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January 2010

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VELASMOOTH PROCLINICAL PRESENTATION

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Superficial plane: <15 mm from skin surface(this area includes dermal and sub-dermal zones)

Subcutaneous TissueAnatomy & Histology

VelaSmoothPro II, LipoLite

LiposuctionLipoLite

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Subcutaneous Tissue

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 depots-

white adipose tissue

Anatomy & Histology

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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

- Bumpy appearance (cellulite)

What is the etiology?

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Fat cells swell and push skin upwards as septae are rigid

Blood and lymph vessels are compressed

Accumulation of intercellular fluids and physiological

waste

Cellulite and Circumference

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Factors inducing Cellulite

Heredity

Hormones

Smoking

Lack of exercise

Poor diet

Physiological status

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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)

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Regulatory Clearance

FDA, CE

The VelaSmoothPro 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

Indications For Use

*CE only

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Features and Benefits

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VelaSmoothPro Platform

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What is VelaSmoothPro?

More powerful - RF energy increased by 75% to 35 Watts

Higher efficacy

Faster patient’s turnover

Disposable applicator Covers – ‘per patient’- Large: 16H /

Small: 4H

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

Monitors device’s activity and performance

Intuitive feedback for user

Service diagnostics

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The Technologies

Vacuum (Suction) Infrared (IR) Radiofrequency (bipolar RF) Mechanical massage (Rollers)*

*Large appl. only

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Applicators Specifications

Large SmallApplicator Applicator

RF Power Up to 35W Up to 8W

IR electrical power Up to 35W Up to 20W

Spot Size 40x40 mm 30x30 mm

Penetration 5-20 mm

Wavelength 700-2000 nm (Broad Band

IR)

Vacuum Pulsed 180-380 mbar

Disposable covers 16 hrs 4 hrs

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VelaSmoothPro Applicators

RF IR Vacuum Massage (Rollers) -

The Technology Large SmallApplicator Applicator

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VelaSmooth/ VelaSmoothProApplicator Specs. VelaSmoo

thVelaSmoot

hPro

Large

RF electrical power 20W 35W

IR electrical power35W 35W

Vacuum ? 420 mbar

Disposable covers/filters 30 hrs/10 hrs 16 hrs/10 hrs

Small

RF electrical power8W 8W

IR electrical power20W 20W

Vacuum ? 340 mbar

Disposable covers/filters 10 hrs

(cover with filter)

4 hr/4 hrAlternate filter for every

treatment

Communication Terminal

- +

Dual Connector

- +

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Small covers Large covers Bundle box5 pack 5 pack 1 large 5pck+ 1 small 5pck

Consumables

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Button Treatment Mode Description

IR mode Continuous infrared light energy is applied

RF mode Radio frequency current is applied

Vacuum mode Pressing this button activates the vacuum pump

Applicator cover indicators Green LED: cover is operative and installed properly

Red LED: cover is expired or not installed properly

Applicator’s operating panels

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Communication Terminal

: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.

Also various Maintenance or Error messages will be displayed, these appear in

the troubleshooting guide in User Manual .

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System Type – VelaSmoothPro VelaSmoothPro - 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

Communication Terminal – info button

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VelaSmooth Treatment Mechanism

Improved blood supply:

90% of vessels are compressed at normal atmospheric pressure

Applying negative pressure → vessel dilation and blood flow ↑↑

Vacuum also enables deeper penetration of RF

Fibroblast stimulation

Vacuum Effects

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VelaSmoothPro Treatment Mechanism

Mechanical massaging effect enhances drainage of trapped intercellular fluid to lymphatics

Mechanical Effect of Rollers – Massage

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IR light heats the tissue down to the deep dermis

RF heats tissue down to the subcutis

VelaSmoothPro Treatment Mechanism

Deep Heating by IR + RF

RF electrodes

Lamp

Infrared filter

Parabolic reflector

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Temperature,˚C

Viscosity of H2O, centipoises

Diffusivity of O2,cm2/s

20 1.002 1.97x10-5

40 0.653 3.24x10-5

50 0.547 3.99x10-5

VelaSmoothPro Treatment MechanismHeating Effect On Oxygen Diffusivity

Heat increases oxygen diffusivity →

delivering more oxygen from capillaries to fat

cells

Oxygen Diffusivity in Water

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VelaSmoothPro Treatment Mechanism

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

Heating Effect On Metabolism

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The science of Vela – Biological Model

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Clinical Procedure

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

Pre-Treatment

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Clinical Procedure

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

Patient Selection

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Clinical Procedure

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

Weight gain may worsen results

Patient Selection

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Clinical ProcedureDefining 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

~15x20 cm (large hand palm)

Possible to combine Large and Small

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Clinical Procedure

Recommended Treatment Motions

Backward & ForwardForwardCircular

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

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Clinical Procedure

Applying the applicator:

In a perpendicular orientation to the skin

With slight pressure for good contact

10-20% overlap

Release trigger before lifting applicator from skin!

Large Applicator& Small Applicator

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Clinical Procedure

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!

Desired Endpoint

Skin Surface40˚C

Dermal Skin45˚C

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Clinical 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)

and repeat procedure till reaching endpoint again

Large Applicator Treatment Procedure

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Clinical 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

* According to patient tolerance and skin response

Small Applicator Treatment Procedure

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Desired Treatment Cellulite Improvement

(Upper Hypodermis)

Circumference Reduction (Deep

Hypodermis)

IR 2-3 1

RF 3 3

Vacuum* 1-2 2-3

Treatment ParametersRecommended Parameters

IR + Vacuum ≤ 5 (For Safety)

For both applicatorsFor both applicators

* * Vacuum levels may be reduced according to patient’s tolerance

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Treatment Parameters

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

Selecting And Adjusting

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Clinical Procedure

Long-term effect:

Circumference reduction improvement (before)

Cellulite improvement (later)

8-12 sessions

Short-term effect: Transient skin texture improvement – after each session

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Clinical Protocol

Treatment protocol is individual:

8-12 sessions

Twice a week

Maintenance treatment: One maintenance treatment in the month following the initial

series of VelasmoothPro treatments, followed by once in 2–3 months and then with decreasing frequency as needed.

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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

4-6 weeks post liposuction for homogeneous

healing

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Patient Record

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Cellulite and Body Contouring

Progressive Results

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Before and After

Photos Courtesy of J. Shaul, M.D.Post 10 Treatments

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Before and After

7 days after 11 treatments

Before After

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Before and After

1 week post 4 treatments

Before After

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Body Contouring

Photos courtesy of Gerald Boey, MD, Canada

Post 8 treatmentsBefore

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Cellulite Reduction

Photos courtesy of Gerald Boey, M.D., Canada

Post 7 treatmentsBefore

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Skin Tightening via Body Contouring

Photos courtesy of Moshe Lapidot, MD, Israel.

Post 3 treatmentsBefore

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Thank You& Good Luck

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