Candela VelaShape User manual
VelaShape
Copyright 2020. Manufacturer’s User Instruction Manual
Copyright 2020 Product Guide. All Rights Reseved
ō
Copyright 2020 Product Guide. All Rights Reseved
Copyright 2020 Product Guide. All Rights Reseved
Warning
• Read this manual to become familiar with all safety requirements
and operating procedures before attempting to operate the
system.
• Any intense optical energy or radio frequency (RF) device can
cause injury if used improperly.
• High voltage is present inside the system. Always be aware of
the possible dangers and take proper safeguards as described in
this manual.
• The VelaShape II system must be serviced only by Syneron-
Candela qualified personnel.
Conventions Used in this Manual
The following conventions in the form of notes, cautions and warnings are used
in this manual:
Note: The content of this Note offers general information that is important to
keep in mind.
Caution: A Caution alerts the user to the possibility of a potentially hazardous
situation which, if not avoided, may result in minor or moderate injury
to the user or damage to the equipment.
Warning: A Warning alerts the user to the possibility of injury, death, or
serious adverse effects associated with the use or misuse of the
system.
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Explanation of the Symbols Used in the System
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This chapter describes the safety issues regarding the use and maintenance of the VelaShape
system, with special emphasis on optical and electrical safety.
Note: Protect the VelaShape system against unqualified use by removal of the key from the
keyswitch when the system is unattended.
Introduction
The system is designed for safe and reliable treatment, when used in accordance with proper
operation and maintenance procedures. Only trained practitioners are qualified to operate the
system. The user and all other personnel operating or maintaining the system should be familiar
with the safety information provided in this chapter. Global Wellness Enterprises assumes no
liability what so ever for any damage or injury as a result of an application of a product which is
not in strict accordance with the instructions provided with the product. The primary
consideration should be to maximize safety for both treating attendant and the patient.
Warning
• Read this chapter to be familiar with all of its safety requirements and operating
procedures prior to operating the system.
• Any intense optical energy or RF device can cause injury if used improperly.
• High voltage is present inside the system.
• Always be aware of the possible dangers and take proper safeguards as described in
this manual.
• In the event of adverse effects or injury/illness, immediately contact:
Global Wellness Enterprises
• For complete contact information please refer to page 3 of this manual.
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The VelaShape system incorporates the following safety features:
• The system is activated by a key that should be available only to trained personnel.
• The power electronics cannot be activated unless an applicator has been connected to
the system.
• Upon system activation, IR, RF, and Vacuum are at Level 0 on the operator panels.
• During activation, the system performs a self-test of the hardware to detect any faults,
so that you can shut down the system if necessary.
• IR and RF energies are not delivered unless full contact with the tissue is conducted.
Patient and Personnel Safety
When handling the VelaShape II system, the primary safety concern should be the safety of
both the treating attendant and the patient. Follow these personal safety guidelines to maintain
a high level of personnel safety:
• Make sure that only well-trained attendants perform treatment.
• Prior to scheduling treatments, obtain a detailed patient history to verify that the patient
is eligible and is in fit condition to undergo treatment.
• Fully inform the patient regarding the treatment protocol, the likely results and any risks
associated with treatment.
• Before activating the system, make sure any long hair of the treating attendant or the
patient is safely pulled back and tied.
• Ascertain that all jewelry is removed.
• Improper treatment technique may cause local burns.
Warning
• Prior to system activation, any personnel operating or maintaining the system should be
familiar with the safety information provided in this chapter.
• Opaque eye protection should be used when working within a 30 cm proximity to the patient's
eyes.
System Safety Features
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When installing the system, ensure that the system is grounded through the grounding
conductor in the power cable. This protective grounding is essential for safe operation.
Operating the System
• Keep all system panels closed. Do not remove the panels and do not touch any of the
system's inner components.
• Keep your hands away from the applicators during system start-up.
• Always turn the system off before connecting/disconnecting an applicator, or the Dual
Connector.
• Keep the applicators clean and dry.
• Do not allow the replaceable applicator covers to come in contact with hard materials,
excessive heat or humidity; these may damage the RF electrodes.
• Never use the system in the presence of explosive or flammable materials.
• Make sure that all treatment personnel are familiar with the system's controls and know
how to shut down the system instantly.
Infrared Energy Safety Issues
The VelaShape emits gentle heating infrared light between 700-2000nm in a continuous wave
mode. Light emission is contained within the applicator chamber and occurs only when the
operator presses the trigger button on the applicator, when an adequate vacuum seal is
achieved and the RF electrodes are in full contact with the treated surface. Opaque eye protec-
tion should be used when working within a 30 cm proximity to the patient's eyes.
Do not aim the applicator at anything but the intended target area; it should always be oriented
toward the treatment area, and the trigger button pressed only when full contact is made with
the skin. In rare cases superficial crusting may be formed on the skin from the IR effect.
Installing the System
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The RF energy provides gentle heating that is distributed deep into the skin via bi-polar elec-
trode rollers. Full coupling of both electrodes (spiral shaped rollers) to the skin, after applying
VelaSpray Ease, is necessary before pressing the trigger button, so that the RF energy is safely
conducted to penetrate the skin. If coupling with the skin is broken due to incomplete contact or
removing the applicator from the treatment site while the trigger is pressed, IR and RF modes
are disabled and blinking lights on the applicator’s operator panel indicate insufficient coupling.
The trigger should be released immediately and the applicator should be re-oriented on the
skin. In rare cases superficial crusting may be formed on the skin from the RF effect.
Because of the heating effect by RF energy, highly conductive objects such as superficial metal
or conductive implants, rods, plates or pins should be avoided in the treatment area.
Mechanical Rollers Safety Issues
Beware of any loose material in or near the immediate treatment area that may get caught in
the rollers. There should be no loose cords, clothing, hair, etc. in the treatment area. Ensure
integrity of rollers' coating before and during treatment.
Electrical and Mechanical Safety
• Keep all covers and panels of the system closed. Removing the covers creates a safety
hazard.
• Keep hands away from the applicators during system start-up.
• Perform maintenance procedures when the system is shut down and disconnected from its
electrical power source.
• The system's cables are equipped with isolation coating and the electronic circuitry is also
isolated from the mains power supply. In addition, the system’s plastic covers serve as a means
of isolation.
• Move the system slowly and carefully. The system weighs approximately 27 kg (59.5 lbs.) and
may cause injury if proper care is not used when moving it.
• The system is grounded through the grounding conductor in the power cable. This protective
grounding is essential for safe operation. The RF electrodes are the only non-grounded compo-
nent of the system, due to the nature of the treatment.
• Portable and mobile RF communications equipment can affect medical electrical equipment,
Interference may occur in the vicinity of the equipment.
• The use of accessories and cables other than those specified may result in increased
emissions or decreased immunity of the device. It is forbidden to connect any third-party
equipment to the system.
Radio-Frequency Energy Safety Issues
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Maintaining the System
• Only authorized Syneron-Candela technicians are qualified to service the system.
• Shut down the system and disconnect the power cable before performing any mainte
nance procedures (see Chapter 7).
Fire Hazards
• The absorption of optical energy or conduction of RF raises the temperature of the
absorbing material. Do not use the system in the presence of explosive or flammable
materials.
• Keep drapes and towels moist to prevent them from igniting and burning. Use non-flam
mable prepping solutions.
• Do not use flammable substances when preparing the skin for treatment.
• If alcohol is used for disinfecting, it must be allowed to dry thoroughly before the system
is used.
System Classifications
• Electric shock protection: Class I, Type BF
• Protection against ingress of liquids: Ordinary equipment
• Not suitable for use in presence of flammable substances
Warning
No modifications to this equipment are allowed!
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System Nameplate
The following illustration (see Figure 1) displays the location of the system's nameplate, which
includes the system's identification, regulatory and electrical requirement information:
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The VelaShape II is a device that combines elōs technology (electro-optical synergy) with
mechanical manipulation of the skin using gentle vacuum suction with or without mechanical
massage. It is designed for use in medical and aesthetic practices and is indicated for:
• EU: non-invasive treatment for body contouring via temporary cellulite and
circumference reduction.
• USA: temporary reduction in the appearance of cellulite and temporary reduction of
thighs circumferences. It is also indicated for the relief of minor muscle aches and
spasms, as well as for the temporary improvement of local blood circulation.
The system is designed to be user-friendly, safe and reliable. It integrates the following
technologies:
• Infrared (IR) optical energy
• Bipolar conductive radio frequency (RF) current
• Mechanical manipulation (vacuum with or without massage rollers)
These three technologies work together to provide dermal and sub-dermal heating, and
mechanical modifications resulting in improved blood circulation, enhanced lymphatic drainage,
as well as an increased metabolic rate of the adipose tissue.
While this system is considered safe for both the operator and the patient, it should be operated
only by trained, qualified treating attendants.
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Applicators
The smooth and contour applicators incorporate the operator panels, and are used for the
physical implementation of the RF current, IR energy and mechanical manipulation treatment
parameters.
The Smooth applicator (see Figure 3) utilizes IR, RF and mechanical manipulation by vacuum
and massage rollers. It is used for cellulite reduction in large areas such as the thighs, buttocks,
or abdomen and for circumference reduction.
The Contour applicator (see Figure 4) utilizes IR, RF and mechanical manipulation by vacuum.
It is used for cellulite and circumference reduction of curved areas, for localized fatty deposits,
and to reinforce results of smooth applicator, thus leading to contouring of smaller areas such
as the lower abdomen, flanks and arms.
The Connector enables the attachment of all 3 applicators at the same time. Please note that
working simultaneously with all 3 applicators is not possible.
The VelaShape applicators are composed of a permanent handpiece and a replaceable cover.
The replaceable covers of the VelaShape applicators are usable for limited periods of time.
The replaceable cover of the Vsmooth applicator should be replaced according to
the schedule printed on the cover's storage box, or sooner if one of the following
is observed:
• The IR & RF columns of LEDs blink continuously (inadequate coupling).
• The applicator does not move smoothly over the skin.
• Rollers appear damaged, discolored or their movement is impaired.
• Roller axis appears to wear out (color turns from silver to copper).
The replaceable cover of the Vcontour applicator should be replaced according to the schedule
printed on the cover's storage box, or sooner if one of the following is observed:
• The IR & RF columns of LEDs blink continuously (inadequate coupling).
• Electrodes appear damaged.
• The cover's shape appears distorted.
• The vacuum LEDs column of LEDs is cycling continuously from 1 – 3, indicating a
clogged filter.
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The display and selector controls are located on the operator panel of each applicator. The
three user-defined treatment modes are: IR, RF, and Vacuum. The levels are indicated by 0, 1,
2, or 3 illuminated LEDs which correspond to no energy, low, medium and high levels,
respectively (see Figure 3 and Figure 4).
Note
The images in the figures are for illustration purposes only.
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The applicators are applied to the treatment area so that all four edges of the aperture make a
seal with the skin. This allows the vacuum to be effective and ensures that the RF electrodes
are fully coupled to the skin. Failure to achieve full contact between the RF electrodes and skin
will result in disabled IR and RF energies, indicated by:
• Blinking of the LEDs on the applicator's operator panel.
• An Improve Contact message on the communication terminal's display (see Figure 5).
Communication Terminal
The communication terminal is a digital message board that keeps the user of the VelaShape
system informed of various system conditions and alerts that will occur during the normal
course of operation. It also displays system error messages that require resolution by the user
before treatment can be continued.
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Anatomy of Cellulite
Cellulite is characterized by Dimpled
Skin Surface – mattress-like
appearance (see Figure 2-4). The fat
cells are located in chambers which
are separated by vertical and
horizontal Connective Tissue
Septa. The Septa are anchored rigid
fibers that do not stretch with the skin
as the volume within the walls of the
chamber increases. When the fat
chamber becomes too distended by
enlarged fat cells and by retained
intercellular fluids, it protrudes beyond the length of the vertical septa, pushing
up the skin's surface and resulting in a dimpled skin appearance.
The VelaShape Procedure
The application of elōs (IR and RF energies) to the dermis/hypodermis is intended to deploy
heat to the tissues that contribute to cellulite. The vacuum contributes to increased blood
circulation (see Figure 7). The blood, which is one of the targets of the hyperthermic effect of the
IR and RF, responds in a higher diffusivity of oxygen. This in turn increases the metabolic
breakdown of stored fat by the fat cells (lipolysis), thereby reducing the size of the fat cells.
Consequently, the bumpiness of the skin, which is largely caused by distended fat cells
protruding up from the anchored connective tissue septa, is reduced. The mechanical action of
the vacuum and rollers gently kneads the skin and facilitates deeper penetration of heat, deliv-
ering the RF and IR energies to the dermis and hypodermis. This mechanical action helps in
draining the excess intercellular fluids from the dermis and the upper part of the hypodermis into
the lymphatic system.
Both actions, reducing the size of the fat
cells and draining excess fluids to the
lymphatic system, are accompanied by
shrinkage of the connective tissue septa
and facilitate the overall shrinkage of the
size of the fat chambers, thus leading to
a reduction in the appearance of cellulite
and a reduction in the circumference of
the treated area.
Figure 6: Anatomy of Cellulite
Figure 7: Heating and Mechanical
Manipulation Action
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Figure 8: Before Treatment
Figure 9: IR Heats the Tissue Up To 2 mm. RF Heats the Tissue
Up To 20 mm in Depth
Figure 10: After VelaShape Treatment Reduction in the Size
of the Fat Cells and Fat Chambers
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Heating of Dermis and Hypodermis
Light Energy (see Figure 7):
• Broad spectrum IR light at wavelengths of 700-2000 nm.
• Maximum electrical power of the IR light is 35 Watts (35 J/sec) for both smooth and
contour applicators.
• Depth of heating from light reaches the deep dermis. RF Energy (see Figure 7):
• Bi-polar conductive RF energy is emitted from the RF electrodes which are embedded
in the rollers at a frequency of ~1 MHz.
• Maximum RF energy applied to the patient's skin is 60 Watts for the
smooth applicator and 23 Watts for the contour applicator.
• The heat generated by the RF energy reaches the depth of the hypodermis.
Mechanical Effects on the Skin
Mechanical Rollers (see Figure 9):
• Rollers knead the skin inward so that the IR and RF energies can penetrate deeper in
the skin.
• Rolling the skin upward facilitates a better suction effect from the vacuum.
• The repeated kneading of the skin between the rollers improves lymphatic drainage,
with overall improvement of the dimpled appearance of cellulite.
Vacuum/Negative Pressure (see Figure 9):
• When all edges of the applicator are in full contact with the skin, a seal is made,
allowing the vacuum pump to apply gentle suction.
• Negative pressure dilates the blood vessels, increasing the perfusion in the local area.
• Vacuum levels are:
- Smooth applicator – up to 380 mbar of negative pressure
- Contour applicator – up to 440 mbar of negative pressure
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Unpacking the System
After unpacking the system, Syneron-Candela recommends that you retain the shipping box
and the internal Styrofoam covers and braces in the event that the system will have to be relo-
cated anytime in the future.
Unpack the system as follows:
1. Cut off and remove the three plastic straps that encase the cardboard box.
2. Lift the cardboard box up and off the packaged components and set it aside.
3. You will find a "Vela Product Line Unpacking Instructions" sheet taped to the side of
the top Styrofoam cover; follow the instructions on this sheet, and then continue with
unpacking and installation from this point.
4. Carefully remove the packed accessories and small Styrofoam boxes from inside the
Styrofoam covers.
5. Finish removing all of the Styrofoam covers and braces from around the body of the
system.
6. Remove the plastic bag that is wrapped around the system.
Caution: The Smooth (large) applicator is taped inside the top Styrofoam cover; unpack it
carefully.
7. Compare the accessories you unpack to the equipment list (next section) to ensure
that all accessories are present.
8. Lift the system up and out of the bottom Styrofoam brace and carefully set it on the
floor.
Warning
The system weighs 27 kg (59.5 lbs.) and should only be lifted by two people. Lift correctly and
protect your back!
9. Finish unpacking the accessories and continue with the installation process.
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Equipment List
The VelaShape II system is delivered with the following:
• VelaShape II system console
• Vsmooth applicator (with non-operational protective cover)
- Disposable cover for Vsmooth applicator (x 2)
• Vcontour applicator (with non-operational protective cover)
- Disposable cover for Vcontour applicator (x 2)
• Software plug (installed in system's rear panel)
• Dual-Connector assembly
• Vcontour applicator cradle
• Umbilical support mast (includes five harness loops)
• Accessories kit, including:
- Communications terminal with cable
- User Manual
- Quick-Reference Guide / Quick-Service Guide
- Infrared thermometer (warranted and serviced by manufacturer)
- One pair of protective opaque goggles
- Filter extractor
- Set of two keys
- Cleaning brush
- VelaSpray Ease bottles (x 4)
- System air filters (x 3)
Consumable Supplies
The following consumable supplies may be ordered using the following part numbers:
• Replaceable covers for the Smooth applicator1
• Replaceable covers for the Contour applicator1
• VelaSpray Ease bottles (10-pack)
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