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Candela VelaShape - User Manual

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VelaShape
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Copyright 2020. Manufacturer’s User Instruction Manual

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Summary

BEFORE YOU START

Conventions Used in this Manual

Explains the conventions (notes, cautions, warnings) used in the manual.

SAFETY

Introduction

Provides an overview of the safety chapter and the system's safe operation.

System Safety Features

Lists the built-in safety mechanisms of the VelaShape system.

Patient and Personnel Safety

Outlines essential safety guidelines for both the operator and the patient.

Installing the System

Instructions on how to properly install the system.

Operating the System

General guidelines and precautions for operating the VelaShape system.

Infrared Energy Safety Issues

Details safety precautions related to the infrared energy component.

Radio-Frequency Energy Safety Issues

Safety guidelines specific to the radio-frequency energy used by the system.

Mechanical Rollers Safety Issues

Safety precautions regarding the mechanical roller components.

Electrical and Mechanical Safety

Covers safety aspects related to the electrical and mechanical design of the system.

SYSTEM DESCRIPTION

System Nameplate

Explains the information found on the system's identification nameplate.

General System Overview

Describes the VelaShape II device, its technology, and indications.

Integrated Technologies

Lists the key technologies (IR, RF, Vacuum) integrated into the system.

Applicators

Details the smooth and contour applicators and their functions.

Operator Panel Controls

Explains the display and selector controls on the applicators.

Communication Terminal

Describes the function of the communication terminal for system information.

Anatomy of Cellulite

Explains the biological basis of cellulite for treatment understanding.

The VelaShape II Procedure

Describes how the VelaShape II technology works to treat cellulite.

Heating of Dermis and Hypodermis

Explains how IR and RF energies heat the skin layers for treatment.

Mechanical Effects on the Skin

Details the effects of mechanical rollers and vacuum on the skin.

SYSTEM INSTALLATION

Unpacking the System

Step-by-step instructions for safely unpacking the VelaShape system.

Equipment List

Lists all components included with the VelaShape II system.

Consumable Supplies

Identifies consumable items that can be ordered for the system.

Installation Process

Detailed steps for assembling and installing the system components.

OPERATING INSTRUCTIONS

Moving the System within the Facility

Procedures for safely moving the system within a facility.

Moving the System to another Facility

Guidelines for transporting the system to a different location.

Electrical Requirements

Specifies the necessary electrical power and connection requirements.

Environmental Requirements

Outlines the recommended environmental conditions for system operation.

Activating the System

Step-by-step guide to powering on and initializing the VelaShape system.

Automatic Vacuum and RF Test

Explains the system's automatic self-test for vacuum and RF performance.

Defining the Treatment Mode

Guides the user on selecting and setting the system's treatment modes.

Controlling the Treatment Level

Instructions on adjusting the intensity levels for IR, RF, and Vacuum.

Communication Terminal Messages

Explains messages displayed on the communication terminal during operation.

Initiating Treatment

Steps on how to start a treatment session after settings are defined.

CLINICAL GUIDE

Realistic Expectations

Sets expectations for treatment outcomes and results.

Indications

Lists the medical and aesthetic conditions for which the system is indicated.

CONTRAINDICATIONS

Details conditions or situations where the treatment should not be performed.

Possible Side Effects

Describes potential temporary side effects that may occur during or after treatment.

Pre-Treatment Preparation

Steps and advice for preparing the patient and treatment area before sessions.

Selecting the Appropriate Treatment Type

Guidance on choosing the correct applicator and treatment strategy.

VelaShape Circumference Measurement

Instructions on how to measure circumference for baseline and follow-up.

Treatment Procedure

Detailed steps for performing a VelaShape treatment session.

Treatment Protocols

Recommendations on treatment frequency, duration, and maintenance.

Treatment Parameters

Recommended settings for IR, RF, and Vacuum levels for different treatments.

Post-Treatment Care

Guidelines for managing the patient's skin after treatment.

Treatment Conclusion

Criteria for concluding treatment and expected results timeline.

MAINTENANCE

Cleaning the VelaShape System

Procedures for cleaning the main console and external surfaces.

Cleaning the VelaShape Applicators

Steps for cleaning the Vsmooth and Vcontour applicator components.

Replacing the Vsmooth Applicators Filters

Instructions on how to replace the filters for the Vsmooth applicator.

Cleaning and Maintaining the Vcontour Applicator

Procedures for cleaning and replacing the Vcontour applicator's cover and components.

Cleaning the Vcontour Applicators Filter

Steps for cleaning or replacing the filter for the Vcontour applicator.

Cleaning the Air Grids

Guidelines for cleaning the system's air intake grids.

Cleaning the System Air Filter

Instructions for cleaning the main air filter of the VelaShape system.

TROUBLESHOOTING GUIDE

System Errors Displayed by Terminal Messages and Operator Panel Indicators

Lists system errors and corresponding corrective actions.

Fault Situations with No Indicators or Error Messages

Lists fault situations without specific error messages and their solutions.

SYSTEM SPECIFICATIONS

Parameters

Technical specifications for RF Power, IR Power, Light Spectrum, and Vacuum.

Treatment Area Footprints

Dimensions of the treatment areas for Vsmooth and Vcontour applicators.

Electrical Requirements

Details electrical specifications for system operation.

Environmental Requirements

Specifies operating temperature, humidity, and pressure for the treatment room.

Degree of Protection Against Ingress of Water

Information on the system's protection rating against water ingress.

Dimensions

Physical dimensions of the system and applicator harness.

Weight

Specifies the weight of the system and its applicators.

ELECTROMAGNETIC REGULATION

Electromagnetic Emissions

Details the electromagnetic emissions compliance of the VelaShape II system.

Electromagnetic Immunity

Covers the system's immunity to various electromagnetic interference tests.

Recommended Separation Distances

Guidelines for maintaining safe distances from RF communication equipment.

Candela VelaShape Specifications

General IconGeneral
ManufacturerCandela
CategoryCosmetic Equipment
RadiofrequencyYes
Vacuum PressureAdjustable
PurposeCellulite Reduction, Circumferential Reduction
Treatment AreasThighs, Buttocks, Abdomen, Arms
Recommended Sessions4-6 sessions, spaced 1-2 weeks apart
FDA ApprovalFDA cleared

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