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Reveal AURA Operator's Manual

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OPERATOR
MANUAL

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Summary of Contents for Reveal AURA

  • Page 1 OPERATOR MANUAL...
  • Page 2 Reveal Lasers Ltd info@reveallasers.com reveallasers.com Copyright © Reveal Ltd. All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Reveal Ltd. Operator Manual...

  • Page 3: Table Of Contents

    TABLE OF CONTENTS Section Title Page System Overview Safety System Installation System Description Operating the system Treatment Guidelines Operator Manual...

  • Page 4: System Overview

    System Overview 1.1 Use of this Manual The AURA™ system is designed to meet international safety and performance standards. Personnel operating the system must have a thorough understanding of the proper operation of the system. This manual has been prepared to aid medical and technical personnel to understand and operate the system.

  • Page 5: Safety

    Safety 2.1 Introduction This chapter describes general safety issues regarding the use of the AURA™ system, with special emphasis on optical and electrical safety. With proper operation and maintenance, trained and qualified medical practitioners can use the AURA™ system safely. The supervising physician and all other personnel operating or maintaining the AURA™...
  • Page 6 If necessary, use soap and water to clean before treatment. Keep towels moist to prevent them from igniting and burning. If alcohol is used to clean and disinfect any part of the AURA™ system, allow it to dry thoroughly before operating the system.
  • Page 7 To avoid the RISK of electric shock, this equipment must only be connected to a SUPPLY MAINS with protective earth. Do not use the AURA™ on patients with pacemakers or internal defibrillators.

  • Page 8: System Installation

    SECTION 3 System Installation 3.1 Introduction The AURA™ system is designed for installation in an office or a clinic and requires minimal site preparation. When the AURA™ system is purchased, complete on-site installation, including initial system testing and calibration, is included.
  • Page 9 3.3 Environmental Requirements Air Quality: the system should operate in a non-corrosive atmosphere. Corrosive materials such as acids can damage electrical wiring, electronic components and the surfaces of optical components. Air-borne dust particles should be kept to a minimum. Dust particles absorb light/laser energy and heat up.
  • Page 10 Operator Manual...
  • Page 11 3.5 Equipment List The AURA system includes the following: AURA System Applicator 64 (8X8) Tip Power cord 3.4 Unpacking Open the Box and slide the machine out of the box in the upright position. Operator Manual...
  • Page 12 3.7 Installation The System is designed for installation in a clinic environment. To install the System, perform the following tasks: Check the System and all its components for damage. Connect Handpiece to the connector and place into the cradle. Connect the Footswitch. Connect the power cord to the System inlet.
  • Page 13 3.7.2 Connecting the tip to the Applicator STEP 1 To connect a tip to the applicator, hold it in the correct orientation, facing the top of the applicator aligned with the tip. STEP 2 Rotate the tip in the clockwise direction and connect the tip to the applicator.

  • Page 14: System Description

    SECTION 4 System Description 4.1 Introduction This chapter provides a detailed description of the AURA™ system. The description covers the system’s main components, controls and functional sub- systems and system & module specifications. 4.2 General System Description and Intended Use...
  • Page 15 4.3 System Specification Input Power Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal 100-240VAC Input Current (rms) Operating Parameters Ambient Temperature Range 15 – 30°C [59 – 86°F] Relative Humidity 30% to 80%, non-condensing Atmospheric Pressure 90 - 110kPa Transport and Storage Ambient Temperature Range -2 –...
  • Page 16 4.4 System Components and Controls Handpiece Connector Handpiece Holder Switch ON/OFF Button Power Cord Operator Manual...
  • Page 17 Operator Manual...
  • Page 18 System Controls and indicators 5.1 Introduction This chapter provides a detailed description of the AURA™ system. The description covers the system’s main components, controls and functional sub- systems and system & module specifications. 5.2 Preparing the system for operation 1. Connect the Handpiece to the Handpiece connector socket on the System.
  • Page 19 5.3 The Treatment Screen Operator can control treatment parameters, start and stop a treatment, and access Tools screen from this screen. Select the area to be treated either “Face” or “Body”. Switch between “Face” and “Body” by clicking on the respective button.

  • Page 20: Treatment Guidelines

    SECTION 6 Treatment Guidelines 6.1 Introduction The AURA system, is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. Through an array of small electrodes organized on a tip, Radiofrequency energy is transmitted into the tissue, producing an injury in a certain pattern to the skin. The un- affected areas promote faster healing and the result is an improvement in the tone and texture of the skin.
  • Page 21 History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. History of bleeding coagulopathies, or use of anticoagulants. Face lift or eyelid surgery (if periorbital treatment is performed) within a year prior to treatment. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
  • Page 22 Possible Side Effects Improper use of the system could result in side effects. Although these effects are rare and expected to be transient, any adverse reaction should be immediately reported to the physician. Side effects may include any of those conditions listed below. Side effects may appear either at the time of treatment or after.
  • Page 23 No lotion, gel or coupling medium should be used during treatment. Areas of dental crowns, caps, braces, or other metal dental implants may be more sensitive to treatment and the clinician may use dental rolls, gauze or a tongue depressor to isolate the area and make the treatment more comfortable.
  • Page 24 Treatment Procedure 1. Shave any hair in the treatment area. 2. Ensure skin is completely dry during the entire treatment. If skin moistens during treatment (i.e., perspiration, etc.) re-wipe the skin with an alcohol pad and ensure that the skin is completely dry before continuing treatment.
  • Page 25 Fine-tuning of the parameters should be done before proceeding to treatment of the entire facial sub-area with the selected parameters. 10. Treatment consists of a single pass over the designated area. The applicator tip should be placed on the skin, a pulse emitted, then lifted and moved to an adjacent spot of the skin.
  • Page 26 Treatment Parameters Selecting the appropriate RF Energy level is essential for successful treatment. Always start with a low energy level and observe the skin's reaction before increasing the energy. When applying energy to tissue, there are different effects achieved in the tissue: at a relatively low increase of temperature there may be activation of cellular components of the skin;...
  • Page 27 The patient should use a high-factor sunscreen (at least 30 SPF) and protect the treated area from sunlight for at least one month after the treatment. Tanning of any sort (sun exposure, tanning beds, and artificial sunless tanning lotions) is not allowed in the treated areas during the entire course of the treatment.
  • Page 28 Exclusion Criteria Active Inflammation and/or Infection on the treatment area. Current or history of cancer & premalignant condition. Degenerative neurologic diseases. Diseases stimulated by heat, (such as recurrent Herpes Simplex in the treatment area). Internal defibrillator/pacemaker. Metal implants in the treatment area, excluding dental implants. Uncontrolled disorder of the Thyroid gland.
  • Page 29 Rosacea (applicable to face treatments only). In case of uncertainty regarding potential side effects, have the patient consult his/her primary care physician and bring a written consent for treatment. Pre-Treatment Recommended Accessories - Prior to treatment, it is advised to ensure that you have the following: Glycerin in gel or liquid formulation.
  • Page 30 Documentation It is strongly recommended that photographs of the treatment area are taken before and upon completion of the treatment series, to document clinical results and ensure a positive outcome. Consistency in photography conditions is imperative and efforts should be made to keep it.
  • Page 31 For optimal results, it is recommended to maintain the highest temperature tolerated by the patient, as long as it does not exceed 45°C. If large areas are treated, it is recommended to divide it into smaller areas, and divide the total treatment time accordingly.
  • Page 32 Reveal Lasers Ltd info@reveallasers.com reveallasers.com OPERATOR MANUAL...