Reveal AURA User manual

OPERATOR
MANUAL

Operator Manual
Reveal Lasers Ltd
[email protected]
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.
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Operator Manual
TABLE
OF CONTENTS
Section Title Page
1System Overview 5
2Safety 6
3System Installation 6
4System Description 8
5Operating the system 8
6Treatment Guidelines 9
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Operator 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. Do not operate the system before reading this manual and gaining a clear understanding
of system operation. If any part of this manual is not clear, please contact your representative for
clarication.
The information provided in this manual is not intended to replace professional training on the
clinical use of the system. Please contact your representative for current information on available
training. For clinical information, refer to the clinical guides in this manual, which includes set up
guidelines for each application. This manual should always accompany the system and all operating
personnel must know its location.
1.1 Use of this Manual
SECTION 1
System Overview
The AURA™ machine is a non-invasive
bipolar Radio-frequency (RF) technology
for use in dermatologic and general
surgical which require ablative treatment
and various aesthetic applications. The
device provides adjustment of treatment
parameters to provide maximum eciency,
controlled ablative treatment and safety for
each patient.
1.2 About the machine
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Operator Manual
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
qualied medical practitioners can use the AURA™ system safely. The supervising physician and all
other personnel operating or maintaining the AURA™ must be familiar with the safety information
provided in this chapter. The primary consideration should be for the safety of the patient, the
physician and other personnel. Patient safety is mainly assured with a well-trained sta and a well
laid-out treatment room. Patient education is also important, including information about the nature
of the treatment.
2.1 Introduction
SECTION 2
Safety
The following precautions, cautions and warnings must be observed for the safe use of the
AURA™ system.
1. Physicians and clinicians should read this manual thoroughly before attempting to operate
the AURA™ system.
2. The system weighs approximately (20 kg) and may cause injury if proper care is not
used when moving it. The system is well balanced and is designed to be moved, but
should always be moved carefully and slowly. Never pull the system by the module or its
umbilical cable.
3. An audible tone indicates energy activation.
4. During activation, the system performs a self-test of the hardware.
5. The hardware is tested every 10ms to ensure proper operation of electrical circuit.
2.2 Electrical and Mechanical Safety
Features of the System
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Operator Manual
Observe the following cautions when using the AURA™.
1. Only Reveal Lasers™ authorized personnel may service the AURA™ system. This includes
making internal adjustments to the power supply, cooling system, optics, modules, etc.
2. Verify that the AURA™ is wired for the appropriate electrical voltage of your country
(110V/ 230V AC).
3. Maintenance performed by the operator must only take place when the system is shut
down and disconnected from the electrical power source. Performing maintenance
procedures with the system powered-up can be hazardous to the operator and/or
destructive to the system.
4. Always turn o the system when it is not in use.
5. Never leave the system in Ready mode unattended.
6. Never allow untrained personnel to operate the system.
7. Never press the module’s trigger and/or foot-switch unless the module is safely oriented
at a specic and intended target.
8. The module and tips must always be visually inspected before treating the patient. If any
wear or damage is apparent, do not use the module or tip.
9. Never leave the system turned on, open or unattended during system maintenance.
2.3 Cautions
Take precautions to reduce the risk of igniting combustible materials in and around the
treatment area.
The RF energy and heating associated with the System can provide an ignition source.
Observe re precautions at all times.
The system is not suitable for use in the presence of ammable mixtures with air or
oxygen, conductive to RF.
Do not operate in the presence of volatile solvents such as alcohol, gasoline or other
solvents.
Do not use any ammable substances such as alcohol or acetone in the preparation of
the skin for treatment. 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.
Flammable materials must be kept at a safe distance from the system.
Do not use the System in the presence of explosive or ammable materials.
During treatment also pay attention to the possible danger of ignition of endogenous
gases or use non-ammable prepping solutions.
2.4 Fire Hazards
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Operator Manual
This equipment is for use only by qualied medical professionals trained in the particular
technique to be performed.
Connect the power cord to a properly polarized and grounded power source with the
frequency and voltage characteristics that match those listed on the back of the unit.
Connect the System power cord to a properly grounded receptacle.
Do not use power plug adapters.
Always turn o and unplug the device before cleaning.
The patient should not come into contact with metal parts which are earthed or which have
an appreciable capacitance to earth. The use of anti-static sheeting is recommended for
this purpose.
Treatment bed or chair should not be electric. Use the lowest output setting necessary to
achieve the desired treatment eect.
The higher RF is applied, the greater the possibility of unintended thermal damage. Failure
of the equipment could result in an unintended increase of output power.
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 debrillators.
2.5 Warnings Related to RF Energy Emission
As required by national and international
regulatory agencies, appropriate warning and
information labels have been attached in specic
locations on the instrument as identied below.
Figure 2-1: AURA System Rear Panel with Label.
2.6 System and Handpieces Labels
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Operator Manual
The AURA™ system is designed for installation in an oce 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.
System transportation and installation is carried out by authorized technical personnel, who will
do the following:
1. Unpack the system and position it in its pre-selected location.
2. Verify the integrity of the system and its components.
3. Connect system components (module).
4. Plug the system into a designated electrical outlet.
5. Test the system for proper calibration and functional operation of all components and
software.
6. Coordinate the performance of an on-site safety inspection, if required.
Note: Any damage to the packaging or to the system found prior to opening the package should be
reported to your REVEAL™ representative and to the insurance carrier.
3.1 Introduction
SECTION 3
System Installation
The System can automatically accommodate the most of the local mains voltage. Specically, the
System can be energized of the mains voltage as follow: (100V AC; 10A) or (115V AC; 10A) or (230V
AC; 10A) or (240V AC; 10A) 50-60Hz.
3.2 Electrical Requirements
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Operator Manual 9
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. Hot particles located on the optical lenses can
damage them. Metallic dust is destructive to electrical equipment.
Temperature: to ensure that the system performs optimally, maintain room temperature
between 20°C and 25°C (68°F - 77°F) and relative humidity of less than 80%. Note: When
the system is used intensively, it emits heat. Therefore, it is recommended to install air
conditioning in the room in which the system will be used.
3.3 Environmental Requirements
Space should be allocated with
adequate ventilation and free airow.
The working area for the system should
be prepared according to the system
dimensions presented in the Figure. In
order to guarantee proper ventilation,
always keep the sides of the system at
least 20” (0.5m) from the wall or from
other obstructions to air ow. After
positioning the system, lock the breaks
on the front wheels by pressing the
pedals on top of each wheel.
3.4 Space and Positioning
1m
0.44 m
0.33 m

Operator Manual
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Operator Manual
The AURA system includes the following:
AURA System
Applicator
64 (8X8) Tip
Power cord
3.5 Equipment List
Open the Box and slide the machine out of the box in the upright position.
3.4 Unpacking
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Operator Manual
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.
Plug the System Power Cord into an appropriate electrical outlet.
3.7 Installation
1. Connect the applicator's to the system's connection port at the back of the machine.
2. Match the line on the connector and the slot to x the handpiece.
3. Place the applicator in the Handpiece holder.
4. To Disconnect pull the outer cover of the connector; the locks will get disengaged and
then pull the connector.
3.7.1 Connecting the Applicator
Match the markings
Pull the outer cover to remove
the connector
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Operator Manual
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. A click sound ensures the tip is
connected properly yo the applicator.
STEP 3
To remove the tip from the applicator, rotate the tip in
the counterclockwise direction.
To move the system within the clinic, do the following:
1. Place the module in its cradle.
2. Disconnect the power cable.
3. Release the wheel breaks.
4. Slowly push or pull the system using the handle.
3.8 Moving the System
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Operator Manual
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 specications.
4.1 Introduction
SECTION 4
System Description
Aura is an innovative Fractional Radio Frequency
solutions for Skin rejuvenation, remodeling, antiaging
etc. The machine has a maximum peak power of
250W thus providing superior thermal depth and
penetration in the skin.
The 1Mhz Frequency and 1mm Gold plated tip have
low resistance and higher conductivity in the skin for
optimal results.
Gold plated RF tips are the ingenious combination
of penetration and radio frequency. During the
treatment, the doctor regulates the radiofrequency
energy according to the microneedle and treatment
area, then under the microcontroller system, dozens
of insulated gold plated tips penetrate the epidermis
at the same time, and transmit the radio frequency
energy from the micro crystal tip.
4.2 General System Description and Intended Use
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Operator Manual
4.3 System Specification
Input Power
Main Line Frequency (nominal) 50-60Hz
Input Voltage (nominal 100-240VAC
Input Current (rms) 2A
Power
Maximum Output Power 250[W]
Frequency 1MHz
Crest Factor (Rated Load 1.4± 2%
Tip Depth 1mm; matrix 64
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 – 65°C [-4 – 14°F]
Relative Humidity 0% to 80%, non-condensing
Atmospheric Pressure 50 to 110kPa
Dimension and Weight
Dimension Length:0.33m Breadth: 0.44m Height: 1m
System Weight 15.000kg ;[33.069lb]
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Operator Manual
4.4 System Components and Controls
Handpiece Connector
Handpiece Holder
Switch ON/OFF Button
Power Cord
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Operator Manual 17

Operator Manual
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 specications.
5.1 Introduction
SECTION 5
System Controls
and indicators
1. Connect the Handpiece to the Handpiece connector socket on the System.
2. Connect the 64 pin Tip(8mm*8mm) to the handpiece. The 64mm tip is a-sterilized and
single use only.
3. Before turning the System “ON”, verify that the power cord is connected to the inlet located
on the rear panel of the system and to the main power outlet. Switch on the system by
turning the main power switch located in the rear panel of the system to its “ON” position.
4. The System loads the software and enters a self-test mode. If any problem is detected
during the test the error message will pop up.
5. Verify on the screen that the Software version is properly displayed and the connected
Handpiece type is recognized correctly.
6. The Home screen Fig (1) appears on the screen, when you start the machine. Press Start
on the screen to switch to treatment mode.
7. Select the treatment parameters.
8. Press the Ready button to start the treatment.
9. Apply Handpiece on the area to be treated, ensuring a full contact with pressure.
5.2 Preparing the system for operation
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Operator Manual
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.
COUNT: This indicator displays the total number of pulses red from
the handpiece since the beginning of the treatment.
The connected Tip has a shot count Limit.
TIME: The timer can be set for the machine to re shots continuously
until the timer counts to zero. The timer is displayed in min:sec. The
timer can be adjusted by pressing the "+" and "-" buttons at the
bottom of the settings. The machine turns to standby mode from
ready mode once the timer is 0.0.
DURATION: Select the "Duration” button to adjust the pulse duration.
Pulse duration can be adjusted by pressing the "+" and "-" at the
bottom of the screen. Pulse duration is measured in seconds The
minimum is 0.1s and the maximum is 1 sec.
POWER: This button allows the operator to determine the RF output
of the applicator with respect to the area to be treated. Power is
adjusted by pressing the “Power” button and the “+” and “-“ at the
bottom of the settings. The Power increments/decrements in the
value of 1W. The maximum power is 250 W.
READY/STANDBY:
Press ready mode when you are ready to start the treatment.Press standby when you are done with
the treatment.
5.3 The Treatment Screen
As a standard safety measure whenever light/laser emission is not immediately required, the system
should be set to Standby mode. Before leaving the room, the operator should turn the system o
as described.
5.4 To turn off the system
1. Set the system to Standby mode.
2. Toggle the main power switch to the
O position.
3. Disconnect the power cable from the
mains outlet.
4. Clean the module and other
accessories.
5. Set the module in its holder.
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Operator Manual
SECTION 6
Treatment Guidelines
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- aected areas promote faster
healing and the result is an improvement in the tone and texture of the skin.
6.1 Introduction
Pacemaker or internal debrillator, or any other active electrical implant anywhere in the
body.
Permanent implant in the treated area such as metal plates and screws, or an injected
chemical substance.
Current or history of skin cancer, or current condition of any other type of cancer, or pre-
malignant moles.
History of any kind of cancer *.
Severe concurrent conditions, such as cardiac disorders.
Pregnancy and nursing.
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or
use of immunosuppressive medications*.
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in
the treatment area, may be treated only following a prophylactic regime.
Poorly controlled endocrine disorders, such as diabetes.
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
Exclusion Criteria
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