Reveal VEGA LUX User manual
USER
MANUAL
HAIR REMOVAL - PERFECTED™
Reveal Lasers - User Manual
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Reveal Lasers - User Manual
Reveal Lasers Ltd
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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Reveal Lasers - User Manual
Section Title Page
1.1 Use of this Manual 5
1.2 Maintenance 6
1.3 Modication of the System 6
1.4 Abbreviations and Acronyms 7
CHAPTER 1
System Overview
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Reveal Lasers - User Manual
The VEGA LUX™ 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 clarication.
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.
Warning:
Use of controls or adjustments, or performance of procedures other than thosespecied herein
may result in hazardous radiation exposure. Therefore, beforeattempting to use or operate the
system, practitioners operating the system should read this manual and become thoroughly
familiar with all its safety requirements and operating procedures.
For further information about REVEAL™v, isit the company website at: www.reveallasers.com
. Use of this Manual
CHAPTER 1
System Overview
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Reveal Lasers - User Manual
The VEGA LUX™ system is a precision, technical medical device that requires periodic routine
maintenance service, which much be performed by REVEAL™ authorized technical personnel.
Failure to obtain service voids all warranties expressed and implied. Please contact REVEAL™
personnel or your local representative for details.
. Maintenance
Unauthorized modication of the hardware, software or specications of the VEGA LUX™ system
voids all warranties, expressed and implied. REVEAL™ta kes no responsibility for the use or
operation of such a modied device.
Warning:
No modication of this equipment is allowed.
. Modification of the System
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Reveal Lasers - User Manual
“
°C
°F
A
AC
CFR
cm2
CW
HR
Hz
IEC
J
J/cm2
Kg
Lbs
. Abbreviations and Acronyms
LCD
LED
m
mm
msec
NIR
nm
OD
PWM
Sec
SPF
TEC
V
VAC
W
Liquid Crystal Display
Light-emitting Diode
Meter(s)
Millimeter(s)
Millisecond
Near Infrared
Nanometers
Optical Density
Pulse Width Modulation
Second(s)
Skin Protection Factor
Thermoelectric Cooling
Volt(s)
Volt(s) AC
Watt(s)
Inches
Degree(s) Centigrade/Celsius
Degree(s) Fahrenheit
Ampere(s)
Alternating Current
Code of Federal Regulations
Centimeter(s)
Continuous Wave
Hair Removal
Hertz
International Electro Technical Commission
Joule(s)
Joule(s) per square Centimeter
Kilogram(s)
Pound(s)
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Reveal Lasers - User Manual
Section Title Page
2.1 Introduction 9
2.2 System Safety Measures 9
2.2.1 Electrical Safety 9
2.2.2 Light and Laser Safety 10
2.3 General Precautions and Cautions 11
2.3.1 Precautions 11
2.3.2 Cautions 11
2.4 The Treatment Room 12
2.5 Warnings Related to Light/Laser Energy Emission 12
2.5.1 Burn Hazards 12
2.5.2 Direct and Reected Eye Exposure Hazards 12
2.5.3 Safety Eyewear 13
2.5.4 Explosion and Fire Hazards 13
2.5.5 High Voltage Hazards 13
2.5.6 Grounding the System 14
2.6 System Safety Features 14
2.6.1 Emergency Shut-O Knob 14
2.6.2 Main Circuit Breaker 14
2.6.3 Light/Laser Emission Indicators 14
2.6.4 Double-Tiered Security for Laser Emission 15
2.6.5 Foot-switch 15
2.6.6 Tissue Cooling System 15
2.6.7 Module Design 15
2.6.8 Compliance 16
CHAPTER 2
Safety
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Reveal Lasers - User Manual
. Introduction
This chapter describes general safety issues regarding the use of the VEGA LUX™ system, with
special emphasis on optical and electrical safety.
With proper operation and maintenance, trained and qualied medical practitioners can use
the VEGA LUX™ system safely. The supervising physician and all other personnel operating or
maintaining the VEGA LUX™ 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.
. System Safety Measures
The VEGA LUX™ system is designed to maximize safety for both patient and personnel. The
following are some of the preventive safety measures:
.. Electrical Safety
The following electrical safety features are incorporated in the VEGA LUX™ system.
1. A semi-automatic circuit breaker, located on the service panel, protects the system by
tripping when power overload occurs. To resume normal operation, lift the circuit breaker
handle and restart the system.
2. There are fuses in the machine to protect the system from any electrical spikes.
3. Software protection, includes:
The software checks all safety related hardware after the system is switched on.
A watchdog cycle continuously monitors operation of the system during treatment.
If an error occurs, the system displays a warning message to the operator and disables
further operation. A self-test of the attached module is performed when the system is
turned on. The test includes module identication.
A self-test of the electrical circuitry takes places after the system is turned on. The test
circuits continuously monitor system operation during treatment.
CHAPTER 2
Safety
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Reveal Lasers - User Manual
.. Light and Laser Safety
The following Light & Laser safety features are incorporated in the VEGA LUX™ system.
1. Closed light-guide geometry is used to transmit Light/Laser energy to the treatment site.
Light/ Laser energy is emitted only through the front plane of the light-guide.
2. An emergency shuto knob expedites shutdown when necessary. When pressed, it
immediately shuts down system operation.
3. The system can be turned on only when the key is inserted in the key-switch. When not in
operation, the key should be removed to prevent unauthorized use of the system.
4. A password on the service screen prevents unauthorized changes to the system's basic
operating parameters
5. The system features one emission indicators: a red emission indicator lamp located on the
handpiece and a buzzer.
6. Light emission is enabled only when the operator switches to Ready mode and presses
the footswitch (minimum risk).
7. Laser emission is enabled only if both the foot-switch and the module's trigger are pressed
at the same time, reducing the risk of unintentional Light/Laser emission.
8. Water is circulated through the module as soon as the system is turned on in order to cool
the light source.
9. The ow and temperature of the water are monitored in order to eliminate the risk of
module overheating. Light/Laser emission is not permitted if the water ow stops or if the
water temperature is equal to or higher than 40°C (104°F).
10. The system is equipped with an electric foot-switch for the ease of use.
Warning:
Any Light/Laser emitting device can cause injury if used improperly. High voltages are
present inside the VEGA LUX™ system. Personnel who work with lasers must always be
aware of the possible dangers and must take the proper safeguards as described in this
manual.
Use carefully may cause serious burns. Do not use over sensitive skin areas or in the
presence of poor circulation. The unattended use of the VEGA LUX™ system by children
or incapacitated persons may be dangerous.
Caution:
Laser fume and/or plume may contain viable tissue particulates.
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2.3 General Precautions and Cautions
The following precautions, cautions and warnings must be observed for the safe use of the VEGA
LUX™ system.
.. Precautions
Observe the following precautions when using the VEGA LUX™ system.
1. Physicians and clinicians should read this manual thoroughly before attempting to operate
the VEGA LUX™ system.
2. The module's light-guide must be kept clean at all times. Remember to clean the cooling
gel from the light-guide after each patient.
3. The system weighs approximately 154 Lbs (70 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.
2.3.2 Cautions
Observe the following cautions when using the VEGA LUX™ system.
1. Only REVEAL™a uthorized personnel may service the VEGA LUX™s ystem. This includes
making internal adjustments to the power supply, cooling system, optics, modules, etc.
2. Verify that the VEGA LUX™ is wired for the appropriate electrical voltage of your country
(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 specic 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.
Reveal Lasers - User Manual
2.4 The Treatment Room
The treatment room must be clearly labelled with a sign indicating that high intensity light/laser
energy is in use. The treatment room sign that is supplied with the VEGA LUX™ system.
The treatment room should not include any light reecting objects such as a mirror.
Access to the VEGA LUX™ treatment room should be allowed only to personnel essential to the
procedure and who are well trained in the required safety procedures.
Assure that all of the treatment room personnel are familiar with the VEGA LUX™ controls and
know how to shut down the system instantly.
2.5 Warnings Related to Light/Laser
Energy Emission
.. Burn Hazards
The VEGA LUX™ emits high-intensity light/laser radiation which is invisible to the human eye and
can cause third degree burns.
.. Direct and Reflected Eye Exposure Hazards
1. It is essential that all people present in the treatment room during the treatment (patient and
medical personnel) protect their eyes by wearing REVEAL™ recommended protective
eyewear.
2. It is good practice to instruct the patient to close their eyes during treatment even when
wearing protective eyeglasses.
3. If the patient cannot wear the protective eyewear, t the patient with opaque eye
protection that completely blocks light from the eyes.
4. If the treatment area is very close to the eyes (e.g. eyelids), protect the eyes with corneal
shields.
5. The Ocular Hazard Distance (OHD) is 10 m.
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Reveal Lasers - User Manual
.. Safety Eyewear
1. All personnel must use safety eyewear and must ascertain that the eyewear provides
adequate protection: for the diode laser module OD> 7 at wavelength range of 750-820
nm.
2. The safety eyewear and opaque eye protectors supplied with the system oers adequate
protection, and more can be ordered from your representative.
.. Explosion and Fire Hazards
1. The absorption of optical energy raises the temperature of the absorbing material.
Take precautions to reduce the risk of igniting combustible materials in and around the
treatment area.
2. The system is not suitable for use in the presence of ammable mixtures with air or
oxygen.
3. Do not operate in the presence of volatile solvents such as alcohol, gasoline or other
solvents.
4. 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.
5. If alcohol is used to clean and disinfect any part of the VEGA LUX™ system, allow it to dry
thoroughly before operating the system.
6. Flammable materials must be kept at a safe distance from the system.
7. During treatment also pay attention to the possible danger of ignition of endogenous
gases.
.. High Voltage Hazards
The system utilizes 230V AC. To avoid personnel injury, do not operate the system before
ensuring that the exterior panels are properly closed. Do not attempt to remove or disassemble
the exterior panels.
The VEGA LUX™ system produces very high voltages in various components. Some components
may retain a charge after the power supply has been turned o, so no part of the exterior housing
should be removed, except REVEAL™a uthorized personnel.
Whenever system maintenance is performed, never leave the VEGA LUX™ system turned on,
open or unattended.
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Reveal Lasers - User Manual
.. Grounding the System
The system is grounded through the grounding conductor in the power cable & internal grounding
pin.
Warning:
To avoid the risk of electric shock, this equipment must only be connected to a supply main with
protective earth.
2.6 System Safety Features
The VEGA LUX™ system is equipped with a number of safety features. All treatment room
personnel should be familiar with the location and operation of these safety features.
.. Emergency Shut-Off Knob
This red knob is used for emergency shutdown. When pressed, it immediately shuts o power
to the entire system.
To release the emergency shut-o knob, turn it clockwise. Otherwise, the system will remain o.
Caution:
Use the emergency shut-o knob only in the event of an emergency.
2.6.2 Main Circuit Breaker
A semi-automatic circuit breaker, located on the rear panel, protects the system against excessive
current consumption. The circuit breaker disconnects power to the system in case of an electrical
overload. To resume system operation, lift the circuit breaker handle.
2.6.3 Light/ Laser Emission Indicators
The system features two emission indicators:
A Red LED located on the handpiece and a buzzer.
ContinuousBlink-duringlight/laseremission(module'striggerand/orfoot-switcharepressed).
The buzzer beeps:
1. Once the light/ laser is Ready to emit.
2. Intermittently during light/ laser emission, at the same rate as the pulse repetition rate.
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Reveal Lasers - User Manual
2.6.4 Double-Tiered Security for Laser Emission
Diode laser beam emission is enabled only when the operator presses both the foot-switch and
module trigger; therefore, accidental lasing may only occur due to double error condition (minimum
risk).
2.6.5 Foot-switch
The system is equipped with electric foot-switch for the ease of use.
2.6.6 Tissue Cooling System
The module light-guide is cooled by a thermoelectric cooling method to reduce patient discomfort
during treatment and to reduce post-procedure side eects, such as local skin redness and
swelling. The tissue is cooled through a metallic ring and a cold sapphire window. The light-
guide's temperature is reduced to 4°C (39°F) during system operation.
2.6.7 Module Design
Several aspects of the module design contribute to the safety of the VEGA LUX™ system:
1. Since the Light/Laser energy is generated in the module itself and not in the console (as in
conventional lasers), there is no need for an articulated arm or other beam delivery system with
inherent beam quality and alignment concerns. Instead, the VEGA LUX™ modules incorporate
a onepiece light mixer that combines the emission from thousands of emitters to produce a
uniform square beam. Since light/laser emission is conned to the module, there is no hazardous
optical radiation in the console or the umbilical cable.
2. The light-guide is placed against the patient's skin during the system use, reducing stray light/
laser energy while increasing the therapeutic eect.
2.6.8 Compliance
In compliance with these standards, the system is equipped with:
Light/Laser emission indicators Key switch
Fluence Display Emergency shut-o knob
Foot-switch connector Trigger button (diode laser module)
Proper labeling
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Reveal Lasers - User Manual
Section Title Page
3.1 Introduction 17
3.2 Equipment List 17
3.3 Facility Requirements 18
3.3.1 Space and Positioning 18
3.3.2 Electrical Requirements 18
3.3.3 Environmental Requirements 19
3.4 System Installation 19
3.4.1 Environmental Conditions during Storage and Transportation 19
3.4.2 Foot-switch Connection 20
3.4.3 Filling the Coolant Reservoir 20
3.4.4 Module Connection 21
3.4.5 Moving the System 22
CHAPTER 3
Installation
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Reveal Lasers - User Manual
. Introduction
The VEGA LUX™ system is designed for installation in an oce or a clinic and requires minimal site
preparation. When the VEGA LUX™ 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, foot-switch).
4. Plug the system into a designated electrical outlet.
5. Fill the cooling system reservoir with de-ionized water.
6. Test the system for proper calibration and functional operation of all components and
software.
7. Coordinate the performance of an on-site safety inspection, if required.
3.2 Equipment List
The VEGA LUX™ platform includes the following:
1. VEGA LUX™ system console
2. Selection of modules purchased with the platform
3. Module
4. Set of keys
5. Foot-switch
6. Safety eyewear
7. Opaque eye protectors
8. Operator's manual
9. Water lling kit for the cooling system
10. Light/Laser radiation danger sign
CHAPTER 3
Installation
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Reveal Lasers - User Manual
. Facility requirements
Before unpacking the system, ensure that the site meets requirements described in the following
sections:
.. Space and Positioning
Space should be allocated with adequate ventilation and free airow. The working area for the
system should be prepared according to the system dimensions presented. 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.
Caution:
In order to guarantee safe disconnection of the system in any hazardous situation, system shall
be allocated in such a way that appliance coupler always accessible.
3.3.2 Electrical Requirements
The system is factory pre-wired for the local line voltage, as ordered by the customer. Accordingly,
the system will require a separate line supply of: 220V AC single phase. Input power lines should
be free of transients, voltage and current spikes, sags and surges. Consequently, the system
power line should not be shared with other heavy variable loads such as elevators, air conditioning
systems, large motors, etc. The system is grounded through the grounding conductor in the
power cable that is plugged into the wall power outlet. Good grounding is essential for safe
operation.
Caution:
The system should be connected to a separate power line with separate circuit breakers. REVEAL™
cannot guarantee adequate performance unless the system is connected to a dedicated circuit.
Caution:
In order to guarantee safe disconnection of the system in any hazardous situation, system shall
be allocated in such a way that appliance coupler always accessible.
Caution:
The system should be connected to a separate power line with separate circuit breakers. REVEAL™
cannot guarantee adequate performance unless the system is connected to a dedicated circuit.
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Reveal Lasers - User Manual
.. Environmental Requirements
Air Quality:
the system should operate in a non-corrosive atmosphere. Corrosive materialssuch 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.
Water Quality:
the system should be operated using de-ionized water only. Regular tap water contains sediments
that may damage the cooling system.
Temperature:
to ensure that the system performs optimally, maintain room temperature between 17°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
. System Installation
.. Environmental Conditions during Storage
and Transportation
Transportation of the VEGA LUX™ system should be under normal environmental conditions
within the following range:
1. Ambient temperature: 0°C to 50°C
2. Relative air humidity: 10% to 60%
3. Atmospheric pressure: 90 kPa to 110 kPa
Note: If the system is to be stored in a cold area where the temperature may fall below 0°C (32°F),
the deionized water must be drained from the cooling system. Only authorized service personnel
may perform this procedure.
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Reveal Lasers - User Manual
.. Foot-switch Connection
The foot-switch supplied with the system is electrically operated To connect the foot-switch,
insert the foot-switch wire to the provided slot at the back of the machine & rotate the knob in the
clockwise direction.
.. Filling the Coolant Reservoir
The cooling system's reservoir must be lled with de-ionized water. It is imperative that the level
of the water in the reservoir be checked every three months and de-ionized water added if
necessary.
The VEGA LUX™ cooling system's water reservoir must be lled (or relled) with de-ionized water
in the following instances:
1. Upon installation of a new system
2. Every six months
3. LCD screen shows an error message denoting low water
level Filling / Relling the water reservoir is done with
the water lling kit (Fig. 34) that is supplied with the VEGA
LUX™ which includes:
1. A water lling tube, with a funnel connected to one side and a quick-connector
attached to the other side.
2. An elbowed white CPC connector.
3. A ve liter (1.3 gallons) container of de-ionized water
Water Filling Procedure
1. Connect the small connector to the left port marked VENT on the lower right side of the
service panel
2. Connect the clear tube with the funnel to the port marked FILL on the upper side of the
service Panel
3. Use the supplied 5 liter (1.3 gal.) container of de-ionized water and pour it slowly into
the funnel. Align the clear tubing with the service panel. Stop lling as soon as the water
starts to spill from the VENT port.
4. Plug in the main power supply cable.
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