VELASMOOTH PRO CLINICAL PRESENTATION January 2010 PB 73051 EN
Subcutaneous Tissue Anatomy & Histology § Superficial plane: <15 mm from skin surface (this area includes dermal and sub-dermal zones) Vela. Smooth. Pro II, Lipo. Lite PB 73051 EN Lipo. Lite Liposuction
Subcutaneous Tissue Anatomy & Histology § A person’s body layout depends on: § Pattern of adipocytes distribution § Increased size of fat cells (hypertrophy) § Enlargement of the number of adipocytes (hyperplasia) § Fat-cell replication by postadipocytes § Eating and exercise habits § Poor lymphatic drainage Major human fat depotswhite adipose tissue PB 73051 EN §
What is the etiology? Atrophic degeneration of the hypodermal and dermal zones: § Hypertrophic and hyperplasic changes of the fat cells § Poor blood flow and lymphatic drainage § Glycation of collagen and hypertrophic septae Resulting in § Favorable environment for fat cells having a relatively low metabolism § Cycle of atrophy leading to - Increased circumferences PB 73051 EN - Bumpy appearance (cellulite)
Cellulite and Circumference Fat cells swell and push skin upwards as septae are rigid § Blood and lymph vessels are compressed § Accumulation of intercellular fluids and physiological waste PB 73051 EN §
Factors inducing Cellulite Heredity § Hormones § Smoking § Lack of exercise § Poor diet § Physiological status PB 73051 EN §
Classification of Cellulite § Class 1: § No spontaneous dimpling § Pinch test positive for dimpling § Class 2: § Spontaneous dimpling while standing Class 3: § Spontaneous dimpling while standing and lying (morbid obesity or menopausal) PB 73051 EN §
Regulatory Clearance Indications For Use FDA, CE § The Vela. Smooth. Pro II is indicated for: § Temporary reduction in the appearance of cellulite § Temporary reduction of thighs circumferences § Temporary improvement in the local blood circulation § Relief of minor muscle aches and spasms § Body contouring* Additional treatment programs: § Post-liposuction treatment via circumferential reduction § Post-baby treatment via circumferential reduction * CE only PB 73051 EN §
PB 73051 EN Features and Benefits
PB 73051 EN Vela. Smooth. Pro Platform
What is Vela. Smooth. Pro? § More powerful - RF energy increased by 75% to 35 Watts § Higher efficacy § Faster patient’s turnover § Disposable applicator Covers – ‘per patient’- Large: 16 H / Small: 4 H § Optimize treatment results § Eliminate cross contaminations § Improved quality and reliability § Higher patient comfort § Easier and more comfort for operation § Diagnostic Terminal § Better control of patients treatment protocol § Intuitive feedback for user § Service diagnostics PB 73051 EN § Monitors device’s activity and performance
The Technologies Vacuum (Suction) Infrared (IR) Radiofrequency (bipolar RF) Mechanical massage (Rollers)* *Large appl. only PB 73051 EN § §
Applicators Specifications Large Applicator Small Applicator § RF Power Up to 35 W Up to 8 W § IR electrical power Up to 35 W Up to 20 W § Spot Size 40 x 40 mm 30 x 30 mm § Penetration 5 -20 mm § Wavelength 700 -2000 nm (Broad Band IR) § Vacuum Pulsed 180 -380 mbar § Disposable covers 16 hrs PB 73051 EN 4 hrs
Vela. Smooth. Pro Applicators The Technology Small Applicator § RF § IR § Vacuum § Massage (Rollers) - PB 73051 EN Large Applicator
Vela. Smooth / Vela. Smooth. Pro Applicator Specs. RF electrical power Vela. Smooth. P h ro 35 W 35 W ? 420 mbar 30 hrs/10 hrs 16 hrs/10 hrs 8 W 8 W 20 W ? 340 mbar 10 hrs (cover with filter) 4 hr/4 hr Alternate filter for every treatment Communicatio n Terminal - + Dual Connector - + IR electrical power Large Vacuum Disposable covers/filters RF electrical power IR electrical power Small Vacuum Disposable covers/filters PB 73051 EN 20 W
Consumables PB 73051 EN Small covers Large covers Bundle box 5 pack 1 large 5 pck+ 1 small 5 pck
Applicator’s operating panels Treatment Mode Description IR mode Continuous infrared light energy is applied RF mode Radio frequency current is applied Vacuum mode Applicator cover indicators Pressing this button activates the vacuum pump Green LED: cover is operative and installed properly Red LED: cover is expired or not installed properly PB 73051 EN Button
Communication Terminal Messages: Ready – the applicator is connected, the treatment level configured, but the trigger is not yet pressed. Treatment - the applicator is connected, the treatment level configured, and the trigger is pressed. Not Available – the applicator is not connected. PB 73051 EN Also various Maintenance or Error messages will be displayed, these appear in the troubleshooting guide in User Manual.
Communication Terminal – info button § § System Type – Vela. Smooth. Pro - System S/N – the system's factory serial number. LA/SA S/N – the Large applicator or Small applicator type and factory serial number. LA/SA Working Hours – the total number of hours already performed by the connected Large or Small applicator. Disposable Status – how much time remains to operate the disposable covers. System Freq: 50 or 60 Hz – the system's electrical frequency PB 73051 EN § §
Vela. Smooth Treatment Mechanism Vacuum Effects § Improved blood supply: § 90% of vessels are compressed at normal atmospheric pressure § Vacuum also enables deeper penetration of RF § Fibroblast stimulation PB 73051 EN § Applying negative pressure → vessel dilation and blood flow ↑↑
Vela. Smooth. Pro Treatment Mechanism Mechanical Effect of Rollers – Massage Mechanical massaging effect enhances drainage of trapped intercellular fluid to lymphatics PB 73051 EN §
Vela. Smooth. Pro Treatment Mechanism Deep Heating by IR + RF § IR light heats the tissue down to the deep dermis § RF heats tissue down to the subcutis Parabolic reflector Lamp Infrared filter PB 73051 EN RF electr odes
Vela. Smooth. Pro Treatment Mechanism Heating Effect On Oxygen Diffusivity in Water Temperature, ˚C Viscosity of H 2 O, centipoises Diffusivity of O 2, cm 2/s 20 1. 002 1. 97 x 10 -5 40 0. 653 3. 24 x 10 -5 50 0. 547 3. 99 x 10 -5 Heat increases oxygen diffusivity → PB 73051 EN delivering more oxygen from capillaries to fat cells
Vela. Smooth. Pro Treatment Mechanism Heating Effect On Metabolism § Deep heat is produced by IR/RF in dermal blood vessels § → Oxygen dissociation from Oxy-Hb ↑↑ § → Extravasation of nutrients and oxygen ↑↑ § Fat metabolic reactions in fat cells ↑↑ § Extended use of stored energy from fat cells (lipolysis) results in shrinkage of cells themselves • The septae, and consequently the fat chambers, shrink Stimulation of fibroblasts for collagen synthesis ↑↑ § Collagen shrinkage for overall skin surface improvement PB 73051 EN §
PB 73051 EN The science of Vela – Biological Model
Clinical Procedure Pre-Treatment § Proper patient selection § Aligning expectations § Pre-treatment : § Exfoliate the skin § Avoid anticoagulants if medical condition permits (advisable) § Shave hair (advisable) Weigh patient, photograph and measure circumference § Define treated areas, and set treatment parameters PB 73051 EN §
Clinical Procedure Patient Selection § Skin type I-VI § No medical contraindications to IR/RF/Vacuum treatment § Not recommended to treat: § Varicosity § BMI > 30 § Marginal results with: § Obese patients § Patients with edema due to lymphatic drainage problem Avoid thyroid area if there are thyroid pathologies PB 73051 EN §
Clinical Procedure Patient Selection § Aligning expectations § Improvement – not elimination § Temporary results – maintenance is essential § Skin tightening by RF may occur § Not for excessive loose skin § Stretch marks may improve – not always § Diet and exercise may improve results – not essential PB 73051 EN § Weight gain may worsen results
Clinical Procedure Defining Treatment Areas Large: § Treatment area: thighs / buttocks / abdomen § Each area divided into strips § Each strip: ~30 cm long and as wide as the Large applicator Small: § Arms / calf / bra-line / flanks § Curved areas and localized fatty deposits § ~15 x 20 cm (large hand palm) PB 73051 EN Possible to combine Large and Small
Clinical Procedure Recommended Treatment Motions Large Applicator § Work in motion to achieve best contact: § Backward & Forward/ Forward: preferred motion § Possible with Small § Circular, Zig-Zag: reinforcement motions Small Applicator § Stacks: preferred motion § Possible with Large, when movement and seal are difficult, Zig-Zag Stacks PB 73051 EN Backward & Forward Circular
Clinical Procedure Large Applicator& Small Applicator § Applying the applicator: § In a perpendicular orientation to the skin § With slight pressure for good contact § 10 -20% overlap PB 73051 EN § Release trigger before lifting applicator from skin!
Clinical Procedure Desired Endpoint Immediate response: § Persistent radiant heat (>40 -42˚C) for at least 5 -10 min § Can be felt ~5 mm above the skin or using IR thermometer § Erythema/edema accompany heating but are not the endpoint! Dermal Skin 45˚C PB 73051 EN Skin Surface 40˚C
Clinical Procedure Large Applicator Treatment Procedure Reaching end-point on an anatomical area: § Treat 1 strip repeatedly until endpoint § Move to adjacent strip and treat similarly § Reinforce: cross-hatched pass on all previous strips, following each new strip, to sustain heat Enhanced mode: § Step 1: reach endpoint in a certain anatomical area (~10 minutes) § Step 2: treat another anatomical area till endpoint (~10 minutes) § Step 3: return to first anatomical area (after ~10 minutes) PB 73051 EN and repeat procedure till reaching endpoint again
Clinical Procedure Small Applicator Treatment Procedure Reaching end-point on a small area: § Treat the whole area with “Stacking” (up to 15 pulses on each spot) § Reduce number of stacked pulses each successive pass* Enhanced mode: § Step 1: reach endpoint in a certain small area (~5 minutes) § Step 2: treat another area till endpoint (or wait) (~5 minutes) § Step 3: return to first anatomical area (after ~5 minutes) and repeat procedure till reaching endpoint again PB 73051 EN * According to patient tolerance and skin response
Treatment Parameters Recommended Parameters For both applicators Desired Treatment Cellulite Improvement (Upper Hypodermis) Circumference Reduction (Deep Hypodermis) IR 2 -3 1 RF 3 3 1 -2 2 -3 Vacuum* IR + Vacuum ≤ 5 (For Safety) PB 73051 EN * Vacuum levels may be reduced according to patient’s tolerance
Treatment Parameters Selecting And Adjusting IR § Reduce for deep treatment (to avoid superficial heating) § Reduce on very dark or tanned skin, or when stacking pulses RF § Set at highest level tolerated Vacuum Gradually increase in subsequent sessions § Increase for deep treatment § Reduce on sensitive areas (e. g. , inner-thigh), or on loose skin § Adjust according to skin response and patient tolerance PB 73051 EN §
Clinical Procedure Short-term effect: § Transient skin texture improvement – after each session Long-term effect: Circumference reduction improvement (before) § Cellulite improvement (later) § 8 -12 sessions PB 73051 EN §
Clinical Protocol § Treatment protocol is individual: § 8 -12 sessions § Twice a week § Maintenance treatment: PB 73051 EN One maintenance treatment in the month following the initial series of Velasmooth. Pro treatments, followed by once in 2– 3 months and then with decreasing frequency as needed.
Combination Treatments with Other Modalities § Alternate with mesotherapy (if same session- Vela first) § 5 weeks with meso 1/w and Vela 2/w § Other protocols § Combined Vela with deoxycholate treatment § 4 sessions 6 weeks apart § For circumference reduction only PB 73051 EN § 4 -6 weeks post liposuction for homogeneous healing
PB 73051 EN Patient Record
PB 73051 EN
Cellulite and Body Contouring PB 73051 EN Progressive Results
Photos Courtesy of J. Shaul, M. D. Post 10 Treatments PB 73051 EN Before and After
Before and After Before After PB 73051 EN 7 days after 11 treatments
Before and After Before After PB 73051 EN 1 week post 4 treatments
Body Contouring Post 8 treatments Photos courtesy of Gerald Boey, MD, Canada PB 73051 EN Before
Cellulite Reduction Post 7 treatments Photos courtesy of Gerald Boey, M. D. , Canada PB 73051 EN Before
Skin Tightening via Body Contouring Post 3 treatments Photos courtesy of Moshe Lapidot, MD, Israel. PB 73051 EN Before
PB 73051 EN Thank You & Good Luck
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