Manual de Operador Spectra

8/21/2019 Manual de Operador Spectra

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SPECTRA Technology for Beauty and Health

Revision 1.3 /4100124013 1/9

SPECTRA Dual Pulsed Nd:YAG Laser

Operator’s Manual

CAUTION : Users must read this manual carefully and thoroughly before using

this product.

0434




Revision 1.3 /4100124013 2/9

Copyright ©©©© 2012 Lutronic Corporation. All rights reserved.

No part of this manual may be re-manufactured or copied in any form without thewritten 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 3/9

Lutronic Inc.

850 Auburn CourtFremont, CA 94538

USA

Tel: 888-588-7644

E-mail:

[email protected]

Obelis s.a

Bd. Général Wahis 53

1030 Brussels, BELGIUM

Tel: + (32) 2. 732.59.54

Fax: + (32) 2.732.60.03

E-Mail : [email protected]

Lutronic Corporation

Room 403-1, 2, 3, 4, 5, 404

Ilsan Technotown 1141-1

Baekseok-dong, Ilsandong-

gu,

Goyang-si, Gyeonggi-do,

Korea

Tel: +82-31-908-3440

Fax: +82-31-907-3440

Web site: www.lutronic.com

E-mail: [email protected]




Revision 1.3 /4100124013 4/9

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

room

5/18

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




Revision 1.3 /4100124013 5/9

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




Revision 1.3 /4100124013 6/9

5.4 Memory 13/20

5.4.1 Saving 13/20

5.4.2 Recalling a memory 15/205.5 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




Revision 1.3 /4100124013 7/9

Chapter 8. Warranty

8.1 Overview 1/4

8.2 Unpaid Services 1/48.3 Exclusion to unpaid service within the period of the warranty 2/4

8.4 Consumable Items Not Covered Under the Warranty 3/4




Revision 1.3 /4100124013 8/9

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

cable connector

5/9

Figure 4.4 Connecting the cable of the articulated arm 6/9

Figure 4.5 Connected System Inlet 7/9




Revision 1.3 /4100124013 9/9

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 7/20Figure 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



SPECTRA Chapter 1. Overview

Revision 1.3 /4100124013 Ch1-1/3

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 surgicalapplications 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.




Revision 1.3 /4100124013 Ch1-2/3

1.2 Symbols used in this manual and the device

Symbols Descriptions

WARNING

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.

CAUTION

This symbol indicates that caution should be

applied to prevent a state of potential danger

or an emergency situation whereby the deviceitself 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.

IMPORTANT

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

medical history, to ensure the optimumclinical 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).




Revision 1.3 /4100124013 Ch1-3/3

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 productcomplies 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.

NOTE

This symbol indicates important instructional

items and information to be noted to achieveoptimal use of this device.

Ref.Indicates where more information relevant to

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.

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.

WARNING



SPECTRA Chapter 2. Safety Precautions

Revision 1.3 /4100124013 Ch2-1/18

Chapter 2. Safety Precautions

2.1 OverviewThis 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 isemployed 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.




Revision 1.3 /4100124013 Ch2-2/18

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.

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.

DANGER




Revision 1.3 /4100124013 Ch2-3/18

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 personnelessential 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.




Revision 1.3 /4100124013 Ch2-4/18

Figure 2.2 Laser Safety Goggles

for the Physician (A) / for the Patient(B)

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 tothe eyes. Even with safety goggles are worn, all users are

cautioned against the inherent risk of dealing with laser

devices.

DANGER

A BL-702YGII L-702HE




Revision 1.3 /4100124013 Ch2-5/18

2.3 General Precautions for Users, Staff and Patients

2.3.1 Precautionary 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.




Revision 1.3 /4100124013 Ch2-6/18

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.

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.

WARNING




Revision 1.3 /4100124013 Ch2-7/18

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 surgicaltools. 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.

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 safetygoggles 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.

DANGER




Revision 1.3 /4100124013 Ch2-8/18

2.6 Precautions against Fire Hazards

Laser may ignite most non-metallic objects.

Various types of covers and gowns commonly used in proceduresshould 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.

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.

One should never direct the rays of a laser beam at any target

other than skin. This may lead to ignition of the object.

DANGER

WARNING




Revision 1.3 /4100124013 Ch2-9/18

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 theOFF position to the ON position, and vice versa.

Figure 2.3 Position of Key Switch

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.

CAUTION

(1)OFFKey Switch OFF

Status: Power is shut off.Key Switch ON

Status: Power is on.

(2)ON




Revision 1.3 /4100124013 Ch2-10/18

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

the 0 position which power is shut off and

then follow the normal startup procedure.

Figure 2.4. Emergency

stop button

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




Revision 1.3 /4100124013 Ch2-11/18

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.




Revision 1.3 /4100124013 Ch2-12/18

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/

RegulationTitle Ratification

93/42/EEC

As amended

by 2007/47/EC

Medical Device Directive 2007

EN 60601-1-6

IEC 60601-1-6

Medical electrical equipment – Part 1-6

General requirements for basic safety and

essential performance

- Collateral Standard: Usability

2007

2006

EN 60601-1

IEC 60601-1

Medical electrical equipment

Part 1: General requirements for safety

1990;A1;1993;A

2;1995;

A13;1996

EN 60601-1-2

IEC 60601-1-2


Part1-2: General requirements for safety

–Collateral standard: Electromagnetic

compatibility - Requirements and Tests

2007

EN 60601-1-4

IEC 60601-1-4


Part 1-4: General requirements for safety

- Collateral Standard: Programmable electrical

Medical systems

1996;A1;1999

2000

EN 60601-2-

22

IEC 60601-2-

22

Medical electrical equipment –

Part 2: Particular requirements for the safety of

diagnostic and therapeutic laser equipment

1996

1995

EN 60825-1

IEC 60825-1

Safety of laser products

Part 1: Equipment classification,

requirements and user's guide

2007

EN 980Graphical symbols for use in the labeling of

Medical devices2008

EN ISO 14971

ISO 14971

Medical devices - Application of risk

management to medical devices

2009

2007




Revision 1.3 /4100124013 Ch2-13/18

EN 62304Medical device software-Software life cycle

processes2006

21CFR/FDAUS Federal Performance Standards 21CFR1040.10 and 1040.11 for Class IV Laser

Product

_

EN1041Information Supplied by the manufacturer of

medical devices2008




Revision 1.3 /4100124013 Ch2-14/18

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.

Physicians and staff should be fully aware of the locations and the meaning

of all the safety labels attached to the system.

Figure 2.6 Locations of Labels on the Front

2.9.1 Caution Label of Emergency StopThe 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

CAUTION

Side




Revision 1.3 /4100124013 Ch2-15/18

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 Ch2-16/18

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 Ch2-17/18

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

2.9.10 Footswitch Label

This label indicates that laser emission is performed only if the footswitch is

depressed.

Figure 2.16 Footswitch Label

2.9.11 Grounding LabelThis 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 Ch2-18/18

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



SPECTRA Chapter 3. System Description

Revision 1.3 / 4100124013 Ch3-1/7

Chapter 3. System Description

3.1 OverviewThis 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

Pulse Energy

1064 mode (Q-switched

mode)Max. 1200mJ

532 mode(Q-switched

mode)Max. 400mJ

Spectra mode(1064nm) Max. 1500mJ

585 mode Max. 250mJ

650 mode Max. 150mJ

Pulse Duration Q-switched mode 5 ~ 10ns

Pulse Rate

1064, Spectra mode 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)

Classifications

CDRH Class Class IV

MDD Class Class IIb

Applied Part Class B

FDA Class Class II

HandpieceZoom 1~5mm(1064nm)/0.8~4.3mm(532nm)

3~8mm-Zoom-Collimated ~8mm(1064nm)/2.6~6.9mm(532nm)

[Optional]

Handpiece

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




Revision 1.3 / 4100124013 Ch3-2/7

Cooling System Air + Water Cooling

Laser transfer method Articulated arm

Protective Eyewear Optical Density >5 at 1064, 532, 650, 585nm

Display System Touch LCD

Electrical rating

Single phase

AC100~120V or AC220~230V

(Fuse 125V/25A or 250V/15A)

50/60Hz,

Power consumption: 1.7kVA




Revision 1.3 / 4100124013 Ch3-3/7

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

Figure 3.1 Main Components of SPECTRA Laser System

Handpiece

Caster

System

Main Body

Emergency stop

Button

Key switch

Handle

Control Panel

Articulated arm

Calibration Port

Foot

Switch




Revision 1.3 / 4100124013 Ch3-4/7

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

System Control

Module

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.

Power Supply

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.

Laser ModuleGenerates the laser beam of a wavelength of

the 1064 nm and 532 nm.

Control Panel

Displays information of the current status and

the value of each parameter. The function of

each button is explained in detail in Chapter 5.

Handle and Casters

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.




Revision 1.3 / 4100124013 Ch3-5/7

3.3.2 Handpiece & Articulated arm

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. 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 655nmwavelength 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.

Articulated Arm

2mm-SD585(585nm)

2mm-SD650(650nm)

Collimated hand iece

Zoom hand iece

8mm-Zoom-Collimated

(3-8mm/2.6-6.9mm)

Handpiece

7mm-Zoom-Collimated

3-7mm/2.6-6mm

5mm-SD585 hand iece

Fractional handpiece

532 hand iece




Revision 1.3 / 4100124013 Ch3-6/7

3.3.3 Footswitch and System Inlet

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.

When moving the SPECTRA laser system, the foot switch mustbe detached from the device. This will prevent severe damage

to the connector or disconnection from the wiring in the foot

switch.

CAUTION

Foot Switch

Socket

External

Ground

Remote interlock socketMain Power

Switch

Power Cord




Revision 1.3 / 4100124013 Ch3-7/7

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.



SPECTRA Chapter 4. Installation

Revision 1.3 /4100124013 Ch4-1/9

4.1 OverviewChapter 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)

8mm-Zoom-collimated handpiece

[Optional] 7mm-Zoom-collimated handpiece

[Optional] Zoom handpiece

[Optional] Collimated handpiece

[Optional] 2mm-SD585



[Optional] Fractional handpiece

[Optional] 532 handpiece

System key

Footswitch

Remote interlock

Laser radiation warning sign (For the treatment room)

Laser protection goggles for operator

Laser protection goggles for patient

Operator’s manual

Funnel & Tube (For refilling cooling water)

1 unit

1 unit

1 unit

1 unit

1 unit

1 unit1 unit

1 unit

1 unit

1 unit

2 units

1 unit

1 unit

1 unit

2 units

1 unit

1 vol

1 set

Chapter 4. Installation




Revision 1.3 /4100124013 Ch4-2/9

4.3 Conditions for Installation

4.3.1 Space Requirements

The entire area of the device is shown in Figure 4.1. To maintain optimalefficiency, 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 ornext to another medical device, or any other device that generates

heat.

Figure 4.1 Dimensions of SPECTRA Laser System

1700mm

656mm

295mm

840mm




Revision 1.3 /4100124013 Ch4-3/9

4.3.2 Electrical Requirements

Electric power supplied to SPECTRA laser system should satisfy the

following requirements in order to maintain optimal efficiency andelectrical 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.

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.

WARNING




Revision 1.3 /4100124013 Ch4-4/9

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 Ch4-5/9

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

Figure 4.3 Connecting the articulated arm cable connector and the

handpiece cable connector

Handpiece cable connector Articulated arm

cable connector




Revision 1.3 /4100124013 Ch4-6/9

In case of connection and disconnection of the handpiececable, 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

Because the cable socket on top of the device may getdamaged, Never put excessive strength to the connector

socket.

CAUTION

CAUTION




Revision 1.3 /4100124013 Ch4-7/9

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 theremote 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.

Figure 4.5 Connected System Inlet

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.

Remote

Interlock

FootswitchSocket

NOTE




Revision 1.3 /4100124013 Ch4-/9

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.)

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.

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.

CAUTION

CAUTION




Revision 1.3 /4100124013 Ch4-9/9

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” andreinstall 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.

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.

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.

CAUTION

WARNING



SPECTRA Chapter 5. Operation

Revision 1.3 / 4100124013 Ch5-1/20

5.1 OverviewThis 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.

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.

Chapter 5. Operation

3

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Revision 1.3 / 4100124013 Ch5-2/20

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 SingleShot (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

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

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 Ch5-3/20

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 anddown 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.

Otional 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

1064 1064nm

Laser radiation at 1064nm in Q-switch. The pulse

width is 5ns~10ns and the energy peak is higher

than that of Spectra Mode. Thus, the energy

intensity is much higher than that of Spectra Mode

for the same duration.

532 532nmGreen laser radiation at 532nm in Q-switch. The

energy peak is high and the energy density is high.

Spectra 1064nm

Laser radiation at 1064nm. The energy peak is

lower than that of Q-switch 1064nm. Thus, theenergy intensity is much lower than that of Q-

switch mode for the same duration.




Revision 1.3 / 4100124013 Ch5-4/20

585

[Optional]585nm

585nm laser radiation derived from the 532nm

source laser and solid-dye pumping of the

SD585nm dye handpiece.

650

[Optional]650nm

650nm laser radiation derived from the 532nm

source laser and solid-dye pumping of the

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. ToningThis 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. StatusThis 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 Ch5-5/20

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?

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.

DANGER




Revision 1.3 / 4100124013 Ch5-6/20

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.

If the main power switch has been off within 10 minutes, youmay 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

CAUTION




Revision 1.3 / 4100124013 Ch5-7/20

5.3.2 STEP 2: Operation Mode

Operating with Normal Handpiece

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 outinitial 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.

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Revision 1.3 / 4100124013 Ch5-8/20

When restarting the system, the control panel recalls and

displays the most resent used parameters.

[Otional]Operating with Dye Handpiece

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.

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Revision 1.3 / 4100124013 Ch5-9/20

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.

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.

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.

DANGER

NOTE

NOTE




Revision 1.3 / 4100124013 Ch5-10/20

[Otional]Operating with Fractional Handpiece

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 aimingbeam in “Ready” status.

Please refer to the physician’s clinical guide to set optimalparameters.

9

34

7

5

6

810

2

1

NOTE




Revision 1.3 / 4100124013 Ch5-11/20

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

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. To adjust the spot size of the

handpieces, hold the regulator and

pull it down as shown in Figure 5.7.

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.

Figure 5.7 Setting the spot

size on the handpiece

1 1

2

NOTE




Revision 1.3 / 4100124013 Ch5-12/20

To use this mode, the operator must make sure its cable isconnected with the port of the articulated arm.

Ue 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.

Figure 5.8 Contacting the Handpiece with Skin

Before using the handpiece during operation, make surethere 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.

CAUTION

NOTE

Correct

Incorrect Incorrect




Revision 1.3 / 4100124013 Ch5-13/20

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.

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.

ParameterSetting Section




Revision 1.3 / 4100124013 Ch5-14/20

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 Ch5-15/20

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 Ch5-16/20

5.5 Setup

5.5.1 Checking Shout Count

1. Enter Setup mode by pressing Setup button at bottom of Operation modescreen.

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 atthe range of 5 ~ 100% by pressing the up & down button(▲▼) next to

Volume window.




Revision 1.3 / 4100124013 Ch5-17/20

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.

2. Before starting calibration on the GUI, connect the articulated arm as


Figure 5.15 Condition of the Articulated Arm for Calibration

3. Enter Setup mode by pressing the setup button at the bottom of the

operation mode screen.

WARNING

If the beam mode is a round shape without any deleted parts,

you may start calibration, otherwise please contact your local

Lutronic distributor.

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.

Calibration

port




Revision 1.3 / 4100124013 Ch5-18/20

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 Ch5-19/20

Figure 5.18 Calibration Progress Screen

During or after the calibration, messages other than “OK” maybe 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

NOTE




Revision 1.3 / 4100124013 Ch5-20/20

5.6 Turning off the System

5.6.1 Normal Turn- Off

1.

Position the handpiece in a safe place and turn the key counterclockwiseback to OFF position.

2. Hang the handpiece on its hook installed on the articulated arm.

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 removethe 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.

OFF



SPECTRA Chapter 6. Maintenance & Management

Revision 1.3 / 4100124013 Ch6-1/12

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.

When inspecting the device first turn off the power and thendisconnect 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.

Do not apply cleansing liquid directly to the system main body

as it may damage, harm or cause the system to malfunction.

Chapter 6. Maintenance& Management

CAUTION

CAUTION




Revision 1.3 / 4100124013 Ch6-2/12

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.

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.

Handpiece tip

Handpiece body




Revision 1.3 / 4100124013 Ch6-3/12

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.

If cleansing protocol fails to eliminate alien substances, then :

Soak a lens paper or cotton swab in ethanol. Allow onedrop of ethanol to fall onto the top of the window and sitfor 3 to 5 seconds.

When the alien substances are thoroughly soaked, use acotton swab to remove the substances.

The handpiece tip should be thoroughly and properlycleaned 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 ofalien substances on its surface, causing damages to the

handpeice’s optical system.

CAUTION

NOTE




Revision 1.3 / 4100124013 Ch6-4/12

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 Ch6-5/12

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 Ch6-6/12

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 mainbody. 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.

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.

Indicatortube

Ball

Proper waterlevel




Revision 1.3 / 4100124013 Ch6-7/12

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.

Upper

Lower




Revision 1.3 / 4100124013 Ch6-8/12

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 Ch6-9/12

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.

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.

CAUTION




Revision 1.3 / 4100124013 Ch6-10/12

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.

Message CodePossible Cause for

ErrorsActions to Take

CODE 01 Emergency Error Turn off the device and restorethe emergency switch. Restart

the device.

CODE 02 Main Shutter Error Turn off the device, wait 2

minutes before restarting the

device.

CODE 03 Water Flow Error Refill cooling water according to

the instruction. (Ref. 6.5)

CODE 04 Door Open Turn off the device, wait 2


device.




Revision 1.3 / 4100124013 Ch6-11/12

CODE 05 KTP Open Fail

Turn off the device, wait 2


device.

CODE 06 KTP Insert Fail


minutes before restarting thedevice.

CODE 07 SPECTRA Insert Fail Turn off the device, wait 2


device.

CODE 08 SPECTRA Open Fail Turn off the device, wait 2


device.

CODE 09 Concave Insert Fail



device.

CODE 10 Concave Open Fail



device.

CODE 11Attenuator Insert

Fail



device.

CODE 12Attenuator Open

Fail



device.

CODE 24Energy Setup

Error

Possible to use the device

temporarily, but the device is unstable and it is very required to

contact your local Lutronic

distributor for inspection and use

it.

CODE 30Power Module

Error



device.

CODE 32 AC Contactor Error



device.

CODE 33 Water Level ErrorRefill cooling water according to

the instruction. (Ref. 6.5)

CODE 34Interlock Switch

Off



device.

CODE 36 Simmer Error



device.

CODE 37 Water Temp. Error

Contact your local Lutronic

distributor for inspection and use

it.




Revision 1.3 / 4100124013 Ch6-12/12

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.

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.

CAUTION

DANGER



SPECTRA


Revision 1.3/4100124013 Ch7-1/4


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.

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, howwell 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.

NOTE



SPECTRA


Revision 1.3/4100124013 Ch7-2/4

7.2 Education and TrainingBefore 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 [email protected]. 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 ConsultationPhysicians 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.



SPECTRA


Revision 1.3/4100124013 Ch7-3/4

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, skintype 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 ContraindicationsFew 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



SPECTRA


Revision 1.3/4100124013 Ch7-4/4

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.

IMPORTANT



SPECTRA Chapter 8. Warranty

Revision 1.3 / 4100124013 Ch8-1/4

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.

In order to maintain the coverage of unpaid services, only

service persons formally authorized by Lutronic should be

hapter 8. Warranty

WARNING




Revision 1.3 / 4100124013 Ch8-2/4

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.




Revision 1.3 / 4100124013 Ch8-3/4

8.4. Consumable Items Not Covered Under the Warranty

• Handpiece window

• Flash lamp

• DI filter

• [Optional] SD585

• [Optional] SD650




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.

L t i C ti

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