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.

Copyright 2020 Product Guide. All Rights Reseved
Explanation of the Symbols Used in the System


Copyright 2020 Product Guide. All Rights Reseved
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.

Copyright 2020 Product Guide. All Rights Reseved
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

Copyright 2020 Product Guide. All Rights Reseved
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

Copyright 2020 Product Guide. All Rights Reseved
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

Copyright 2020 Product Guide. All Rights Reseved
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!