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MOSAIC HP

 Technology for Beauty and Health

TM

MOSAIC HP
Fractional Technology

Operator’s Manual

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

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MOSAIC HP
 Technology for Beauty and Health

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 the MOSAIC HP Laser system


may easily understand its characteristics as a medical device, the safety
features of the instrument and the method for its use. In order to use
this instrument properly and safely, users must be fully conversant with
all the details, training and instructions given in this user’s manual.
Users should be trained properly before using this system.

IMPORTANT

Recommended treatment parameters are provided for reference


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 of the product itself as supplied by Lutronic
Corporation.

踊 Lutronic Corporation
June 2012
P/N: 4100110311
Revision 1.1

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MOSAIC HP
 Technology for Beauty and Health

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

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MOSAIC HP
 Technology for Beauty and Health

Table of Contents

Chapter 1. Overview Of The MOSAIC HP Laser System

1.1 Introduction to the system 1 - 1


1.2 Symbols used in this manual and the device 1 - 2

Chapter 2. General Safety Information

2.1 Overview 2 - 1
2.2 Safety for Treatment Room 2 - 3
2.3 General Caution for Physicians, Staff Members and Patients 2 - 5
2.3.1 Safety Checks on the Handpiece Prior to Use 2 - 5
2.3.2 Cautionary Items for Moving the Device in Treatment Room 2 - 5
2.4 Electrical Safety 2 - 6
2.5 Protecting the Eyes 2 - 7
2.6 Fire hazards 2 - 8
2.7 Safety Features of the MOSAIC HP Laser System 2 - 9
2.7.1 Key Switch 2 - 9
2.7.2 Emergency Stop Switch 2-10
2.7.3 Audible and Visual Warnings during Operation 2-11
2.7.4 Dual Safety Switches 2-11
2.7.5 Remote Interlock 2-12
2.8 The MOSAIC HP Laser System Complies with following Standards 2-13
2.9 Safety Labeling on the MOSAIC HP Laser System 2-15
2.9.1 Emergency Stop Label 2-17
2.9.2 Danger Label of Laser Radiation 2-17
2.9.3 Laser Radiation Label 2-17
2.9.4 Warning Label for Electrical Shock 2-18
2.9.5 Danger Label of Exposure to Laser Radiation 2-18
2.9.6 Label for the Optical Fiber Applicator 2-18
2.9.7 Nameplate Label 2-19

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MOSAIC HP
 Technology for Beauty and Health

Chapter 3. System Description

3.1 Overview 3- 1
3.2 System Specification 3- 1
3.3 Components of the MOSAIC HP Laser System 3- 2
3.3.1 System Console 3- 3
3.3.2 Touch LCD Screen 3- 3
3.3.3 Handpiece 3- 4
3.3.4 Handpiece tips 3- 6
3.3.5 Footswitch and Main Power Area 3- 8
3.4 System Software 3- 9

Chapter 4. Installation

4.1 Overview 4- 1
4.2 Installation Component List 4- 1
4.3 Conditions for Installation 4- 3
4.3.1 Space Requirements 4- 3
4.3.2 Electrical Requirements 4- 4
4.3.3 Environmental Requirements 4- 5
4.4 Installation of the Device 4- 6
4.4.1 STEP 1: Installing the Stand 4- 6
4.4.2 STEP 2: Installing the Handpiece 4- 8
4.4.3 STEP 3: Final Connections 4- 11
4.4.4 STEP 4: Final Checks 4- 12
4.5 Mounting the Handpiece Tip and Starting the System 4- 13
4.5.1 STEP 1: Combining the Handpiece Tip 4- 13
4.5.2 STEP 2: Applying the Main Power 4- 14
4.6 Moving the Device 4- 15
4.6.1 Moving the Device in the Treatment Room 4- 15

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 Technology for Beauty and Health

Chapter 5. Operation

5.1 Overview 5 - 1
5.2 Pre-operational checklist 5 - 1
5.3 Operation of the MOSAIC HP Laser System 5 - 2
5.3.1 STEP 1: Starting the System 5 - 2
5.3.2 STEP 2: Operation Mode 5 - 3
5.3.3 STEP 3: Thermal Mode 5 - 7
5.3.4 STEP 4: Hair Mode 5 - 9
5.3.5 Use of the Handpiece 5- 11
5.3.6 Turning off the System 5- 12
5.4 Descriptions of the buttons in the Operation Mode Screen 5- 14
5.4.1 Basic buttons of Operation Mode 5- 14
5.4.2 SELECT TREATMENT REGION 5- 18
5.4.3 SELECT AREA 5- 19
5.4.4 Measuring the Area by the GRID MASK 5- 21
5.4.5 FACIAL TREATMENT Mode: F-MODE / P-MODE 5- 22
5.5 Descriptions of SETUP Mode Buttons 5- 24
5.6 Calibration Mode 5- 30
5.6.1 User Calibration Process Procedure 5- 30

Chapter 6. Maintain & Management

6.1 Overview 6- 1
6.2 Cleaning the touch LCD Screen and the System Console 6- 1
6.3 Cleaning the Handpiece 6- 2
6.4 Cleaning the Handpiece Tip 6- 3
6.5 Troubleshooting 6- 5
6.5.1 When the power does not turn the device ON, please check the 6- 5
following items.
6.5.2 When the device is powered on but no laser beam is being 6- 5
radiated, please check the following items.
6.5.3 When the laser beam radiates with insufficient output power, 6- 6
please check the following items.
6.6 Understanding Error and Warning Messages 6- 7
6.7 Periodic servicing 6- 8
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MOSAIC HP
 Technology for Beauty and Health

Chapter 7. Clinical Guide

7. 1 Overview 7- 1
Education and Training 7- 1
7. 2 Clinical Guide 7- 2
Introduction of the MOSAIC HP Laser System 7- 2
Fractional Laser Interaction with Skin Tissue 7- 4
What’s New in the MOSAIC HP Fractional Technology? 7- 7
Treatment Parameter 7- 11
7. 3 Clinical Applications 7- 13
7. 4 Treatment Protocol 7- 14
Pre-treatment Preparation 7- 15
Step 1. Consultation 7- 15
Step 2. Preparing the Treatment Area of Skin 7- 15
Step 3. Applying Topical Anesthetic 7- 15
Step 4. Measuring the Size of Treatment Area(in Dynamic Mode) 7- 16
Step 5. Recording and Encoding the Size of the Treatment Area 7- 17
Step 6. Removal of Topical Anesthetic 7- 18
Step 7. Applying Gliding Oil Designated for the MOSAIC HP 7- 18
Laser System
Treatment Procedure except alopecia treatment 7- 19
Step 1. Treatment Parameter Setting 7- 19
Step 2. Operation Technique 7- 19
Caution for the MOSAIC HP Treatment 7- 21
Efficacy Expectations 7- 23
Incidence of Pain 7- 23
Skin Reaction Post Treatment 7- 24
Post-treatment Care 7- 25
Caution and Routine Skin care after Treatment 7- 26
Treatment Interval and Treatment Sessions 7- 27
7. 5 Contraindications 7- 28
7. 6 Treatment Parameter for Each Type of Lesion 7- 29
Treatment Parameter Setting

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 Technology for Beauty and Health

Chapter 8. Warranty

8.1 Overview 8- 1
8.2 Unpaid Services 8- 1
8.3 Exclusion to unpaid service within the period of the warranty 8- 2

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MOSAIC HP
 Technology for Beauty and Health

List of Figures
Figure 2.1 Warning for Laser Radiation 2 - 3
Figure 2.2 Laser protection goggles for the operator(left) 2 - 4
/ for the patient (right)
Figure 2.3 Safety features (1) 2 - 9
Figure 2.4 Emergency Stop Switch and Key Switch 2- 10
Figure 2.5 Safety Features (2) 2- 11
Figure 2.6 Remote Interlock 2- 12
Figure 2.7 Locations of Labels on the Front of the Device 2- 14
Figure 2.8 Locations of Labels on the Back of the Device 2- 15
Figure 2.9 Emergency Stop Label 2- 16
Figure 2.10 Danger Label Of Laser Radiation 2- 16
Figure 2.11 Laser Radiation Label 2- 16
Figure 2.12 Warning Label For Electrical Shock 2- 17
Figure 2.13 Danger Labels Of Exposure To Laser Radiation 2- 17
Figure 2.14 Fiber Optic Applicator Label 2- 17
Figure 2.15 Name Plate Label 2- 18
Figure 2.16 Locations Of Labels On The Rear Of The Device 2- 18

Figure 3.1 Main Components of the MOSAIC HP Laser System 3 - 2


Figure 3.2 Touch LCD Screen 3 - 3
Figure 3.3 Handpiece 3 - 4
Figure 3.4 Footswitch and Main Power Module 3 - 8

Figure 4.1 Dimensions of the MOSAIC HP Laser System 4–3


Figure 4.2 Stand Mounted on the Inside of the Rear Door 4–6
Figure 4.3 Unfolding the Stand 4–6
Figure 4.4 Mounting the Support Stand 4 - 7
Figure 4.5 Opening the Touch Screen LCD and the Inserted Stand 4 - 7
Figure 4.6 Taking out the Handpiece and the Optical Fiber 4 - 8
Figure 4.7 Hooking the Optical Fiber 4 - 8
Figure 4.8 Hooking the Handpiece 4 - 9
Figure 4.9 Mounting the Optical Fiber Stopper 4 - 9
Figure 4.10 Inserting the stand bar holder 4 -10
Figure 4.11 Closing the Rear Case 4 -10
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MOSAIC HP
 Technology for Beauty and Health

Figure 4.12 Main Power Module 4- 11


Figure 4.13 Status of the Installed the MOSAIC HP Laser System 4- 12
Figure 4.14 Inserting the Handpiece Tip 4- 13

Figure 5.1 Initial Selection Screen 5 - 2


Figure 5.2 DYNAMIC Mode Screen 5 - 3
Figure 5.3 STSTIC Mode Screen 5 - 5
Figure 5.4 Operation Mode Screen 5 - 7
Figure 5.5 THERMAL Mode Screen 5 - 7
Figure 5.6 HAIR Selection Screen 5 - 9
Figure 5.7 HAIR Mode Screen 5 - 9
Figure 5.8 Using the Handpiece 5- 11
Figure 5.9 Screen of Turning off the system 5- 12
Figure 5.10 Key Switch first Step 5- 12
Figure 5.11 Operation mode Screen 5- 14
Figure 5.12Example of the Treatment Area Selected in DYNAMIC 5- 18
Figure 5.13 Entering the region of the treatment area FACE mode 5- 19
Figure 5.14 Input Dialogue for the Size of the Treatment Area in BODY Mode 5- 20
Figure 5.15 Grid Mask 5- 21
Figure 5.16 Initial Screen in F-MODE 5- 22
Figure 5.17 How to Select Left and Right Cheek in F-MODE 5–22
Figure 5.18 Initial Screen in P-MODE 5- 23
Figure 5.19 FOREHEAD selected as the treatment area in P-MODE 5- 23
Figure 5.20 Initial SETUP Screen 5- 24
Figure 5.21 P-MODE Setting 5- 25
Figure 5.22 F-MODE Setting 5- 25
Figure 5.23 SIMULATION Mode Setting 5- 26
Figure 5.24 SIMULATION Mode Being ON/OFF 5- 26
Figure 5.25 INFO Screen 5- 27
Figure 5.26 Effect Sound ON/OFF Setting 5- 28
Figure 5.27 Laser Sound ON/OFF Setting 5- 28
Figure 5.28 Calibration Mode Selection Screen 5- 30
Figure 5.29 Calibration Screen 5- 30
Figure 5.30 The method of handpiece insertion 5- 31

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MOSAIC HP
 Technology for Beauty and Health

Figure 6.1 Cleaning the Handpiece window 6 - 2


Figure 6.2 Cleaning the Handpiece Tip 6 - 3
Figure 6.3 Interlock plug Warning Message 6 - 7

Figure 7.1 Absorption spectrum of water 7 - 3


Figure 7.2 FRACTIONAL TECHNOLOGY CREATES MNCS 7–5
Figure 7.3 Stimulation of hair follicle and improvement of scalp 7 - 6
Figure 7.4 MNC in Thermal and Normal Mode 7- 8
Figure 7.5 Grid mask 7- 17
Figure 7.6 Input Dimension of Each Region 7- 17
Figure 7.7 Five Cosmetic Units of Face 7- 18
Figure 7.8 Multiple Moving Patterns and Facial Areas Needed Special 7- 20
Cautions
Figure 7.9 Cooling down the treated skin 7- 25
Figure 7.10 High Pulse Energy Tx in Static Mode 7- 34

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MOSAIC HP  Chapter 1. Overview Of The MOSAIC HP Laser System

Chapter 1. Overview Of The MOSAIC HP


Laser System

1.1 Introduction to the system


The MOSAIC HP laser system is designed so that it is in accordance with
international standards for manufacturing medical devices in order to
guarantee user’s safety and durability of use. This device is convenient to
use and the prolonged lifetime for use is guaranteed. It only requires users
to exert the basic maintenance/repair efforts such as replacing the tip of its
handpiece and cleaning the device thoroughly on a periodic basis.

 A flash GUI is applied to the LCD touch screen so that users can
easily adjust parameters to their optimal settings. The contained
software provides device information and clinical information to
the users.

 The MOSAIC HP laser system utilizes optical fibers to generate a


laser beam with a wavelength of 1550nm by applying Controlled
Chaos Technology™ (CCT). It radiates multiple micro-laser
beams, with each beam having a diameter of 100矛, to the surgical
area.

 When the micro-laser beam is radiated onto the operation area,


Micro Necrotic Column (MNCs) is created. As the surgical area
recovers itself to its normal state, the condition of the skin is
greatly improved. Each time a surgical operation has been
performed, the resulting MNC occupies 5 to 20% of the entire area
of the skin. Generally speaking, 5 - 20% of the fractionalized skin
stimulates 80 - 90% of the adjacent viable tissue.

 To perform surgical operation effectively, please refer to the


provided clinical treatment protocol manual.

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MOSAIC HP  Chapter 1. Overview Of The MOSAIC HP Laser System

1.2 Symbols used in this manual and the device

Symbols Description

Indicates the potential danger for users,


patients or staff members of direct exposure to
laser beam radiation.
DANGER

Warns users, patients or staff members that


they may be severely injured if directly
exposed to laser beam radiation.
WARNING

Warns against possible danger and risk of


electrical shock that may result in severe
injury to the device and/or relevant persons.
Electrical complications may cause damage
WARNING and/or fire during exposure to laser radiation.

Cautions against the possible risk of electrical


shocks that may result in severe damage to the
device and/or persons. Electrical
complications may cause damage and/or fire
CAUTION during exposure to laser radiation.

Indicates that prior to any procedure with the


ADVANTAGE laser system, the operator
should check the patient’s individual
circumstances and treatment history to get
IMPORTANT good clinical efficacy.

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 for
Electrical Shocks (IEC 417 /878-03-01).

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MOSAIC HP  Chapter 1. Overview Of The MOSAIC HP Laser System

This symbol indicates that the POWER is


OFF, which complies with the Protective
Regulations for electrical shocks (IEC 417 /
5008).
This symbol indicates that the POWER is ON
and is in compliance with the Protective
Regulations for electrical shocks (IEC 417 /
5007).

Marking regarding disposal of Waste


Electrical and Electronic Equipment (WEEE)

Indicates important items to be noted during


NOTE the use of this device.

CE Marking

Manufacturer

Authorized representative in the European


Community

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.

CAUTION
If you adjust or manipulate the device in a way that does not
comply with the instructions given in this manual, then you
may be exposed to dangerous laser beams that may cause
you severe injury or loss of sight.

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MOSAIC HP
 Chapter 2.General Safety Information

Chapter 2. General Safety Information

2.1 Overview
This chapter provides basic safety information for laser generating devices
and cautionary items, covering electrical safety and is intended
characteristics of the laser beams, for users who want to operate this
product. A physician performing a surgical operation using the MOSAIC
HP laser system, an operator using the MOSAIC HP laser system or a
patient or staff member who receives medical service from it must be made
fully aware of the potential danger and safety guidelines associated with the
use of this laser-generating device. In addition, this device should only be
handled by operators or staff members who have attended a certified
training session. Before a surgical operation, the patient should be informed
of the possible danger and cautionary items. Every operator who uses this
device is responsible for the safety issues that may arise while performing a
surgical operation.

The MOSAIC HP laser system is designed in such a way that it


guarantees optimal safety for physicians, staffs and patients
and is equipped with the safety system described below.

1. This device protects itself from possible over current and voltage
problems by utilizing a slow-blow fuse with 250VAC/3A,
125VAC/6A. Safety Extra Low Voltage (SELV) method is used
in the design of this system. The fuse installed in the inner area of
MOSAIC HP laser system successfully blocks off unwanted
power supply.

2. The protective device using the software installed in the


MOSAIC HP laser system.

 After the operator starts the MOSAIC HP laser system by


using the key switch located on the front panel of the device,
the safety-related parts of this device will start running to
ensure the safe use of this device by the user.

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MOSAIC HP
 Chapter 2.General Safety Information

 The device automatically runs a supervising system that is


continuously monitored during the entire surgery procedure in
order to notify the user of the system’s safety status.

 The software installed in the MOSAIC HP laser system will


block off the radiation of the laser beam immediately after an
error occurs. An error message will be promptly displayed to
notify the operator.

3. The LED on the handpiece and the tip of the handpiece visually
displays the status of laser-beam radiation that is achieved when
the handpiece is in contact with the patient’s skin. In addition,
while the laser beam is being radiated, an audible continual
‘humming’ sound can be heard and signifies radiation is
occurring.

4. The MOSAIC HP laser system automatically detects the lifetime


and the size of an attached handpiece tip and displays the
information on the screen.

5. A remote interlock system will halt the device’s operation if there


is no socket connected to the remote interlock. To install an
interlock system, which may be connected to the surgery room
door, please contact customer support.

6. The laser beam will radiate only if the footswitch is depressed


and the tip of the handpiece is in physical contact with the
surgical area of the patient’s skin.

DANGER
The MOSAIC HP laser system is in compliance with the US
Federal Regulation (21. CFR 1040.10 and 1040.11) of the CDRH
(the Center for Devices and Radiological Health), which is
governed by the FDA (the Food and Drug Administration). In
terms of the CDRH standards, MOSAIC HP laser system belongs
to CLASS IV. This is the most powerful class of lasers used for
medical applications and requires that extra precautions be
taken when using this device.

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MOSAIC HP
 Chapter 2.General Safety Information

2.2 Safety for Treatment Room


Before operating the equipment, the physician and/or other
responsible staff should perform the following checks:

Figure 2.1.Warning for Laser Radiation

 A warning sign indicating that the room is used for laser-beam


radiation treatment or another appropriate and equivalent warning sign
should be attached to the door of the operation room. A sign is
provided by Lutronic with new equipment, the purchase of additional
signs may be purchased as necessary.

 Only properly trained personnel and persons essential to the procedure


should have access to the treatment room. Everyone including the
physician and other staff members present in the treatment room should
be fully aware of the technical details of the device. In the event of an
emergency all persons present should know how to shut down the
system. No objects that reflect light, such as a mirror, should be
allowed in the surgery room.

 If the device is improperly used, people present in the operating room


may be exposed to laser radiation in the form of direct-rays, reflected-
rays or scattered rays. As a result, it is possible for serious injury,
blindness or property damage to result. Everyone in the treatment room
should wear laser protection goggles approved and provided by
Lutronic Corp at all times.

 Before connecting the equipment to a power source, the operator


should check that the power source matches the requirements of the
equipment as described on the plate on the rear of the machine.

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MOSAIC HP
 Chapter 2.General Safety Information

Figure 2.2 Laser protection goggles for the operator (left) for the patient (right)

DANGER
The laser beam of the MOSAIC laser system is in the form of
infrared rays which are invisible to the naked eye. All persons
present in the operating area must wear protective goggles at
all times. Failure to do so may result in eye exposure to laser-
beam radiation causing severe if not permanent damage and/or
injury. Everyone participating in an operation should wear
goggles with protection from 1550nm wavelength laser beam or
glasses with side protection pursuant to the relevant safety
standard. Prolonged or direct exposure to the radiation produced
by this machine may result in serious injury or even blindness
even if laser safety goggles are worn.

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MOSAIC HP
 Chapter 2.General Safety Information

2.3 General Caution for Physicians, Staff Members and Patients

2.3.1 Safety Checks on the Handpiece Prior to Use


 Before applying the electrical power to the MOSAIC HP laser system,
make sure that the tip of the handpiece is clean. In addition, thoroughly
remove any remaining on the handpiece and tip with alcohol of 90% or
higher immediately after finishing an operation in order to maintain
energy efficiency.

 Although the operator is wearing laser protection goggles for 1550nm


laser beams, do not directly look into the laser aperture of the
handpiece while the main power of the device is turned on.

2.3.2 Cautionary Items for Moving the Device in Treatment Room


 The MOSAIC HP laser system is a device that weighs about 53kg.
Attempting to move it without the proper means of protection in the
treatment room may cause damage to the device cause or physical
injuries to the person in the treatment room. This device is designed in
such a way that its center of mass is optimized to facilitate convenient
moving of this device. Be sure to move the device very carefully and
slowly at all times.

 Attempt to move the instrument by means of the optical fiber


connected to the hand piece is prohibited; doing so may severely
damage the handpiece if not the device itself. The center of mass will
be disrupted and the instrument may fall over causing physical
damages to any person near it. The correct moving procedure can be
done conducted by using the provided handle attached to the system.

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 Chapter 2.General Safety Information

2.4 Electrical Safety


 The MOSAIC HP laser system is an instrument that uses a voltage
source of 250VAC/3A, 125VAC/6A. Since it uses high voltage
components, removing its protection cover from the main body may
expose the user to severe electrical shock. Persons other than those
who are authorized by Lutronic Corporation may not disassemble this
instrument.

 Some residual electrical power may remain within the electrical


components of the MOSAIC HP laser system after blocking off the
power supply. Persons other than those who are authorized by Lutronic
Corporation may not disassemble this instrument or inspect its inner
components as this will void device warranty.

 Never allow any liquids to enter the console of the MOSAIC HP laser
system. This may lead to the danger of electrical shock.

 Only use power cables with grounding pins provided by Lutronic


Corporation. If the power cable is damaged or worn out, then you
should not use or operate this device.

 The user should not clean the handpiece or repair this instrument while
electrical power is being supplied to this instrument.

WARNING
If persons other than service persons authorized by Lutronic
Corp. attempts to remove the external cover or disassemble
this device, then they may get exposed to the dangerous
laser beam or high voltage or current generated by this
device. Such actions are excluded from the coverage of the
warranty of this product.

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 Chapter 2.General Safety Information

2.5 Protecting the Eyes


 The laser beam of the MOSAIC HP laser system is in the infrared
spectrum and is invisible to the naked human eye. Users and
patients must wear protective goggles at all times. Unprotected
exposure of the human eye to the laser radiation produced by this
equipment will result in serious injury and/or blindness.

 Everyone in the vicinity of the machine when it is in use must wear


approved goggles or glasses designed for protection from 1550nm
laser beams (optical shade density of 5 or higher) as described in
the relevant safety standard.

 Laser beams can be reflected from the surface of surgical


instruments procedure packs and other reference items. Ideally any
equipment that is not required for the procedure should be removed
from the room to minimize the risk of reflected radiation.

 Goggles made of glass or other materials which have not been


specially designed for use with laser beams do not provide
protection from exposure to the direct or even scattered ray of
1550nm wavelength produced by this equipment. Failure to use
appropriate eye protection may result in irreparable damage to the
retina of the human eye and possible blindness.

 Under no circumstances look directly into the handpiece while the


main power of the device is turned on or while the system is
connected to an electrical power source even when wearing laser
protection goggles for 1550nm laser beams. Doing so may result in
serious injury or blindness.

 Patients should wear goggles to protect their eyes from accidental


exposure to laser beam during treatment.

DANGER
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, even if laser safety goggles are worn.
Never direct the rays of the laser beam onto any object other
than necessary targets. A laser beam reflected from another
surface (regardless of its color) into the eye may cause
injury, permanent damage or even blindness.

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 Chapter 2.General Safety Information

2.6 Fire hazards

 Lasers can cause many non-metallic materials to ignite and burn.

 Fire retardant fabrics should be used in the surgery to minimize the risk
of fire. Avoid using materials saturated with oxygen.

 Be especially careful when using the laser beam near flammable


material. If the laser beam hits an anesthetic, gaseous material such as
nitric acids or oxygen, or flammable material such as alcohol or cotton
a fire may ignite.

 Before using the laser, make sure all solvent, adhesives and cleansing
liquids have completely evaporated.

 A fire extinguisher should be placed near the laser-generating device at


all times.

 Never operate this device in a confined space or while it is covered.

DANGER
You 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 a fire.

DANGER
Never direct the rays of a laser beam at unnecessary targets.
It may damage or burn the object.

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MOSAIC HP
 Chapter 2.General Safety Information

2.7 Safety Features of the MOSAIC HP Laser System


MOSAIC HP laser system incorporates various safety features designed
reduce the risk of injury and meets or exceeds relevant international
standards for this type of device.

Touch LCD Screen

2.7.2 Emergency Stop Switch

2.7.1 Key Switch

2.7.3 Speaker

2.7.3 Handpiece

2.7.4 Foot Switch

Figure 2.3 Safety Features (1)

2.7.1 Key Switch


 The MOSAIC HP laser system may be only turned on or off by the key
provided by Lutronic Corp.

 To prevent unauthorized persons from using this device, remove the


key from the key switch after performing a surgical operation and store
it in a safe place.

 The key switch is composed of three steps. The key switch’s LED
displays the status of the switch corresponding to each step.

 Shifting the key from the 2nd step to the 3rd step is quickly followed by
an automatic return to the 2nd step position; the motion is like that of a
car ignition.

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 Chapter 2.General Safety Information

Note: To remove the key, you must turn the system off.
st
Key Switch 1 step
Key Switch LED:
No light on & Power is OFF

nd
Key Switch 2 step
Key Switch LED:
Blue light on / Red blinking

rd
Key Switch 3 step
Key Switch LED:
Red/Blue blinking

Figure 2.4 Emergency Stop Switch and Key Switch

CAUTION
Only authorized and trained persons should operate this
device. To prevent unauthorized persons from using this
device, remove the key from the key switch after performing
an operation and store it in a safe place.

2.7.2 Emergency Stop Switch


 In an emergency, laser output can be stopped immediately by using the
laser emergency stop switch.

 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.

 If you want to start the device again, you should turn the emergency
switch clockwise (direction of arrow) to let the button pop out. After
that, turn the key switch to turn off the device and turn it on again.

 This emergency stop switch should not be used in normal situations.


Always use the key switch to turn on or off the instrument in a normal
situation.

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2.7.3 Audible and Visual Warnings during Operation


 The LED’s on the handpiece and the tip of the handpiece illuminate
to provide visual confirmation that laser-beam radiation is being
emitted when the handpiece is in contact with the patient’s skin.

 In addition, while the laser beam is being radiated, an alarm sound of


45dB or higher will be heard in order to confirm to the operator and
others that laser radiation is being generated.

 A message saying “LASING” will blink in the upper part of the LCD
screen to notify the user that a laser beam is being produced.

2.7.4 Dual Safety Switches


A laser beam will only be generated if the footswitch is depressed and the
tip of the handpiece is touching the patient’s skin. Please note that the
footswitch must be depressed first and then the contact made between the
handpiece and the skin in order to initiate lasing.

Rear case lock

Foot Switch Hook

Main Power Socket

Main Power Switch

Remote Interlock Socket

External Grounding
Terminal

Foot Switch Socket

Figure 2.5 Safety Features (2)

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2.7.5 Remote Interlock


 If either the supplied interlock plug (shown below) or a remote
interlock switch is not installed, the system will not operate.

 With an installed remote interlock, the MOSAIC HP laser system will


only operate when the interlocked device allows it to do so.

Figure 2.6 Remote Interlock

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 Chapter 2.General Safety Information

2.8 The MOSAIC HP Laser System Complies with the following


Standards
This device complies with the following international standards for the
safety of doctors and patients.

Standard/
Title Ratification
Regulation
93/42/EEC
As amended by Medical Device Directive 2007
2007/47/EC
1990;A1;1993;A
EN 60601-1 Medical electrical equipment
2;1995;
IEC 60601-1 Part 1: General requirements for safety
A13;1996
Medical electrical equipment
EN 60601-1-2 Part1-2: General requirements for safety
2007
IEC 60601-1-2 –Collateral standard: Electromagnetic
compatibility - Requirements and Tests
Medical electrical equipment
EN 60601-1-4 Part 1-4: General requirements for safety
1996;A1;1999
IEC 60601-1-4 - Collateral Standard: Programmable electrical
Medical systems
Medical electrical equipment – Part 1-6
EN 60601-1-6 General requirements for basic safety and essential 2007
IEC 60601-1-6 performance 2006
- Collateral Standard: Usability

Medical electrical equipment –


EN 60601-2-22 1996
Part 2: Particular requirements for the safety of
IEC 60601-2-22 1995
diagnostic and therapeutic laser equipment

Safety of laser products


EN 60825-1
Part 1: Equipment classification, requirements and 2007
IEC 60825-1
user's guide
EN ISO 14971 Medical devices - Application of risk management 2009
ISO 14971 to medical devices 2007

Graphical symbols for use in the labeling of Medical


EN 980 2008
devices

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 Chapter 2.General Safety Information

Information Supplied by the manufacturer of


EN1041 2008
medical devices

Medical device software. Software life-cycle


EN 62304 2006
processes

US Federal Performance Standards 21CFR 1040.10


21CFR/FDA _
and 1040.11 for Class IV Laser Product

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2.9 Safety Labeling on the MOSAIC HP Laser System

 In accordance with domestic and international standards, various safety


and device information labels are attached in appropriate locations.
Under no circumstances should these be removed, covered or obscured.

 Clinicians and operators should familiarize themselves with the location


and the meaning of each safety label attached to the system.

Please, Push Foot Switch Before


CAUTION Contacting Handpiece Tip

2.9.1 Emergency Stop Label

LASER APERTURE

Figure 2.7 Locations of Labels on the Front of the Device

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2.9.3 Laser-Beam
Radiation Label

2.9.4 Warning Label for


Electrical Shock
2.9.5 Danger Label of
Exposure to the Laser

2.9.7 Nameplate Label


2.9.2 Danger Label of Laser Radiation

Figure 2.8 Locations of Labels on the Back of the Device

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 Chapter 2.General Safety Information

2.9.1 Emergency Stop Label


The labels associated with the emergency stop switch are located near
the emergency stop switch on the front of the device.

Figure 2.9 Emergency Stop Label

2.9.2 Danger Label of Laser Radiation


The laser beam produced by the MOSAIC HP laser system is a CLASS IV
laser. This label provides information about the maximum laser output,
radiation time, pulse rate, and other important information.

Figure 2.10 Danger Label of Laser Radiation

2.9.3 Laser Radiation Label


This label indicates the laser beam radiation and its path

Figure 2.11 Laser Radiation Label

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2.9.4 Warning Label for Electrical Shock


This label warns of the risk of electrical shock when a door is opened
and advises that only authorized and trained personnel should open the
cover.

Figure 2.12 Warning Label for Electrical Shock

2.9.5 Danger Label of Exposure to Laser Radiation

This label warns users of the risk of exposure to direct or scattered laser
radiation if the cover is removed or opened.

Figure 2.13 Danger Labels of Exposure to Laser Radiation

2.9.6 Label for the Optical Fiber Applicator


This label indicates the fact that an optical fiber transfer system is applied
to this device.

Figure 2.14 Fiber Optic Applicator Label

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2.9.7 Name Plate Label


This label shows the product name, the model name, the laser class and
other important information.

Figure 2.15 Name Plate Label

2.9.6 Fiber Optic Applicator Label

2.9.2 Danger Label of Laser Radiation

2.9.4 Warning Label for Electrical Shock

Figure 2.16 Locations of Labels on the rear of the Device

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MOSAIC HP
 Chapter 3. System Description

Chapter 3. System Description

3.1 Overview
This chapter provides a general description of the MOSAIC HP Laser
System, including its main components, system control, and technical
specifications.

3.2 System Specification

Component Specification
Laser wavelength 1550nm

Medium of transmission Er:Glass Fiber Laser

Laser transfer method Optical Fiber


10 x 10mm, 8 x 8mm, 6 x 6mm, 5 x 10mm,
Handpiece Tips
12 x 2mm Hair Tip , 10 x 10mm Non-Contact Tip
Spot Size per Pulse 100um

Pulse Energy 4 – 120mJ

Type and degree of


protection against CLASS I / B-type
electrical shock

Laser Class CLASS IV

User interface Touch LCD, Flash Technology

Dimensions 400箱583箱1580 (W箱D箱H) unit mm

Weight 53kg

Cooling system Air Cooled


Single phase 100~240VAC
Electrical rating (FUSE 250VAC/3A or 125/6A), 50/60Hz,
Power consumption: 350VA

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3.3 Components of the MOSAIC HP Laser System


The MOSAIC HP Laser System is largely composed of four main
components.

 System console
 Touch Screen LCD
 Handpiece
 Foot switch

Handpiece Hook
Optic Fiber Cable

Stand
Touch Screen LCD

Calibration Port
Handpiece Ball

Handle for moving system


Key Switch

Emergency Stop Switch


System Console

Casters

Figure 3.1 Main Components of the MOSAIC HP Laser System

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3.3.1 System Console

The system console contains the control systems and main laser generation
systems. There are no user serviceable parts inside the system console, and it
should never be opened by unauthorized personnel. The main parts of the system
are:
 Computer and System Control Module
 DC Power Supply
 LASER Module
 Scanner Module Energy Calibration Port
 Handpiece Hook
 Handle and Castors

3.3.2 Touch LCD Screen

Figure 3.2 Touch LCD Screen

 The user interface of the MOSAIC HP Laser System includes a touch LCD
screen system with a Flash Graphical User Interface(GUI)
 The size of the LCD is 15 inches (measured diagonally) and provides users
with a clear uncluttered interface and access to all relevant controls and
settings.
 The LCD displays information about the current status of the system and
the value of each parameter. The function of each button is explained in
detail in Chapter 5.
 Operators may select one of four modes from the initial selection screen.
-CALIBRATION / OPERATION / HAIR / SETUP
 The system is designed in such a way that the LCD screen can be folded
away for protection when the device is not being used.

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CAUTION
Do NOT touch the Handpiece LCD while moving the device.
Doing so may damage the device. To properly transport the
system, hold the handle and slowly pull the device to the
desired position.

3.3.3 Handpiece Handpiece LED

STANDBY mode: LED glows Blue


READY mode: LED bright Blue
LASING status: LED flashes Red and Blue
SETUP status: LED flashes Red and Blue
CALIBRATION status: LED flashes Red and Blue

Handpiece Tip LED

STANDBY mode: LED Off


READY mode: LED Off
LASING status: LED Red
SETUP status: LED Red
CALIBRATION status: LED Red

Handpiece tip

Figure 3.3 Handpiece


 The handpiece and the handpiece tips contain LED indicators to provide
visual feedback on system status and show if the handpiece tip is contacting
the patient’s skin properly is in progress.
 Various sizes and shapes of tips are provided and can be fitted to the
handpiece to suit the procedure being performed.
 The handpiece tips should be replaced whenever there is any risk of cross
infection between clinical procedures.

CAUTION
Never use the handpiece to move the machine or attempt to
move the equipment by pulling on the handpiece. Doing so may
damage the equipment and void warranty. To move the system
use the installed handle and pull the device into position
slowly.

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 Chapter 3. System Description

3.3.4 Handpiece tips

A range of handpiece tips are available to suit various procedures.


Handpiece tip
DYNAMIC Mode STATIC Mode
(Unit: mm)
10 X 10
Pulse Rate :
Normal, 3/4 Speed,
1/2 Speed,1/3 Speed

•When pulse energy is below


8X8 14mJ, pulse density can be
Pulse Rate : adjusted between 50 and 500
Normal, 3/4 Speed,
1/2 Speed,1/3 Speed

6X6
• When pulse energy is below
Pulse Rate : 25mJ, pulse density can be
1/2 Speed, 1/3 Speed
adjusted between 50 and 400

5 X 10
Not used. When loaded
system automatically
switches to Static Mode • When pulse energy is above
and makes Dynamic 26mJ, pulse density can be
Mode unavailable. adjusted between 50 and 300
1
10 x 10mm
Non-Contact Tip
Pulse Rate :
Normal, 3/4 Speed,
1/2 Speed,1/3 Speed

12 x 2mm
Hair Tip
Not used. It is available to use in
N/A
HAIR Mode


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 Chapter 3. System Description



CAUTION
Handpiece tips require constant and careful maintenance for
optimal performance and safety. If the window of the handpiece
tip becomes damaged or rendered unsuitable for operation,
replace it with a new tip immediately. The handpiece tip is no
longer fit to exert optimal lasing and may affect clinical outcome.

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3.3.5 Footswitch and Main Power Area


Main power switch
Main power
socket Remote interlock socket

External grounding
terminal

Foot switch socket


Figure 3.4 Foot Switch and Main Power Module

 The foot switch is designed with a metal cover for durability and to guard
against accidentally system initiation as required by international standards
(IEC60601-2-22).
 Before the system will operate, the foot switch cable must be connected to
the foot switch socket located on the main power panel on the back of the
system.
 As you step on the foot switch, the touch LCD screen will display the
“READY” message and enters into the standby mode for lasing. Lasing
actually starts only if the handpiece tip touches the treatment area while the
foot switch is pressed.

CAUTION
When moving the MOSAIC HP laser system, the foot switch
must be disconnected from the device in order to prevent
damage to the connector or cable. Never pull on the cable or
subject it to unnecessary stress.

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 Chapter 3. System Description

3.4 System Software


The software installed on the MOSAIC HP laser system is designed to provide
user- friendly control over all aspects of operation. The software allows:
 Continuous feedback on system operation to ensure the safety of the
operator, staff and patients.
 Allow operators to easily select and apply the optimum clinical parameter
for each patient.

 The operator may generate the correct amount of laser radiation by varying
output of the laser beam for each different purpose.

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MOSAIC HP
 Chapter 4. Installation

Chapter 4. Installation

4.1 Overview
This chapter describes the installation of process and optimum operational
environment for the MOSAIC HP laser system. Only qualified personnel
and/or people trained by Lutronic Corporation should install, operate or
move the device.

4.2 Installation Component List


Before installing the device, check the following list of standard
components that are provided with the device:
• 1 The MOSAIC HP laser system
• 1 Handpiece tip 10箱10mm
• 1 Handpiece tip 8箱8 mm
• 1 Handpiece tip 6箱6 mm
• 1 Handpiece tip 5箱10mm
• 1 Handpiece tip 10箱10mm Non Contact Tip
• 1 Handpiece tip 12箱2mm Hair Tip
• 1 Protective (Dummy) Handpiece Tip
• 2 The MOSAIC HP Operation Key
• 2 Rear Case Lock Key
• 1 Foot Control Switch
• 1 Remote Interlock plug
• 1 Laser Radiation Warning Sign (For the treatment room door)
• 2 Protective Goggles for the Operator
• 1 Protective Goggles for the Patient
• 1 Gliding oil
• 200 Grid Mask
• 200 Grid Sheet
• 1 Power Cord
• 1 Operator’s Manual

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NOTE
Use only original, replacement parts and accessories provided
by Lutronic Corporation, which can be obtained from Lutronic
Corporation or an authorized Lutronic Corporation distributor.
The use of unapproved parts and accessories will void
warranty.

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 Chapter 4. Installation

4.3 Conditions for Installation


4.3.1 Space Requirements
 A clear working area is required for the proper operation and
manipulation of the device. To ensure operator comfort and ease of
use, please allow at least as much space shown in the diagram below
(Figure 4.1)
 Before installing the device please ensure that there is adequate space
available and that there is an appropriate grounded power socket
available. Always check that the power available matches the
requirements of the system. (Information about system power
requirements can be found on the back of the machine near the main
power socket.)
 Allow a minimum of 24 cm of free space around the unit on all sides.
 Place the equipment as far away as possible from other medical
devices or any device that generates heat.

1580mm

583mm

400mm

Figure 4.1 Dimensions of the MOSAIC HP Laser System

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 Chapter 4. Installation

4.3.2 Electrical Requirements


 Before connecting the system, ensure that the power available
matches the requirements of the system as shown on the sticker
located on the rear of the machine near the power input socket.
Under no circumstances connect a system unless the power supply
matches that described on the system. To do so will damage the
machine and may result in injury.

 The 125VAC/6A, 250VAC/3A fuses are used to protect the device


from over-voltage or over-current. If you suspect the fuse is broken
(for example if the device will not switch on) please refer to the
troubleshooting section of this manual and then contact the customer
support department of Lutronic Corp or our agents for service and
support as necessary.

 Lutronic recommends the use of a separate earth/grounding in


addition to that which is provided via the standard power supply for
additional safety. An external ground terminal is provided next to the
power input socket on the back of the machine. Always ensure that
additional earth/grounding connections are made by a qualified
electrician or trained Lutronic personnel.

WARNING
Always check that the correct power supply is available for the
equipment. The connection of a power supply of the wrong
voltage or frequency may damage the equipment and/or result
in injury.

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 Chapter 4. Installation

4.3.3 Environmental Requirements


The MOSAIC HP Laser System is a sophisticated clinical device and
contains delicate optical and electronic components. To maximize the life
of your investment, please ensure the system is used and stored in a clean
environment. Note:
 The system must not be stored or used in a corrosive or acidic
atmosphere as this may lead to damage to the internal electrical
components or the laser module.

 Keep the system away from dust; air-borne dust and fine dust
particles can damage sensitive electrical equipment and/or interfere
with the operation of the device.

 The optimum temperature for storing the system is between 15 and


35°C.

 The optimum temperature for using the device is between 20 and


30°C.

 The optimum relative humidity for using the device is between 40


and 60%.

 The optimum atmospheric pressure for using the device is between


86 and 106kPa.

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 Chapter 4. Installation

4.4 Installation of the Device


4.4.1 STEP 1: Installing the Stand
System installation should be performed by a Lutronic Corporation engineer.
However, the following may still be reviewed as reference and through.

1. First ensure that the system is disconnected from the AC power supply.
To locate the optical cable support, open the rear door by inserting the
key into the lock on the rear door and turning it approximately 90
degrees. The optical cable support stand is mounted inside the door.

Figure 4.2 Stand Mounted on the Inside of the Rear Door

2. Loosen the red capped bolt as shown in figure 4.3 and undo the
VelcroTM binding straps holding the stand in place.

3. Remove the stand from its mounting, and completely unfold the stand
before tightening the red capped bolt again.

Joint Bolt

Figure 4.3 Unfolding the Stand

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4. Remove the plug from the stand mounting bracket and, as shown in
Figure 4.4, align the marks on the outside of the stand base and the
stand mounting bracket while carefully sliding the post at the bottom of
the stand into the socket on the mounting bracket.

Groove on stand base

Stand mounting bracket

Groove on
stand socket

Figure 4.4 Mounting the Support Stand

5. Open up the touch screen LCD as shown in Figure 4.5.

Figure 4.5 Opening the Touch Screen LCD and the Inserted Stand

CAUTION
Never use excessive force as it may result in damage to the
system.

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 Chapter 4. Installation

4.4.2 STEP 2: Installing the Handpiece


1. Release the Velcro bindings (4 off) securing the armored cable; undo the
strap holding the handpiece in place and gently unwind the coiled
armored cable containing the optical fibers ensuring not to kink or bend
the cable sharply. See Figure 4.6.

Figure 4.6 Taking out the Handpiece and the Optical Fiber

2. Drape the armored cable containing the optical fibers into the groove of
the stand as shown in Figure 4.7 taking care not to let the handpiece fall.

Figure 4.7 Hooking the Optical Fiber

CAUTION
Never coil or bend the armored cable containing the optical
fibers too sharply or pull or twist them. Such actions can
seriously damage the optical fibers and lead to degradation in
performance or failure. Improper handling will void the warranty.

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 Chapter 4. Installation

3. As shown in Figure 4.8, hook the handpiece fixing ball into the
handpiece hook or the stand hook.

Figure 4.8 Hooking the Handpiece

4. As shown in Figure 4.9, slot the armored cable into the provided recess
on the top cover and firmly tighten the locator rings.
Optical Fiber Stopper

Figure 4.9 Mounting the Optical Fiber Stopper

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 Chapter 4. Installation

5. Slot the provided clips onto the vertical section of the stand to keep the
armored cable safely in place as shown in Figure 4.10.

Slot provided clips onto stand to


retain armored cable

Figure 4.10 Inserting the stand bar holder

6. Check that the cable is securely located in the support, that there is no
snagging of the cables and that the arm and handpiece can be moved
freely. Close and lock the rear door and remove the key.

Figure 4.11Closing the Rear Case

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 Chapter 4. Installation

4.4.3 STEP 3: Final Connections

1. Remote Interlock
Insert the remote interlock plug into its socket on the main power panel
located on the back of the system. The remote interlock plug has only
two prongs and can only be located in the correct corresponding socket.
It will not fit into the adjacent three-pronged socket which is designed for
the footswitch control cable. To install the remote interlock plug, locate
the two prongs over their sockets and allow the locking ring to snap into
place. Once in place, check that the plug is secure by gently pulling on
the rubber cover of the plug. Do not pull back on the locking ring as this
will release the locking mechanism which allows one to remove the plug.

2. Footswitch
Insert the footswitch connector into the three-pronged socket on the main
power panel as you did remote interlock plug.

3. Main Power Cable


After checking that the main power switch is turned off (O), mount the
power cord in the main power cable socket of the power terminal.
Insert the main power cord very firmly until the ground of the power
supply is secured. At this time, do not insert the power plug into the
outlet on the wall.

Remote interlock socket

Main power socket Foot switch socket

Figure 4.12 Main Power Module

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 Chapter 4. Installation

4.4.4 STEP 4: Final Checks


1. Position the device in a place that satisfies the requirements for installation
space set out in 4.3 of this manual.

2. Lock the casters on the front of the device by pushing firmly down on the
levers.

3. After installation is complete, do a visual check to make sure installation


matches one of the pictures shown below in Figure 4.13.

Figure 4.13 Status of the Installed the MOSAIC HP Laser System

CAUTION
Before moving the device, secure the handpiece, the optical
fiber cable, the power cord and the foot switch. Use the handle
on the front of the machine to slowly and gently locate the
device in the desired location. After having finished moving the
unit, lock the front and/or rear casters.

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 Chapter 4. Installation

4.5 Mounting the Handpiece Tip and Starting the System


4.5.1 STEP 1: Combining the Handpiece Tip
1. Ensure all persons present are wearing appropriate protection, such as
protective goggles, before connecting the main power cable.

2. While holding the handpiece pointing downwards, remove the dummy


handpiece tip. (Dummy tips are clearly marked as such.)

3. Depending on the treatment to be undertaken, select the appropriate


handpiece tip and attach it to the handpiece. Handpiece tips will only fit
one way and slot smoothly onto the handpiece. Never force a handpiece
tip into position.

After inserting
handpiece tip

Insert
carefully

Figure 4.14 Inserting the Handpiece Tip

Note: If a handpiece is left unused for an extended period


of time, replace the dummy tip and stow the unused
handpiece tip(s) in the provided case in a clean, dry place.

WARNING
Always wear protective goggles. The handpiece should always
be held face downward. Never look down into the handpiece
when power is being supplied to the system. Avoid holding the
handpiece face-upwards or leaving it unprotected to prevent
the ingress of foreign matter.

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 Chapter 4. Installation

4.5.2 STEP 2: Applying the Main Power


 Make sure that the main power switch is off (O) down.

 Check that the power supply is compatible with the system and
connect the power cord to the outlet on the wall.

CAUTION
When the device is not in use, make sure that the main power
switch is (O) off. If the device is to be left unused for a long
period of time, disconnect the system from the power and
consider removing the remote interlock plug and putting it in a
safe place as this will prevent accidental starting of the system.

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 Chapter 4. Installation

4.6 Moving the Device


Only persons authorized and trained by Lutronic Corporation should
disassemble and or reassemble the device or move it long distances. When
moving the device within a treatment room or over short distances within a
single location, note the following.

4.6.1 Moving the Device in the Treatment Room


 Ensure the system is switched off and unplugged.

 While holding the handle on the front of the unit, carefully move the
device to the new location while taking note of the general conditions
for installation previously explained in this chapter.

 If unsure or require assistance, please contact Lutronic Corporation.


Damage incurred while moving the system is not covered by warranty
unless the system has been prepared for transport by a Lutronic
Corporation trained engineer.

CAUTION
When moving the device to a different location, we encourage
you to contact Lutronic Corporation and request that a service
representative be sent to uninstall and re-install the system.
A fee may be charged for this service.

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MOSAIC HP
 Chapter 5. Operation

Chapter 5. Operation

5.1 Overview
This chapter contains important information about operating the MOSAIC
HP Laser System in a clinical environment and should be read in full before
using the system.

5.2 Pre-operational checklist

Prior to performing a treatment procedure, please check the


following items before operating the MOSAIC HP Laser System
while paying close attention to the cautionary items presented in
Chapter 2. General Safety Information.

 Everyone in the treatment room is wearing 1550nm laser protection


goggles or glasses with side protection in accordance with the ANSI
standard.

 The patient is wearing protective goggles.

 The tips of the handpiece and other devices are clean.

 The device is installed properly according to the procedure shown in


Chapter 4 Installation.

 The casters for the device are properly fixed in order to prevent the
device from moving?

 Any objects nearby that can reflect light, such as a mirror, should be
covered if not removed from the treatment room.

 Power plug is connected to the outlet only after making sure that the
local power supply in the treatment room is 100~240VAC with
proper grounding.

DANGER
Before connecting the power plug of the device to the local
power supply outlet, insert the handpiece tip on the handpiece
to be used. 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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 Chapter 5. Operation

5.3 Operation of the MOSAIC HP Laser System


5.3.1 STEP 1: Starting the System
 After completing the pre-operational checklist (see 5.2), ensuring that
the main power is on and that the correct handpiece tip for the
procedure has been installed, turn the key switch until the key LED’s
flash and the system starts.

 When the LCD display is activated, release the key which will
automatically return to the middle position. With the key in the
middle position, the system is operational and the key cannot be
removed. The system will perform various Power On Self Test
(POST) procedures before presenting the main welcome screen.

 The initial selection screen offers four options. Of these four,


OPERATION, HAIR and SETUP are selectable. The fourth,
CALIBRATION is reserved Lutronic trained engineers.

1 2 3 4

Figure 5.1 Initial Selection Screen

1. CALIBRATION
This is the device to measure the output energy of the system whenever it
is necessary to do so.

2. OPERATION
The operator may press this button to enter into the OPERATION mode.

3. HAIR
The operator may press this button to enter into the HAIR mode.

4. SETUP
The operator may press this button to set user-defined functions such as
simulation mode or buzzer sounds.

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5.3.2 STEP 2: Operation Mode


 DYNAMIC Mode
1. In the initial screen, select the “OPERATION” mode.
2. Press button 4 to select DYNAMIC mode as shown in Figure 5.2.

1
7 8
11
2 9

5 10 12

Figure 5.2 DYNAMIC Mode Screen

3. Press button 7 to select the treatment area (Body/Face) desired Ref 5.4.2
4. Press button 8 to enter to set the size of the treatment area. Ref 5.4.3

5. Select button 11 (Pulse Energy) and 12 (Pulse Rate) to adjust the amount
and speed of laser radiation that is suitable for the treatment area.
6. Step on the footswitch. At this moment, status message (#6) will shift
from “STANDBY” to “READY”.
7. If contacting the treatment area with the handpiece, the status message
(#6) will display “Lasing.” The laser beam will be radiated while the
buzzer sounds.
8. To terminate a session of treatment operation, lift foot off the footswitch
and hook the handpiece on its hanger.

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NOTE
 Before contacting the treatment area with handpiece,
the operator must first press the foot switch to start the
laser beam radiation.

 If the handpiece is not contacting the treatment area or


if the operator takes foot off the foot switch, the laser
beam radiation will stop immediately.

 The initial screen stores the status of the most recent


settings used by the user, thus the initial screen may
display different information each time is run the
device.

DANGER
In DYNAMIC mode, the laser beam radiates continuously as the
handpiece contacts the treatment area. Thus it is imperative
that the operator continuously moves the handpiece in
accordance with the treatment area.

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 STATIC Mode
1. In the initial screen, select the “OPERATION” mode.
2. Press button 4 to select STATIC mode as shown in Figure 5.3.

1
7
11
2 9

5 14 13

Figure 5.3 STATIC Mode Screen

3. Press button 7 to select the treatment area (body / face) desired Ref 5.4.2

4. Select buttons 11(Pulse Energy) and 14(Density) to adjust the energy and
density of laser beam radiation.

5. Depress the footswitch. At this time, the status message (#6) menu will
shift from “STANDBY” to “READY”.

6. Contacting the handpiece to the treatment area will cause the status
message (#6) to display “Lasing.” The laser beam of the energy and
density set by the operator will be radiated accompanying buzzer sound.
Removing the handpiece from contact in the skin will shift to “Ready”.

7. Remove the handpiece from the treatment area and make contact with
the treatment area, and then the laser beam will be radiated once again as
shown in step 6. For treatment operation, keep repeating this step.

8. To terminate a treatment session, take foot off the footswitch and hook
the handpiece on its hook.

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NOTE
 Before putting the handpiece in contact with the patient’s
skin, depress the footswitch. The MOSAIC HP laser system
is designed to initiate radiation only in this order of
operation.

 The system stores the most recent operation settings used.

 In STATIC mode, laser beams of the input density will be


radiated only once each time the handpiece is in contact
with the treatment area.

 For multiple applications, remove the handpiece from the


treatment area and then resume contact again. Radiation
will be radiated to the treatment area once again.

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5.3.3 STEP 3: Thermal Mode

 Thermal mode

1. In the initial screen, select the “OPERATION” mode.

Figure 5.4 Operation mode screen

2. Press “Thermal” button to enter Thermal mode as shown in Figure 5.5.


It does not make a difference whether Dynamic or STATIC mode is set
for the thermal operation.

Figure 5.5 THERMAL mode screen

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NOTE
 If the handpiece is not contacting the treatment area or if
the operator takes foot off the foot switch, the laser beam
radiation will stop immediately.

 The initial screen recalls the status of the most recent


settings used by the user, thus the initial screen may
display different information the operator runs the device.

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5.3.4 STEP 4: HAIR Mode

 HAIR mode

1. In the initial screen, select the “HAIR” mode.

Figure 5.6 HAIR selection screen

2. HAIR mode is as shown in Figure 5.7

6
1

11
2

4
13
5

Figure 5.7 HAIR mode screen

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3. Select buttons 11(Pulse Energy) and 13(Density) to adjust the


energy and density of laser beam radiation.

4. Push the status message (#6). At this time, the status message (#6)
will shift from “STANDBY” to “READY”.

5. Depress the footswitch. Contacting the handpiece to the treatment


area will cause the status message (#6) to display “Lasing.” The
laser beam of the energy and density set by the operator will be
radiated accompanying buzzer sound. Removing the handpiece
from contact in the skin will shift to “Ready”.

6. Remove the handpiece from the treatment area and make contact
with the treatment area, and then the laser beam will be radiated
once again as shown in step 4 and 5. For treatment operation, keep
repeating this step.

7. To terminate a treatment session, release the footswitch and hook


the handpiece on its hook

NOTE

 If the handpiece is not contacting the treatment area or if


the operator does not press the foot switch, then the laser
beam radiation will stop immediately.

 HAIR mode, laser beams of the input density will be radiated


only once each time the handpiece contacts with the treatment
area.

DANGER
It is required the exclusive hair tip is used properly for treating
hair only.

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 Chapter 5. Operation

5.3.5 Use of the Handpiece


 The handpiece tip is installed with a skin sensor to automatically sense
the handpiece tip contacting with the patient’s skin.

 To obtain good surgical effects, make sure handpiece tip is vertical to


the skin surface as possible. See figure 5.8

Right
Right Wrong

Figure 5.8 Using the Handpiece

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 Chapter 5. Operation

5.3.6 Turning off the System


 Normal Shut down

1. Hook the handpiece on its hook.

2. Press the “END” button on the LCD screen.

Figure 5.9 Screen of Turning off the system

3. Once the message “It is now safe to turn off the system” shows up, turn
the key switch counterclockwise until it stops, remove the key and keep
it in a safe place to prevent unauthorized and untrained persons from
operating with the device.

Figure 5.10 Key Switch first Step


4. If the device will be unused for a long period of time, remove the power
cord and/or the interlock plug from the system.

 Turning off the device with the Emergency Stop Switch

1. The operator should only use the emergency stop switch in case of
emergency. Press the emergency stop switch and the device will stop
running immediately.

2. To restore the system, rotate the emergency stop switch clockwise until
the switch clicks into position.

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WARNING
Because the latest set parameters are recalled, even though the
device is restarted, the operator must first reset the parameters
before carrying out a new treatment.

NOTE
 When turning off the device, the operator must press the
“END” button. Once the message “It is now safe to turn off
the system” is displayed, the operator can turn off the
device. This ensures device safety and stability.

 If the “CANCEL” button is pressed after pressing the “END”


button, the device will enter the operation mode.

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 Chapter 5. Operation

5.4 Descriptions of the buttons in the Operation Mode Screen

The function of each button in Operation Mode (Refer to Figure 5.11.) and
provided the descriptions of multi-functional buttons separately are
provided below.

5.4.1 Basic buttons of Operation Mode

Figure 5.11 Operation mode Screen

1. MODE SELECTION

ICON Button Name Description


It is a function used to reset the
treatment parameters including the
RESET size of the treatment area. If you press
this button for 3 seconds then the
device will be initialized.

CALIBRATION Energy Calibration button

SETUP Additional function-setting button

END Turn off button of system


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 Chapter 5. Operation

2. TIP LIFE

The unit for tip life is kJ (Maximum 9999kJ) and the tip life of a new tip is
indicated as “0kJ”. The tip lives are indicated according to each tip
distinguished from the others. Each tip life is derived as the total energy
accumulated as many as the number of times each tip is used.

 Derivation of the equation:


 (Total Energy each time(kJ) =
Pulse Energy(mJ) x Total Density(spot/ ) x treatment area( )

3. TIP INFORMATION
Indicates whether the handpiece tip is inserted to the handpiece or not. The
information on the size of the tip is also displayed. If the tip is not inserted
in the handpiece properly, then a warning sign will be initiated.

An L5x10mm handpiece tip is only detectable in STATIC mode, so


you should be careful when using it.

4. OPERATION MODE
This function allows users to choose operation mode. This button converts
STATIC to READY, and vice versa.
 STATIC: In this mode, the laser beam with the input density set by the
user will be radiated once each time the handpiece contacts the
treatment area. Ref 5.3.2
 DYNAMIC: In this mode, the laser beam will radiate continuously
while the handpiece is in contact with the treatment area. Ref 5.3.2

5. TOTAL ENERGY
This is the total amount of laser-beam radiation and it is the value obtained
by multiplying the total number of spots in the laser-beam and its pulse
energy.

 Derivation of the equation:


 Total Energy( kJ) =
total shots of the laser beam x Pulse Energy (mJ) x 1000 / 1000

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6. STATUS MESSAGE
Displays the status of the device and represents the following information.
 Lasing : Status of the laser radiation
 Ready : Status of preparation for the laser radiation
 Standby: Status of standby for the laser radiation

7. SELECT TREATMENT REGION


This function allows user to choose the treatment area of a patient’s body
(face or body). This button converts Face to Body, and vice versa. The
screen will change according to the treatment area chosen. Ref 5.4.2

8. AREA
Enter the size of each treatment area targeted for operation.
Ref 5.4.4 & 5.4.5

9. FACIAL REGION
 This screen appears when selecting FACE in the 7. SELECT REGION
menu.

 The region(s) display the density of the laser radiation in the treatment
area selected.

10. TOTAL DENSITY


It is the value obtained by multiplying the total number of spots in the laser-
beam that is radiated in one second (Hz) and the duration of such radiation
(sec) which is then divided by the size of the treatment area. And Coverage
(%) indicates the value which beam size times Total Density according to
each Pulse Energy.
Derivation of the equation:
 Accumulated number of radiated spots =
Spots (Hz) x Time of the laser radiation (sec)
 Total Density (Unit:spots/cm2 ) =
Accumulated number of radiated spots/Selected treatment area
 Coverage (%) =
Beam Size of each Pulse Energy x Total Density

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11. PULSE ENERGY


It displays the unit energy per each pulse of the laser-beam. It is
possible to set the pulse energy by using the Jog Shuttle or (+)/(-)
button
Setting Range: 4~120 (Unit: mJ )

12. PULSE RATE


It displays the speed of the laser radiation in DYNAMIC mode. It is
possible to set the speed of the laser radiation by using the Jog Shuttle or
(+)/ (-) button.

Display :

 Normal : 100% of the default speed of the laser radiation


 3/4 Speed : 75% of the default speed of the laser radiation
 1/2 Speed : 50% of the default speed of the laser radiation
 1/3 Speed : 33% of the default speed of the laser radiation

13. DENSITY
In STATIC mode, it is possible to set the density of the laser-beam by using
the Jog Shuttle or (+)/ (-) button. Ref 3.3.4

Setting Range: 50/75/100/200/300/400/500 (Unit: spots/cm2 )

14. Total Shot Count


In STATIC mode, this function shows the number of radiated spots. The
laser pulse emitted by pressing the footswitch is counted cumulatively. The
present shot count can be reset by pushing the reset button.

CAUTION
Since, in DYNAMIC mode, three different modes for the speed
of the laser beam radiation, namely, “Normal, 3/4 Speed, 1/2
Speed, 1/3 Speed” are the values set with respect to the pulse
rate.

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 Chapter 5. Operation

5.4.2 SELECT TREATMENT REGION


This function allows users to select the desired treatment area (face or
body). It converts face to body, and vice versa. The screen will be changed
properly according to the treatment area.

 Select the desired treatment area in operation mode by pressing


button 7.

 Each time button 7 is pressed, the icon and the screen will change.

7 7

Figure 5.12Example of the Treatment Area Selected in DYNAMIC

NOTE
When restarting the system, all the settings regarding
previously used parameters will be restored but the treatment
area will always remain in Face mode.

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5.4.3 SELECT AREA


Operator may select the treatment area and enter the region of each
treatment area.

 Entering to set the area of the treatment region in FACE mode

1. Press the AREA mode in Operation mode then the screen as


shown in Figure 5.13 will appear.

The color indicating the


selected area in the
forehead of a patient

Figure 5.13 Entering the region of the treatment area FACE mode

2. The selectable areas include Forehead, Left Cheek, Right Cheek,


Chin and Upper Lip and Nose. Select each region and then
enter the area of the treatment operation. Ref 5.4.4

3. As shown in Figure 5.13, selecting Forehead as the desired


treatment area causes a yellowish colored area to appear in the
screen to indicate the treatment area has been selected.

4. Use the (1) Jog Shuttle or press the (+)/ (-) button to enter the
region of the treatment area.

5. Follow the above steps for Left Cheek, Right Cheek, Chin and
Upper Lip and Nose and enter proper sizes of the treatment areas.

6. Press the 2 button and the screen shifts to operation mode.





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 Chapter 5. Operation

 SELECT AREA function in BODY mode

1. Select AREA in Operation MODE, the screen will be changed as


shown in Figure 5.14

Figure 5.14 Input Dialogue for the Size of the Treatment Area in
BODY Mode

2. Enter the size of the treatment area by using the (1) Jog Shuttle or
(+)/ (-) button.

3. Press the 2 button and the screen shifts to operation mode.

NOTE
When restarting the system, all the settings regarding
previously used parameters will be restored but the treatment
area will always remain in Face mode.

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5.4.4 Measuring the Area by the GRID MASK


 Features of the GRID MASK

去 Each block has a size of 1 x 1 cm2.


去 The basic size of each treatment area is displayed by numbers
and colors.

 How to use the GRID MASK

Fore Head

Block
Nose

Left Cheek Right Cheek

Specific Chin &Upper Lip


Basic Size

Figure 5.15. GRID MASK

1. Place the GRID MASK onto the facial area of the patient and then
firmly attach it.

2. The basic size of each treatment area and the number of blocks
located in the outer region should be summed up.

 Calculation of the size of each treatment area


Basic size of each treatment area + number of blocks outside the basic
area

3. With the SELECT AREA function, operator may enter the size of
each treatment area. Ref 5.4.3

NOTE
IT is recommended that the measured size of the treatment area
be recorded in a separate record log, as it could be very useful
for future treatment operation(s). For accuracy, the treatment
area may be marked using the provided treatment pen.

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 Chapter 5. Operation

5.4.5 FACIAL TREATMENT Mode: F-MODE / P-MODE


In SETUP mode, it is possible to choose either F-MODE or P-MODE
Ref 5.5 - 5. TREATMENT

 F-MODE

1. F-MODE is the basic mode with the default setting where the
entire facial area is selected as a treatment area.

Figure 5.16 Initial Screen in F-MODE

2. If there are some areas to be excluded from treatment operation,


touch those areas shown in the screen, the selected area will be
removed from treatment area as shown in Figure 5.17.

Total Density
of the area
excluded from
surgery

Figure 5.17 How to Select Left and Right Cheek in F-MODE

3. To perform on an area that was excluded, simply touch the desired


area on the screen again.

4. As shown in Figure 5.16, total density of the area excluded from


surgery represents the density of the laser-beam radiation before
being excluded.

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 Chapter 5. Operation

 SELECT FACIAL REGION in P-MODE

1. In P-MODE, users may select a certain treatment area of the


patient’s face by touching the desired facial shown on the screen.

Figure 5.18 Initial Screen in P-MODE

2. The selected treatment area will be displayed in yellowish blocks.


The facial area selected for the surgery will now have different
value of TOTAL DENSITY.

Total Density of
the area selected
for surgery

Figure 5.19 FOREHEAD selected as the treatment area in P-MODE

3. Touching the selected area again will exclude it from treatment


operation.

WARNING
If no treatment area is selected in P-MODE, then the warning
sign will be displayed on the screen and no laser-beam will be
radiated.

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 Chapter 5. Operation

5.5 Descriptions of SETUP Mode Buttons


It is possible to enter SETUP mode from the initial screen or Operation
mode. Operators may set parameters in relation to simulation or sound. At
this moment, the LED of the handpiece tip and the LED of the handpiece
will lite and start blinking.

2 5

3 6

4 7

Figure 5.20 Initial SETUP Screen

1. MODE SELECTION

ICON Button Name Description

CALIBRATION
Energy calibration mode button
MODE

OPERATION
Operation mode button
MODE

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 Chapter 5. Operation

2. TREATMENT

 P-MODE Setting

In this mode only a certain area of the patient’s face can be selected.
Manipulate the touch screen in the sequence as shown in Figure 5.21

Figure 5.21 P-MODE Setting

 F-MODE Setting

In this mode the entire area of the patient's face as a treatment area can be
selected. Manipulate the touch screen in the sequence as shown in Figure
5.22

1
2

Figure 5.22 F-MODE Setting

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 Chapter 5. Operation

3. SIMULATION
 Simulation mode helps operators to become familiarized with the
device in the earlier stages of use.

2
1

Figure 5.23 SIMULATION Mode Setting

1. As shown in Figure 5.23, select “SIMULATION” (1).


2. Select “ON (2)” in “OFF” mode.
3. Select the Operation Mode Button (3).

Figure 5.24 SIMULATION Mode Being ON/OFF

 Once the SIMULATION mode is set properly, the Operation screen


will display the status of setting as shown in Figure 5.24.

NOTE
Once the simulation mode is set, the laser-beam will not be
radiated. But all the treatment parameters and information will
be displayed on the screen as if a real treatment operation is
taking place.

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4. INFO
Touch the INFO button to view the location and address of Lutronic
Corporation headquarters as shown in Figure 5.25.

Figure 5.25 INFO Screen

5. HELP
Help button allows users to learn how to operate the device.

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 Chapter 5. Operation

6. SOUND
 EFFECT SOUND Setting

The Effect Sound function allows users to set the sound-effect ON/OFF.
Manipulate the touch screen in the sequence as shown in Figure 5.26.

2
1

Figure 5.26 Effect Sound ON/OFF Setting

 LASER SOUND Setting

The Laser Sound function allows users to set the laser sound ON/OFF.
Manipulate the touch screen in the sequence as shown in Figure 5.27.

1
2

Figure 5.27 Laser Sound ON/OFF Setting

DANGER
According to IEC60601-2-22, the sound effect when lasing
might be set “OFF” only the simulation mode that real laser
never emits, and it is required that the sound effect when lasing
is set “ON” in the operation mode that real laser emits.

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 Chapter 5. Operation

7. SERVICE
This service mode is available for updating the software of the device and
repairing the device. Only persons authorized by Lutronic may access this
mode.

WARNING
If an unauthorized service person uses this service mode, it
may cause malfunction of the device which in turn could result
in severe physical injury. If such an action occurs, it will void
the warranty of the product.

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 Chapter 5. Operation

5.6 Calibration Mode


Calibration Mode can be selected from the Touch LCD opening menu or
operation mode, and allows to user check to the output energy using the
handpiece if necessary.

Figure 5.28 Calibration Mode Selection Screen

5 .6.1 User Calibration Process Procedure


Once the user entered Calibration Mode by touching on Screen, it will be
displayed like 5.29

1 2 3

Figure 5.29 Calibration Screen

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 Chapter 5. Operation

1. After removal of the handpiece tip, please insert the handpiece into the
Calibration port located on the device.

Figure 5.30 The method of handpiece insertion


2. When the handpiece is connected correctly, it works automatically from
0 to 100.

3. The result of calibration is classified to 3 types “OK”, “CHECK”,


“ERROR” and displays on the Touch LCD screen.

NOTE
 If the result of calibration displays as CHECK or Error
message, please contact Lutronic or your local Lutronic
agent.

 In case of running calibration again, the time interval


should be at least 2 minutes.

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 Chapter 6. Maintenance & Management

Chapter 6. Maintenance & Management

6.1 Overview
Chapter 6 describes the maintenance guidelines, including the periodic
inspection needed to maintain the performance of the device and the
information on error codes to be used in self-testing devices for the device.

CAUTION
When users wish to inspect the device on their own, they must
first turn off the power of the device and then disconnect the
power cord. Attempting to inspect the device while the electrical
power is on may cause severe damage to the device or to the
user.

The MOSAIC HP laser system is designed so that maintenance and


management of the device is minimized. However, to guarantee the most
effective result of the surgical operation, the exterior of the device and the
handpiece, including its tip, should be cleaned thoroughly at all times.

6.2 Cleaning the Touch LCD Screen and the System Console
 Soak a soft pad in non-corrosive cleansing liquid such as isopropyl
alcohol or 90% ethanol and gently wipe the surface areas.
 Wipe down the device once again with a clean, dry pad or let it
naturally air dry.

CAUTION
Do not apply cleansing liquid directly to the system console or
the LCD touch screen as it may damage or cause the system to
malfunction.

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6.3 Cleaning the Handpiece


The handpiece unit should remain clean at all items. Follow the cleaning
procedure below.

拠居 Use a soft, lint-free dry cloth. Soak it in alcohol and clean the entire
area of the handpiece except its window.

挙居 When alien substances are found on the lens of the handpiece, blow
them away with an air blower carefully so that the window is not
damaged.

渠居 If the above procedure does not eliminate all the alien substances,
then as shown in Figure 6.1, soak a cotton bud in 90% alcohol and
wipe out the area thoroughly.

Window

Figure 6.1 Cleaning the Handpiece Window

虚居 After cleaning, shine a light onto the tip of the handpiece and
examine it.

NOTE
If you are unable to eliminate alien substances using the above
protocol, then:
 Soak a lens paper or cotton swab in ethanol. Allow one drop
of ethanol to fall onto the top of the lens. Soak alien
substances in ethanol for 3 to 5 seconds.
 Once the alien substance is thoroughly soaked, use a
cotton swab to remove it.

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 Chapter 6. Maintenance & Management

6.4 Cleaning the Handpiece Tip


The handpiece tip should be clean at all times. Follow the cleaning procedure
below.

1. Use a soft, lint-free dry cloth and soak one end of it in alcohol.

2. Clean the tip window carefully so that the window is not


damaged.

3. If the above procedure does not eliminate all of the alien substances,
then as shown in Figure 6.2, soak a cotton swab in 90% alcohol and
wipe the area thoroughly.

Window

Figure 6.2 Cleaning the Handpiece Tip

4. After cleaning it, shine a light onto the tip and examine it.

5. Store the tip in the provided case until its next use.

NOTE
If you are unable to eliminate alien substances using the above
protocol, then:

 Soak a lens paper or cotton swab in ethanol. Allow one


drop of ethanol to fall onto the top of the lens. Soak alien
substances in ethanol for 3 to 5 seconds.

 Once the alien substance is thoroughly soaked, use a


cotton swab to remove it.

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 Chapter 6. Maintenance & Management

CAUTION
 The handpiece tips should be sterilized before applying it
to the surgical area of a patient. Improper handling of the
handpiece tip may incur damage as a result.

 When using cotton swab to wipe out alien substances, do


not exert excessive force on the lens as to avoid
damaging the coating of the lens’s surface.

 Failure to maintain or manage the condition of the window


of the handpiece tip will result in undesired accumulation
of on its surface, result in possible fatal damages to
handpieces optical system.

NOTE
When the user irradiates with the laser beam, irradiation is not
only possible through the surface of the tip window but also on
the out sides of the tip window. This is visible as black spots
will appear on the surface of the tip window. In such cases,
please contact the Lutronic service representative immediately
for advice.

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 Chapter 6. Maintenance & Management

6.5 Troubleshooting
Chapter 6 describes the maintenance guidelines, including the periodic
inspections, needed to maintain quality performance of the device, and the
information on error codes to be used in self-testing devices for the device.

6.5.1 When the power does not turn the device ON, please check the
following items.
 Check that the power cord is correctly inserted into the main power
outlet.

 Check that the main power switch is in the ON (1) Mode.

 Check the condition of the fuse inside the device.

6.5.2 When the device is powered on but no laser beam is being


radiated, please check the following items.
 Check if the foot switch is correctly inserted into the socket.

 Check to see if the tip is correctly mounted to the handpiece.

 Check the lifetime of the handpiece tip.

 Check to see if the handpiece tip is making good contact with the
surface area.

 Check to see if the remote interlock is properly inserted into the socket.

CAUTION
If the laser beam is not being radiated for a long period of time,
turn off the device first and then turn it on again after two
minutes. Even if the problem persists, do not disassemble the
device or take inadequate actions on your own. Always contact
your authorized distributor or contact Lutronic for assistance.

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6.5.3 When the laser beam radiates with insufficient output power,
please check the following items.
 Check to see whether the handpiece window is damaged or dirty.
If alien substances reside on it, clean the window first before using
it again.

 If the problem persists after taking the above actions, contact your
authorized distributor or contact Lutronic for assistance.

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6.6 Understanding Error and Warning Messages

The system continuously monitors its condition and notifies the user of any
problem by displaying error messages such as that shown in Figure 6.3
listed in the following table.

Figure 6.3 Interlock plug Warning Message

Message Possible Cause Recommended Action

Turn off the device and reset


Error 01 Emergency Switch On the emergency switch. Restart
the system.

Turn off the device and restart


Error 02 Network Failure
the device after two minutes.

Turn off the device and restart


Error 03 Network Failure
the device after two minutes.

Turn off the device and restart


Checking 04 Checking Scanner
the device after two minutes.

Turn off the device and restart


Checking 05 Testing... Please Wait
the device after two minutes.

Turn off the device and then


Error 06 Faulty Door Lock close the door lock on the
back of the device.

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Mount the remote interlock in


Error 07 Faulty Interlock Connection the socket located on the back
of the device.

Insert Handpiece into


Warning 08 Insert Handpiece
calibration port correctly.

You cannot use laser in this Select Facial Region and


Warning 99
situation operate the device.

CAUTION
You are advised to take proper actions for the nature of each
error message. If the error persists after taking proper
actions, contact your authorized distributor or Lutronic for
assistance. If a person, not properly authorized by Lutronic,
opens the cover of the device or takes an improper action,
then the purchaser will be ineligible for any unpaid services
guaranteed by the product warranty and may even lead to
fatal damage to the device or even cause severe physical
injury.

6.7 Periodic Servicing


Lutronic recommends the periodic servicing of this equipment by a
trained Lutronic engineer 12 months after its first installation and
every subsequently 12 months.

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Chapter 7. Clinical Guide

7.1 Overview

The following clinical information comes from material recommended or proposed


by doctors who have experience in using the MOSAIC HP laser system or excerpts
from literature in the relevant fields of study. Lutronic Corporation shall not be
held liable in any way for potential problems that may occur due to inadequate or
wrongful use of such materials or excerpts.

Education and Training


Before using the MOSAIC HP laser system, every operator should read the
contents of this manual very carefully and be fully familiar with all relevant items.
Every user of the MOSAIC HP laser system is advised to attend a lecture on
∫related physics, safety issues on lasers, laboratory
fractional laser covering laser∫
participation and observation of patients. Special recommendation materials
intended for training doctors are already made available in the publication of
‘ANSI Z136.4 standard’. However, users should always refer to the newest
literature relevant to modern clinical practice. If you wish to obtain more detailed
∫908∫
information, please contact Lutronic Corporation by dialing 82 - 31∫ ∫3440
or sending an email inquiry to edu@lutronic.com.

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7.2 Clinical Guide

Introduction of the MOSAIC HP Laser System

The MOSAIC HP laser system is an Er:Glass laser with a wavelength of 1550nm,


∫upgraded fractional technology applied and it can create multiple
with newly∫
micro laser beams based on fractional photothermolysis theory. The fractional
laser system is a total aesthetic solution with a new concept that includes the
exceptional clinical effects of the conventional Ablative Skin Resurfacing (ASR)
∫Ablative Skin Rejuvenation (NAR) lasers.
lasers and the safety of the Non∫

The wavelength of Er:Glass laser (1550nm) is very weakly absorbed by water of


intracellular and skin tissue. As a result, unlike the CO2 or Er:YAG lasers which
show very high rates of absorption to water when radiated onto the skin, the
Er:Glass laser causes hardly any vaporization or punch in the skin tissue. (Refer to
Figure 7.1)

The MOSAIC HP laser system allows users to accurately and precisely adjust
number of micro beams from 300-2,000 per unit area (described as spots/cm2) of
the skin and penetrate laser beams from the epidermis to the deep dermis. The
non-treated skin tissue surrounding the MNCs is stimulated by micro necrotic
columns promoting rapid recovery of the entire skin by biostimulation reaction of
normal tissue.

Because less than 20% of the skin surface area is treated per each treatment,
which is a fraction of the target area, more than 80% of the adjacent viable tissue
is left intact, the downtime is minimized and severe side effects hardly occur.
Therefore, the treatment itself is much less destructive and promotes regeneration
of both epidermis and dermis, showing excellent total skin regeneration effects
compared to that of ablative skin rejuvenation method.

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CO2
(10,600nm)

Er: YAG
(2940nm)

Er:Glass
(1550nm)

Figure 7.1 ABSORPTION SPECTRUM OF WATER

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Fractional Laser Interaction with Skin Tissue

Although the MOSAIC HP laser system causes micro thermal damage in the skin,
that is necrosis and coagulation, skin renewal is stimulated via the rapid
remodeling response from surrounding normal tissues. MOSAIC HP does not
cause any ablation of skin due to vaporization of epidermal tissue during
treatment. After the treatment, stratum basale multiplies new cells pushing
epidermal debris formed from damaged epidermis toward stratum corneum.
During the healing process, the epidermal debris safely protects against invasive
damage and infection from outside until it naturally peels off, so that rapid wound
healing is achieved. Therefore, within 24 hours after laser was irradiated, re-
epithelialization on the damaged epidermal skin can be achieved through rapid
proliferation and movement of cells from stratum basale and patients won’t feel
any inconvenience for normal daily living. At the same time, the micro beams that
have penetrated into the deep dermis will induce synthesizing and remodeling of
collagen, while simultaneously replacing micro necrotic collagen and initiating
photobiostimulation to the surrounding normal fibroblasts. As a result, we may
∫term skin rejuvenation effects. (Refer to Figure 7.2)
expect long∫

Through remodeling of epidermis and dermis by numerous micro laser beams


onto the skin provides regenerative solution to various epidermal and dermal skin
lesions. This treatment method effectively improves photo-aging skin lesions with
epidermal and dermal complications such as pigmentary changes, wrinkles,
telangiectasia, etc. It also shows effectiveness in improving messy and dark skin
tone by non-selectively destroying the epidermal layer which contains pigmentary
lesion, and replacing it with normal tissue. This treatment is applicable to
pigmentary disorders such as melasma or PIH. Fractional laser dramatically
improves various deep dermal lesions (acne scar, traumatic scar, post-operative
scar, striae distensae) by regulating pulse energy which determines penetration
depth of micro laser beam and diameter of micro necrotic columns.

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Its effectiveness as a non-ablative fractional skin regeneration, which has less


downtime in daily living and causes less side effects after treatment than the
traditional ablative resurfacing method in treating such as wrinkles, scars and
photo-damaged skin, etc. has already been proven through numerous clinical
studies.

Figure 7.2 FRACTIONAL TECHNOLOGY CREATES MNCS

The MOSAIC HP laser system has shown promotable effects in the various types
of alopecia - Androgenic alopecia, female pattern alopecia and alopecia areata.
(Figure 7.3) Followings are strong points of depilatory treatment with Fractional
Laser MOSAIC:
Firstly, hair re-growth would be expected by the mechanical stimulation with
depth control of micro beam.
Secondly, it does not interrupt to normal hormones inside the body. Therefore, it
would be a safe treatment for women who are contraindicated to systemic
medications for hair re-growth.
Thirdly, a synergy effect can be expected with the combination therapy with other
treatments for hair re-growth.
Lastly, this is a safe treatment which does not cause damages to normal hair and
normal hairs are not cut by the treatment.

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Figure 7.3 Stimulation of hair follicle and improvement of scalp

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What’s New in The MOSAIC HP Fractional Technology?

1. Controlled Chaos Technology™


The patented technology of The MOSAIC HP Laser System, “Controlled Chaos
Technology™” allows users to radiate micro laser beams on the treatment area
in a random spray pattern. Conventional fractional laser system uses regular
beam pattern which radiate numerous micro beam simultaneously in a relatively
limited small area. However, this creates extremely insufficient space area in
between each laser beams, not allowing enough thermal relaxation time.
Eventually this results in not only pain during treatment but also post-treatment
side effects by bulk thermal damage. Furthermore, irregular overlapping
incurred by paint brush method induces excessive thermal damage on some
treatment area. The significant advantage of The MOSAIC HP is to create a
uniform and even distribution of laser beam by maintaining maximum distance
between each laser beam at a properly timed interval. (This occurs very rapidly,
therefore not interfering treatment time). In conclusion, The MOSAIC HP
fractional technology is far more accurate and safer than other fractional laser
systems, yet still treatment result is natural satisfying patient satisfaction.

2. Dual Operation Mode


The MOSAIC HP laser system is equipped with two different operation modes,
namely, Dynamic Mode, where the laser beam is continuously radiated as the
handpiece moves and Static Mode, where the amount of laser beam radiation is
proportional to the density set for a unit area. The former is used for large
treatment areas such as full face or body which requires rapid treatment and
uniform result, and the latter is used for local or small sized scar which requires
a more selective and delicate approach. Users can freely switch between these
two modes or combine both according to users’ preference.

In Dynamic Mode, the MOSAIC HP Laser System can accurately calculate and
automatically display the Total Density which is computed as dividing total

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number of micro laser beams radiated(total spots) by encoded total treatment


area(cm2), This provides objective numerical data which enables users to adjust
the parameter more accurately and precisely.

3. Thermal Mode
Though it has been impossible to change pulse width in existing Er:Glass
fractional lasers, MOSAIC HP laser system supplies thermal mode which has
wider pulse width compared to the normal mode. Pulse width at Thermal
Mode is double that of Normal Mode and it will maximize efficacy of Dermal
Heating. MNCs (Micro Necrotic Columns) are formed as thinner and deeper
shapes in the thermal Mode than in the normal mode. Lateral damaged areas
in the thermal mode are wider and shallower than that of the normal mode.
(Figure 7.4) On the basis of indications, normal or thermal mode would be
selected. Thermal Mode which has more efficient in Dermal Heating effect is
recommended for Skin Rejuvenation treatment. And normal mode is
recommended for treating dermal scars. Coverage percentage will be increased
relatively in the thermal mode that it is recommended to reduce the total density
of thermal mode to half of the normal mode considering the PIH occurrence in
Asian skin.

MNC in Normal Mode MNC in Thermal Mode


Figure 7.4 MNC in Thermal and Normal Mode

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4. Transparent Gliding Oil


Transparent gliding oil developed for this system is made from natural sources,
and enables the hand piece to move freely without any friction against skin on
dynamic mode. In addition, transparency also provides users clear observation
on skin reaction. However, in Static Mode gliding oil is not needed during
treatment procedure.

5. Operational Options : P mode and F mode


As additional operational options, users can select between two modes,
P(Partial) mode and F(Full face) mode for more convenient treatments. The
MOSAIC HP divides whole facial area into five cosmetic units(namely, forehead,
right and left cheeks, nose, chin) based on the skin types and reactions of each
region. P mode displays computed Total Density of selected cosmetic unit,
providing more accurate and precise approach to treating only one of specific
regions of the faces such as forehead or cheeks, etc. On the other hand F mode
displays computed Total Density based on full face area. In this F mode, the
operator can exclude a certain cosmetic unit from the full face area, and Total
Density will be computed based on the remaining areas of the face. F mode is
recommended for full face skin rejuvenation.

6. Skin Sensing Tip (Skin Contactable)


MOSAIC HP radiates laser beam only when hand piece tip touches on skin after
stepping on its foot switch. Therefore, treatment time is minimized, and safety
and accuracy is ensured during treatment. Four different sized tips (e.g. 10X10,
8X8, 6X6, 5X10mm) are available according to size and location of skin lesions.

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7. Tip for Hair Re-growth Treatment


There are two types of tips for hair re-growth treatment. If 12x2 mm hair tip is
applied to the handpiece, the MOSAIC HP will automatically turned on to
“Skin Sensor Off”.

12x2 mm Hair tip: functioning as a Skin Sensor OFF, convenient for


treating in-between parts of hair on both sides.
10x10 mm Non-Contact tip: functioning as a Skin Sensor ON,
convenient for treating wider areas. Using this tip significantly reduces
operating time.

12x2
12x2 mm Hair tip 求10x10 mm Non-
Non-contact tip

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Treatment Parameter

The most important treatment parameters used in the MOSAIC HP laser system
are Pulse Energy(mJ) that determines the penetration depth and diameter of the
Micro Necrotic Columns (MNCs), and Total Density(spots/cm2) that determines
the density of the micro beam radiated to each unit area of a patient’s skin. As the
Pulse Energy increases, the laser beam can penetrate more deeply through the skin
tissue and the diameter of the MNC increases as well. Therefore, operator should
avoid excessive thermal damage by relatively decreasing Total Density whenever
use high Pulse Energy in each treatment session, targeting the same treatment area
which is 5-20% in general). Since both Pulse Energy and Total Density are
important clinical parameters, they should be adjusted delicately to achieve
optimal clinical result while minimizing side effects.

1. Adjusting Pulse Energy


High energy above 50mJ is more effective to treat Acne scars. It is also effective
in Skin rejuvenation treatment to improve aging skins such as wrinkles, large
pores and skin laxities. On the other hand, low energy about 10mJ is good for
the normalization of epidermis such as the improvement of uneven skins.

Even when treating same kinds of lesions, users should apply different pulse
energies according to its particular location on the body such as face, neck, and
extremities, and should also consider different approach according to skin types
and different age groups. Generally, body area recovers slower than facial area,
and tends to involve post treatment complications easily. Therefore choice of
appropriate Pulse Energy should be very critical. The younger patients, the
more sensitive to pain induced by laser.

2. Appropriate Total Density


Total Density is correlated with treatment coverage which is the averaged
percentage of the treated to total skin area at each session. At the same energy

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level, higher Total Density yields more dramatic effects due to larger area
stimulated by laser beams per session. However, since higher Total Density also
means dense spread of micro laser beams, there is higher risk to incur burning
to tissue due to overlapping of thermal damage (especially in skin type V and VI).
To prevent this side effect, it is advisable to avoid high Total Density when
applying high energy since higher energy involves wider thermal damage to the
area.

Generally, lower energy level is set in combination with higher Total Density
and vice versa. In the instance of achieving high Total Density at high Pulse
Energy, it is advisable to decrease Unit Density per pass (in Dynamic Mode) or
per stamp (in Static Mode), and repeat multiple passes or stamps instead in
order to achieve the same high Total Density. Intermittent cooling in between
each successive pass also minimizes thermal damage.

For The MOSAIC HP treatment, the treatment coverage percentage is


automatically displayed on the MOSAIC HP operation screen (on the left-hand
side of the Total Density display in Dynamic Mode) based on the applied Pulse
Energy and Total Density. Users should be advised to limit treatment coverage
percentage to no more than 20% in each treatment session.

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7.3 Clinical Applications

The MOSAIC HP Laser System is basic device for various scars and total skin
rejuvenation, and it can be applied to any of the following applications;

 Various types of scars: acne scars, surgical scars, traumatic scars, burn
scars, keloid and striae distensae
 Wrinkles: periorbital, periorbital wrinkles
 Photo-damaged skin: rough and uneven skin tone and texture, large pores,
excessive secretion of sebum
 Melasma
 Pigmented lesions such as dyschromia, dyspigmentation, seborrheic
keratosis, etc.
 Redness and telangiectasia
 Inflammatory acne
 Eyelid laxity
 Total skin rejuvenation of face and off-face area (hand, neck, chest)
 Hair Re-growth (New!)

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7.4 Treatment Protocol

Lutronic Corporation does not recommend a specific variable or clinical guideline


for treatment with laser beams. The following is merely recommended by the
clinical experiences of doctors who have used fractional lasers and published
academic articles.

The treatment procedure using the MOSAIC HP Laser System includes the
followings; Recording a patient’s clinical history, Accurate diagnosis of the lesions,
Notifying the patients of information on laser treatment, Informing patient of
expected outcomes and potential post-treatment side effects, informing patient of
pre-treatment cautions and general laser treatment procedure including anesthesia,
post-treatment care; prescribing post-treatment medication; notification of
guidelines to be followed after treatment; and finally follow-up for monitoring the
recovery process.

The post-treatment clinical results may differ significantly depending on


characteristics of the patient’s skin types or lesions to be treated. So, it is very
difficult to predict the clinical results accurately before treatment. In order to
select proper treatment parameters for The MOSAIC HP laser therapy and to
obtain the most effective clinical result, first of all, the operator should have a very
good clinical and pathological understanding of each lesion. To perform a safe
treatment, you should carefully try conservative treatment parameters at the first
session.

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Pre-treatment Preparation

Step 1. Consultation
 Before performing The MOSAIC HP Laser Therapy, every doctor should
first check presence of contraindication to laser therapy by reviewing the
patient’s symptoms, clinical history, body condition, history of drug abuse
in order to determine laser therapy is appropriate or not. Patients should
be informed of potential complications and expected outcomes of the
therapy.

Step 2. Preparing the Treatment Area of Skin


 Clean the treatment area thoroughly and remove any make-up and
sebum.
 Take at least three photographs from the sides and the front prior to
treatment.

Step 3. Applying Topical Anesthetic


 Apply topical anesthetic on the entire skin surface. Wait for 40 minutes to
one hour (Time may vary according to the concentration of topical
anesthetics). Apply topical anesthetic just a little bit more outside the
borderline of the treatment area to minimize the pain that the patient may
feel whenever handpiece tip passes over the borderline during the
treatment. In order to help anesthetic ointment to be absorbed by skin, you
should put in place a grid mask.
 Local anesthetic may be used when treatment requires high Pulse Energy.
(e.g. local scars)

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Step 4. Measuring the Size of Treatment Area (in Dynamic Mode)


 You may easily measure the size of the treatment area by using a Facial
Grid Mask (Refer to Figure 7.5) and Grid Sheet designated for the
MOSAIC HP treatment.
 How to use the MOSAIC HP’s Facial Grid Mask or Grid Sheet
∫After applying topical anesthetic and outlining the borderline of each
facial area or localized skin lesions, place a polyethylene Facial Grid Mask
or Grid Sheet on the skin surface. Please make sure the nasal cavities and
mouth are aligned with the holes of the Facial Grid Mask.
∫ Count additional blocks that are beyond the pre-counted shaded area,
and add it to the number of blocks in pre-counted shaded area. In case
pre-counted shaded area is bigger than actual facial treatment area of the
patient, the number of blocks that is beyond the actual facial treatment
area of the patient is subtracted from the number of blocks in pre-counted
shaded area. For example if the forehead region is larger than the pre-
counted shaded area(42), add the number of additional blocks to be
covered during treatment to the number of blocks in pre-counted shaded
area in order to arrive at the total area number that will be treated during
the treatment. If the forehead is smaller than the pre-counted area(42), do
subtraction instead of addition. (1 Block=1cm2)
 Measure the size of the treatment area at the first session of each patient
and record it on the chart. It is not necessary to take another measurement
from the second treatment.
 The more accurate the measurement of the treatment area is, the more
accurate the Total Density will be displayed.

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Number of
1 Block=1cm2
blocks in pre-
counted shade
area of each
cosmetic unit

A patient with a Grid Mask

Figure 7.5 Grid Mask

Step 5. Recording and Encoding the Size of the Treatment Area


 Enter the size of each treatment area in the main operation screen of the
MOSAIC HP Laser System. (Refer to Figure 7.6)

Figure 7.6 Input Dimension of Each Region

 To enter the size of the treatment area, select and touch a certain cosmetic
unit on figure of face on the screen. The selected area will appear in orange
and the color of the input field corresponding to the selected area will also
change. To adjust treatment area size, press the + or – key or use the
∫shaped ring on the right.
circle∫

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 After finishing adjustment of treatment area size of all cosmetic units,


press “SUBMIT” to save your settings.

Step 6. Removal of Topical Anesthetic


 After 40 minutes to one hour for topical anesthesia, remove the Facial Grid
Mask or Grid Sheet and wipe off the topical anesthetic thoroughly. (Time
for anesthesia may vary depending on the concentration of each topical
anesthesia)

Step 7. Applying Gliding Oil Designated for the MOSAIC HP


Laser System
 When operating, the MOSAIC HP handpiece tip must remain in contact
with the skin surface while the laser beam is being radiated. To move the
handpiece along the skin surface smoothly in Dynamic Mode, apply a thin
layer of the specially formulated gliding oil onto the skin surface before
treatment. This oil is not harmful to human skin, you may easily check skin
reaction during treatment because it is colorless. Patient does not need
cleansing of Gliding Oil after treatment. The gliding oil is not needed when
using static mode only.

Forehead : Area below Hair line and area above


eyebrow
Cheek region: Area outside the nasal furrows
Forehead ZoneForehead and area in front of the ear. Area below the
eyebrow including the per orbital area.(Both
left and right sides are considered to be
Cheek Zone Cheek Region separate area)
(+Periorbital) (+Periorbital area)
Chin region : Area inside the nasal furrows and
Nasal the chin, including the upper lip area below
nose.
Chin Region
(+Perioral area) Nasal region : Entire area of the nose starting
from the middle of the eyebrow

Figure 7.7 Five Cosmetic Units of Face

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Treatment Procedure except alopecia treatment

Step 1. Treatment Parameter Setting

 Before starting the treatment, you should set the treatment parameters
based on location of treatment area, size and characteristics of lesions.
First of all, select the Operation Mode in the main operation screen. Next,
in dynamic mode, select Pulse Rate (Hz) which means micro beams
radiation speed (Normal, 3/4 speed, 1/2 Speed, 1/3 Speed) and in static
mode, select the density (50, 75, 100, 200, 300, 400, 500 spots/cm2) which
means numbers of beams per square centimeter. Then adjust the Pulse
Energy based on the depth of each lesion. After that, start the treatment.

Step 2. Operation Technique

 Handpiece tip should always remain perpendicular to the skin surface.


 In dynamic mode, the laser beam is radiated continuously, thus it is
imperative to constantly move the handpiece at a consistent speed and in
the same pattern, so it does not stay in one area.
 In static mode, only when contact the handpiece tip on skin surface after
stepping on the foot switch, the specific numbers of laser beams with the
selected density will be radiated. At this moment, the operator must wait
until the red LED located on the handpiece tip completely turns off before
removing the handpiece from the skin surface.
 In dynamic mode, users can move the handpiece freely in various moving
patterns as shown in Figure 7.6. However, at each pass users should use
only one moving pattern at consistent speed for more accurate
computation of Total Density on the operation screen.

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Figure 7.8
Multiple Moving Patterns and Facial Areas Needed Special Cautions

 When treating a relatively small area in dynamic mode, the Total Density
count displayed increases quickly. Thus use small sized tip (6X6mm) and
set the speed of the laser beam radiation to "1/2 Speed" or "1/3 speed" to
reduce any unexpected thermal damage due to thermal overlapping.
 Repeat pass on the entire treatment area until the Total Density per unit
area reaches the desired value. Frequently monitor skin reaction of the
patient and sensitivity to pain throughout treatment and adjust the Total
Density accordingly. Sensitive areas should be exposed to less Total Density
compared to other areas. Carefully observe skin reaction at the end of each
pass, then determine necessity of additional pass. Apply cooling frequently
in between each pass.
 It is convenient to use static mode when treating sparsely-distributed scars.
To avoid unnatural looking of demarcation between treated areas and
untreated areas in static mode, finally apply 2-3 passes at the same energy
setting in dynamic mode to create smooth and natural looking. For broad
distributed lesions such as acne scars, dynamic mode is more effective than
static mode.
 In general, treat specific lesions such as scars with high Pulse Energy at
first, and then treat entire treatment area with skin rejuvenation
parameter.

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 For detailed information on Pulse Energy and Total Density for each
indication, please refer to our the MOSAIC HP Clinical Parameter
Guidelines
 Cautions for the MOSAIC HP Treatment

The treatment parameters for each lesion should be adjusted properly based on
the skin reaction of each patient. When performing the first session, you should
use relatively conservative treatment parameters. From second session, adjust
those parameters gradually based on the skin reaction (persistent time of
erythema and edema) and clinical effects.

 When treating the perioral or periorbital area, avoid very high Pulse
Energy and Total Density. In particular, the perioral area requires special
attention as herpes simplex or PIH is likely to occur. Be sure to carefully
examine skin reaction of the treated area for 1-3 days post treatment. In
general, for the same level of Pulse Energy, the Total Density should be
around 1/3 of other areas.
 When treating small areas such as nasal or periorbital area in dynamic
mode, use 6*6 handpiece tip at 1/2 or 1/3 speed.
 According to the location of treatment area(i.e. face, neck) and the
characteristics of the lesions, the Pulse Energy should be properly adjusted.
In addition, based on the observed skin reaction (i.e. erythema or edema),
Total Density should also be properly adjusted.
 When increasing Pulse Energy upto 25mJ or above in static mode, set
Total Density at 200spots/cm2, then reach desired Total Density by
repeating stamping. Always examine skin reaction after lasing two
successive shots over the same area, and apply cooling for about one
minute.
 When treating acne scars accompanied by active inflammatory acne, active
acne may improve. However occasional aggravation and worsening may
also occur. Therefore special caution is required.

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 For high pulse energy treatment, Total Density need to be devided into 2
treatments with 50 spots/cm2 per each. It is recommended not to exceed
Total Density of 100 spots/cm2. After the first pass, clinician should check
the patient’s skin reaction carefully and decide to continue or cease the
procedure. For avoiding overlapping, lased area may be slightly changed
in the second pass.
 Although the energy is high, density is very low in high pulsed energy
treatment. Following the guidance of treatment protocol, blisters would not
be occurred in high pulse energy treatments. Due to the heat in the skin,
a sufficient cooling after the MOSAIC HP treatment is required.

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 Chapter 7. Clinical Guide

Efficacy Expectations

After a MOSAIC HP Laser System treatment, satisfactory clinical outcomes in


most cases are expected. However some patients are not. In many cases,
unsatisfying clinical effects are resulted from inappropriate handling of
parameters. Factional laser treatment affects only 20% of the total treatment area
at each session. Dermal remodeling requires several months. Therefore to have
satisfying result, at least 3 sessions are recommended. Doctors should notify
patients of all such relevant information of treatment and treatment outcome so as
to avoid unrealistic expectations of therapy.

Incidence of Pain

The MOSAIC HP laser system creates micro laser beams that penetrate into the
deep dermis and some pain is expected during treatment. However, the level of
sensitivity to pain differs from one patient to another. The deeper the location of the
lesion, the higher the Pulse Energy should be used and thus patients may feel more
pain. And Dynamic Mode induces more pain than Static Mode. The pain is often
described as if a fine needle is irritating the skin with a slight burning sensation.
Lowering Pulse Rate from “Normal” to “3/4” , “1/2” or “1/3” speed helps to relieve
such irritation. In general, topical anesthesia is applied for more comfortable
treatment for patient. To minimize post-operative flushing and pain, use an air
cooler to blow cool air onto the treatment area or apply an ice pack to cool down the
skin.

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 Chapter 7. Clinical Guide

Skin Reaction Post Treatment


The set parameters, that are Pulse Energy and Total Density, may lead to different
skin reactions. In general, the treated area may observe a slight erythema
accompanied with slight edema immediately after treatment.

For approximately one week post treatment, the epidermal debris on the stratum
corneum gives the treated skin area a bronze and rough appearance. After that the
epidermal debris naturally exfoliates as the newly proliferated epidermal tissues
replace the dead tissue. The skin naturally peels off, the skin color will become
brighter.

 Pain
Largely reduced via cooling mask post treatment.

 Erythema and Flushing


Erythema with some “sunburn” symptoms will persist for at least 1-3 days.
Using the same treatment parameters, perioral or periorbital area may
show more severe skin reaction than other areas.

 Edema
Disappears along with erythema after 1-3 days.

 Bronzing and Exfoliation


After erythema and edema has faded, the skin color may darken. This
phenomenon is caused by epidermal debris before it naturally peels off. The
time required for peeling varies depending on the patient and treated area.
Generally, facial treatment areas conclude peeling within 3-7 days.

 Blisters or PIH (Post Inflammatory Hyperpigmentation)


Sensitive areas such as perioral and periorbital area are susceptible to PIH
if exposed to excessive thermal damage. Special caution is required. Large
handpiece tips (i.e. 10X10) in relatively small areas such as the nose in
normal speed and dynamic mode may expose excessive laser beams to the

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MOSAIC HP
 Chapter 7. Clinical Guide

specific treatment areas, and induce burning. Pay special attention to such
relatively small treatment areas.

 Herpes Simplex
Perioral areas are easily vulnerable to herpes simplex after laser therapy.
Thus patients should be asked to indicate any history of herpes simplex in
perioral area. If relatively high Pulse Energy and Total Density are used in
one session, please prescribe oral anti-virus medication for approximately 3
days post treatment to prevent herpes simplex.

Post-treatment Care

 Sooth treated area during and after the surgery by applying an air cooler
or ice pack.
 Use a moist cooling mask pack to calm down, erythema, flushing and pain
of the treated skin.
 After calming down the skin, apply some moisture cream and sun-block
cream and allow patient to go home.
 Right after treatment, the burning and stinging feeling may persist for
about one to two hours.
 Immediately after treatment with the MOSAIC HP Laser System, the
patients can wash their faces, make-up or even shave.

Figure 7.9 Cooling down the treated skin

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MOSAIC HP
 Chapter 7. Clinical Guide

Cautions and Routine Skin care after Treatment

 In general, sufficient moisture mask pack after treatment will rapidly


reduce erythema and edema of the skin, and allow the epidermal debris to
peel off more naturally. Patients are advised to avoid excessive exposure to
sunlight. The epidermal debris starts peeling off 5-7 days after treatment.
Patients must apply sun-block cream when they spend time outdoors.
 Patients may apply make-up and wash their faces immediately after the
treatment, but they should avoid alcohol-containing cosmetics or excessive
stimuli on the skin. Instead, patients are advised to use cosmetics
containing lots of moisture.
 During first week after the treatment, the treated area will have a bronze
appearance and the epidermal debris will start to peel off. Such
phenomena promise more positive results for the therapy, there is no need
to worry. Do not try to peel off the epidermal debris by force, just leave it
to peel off naturally.
 For at least one week after treatment, do not use any substance to
scrubbing substances on the skin.
 Within 48 hours after the treatment, refrain from using functional
cosmetics.
 While redness remains on the skin after treatment, do not indulge in heavy
drinking, heavy exercise, or going to a sauna or heavy exercise. Those
activities will worsen the redness of your skin.
 Absence of sun cream application after the treatment may cause PIH. Use
SPF 30 or higher even indoors and on cloudy days. Wearing hat, umbrella,
or thick make-up may also provide additional protection to the skin
against sun exposure.

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MOSAIC HP
 Chapter 7. Clinical Guide

Treatment Interval and Treatment Sessions

Treatment Interval
The treatment interval should be properly adjusted depending on the type of
lesion, the treatment area (face, neck, arms and legs, etc.), and the relative
location within the skin (epidermis or dermis), and the percentage of entire
skin area the Total Density occupies at each session. As a lesion is located in
epidermis and superficially, or as treatment goes with low Total Density, a
shorter treatment interval is possible.

 Pigmentary lesions such as melasma, seborrheic keratosis, messy and


uneven skin tone; skin rejuvenation such as photo-aged skin, rhytides,
large pore : every 3-4 weeks
 Hair Re-growth : 1-2 weeks.

The above recommendation is made available by considering the recovery time


for the epidermal and dermal skin after treatment. You should adjust it
properly according to reaction of the treated skin.

Number of Treatment Sessions


The MOSAIC HP laser system may give you very satisfactory clinical results
after just one session. However, as each session targets only 20% or below in
proportion to the entire treatment area, the number of treatment sessions is
determined based on the percentage ratio of treated area in each session to the
entire treatment area which is 100%. In conclusion, at least 3-5 sessions is
highly recommended to complete treatment on the entire treatment area
especially for the treatment of hair re-growth.

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MOSAIC HP
 Chapter 7. Clinical Guide

7.5 Contraindications

The MOSAIC HP Laser System is equipment that can be very effective in


renewing a patient’s skin with various symptoms such as scars, wrinkles,
∫aged skin. However, just like any other laser equipments, it may have some
photo∫
negative effects for a few patients. So when you wish to treat patients with the
symptoms described below, special caution is required.

 Skin allergy to topical or local anesthesia, antibiotic medication or any


other type of medication.

 Open fresh wound on treatment skin area.

 If simple herpes has occurred on any location in the treatment area within
the past one month.

 Photo-sensitive skin.

 Psycho-neurotic patient including persons abusing alcohol or drugs.

∫treatment
 Patients who are unable or unwilling to follow the post∫
instruction.

 Patients with unrealistic expectations on the outcome of the treatment.

 Patients with cancer or other malignant diseases.

 Lesions caused by Diabetes Mellitus, Connective Tissue Disease, Radiation


Therapy or Chemotherapy.

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MOSAIC HP
 Chapter 7. Clinical Guide

7.6 Treatment Parameters for Each Type of Lesion

 Acne Scar

< 1st step : Static Mode >

 Pulse Energy : 50 – 120mJ


 Density : 50 spots/cm2, 1 pass or 2 passes

Treat cheek, chin and nose areas which contain in acne scars

< 2nd step : Dynamic Mode >

 Pulse Energy : 18 - 25mJ


 Pulse Rate : 1/2 Speed, 1/3 Speed
 Total Density : max. 300 spots/cm2

Decrease energy in dynamic mode, and then constantly emit beams


around skins. Though total density 300 spots/cm2 is recommended,
it is possible to cease the treatment according to patient’s skin
reactions. This treatment is for feathering the boundaries formed
at the Static mode treatment.

- Treatment interval : 4 to 6 weeks


- The number of sessions required: Minimum 3 to 5 sessions.

For more information about how to operate, please refer to 7.4 MOSAIC
HP Treatment Protocol.

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 Chapter 7. Clinical Guide

 Atrophic Scar, Burn Scar


 Pulse Energy: 20-40mJ; Total Density: 400~1000 spots/cm2
 Treatment interval : 4-6 weeks
 The number of sessions required: min 3-5 sessions
 Treatment Method:
Aggressive operation is more effective for old scars. For burn scars,
adjust pulse energy according to the thickness of scars.
Combination therapy with CO2 fractional laser is recommended.

 Hypertrophic Scar
 Pulse Energy: < 10mJ; Total Density: 1000~2000 spots/cm2
 Treatment interval : 3-4 weeks
 The number of sessions required: min 3-5 sessions
 Treatment Method:
For fresh scars less than 3 moths, combination therapy with Pulse
Dye Laser is recommended.

 Keloid
 Pulse Energy: 7-12mJ; Total Density: 500~1000 spots/cm2
 Treatment interval : 3-4 weeks
 The number of sessions required: min 3-5 sessions

 Striae Distensae
 Pulse Energy: 18-24J; Total Density: 300~500 spots/cm2
 Treatment interval : 4-6 weeks
 The number of sessions required: min 3-5 sessions

 New Surgical Scar Prevention


 Pulse Energy: 6-10mJ; Total Density: 1000-2000 spots/cm2
 First Treatment Schedule: Right after the suture removal
 Treatment interval : 4-6 weeks

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MOSAIC HP
 Chapter 7. Clinical Guide

 The number of sessions required: min 3-5 sessions


 Treatment Method:
Treat on scar selectively in the static mode with the density from
300 to 500 spots/cm2. No more than 2 passes should be radiated
successively onto the same area. Intermittent cooling within one
minute is needed. Observe skin reaction carefully. Repeat passes
until Total Density reaches 1000~2000 spots/cm2. Continue
observing skin reaction inbetween each passes, and apply
intermittent cooling as well. For feathering effect, 1 to 2 passes
around the border line in Dynamic Mode would be recommended.

 Skin Rejuvenation : Skin Laxity, Wrinkles and Large Pore


Uneven Skin Tone (Dyschromia, Telangiectasia)

< 1st step : Static Mode >

 Pulse Energy : 50 – 120mJ


 Density : 50 spots/cm2, 1 pass or 2 passes

Treat cheek, chin and nasal areas which contain deep wrinkle
and sagged skin

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MOSAIC HP
 Chapter 7. Clinical Guide

< 2nd step : Dynamic Mode >

 Pulse Energy : 18 - 25mJ


 Pulse Rate : 1/2 Speed, 1/3 Speed
 Total Density : max. 300 spots/cm2

In order to improve skin tone, large pores and wrinkles, treat with
lower pulse energy (18-25mJ) and lower total density
(300spots/cm2) than in the static mode

 Treatment interval : 3-4 weeks


 The number of sessions required: min 3-5 sessions

 Overall Skin Rejuvenation of body (Off-face)


: Face, Hand, Neck, Chest

 Pulse Energy: 10-14mJ; Total Density: 300-400 spots/cm2


 Treatment interval : 3-6weeks
 The number of sessions required: min 3-5 sessions

In order to achieve dramatic clinical results, treatment with higher pulse energy
and lower total density is recommended. Decrease in Total Density allows users to
minimize the patient’s pain and erythema, or edema would be reduced after the
treatment.

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MOSAIC HP
 Chapter 7. Clinical Guide

High-Pulse Energy Treatment Method with MOSAIC HP


Treat cheek, chin and nasal areas which contain deep wrinkle and sagged skin
would be generally treated. Select 60mJ for the first session and gradually
increase it up to 120mJ for the following sessions according to the patient’s skin
reaction. However, do not use higher energy than 50mJ on bony areas. (e.g.
forehead, cheek bone area)

Oily skin treated in high energy may not cause any problem. For thin skin type,
it would be better to start from lower energy and increase it according to the
patient’s skin reaction. In case of patients who have thin and bright skins, there
would be pin point bleeding.

 Preparation of the treatment


: 5% EMLA anesthetic (No need nerve block)

< 1st step : Static Mode >

 Pulse Energy : 50 – 120mJ


 Density : 50 spots/cm2, 1 pass or 2 passes

Treat with 1~2 mm space between stamp by stamp because edema would
be occurred around stamps. Select the most conservative parameter for the
first session, and then gradually increase it for the following sessions
according to the patient’s skin reaction. For high pulse energy treatment,
Total density need to be devided into 2 treatments with 50 spots/cm2 per
each. It is recommended not to exceed Total Density of 100 spots/cm2

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MOSAIC HP
 Chapter 7. Clinical Guide

Treat with 2~3 mm spaces among Treat like filling in the space which was
stamps in the 1st pass. not treated in 1st pass.
Figure 7.10 High Pulse Energy Tx in Static Mode

< 2nd step : Dynamic Mode >

 Pulse Energy : 18 - 25mJ


 Pulse Rate : 1/2 Speed, 1/3 Speed
 Total Density : max. 300 spots/cm2


Treat generally whole face including treated area at the 1st step. In the
second step, the energy should be controlled by skin types. It is
recommended to use less than 18mJ for patients who have thin and dry
skins. For patients who have oily and wrinkly skins, 22-25mJ in dynamic
mode are recommended. Since skins have been stimulated and have some
edema and erythema, use reduced pulse rate at 1/2 or 1/3 speed. In order
to reduce patient’s inconvenience, do not exceed Total density of 300
spots/cm2 at the 2nd step.

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 Chapter 7. Clinical Guide

其 Recommended Total Density in the thermal mode

Considering wide lateral damaged area, it is recommended to reduce the


total density at thermal mode as down to the half of normal mode.

求求
Recommended Total Density in the normal mode


Recommended Total Density in the thermal mode

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MOSAIC HP
 Chapter 7. Clinical Guide

 Hair Re-growth
 Pulse Energy: 4-6mJ
 Density: 300~500 spots/cm2 (3-4 passes without overlapping)
 Total Density: 900-2000 spots/cm2
 Treatment interval and the number of sessions required
: 1-2 weeks, 3 months standard course

Treatment Procedure for hair re-growth

Step 1. Treatment Parameter Setting

 Treatment area should be area which starts alopecia or is thin on top.


Before treatment, select Hair Mode in the main operation screen. Then, fit
the alopecia tip to handpiece. After controlling both Density and Pulse
Energy in Static Mode, start the treatment.

Press “standby” button and change into “ready” state. For lasing, press
foot switch and contact handpiece tip to the scalp.
Treatment with hair tip will be available regardless of skin contact.

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 Chapter 7. Clinical Guide

Step 2. Operation Technique

 Handpiece tip should always remain perpendicular to the skin surface, and
emit the beams in one direction to avoid lasing to normal hairs. Emit
beams directly to the scalp for minimizing energy loss.

 Treatment should be done stamp by stamp without overlapping. Observe


skin reactions and decide whether additional treatment is required or not.
Cooling during the treatment is recommended in order to soothe the scalp.
 Parameters should be controlled according to the degree of patient’s pain
Total energy after each treatment should be recorded in order to control
successive sessions.
 Sufficient cooling after treatment would minimizes side effects.
 The alopecia operation of the MOSAIC HP is available to everyone
because this operation does not need any anesthesia and rarely have pains
and inconvenience.
 Inform patients of Shedding phenomenon, that is, temporary hair
loss out might be occurred in 15% of patients in the early days of
operating period normally within a month.

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MOSAIC HP
 Chapter 7. Clinical Guide

Treatment Parameter Guideline


Pulse Energy Total Density
Indications 2 Remarks
(mJ) (spots/cm )
1 pass (for dry or
thin skin) or 2 passes
(for oily skin) on
cheeks chin and nose
in Static Mode with
50 – 120 50 - 100 a Density of 50
spots/cm2. However,
Skin Laxity No more than 50mJ
on bony areas. (e.g.
Deep Wrinkles
forehead, cheek
Large Pore bone area)
Wrinkles Treat full face in
Dynamic Mode with
Skin a Pulse Rate of 1/2
Rejuvenation or 1/3 speed.
6 - 12 300 - 500
*Full face includes
the area treated with
high pulse energy
already.
Uneven Skin
Tone (pigment, 8 - 14 < 500
telangiectasia)
Edema and
Off-Face Erythema last longer
(Neck, Chest, 10 - 14 300 - 400 than face.
Hands) (Approximately 7-10
days)
Treat scars only in
50 - 120 50 - 100
Static Mode.
Acne Scar
Treat full face in
20 - 30 300 - 500
Dynamic Mode.
Adjust Pulse Energy
according to the
thickness of scars.
Burn Scar 20 - 40 400 - 1000
Combination with
CO2 fractional laser
is recommended.
For fresh scar less
than 3 months.
Hypertropic
< 10 1000 - 2000 Combination with
Scars Scar Pulse Dye laser is
recommended.
Aggressive
Atrophic Scar 20 - 40 300 – 1000 treatment parameter
is required.
Start right after the
Surgical Scar
6 – 10 1000 – 2000 removal of surgical
Prevention suture.
Combination
therapy with other
Keloid 7 – 12 500 – 1000
treatment methods is
recommended.
Striae
18 – 24 300 – 500 Caution for PIH
Distensae

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 Chapter 7. Clinical Guide

Pulse Energy Total Density


Indications 2 Remarks
(mJ) (spots/cm )
For normalization of
5 - 10 500 - 800 epidermis and
Inflammatory Acne & Redness dermis
Post Acne Selectively treat
18 - 25 200 - 300 active acne in Static
Mode

Eyelid Laxity 8 - 14 300 - 500 Use 6x6mm tip

Treat density of 300-


500 spots/cm2 per
each pass without
Hair Re-growth 4–6 900 – 2000
overlapping. 1 week
interval for 3~6
moths

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MOSAIC HP
 Chapter 8. Warranty

Chapter 8. Warranty

8.1 Overview
Chapter 8 describes unpaid services available for those who use the
instrument properly and exclusions from such unpaid services are provided
by the warranty of this product.

8.2 Unpaid Services

 If you have used the MOSAIC HP Laser System properly and


apply for after-service, you are eligible for unpaid service up to one
year from the date of purchase, as guaranteed by Lutronic.

 Unpaid services include the coverage of the main body of the


instrument, the footswitch, the optical fiber support, and the remote
interlock, while excluding consumable parts such as the handpiece
tip and safety goggles.

 If Lutronic 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 instrument to be repaired,
Lutronic may decide to repair or replace the instrument either on
the premises of Lutronic headquarters or the place where the
instrument is installed.

 If it is necessary to recall the instrument for the purpose of


adjustment or inspection, Lutronic will provide the information that
our customer requests or allow them to rent a temporary device.

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MOSAIC HP
 Chapter 8. Warranty

WARNING
In order to maintain the coverage of unpaid services, only
service persons authorized by Lutronic should be allowed to
configure, modify or inspect the instrument. If the instrument 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. Our
customers are strongly advised to be fully aware of all the
details of this manual. Lutronic reserves all rights and
responsibilities for judging the nature of damages to the
product and the possible causes for such damages. Such a
judgment made by Lutronic 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


were not properly followed, altered, or neglected in any manner, the
purchaser will not be eligible for unpaid service. Please pay close attention
to the items below while using the instrument.

 If you pull out the optical fiber or its handpiece with excessive
force to move the instrument, which results in damages to the
optical fiber, then you shall not be eligible for unpaid service
covered by this letter of warranty.

 If the user uses, modifies or disassembles this instrument for


purposes other than those initially intended, then they will be
excluded from the coverage of this warranty.

 Consumable parts like the handpiece tip, which are necessary for
consistent maintenance of the instrument, are not covered by
unpaid services.

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MOSAIC HP
 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 laser or its marketability for any purpose.

Practice name: ___________________________

Doctor: ____________________________

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 to the address or number 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

E-mail: office@lutronic.com

Revision 1.1 / 4100110311 8-3 Lutronic Corporation

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