Professional Documents
Culture Documents
SPECTRA
Dual Pulsed Nd:YAG Laser
Operators Manual
0434
CAUTION : Users must read this manual carefully and thoroughly before using
this product.
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SPECTRA
IMPORTANT
As the recommended treatment values for each symptom and/or effects
are standards to be used for consultative purposes only, we
recommend adjusting such values for patients depending on each
patient's special circumstances and treatment history. Lutronic shall
not be liable for any injuries, problems or issues that arise as a result of
negligence or inexperience in using the product supplied by Lutronic
Corporation rather than as a result of any actual defect on the product
itself as supplied by Lutronic Corporation.
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SPECTRA
Lutronic Inc.
Tel: 888-588-7644
E-mail:
officeusa@lutronic.com
USA
Obelis s.a
Lutronic Corporation
Room 403-1, 2, 3, 4, 5, 404
Ilsan Technotown 1141-1
Baekseok-dong,
gu,
Tel: +82-31-908-3440
Fax: +82-31-907-3440
Ilsandong- Web site: www.lutronic.com
E-mail: office@lutronic.com
Goyang-si, Gyeonggi-do,
Korea
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SPECTRA
Table of Contents
Chapter 1. Overview
1.1 Introduction to the system
1.2 Symbols used in this manual and the device
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room
2.3.3 Caution for replacing the handpiece tip
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Chapter 4. Installation
4.1 Overview
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Chapter 5. Operation
5.1 Overview
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5.4 Memory
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5.4.1 Saving
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5.5 Setup
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5.5.3 [Optional]Calibration
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6.6 Troubleshooting
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6.6.3 When the laser beam radiates with insufficient output power.
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Chapter 8. Warranty
8.1 Overview
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List of Figures
Figure 2.1 Warning Sign for Laser-Beam Radiation
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Figure 2.2 Laser Protective Goggles for the Physician (A) / for the Patient(B)
Figure 2.3 Position of Key Switch
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SPECTRA
Chapter 1. Overview
Chapter 1. Overview
1.1 Introduction to the system
The SPECTRA laser system is produced in accordance with international
standards for manufacturing medical devices in order to guarantee the
users safety and durability of use. This device is designed for
convenience and for prolonged use. The SPECTRA laser system only
requires users to exert basic maintenance and repair efforts on a periodic
basis.
Ch1-1/3
SPECTRA
Chapter 1. Overview
WARNING
CAUTION
IMPORTANT
Descriptions
This symbol indicates a state of potential
danger or an emergency situation whereby the
device itself may be severely damaged, or
users, patients and staff members may be
exposed to electrical injury resulting in
electrical shock or burn injuries, or potentially
hazardous exposure to the radiation of the
laser beam.
This symbol indicates that caution should be
applied to prevent a state of potential danger
or an emergency situation whereby the device
itself may be severely damaged, or users,
patients and staff members may be exposed to
electrical injury resulting in electrical shock
or burn injuries, or potentially hazardous
exposure to the radiation of the laser beam.
This symbol indicates that, prior to any
procedure with the SPECTTRA system; the
operator should thoroughly check any special
circumstances regarding the patients
condition before treatment, including their
medical history, to ensure the optimum
clinical results.
This symbol indicates that the product
specifications comply with Class B of the
Protective Regulations for electrical shocks
(IEC 417 / 878-02-02).
This symbol indicates that the operational
voltage of this product exceeds the danger
limits set out in the Protective Regulations
regarding Electrical Shocks (IEC 417 /87803-01).
This symbol indicates that the POWER is
OFF, which complies with the Protective
Regulations regarding electrical shocks (IEC
417 / 5008).
This symbol indicates that the POWER is ON
and is in compliance with the Protective
Regulations regarding electrical shocks (IEC
417 / 5007).
Ch1-2/3
SPECTRA
Chapter 1. Overview
NOTE
Ref.
WARNING
Improper handling and/or manipulation of the device in a way
that does not comply with the instructions given in this manual
may result in severe damage to the device and injury to the
user.
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6. The SPECTRA laser system senses the spot size of the handpiece
and displays it on the control panel.
7. A remote interlock device will halt the systems operation when no
plug is connected to the remote interlock. To install an interlock
system to a location, please contact Lutronic Corporation customer
support.
8. In Ready status, the laser beam will radiate only if the footswitch
is depressed.
DANGER
The SPECTRA laser system is in compliance with the US
Federal Regulation (21. CFR 1040.10 and 1040.11) of the CDRH
(Center for Devices and Radiological Health), which is
governed by the FDA (Food and Drug Administration). In
terms of the CDRH standards, the SPECTRA laser system is
deemed CLASS IV. This is the most powerful class of lasers
used for medical applications and requires that extra
precautions be taken when using this system.
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3.
4.
5.
6.
Ch2-3/18
SPECTRA
L-702YGII
L-702HE
DANGER
The SPECTRA laser system uses near infrared laser beam
which is invisible to the naked eye. All persons in the operating
area must wear safety goggles at all times during the
procedure. Exposure to the laser beam may result in serious
injury including loss of eyesight. Goggles should protect eyes
against 532 nm and 1064 nm laser beam. The protective
eyewear should be pursuant to the ANSI standard.
Inappropriate or inadequate protection may cause damage to
the eyes. Even with safety goggles are worn, all users are
cautioned against the inherent risk of dealing with laser
devices.
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SPECTRA
WARNING
Persons other than service engineers authorized by Lutronic
Corporation should not attempt to remove the external cover or
disassemble the system. Exposure to dangerous laser beams,
high voltage or current generated by this system may occur.
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SPECTRA
DANGER
Never look directly into the laser aperture or at the end of the
handpiece when power is applied to the system. It could result
in serious eye injury and/or blindness even though laser safety
goggles are worn. Never direct the rays of laser beam to any
object other than necessary targets. Regardless of its color, the
laser beam reflected from the surface may cause damage at any
time.
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SPECTRA
Before using the laser, make sure all solvent, adhesives and cleaning
liquids have fully evaporated.
DANGER
Operator should be especially careful when using the laser
beam near flammable material. For instance, if the laser beam
hits an anesthetic, gaseous material such as nitric acids or
oxygen, or flammable material such as alcohol or cotton, it may
cause fire.
WARNING
One should never direct the rays of a laser beam at any target
other than skin. This may lead to ignition of the object.
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SPECTRA
The SPECTRA laser system may be turned on or off only via the
system key provided by Lutronic Corporation.
To prevent unauthorized persons from using this system, the key should
be removed from the key switch and stored in a safe place after
performing a surgical procedure.
The key switch operation is composed of two steps. It shifts from the
OFF position to the ON position, and vice versa.
(2)ON
(1)OFF
Key Switch OFF
Status: Power is shut off.
Key Switch ON
Status: Power is on.
CAUTION
Only authorized and properly trained persons should operate
this system. To prevent unauthorized persons from using this
system, remove the key from the key switch after performing an
operation and store it in a safe place.
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Title
Ratification
93/42/EEC
As amended Medical Device Directive
by 2007/47/EC
Medical electrical equipment Part 1-6
EN 60601-1-6 General requirements for basic safety and
IEC 60601-1-6 essential performance
EN 60601-1
IEC 60601-1
EN 980
1990;A1;1993;A
2;1995;
A13;1996
2007
1996;A1;1999
2000
1996
1995
2007
2007
2006
EN 60601-222
2007
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2008
2009
2007
SPECTRA
EN 62304
2006
21CFR/FDA
EN1041
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2008
SPECTRA
CAUTION
Physicians and staff should be fully aware of the locations and the meaning
of all the safety labels attached to the system.
Side
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2.9.10Footswitch Label
This label indicates that laser emission is performed only if the footswitch is
depressed.
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System Specification
Laser wavelength
1064/650/585/532m
Medium of transmission
Articulated arm
Pulse Duration
Pulse Rate
Classifications
Handpiece
[Optional]
Handpiece
Max. 1200mJ
Max. 400mJ
Max. 1500mJ
585 mode
Max. 250mJ
650 mode
Q-switched mode
1064, Spectra mode
Max. 150mJ
5 ~ 10ns
S1, 1, 2, 5, 10(Hz)
532 mode
S1, 1, 2, 5, 8, 10(Hz)
585 mode
S1, 1, 2, 5(Hz)
650 mode
S1, 1, 2(Hz)
CDRH Class
Class IV
MDD Class
Class IIb
FDA Class
Class II
Zoom
1~5mm(1064nm)/0.8~4.3mm(532nm)
3~8mm-Zoom-Collimated 3~8mm(1064nm)/2.6~6.9mm(532nm)
Collimated
7mm(1064nm)/6mm(532nm)
532 Handpiece
1.7 mm
Fractional Handpiece
6 x 6 (mm)
3~7mm-Zoom-Collimated 3~7mm(1064nm)/2.6~6mm(532nm)
2mm-SD585
2mm
5mm-SD585
5mm
2mm-SD650
2mm
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SPECTRA
Cooling System
Articulated arm
Display System
Touch LCD
Single phase
AC100~120V or AC220~230V
(Fuse 125V/25A or 250V/15A)
50/60Hz,
Power consumption: 1.7kVA
Electrical rating
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Articulated arm
Handpiece
Calibration Port
Control Panel
Handle
System
Main Body
Key switch
Foot
Switch
Emergency stop
Button
Caster
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System Control
Module
Power Supply
Laser Module
Control Panel
Functions
This includes the key switch and the
emergency stop button which controls the
overall operation of the entire system. The
control module receives input signals from
other modules and sends output signals to
execute the proper operation of the system.
Converts the commonly-used power supply
(AC100~120V or AC220~230V) to the level
of electric power that the device requires and
provides it for each module.
Generates the laser beam of a wavelength of
the 1064 nm and 532 nm.
Displays information of the current status and
the value of each parameter. The function of
each button is explained in detail in Chapter 5.
The four casters may move in all four
directions. The handle may be used to easily
move and direct the casters. The front two
casters additionally have locking devices to
allow the operator to station the device firmly
and safely in a fixed position.
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SPECTRA
Articulated Arm
Handpiece
7mm-Zoom-Collimated
(3-7mm/2.6-6mm)
Zoom handpiece
2mm-SD585(585nm)
Collimated handpiece
2mm-SD650(650nm)
Fractional handpiece
532 handpiece
5mm-SD585 handpiece
The beam delivery system begins at the post mount. Here, the infrared
and visible laser beam exits the laser optical system.The laser beam
will then enter the articulated arm and the 7 mirrors attached inside the
arm reflect and deliver the beam.
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SPECTRA
Main Power
Switch
External
Ground
Power Cord
Foot Switch
Socket
CAUTION
When moving the SPECTRA laser system, the foot switch must
be detached from the device. This will prevent severe damage
to the connector or disconnection from the wiring in the foot
switch.
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Chapter 4. Installation
Chapter 4. Installation
4.1 Overview
Chapter 4 describes the installation method for SPECTRA laser system as
well as the optimal environment for using this device. Only persons
authorized or trained by Lutronic Corporation may move or install the
device.
Qty
1 unit
8mm-Zoom-collimated handpiece
1 unit
1 unit
1 unit
1 unit
[Optional] 2mm-SD585
1 unit
[Optional] 5mm-SD585
1 unit
[Optional] 2mm-SD650
1 unit
1 unit
1 unit
System key
2 units
Footswitch
1 unit
Remote interlock
1 unit
1 unit
2 units
1 unit
Operators manual
1 vol
1 set
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Chapter 4. Installation
1700mm
840mm
656mm
295mm
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Chapter 4. Installation
WARNING
Verify the electrical requirements and use the correct power
supply or a power supply system. Failure to follow these
instructions may lead to damage to the device, device
malfunctions and/or fatal electrical shock to users. Improper
installation and use of the device may void the warranty
coverage.
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Chapter 4. Installation
Temperature/relative humidity
-
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Chapter 4. Installation
Articulated arm
cable connector
Figure 4.3 Connecting the articulated arm cable connector and the
handpiece cable connector
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Chapter 4. Installation
CAUTION
In case of connection and disconnection of the handpiece
cable, the operator must follow the instructions below in order
to prevent any breakage of the connectors.
When connecting the handpiece cable connector and the
articulated arm cable connector, it is required to hold the
black parts, which are the end of the connectors, and
check the arrows on the two connectors.
When separating the handpiece cable connector and the
articulated arm cable connector, it is required to hold the
metal parts, which are the front of the connectors, and
separate them slightly.
4.
CAUTION
Because the cable socket on top of the device may get
damaged, Never put excessive strength to the connector
socket.
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SPECTRA
Chapter 4. Installation
Remote interlock
Insert the remote interlock into the socket of the system inlet
located at the lower back of the system main body. Insert the
remote interlock into the socket, pulling the metallic part of the
interlock back; a resulting frictional sound indicates that the
interlock has fitted into the socket correctly.
The remote interlock is not designed for other types of socket. Use
of excessive force while attempting to insert interlock into an
inappropriate socket may cause damages. Please be careful at all
times.
2.
Footswitch
Insert the footswitch connector in the socket of the main power
module located in the lower rear side of the device. While pulling
the metallic part of the footswitch connector back, insert the
connector into the socket; a frictional sound will result indicating
that the footswitch connector has fitted into the socket hole
correctly.
The footswitch connector is not designed for another type of socket.
Use of excessive force while attempting to insert the footswitch into
an inappropriate socket may cause damage. Please be careful at all
times.
Remote
Interlock
Footswitch
Socket
Figure 4.5 Connected System Inlet
NOTE
If any component(s) is missing, please notify Lutronic
Corporation or your local Lutronic sales representative.
Replacement and additional components can be ordered or
purchased from Lutronic Corporation.
Ch4-7/9
SPECTRA
Chapter 4. Installation
CAUTION
Before moving the device, the handpiece, articulated arm,
power cord and the footswitch must first be secured. Use the
moving handle to transport the device to a desired location. Be
sure to use slow, cautious motions and speed. Fix all the
casters to secure the device in its desired location.
CAUTION
When the device is not used, make sure that the status of main
power switch is in the (O) position. Furthermore, if the device
is left unused for a long period of time, please remove the
main power cord from the wall outlet and the main power
socket of the device.
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SPECTRA
Chapter 4. Installation
Using the moving handle to transport the device, move the device to a
location that is compliant to the 4.3 Conditions for Installation and
reinstall the device according to 4.4 Installation of the Device.
CAUTION
When moving the device to a remote location, contact your
Lutronic Corporation distributor to do so safely and efficiently.
This will prevent potential damages or breakage of the device
and potential physical injuries to the operator and staff.
WARNING
Never use the footswitch hanger to move the device. Such
improper use of the footswitch causes internal system
complications. Problems and complications resulting in
misuse, will result in voiding of warranty.
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SPECTRA
Chapter 5. Operation
Chapter 5. Operation
5.1 Overview
This chapter contains detailed operating instructions, cautions and warning
items for the SPECTRA laser system.
The control panel allows the user to set optimum parameters of the
treatment beam. The control panel also displays useful information about
the system during operation. While the system is operating, functions are
continuously monitored by a micro-controller and displayed to the
operator.
Please refer to Figure 5.1 for the following information.
1
2
5
3
8
10
9
Figure 5.1 Control Panel of SPECTRA Laser System
1. Shot Count
This function shows the laser shot number emitted since the system is
turned on. The laser shot emitted by pressing the footswitch is counted
cumulatively as far as it is not initialized by pressing the Reset button. The
shot count can be reset by pushing the Reset button.
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SPECTRA
Chapter 5. Operation
2. Pulse Rate
The pulse repetition rate is defined as the number of pulses that are emitted
in one second. The pulse rate can be adjusted by using the push button on
the right. The pulse rate can be set at 1, 2, 4, 5 as well as 10 Hz and Single
Shot (S1).
3. Spot Size
This function displays the spot size of the laser beam at the end of the
handpiece. The fluence display depends on the pulse energy and the beam
spot size.
Range of spot size
1064nm mode & Spectra mode
532nm mode
4. Aiming Beam
The Up()and Down() buttons enable user to control brightness of the
beam. In the Standby status, the aiming beam is inactive.
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SPECTRA
Chapter 5. Operation
5. Fluence
The fluence is displayed in joules per square centimeter (J/cm2). The
fluence is computed by dividing the pulse energy into joules by the spot
area in square centimeters. The fluence is adjustable using the up and
down push buttons on the right side. This display is valid for fluence at the
tissue. The spot area and the fluence depend on which handpiece is being
used.
Derivation of the equation:
Area of Laser Radiation : (Spot size /2) x (Spot size/2) x
Fluence(J/cm2)= Laser output / Area of laser radiation
<Example> Spot size at 0.2cm(2mm) and Pulse energy at 0.1J
Fluence: 0.1 x 0.1 x = 0.0314 cm2
0.1(J) / 0.0314(cm2)= 3.184J/cm2
6. Wavelength
The SPECTRA laser system has three kinds of wavelength mode, 1064nm,
532nm and Spectra (Optional: 585nm and 650nm). The wavelengths can
be selected by pressing each wavelength button. Each selected
wavelength is illuminated.
Optional Wavelength :
In addition, 585nm or 650nm for wavelength mode can be
automatically selected only by connecting its dye handpiece (2mmSD585/5mm-SD585/2mm-SD650) to articulated arm.
Mode
Wavelength
Description
1064
1064nm
532
532nm
1064nm
Spectra
Ch5-3/20
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Chapter 5. Operation
585
[Optional]
650
[Optional]
585nm
650nm
7. Memory
This button allows user to enter Memory mode and save parameters in a
memory. Additionally, users can recall a memory by pressing one of the
memories in the mode.
8. Toning
This function button saves the special parameters to treat skin toning. And
only the 1064 mode allows users to save a laser toning parameter.
9. Setup
This button allows users to carry out calibration and adjust volume of the
GUI.
10. Status
This button allows the laser system to shift from Standby to Ready. As
the button is pressed, the current status of the system is displayed below
the button.
Standby status allows users to set parameters. And the laser
beam will not radiate even though the footswitch is depressed. This
is the default status of the device.
Ready status means that the laser is very ready for shooting.
Once Status button of Standby is pressed, laser pumping starts, (At
this time, warning sounds for 5 seconds and laser does not emits
even if the footswitch is depressed.) Status button blinks changing
its color to orange. Ready status reverts automatically to Standby
status if the foot switch is not pressed for 3 minutes.
Once laser emission starts by depressing the footswitch in the
Ready status, Status button blinks changing its color to orange.
And the word Lasing is displayed blinking under the button.
Ch5-4/20
SPECTRA
Chapter 5. Operation
DANGER
Before connecting the power plug of the device to the local
power supply outlet, be sure that the local power supply is
AC100~120V or AC220~230V with proper grounding. Never look
directly into the laser aperture or at the end of the handpiece
when power is applied. Serious eye injury and/or blindness
could result.
Ch5-5/20
SPECTRA
Chapter 5. Operation
CAUTION
If the main power switch has been off within 10 minutes, you
may turn on the key switch shortly to restart the system.
3. The control panel displays OK button pops up as shown in Figure 5.2
and press the button to allow the system to enter the operation mode.
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SPECTRA
Chapter 5. Operation
1
2
4
3
8
10
9
Figure 5.3 Control Panel for Normal Handpiece
1. Turn the Spot Size regulator at the handpiece clockwise or
counterclockwise to adjust spot size.
2. Press the Pulse Rate button 2 and one of the Wavelength buttons 6 to
set the Wavelength and speed of laser radiation suitable for the
treatment area.
3. Press the Fluence button 4(,) to set the energy of laser beam to
the per unit area.
4. After setting the desired treated parameters on the control panel,
press the Standby button when it is ready to begin. For 5 seconds
immediately after pressing the Ready button, the system carries out
initial flash lamp pumping according to the wavelength mode set
currently in order to stabilize the energy. The footswitch does not
work during the lamp pumping. The pumping phase can be
recognized by a series of short beeps.
5. Press the Aiming Beam button 5 to set the brightness of aiming
beam in Ready status.
6. With the footswitch depressed, contact the handpiece to the
treatment area. Upon pressing the footswitch, the laser beam will
begin to radiate according to the current set pulse rate.
Ch5-7/20
SPECTRA
Chapter 5. Operation
NOTE
When restarting the system, the control panel recalls and
displays the most resent used parameters.
[Optional]Operating with Dye Handpiece
1
2
4
3
7
10
9
Figure 5.4 Control Panel for Dye Handpiece
1. Make sure that a dye handpiece is connected to the articulated arm
firmly, and that its cable is inserted into the related port of the
articulated arm correctly as well.
2. Once the cable is connected correctly, the system recognizes and
the control panel displays the Wavelength indicator for the dye
handpiece. The button is illuminated. (see 6)
3. Set Pulse Rate by pressing its button 2. And regarding spot size, it
is fixed 2mm which is the only one available.
4. Set Fluence by pressing its buttons 4.
5. Press the Standby button, and in 5 seconds, contact the handpiece
tip on the treatment area and depress the footswitch. Laser beam
emission will begin.
Ch5-8/20
SPECTRA
Chapter 5. Operation
NOTE
Dye-Handpiece Laser has a finite lifetime. The Dye element
must be replaced when the laser starts to become ineffective
during treatment. The minimum expected life time of the laser is
60,000 shots.
DANGER
Never look directly into the laser aperture or at the end of
the handpiece when power is applied. It could result in
serious eye injury and/or blindness.
Never leave the device unattended when it is turned on.
Secure the device against unauthorized use by removing
the key from the key switch.
NOTE
If the spot size of the handpiece does not match the spot
size of the control panel, the spot size display window on
the control panel will continue blinking until both of them
match, and the device will remain in Standby status.
Changing pulse rate and fluence in Ready status is
permissible; however, if other parameters including the spot
size of the handpiece are changed in Ready status, the
device will revert to Standby status.
Ch5-9/20
SPECTRA
Chapter 5. Operation
1
2
4
3
8
10
6
9
Figure 5.5 Control Panel for Fractional Handpiece
1. Make sure that a fractional handpiece is connected to the articulated
arm firmly. Press the Spot Size button 3 to set 6 mm spot size for
the fractional handpiece.
2. Press the Pulse Rate button 2 to set the speed of laser radiation.
3. Press the 1064 Wavelength indicator 6 to set wavelength of laser
radiation for the treatment area.
4. Press the Fluence button 4(,) to set the energy of laser beam to
the per unit area.
6. Press the Standby button, and in 5 seconds, contact the handpiece
tip on the treatment area and depress the footswitch. Laser beam
emission will begin.
5. Press the Aiming Beam button 5 to set the brightness of aiming
beam in Ready status.
NOTE
Please refer to the physicians clinical guide to set optimal
parameters.
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Chapter 5. Operation
NOTE
Once a memory is recalled by the memory button or the
toning button, if the spot size of the memory does not
conform to the spot size set at the handpiece, the spot size
indicator will keep flashing in Standby mode. To resolve it,
set the same spot size at the handpiece as the spot size on
the control panel. Or, press the spot size button, then, the
indicator displays the spot size of the handpiece. In this case,
the Fluence of the memory selected is not kept.
Adjusting spot size on the handpiece
The spot size regulator is built-in the
zoom handpiece and blue collimated
handpiece. The positive numbers are
available at 1064nm and the figures in
parentheses are the spot sizes at 532nm.
1
2
1.
2.
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Chapter 5. Operation
NOTE
To use this mode, the operator must make sure its cable is
connected with the port of the articulated arm.
Use of Handpiece
1. Hold the handpiece slightly vertically as shown in Figure 5.8.
2. Contact the handpiece tip with treatment area slightly.
3. During the treatment, be careful not to change the spot size by
touching the spot size regulator of the handpiece.
Correct
Incorrect
Incorrect
CAUTION
Before using the handpiece during operation, make sure
there is no debris or residue on the lens and window. A dirty
lens and window can cause a loss of energy and produce
less effective results during treatment. Incurred damages as
a result of failure to perform this routine maintenance will
void the warranty. Ref. Chapter 6
For the automatic spot size setup, make sure that the cable
of the handpiece is connected to the relevant port of the
arm.
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Chapter 5. Operation
5.4 Memory
This function is to set parameters and save it in a memory. It allows users to
easily recall a memory without setting parameters every treatment.
5.4.1 Saving
1. Enter Memory mode by pressing Memory button located at bottom of
the screen as shown in Figure 5.9.
2. Activate the parameter setting section by pressing Modify button
Parameter
located at bottom of the screen.
Setting Section
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Chapter 5. Operation
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Chapter 5. Operation
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Chapter 5. Operation
5.5 Setup
5.5.1 Checking Shout Count
1. Enter Setup mode by pressing Setup button at bottom of Operation mode
screen.
2. User Shot Count and Total Shot Count can be checked at the upper of the
screen. For reference, User Shot Count is the total number of times that
laser emits outwards by the user and Total Shot Count is the total number
of laser pumping times within the main body.
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SPECTRA
Chapter 5. Operation
WARNING
If the beam mode is a round shape without any deleted parts,
you may start calibration, otherwise please contact your local
Lutronic distributor.
2. Before starting calibration on the GUI, connect the articulated arm as
shown in Figure 5.15.
Calibration
port
WARNING
You may start a calibration if the articulated arm is connected
into the calibration port. In case of the articulated arm is
disconnected during calibration, its operation stops shortly.
3. Enter Setup mode by pressing the setup button at the bottom of the
operation mode screen.
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SPECTRA
Chapter 5. Operation
4. After entering the setup mode, press the Calibration button at the
bottom of the screen.
5. As shown in Figure 5.16, the device checks that the end of the
articulated arm is connected to the calibration port on top of the device.
If the device is just turned on, the device may heat the inside 532
module before the checking.
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SPECTRA
Chapter 5. Operation
NOTE
During or after the calibration, messages other than OK may
be displayed on the screen and the situations related to the
messages are as below. In these cases, please contact your
local Lutronic distributor.
Failed : Calibration stopped due to too low energy
Halted : Calibration stopped due to other disorders
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Chapter 5. Operation
OFF
CAUTION
DO NOT leave the device unattended while it is running! After
using the device, remove the key from the key switch to
prevent random access by unauthorized persons. The
Emergency Stop Switch stops laser emission immediately. Do
Not use this switch to turn off the device. Use the key switch to
turn off the device.
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Chapter 6. Maintenance
& Management
6.1 Overview
Chapter 6 describes maintenance guidelines, including periodic inspection
needed to maintain performance, and information on error codes to be used
in self-testing mechanisms for the device.
CAUTION
When inspecting the device first turn off the power and then
disconnect the power cord. Attempting to inspect the device
while the electrical power is on may result in severe damage to
the device or the user.
The SPECTRA laser system is designed so that maintenance and
management of the device is minimized. However, to guarantee the most
effective results the exterior of the device and the handpiece window,
including its tip, should be cleaned thoroughly at all times.
Wipe down the device again with a clean, dry pad or let it naturally air
dry.
CAUTION
Do not apply cleansing liquid directly to the system main body
as it may damage, harm or cause the system to malfunction.
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Handpiece body
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6.
7.
When not using the handpiece, wipe the handpiece with dried
cotton cloths and keep it in the handpiece case.
NOTE
If cleansing protocol fails to eliminate alien substances, then :
CAUTION
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Proper water
level
Ball
Indicator
tube
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Upper
Lower
Figure 6.8 Disconnecting the indicator tube
5. As shown in Figure 6.9, insert the extra tube provide with the funnel into
the upper inlet, and then, insert the nipple of the funnel into the lower
inlet.
Figure 6.9 Inserting the funnel and the tube into the tank
6. Hold up the funnel and pour the distilled water into the funnel. At this
time, while the distilled water flows into the tank, the air inside the tank
comes out through the upper tube. If the distilled water does not flow
smoothly into the tank, hold up the funnel higher.
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6.6 Troubleshooting
6.6.1 When the device fails to turn ON.
Check whether the power cord is correctly inserted into the main power
outlet.
Check whether the main power switch is flipped to the ON (I) position.
Check the condition of the fuse inside the device.
CAUTION
If the laser beam does not radiate for a long period of time, turn
off the device and wait two minutes before turning it on again. If
the problem persists, do not disassemble the device or take
any inadequate or unauthorized actions of your own. Always
contact
an
authorized
Lutronic
distributor
or
Lutronic
6.6.3 When the laser beam radiates with insufficient output power.
Check whether the handpiece window is damaged or dirty. If alien
substances are found, clean the window before using it again. Ref. 6.3
Cleaning Handpiece
If the problem persists after taking the above actions, contact your
authorized Lutronic distributor or Lutronic Corporation for assistance.
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CODE 02
CODE 03
CODE 04
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CODE 05
CODE 06
CODE 07
CODE 08
CODE 09
CODE 10
CODE 11
CODE 12
CODE 24
CODE 30
CODE 32
CODE 33
CODE 34
CODE 36
CODE 37
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DANGER
If CODE 24 occurred, the actual fluence can be lower or a bit
higher than the parameter set on the control panel. The
operator may continue to use the machine temporary, but must
contact the Lutronic corporation customer service department
for stable use.
CAUTION
The operator is advised to take proper actions for the nature of
each message code. If the error persists after taking proper
action, contact your authorized Lutronic distributor or Lutronic
Corporation for assistance. If a person not formally authorized
by Lutronic Corporation opens the cover of the device or takes
any improper actions, the warranty will be voided. Fatal damage
to the device severe physical injury may occur.
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SPECTRA
NOTE
Important factors to consider when deciding treatment
parameters are wavelength, spot size and fluency. Larger spot
sizes and higher fluency result in deeper penetration.
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SPECTRA
7.3 Consultation
Physicians should provide patients with detailed information regarding the
nature of their problem area, the treatment options, risks, benefits,
potential complications and anticipated outcomes. Written consent of the
patient should also be obtained prior to commencing a laser treatment
program. During consultation, a clinical history should be established with
specific and detailed attention paid to any contraindications. It is
recommended that:
All patients should have a full consultation prior to treatment
The consultation should be used to screen out unsuitable patients
for reasons of skin type, skin condition, or any other clinical
contraindications
The patient should be provided with an informational literature
explaining expectations and after care, a medical history
questionnaire and consent form.
The consultant should discuss the patients medical history,
treatment requests, anesthetic requirements and projected
treatment cost.
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SPECTRA
7.4 Contraindications
Few situations exist in which the SPECTRA laser system is
contraindicated for benign pigmented lesions and/or tattoo removal
procedures. However, as with any other laser equipment some side effects
and contraindications are possible in a minority of patients after treatment
with a Q-switched Nd:YAG laser. Take special care and precautions when
treating patients with the following symptoms:
Allergic response to topical anesthetics, antibiotics, or other
medications
Healing disorders such as those caused by diabetes mellitus,
connective tissue disease, radiation therapy, or chemotherapy
Seizure disorder caused by bright light
Patients with psychoneurosis and/or a history of alcohol or drug
abuse
Patients with unrealistic expectations regarding to the outcome of
the treatment
Patients who are unable or unwilling to follow post treatment
guidelines
Cancerous or pre-malignant lesions
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SPECTRA
IMPORTANT
As the recommended treatment values for each symptoms
and/or effects are standards to be used for consultative
purposes only, we recommend adjusting such values for
patients depending on each patient's special circumstances and
treatment history. Lutronic Corporation shall not be liable for
any injuries, problems or issues that arise as a result of
negligence or inexperience in using the product supplied by
Lutronic Corporation, rather than as a result of any actual defect
on the product itself as supplied by Lutronic Corporation.
Revision 1.3/4100124013
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SPECTRA
Chapter 8. Warranty
Chapter 8. Warranty
8.1 Overview
Chapter 8 describes unpaid services available for those properly using the
system and exclusions from such unpaid services provided by the warranty
of this product.
WARNING
In order to maintain the coverage of unpaid services, only
service persons formally authorized by Lutronic should be
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Chapter 8. Warranty
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Chapter 8. Warranty
Handpiece window
Flash lamp
DI filter
[Optional] SD585
[Optional] SD650
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SPECTRA
Chapter 8. Warranty
This letter of warranty can replace any form of implicit or explicit warranty
agreed by interested parties. However, the sales agent shall not provide
any kind of warranty for the condition of the system or its marketability for
any sort of purposes.
Fax: _________________________
E-mail: _____________________________
Model: __________________
Serial No.: ____________________
Date of purchase: ________________
Expiration Date of Warranty: ____________________
Sales Agent: ______________________
Tel. : ____________________
Important! To validate this warranty, please completely fill out the above
items and email it or fax it to below within fifteen days of the installation.
Lutronic Corporation
Room 403- 1, 2, 3, 4, 5, 404, Ilsan Technotown
1141-1, BaekSeok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, KOREA
Phone: 82-31-908-3440 Fax: 82-31-907-3440
Homepage: www.lutronic.com
E-mail: office@lutronic.com
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