is easy to operate, cause little pain when operation, does not require consumables and requires low maintenance fee. Specification Model No : K1-W1601 Electrical Power : 220V/60Hz Power Consumption : 100VA Dimensions : L200 X W397 x H370 (Main unit only) Weight : 12kg

2 MECHANISM What is an Ultrasound? Ultrasound is an oscillating sound pressure wave with a frequency greater than the upper limit of the human hearing range. Ultrasound is thus not separated from 'normal' (audible) sound by differences in physical properties, only by the fact that humans cannot hear it. Although this limit varies from person to person, it is approximately 20 kilohertz (20,000 hertz) in healthy, young adults. Ultrasound devices operate with frequencies from 20 khz up to several gigahertz. What is HIFU? High Intensity Focused Ultrasound (HIFU) is a medical procedure that applies high-intensity focused ultrasound energy to locally heat and destroy diseased or damaged tissue through ablation. HIFU in cosmetic medicine HIFU devices have been cleared to treat subcutaneous adipose tissue for the purposes of body contouring (known collo quially, and incorrectly, as "non-invasive liposuction"). These devices are available in the world markets. HIFU is also cleared for eyebrow lifts, albeit with lower energy levels.

3 MECHANISM Image of local region & focused ultrasound beam 65 Mode A Use for facial skin Weak power than B Thermo-coagulation Mode B Use for body / thick facial skin Strong power than A Lipolysis Thermal effect Ultrasound energy is delivered to the focused area. Heating point is formed and focused area is burned. Wound healing reaction, coagulation, is starting. coagulation body temperature 65 Vaporization and ablation

4 MECHANISM Depth of Penetration 3.5~4.5mm Epidermis Dermis Subcutaneous Panniculus Carnosus SMAS 1.8~2.5mm Over 10mm - Facial skin / SMAS LAYER : 3.5~4.5mm- - Body skin / FAT LAYER : over 12 mm- *Superficial muscular aponeurotic system (SMAS) is an area of musculature of the face. This muscular system is manipulated during facial cosmetic surgery, especially rhytidectomy. The SMAS extends from the platysma to the galea aponeurotica and is continu ous with temp oroparietal fascia and galea. It connects to the dermis via vertical septa.

5 MECHANISM HIFU VS. OTHERS Penetration Depth 3.5~4.5mm Epidermis Dermis Laser & RF Needing RF Others Subcutaneous Panniculus Carnosus SMAS HIFU

6 PRODUCT INTRODUCTION V-ZET HIFU (High Intensity Focused Ultrasound) is V-ZET helps to improve wrinkle, skin elasticity and appearance of lines and to form collagen. HIFU thermal energy at 65 is delivered into SMAS layer (about 3.5mm~4.5mm) in the face skin and it contracts skin muscle layer. Moreover, V- ZET enables to do obesity treatment by melting fat layer which is in between 10mm~20mm depth in the body skin. Wrinkle Care V-line Lifting Destroy Fat Cell Cellulite Removal Skin Elasticity

7 PRODUCT INTRODUCTION Features of V-ZET HIFU As it is equipped with the Probe (3.5mm/4.5mm) which is the most widely used in HIFU equipment, it can be used for both facial and body treatment. By adopting a self-cooling method, not a cartridge-changing way which is widely known in the market in normal HIFU devices, V-ZET can be used for a long time without replacing a consumable cartridge. (Durable handles) Probe-rubbing methods enable easy and particular region operation. Easy control though user friendly interface on 7 inch touch LCD

8 PRODUCT INTRODUCTION Advantages of V-ZET HIFU Because V-ZET HIFU focuses energy shortly and intensively on the target area while rubbing probe, it makes less pain than other HIFU brands. Various shot intensity, shot time and shot interval can be adjusted by user s purpose. As applying rubbing operation, reducing shot and interval time, operation time can be shorter than normal HIFU operation. These shorter operation time enables to do more operations and it helps to get good results rapidly. V-ZET doesn t need maintenance cost which mostly made by cartridge changing. It reduces medical expense and increases competitiveness. And it helps to do additional treatment without big burden. By adopting a probe-rubbing method which is not widely used in HIFU equipment, it is possible to perform detailed operation. Ex) near cheek-bone Water cooling system enables to give stable operations, though long time working.

9 DESCRIPTIONS OF OUTPUT LEVEL

10 CLINICAL TRIAL BY Key Doctors / Advisors Hee Chul Yun, M.D. (Dermatologist / Incheon) Han Jin Kwon, M.D. (Plastic Surgeon / Seoul) An Beck Lee, M.D. (Dermatologist / Pyeongtaek) Jin Woo Do, M.D. (Plastic Surgeon / Seoul) Young So Yun, M.D. (Dermatologist / Seoul) Jae Yun Do, M.D. (Plastic Surgeon /Kyung Gi) Eun Ju Lee, M.D. (Dermatologist / DaeJeon) Jung Bun Lee, M.D. (Dermatologist / DaeJeon) Mu young Lee, M.D. (Plastic Surgeon / Seoul)

11 CLINICAL TRIAL Clinical cases of obesity and face by key doctors CASE 1 : A woman in 30 s (Mode A for Face/Intensity:60/Shot time:0.1/total shot number :2500/ Two times for 4 weeks) - Doctor s medical opinion : After first surgery, it showed an excellent lifting effects on cheek and jaw. 2 weeks later, then after 2 times surgery, discernible changes have appeared on her double chin and brow. CASE 2 : A nurse in early 20 s (Mode B for Belly/Intensity:90/Shot time:0.1/total shot time:30min /Three times for 6 weeks) - After three times surgery, her waist size was reduced by 1.2 Inch, and also thickness of subcutaneous fat was reduced. CASE 3 : A woman in mid-20s (Mode A for Double chin/intensity:50/shot time:0.1/total shot:2000 /Two times for 6 weeks) - The result : A week later, her chin line became more defined after first surgery. CASE 4 : A woman in mid-40s (Mode A for Nasolabial folds/intensity:50/shot time:0.1/total shot:2000/two times for 5 weeks) - Doctor s medical opinion : It showed highly effective in treating nasolabial folds and fine lines Our key doctors had many times of clinical trial for 7 months. Most clinical trial have shown that it has effect on skin treatment and reducing fat. Some patients felt itch on skin or their skin changed red after body treatment. But most of the symptoms disappeared after 2 weeks. Some patients has a slight headache or toothache after facial treatment. But most of the symptoms disappeared after 1 week. There s a special case that a patient has suffered minor burns by doctor's negligence. (As a reminder, Do not stay in the same area without rubbing for more than 0.5 sec.)

12 V-ZET HIFU User s Guide (How to set the software according to the area to be treated) INDICATION INTENSITY SHOT TIME TOTAL SHOT MODE 1. Forehead line (Excepting the central area of forehead) 2. Wrinkles around eyes (Excepting near eyes) RUN TIME Number of times 15~25 0.1~ ~800 A 3~5 15~25 0.1~ ~800 A 3~5 3. Chin V-line / Cheek 20~30 0.1~0.2 1,500~2,000 A 3~5 4. Double chin line 20~30 0.1~ ~800 A 3~5 5. Wrinkles on the neck 20~30 0.1~ ~800 A 3 6. Obesity (abdomen) fat layer more than 20mm thick 7. Obesity (other local regions except for abdomen) fat layer more than 15mm thick 50~60 50~60 0.1~ ~0.2 For obesity care, perform the surgery 20 min or over. The operating area should be limited less one span of a hand. B B 40min 20min 3~5 3~5 Proper mode (intensity, shot time and mode A/B) must be set up and set up value must be in allowed condition which is not damaged on device. (Improper shot time, intensity and mode caused of burn) We recommend that the probe s moving speed is drawing 1 circle (circle size is around US25cent coin) per 1 sec. (Don t start machine, step on pedal, before attaching probe on the skin. The reverse working order is caused of burn) Above supplied Total Shot number is recommended per 1 session and recommend 2 or 3 weeks suspension period for supplement operation. Recommended SHOT TIME is below 0.2. And don t stay in same area over 1 second under setting up 0.2. *Gel should be fully applied on the target skin. In case of 50 or less INTENSITY for skin lifting, recommended operation number is 2 times a month. In case of 60 or more INTENSITY for skin lifting, recommended operation number is once a month. Total 1500 or less is enough number for the full face operation. *The above TOTAL SHOT number is for half face operation.

13 V-ZET FAQ What is V-ZET? V-ZET helps to improve wrinkle, skin elasticity and appearance of lines and to form collagen. HIFU thermal energy at 65 is delivered into SMAS layer (about 3.5mm~4.5mm) in the face skin and it contracts skin muscle layer. Moreover, V-ZET enables to do obesity treatment by melting fat layer which is in between 10mm~20mm depth in the body skin. How does V-ZET differ from other HIFUs? As it is equipped with the Probe (3.5mm/4.5mm) which is the most widely used in HIFU equipment, it can be used for both facial and body treatment. By adopting a self-cooling method, not a cartridge-changing way which is widely known in the market in normal HIFU devices, V-ZET can be used for a long time without replacing a consumable cartridge. (Durable handles). Probe-rubbing methods enable easy and particular region operation. Easy control though user friendly interface on 7 inch touch LCD. Is there any pain while V-ZET treatment? Because ultrasound energy is delivered into the target depths, a patient can feel pain - pain levels are various, individual's feeling. However, V-ZET's unique probe-rubbing treatment doesn't make any pains. Will patients need to take time off? There is no downtime. A patient can resume his/her normal activities immediately. How long takes time to get V-ZET treatment? It is depended on the areas where need to be treated. A face treatment takes 30 minutes and abdomen treatment including sides takes 40~60 minutes. When can a patient see the results? How long do they last? Most patients can see the results immediately after V-ZET treatment. However, it is mainly depended on the individual's skin elasticity and collagen rebuilding process. In general, 6 months duration of treatment effect is expected, in general. How many V-ZET treatments is required? To keep long duration of treatment effect, 2~4 times treatments are recommended. Are there any side effects? Redness can be seen immediately after V-ZET treatment but it should disappear in few hours.

14 V-ZET vs. Other HIFU Devices CARTRIDGE HIFU VS. V-ZET HIFU CARTRIDGE HIFU V-ZET HIFU Ultrasound Transducer

15 V-ZET vs. Other HIFU Devices SOME CUSTOMERS FEEDBACK AFTER GETTING NORMAL CARTRIDGE HIFU TREATMENT More Painful Than Childbirth - M, NJ 10 Dec Day of treatment Had lower face, jowls and upper neck/chin. Opted for Tylenol only with no pain meds. I literally cried for most of the procedure. Worst pain ever felt in my life! I strongly suggest getting someone to drive you and take strong pain meds. I wi sh I had. Hoping the result is with it! XXX the provider was reassuring and worked quickly. *Original comment from 46 YO Just Enjoying Me Time and Touching Myself Up for the Next Half of Life - G, AZ 25 Feb Okay, so to start "OUCH!" yes evidently my pain threshold is pretty low. I did take a Xanax to calm me, but right before finishing w e had to stop because of the pain, tomorrow I go in to finish. I experienced a lot of the negative side effects, numbness (which I wis h were back because know I feel the soreness on my neck), mild swelling & bruising. I am not sure if my before and after pics are due to swelling or not, I hope not it has been a week since the procedure and so far if these are actual results I cant wait until another month fr om know. I will try to post pictures once a month or so for the next several months if I remember, because when doing my research I ha d wished I saw more results with longer term pictures. I am not sure if it was worth the pain yet, I hope so. *Original comment from Didn't Work - C, OH I was so excited to get the chin and lower face done with XXX. Dr. XX told me I was a excellent candidate for this. The procedure itself took about an hour. Wasn't really painful. Some redness to the area afterwards. My chin felt numb for about a week. As the months we nt on I decided in wasn't seeing any improvement. I called the office and went in to view the before and after pics. I was 6 months out fr om procedure. The lady took the pics and we viewed the before and after on the computer. Absolutely no change at all. I was just so sick to my stomach that I had waisted $ that took me months to save. I just wanted to cry. I asked the lady if they would redo the procedure since it didn't work on me. She said I'd have to pay another $ !! Unbelievable!! I said if I would hav e know before hand I would have just spent the money on chin lipo. At least I would have seen results with that. She agreed. *Original comment from

16 V-ZET vs. Other HIFU Devices SOME CUSTOMERS FEEDBACK AFTER GETTING NORMAL CARTRIDGE HIFU TREATMENT More Painful Than Childbirth - M, NJ 10 Dec Day of treatment Had lower face, jowls and upper neck/chin. Opted for Tylenol only with no pain meds. I literally cried for most of the procedure. Worst pain ever felt in my life! I strongly suggest getting someone to drive you and take strong pain meds. I wi sh I had. Hoping the result is with it! XXX the provider was reassuring and worked quickly. *Original comment from Probe-rubbing methods enable easy and particular region operation with less pain. Because V-ZET HIFU focuses energy shortly and intensively on the target area while rubbing probe, it makes less pain than other HIFU brands. Painless treatment!

17 V-ZET vs. Other HIFU Devices xxx xxx xxx xxx xxx *Need Special skill Easy rubbing treatment!

18 V-ZET vs. Other HIFU Devices Other HIFU Guarantee shot number : 1 year regardless of shot number -> Unlimited treatment within 1 year Guarantee shot number : 10,000~30,000 shots (over or less) -> Replace cartridge after 30~100 treatments. By adopting a self-cooling method, not a cartridge-changing way which is widely known in the market in normal HIFU devices, V-ZET can be used for a long time without replacing a consumable cartridge. (Durable handles) High durable handles (Long life time -> Low maintenance cost)

19 V-ZET vs. Other HIFU Devices Didn't Work - C, OH I was so excited to get the chin and lower face done with XXX. Dr. XX told me I was a excellent candidate for this. The procedure itself took about an hour. Wasn't really painful. Some redness to the area afterwards. My chin felt numb for about a week. As the months went on I decided in wasn't seeing any improvement. I called the office and went in to view the before and after pics. I was 6 months out from procedure. The lady took the pics and we viewed the before and afters on the computer. Absolutely no change at all. I was just so sick to my stomach that I had waisted $ that took me months to save. I just wanted to cry. I asked the lady if they would redo the procedure since it didn't work on me. She said I'd have to pay another $ !! Unbelievable!! I said if I would have know before hand I would have just spent the money on chin lipo. At least I would have seen results with that. She agreed. *Original comment from xxx Good results immediately after treatment

20 V-ZET vs. Other HIFU Devices I think the treatment you did for me is continuing it's result. Perhaps it works similar as XXX, where a some result is instant and it improves skin for another 2-3 weeks.

21 V-ZET vs. Other HIFU Devices Item V-ZET Other cartridge type HIFUs Total shot number for facelift Around 3,000 shots Initial version : around 3,000 shots Newly released version : 3,000, 4,000, 6,000 shots (over or less -due to reduced intensity, peak power) *In general, 1 press emits 10 shots. After treatment facelift effects immediately after treatment. Can see results in 3 weeks, steadily. Side effects Pain during treatment Recommended treatment times Redness *Not all but individually : swelling, tingling, numbness Reduce or increase parameter based on patient s feeling during treatment (Don t need anesthesia). *Rubbing treatment to avoid pain caused by focused energy at one spot. 3~4 times *Although HIFU energy is overlapped at the same point, it doesn t make side effects like burn. Redness *Not all but individually : swelling, tingling, numbness 1. Initial version : Need regional anesthesia but huge pain 2. Newly released version : Recommended regional anesthesia, though reduced intensity, peak power. 1. Initial version : 1 time *Not recommend reoperation. If apply energy at the same point, it makes burn. 2. Newly released version : over 2 times. (Reduced peak power) Available shot number 1 year full warranty regardless of shot number. Wide range : 8,500 ~30,000 shot (over or less) How long does the treatment result last? After full protocol Remarks Expecting 6 months 1. High patients satisfaction through customized treatment, if need, additional retreatment without cost burden. 2. Less discomfort for HIFU treatment, easy revisit promotion. 3. Wide application, face and body without additional cost. Ex)seasonal promotion- Body line sides- care. Expecting 6months 1. Although insufficient patient s satisfaction, not easy to decide retreatment due to cost burden. 2. Many patient who had experience with HIFU treatment, hesitate to get HIFU treatment again due to pain. 3. Limited application, face treatment only.

22 Before & After Pictures Just after 1 st treatment [ ] Just after 1 st treatment [ ] Just after 1 st treatment [ ] Just after 2 nd treatment [ ] 2 weeks interval

23 Before & After Pictures Just after 1 st treatment [ ] Just after 2 nd treatment[ ] 1week interval just after 1 st treatment [ ] Just after 2nd treatment [ ] 1 week interval

24 Before & After Pictures Just after 1 st treatment [ ] Just after 1 st treatment [ ] Just after 1 st treatment [ ] Just after 1 st treatment [ ]

25 Before & After Pictures Combination treatment with Aqua Injector Just after 1 st treatment [ ] Just after 1 st treatment [ ]

26 Before & After Pictures Combination treatment with Aqua Injector Just after 1 st treatment [ ] Just after 1 st treatment [ ]

27 Before & After Pictures Combination treatment with Aqua Injector Just after 1 st treatment [ ] *Cavitation 5 Min. + V-ZET 30 Min. Just after 1 st treatment [ ] *Cavitation 5 Min. + V-ZET 30 Min. Just after 1 st treatment [ ] *Cavitation 5 Min. + V-ZET 30 Min. Just after 1 st treatment [ ] *Cavitation 5 Min. + V-ZET 30 Min.

28 PRECAUTIONS Directions for use Do not use the equipment by directing the location of a probe upward. Do not perform the operation on areas where nerves pass by such as forehead, thyroid-gland, and the area from under the ear to under the lower jaw. Do not stay in the same area without rubbing for more than 0.5 sec. Perform operation by moving the probe at a drawing 1 circle (circle size is around 25 US cent coin) per 1 second. Do not use the equipment on other purposes except for testing purpose, allowed by K1MED CO.,LTD. It may cause breakdown of the probe. Areas which are prohibited to be treated with V-ZET HIFU Perform an operation on teeth or around teeth after wrapping the area to be treated with gauze. Especially, those who had implants or laminate treatment may feel toothache. Do not perform the operation around eyes, on the lower jaw and on lips where there are nerves passing by. You cannot perform the operation on the thyroid gland around the neck. When performing an obesity care operation, do not perform the operation on areas with lots of blood vessels ( lymph and the groin region)

29 WARNING The copyright of this material is on K1MED CO.,LTD. As this material is made for training in the company, illegal distribution is strictly prohibited. Also, illegal reprint and copy of the material without prior agreement is strictly prohibited, and when you violate this, you will be punished by law according to the copyright law.