Manual de Operador Spectra PDF

SPECTRA
Technology for Beauty and Health
SPECTRA
Dual Pulsed Nd:YAG Laser
Operator’s Manual
0434
CAUTION : Users must read this manual carefully and thoroughly before using
this product.
Revision 1.3 /4100124013 1/9

SPECTRA
Copyright  2012 Lutronic Corporation. All rights reserved.
No part of this manual may be re-manufactured or copied in any form without the
written consent of Lutronic Corporation.
Use of this manual
This manual is designed so that users of SPECTRA laser system may

easily understand the characteristics as a medical instrument, the safety
device of the instrument and the method for use. In order to use this
instrument properly and safely, users must be fully aware of all the
details given in this user’s manual. Users should be trained and
educated properly before using this instrument.
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.
Revision 1.3 /4100124013 2/9

SPECTRA
Lutronic Inc.
Tel: 888-588-7644
850 Auburn Court
E-mail:
Fremont, CA 94538
officeusa@lutronic.com
USA
Obelis s.a Tel: + (32) 2. 732.59.54
Bd. Général Wahis 53 Fax: + (32) 2.732.60.03
1030 Brussels, BELGIUM E-Mail : mail@obelis.net
Lutronic Corporation
Room 403-1, 2, 3, 4, 5, 404 Tel: +82-31-908-3440
Ilsan Technotown 1141-1 Fax: +82-31-907-3440
Baekseok-dong, Ilsandong- Web site: www.lutronic.com
gu, E-mail: office@lutronic.com
Goyang-si, Gyeonggi-do,
Korea
Revision 1.3 /4100124013 3/9

SPECTRA
Table of Contents
Chapter 1. Overview
1.1 Introduction to the system 1/3
1.2 Symbols used in this manual and the device 2/3
Chapter 2. Safety Precautions

2.1 Overview 1/18
2.2 Safety for the treatment room 3/18
2.3 General Precautions for operators, staff members and patients 5/18
2.3.1 Precautionary items for the handpiece prior to procedure 5/18
2.3.2 Precautionary items for moving the device in the treatment 5/18
room
2.3.3 Caution for replacing the handpiece tip 5/18
2.4 Cautions regarding Electrical Hazards 6/18
2.5 Protecting the eyes 7/18
2.6 Precautions against Fire Hazards 8/18
2.7 Safety system for the SPECTRA Laser System 9/18
2.7.1 Key switch 9/18
2.7.2 Emergency Stop Button 10/18
2.7.3 Warning sound and signal of the laser radiation 10/18
2.7.4 Remote interlock 10/18
2.7.5 Door interlock 11/18
2.8 Main International standards Applied to SPECTRA Laser System 12/18
2.9 Safety labels for SPECTRA Laser System 14/18
2.9.1 Caution Label of Emergency Stop 14/18
2.9.2 Caution Label for Hanpiece Cable Insertion 15/18
2.9.3 Caution Label for Refilling Cooling Water 15/18
2.9.4 Warning Label of Hanger Use 15/18
2.9.5 Danger Label of Laser Radiation Path 15/18
2.9.6 Warning Label against Electrical Shock 16/18
2.9.7 Danger Label regarding Exposure to Laser 16/18
2.9.8 Danger Label regarding Laser Radiation Output 16/18
2.9.9 Remote Interlock Label 17/18
2.9.10 Footswtich Label 17/18
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2.9.11 Grounding Label 17/18

2.9.12 Power Cable Label 17/18
2.9.13 Name Plate Label 18/18
Chapter 3. System Description

3.1 Overview 1/7
3.2 System Specifications 1/7
3.3 Components of the SPECTRA Laser System 3/7
3.3.1 System Main Body 4/7
3.3.2 Articulated arm & Handpiece 5/7
3.3.3 Footswitch & System Inlet 6/7
3.4 System Software 7/7
Chapter 4. Installation
4.1 Overview 1/9
4.2 Installation Component List 1/9
4.3 Conditions for Installation 2/9
4.3.1 Space Requirements 2/9
4.3.2 Electrical Requirements 3/9
4.3.3 Environmental Requirements 4/9
4.4 Installation of the Device 5/9
4.4.1 STEP 1 : Connecting the Handpiece 5/9
4.4.2 STEP 2 : Connecting the Accessories 7/9
4.4.3 STEP 3 : Final Check-up and Fixing the Device 8/9
4.4.4 STEP 4 : Supplying Main Power 8/9
4.5 Moving the Device 9/9
4.5.1 Moving the Device in the Treatment Room 9/9
4.5.2 Moving the Device to a Remote Location 9/9
Chapter 5. Operation
5.1 Overview 1/20
5.2 Checking of the Caution and Inspection Items 5/20
5.3 Operation of the SPECTRA Laser System 6/20
5.3.1 STEP 1 : Turning on the System 6/20
5.3.2 STEP 2 : Operation Mode 7/20
5.3.3 Use of Handpiece 11/20
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5.4 Memory 13/20

5.4.1 Saving 13/20
5.4.2 Recalling a memory 15/20
5.5 Setup 16/20
5.5.1 Checking Shot Count 16/20
5.5.2 Adjusting Sound Volume of GUI 16/20
5.5.3 [Optional]Calibration 17/20
5.6 Turning off the System 20/20
5.6.1 Normal Turn-Off 20/20
5.6.2 Emergency Turn-off 20/20
Chapter 6. Maintenance & Management

6.1 Overview 1/12
6.2 Cleaning the System Main Body 1/12
6.3 Cleaning Handpiece 2/12
6.3.1 Cleaning Normal Hanpdiece 2/12
6.3.2 Cleaning Dye Handpiece 4/12
6.4 Keeping the Articulated Arm 5/12
6.5 Refilling Cooling(Distilled) Water 6/12
6.5.1 Cooling water indicator 6/12
6.5.2 How to refill cooling water 6/12
6.6 Troubleshooting 9/12
6.6.1 When the device fails to turn ON. 9/12
6.6.2 When the device is powered on but no laser fails to be radiated. 9/12
6.6.3 When the laser beam radiates with insufficient output power. 9/12
6.7 Status Message 10/12
6.8 Request for Periodic A/S 12/12
Chapter 7. Clinical Guidance

7.1 Overview 1/4
7.2 Education and Training 2/4
7.3 Consultation 2/4
7.4 Contraindications 3/4
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Chapter 8. Warranty
8.1 Overview 1/4
8.2 Unpaid Services 1/4
8.3 Exclusion to unpaid service within the period of the warranty 2/4
8.4 Consumable Items Not Covered Under the Warranty 3/4
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SPECTRA
List of Figures
Figure 2.1 Warning Sign for Laser-Beam Radiation 3/18

Figure 2.2 Laser Protective Goggles for the Physician (A) / for the Patient(B) 4/18
Figure 2.3 Position of Key Switch 9/18
Figure 2.4 Emergency Stop Button 10/18
Figure 2.5 Remote Interlock 10/18
Figure 2.6 Locations of Labels on the Front 14/18
Figure 2.7 Caution Label of Emergency Stop 14/18
Figure 2.8 Caution Label for Hanpiece Cable Insertion 15/18
Figure 2.9 Caution Label for Refilling Cooling Water 15/18
Figure 2.10 Warning Label of Hanger Use 15/18
Figure 2.11 Danger Label of Laser Radiation Path 15/18
Figure 2.12 Warning Label of Electrical Shock 16/18
Figure 2.13 Danger Label of Exposure to Laser 16/18
Figure 2.14 Danger Label of Laser Radiation Output 16/18
Figure 2.15 Remote Interlock Label 17/18
Figure 2.16 Foot switch Label 17/18
Figure 2.17 Grounding Label 17/18
Figure 2.18 Power Cable Label 17/18
Figure 2.19 Name Plate Label 18/18
Figure 2.20 Locations of Labels on the Back 18/18
Figure 3.1 Main Components of SPECTRA Laser System 3/7

Figure 3.2 Articulated Arm and Handpieces 5/7
Figure 3.3 Foot Switch and System Inlet 6/7
Figure 4.1 Dimensions of the SPECTRA Laser System 2/9

Figure 4.2 Connecting the handpiece to the articulated arm 5/9
Figure 4.3 Connecting the articulated arm cable connector and the handpiece 5/9
cable connector
Figure 4.4 Connecting the cable of the articulated arm 6/9
Figure 4.5 Connected System Inlet 7/9
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SPECTRA
Figure 5.1 Control Panel of SPECTRA Laser System 1/20

Figure 5.2 Pressing OK button 6/20
Figure 5.3 Control Panel for Normal Hanpdiec 7/20
Figure 5.4 Control Panel for Dye Handpiece 8/20
Figure 5.5 Control Panel for Fractional Handpiece 9/20
Figure 5.6 Automatic Spot Size Setup 11/20
Figure 5.7 Setting the spot size on the handpiece 11/20
Figure 5.8 Contacting the Handpiece with Skin 12/20
Figure 5.9 Setting Parameter to Save 13/20
Figure 5.10 Choosing a Memory to Save 14/20
Figure 5.11 Entering a Memory Name 14/20
Figure 5.12 Memory Completed to Save 15/20
Figure 5.13 Memory Recalled Screen 15/20
Figure 5.14 Setup Mode 16/20
Figure 5.15 Condition of the Articulated Arm for Calibration 17/20
Figure 5.16 Ready Screen for Calibration 18/20
Figure 5.17 Start Screen for Calibration 18/20
Figure 5.18 Calibration Progress Screen 19/20
Figure 5.19 Turning off the Key Switch 20/20
Figure 6.1 Separated Handpiece 2/12

Figure 6.2 Cleaning the window and tip of handpiece 2/12
Figure 6.3 Separated Dye Handpiece 4/12
Figure 6.4 Cleaning the window and tip of Dye handpiece 4/12
Figure 6.5 Fixing the tube of the articulated arm 5/12
Figure 6.6 Fixing the end of the articulated arm 5/12
Figure 6.7 Separating the water level window 6/12
Figure 6.8 Disconnecting the indicator tube 7/12
Figure 6.9 Inserting the funnel and the tube into the tank 7/12
Figure 6.10 Pouring distilled water into the funnel 8/12
Figure 6.11 Connecting the indicator tube to the tank 8/12
Figure 6.12 Status Message for Code: E01 10/12
Revision 1.3 /4100124013 9/9

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
user’s 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.
LCD Touch Screen is applied to the control panel so that users

may easily adjust parameters for optimal settings. The software
included provides device and clinical information to the users.
The pulsed beam is directed to the treatment zone by means of an

articulated arm fixed to a handpiece. When the beam contacts
human tissue, the energy of the beam is absorbed into the tissue,
resulting in a very rapid and highly localized temperature increase
to target chromospheres such as melanin and tattoo ink particles.
The momentary temperature increase causes fragmentation of the
chromospheres to smaller particles.
SPECTRA is the medical laser system which should perform for

the following intended use, emitting the wavelength of 1064 nm,
532 nm, 585 nm, 650 nm with its articulated arm, handpiece and
footswitch.
The SPECTRA Laser System is indicated for use in surgical

applications requiring ablation, vaporization, excision,
incision, and coagulation of soft tissue in medical specialties
including; epidermal pigmented lesions, epidermal & dermal
pigmented lesions, dermal pigmented lesions, tattoo, facial
telangiectasia, skin rejuvenation, carbon assisted skin
rejuvenation, scars, and carbon assisted hair removal.
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SPECTRA
Chapter 1. Overview
1.2 Symbols used in this manual and the device
Symbols 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
WARNING 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
CAUTION 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 patient’s
condition before treatment, including their
IMPORTANT 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 /878-
03-01).
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).
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SPECTRA
Chapter 1. Overview
This symbol indicates that this product adopts

equi-phase grounding which complies with
the Protective Regulations regarding electrical
shocks (IEC 417 / 5021)
This symbol indicates that this product
complies with the European Union’s directive
for disposal of electrical and electronic
products (Directive 2002/96/EC & EN50419).
It may not be disposed of in a general manner.
To properly dispose of this product, it must be
disassembled or properly recycled. For more
information regarding proper disposal please
contact Lutronic Corporation.
This symbol indicates important instructional
NOTE items and information to be noted to achieve
optimal use of this device.
Indicates where more information relevant to
Ref. the current issue may be found elsewhere in
this manual.
Manufacturer
Authorized representative in the European

Community
CE Marking
The use of mobile telephones or similar

appliances is not allowed while the laser
system is working.
On account of the possible risk of interference
from electromagnetic radiation while the laser
system is in operation, persons with heart
pacemakers may not be present in the room.
Pregnant women should also not be present in
the laser room during operation of the device.
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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SPECTRA
2.1 Overview
This chapter provides the basic safety and precautionary items regarding
laser-generating devices. The items will also serve to inform users of the
electrical safety and laser beam characteristics of the system.
All persons involved in the SPECTRA laser system operation (e.g.

operator, patient, and staff) should be aware of all the potential dangers
and the safety regulations of the system. The system should not be
handled without proper knowledge and training. The operator or the staff
should inform patients of precautions prior to treatment.
The SPECTRA laser system is designed to ensure optimal safety for

operators, staff and patients and is equipped with the safety system
described below:
1. This system utilizes a slow-blow fuse at 125V/25A or 250V/15A

which protects the system from possible current and voltage
complications. The Safety Extra Low Voltage (SELV) method is
employed in this system. The fuse installed in the inner area of the
SPECTRA laser system successfully blocks unwanted power surges.
2. Upon successfully starting the system, by turning the key switch

located on the front panel, the safety-related parts of this laser
system will run in safe operation.
3. The system automatically runs in a supervisory mode, continuously

monitoring the entire procedure in order to notify the user of the
system’s safety status.
4. The software installed in the SPECTRA laser system will block any
laser beam radiation immediately after an error occurs. An message
code will be promptly displayed to notify the operator.
5. The SPECTRA laser system automatically detects the spot size of

the handpiece and displays the information on the Touch LCD
screen.
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SPECTRA
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 system’s 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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SPECTRA
2.2 Safety for Treatment Room

Before performing a procedure, the operator and staff handling the
system should check the following items:
1. All warning signs should be attached to the door of the treatment

room. Warning signs are provided by Lutronic Corporation. Any
missing signs should be replaced before installing and operating
the SPECTRA laser system. (Figure 2.1)
Figure 2.1 Warning Sign for Laser-Beam Radiation
2. Access to the treatment room should be restricted to personnel

essential to the procedure and who are well trained in the required
safety precautions.
3. All present during a procedure should be fully aware of the

technical details of the system. If necessary, all persons should be
able to halt the system in case of an emergency.
4. No hazardous reflective objects (i.e. mirrors), should be allowed in

the operation room.
5. All present during a procedure must wear safety goggles. Safety

goggles (L-702YGII : for 532nm, 1064nm / L-702HE : for 585nm,
650nm) is provided by Lutronic Corporation. Please contact
Lutronic Corporation to inquire about reordering when needed.
6. Common power supply must be AC100~120V or AC220~230V in

order to use and operate the SPECTRA laser system safely.
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SPECTRA
A B
L-702YGII L-702HE
Figure 2.2 Laser Safety Goggles

for the Physician (A) / for the Patient(B)
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
2.3 General Precautions for Users, Staff and Patients
2.3.1Precautionary Items for the Handpiece Prior to the Procedure

The handpiece must be cleaned before each procedure. Thorough
maintenance protocol should be reviewed before cleaning the
handpiece. Any alien substances on the internal lens and tip of the
handpiece should be removed using alcohol of 90% or higher in order
to maintain energy efficiency. Ref. Chapter 6
Even if proper safety goggles are worn, looking directly into the laser
aperture of the handpiece could pose an eye hazard.
2.3.2 Precautionary Items for Transporting the System in the

Treatment Room
The SPECTRA laser system weighs about 88kg. Mishandling of the
system may cause damage to the system internally and externally both,
possibly adversely affecting its performance.
The system is designed in such a way that its center of mass is

optimized to facilitate convenient moving of the system. Handle it with
extreme care.
Do not attempt to move the instrument while holding the articulated

arm and/or the handpiece. Attempting to do so will disrupt the center of
mass and may cause the instrument to fall over resulting in damages to
system and surrounding persons.
2.3.3 Caution for Replacing the Handpiece

When handling the handpiece for purposes other than lasing during a
procedure, be sure not to press down on the footswitch. This kind of
manipulation or replacing the handpiece requires that it remain in a
vertical position and in a safe location at all times.
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SPECTRA
2.4 Cautions regarding Electrical Hazards

The SPECTRA laser system is an instrument that uses a voltage source
of AC100~120V or AC220~230V and thus contains high voltage
components. Removing the protection cover from the main body may
result in high risk of severe electrical shock.
Do not attempt to disassemble this instrument. Persons other than those

authorized and trained by Lutronic Corporation may not disassemble
this instrument.
Some residual electrical power may remain within the electrical

components of the SPECTRA laser system after blocking the power
supply. Persons other than those who are authorized by Lutronic
Corporation may not disassemble this instrument or inspect the inner
components, as this will void the warranty.
Never allow any type of liquid to enter the main body of the SPECTRA
laser system. This may lead to electrical shock.
Only use power cables with grounding pins provided by Lutronic

Corporation. If the power cable is damaged or worn out, contact
Lutronic Corporation or an authorized Lutronic distributor to replace
the cable. Do not attempt to use or operate this system with inferior or
alternative cables.
The user should not clean the handpiece or repair this instrument while
electrical power is being supplied to this instrument.
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
2.5 Protecting the Eyes

The SPECTRA laser system produces near infrared rays that are
invisible to the naked eye. Users and patients must wear safety goggles
at all times. Eye exposure, during procedures, to the laser beam may
result in severe injury or even loss of eyesight.
All persons involved with the laser operation should wear goggles with
protection from 1064nm and 532nm laser beams (optical density of 5 or
higher) or glasses with side protection that is pursuant to the ANSI
standard. Simple goggles made of glass that do not have any safety
functions may be penetrated by the laser beam.
The laser beam may reflect off the smooth surfaces such as surgical
tools. Therefore, all tools irrelevant to the procedure should be moved
to a safe place before performing the procedure.
A direct or scattered ray of the 532nm and 1064nm laser may cause
unrecoverable damage to the retina as it comes in contact with eyes.
Although proper laser safety goggles are worn, all persons should not
look directly into the laser aperture of the handpiece while the main
power of the system is turned on.
Patients are also required to wear the proper eye protection.
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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2.6 Precautions against Fire Hazards

Laser may ignite most non-metallic objects.
Various types of covers and gowns commonly used in procedures

should be made of material that is flame resistant. Avoid using
materials saturated with oxygen.
Be especially careful when using the laser beam near flammable

material. For instance, if the laser beam hits anesthetic, gaseous
materials such as nitric oxide or oxygen, or flammable material such as
alcohol or cotton, it may cause a fire.
Before using the laser, make sure all solvent, adhesives and cleaning
liquids have fully evaporated.
A fire extinguisher should be placed near the laser-generating device at

all times.
Never operate this system while it is covered.
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
2.7 Safety System for the SPECTRA laser system

This system includes safety devices fully compliant with international
standards to secure the safety of operator, staff and patients.
2.7.1 Key Switch

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.
(1)OFF (2)ON
Key Switch OFF Key Switch ON
Status: Power is shut off. Status: Power is on.
Figure 2.3 Position of Key Switch
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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SPECTRA
2.7.2 Emergency Stop Button

In case of an emergency, laser emission
can be stopped immediately by pressing
the emergency stop button.
To restore operation, rotate the button

clockwise (in the direction of the arrows)
until it pops out again and follow the
normal startup sequence. See Chapter 5 for
startup procedure. Turn the key switch to Figure 2.4. Emergency
stop button
the 0 position which power is shut off and
then follow the normal startup procedure.
This emergency stop button should not be used as part of a normal

operation procedure. Because it may lead to a electrical damage in the
system. Always use the key switch to turn on or off the instrument in
normal situations.
2.7.3 Warning Sound and Signal of the Laser Radiation

Once laser emits by depressing the foot switch, the status button color
changes to orange. And under the button, the word “Lasing” blinks to
warn users of lasing in progress.
Pressing the ready button will alert an alarm sound for 5 seconds to let
all present know that the system is ready to emit laser beam.
2.7.4 Remote Interlock

When a remote interlock to the socket located on the back of the
SPECTRA laser system, the electrical circuitry will be closed and the
system can start its normal operation. If the remote interlock device is
not attached to the connector, then the system will not operate.
You may install a remote interlock device to the door of the treatment
room to halt the system immediately if unauthorized persons enter the
treatment room in the middle of a treatment.
Figure 2.5 Remote Interlock
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2.7.5 Door Interlock

The door interlock located on the back top of the system stops
operating if the back panel is left open.
If the back panel while the system is in operation, the system will stop
operating immediately and generate an error message.
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SPECTRA
2.8 Main International Standards Applied to SPECTRA laser

system
This system complies with the following international standards for the
safety of doctors and patients.
Standard/
Title Ratification
Regulation
93/42/EEC
As amended Medical Device Directive 2007
by 2007/47/EC
Medical electrical equipment – Part 1-6
EN 60601-1-6 General requirements for basic safety and 2007
IEC 60601-1-6 essential performance 2006
- Collateral Standard: Usability
1990;A1;1993;A
EN 60601-1 Medical electrical equipment
2;1995;
IEC 60601-1 Part 1: General requirements for safety
A13;1996
Medical electrical equipment
EN 60601-1-2 Part1-2: General requirements for safety
2007
IEC 60601-1-2 –Collateral standard: Electromagnetic
compatibility - Requirements and Tests
Medical electrical equipment
EN 60601-1-4 Part 1-4: General requirements for safety 1996;A1;1999
IEC 60601-1-4 - Collateral Standard: Programmable electrical 2000
Medical systems
EN 60601-2-
Medical electrical equipment –
22 1996
Part 2: Particular requirements for the safety of
IEC 60601-2- 1995
diagnostic and therapeutic laser equipment
22
Safety of laser products
EN 60825-1
Part 1: Equipment classification, 2007
IEC 60825-1
requirements and user's guide
Graphical symbols for use in the labeling of
EN 980 2008
Medical devices
EN ISO 14971 Medical devices - Application of risk 2009

ISO 14971 management to medical devices 2007
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SPECTRA
Medical device software-Software life cycle

EN 62304 2006
processes
US Federal Performance Standards 21CFR

21CFR/FDA 1040.10 and 1040.11 for Class IV Laser _
Product
Information Supplied by the manufacturer of

EN1041 2008
medical devices
Revision 1.3 /4100124013 Ch2-13/18

SPECTRA
2.9 Safety Labels for SPECTRA Laser System

Pursuant to domestic and international standards, various types of safety
and system information labels are attached to the appropriate locations.
CAUTION
Physicians and staff should be fully aware of the locations and the meaning
of all the safety labels attached to the system.
Side
Figure 2.6 Locations of Labels on the Front
2.9.1 Caution Label of Emergency Stop

The emergency stop button is used for immediate stop of the laser
equipment in case of emergency. The label is located next to the emergency
stop button on the front of the system.
Figure 2.7 Caution Label of Emergency Stop
Revision 1.3 /4100124013 Ch2-14/18

SPECTRA
2.9.2 Caution Label for Handpiece Cable Insertion

The label informs users of the proper way to insert the handpiece cable to
the cable socket installed on the arm port to prevent breakage.
Figure 2.8 Caution Label for Handpiece Cable Insertion
2.9.3 Caution Label for Refilling Cooling Water

The label instructs the user on refilling the water tank, so it can be done
properly and independently.
Figure 2.9 Caution Label for Refilling Cooling Water
2.9.4 Warning Label of Hanger Use

The label states that the foot switch hanger should not be used to move the
system because lifting the system may cause system operation damage.
Figure 2.10 Warning Label of Hanger Use
2.9.5 Danger Label of Laser Radiation Path

The label indicates the laser beam radiation and its path.
Figure 2.11 Danger Label of Laser Radiation Path
Revision 1.3 /4100124013 Ch2-15/18

SPECTRA
2.9.6 Warning Label against Electrical Shock

The label warns of electrical shock and exposure to high voltage in the
instance that the panel is opened or removed. Only authorized and trained
persons may open or remove the cover.
Figure 2.12 Warning Label of Electrical Shock
2.9.7 Danger Label regarding Exposure to Laser

This warning label states that the eyes or skin should not be exposed to
direct or scattered rays of the laser beam due to possible severe injury.
Figure 2.13 Danger Label of Exposure to Laser
2.9.8 Danger Label regarding Laser Radiation Output

This label identifies the class of the laser beam (CLASS IV). It indicates
laser output information, such as, the radiation time for maximum pulses,
the danger items for the wavelength and the medium of transmission for
proper safety.
Figure 2.14 Danger Label of Laser Radiation Output
Revision 1.3 /4100124013 Ch2-16/18

SPECTRA
2.9.9 Remote Interlock Label

This label indicates that laser emission is performed only if remote interlock
is connected its socket.
Figure 2.15 Remote Interlock Label
2.9.10Footswitch Label
This label indicates that laser emission is performed only if the footswitch is
depressed.
Figure 2.16 Footswitch Label
2.9.11 Grounding Label

This symbol indicates that this product adopts equi-phase grounding which
complies with the protective regulations for electrical shocks.
Figure 2.17 Grounding Label
2.9.12 Power Cable Label

This label warns users of the precaution when connecting the main power
cord to a wall outlet.
Figure 2.18 Power Cable Label
Revision 1.3 /4100124013 Ch2-17/18

SPECTRA
2.9.13 Name Plate Label

This label indicates the product name, model name, laser class and other
electrical specifications of the SPECTRA laser system.
Figure 2.19 Name Plate Label
Figure 2.20 Locations of Labels on the Back
Revision 1.3 /4100124013 Ch2-18/18

SPECTRA
3.1 Overview
This chapter provides a general description of the SPECTRA laser system,
including its main components, system control, and technical specifications.
3.2 System Specifications

Performance System Specification
Laser wavelength 1064/650/585/532m
Medium of transmission Q-switched Nd:YAG laser
Laser transfer method Articulated arm
1064 mode (Q-switched
Max. 1200mJ
mode)
532 mode(Q-switched
Max. 400mJ
mode)
Pulse Energy
Spectra mode(1064nm) Max. 1500mJ
585 mode Max. 250mJ
650 mode Max. 150mJ
Pulse Duration Q-switched mode 5 ~ 10ns
1064, Spectra mode S1, 1, 2, 5, 10(Hz)
532 mode S1, 1, 2, 5, 8, 10(Hz)
Pulse Rate
585 mode S1, 1, 2, 5(Hz)
650 mode S1, 1, 2(Hz)
CDRH Class Class IV
MDD Class Class IIb
Classifications
Applied Part Class B
FDA Class Class II
Zoom 1~5mm(1064nm)/0.8~4.3mm(532nm)
Handpiece
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)
[Optional]
3~7mm-Zoom-Collimated 3~7mm(1064nm)/2.6~6mm(532nm)
Handpiece
2mm-SD585 2mm
5mm-SD585 5mm
2mm-SD650 2mm
Revision 1.3 / 4100124013 Ch3-1/7

SPECTRA
Cooling System Air + Water Cooling

Laser transfer method Articulated arm
Protective Eyewear Optical Density >5 at 1064, 532, 650, 585nm
Display System Touch LCD
Single phase
AC100~120V or AC220~230V
Electrical rating (Fuse 125V/25A or 250V/15A)
50/60Hz,
Power consumption: 1.7kVA
Revision 1.3 / 4100124013 Ch3-2/7

SPECTRA
3.3 Components of SPECTRA Laser System

SPECTRA laser system is largely composed of three main components.
System main body

- Dimensions(mm) : 295(W) x 656(L) x 1700(H)
Handpiece
Foot switch
Articulated arm
Handpiece
Calibration Port
Control Panel
Handle
System Foot
Key switch Switch
Main Body
Emergency stop
Button
Caster
Figure 3.1 Main Components of SPECTRA Laser System
Revision 1.3 / 4100124013 Ch3-3/7

SPECTRA
3.3.1 System Main Body

The system main body is an essential part for device operation. It is
composed of components and modules necessary for controlling and
operating the device. The system main body is organized as follows.
Components Functions
This includes the key switch and the
emergency stop button which controls the
System Control overall operation of the entire system. The
Module 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
Power Supply
of electric power that the device requires and
provides it for each module.
Generates the laser beam of a wavelength of
Laser Module
the 1064 nm and 532 nm.
Displays information of the current status and
Control Panel 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
Handle and Casters
casters additionally have locking devices to
allow the operator to station the device firmly
and safely in a fixed position.
Revision 1.3 / 4100124013 Ch3-4/7

SPECTRA
3.3.2 Handpiece & Articulated arm

8mm-Zoom-Collimated
Articulated Arm (3-8mm/2.6-6.9mm)
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
Figure 3.2 Articulated arm and Handpieces

The beam delivery system begins at the post mount. Here, the infrared
and visible laser beam exits the laser optical system.求The laser beam
will then enter the articulated arm and the 7 mirrors attached inside the
arm reflect and deliver the beam.
The articulated arm contains an aiming beam system with 655nm

wavelength to visually show where the tip of handpiece is directing to
for treatment area.
Handpieces can be easily interchanged with the laser system’s
articulated arm depending on the purpose of surgical operation. The
handpiece tip should be replaced before each clinical operation to avoid
danger of infection between patients and treatments.
Revision 1.3 / 4100124013 Ch3-5/7

SPECTRA
3.3.3 Footswitch and System Inlet
Remote interlock socket Main Power

Switch
External Power Cord

Foot Switch
Ground
Socket
Figure 3.3 Footswitch and System Inlet
The footswitch is designed with a metal cover to satisfy firmness,

weight and safety to prevent unwanted malfunctions pursuant to the
international standard IEC60601-2-22.
The footswitch should be connected to the footswitch socket located on

the system inlet of the backside of the device.
When the Ready button is pressed, the footswitch is then in control of

laser emission. Laser beam will be emitted from the handpiece as long
as the foot switch is depressed. The micro-controller continuously
monitors the foot switch to ensure that the laser fires only when the foot
switch is depressed. If the foot switch is not connected to the system
main body, the laser beam will not fire.
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.
Revision 1.3 / 4100124013 Ch3-6/7

SPECTRA
3.4 System Software

The software installed in SPECTRA laser system provides the optimal
environment for clinical operations. It is programmed for the following
purposes:
Selection and application of optimal and individual surgical

parameters for each patient.
Prompt and accurate control of the driving device for the

SPECTRA laser system.
Ability to consistently monitor the device in order to secure the

safety of operator, staff and patients.
Generating an accurate amount of laser radiation by checking the

varying output of the laser beam due to use.
The initial screen on the control panel stores the status of the most
recent operation performed; thus the panel information may appear
different each time the system is run.
Revision 1.3 / 4100124013 Ch3-7/7

SPECTRA
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.
4.2 Installation Component List

Before installing the system, check the following list of installation
components.
Items Qty
SPECTRA laser system body (including articulated arm) 1 unit
8mm-Zoom-collimated handpiece 1 unit
[Optional] 7mm-Zoom-collimated handpiece 1 unit
[Optional] Zoom handpiece 1 unit
[Optional] Collimated handpiece 1 unit
[Optional] 2mm-SD585 1 unit
[Optional] Fractional handpiece 1 unit
[Optional] 532 handpiece 1 unit
System key 2 units
Footswitch 1 unit
Remote interlock 1 unit
Laser radiation warning sign (For the treatment room) 1 unit
Laser protection goggles for operator 2 units
Laser protection goggles for patient 1 unit
Operator’s manual 1 vol
Funnel & Tube (For refilling cooling water) 1 set
Revision 1.3 /4100124013 Ch4-1/9

SPECTRA
4.3 Conditions for Installation

4.3.1 Space Requirements
The entire area of the device is shown in Figure 4.1. To maintain optimal
efficiency, the surrounding space indicated below should be allocated
when installing the device.
Before installation, be sure to first survey and consider the

appropriateness of the intended location and space.
Each vertical side of the device should be at least 12 inches (30 cm)
away from the wall.
Maximum distance is encouraged when placing the device near or

next to another medical device, or any other device that generates
heat.
1700mm
840mm
656mm
295mm
Figure 4.1 Dimensions of SPECTRA Laser System
Revision 1.3 /4100124013 Ch4-2/9

SPECTRA
4.3.2 Electrical Requirements
Electric power supplied to SPECTRA laser system should satisfy the

following requirements in order to maintain optimal efficiency and
electrical safety.
The wall socket outlet should include at least two terminal units
and grounding terminals.
Check the output power of the outlet within the wall. Output
should be a single phase, AC100~120V or AC220~230V and
50/60Hz outlet. Please confirm this condition before connecting the
device power plug to the outlet.
After confirming the wall outlet in the treatment room complies

with the power consumption of the device, the operator should run
the device.
A 125V/25A or 250V/15A fuse is used to protect the device from

exceeding voltage. If the fuse is open-circuited, contact the
Lutronic Corporation customer service department for proper
actions to be taken.
For the safety of patients, operator, staff members, as well as

electrical safety, connect the external ground terminal of the device
to the separate ground terminal in the operating room. Please
contact Lutronic Corporation customer service department to
ensure safe grounding during 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.
Revision 1.3 /4100124013 Ch4-3/9

SPECTRA
4.3.3 Environmental Requirements

The environment for using SPECTRA laser system should satisfy the
following requirements:
Atmosphere
- Use of the device in a strong corrosive or acidic atmosphere

may lead to corrosion of the electrical cord, the electrical
components or the laser module.
- Air-borne dust particles should be kept to a minimum. Such

fine particles of dust may severely damage the device once it
has entered into the electrical components or the laser modules.
Temperature/relative humidity
- The optimal temperature for storing the device is a range of

50°F (10°C) to 104°F (40°C). The optimal temperature for
using the device is a range of 20°C to 30°C.
- Relative humidity should remain between 0% and 90%, and

install the device in an airy place in order to keep proper
humidity according to the temperature.
Revision 1.3 /4100124013 Ch4-4/9

SPECTRA
4.4 Installation of the Device

4.4.1 STEP 1: Connecting the Handpiece
1. Take off the protective cap covering the end of the articulated arm.
2. Hold the end of the articulated arm steadily. Carefully insert the
handpiece to the end by screwing the end of the articulated arm to the
side as the arrow shown in Figure 4.2 until the handpiece is connected
firmly. Be sure that the handpiece is securely fastened.
Figure 4.2 Connecting the handpiece to the articulated arm
3. Hold the handpiece cable connector and articulated arm cable

connector. Check the arrows on the two connectors in a beeline and
connect them each other as shown in Figure 4.3
Handpiece cable connector Articulated arm

cable connector
Figure 4.3 Connecting the articulated arm cable connector and the
handpiece cable connector
Revision 1.3 /4100124013 Ch4-5/9

SPECTRA
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. Connect the articulated arm cable connector to its socket located on

the left top of the back of the system as shown in Figure 4.4.
Figure 4.4 Connecting the articulated arm cable
CAUTION
Because the cable socket on top of the device may get
damaged, Never put excessive strength to the connector
socket.
Revision 1.3 /4100124013 Ch4-6/9

SPECTRA
4.4.2 STEP 2: Connecting the Accessories

1. 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.
Revision 1.3 /4100124013 Ch4-7/9

SPECTRA
4.4.3 STEP 3: Final Check-up and Fixing the Device
1. Position the device in a place that satisfies the requirements of 4.3

Conditions for Installation for the installation space.
2. Depress the caster brakes located on all the four casters of the device
to lock the position of the device. (To move the device again, please be
sure to release all breaks.)
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.
4.4.4 STEP 4: Supplying Main Power

1. Make sure that the status of main power switch is in the (O) position
indicating that the main power is off and not running.
2. Connect the power plug for the main power cord to the outlet on the
wall.
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.
Revision 1.3 /4100124013 Ch4-8/9

SPECTRA
4.5 Moving the Device

When moving the device in the treatment room or to a remote location, first
carefully check the following items. Only persons authorized and trained by
Lutronic Corporation may move the device. All other persons must
explicitly read and follow the instructions below.
4.5.1 Moving the Device in the Treatment Room

To move the device safely, repeat steps shown in “4.4 Installation of
the Device” in the reverse order.
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.”
4.5.2 Moving the Device to a Remote Location

When moving the device to a remote location, contact your Lutronic
Corporation distributor for safe and efficient transportation.
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.
Revision 1.3 /4100124013 Ch4-9/9

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.
5 4
3
7 8
10
6
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.
Revision 1.3 / 4100124013 Ch5-1/20

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
求
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
求
8mm-Zoom-collimated handpiece : 3, 4, 5, 6, 7, 8mm

7mm-Zoom-collimated handpiece : 3, 4, 5, 6, 7mm
Zoom handpiece : 1, 2, 3, 4, 5, 6, 7mm
Collimated handpiece : 7mm
Fractional handpiece : 6x6(mm)
532nm mode
求
8mm-Zoom-collimated handpiece 2.6, 3.4, 4.3, 5.2, 6, 6.9mm

7mm-Zoom-collimated handpiece 2.6, 3.4, 4.3, 5.2, 6mm
Zoom handpiece : 0.8, 1.7, 2.6, 3.4, 4.3, 5.2, 6mm
Collimated handpiece : 6mm
532 handpiece : 1.7mm
585nm & 650nm mode-Dye handpiece mode

2mm-SD585 : 2mm
5mm-SD585 : 5mm
2mm-SD650 : 2mm
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.
Revision 1.3 / 4100124013 Ch5-2/20

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 π
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 π = 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 (2mm-
SD585/5mm-SD585/2mm-SD650) to articulated arm.
Mode Wavelength Description

Laser radiation at 1064nm in Q-switch. The pulse
width is 5ns~10ns and the energy peak is higher
1064 1064nm than that of Spectra Mode. Thus, the energy
intensity is much higher than that of Spectra Mode
for the same duration.
Green laser radiation at 532nm in Q-switch. The

532 532nm
energy peak is high and the energy density is high.
Laser radiation at 1064nm. The energy peak is

lower than that of Q-switch 1064nm. Thus, the
Spectra 1064nm energy intensity is much lower than that of Q-
switch mode for the same duration.
Revision 1.3 / 4100124013 Ch5-3/20

585nm laser radiation derived from the 532nm

585 source laser and solid-dye pumping of the
585nm
[Optional]
SD585nm dye handpiece.
650nm laser radiation derived from the 532nm

650 source laser and solid-dye pumping of the
650nm
[Optional]
SD650nm dye handpiece.
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.
Revision 1.3 / 4100124013 Ch5-4/20

5.2 Checking Caution and Inspection Items

Prior to performing a treatment procedure, please check the following items.
Pay close attention to the cautionary items presented in Chapter 2. Safety
Precautions
Is everyone in the treatment room wearing 532~1064 nm laser protection

goggles or glasses with side protection in accordance with the ANSI
standard?
Is the patient wearing protective goggles?
Are the handpiece window and system main body clean?
Is the device installed properly according to the conditions expressed in
Chapter 4. Installation?
Are the casters for the device properly fixed in order to prevent the
device from moving?
Are there any objects nearby that can reflect light, such as a mirror,
installed in the treatment room?
Is the power plug connected to an outlet that is of the appropriate energy,
that is the local power supply in the treatment room is AC100~120V or
AC220~230V with proper grounding?
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.
Revision 1.3 / 4100124013 Ch5-5/20

5.3 Operation of the SPECTRA Laser System

5.3.1 STEP 1: Turning on the System
1. Flick the main power switch, located at the back of the system, to the
ON(I) position.
2. After 20 minutes, insert the key into the key switch located on the
front of the system and then turn it to 1st position. The cooling pump
will start running. The control panel will light.
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.
Figure 5.2 Pressing OK button
Revision 1.3 / 4100124013 Ch5-6/20

5.3.2 STEP 2: Operation Mode

Operating with Normal Handpiece
4 5
3
7 8
10
6
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.
Revision 1.3 / 4100124013 Ch5-7/20

NOTE
When restarting the system, the control panel recalls and
displays the most resent used parameters.
[Optional]Operating with Dye Handpiece
4 5
3
7 8
10
6
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.
Revision 1.3 / 4100124013 Ch5-8/20

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.
Revision 1.3 / 4100124013 Ch5-9/20

[Optional]Operating with Fractional Handpiece
1
2
4 5
3
7 8
10
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 physician’s clinical guide to set optimal
parameters.
Revision 1.3 / 4100124013 Ch5-10/20

5.3.3 Use of Handpiece

Automatic Spot Size Setup
The spot size on the control panel is set automatically by adjusting the
spot size regulator located at the handpiece. For the automatic sensing,
the operator must make sure that its cable is correctly connected to the
port of the articulated arm.
Figure 5.6 Automatic Spot Size Setup
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 1
1
parentheses are the spot sizes at 532nm.
2
1. To adjust the spot size of the
handpieces, hold the regulator and Figure 5.7 Setting the spot
pull it down as shown in Figure 5.7. size on the handpiece
2. And rotate it to the left or the right in

order to show the spot size to set as
shown in Figure 5.7.
Revision 1.3 / 4100124013 Ch5-11/20

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
Figure 5.8 Contacting the Handpiece with Skin
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.
Revision 1.3 / 4100124013 Ch5-12/20

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

located at bottom of the screen. Parameter
Setting Section
Figure 5.9 Setting Parameter to Save
3. After setting parameters in the parameter setting section, press one of

the memories to save at left of the screen. At this time, a popup
window is displayed to make sure users want to save it in the selected
memory. Then, press OK button.
Revision 1.3 / 4100124013 Ch5-13/20

Figure 5.10 Choosing a Memory to Save
4. Press Rename button located at bottom of the screen to set memory

name. Then, a keyboard pops up.
5. Put a memory name in the blank of the keyboard and press Accept
button.
Figure 5.11 Entering Memory Name
Revision 1.3 / 4100124013 Ch5-14/20

6. As shown in Figure 5.12, saving a memory is completed. During

putting letters on the keyboard, it is possible to return to the original
name by pressing Restore button.
Figure 5.12 Memory Completed to Save
5.4.2 Recalling a memory

1. Enter Memory mode by pressing Memory button at bottom of the
operation mode screen.
2. Press a memory to recall. The selected memory is highlighted in
yellow.
3. Recall the memory to the operation mode by pressing Accept button
on top of the screen. And the memory selected is cancelled by pressing
Restore button.
Figure. 5.13 Memory Recalled Screen
Revision 1.3 / 4100124013 Ch5-15/20

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.
Figure 5.14 Setup Mode
5.5.2 Adjusting Sound Volume of GUI

1. Volume is the function to adjust sound of the GUI. It can be adjusted at
the range of 5 ~ 100% by pressing the up & down button(▲▼) next to
Volume window.
Revision 1.3 / 4100124013 Ch5-16/20

5.5.3 [Optional] CALIBRTAION

Calibration allows the operator to check the current energy condition of the
device by following the three steps below.
1. Before starting calibration, check the beam mode.
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

Calibration
port
Figure 5.15 Condition of the Articulated Arm for Calibration
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.
Revision 1.3 / 4100124013 Ch5-17/20

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.
Figure 5.16 Ready Screen for Calibration

6. Once the start button is displayed as shown in Figure 5.17, press the
start button.
Figure 5.17 Start Screen for Calibration
7. As the start button is pressed, the calibration works and is completed as

Revision 1.3 / 4100124013 Ch5-18/20

Figure 5.18 Calibration Progress Screen
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
Revision 1.3 / 4100124013 Ch5-19/20

5.6 Turning off the System

5.6.1 Normal Turn- Off
1. Position the handpiece in a safe place and turn the key counterclockwise
back to OFF position.
2. Hang the handpiece on its hook installed on the articulated arm.
OFF
Figure 5.19 Turning off the Key Switch
3. Remove the key from the key switch in order to prohibit unauthorized
persons from using the device.
4. Flick the main power switch located on the rear of the device to (O) in
order to shut off the main power supply.
5. If the device will be idle for a prolonged period of time, please remove
the power cord from the outlet.
5.6.2 Emergency Turn- Off

1. The operator should use the emergency stop button in case of an
emergency only. Pressing the emergency stop button consequently
stops the device immediately.
2. To restart the device, turn the emergency stop button clockwise until it
stops, and then turn the device.
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.
Revision 1.3 / 4100124013 Ch5-20/20

SPECTRA
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.
6.2 Cleaning the System Main Body

Soak a soft pad in a non-corrosive cleansing liquid such as Isopropyl
alcohol or ethanol 90% or higher and gently wipe the surface areas of
the device.
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.
Revision 1.3 / 4100124013 Ch6-1/12

SPECTRA
6.3 Cleaning Handpiece

6.3.1 Cleaning Normal Handpiece
The handpiece unit should remain clean at all items. Follow the cleaning
procedure below after cleaning your hands.
1. Remove the handpiece tip from the handpiece, hold the handpiece
body with one hand and pull the handpiece tip with the other
hand. Do not use excessive force.
Handpiece tip
Handpiece body
Figure 6.1 Separated Handpiece
2. Obtain a soft, lint-free dry cloth and soak it in alcohol. Thus

saturated, use the cloth to clean the entire area of the handpiece
except its window at the end of the handpiece body.
3. To eliminate the area of all alien substances, use a cotton swab

saturated in 90% alcohol to wipe out the area thoroughly.
4. Be sure to also remove debris on the inner side of handpiece tip

using the same method.
Figure 6.2 Cleaning the window & tip of handpiece
5. After thoroughly cleaning the handpiece, shine a light onto the

window of the handpiece to examine it and check for cleanliness.
Revision 1.3 / 4100124013 Ch6-2/12

SPECTRA
6. Reassemble the handpiece in reverse order of the disassembling

step.
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 :
Soak a lens paper or cotton swab in ethanol. Allow one
drop of ethanol to fall onto the top of the window and sit
for 3 to 5 seconds.
When the alien substances are thoroughly soaked, use a
cotton swab to remove the substances.
CAUTION
The handpiece tip should be thoroughly and properly
cleaned before applying it to treatment area of a patient.
Failure to do so may result in damages or negatively affect
clinical treatment.
When using a cotton swab to wipe out alien substances, do

not exert excessive pressure on the window as this may
damage the natural coating of the window’s surface.
Failure to properly maintain or manage the condition of the

window of the handpiece may result in accumulation of
alien substances on its surface, causing damages to the
handpeice’s optical system.
Revision 1.3 / 4100124013 Ch6-3/12

SPECTRA
6.3.2 Cleaning Dye Handpiece

1. Turning the handpiece tip to remove the handpiece tip from the
handpiece as shown in Figure 6.3.
Figure 6.3 Separated Dye Handpiece
2. To clean the window from alien substances, hold the handpiece body
and wipe the tip using a cotton swab saturated in 90% alcohol
thoroughly. Repeat the same procedure to clean the window.
Figure 6.4 Cleaning the window and tip of Dye Handpiece
3. After thoroughly cleaning the handpiece, shine a light onto the window
of the handpiece to examine it and check for cleanliness.
4. Reassemble the handpiece in reverse order of the disassembling step.
5. When not using the handpiece, wipe the handpiece with dried cotton
cloths and keep it in the handpiece case.
Revision 1.3 / 4100124013 Ch6-4/12

SPECTRA
6.4 Keeping the Articulated Arm

When the system is not in use for over 12 hours, store the articulated arm
by following the below instructions:
1. Fix the tube of the articulated arm in its hook shown in Figure 6.5
Figure 6.5 Fixing the tube of the articulated arm
2. Cover the end of the articulated arm with the protective cap. Fix the
end of the articulated arm, with the handpiece connected, in its
hook. See Figure 6.6
Figure 6.6 Fixing the end of the articulated arm
Revision 1.3 / 4100124013 Ch6-5/12

SPECTRA
6.5 Refilling Cooling(Distilled) Water

6.5.1 Cooling water indicator :
The distilled water level window is located on left side of the system main
body. The cooling water level is indicated by a ball floating in the
indicator tube. When the ball floats on, approximately, 1/2 to 1/3 level of
the indicator tube as shown in Figure 6.7, the operator should refill the
system’s distilled water.
6.5.2 How to refill cooling water:
1. Ready the funnel, tube provided and fresh distilled water for use.
2. Take off the water level window by unscrewing the upper bolt and the
lower bolt with hands as shown in Figure 6.7.
Proper water
level
Ball
Indicator
tube
Figure 6.7 Separating the water level window
3. As shown in Figure 6.8, pull out the upper nipple of the indicator tube by
pushing the valve of the upper inlet.
4. Pull out the lower nipple of the indicator tube by pushing the valve of the
lower inlet. At this time, because the distilled water inside the indicator
tube flows out, put a piece of cloth or tissue under the lower nipple.
Revision 1.3 / 4100124013 Ch6-6/12

SPECTRA
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.
Revision 1.3 / 4100124013 Ch6-7/12

SPECTRA
Figure 6.10 Pouring distilled water into the funnel
7. Once the cooling water tank is filled with distilled water to the top, pull
out the funnel and the tube from the inlets of the tank.
8. Connect the indicator tube to the tank by pushing the nipple of the tube
into the inlets of the tank as shown in Figure 6.11. Then, the indicator
tube is filled up with distilled water to the water level of the tank,
together with the ball. It is proper that the water with the ball is filled up
to the proper water level shown in Figure 6.7.
Figure 6.11 Connecting the indicator tube to the tank
9. Attached the water level window by screwing the two bolts.
Revision 1.3 / 4100124013 Ch6-8/12

SPECTRA
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.
6.6.2 When the device is powered on but laser beam fails to be

radiated.
Check if the footswitch is correctly inserted into the socket.
Check to see if the remote interlock is properly inserted into the socket.
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
Corporation for assistance.
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.
Revision 1.3 / 4100124013 Ch6-9/12

SPECTRA
6.7 Status Message

The system is continuously self-monitored and will notify the user of any
problem by displaying a message code as seen in Figure 6.12.
Figure 6.12 Status Message for Code 01

When an error occurs, the corresponding message code will be displayed
on the control panel as shown in Figure 6.12. In case of an error, the laser
beam radiation will stop immediately.
The following is the list of message codes:
▼ The following Message Codes do not mean the system is broken

down, but it can be resolved by the operator taking the instructed
actions.
Possible Cause for
Message Code Actions to Take
Errors
Turn off the device and restore
CODE 01 Emergency Error the emergency switch. Restart
the device.
Turn off the device, wait 2
CODE 02 Main Shutter Error minutes before restarting the
device.
Refill cooling water according to
CODE 03 Water Flow Error
the instruction. (Ref. 6.5)
CODE 04 Door Open minutes before restarting the
device.
Revision 1.3 / 4100124013 Ch6-10/12

SPECTRA

CODE 05 KTP Open Fail minutes before restarting the
device.
CODE 06 KTP Insert Fail minutes before restarting the
device.
CODE 07 SPECTRA Insert Fail minutes before restarting the
device.
CODE 08 SPECTRA Open Fail minutes before restarting the
device.
CODE 09 Concave Insert Fail minutes before restarting the
device.
CODE 10 Concave Open Fail minutes before restarting the
device.
Attenuator Insert
CODE 11 minutes before restarting the
Fail
device.
Attenuator Open
Fail
device.
Possible to use the device
temporarily, but the device is un
Energy Setup stable and it is very required to
CODE 24
Error contact your local Lutronic
distributor for inspection and use
it.
Power Module
Error
device.
CODE 32 AC Contactor Error minutes before restarting the
device.
Refill cooling water according to
CODE 33 Water Level Error
the instruction. (Ref. 6.5)
Interlock Switch
Off
device.
CODE 36 Simmer Error minutes before restarting the
device.
Contact your local Lutronic
CODE 37 Water Temp. Error distributor for inspection and use
it.
Revision 1.3 / 4100124013 Ch6-11/12

SPECTRA
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.
6.8 Requests for Periodic A/S

For more detailed information on periodic service for this device, contact
your authorized Lutronic distributor or contact Lutronic Corporation for
assistance.
Revision 1.3 / 4100124013 Ch6-12/12

SPECTRA
7.1 Overview
The following clinical guide is compiled from reports and information
provided by medical doctors with experience of using the SPECTRA laser
system and from published clinical reports and professional literature.
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.
In summary, the overall effectiveness of a laser for specific indications

depends on how well the wavelength is absorbed by the chromophore, how
well and deeply the wavelength can penetrate the skin, the thermal
relaxation time (TRT) of the target, pulse duration and its relative
shortness compared to the target’s TRT, and the spot size and fluency level
of the laser beam.
Revision 1.3/4100124013 Ch7-1/4

SPECTRA
7.2 Education and Training

Before using the SPECTRA laser system, operators should ensure that
they are completely familiar with this manual and that they understand
everything in it. The system is intended for use by qualified clinical
professionals. Operators are advised to attend a Lutronic Corporation
authorized training session on the use of the SPECTRA laser system,
receive training in basic laser related safety, and gain hands-on clinical
experience before using the system.
A Q-switched Nd:YAG Laser course includes didactic lectures on: laser

physics, laser safety, and hands-on sessions. Live patient observation
followed by a preceptorship is highly recommended. Specific
recommendations for laser safety training can be found in the relevant
international standards such as the ANSI Z136.4, CA and CE Standards, as
published by the relevant Standards authorities. For more information on
training please contact Lutronic Corporation by dialing +82-31-908-3440
or sending an e-mail to office@lutronic.com. Also we recommend to click
on website edu.lutronic.com for more details about operation video.
Users should stay current with published literature on the clinical use of
lasers.
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 patient’s medical history,

treatment requests, anesthetic requirements and projected
treatment cost.
Revision 1.3/4100124013 Ch7-2/4

SPECTRA
The following key points must be communicated to the patient

prior to commencing treatment program:
- Multiple treatments may be required
- The effectiveness of treatment is related to skin color, skin

type and other factors
- the laser type being used and its appropriateness for

patient’s skin type
Patient comments should be recorded
The patient should be given the opportunity to ask questions and,

only when satisfied, asked to sign a consent form.
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
Revision 1.3/4100124013 Ch7-3/4

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.
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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.
8.2 Unpaid Services
If the SPECTRA laser system has been properly used and applied for
after sales-service, the user is eligible for unpaid services up to one year
from the date of purchase, as guaranteed by Lutronic Corporation.
Free complimentary service includes maintenance of the main body of

the system, foot switch, articulated arm, and remote interlock, but not
of the consumable components, such as the handpiece window, flash
lamp, DI filter, [Optional] SD585 and SD650, all of which are
excluded.
If Lutronic Corporation receives a request for parts/labor during the

warranty period, such requests will be handled in a prompt manner.
Depending on the condition of the system to be repaired, Lutronic
Corporation may decide to repair or replace the system either on the
premises of Lutronic’s headquarters or the location where the system is
installed.
If it is necessary to recall the system for the purpose of adjustment or

inspection, Lutronic will provide the information that our customer
requests or allow them to rent a temporary device.
WARNING
In order to maintain the coverage of unpaid services, only
service persons formally authorized by Lutronic should be
Revision 1.3 / 4100124013 Ch8-1/4

SPECTRA
Chapter 8. Warranty
allowed to configure, modify or inspect the system. If the

system is used for purposes other than originally intended or
not in compliance with the instructions given in this manual,
then the user shall be ineligible for any type of unpaid services.
Lutronic Corporation customers are strongly advised to be fully
aware of all the details of this manual.
In any case, Lutronic Corporation reserves all rights and
responsibilities for judging the nature of damages to the
product and the possible causes for such damages. Such
judgment made by Lutronic Corporation shall be deemed to be
finalized and cannot be overridden.
8.3 Exclusion to unpaid service within the period of the

warranty
If the operational procedures and cautionary items specified in this manual
are not properly followed, altered, or neglected in any manner, the
purchaser will not be eligible for unpaid services. Please pay close attention
to the items below while using the system.
If the handpiece is pulled with excessive force so as to move the

system and results in damages to the articulated arm or the main
body, the system is then no longer eligible for unpaid services
covered by this letter of warranty.
If the system is used, modified or disassembled for purposes other

than those initially intended, then the user forfeits coverage by
warranty and is ineligible for any unpaid services under warranty.
Replacement or repair of consumable parts, such as the handpiece

window, flash lamp, DI filter, [Optional] SD585 and SD650, are
not covered under the terms of the warranty.
The accessories provided for convenience of use, not belongs to the

system.
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SPECTRA
Chapter 8. Warranty
8.4. Consumable Items Not Covered Under the 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.
Practice name: ___________________________
Physician : ____________________________
Address:
_____________________________________________________________
Tel: ________________________ Fax: _________________________
E-mail: _____________________________
Model: __________________
Serial No.: ____________________
Date of purchase: ________________
Expiration Date of Warranty: ____________________
Sales Agent: ______________________ Tel. : ____________________
Date of installation: ______________________
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
Revision 1.3 / 4100124013 Ch8-4/4

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Manual de Operador Spectra PDF

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SPECTRA

Technology for Beauty and Health

Revision 1.3 /4100124013 1/9

Copyright  2012 Lutronic Corporation. All rights reserved.

Use of this manual

This manual is designed so that users of SPECTRA laser system may

As the recommended treatment values for each symptom and/or effects

Revision 1.3 /4100124013 2/9

Revision 1.3 /4100124013 3/9

Chapter 2. Safety Precautions

Revision 1.3 /4100124013 4/9

2.9.11 Grounding Label 17/18

Chapter 3. System Description

Revision 1.3 /4100124013 5/9

5.4 Memory 13/20

Chapter 6. Maintenance & Management

Chapter 7. Clinical Guidance

Revision 1.3 /4100124013 6/9

Revision 1.3 /4100124013 7/9

Figure 2.1 Warning Sign for Laser-Beam Radiation 3/18

Figure 3.1 Main Components of SPECTRA Laser System 3/7

Figure 4.1 Dimensions of the SPECTRA Laser System 2/9

Revision 1.3 /4100124013 8/9

Figure 5.1 Control Panel of SPECTRA Laser System 1/20

Figure 6.1 Separated Handpiece 2/12

Revision 1.3 /4100124013 9/9

1.1 Introduction to the system

LCD Touch Screen is applied to the control panel so that users

The pulsed beam is directed to the treatment zone by means of an

SPECTRA is the medical laser system which should perform for

The SPECTRA Laser System is indicated for use in surgical

Revision 1.3 /4100124013 Ch1-1/3

1.2 Symbols used in this manual and the device

Revision 1.3 /4100124013 Ch1-2/3

This symbol indicates that this product adopts

Authorized representative in the European

The use of mobile telephones or similar

Revision 1.3 /4100124013 Ch1-3/3

Chapter 2. Safety Precautions

All persons involved in the SPECTRA laser system operation (e.g.

The SPECTRA laser system is designed to ensure optimal safety for

1. This system utilizes a slow-blow fuse at 125V/25A or 250V/15A

2. Upon successfully starting the system, by turning the key switch

3. The system automatically runs in a supervisory mode, continuously

5. The SPECTRA laser system automatically detects the spot size of

Revision 1.3 /4100124013 Ch2-1/18

7. A remote interlock device will halt the system’s operation when no

Revision 1.3 /4100124013 Ch2-2/18

2.2 Safety for Treatment Room

1. All warning signs should be attached to the door of the treatment

Figure 2.1 Warning Sign for Laser-Beam Radiation

2. Access to the treatment room should be restricted to personnel

3. All present during a procedure should be fully aware of the

4. No hazardous reflective objects (i.e. mirrors), should be allowed in

5. All present during a procedure must wear safety goggles. Safety

6. Common power supply must be AC100~120V or AC220~230V in

Revision 1.3 /4100124013 Ch2-3/18

Figure 2.2 Laser Safety Goggles

Revision 1.3 /4100124013 Ch2-4/18

2.3 General Precautions for Users, Staff and Patients

2.3.1Precautionary Items for the Handpiece Prior to the Procedure

2.3.2 Precautionary Items for Transporting the System in the

The system is designed in such a way that its center of mass is