Manual de Operador Spectra

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.

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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.

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Lutronic Inc.

Tel: 888-588-7644

850 Auburn Court Fremont, CA 94538

E-mail: [email protected]

USA Obelis s.a

Tel: + (32) 2. 732.59.54

Bd. Général Wahis 53 1030 Brussels, BELGIUM

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, gu,

Tel: +82-31-908-3440 Fax: +82-31-907-3440 Ilsandong- Web site: www.lutronic.com E-mail: [email protected]

Goyang-si, Gyeonggi-do, Korea

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Table of Contents Chapter 1. Overview 1.1 Introduction to the system 1.2 Symbols used in this manual and the device

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Chapter 2. Safety Precautions 2.1 Overview

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2.2 Safety for the treatment room

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2.3 General Precautions for operators, staff members and patients

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2.3.1 Precautionary items for the handpiece prior to procedure

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2.3.2 Precautionary items for moving the device in the treatment

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room 2.3.3 Caution for replacing the handpiece tip

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2.4 Cautions regarding Electrical Hazards

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2.5 Protecting the eyes

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2.6 Precautions against Fire Hazards

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2.7 Safety system for the SPECTRA Laser System

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2.7.1 Key switch

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2.7.2 Emergency Stop Button

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2.7.3 Warning sound and signal of the laser radiation

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2.7.4 Remote interlock

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2.7.5 Door interlock

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2.8 Main International standards Applied to SPECTRA Laser System

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2.9 Safety labels for SPECTRA Laser System

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2.9.1 Caution Label of Emergency Stop 2.9.2 Caution Label for Hanpiece Cable Insertion 2.9.3 Caution Label for Refilling Cooling Water 2.9.4 Warning Label of Hanger Use 2.9.5 Danger Label of Laser Radiation Path 2.9.6 Warning Label against Electrical Shock 2.9.7 Danger Label regarding Exposure to Laser 2.9.8 Danger Label regarding Laser Radiation Output 2.9.9 Remote Interlock Label 2.9.10 Footswtich Label

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2.9.11 Grounding Label 2.9.12 Power Cable Label

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2.9.13 Name Plate Label

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Chapter 3. System Description 3.1 Overview

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3.2 System Specifications

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3.3 Components of the SPECTRA Laser System

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3.3.1 System Main Body

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3.3.2 Articulated arm & Handpiece

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3.3.3 Footswitch & System Inlet

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3.4 System Software

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Chapter 4. Installation 4.1 Overview

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4.2 Installation Component List

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4.3 Conditions for Installation

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4.3.1 Space Requirements

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4.3.2 Electrical Requirements

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4.3.3 Environmental Requirements

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4.4 Installation of the Device

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4.4.1 STEP 1 : Connecting the Handpiece

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4.4.2 STEP 2 : Connecting the Accessories

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4.4.3 STEP 3 : Final Check-up and Fixing the Device

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4.4.4 STEP 4 : Supplying Main Power

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4.5 Moving the Device

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4.5.1 Moving the Device in the Treatment Room

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4.5.2 Moving the Device to a Remote Location

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Chapter 5. Operation 5.1 Overview

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5.2 Checking of the Caution and Inspection Items

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5.3 Operation of the SPECTRA Laser System

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5.3.1 STEP 1 : Turning on the System

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5.3.2 STEP 2 : Operation Mode

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5.3.3 Use of Handpiece

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5.4 Memory

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5.4.1 Saving

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5.4.2 Recalling a memory

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5.5 Setup

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5.5.1 Checking Shot Count

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5.5.2 Adjusting Sound Volume of GUI

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5.5.3 [Optional]Calibration

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5.6 Turning off the System

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5.6.1 Normal Turn-Off

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5.6.2 Emergency Turn-off

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Chapter 6. Maintenance & Management 6.1 Overview

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6.2 Cleaning the System Main Body

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6.3 Cleaning Handpiece

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6.3.1 Cleaning Normal Hanpdiece

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6.3.2 Cleaning Dye Handpiece

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6.4 Keeping the Articulated Arm

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6.5 Refilling Cooling(Distilled) Water

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6.5.1 Cooling water indicator

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6.5.2 How to refill cooling water

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6.6 Troubleshooting

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6.6.1 When the device fails to turn ON.

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6.6.2 When the device is powered on but no laser fails to be radiated.

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6.6.3 When the laser beam radiates with insufficient output power.

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6.7 Status Message

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6.8 Request for Periodic A/S

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Chapter 7. Clinical Guidance 7.1 Overview

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7.2 Education and Training 7.3 Consultation 7.4 Contraindications

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Chapter 8. Warranty 8.1 Overview

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8.2 Unpaid Services

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8.3 Exclusion to unpaid service within the period of the warranty

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8.4 Consumable Items Not Covered Under the Warranty

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List of Figures Figure 2.1 Warning Sign for Laser-Beam Radiation

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Figure 2.2 Laser Protective Goggles for the Physician (A) / for the Patient(B) Figure 2.3 Position of Key Switch

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Figure 2.4 Emergency Stop Button Figure 2.5 Remote Interlock

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Figure 2.6 Locations of Labels on the Front Figure 2.7 Caution Label of Emergency Stop

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Figure 2.8 Caution Label for Hanpiece Cable Insertion

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Figure 2.9 Caution Label for Refilling Cooling Water Figure 2.10 Warning Label of Hanger Use Figure 2.11 Danger Label of Laser Radiation Path

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Figure 2.12 Warning Label of Electrical Shock Figure 2.13 Danger Label of Exposure to Laser Figure 2.14 Danger Label of Laser Radiation Output Figure 2.15 Remote Interlock Label Figure 2.16 Foot switch Label Figure 2.17 Grounding Label Figure 2.18 Power Cable Label Figure 2.19 Name Plate Label Figure 2.20 Locations of Labels on the Back

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Figure 3.1 Main Components of SPECTRA Laser System Figure 3.2 Articulated Arm and Handpieces Figure 3.3 Foot Switch and System Inlet

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Figure 4.1 Dimensions of the SPECTRA Laser System Figure 4.2 Connecting the handpiece to the articulated arm Figure 4.3 Connecting the articulated arm cable connector and the handpiece cable connector Figure 4.4 Connecting the cable of the articulated arm Figure 4.5 Connected System Inlet

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Figure 5.1 Control Panel of SPECTRA Laser System Figure 5.2 Pressing OK button Figure 5.3 Control Panel for Normal Hanpdiec Figure 5.4 Control Panel for Dye Handpiece Figure 5.5 Control Panel for Fractional Handpiece Figure 5.6 Automatic Spot Size Setup Figure 5.7 Setting the spot size on the handpiece Figure 5.8 Contacting the Handpiece with Skin

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Figure 5.9 Setting Parameter to Save Figure 5.10 Choosing a Memory to Save

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Figure 5.11 Entering a Memory Name

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Figure 5.12 Memory Completed to Save Figure 5.13 Memory Recalled Screen Figure 5.14 Setup Mode

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Figure 5.15 Condition of the Articulated Arm for Calibration Figure 5.16 Ready Screen for Calibration Figure 5.17 Start Screen for Calibration Figure 5.18 Calibration Progress Screen Figure 5.19 Turning off the Key Switch

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Figure 6.1 Separated Handpiece Figure 6.2 Cleaning the window and tip of handpiece Figure 6.3 Separated Dye Handpiece Figure 6.4 Cleaning the window and tip of Dye handpiece Figure 6.5 Fixing the tube of the articulated arm Figure 6.6 Fixing the end of the articulated arm Figure 6.7 Separating the water level window Figure 6.8 Disconnecting the indicator tube Figure 6.9 Inserting the funnel and the tube into the tank Figure 6.10 Pouring distilled water into the funnel Figure 6.11 Connecting the indicator tube to the tank Figure 6.12 Status Message for Code: E01

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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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Chapter 1. Overview

1.2 Symbols used in this manual and the device Symbols

WARNING

CAUTION

IMPORTANT

Descriptions This symbol indicates a state of potential danger or an emergency situation whereby the device itself may be severely damaged, or users, patients and staff members may be exposed to electrical injury resulting in electrical shock or burn injuries, or potentially hazardous exposure to the radiation of the laser beam. This symbol indicates that caution should be applied to prevent a state of potential danger or an emergency situation whereby the device itself may be severely damaged, or users, patients and staff members may be exposed to electrical injury resulting in electrical shock or burn injuries, or potentially hazardous exposure to the radiation of the laser beam. This symbol indicates that, prior to any procedure with the SPECTTRA system; the operator should thoroughly check any special circumstances regarding the patient’s condition before treatment, including their medical history, to ensure the optimum clinical results. This symbol indicates that the product specifications comply with Class B of the Protective Regulations for electrical shocks (IEC 417 / 878-02-02). This symbol indicates that the operational voltage of this product exceeds the danger limits set out in the Protective Regulations regarding Electrical Shocks (IEC 417 /87803-01). This symbol indicates that the POWER is OFF, which complies with the Protective Regulations regarding electrical shocks (IEC 417 / 5008). This symbol indicates that the POWER is ON and is in compliance with the Protective Regulations regarding electrical shocks (IEC 417 / 5007).

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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.

NOTE Ref.

This symbol indicates important instructional items and information to be noted to achieve optimal use of this device. 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.

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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Chapter 2. Safety Precautions

Chapter 2. Safety Precautions 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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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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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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A

L-702YGII

L-702HE

B

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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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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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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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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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.

(2)ON

(1)OFF Key Switch OFF Status: Power is shut off.

Key Switch ON 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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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

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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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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/ Regulation

Title

Ratification

93/42/EEC As amended Medical Device Directive by 2007/47/EC Medical electrical equipment – Part 1-6 EN 60601-1-6 General requirements for basic safety and IEC 60601-1-6 essential performance EN 60601-1 IEC 60601-1

Medical electrical equipment Part 1: General requirements for safety

Medical electrical equipment EN 60601-1-4 Part 1-4: General requirements for safety IEC 60601-1-4 - Collateral Standard: Programmable electrical Medical systems Medical electrical equipment – Part 2: Particular requirements for the safety of

IEC 60601-2diagnostic and therapeutic laser equipment 22 EN 60825-1 IEC 60825-1

EN 980

Safety of laser products Part 1: Equipment classification,

1990;A1;1993;A 2;1995; A13;1996

2007

1996;A1;1999 2000

1996 1995

2007

requirements and user's guide Graphical symbols for use in the labeling of Medical devices

EN ISO 14971 Medical devices - Application of risk ISO 14971 management to medical devices

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Collateral Standard: Usability

Medical electrical equipment EN 60601-1-2 Part1-2: General requirements for safety IEC 60601-1-2 –Collateral standard: Electromagnetic compatibility - Requirements and Tests

EN 60601-222

2007

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EN 62304

Medical device software-Software life cycle processes

2006

21CFR/FDA

US Federal Performance Standards 21CFR 1040.10 and 1040.11 for Class IV Laser Product

_

EN1041

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Information Supplied by the manufacturer of medical devices

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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

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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

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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

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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

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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

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Chapter 3. System Description

Chapter 3. System Description 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 1064 mode (Q-switched mode) 532 mode(Q-switched mode) Pulse Energy Spectra mode(1064nm)

Articulated arm

Pulse Duration

Pulse Rate

Classifications

Handpiece

[Optional] Handpiece

Max. 1200mJ Max. 400mJ Max. 1500mJ

585 mode

Max. 250mJ

650 mode Q-switched mode 1064, Spectra mode

Max. 150mJ 5 ~ 10ns S1, 1, 2, 5, 10(Hz)

532 mode

S1, 1, 2, 5, 8, 10(Hz)

585 mode

S1, 1, 2, 5(Hz)

650 mode

S1, 1, 2(Hz)

CDRH Class

Class IV

MDD Class

Class IIb

Applied Part Class

B

FDA Class

Class II

Zoom

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

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

7mm(1064nm)/6mm(532nm)

532 Handpiece

1.7 mm

Fractional Handpiece

6 x 6 (mm)

3~7mm-Zoom-Collimated 3~7mm(1064nm)/2.6~6mm(532nm)

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2mm-SD585

2mm

5mm-SD585

5mm

2mm-SD650

2mm

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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 (Fuse 125V/25A or 250V/15A) 50/60Hz, Power consumption: 1.7kVA

Electrical rating

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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 Main Body

Key switch

Foot Switch

Emergency stop Button

Caster

Figure 3.1 Main Components of SPECTRA Laser System

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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

System Control Module

Power Supply

Laser Module

Control Panel

Handle and Casters

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Functions This includes the key switch and the emergency stop button which controls the overall operation of the entire system. The control module receives input signals from other modules and sends output signals to execute the proper operation of the system. Converts the commonly-used power supply (AC100~120V or AC220~230V) to the level of electric power that the device requires and provides it for each module. Generates the laser beam of a wavelength of the 1064 nm and 532 nm. Displays information of the current status and the value of each parameter. The function of each button is explained in detail in Chapter 5. The four casters may move in all four directions. The handle may be used to easily move and direct the casters. The front two casters additionally have locking devices to allow the operator to station the device firmly and safely in a fixed position.

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3.3.2 Handpiece & Articulated arm 8mm-Zoom-Collimated (3-8mm/2.6-6.9mm)

Articulated Arm

Handpiece 7mm-Zoom-Collimated (3-7mm/2.6-6mm)

Zoom handpiece 2mm-SD585(585nm)

Collimated handpiece 2mm-SD650(650nm)

Fractional handpiece

532 handpiece

5mm-SD585 handpiece

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.

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3.3.3 Footswitch and System Inlet Remote interlock socket

Main Power Switch

External Ground

Power Cord Foot Switch 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.

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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.

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Chapter 4. Installation

Chapter 4. Installation 4.1 Overview Chapter 4 describes the installation method for SPECTRA laser system as well as the optimal environment for using this device. Only persons authorized or trained by Lutronic Corporation may move or install the device.

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


1 unit


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

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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

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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.

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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.

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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

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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.

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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.

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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.

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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.

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Chapter 5. Operation

Chapter 5. Operation 5.1 Overview This chapter contains detailed operating instructions, cautions and warning items for the SPECTRA laser system. The control panel allows the user to set optimum parameters of the treatment beam. The control panel also displays useful information about the system during operation. While the system is operating, functions are continuously monitored by a micro-controller and displayed to the operator. Please refer to Figure 5.1 for the following information.

1 2 5

4

3 8

7

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.

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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.

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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 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 (2mmSD585/5mm-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

532nm

Green laser radiation at 532nm in Q-switch. The energy peak is high and the energy density is high.

1064nm

Laser radiation at 1064nm. The energy peak is lower than that of Q-switch 1064nm. Thus, the energy intensity is much lower than that of Qswitch mode for the same duration.

Spectra

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585 [Optional]

650 [Optional]

585nm

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

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. 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.

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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.

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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

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5.3.2 STEP 2: Operation Mode Operating with Normal Handpiece

1 2 4

3 8

7

5

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.

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NOTE When restarting the system, the control panel recalls and displays the most resent used parameters. [Optional]Operating with Dye Handpiece

1 2 4

5

3 7

8

6

10

9 Figure 5.4 Control Panel for Dye Handpiece 1. Make sure that a dye handpiece is connected to the articulated arm firmly, and that its cable is inserted into the related port of the articulated arm correctly as well. 2. Once the cable is connected correctly, the system recognizes and the control panel displays the Wavelength indicator for the dye handpiece. The button is illuminated. (see 6) 3. Set Pulse Rate by pressing its button 2. And regarding spot size, it is fixed 2mm which is the only one available. 4. Set Fluence by pressing its buttons 4. 5. Press the Standby button, and in 5 seconds, contact the handpiece tip on the treatment area and depress the footswitch. Laser beam emission will begin.

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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.

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[Optional]Operating with Fractional Handpiece

1 2 4

5

3 8

7

10

6 9 Figure 5.5 Control Panel for Fractional Handpiece 1. Make sure that a fractional handpiece is connected to the articulated arm firmly. Press the Spot Size button 3 to set 6 mm spot size for the fractional handpiece. 2. Press the Pulse Rate button 2 to set the speed of laser radiation. 3. Press the 1064 Wavelength indicator 6 to set wavelength of laser radiation for the treatment area. 4. Press the Fluence button 4(▲,▼) to set the energy of laser beam to the per unit area. 6. Press the Standby button, and in 5 seconds, contact the handpiece tip on the treatment area and depress the footswitch. Laser beam emission will begin. 5. Press the Aiming Beam button 5 to set the brightness of aiming beam in “Ready” status.

NOTE Please refer to the physician’s clinical guide to set optimal parameters.

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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 parentheses are the spot sizes at 532nm.

1

1 2

1.

To adjust the spot size of the handpieces, hold the regulator and Figure 5.7 Setting the spot size on the handpiece 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.

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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.

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5.4 Memory This function is to set parameters and save it in a memory. It allows users to easily recall a memory without setting parameters every treatment.

5.4.1 Saving 1. Enter Memory mode by pressing Memory button located at bottom of the screen as shown in Figure 5.9. 2. Activate the parameter setting section by pressing Modify button Parameter located at bottom of the screen. Setting Section

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.

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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

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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

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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.

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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 shown in Figure 5.15.

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.

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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 shown in Figure 5.18.

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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

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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.

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Chapter 6. Maintenance & Management

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.

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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.

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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.

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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.

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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

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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.

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Upper

Lower Figure 6.8 Disconnecting the indicator tube 5. As shown in Figure 6.9, insert the extra tube provide with the funnel into the upper inlet, and then, insert the nipple of the funnel into the lower inlet.

Figure 6.9 Inserting the funnel and the tube into the tank 6. Hold up the funnel and pour the distilled water into the funnel. At this time, while the distilled water flows into the tank, the air inside the tank comes out through the upper tube. If the distilled water does not flow smoothly into the tank, hold up the funnel higher.

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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.

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6.6 Troubleshooting 6.6.1 When the device fails to turn ON. Check whether the power cord is correctly inserted into the main power outlet. Check whether the main power switch is flipped to the ON (I) position. Check the condition of the fuse inside the device.

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.

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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 Code CODE 01

CODE 02 CODE 03 CODE 04

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Possible Cause for Actions to Take Errors Turn off the device and restore Emergency Error the emergency switch. Restart the device. Turn off the device, wait 2 Main Shutter Error minutes before restarting the device. Refill cooling water according to Water Flow Error the instruction. (Ref. 6.5) Turn off the device, wait 2 Door Open minutes before restarting the device.

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CODE 05

CODE 06

CODE 07

CODE 08

CODE 09

CODE 10

CODE 11

CODE 12

CODE 24

CODE 30

CODE 32 CODE 33 CODE 34

CODE 36

CODE 37

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Turn off the device, wait 2 minutes before restarting the device. Turn off the device, wait 2 KTP Insert Fail minutes before restarting the device. Turn off the device, wait 2 SPECTRA Insert Fail minutes before restarting the device. Turn off the device, wait 2 SPECTRA Open Fail minutes before restarting the device. Turn off the device, wait 2 Concave Insert Fail minutes before restarting the device. Turn off the device, wait 2 Concave Open Fail minutes before restarting the device. Turn off the device, wait 2 Attenuator Insert minutes before restarting the Fail device. Turn off the device, wait 2 Attenuator Open minutes before restarting the Fail device. Possible to use the device temporarily, but the device is un Energy Setup stable and it is very required to Error contact your local Lutronic distributor for inspection and use it. Turn off the device, wait 2 Power Module minutes before restarting the Error device. Turn off the device, wait 2 AC Contactor Error minutes before restarting the device. Refill cooling water according to Water Level Error the instruction. (Ref. 6.5) Turn off the device, wait 2 Interlock Switch minutes before restarting the Off device. Turn off the device, wait 2 Simmer Error minutes before restarting the device. Contact your local Lutronic Water Temp. Error distributor for inspection and use it.

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DANGER If CODE 24 occurred, the actual fluence can be lower or a bit higher than the parameter set on the control panel. The operator may continue to use the machine temporary, but must contact the Lutronic corporation customer service department for stable use.

CAUTION The operator is advised to take proper actions for the nature of each message code. If the error persists after taking proper action, contact your authorized Lutronic distributor or Lutronic Corporation for assistance. If a person not formally authorized by Lutronic Corporation opens the cover of the device or takes any improper actions, the warranty will be voided. Fatal damage to the device severe physical injury may occur.

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.

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Chapter 7. Clinical Guidance

Chapter 7. Clinical Guidance 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.

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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 [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 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

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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

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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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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

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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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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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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: [email protected]

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