(Rev 1.1) SOLARI - Operation Manual - 4100133711

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SOLARI  Technology for Beauty and Health

SOLARI
Square Pulse Technology

Operator’s Manual

0434

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

Revision 1.1 /4100133711 1/8


SOLARI  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 SOLARI IPL 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 and instructions given in this user’s manual. Users should
have received appropriate training education properly before using this
system.

IMPORTANT

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


are standards to be used for consultative purposes only, we
recommend adjusting such values for patients depending on each
patient's special circumstances and treatment history. Lutronic
Corporation shall not be liable for any injuries, problems or issues that
arise as a result of negligence or inexperience in using the product
supplied by Lutronic Corporation rather than as a result of any actual
defect of the product itself as supplied by Lutronic Corporation.

Revision 1.1 /4100133711 2/8


SOLARI  Technology for Beauty and Health

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

Revision 1.1 /4100133711 3/8


SOLARI  Technology for Beauty and Health

Table of Contents

Chapter 1. Overview
1.1 Introduction to the System 1/3
1.2 Symbols Used in this Manual and on the Device 2/3

Chapter 2. Safety Precautions


2.1 Overview 1/16
2.2 Safety for the Operation Room 3/16
2.3 General Precautions for Users, Staff and Patients 5/16
2.3.1 Precautions to be taken with the handpiece prior to a procedure 5/16
2.3.2 Precautions to be taken when transporting the system in the 5/16
treatment room
2.4 Cautions against Electrical Hazards 6/16
2.5 Protecting the Eyes 7/16
2.6 Cautions on Fire Hazards 8/16
2.7 Safety Features of the SOLARI IPL System 9/16
2.7.1 Key switch 9/16
2.7.2 Emergency Stop button 10/16
2.7.3 Audible and visible indicators of light radiation 10/16
2.7.4 Remote interlock 10/16
2.7.5 Panel interlock 11/16
2.8 Main International Standards Applicable to the SOLARI IPL System 12/16
2.9 Safety Labels for the SOLARI IPL System 13/16
2.9.1 Emergency Stop caution label 13/16
2.9.2 Caution label for refilling the cooling water tank 14/16
2.9.3 Warning label against electrical shock 14/16
2.9.4 Danger label regarding exposure to light radiation 14/16
2.9.5 Danger label regarding light radiation output 15/16
2.9.6 Remote interlock label 15/16
2.9.7 Grounding label 15/16
2.9.8 Power cable label 15/16
2.9.9 Name plate label 16/16

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SOLARI  Technology for Beauty and Health

Chapter 3. System Description


3.1 Overview 1/5
3.2 System Specifications 1/5
3.3 Components of the SOLARI IPL System 2/5
3.3.1 System main body 3/5
3.3.2 Handpiece & filters 4/5
3.4 System Software 5/5

Chapter 4. Installation
4.1 Overview 1/9
4.2 Installation Component List 1/9
4.3 Conditions for Installation 2/9
4.3.1 Space requirements 2/9
4.3.2 Electrical requirements 3/9
4.3.3 Environmental requirements 4/9
4.4 Installation of the Device 5/9
4.4.1 STEP 1 : Connecting the handpiece 5/9
4.4.2 STEP 2 : Installing the handpiece cable hanger 6/9
4.4.3 STEP 3 : Connecting the accessories 7/9
4.4.4 STEP 4 : Final check-up and locking the system in place 8/9
4.4.5 STEP 5 : Supplying main power 8/9
4.5 Moving the Device 9/9
4.5.1 Moving the device in the treatment room 9/9
4.5.2 Moving the device to a remote location 9/9

Chapter 5. Operation
5.1 Overview 1/17
5.2 Checking of the Caution and Inspection Items 5/17
5.3 Operation of the SOLARI IPL System 6/17
5.3.1 Turning on the system 6/17
5.3.2 Normal operation mode 7/17
5.3.3 Normal library mode 9/17
5.3.4 Advanced operation mode 10/17
5.3.5 Advanced library mode 12/17
5.4 Use of the handpiece 14/17
5.5 Setup 15/17

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SOLARI  Technology for Beauty and Health

5.5.1 Checking the shot count 15/17


5.6 Turning off the System 16/17
5.6.1 Normal turn-off 16/17
5.6.2 Emergency turn-off 16/17

Chapter 6. Maintenance & Management


6.1 Overview 1/12
6.2 Cleaning the System Main Body 1/12
6.3 Cleaning the Handpiece 2/12
6.4 Cleaning the Exchangeable Filters 3/12
6.5 Separating the Handpiece 4/12
6.6 Keeping the Handpiece 5/12
6.7 Refilling the Cooling (Distilled) Water Tank 6/12
6.7.1 Cooling water indicator 6/12
6.7.2 How to refill the cooling water tank 6/12
6.8 Troubleshooting 9/12
6.8.1 When the device fails to turn on. 9/12
6.8.2 When the device is powered on but light energy is radiated 9/12
from the handpiece.
6.8.3 When the light radiation is present but the output power 9/12
appears inadequate.
6.9 Status Messages 10/12
6.10 Request for Periodic After-sales service 12/12

Chapter 7. Clinical Information


7.1 Overview 1/4
7.2 Clinical Guide 1/4
7.3 Clinical Applications 3/4
7.4 Contraindications 3/4
7.5 Possible side effects of treatment 2/4

Chapter 8. Warranty
8.1 Overview 1/3
8.2 Unpaid Services 1/3
8.3 Exclusion to Unpaid Services Within the Period of the Warranty 2/3

Revision 1.1 /4100133711 6/8


SOLARI  Technology for Beauty and Health

List of Figures

Figure 2.1 Light radiation warning sign 3/16


Figure 2.2 Protective goggles for the physician (A) / for the patient(B) 4/16
Figure 2.3 Key switch positions 9/16
Figure 2.4 Emergency Stop button 10/16
Figure 2.5 Remote interlock 10/16
Figure 2.6 Locations of labels on the front and side of the system 13/16
Figure 2.7 Emergency Stop caution label 13/16
Figure 2.8 Caution label for refilling the cooling water tank 14/16
Figure 2.9 Warning label against electrical shock 14/16
Figure 2.10 Danger label regarding exposure to light radiation 14/16
Figure 2.11 Danger label regarding light radiation output 15/16
Figure 2.12 Remote interlock label 15/16
Figure 2.13 Grounding label 15/16
Figure 2.14 Power cable label 15/16
Figure 2.15 Name plate label 16/16
Figure 2.16 Locations of labels on the back of the system 16/16

Figure 3.1 Main components of the SOLARI IPL system 2/5


Figure 3.2 Handpiece & filters 4/5

Figure 4.1 Dimensions of the SOLARI IPL system 2/9


Figure 4.2 The interior of the system main body connector 5/9
Figure 4.3 Connecting the handpiece 5/9
Figure 4.4 Installing the handpiece cable hanger #1 6/9
Figure 4.5 Installing the handpiece cable hanger #2 6/9
Figure 4.6 Installing the handpiece cable hanger #3 6/9
Figure 4.7 The main power module shown with the system interlock connector 7/9
connected.

Figure 5.1 The SOLARI IPL system control panel 1/17


Figure 5.2 The OK button pop-up 6/17
Figure 5.3 Normal operation mode 7/17
Figure 5.4 Normal library mode 9/17

Revision 1.1 /4100133711 7/8


SOLARI  Technology for Beauty and Health

Figure 5.5 Setup mode 10/17


Figure 5.6 Advanced operation mode 10/17
Figure 5.7 Advanced library mode 12/17
Figure 5.8 Advanced library modification #1 12/17
Figure 5.9 Advanced library modification #2 13/17
Figure 5.10 How to place the handpiece on the skin 14/17
Figure 5.11 Setup mode 15/17
Figure 5.12 Turning off the key switch 16/17

Figure 6.1 Cleaning the handpiece tip 2/12


Figure 6.2 Taking out the filter out of the handpiece 3/12
Figure 6.3 Cleaning the used filter with a swab 3/12
Figure 6.4 Separating the handpiece 4/12
Figure 6.5 Putting the handpiece on the handpiece cradle 5/12
Figure 6.6 Hanging the handpiece cable on the handpiece cable hanger 5/12
Figure 6.7 Removing the window over the water level indicator 6/12
Figure 6.8 Disconnecting the indicator tube 7/12
Figure 6.9 Inserting the funnel and the tube into the tank 7/12
Figure 6.10 Pouring distilled water into the funnel 8/12
Figure 6.11 Reconnecting the indicator tube to the tank 8/12
Figure 6.12 Status message for Code: E01 10/12

Revision 1.1 /4100133711 8/8


SOLARI  Chapter 1. Overview

Chapter 1. Overview

1.1 Introduction to the System


The SOLARI IPL system is designed to comply with international
standards for manufacturing medical devices manufacturing in order to
guarantee the user’s safety and durability of use. This device is designed
for convenience and for prolonged use. Regular basic maintenance and
keeping the system clean are required of the user to keep the SOLARI IPL
system in peak condition.

 The control panel is equipped with an interactive LCD touch


screen so that users may easily set the optimum parameters.
Device and treatment information is also displayed on the screen
by the onboard software for the operator’s information.

 The pulsed beam of light energy is directed to the treatment zone


through a handpiece.

 SOLARI IPL is a medical system designed for specific clinical


indications, and emits the following wavebands via the
handpiece: 420 nm~750 nm, 510 nm~950 nm, 570 nm~950 nm,
620 nm~950 nm, 670 nm~950 nm and 710 nm~950 nm.

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SOLARI  Chapter 1. Overview

1.2 Symbols Used in this Manual and on the Device

Symbols Descriptions
This symbol indicates a state of potential
danger or an emergency situation whereby the
device itself may be severely damaged, or
users, patients and staff members may be
exposed to electrical injury resulting in
WARNING electrical shock or burn injuries, or potentially
hazardous exposure to the radiation of the
laser beam.
This symbol indicates that caution should be
applied to prevent a state of potential danger
or an emergency situation whereby the device
itself may be severely damaged, or users,
patients and staff members may be exposed to
CAUTION electrical injury resulting in electrical shock
or burn injuries, or potentially hazardous
exposure to the radiation of the laser beam.
This symbol indicates that, prior to any
procedure with the SOLARI system; the
operator should thoroughly check any special
circumstances regarding the patient’s
condition before treatment, including their
IMPORTANT medical history, to ensure the optimum
clinical results.
This symbol indicates that the product
specifications comply with Class B of the
Protective Regulations for electrical shocks
(IEC 417 / 878-02-02).
This symbol indicates that the operational
voltage of this product exceeds the danger
limits set out in the Protective Regulations
regarding Electrical Shocks (IEC 417 /878-
03-01).
This symbol indicates that the POWER is
OFF, which complies with the Protective
Regulations regarding electrical shocks (IEC
417 / 5008).
This symbol indicates that the POWER is ON
and is in compliance with the Protective
Regulations regarding electrical shocks (IEC
417 / 5007).

Revision 1.1 /4100133711 Ch1-2/3


SOLARI  Chapter 1. Overview

This symbol indicates that this product adopts


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

Manufacturer

Authorized representative in the European


Community

CE Marking

WARNING
Improper handling and/or manipulation of the device in a way
that does not comply with the instructions given in this manual
may result in severe damage to the device and injury to the
user.

Revision 1.1 /4100133711 Ch1-3/3


SOLARI  Chapter 2. Safety Precautions

Chapter 2. Safety Precautions

2.1 Overview
This chapter provides the basic safety and precautionary items regarding
SOLARI IPL system devices. These data will also serve to inform users
of the electrical safety items in general and the safety characteristics of
the SOLARI IPL system in particular.
All persons involved in the operation of the SOLARI IPL system (e.g.
operator, patient, and staff) should be aware of all the potential dangers
and the safety regulations associated with the system. The system should
not be handled without proper knowledge and training. The operator or
the staff should inform patients of the necessary precautions prior to
treatment.

The SOLARI IPL system is designed to ensure optimal safety for


operators, staff and patients and is equipped with the safety features
described below:

1. This system utilizes a slow-blow fuse at 250V/25A which protects


the system from possible current and voltage complications. The
Safety Extra Low Voltage (SELV) method is employed in this
system. The fuse installed inside the main body of the SOLARI IPL
system successfully blocks unwanted power surges.

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


located on the front panel, the safety-related components of this
SOLARI IPL system will be activated to ensure the safe operation of
the system.

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


monitoring the entire procedure in order to notify the user of the
system’s safety status.

4. The software installed in the SOLARI IPL system will block any
light radiation immediately on occurrence of any error. A message
code will be promptly displayed to notify the operator.

Revision 1.1 /4100133711 Ch2-1/16


SOLARI  Chapter 2. Safety Precautions

5. The SOLARI IPL system automatically detects the wavelength of


the exchangeable handpiece filters and displays the information on
the LCD touch screen.

6. A remote interlock socket is provided. If no plug is connected to this


socket, or if the plug is removed, system operation is halted. This
remote interlock may optionally be connected to an operating to an
operating room door which will shut down the system in the even of
unauthorized entry into the treatment room. To install an interlock
system in your location, please contact Lutronic Corporation
customer support.

DANGER
The SOLARI IPL system is in compliance with the US Federal
Regulation of the CDRH (Center for Devices and Radiological
Health), which is governed by the FDA (Food and Drug
Administration).

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SOLARI  Chapter 2. Safety Precautions

2.2 Safety for the Operating Room


Before performing a procedure, the operator and staff handling the
system should check the following items:

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


room. Warning signs are provided by Lutronic Corporation. Any
missing signs should be replaced before installing and operating
the SOLARI IPL system. (Figure 2.1)

Figure 2.1 Light radiation warning sign

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


essential to the procedure and who are well trained in the required
safety precautions.

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


the technical details of the system. If necessary, all persons should
be able to halt the system in case of an emergency.

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


the operating room.

5. All present during a procedure must wear Protective eyewear.


Protective goggles (Model Name: 3PL#33) are provided by
Lutronic Corporation. Please contact Lutronic Corporation to
inquire about reordering when needed.

6. The common power supply must be AC220~230V in order to use


and operate the SOLARI IPL system safely.

Revision 1.1 /4100133711 Ch2-3/16


SOLARI  Chapter 2. Safety Precautions

(A) (B)
3PL#33

Figure 2.2 Protective eyewear


for the physician (A) / for the patient(B)

DANGER
The SOLARI IPL system uses intense pulsed light which is
invisible to the naked eye. All persons in the operating room
must wear Protective eyewear at all times during the procedure.
Exposure to the light may result in serious injury including loss
of eyesight. Goggles should protect eyes from 420 nm ~ 750
nm, 510 nm ~ 950 nm, 570 nm ~ 950 nm, 620 nm ~ 950 nm, 670
nm ~ 950 nm and 710 nm ~ 950 nm wavelengths. The protective
eyewear should be pursuant to the ANSI standard.
Inappropriate or inadequate protection may cause damage to
the eyes. Even with Protective eyewear, all users are cautioned
against the inherent risk of dealing with intense pulsed light
devices.

Revision 1.1 /4100133711 Ch2-4/16


SOLARI  Chapter 2. Safety Precautions

2.3 General Precautions for Users, Staff and Patients

2.3.1Precautions to be taken with handpiece prior to the procedure


 Please refer to Chapter 6 for cautionary items: handpiece and handpiece
tip. The handpiece must be cleaned before each procedure. The
maintenance protocol should be reviewed thoroughly before cleaning
the handpiece. Any foreign substances on the handpiece tip should be
removed using alcohol of 90 % purity or higher in order to maintain
energy efficiency.

 Even if proper Protective eyewear is worn, looking directly at the


handpiece tip could pose an eye hazard.

2.3.2Precautions to be taken when transporting the system in the


treatment room
 The SOLARI IPL system weighs about 82.5 kg. Mishandling of the
system may cause damage to the system both internally and externally,
possibly adversely affecting its performance.

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


optimized for convenient moving. Handle it with extreme care.

 Do not move the SOLARI IPL system when it is in the “READY”


status, as light radiation may be accidentally emitted through the
handpiece.

 Put the handpiece in the handpiece cradle when transporting the


SOLARI IPL system. Failure to comply may cause the handpiece to
drop on the floor.

Revision 1.1 /4100133711 Ch2-5/16


SOLARI  Chapter 2. Safety Precautions

2.4 Cautions against Electrical Hazards


 The SOLARI IPL system is an instrument that uses a voltage source of
AC220~230V and thus contains high voltage components. Removing
the protection cover from the system main body may put personnel at
high risk of severe electrical shock.

 Do not attempt to disassemble this device. Persons other than those


authorized and trained by Lutronic Corporation may not disassemble
this instrument.

 Some residual electrical power may remain within the electrical


components of the SOLARI IPL system after blocking the power
supply. Persons other than those who are authorized by Lutronic
Corporation may not disassemble this instrument or inspect the inner
components, as this will void the warranty.

 Never allow any type of liquid to enter the system main body of the
SOLARI IPL system. This may lead to electrical shock.

 Only use power cables with grounding pins provided by Lutronic


Corporation. If the power cable is damaged or worn out, contact
Lutronic Corporation or an authorized Lutronic distributor to replace
the cable. Do not attempt to use or operate this system with inferior or
alternative cables.

 Do not clean the handpiece nor carry out any maintenance on this
device while electrical power is being supplied to it.

WARNING
Persons other than service engineers authorized by Lutronic
Corporation should not attempt to remove the external cover or
disassemble the system. This will void the warranty coverage,
and exposure to dangerous light, high voltage or current
generated by this system may occur.

Revision 1.1 /4100133711 Ch2-6/16


SOLARI  Chapter 2. Safety Precautions

2.5 Protecting the Eyes


 The SOLARI IPL system produces intense pulses of both visible and
invisible near infrared wavelengths. Users and patients must wear
protective eyewear at all times. Eye exposure to the intense pulsed light
during procedures may result in severe injury or even loss of eyesight.

 All persons involved with the intense pulsed light operation should
wear the protective goggles provided by Lutronic Corporation against
following the wavelength: 420 nm~750 nm; 510 nm~950 nm; 570
nm~950 nm; 620 nm~950 nm; 670 nm~950 nm; and 710 nm~950 nm,
or glasses with side protection that is pursuant to the ANSI standard.
Simple goggles with of lenses that do not have any safety functions
may be penetrated by the intense pulsed light.

 The intense pulsed light may reflect off smooth or polished surfaces
such as surgical instruments. Therefore, all instruments and equipment
not required for the procedure should be moved to a safe place before
performing the procedure.

 A direct ray or scattered rays of the intense pulsed light (wavelength


range 420 nm~750 nm, 510 nm~950 nm, 570 nm~950 nm, 620 nm~950
nm, 670 nm~950 nm, 710 nm~950 nm) may cause unrecoverable
damage to the retina as it comes in contact with the eyes.

 Although the protective eyewear appropriates for the waveband being


used are worn, the handpiece tip must not be directly viewed while the
main power of the system is turned on.

 Patients are also required to wear appropriate eye protection.

DANGER
Never look directly at the handpiece tip when power is applied
to the system. It could result in serious eye injury and/or
blindness even though Protective eyewear is worn. Never direct
the light at any object other than the selected targets.
Regardless of its wavelength, the light energy reflected from
the surface may cause damage at any time.

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SOLARI  Chapter 2. Safety Precautions

2.6 Cautions on Fire Hazards


 Intense pulsed light energy may ignite most non-metallic objects.

 Various types of drapes and gowns commonly used in procedures


should be made of a flame resistant material. Avoid using materials
saturated with oxygen.

 Be especially careful when using the light near a flammable substance.


For instance, if the light comes in contact with anesthetic gases such as
nitric oxide or oxygen alcohol, or any flammable material such as
cotton, it may cause a fire.

 Before using the SOLARI IPL system, make sure all solvents,
adhesives and cleaning liquids have fully evaporated.

 A fire extinguisher should be placed near the SOLARI IPL device at all
times.

 Never operate this system while it is covered.

DANGER
The operator should be especially careful when using the light
near flammable substances. For instance, if the light hits an
anesthetic gas such as nitric oxide or oxygen, or a flammable
liquid or material such as alcohol or cotton, it may cause a fire.

WARNING
The operator must never direct the rays of the light at any
target object other than the intended. This may lead to ignition
of the object.

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SOLARI  Chapter 2. Safety Precautions

2.7 Safety Features of the SOLARI IPL system


This system includes safety features fully compliant with all relevant
standards to secure the safety of operator, staff and patients.

2.7.1 Key switch


 The SOLARI IPL system may be turned on or off only with the system
key provided by Lutronic Corporation.

 To prevent unauthorized persons from using this system, the key should
be removed from the key switch and stored in a safe place after
performing a surgical procedure.

 The key switch operation is composed of two steps. It can be turned


from the OFF position to the ON position, and vice versa.

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

Figure 2.3 Key switch positions

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

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SOLARI  Chapter 2. Safety Precautions

2.7.2 Emergency Stop button


 In case of an emergency, light emission
can be stopped immediately by pressing
the Emergency Stop button.

 To restore operation, rotate the button


clockwise (in the direction of the arrows)
until it pops out again and follow the
normal startup sequence. See Chapter 5 for
Figure 2.4. Emergency
startup procedure. Turn the key switch to
Stop button
the 0 position in which the power is shut
off and then follow the normal startup
procedure.

 This Emergency Stop button should not be used as part of the normal
shut-down procedure. Since it may cause system electrical damage.
Always use the key switch to turn on or off device under normal
circumstances.

2.7.3 Audible and Visible indicators of light radiation


 Once light is emitted when the finger switch on the handpiece is
pressed, the color of the LEDs changes to red. The light passes through
handpiece tip that is inserted in the bottom of the handpiece. The
handpiece tip delivers the light energy to the treatment area.

 Pressing the READY button triggers an alarm sound for 5 seconds to


let all present know that the system is ready to emit intense pulsed light.

2.7.4 Remote interlock


 When the remote interlock connector (Figure 2.5) is connected to the
socket located on the back of the SOLARI IPL system, the remote
interlock electrical circuit is closed and the system can start its normal
operation. If the remote interlock connector is not attached to the
socket, then the system will not operate.

 An optional remote interlock device may be fitted to the door of the


operation room to halt the system immediately if unauthorized persons
enter the treatment room in the middle of a treatment.

Figure 2.5 Remote interlock

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SOLARI  Chapter 2. Safety Precautions

2.7.5 Panel interlock


 The door interlock located on the back top of the system stops
operation if any back panel is left open.

 If the back panel is opened while the system is in operation, the system
will stop operating immediately and show a message code.

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SOLARI  Chapter 2. Safety Precautions

2.8 Main International Standards Applied to the SOLARI IPL


System
To ensure the safety of doctors, ancillary staff and patients, this system 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
EN 60601-1 Medical electrical equipment 1990/A1:1993/A2:
IEC 60601-1 Part 1: General requirements for safety 1995/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 Part 1-4:
EN 60601-1-4 General requirements for safety-Collateral 1996/A1:1999
IEC 60601-1-4 Standard: Programmable electrical Medical 2000
systems
Medical electrical equipment - Part 1-6:
EN 60601-1-6 General requirements for basic safety and 2007
IEC 60601-1-6 essential performance - Collateral Standard: 2006
Usability
Graphical symbols for use in the labeling of
EN 980 2008
Medical devices
EN ISO 14971 Medical devices – Application of risk 2009
ISO 14971 management to medical devices 2007

Information Supplied by the manufacturer


EN 1041 2008
with medical devices

Medical device software. Software life-cycle


EN 62304 2006
processes
Graphical symbols for use in the labeling of
EN 980 2008
Medical devices

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SOLARI  Chapter 2. Safety Precautions

2.9 Safety Labels for SOLARI IPL System


Pursuant to domestic and international standards, various types of safety
and system information labels are attached to the appropriate locations.

CAUTION
Physicians and staff should be fully aware of the locations and the meaning
of all the safety labels attached to the system.

Figure 2.6 Locations of labels on the front and side of the system

2.9.1 Emergency Stop caution label


The Emergency Stop button is used to immediately stop light emission
from the IPL equipment in case of emergency. The label is located next to
the emergency stop button on the front of the system.

Figure 2.7 Emergency Stop caution label

Revision 1.1 /4100133711 Ch2-13/16


SOLARI  Chapter 2. Safety Precautions

2.9.2 Caution label for refilling the cooling water tank


The label instructs the user on refilling the water tank, so it can be done
correctly by the user, without the need to call in a service engineer.

Figure 2.8 Caution label for refilling the cooling water tank

2.9.3 Warning label against electrical shock


The label warns of electrical shock and exposure to high voltage in the
instance that the panel is opened or removed. Only authorized and trained
personnel may open or remove the cover

Figure 2.9 Warning label against electrical shock

2.9.4 Danger Label regarding exposure to light radiation


This warning label states that the eyes or skin should not be exposed to
direct or scattered rays of the light due to possible severe injury.

INTENSE PULSED LIGHT DEVICE


USE PROPER EYE GLASSES WHEN
OPERATING AND/OR TREATING PATIENTS
VISIBLE TO NEAR INFRARED LIGHT
MAX. Intense Pulsed Light Power : 35J/cm2
Intense Pulsed Light Pulse Duration : 3 ~ 300ms
Light Pulse Wavelength : 420 ~ 950nm

Figure 2.10 Danger label regarding exposure to light radiation

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SOLARI  Chapter 2. Safety Precautions

2.9.5 Danger label regarding light radiation output


This label indicates light output information, such as the exposure time for
maximum pulses, wavelength associated hazards and the medium of
transmission for proper safety.

Figure 2.11 Danger label regarding light radiation output

2.9.6 Remote interlock label


This label indicates that light emission is enabled only if the remote
interlock connector is connected to its socket.

Figure 2.12 Remote interlock label

2.9.7 Grounding label


This symbol indicates that this product adopts equi-phase grounding which
complies with the protective regulations for electrical shocks.

Figure 2.13 Grounding label

2.9.8 Power cable label


This label warns users of the precaution when connecting the main power
cord to a wall outlet.

Figure 2.14 Power cable label

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SOLARI  Chapter 2. Safety Precautions

2.9.9 Name plate label


This label indicates the product name, model name and other electrical
specifications of the SOLARI IPL system.

0434
Product Name : Intense Pulsed Light
Model Name : SOLARI
Wavelength : 420~950nm
Electrical Shock Class : CLASS I, TYPE B
Electrical Rating : AC220-230V: 50/60Hz / 4.0kVA

Serial Number :
Manufacturer : Lutronic Corporation.
Room 403-1,2,3,4,5, 404 Ilsan Technotown 1141-1,
Baekseok-dong, Ilsandong-gu, Goyang-si,
Gyeonggi-do, KOREA
TEL : +82-31-908-3440 FAX: +82-31-907-3440
http://www.lutronic.com MADE IN KOREA
Before operating the device, read the operator s manual.
Federal(USA) law restricts this device to sale by the order
of a physician licensed by the law of the state for practice.
EC Representative : Read the operator`s manual.

Figure 2.15 Name plate label

Figure 2.16 Locations of labels on the back of the system

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SOLARI  Chapter 3. System Description

Chapter 3. System Description


3.1 Overview
This chapter provides a general description of the SOLARI IPL system,
including its main components, system control, and technical specifications.

3.2 System Specifications

Performance System Specification


Medium of transmission Flash Lamp
Fluence Max. 35 J/cm2
Normal Mode Pulse Width 5 ms ~ 300 ms
Advanced Mode Pulse Width 3 ms ~ 300 ms
Advanced Mode Pulse Delay 4 ms ~ 280 ms
Scanning Area 12 mm 呆 40 mm (4.8 cm2)
FDA Class Class II
Classificatio MDD Class Class IIb
ns Applied Part
B
Class
Protective Eyewear Optical
>1
Density
Display System Touch LCD
420 nm ~ 950 nm
420 nm ~ 750 nm
510 nm ~ 950 nm
Wavelength 570 nm ~ 950 nm
Interchangeable Filters
620 nm ~ 950 nm
670 nm ~ 950 nm
710 nm ~ 950 nm
Weight 82.5 kg
Dimensions (mm) 367 (W) x 570 (L) x 1,027 (H)
Skin Cooling System Sapphire Contact Cooling
User Interface 8 inches Color Touch LCD
Single phase AC220~230V
Electrical rating Fuse 250V/25A, 50/60Hz,
Power consumption: 4kVA

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SOLARI  Chapter 3. System Description

3.3 Components of the SOLARI IPL System


The SOLARI IPL system consists of three main components.

 System main body


- Dimensions (mm) : 367(W) x 570(L) x 1,027(H)
 Operator control panel
 Handpiece

Figure 3.1 Main components of the SOLARI IPL system

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SOLARI  Chapter 3. System Description

3.3.1 System main body


The system main body is an essential element for device operation. It
consists of components and modules necessary for controlling and
operating the device. The system main body is organized as follows.

Components Functions
This includes the key switch and the
emergency stop button which controls the
System Control overall operation of the entire system. The
Module control module receives input signals from
other modules and sends output signals to
execute the proper operation of the system.
Converts the commonly-used power supply
(AC220~230V) to the level of electric power
Power Supply
that the device requires and provides it for
each module.
Displays information regarding the current
system status and the value of each parameter.
Control Panel
The function of each button is explained in
detail in Chapter 5.
The four casters may move in all four
directions. The handle may be used to easily
move and direct the system on its casters. The
Handle and Casters
four casters have locking devices to allow the
operator to station the device firmly and safely
in a fixed position.

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SOLARI  Chapter 3. System Description

3.3.2 Handpiece & filters


Cradle

420nm

640nm

Handpiece 510nm
Filters

Handpiece tip 570nm

Figure 3.2 Handpiece & filters


 Because the handpiece of the SOLARI IPL system contains
components that may be damaged if the handpiece is dropped on the
floor, when not in use the handpiece should be kept in its cradle at all
times or hung on the hanger.

 The light passes through the handpiece tip that is inserted in the bottom
of the handpiece. The handpiece tip delivers the light energy to the
treatment site.

 When the finger switch located on the handpiece is pressed, intense


pulsed light is emitted and the color of the LEDs changes from green to
red.

 The filters should be thoroughly and properly cleaned before applying


the handpiece to the treatment area. Failure to do so may result in
damage to the system or negatively affect clinical treatment.

WARNING
Never look at the handpiece tip directly when the finger switch
is depressed. It could result in serious eye injuries and/or
blindness.

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SOLARI  Chapter 3. System Description

3.4 System Software


The software installed in the SOLARI IPL system provides the optimal
environment for clinical operations. It is programmed for the following
purposes:

 Selection and application of optimal and individual surgical


parameters for each patient.

 Prompt and accurate control of the driving device for the SOLARI
IPL system.

 Consistent monitoring of the device in order to secure the safety of


operator, staff and patients.

 Please note that the initial screen on the control panel stores the
status of the most recent operation performed; thus the panel
information on the screen may appear different each time the
system is turned on.

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SOLARI  Chapter 4. Installation

Chapter 4. Installation

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

4.2 Installation Component List


Before installing the system, check that the following list of installation
components is complete.
Items Qty
 SOLARI IPL system main body 1 unit
 Handpiece cable hanger 1 unit
 Handpiece 1 unit
 Handpiece filters 1 set
(420 nm, 510 nm, 570 nm, 620 nm, 670 nm, 710 nm)
 System key 2 units
 Remote interlock connector 1 unit
 Warning sign (For the operation room) 1 unit
 Protective goggles for the operator 1 unit
 Protective goggles for the patient 1 unit
 Operator’s manual 1 vol
 Funnel & Tube (For refilling the cooling water tank) 1 set

NOTE
If any component(s) is missing, please notify Lutronic
Corporation or your local Lutronic sales representative.
Replacement and additional components can be ordered or
purchased from Lutronic Corporation.

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SOLARI  Chapter 4. Installation

4.3 Conditions for Installation


4.3.1 Space requirements
The full dimensions of the device are shown in Figure 4.1. To maintain
optimal efficiency, the surrounding space indicated below should be
allocated when installing the device.

 Before installation, first be sure to survey and consider the


appropriateness of the intended location and space.

 Each vertical side of the device should be at least 12 inches (30 cm)
away from any wall.

 Be sure to maintain the maximum distance when placing the device


near or next to another medical device, or any other device that
generates heat.

Length of the
1027mm Handpiece
Cable : 1800mm

570mm

367mm

Figure 4.1 Dimensions of the SOLARI IPL system

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SOLARI  Chapter 4. Installation

4.3.2 Electrical requirements

Electric power supplied to SOLARI IPL system should satisfy the


following requirements in order to maintain optimal efficiency and
electrical safety.

 The wall power outlet should include at least two electrical sockets
complete with grounding terminals.

 Check the output power of the wall outlet. The outlet should supply
single phase, AC220~230V at 50/60 Hz. Please check these
conditions before connecting the device power plug to the outlet.

 After checking that the wall outlet in the operating room complies
with the voltage and power requirements of the device, the operator
can prepare to operate the SOLARI IPL system.

 A 250V/25A circuit breaker-type fuse is used to protect the device


from excessive voltage. If the fuse is open-circuited, contact the
Lutronic Corporation customer service department for proper
actions to be taken.

 For the safety of patients, operator, staff members, as well as


electrical safety, connect the external ground terminal of the device
to the dedicated ground terminal in the operating room. Please
contact Lutronic Corporation customer service department to
ensure safe grounding during installation.

WARNING
Verify the electrical requirements and use the correct power
supply or a power supply system. Failure to follow these
instructions may lead to damage to the device, device
malfunctions and/or fatal electrical shock to users. Improper
installation and use of the device may void the warranty
coverage.

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SOLARI  Chapter 4. Installation

4.3.3 Environmental requirements


The environment for using SOLARI IPL system should satisfy the
following requirements:

 Temperature / relative humidity

- Operating conditions

Temperature : 10°C - 40°C, 50 - 104°F


Relative Humidity : 0 %- 90%
Pressure : 90 - 110 kPa (13 – 16 psi)

- Non-operating conditions

Maximum altitude : Standard commercial shipping altitude


Temperature : -5 - 55°C (23 - 131°F)
Relative Humidity : 90% at 35°C (95°F) non-condensing
32% at 55°C (137°F) non-condensing

- Install the device in a well-aired location in order to


maintain the appropriate proper humidity according to the
temperature.

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SOLARI  Chapter 4. Installation

4.4 Installation of the Device


4.4.1 STEP 1: Connecting the handpiece
1. Before connecting the handpiece to the system main body, check the
condition of the interior of the connector of the system main body. If
there are any liquid droplets, you should wipe off them thoroughly.

Figure 4.2 The interior of the system main body connector


2. Insert the handpiece connector carefully into the system main body as
shown in Figure 4.3. Be sure that the handpiece is securely fastened.

Figure 4.3 Connecting the handpiece

3. A clearly audible “click” indicates that the handpiece connector is


properly connected to the system main body.

CAUTION
In case of connection and disconnection of the handpiece, the
operator must follow the instructions carefully in order to
prevent any damage to the handpiece connector.

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SOLARI  Chapter 4. Installation

4.4.2 STEP 2: Installing the handpiece cable hanger


1. Carefully insert the handpiece cable hanger into the hole located on the
top of the system as shown in Figure 4.4

Figure 4.4 Installing the handpiece cable hanger #1

2. Release the knob located on the optical fiber hanger by turning it in the
same direction as shown in Figure 4.5. Then adjust the height of the
handpiece cable hanger for use.

Knob

Figure 4.5 Installing the handpiece cable hanger #2


3. After installing the handpiece cable hanger, hang the handpiece cable
in the cradle. To help prevent damage to the cable, it should be kept in
the cradle both for storage and during system use.

Figure 4.6 Installing the handpiece cable hanger #3

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SOLARI  Chapter 4. Installation

4.4.3 STEP 3: Connecting the accessories

1. Remote interlock connector


 Insert the remote interlock connector into its socket on the main
inlet and connection panel located at the lower rear of the system
main body (Figure 4.7). Insert the remote interlock into the socket,
pulling the metallic part of the interlock back; the resulting
frictional sound indicates that the interlock connector has fitted into
the socket correctly.

 The remote interlock connector is not designed for any other types
of socket. The use of excessive force while attempting to insert the
interlock connector into an inappropriate socket may cause
damage. Please be careful at all times.

2. Main power cord


 Plug the main power cord into a wall outlet.
Main power circuit Remote
breaker interlock

Main power cable

External
grounding
Figure 4.7 The main power module shown with the system interlock
connector connected.

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SOLARI  Chapter 4. Installation

4.4.4 STEP 4: Final check-up and locking the system in place

1. Position the device in a place that satisfies the requirements of 4.3


Conditions for Installation.

2. Depress the caster brakes located on all the four casters of the system
to lock it in position. (Before moving the system again, please be sure
to release all brakes.)

CAUTION
Before moving the device, the handpiece and power cord must
first be secured. Use the moving handle to transport the device
to a desired location. Fix all the casters to secure the device in
its new desired location.

4.4.5 STEP 5: Supplying the main power


1. Make sure that the status of main power circuit breaker is in the (OFF)
position indicating that the main power is off and not running.

2. Connect the main power plug to the outlet on the wall.

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SOLARI  Chapter 4. Installation

4.5 Moving the Device


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

4.5.1 Moving the device in the treatment room


 To move the device safely, repeat the steps shown in “4.4 Installation
of the Device” but in the reverse order.

 Using the moving handle to transport the device, move the device to the
new location that is compliance with the “4.3 Conditions for
Installation” and reinstall the device according to “4.4 Installation of
the Device.”

4.5.2 Moving the device to a remote location


When moving the device to a remote location, contact your Lutronic
Corporation distributor for safe and efficient transportation.

CAUTION
When moving the device to a remote location, contact your
Lutronic Corporation distributor to do so safely and efficiently.
This will prevent potential damage to or breakage of the device
and potential physical injuries to the operator and staff.

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SOLARI  Chapter 5. Operation

Chapter 5. Operation

5.1 Overview
This chapter contains detailed operating instructions, precautions and
warning items for the SOLARI IPL system.

The control panel allows the user to set the optimum parameters of the
treatment beam. The control panel also displays useful information about
the system during operation. While the system is operating, functions are
continuously monitored by a micro-controller and displayed on the screen
for the operator’s information

g
i h

a b

Figure 5.1 The SOLARI IPL system control panel


Please refer to the following text for information on the various (a) – (i)

侶 Pulse Width
This function represents the total period from the initial sub-pulse of the
light output to last sub-pulse of the light output and includes the inter-pulse
intervals between the light outputs.

 Range of pulse width


: 5 ms ~ 300 ms (In the normal mode)

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SOLARI  Chapter 5. Operation

慮 Fluence
The fluence is displayed in joules per square centimeter (J/cm2). The
fluence is computed by dividing the pulse energy into in joules (J) by the
tip area in square centimeters (cm2). The fluence is adjustable using the up
and down buttons on the right side. This display is valid for fluence at the
tissue.

 Derivation of the equation:


 For a treated area per spot: 4.8 cm2 (area of the treatment tip)
 The equation is as follow (J/cm2) :
E
F= J/cm2
2
4.8 cm
(Where F is the fluence, E is the output energy of the beam
and 4.8 cm2 is the area irradiated by the treatment tip)

<Example> For an irradiated area of 4.8 cm2 and a pulse energy of 10 J.


Fluence: 10 J / 4.8cm2 = 2.1 J / cm2

旅 Cooling Temperature

This function displays the cooling temperature of the handpiece tip. You
may adjust the initial temperature of the handpiece tip by pressing the
temperature button (c) ( , ).

 Range of the temperature :


-5 ~ 15

虜 Filter
This function displays the nominal wavelength with the waveband of the
interchangeable filter inserted into the handpiece. Note that, unlike a
monochromatic laser, polychromatic intense pulsed light energy cannot be
delivered at a specific wavelength.

Handpiece Wavelengths and Associated Waveband

 420 nm (blue cut-off) : 420 nm ~ 750 nm


 510 nm (green cut-off) : 510 nm ~ 950 nm
 570 nm (yellow cut-off) : 570 nm ~ 950 nm
 620 nm (orange-red cut-off) : 620 nm ~ 950 nm
 670 nm (deep red cut-off) : 670 nm ~ 950 nm
 710 nm (near infrared cut-off) : 710 nm ~ 950 nm

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SOLARI  Chapter 5. Operation

User Shot Count


This function shows the accumulated number of light shots of light energy
emitted since the system was turned on for each treatment session. The
shot count can be reset to zero by pushing the User Shot indicator.

亮 STANDBY / READY
This button allows the SOLARI IPL system status to shift from the
“STANDBY” to the “READY” mode. As the button is pressed, the current
status of the system is displayed below the button.

 “STANDBY” status allows users to set parameters. Even though


the finger switch is depressed, no light will be emitted. This is the
default status of the device.

 “READY” status means that the IPL system is armed and ready to
shoot. Once the STANDBY button is pressed in the standby status
to place the system in the “READY” mode, optical pumping starts
to build up the system energy, and proceeds for 5 seconds during
which an audible warning can be heard, the LED indicators on the
handpiece turn orange. During this phase, even if the finger switch
is pressed, no pulsed light will be emitted. After the pumping is
complete, the system reaches “READY” status and the LEDs on
the handpiece turns from orange to green. The system can now be
used for the actual treatment. Note: As a safety and power-saving
feature, if the finger switch is not pressed for approximately 10
minutes with the SOLARI IPL system in the “READY” status, the
automatically reverts to “STANDBY” status.

 When the finger switch is depressed in the “READY” status and


pulsed light emission starts, the READY button blinks and turns
red and the handpiece LEDs also turn red.

両 Setup
This Setup mode comprises the Handpiece Total Shot Count indicator,
Handpiece Temperature Check Mode indicator, Advance Mode Select
indicator, Volume Control indicator, and Service indicator.

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SOLARI  Chapter 5. Operation

凌 Library
This function saves different sets of parameters for the treatment of certain
skin conditions. Users can recall a particular memory by pressing one of the
libraries when in the library mode, and can additionally add sets of their
own favorite parameters to the library.

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SOLARI  Chapter 5. Operation

5.2 Pretreatment Precautions and Inspection Items


Prior to performing a treatment procedure, please check the following items.
Pay close attention to the precautionary items presented in Chapter 2. Safety
Precautions

 Is everyone in the treatment room wearing appropriate protection


goggles or glasses with side protection in accordance with the ANSI
standard?
 Is the patient wearing protective goggles?
 Are the system main body, handpiece and handpiece tip clean?
 Is the device installed properly according to the conditions given in
Chapter 4. Installation?
 Are the casters on the base of the device properly locked in order to
prevent the device from moving?
 Are there any objects nearby in the operation room that can reflect light,
such as a mirror or stainless steel trays?
 Is the power cord of the device plugged into a wall outlet?

DANGER
Before connecting the power plug of the device to the local
power supply outlet, be sure that the local power supply is
AC220~230V with proper grounding. Never look directly at the
handpiece tip when power is applied. Serious eye injury and/or
blindness could result.

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SOLARI  Chapter 5. Operation

5.3 Operation of the SOLARI IPL System


5.3.1 Turning on the system
1. Flick the main power circuit breaker, located in the panel at the lower
rear of the system, to the ON position.

2. After that, insert the key into the key switch located on the front of the
system and then turn it to the 1st position. The cooling pump will start
running. The control panel will light up.

3. The control panel first displays the initial screen as shown in Figure 5.2.
The pop-up screen will appear during the system self-check function.
After that, the system enters into the operation mode.

Figure 5.2 The OK button pop-up

4. If the system detects system errors, a message code will show up on the
screen. Until the error is corrected completely, operation of the system
cannot start.

CAUTION
If any kind of emergency error suddenly occurs, immediately
push the emergency button. Releasing the emergency button,
will not restart the system. Under these circumstances, a
system reboot is required.

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SOLARI  Chapter 5. Operation

5.3.2 Normal operation mode

Jog wheel

a b

Figure 5.3 Normal operation mode

1. Insert the desired interchangeable filter into the handpiece hole. The
nominal wavelength of the filter inserted into the handpiece filter aperture
is displayed on the screen, 420 nm in the example shown.

2. You may adjust the pulse width up or down by pressing the Pulse Width
button (a) (▲,▼) or using the jog wheel.

3. You may adjust the fluence up or down by pressing the Fluence button
(b) (▲,▼) or using the jog wheel to set the light energy to the desired
level per unit area in J/cm2.

4. Press the Temperature button (c) (▲,▼) to set the initial temperature of
the handpiece tip.

NOTE
If the wavelength range of the selected filter and wavelength
stored in the library are different, a warning message appears
prompting you to change the filter. No pulses can be triggered
until the appropriate filter is in place.

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SOLARI  Chapter 5. Operation

5. After setting the desired parameters on the control panel, press the
STANDBY button when you are ready to begin. Wait until the LEDs on
the handpiece change color from orange to green.

6. When pulsed light energy is emitted by pressing the finger switch located
on the handpiece, the color of the LEDs changes to red.

NOTE
Every time the system restarts, the control panel recalls and
displays the most recently used parameters.

DANGER
 Never look directly at the handpiece tip when power is
applied. It could result in serious eye injury and/or
blindness.
 Never leave the device unattended when it is turned on.
Secure the device against unauthorized use by removing
the key from the key switch.

NOTE
 If the wavelength stored in the library does not match the
wavelength of the interchangeable filter in the handpiece,
the warning message on the control panel will continue
blinking until those two match, and the device will remain in
“STANDBY” status.
 It is possible to change parameters while the system is in
the "READY" status; however the system will revert to the
"STANDBY" status.

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SOLARI  Chapter 5. Operation

5.3.3 Normal library mode


This function allows the user to set parameters and save them in the system
library. It allows users to easily recall particular parameter settings without
setting them for every treatment.

1. Enter the library mode by pressing the Library button located on the top
left of the normal operation mode screen.

Figure 5.4 Normal library mode

2. Select one of the four groups.

3. After selecting one of the four groups, choose the one of the skin types
from I to V taking the skin type of the patient into consideration.

4. Next, select one of the five libraries. The library selected by the operator
has four parameters. If the operator wants to change the parameters of the
library, press the indicator for 3 seconds. You may change the parameters
as you want.

5. After setting the desired parameters in the library, press the save button
on the top of the screen to save the parameters. At this time, a popup
window is displayed to make sure users want to save the parameters in
the selected library. If yes, press the OK button.

6. If you want to rename the library, press the button for 3 seconds, you may
change the name as you want.

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SOLARI  Chapter 5. Operation

5.3.4 Advanced operation mode

Figure 5.5 Setup mode

1. Enter the setup mode by pressing setup button on the top of the normal
operation mode screen.

2. Set the advanced mode button to “Enable”.

3. Press the return button. The advanced operation mode comes up on the
screen as shown in Figure 5.6.

4. Insert the desired interchangeable filter into the handpiece filter aperture.

b c

Figure 5.6 Advanced operation mode

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SOLARI  Chapter 5. Operation

5. You may select one of the pulse types: single, double, or triple by
pressing the Pulse Type indicator. If you want to change the pulse width
or delay time, press the section (b) for 3 seconds. You may change them
by pressing button (c) (▲,▼).

6. You may adjust the fluence up or down by pressing the Fluence button
(d) (▲,▼) or using the jog wheel to set the Fluence to the required
setting of energy per unit area (J/cm2 ).

7. Press the Temperature button (e) (▲,▼) to set the initial temperature of
the handpiece tip.

8. The wavelength stored in the library shows up on the screen.

NOTE
If the wavelength range of the selected filter and wavelength
stored in the library are different, a warning message appears
prompting you to change the filter. No pulses can be triggered
until the appropriate filter is in place.

9. After setting the desired parameters on the control panel, press the
STANDBY button when you are ready to begin. After pressing the
STANDBY button, the “STANDBY” status turns to “READY”. Wait
until the handpiece LEDs change color from orange to green.

10. Place the handpiece tip in contact with the treatment area and then, press
the finger switch. As intense pulsed light is emitted, the color of the
LEDs changes from green to red.

NOTE
When the system restarts, the control panel recalls and displays
the most recently used parameters.

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SOLARI  Chapter 5. Operation

5.3.5 Advanced library mode


The Advanced Library Mode is for changing parameters stored in the
library or loading new parameters.

b c

Figure 5.7 Advanced library mode

1. If you select one of the libraries, the parameters stored in the library are
shown on the screen.
2. Press the Indication section, button (b), for 3 seconds, and a popup
window will appear to let you change the library name.
3. If you press the Pulse Type section, button (c), for 3 seconds, a popup
window will appear to let you change the parameters of pulse width,
pulse type and delay time as shown in Figure 5.8.

a 420

Figure 5.8 Advanced library modification #1

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SOLARI  Chapter 5. Operation

4. Press the Fluence section to activate the up and down buttons and then,
adjust the Fluence using the up and down buttons.

5. Press the Temperature section to activate the up and down buttons and
then, adjust the temperature using the up and down buttons.

6. Press the Filter section to activate the up and down buttons and then,
adjust the filter using the up and down buttons.

a 420

Figure 5.9 Advanced library modification #2

9. Once adjustment of the parameters is complete, you may save the


revised parameters by pressing the save button shown at the top right of
the screen.

10. If you want to return to the advanced operation mode, press the
operation button at the top of the screen.

NOTE
If you select another library without saving the revised
parameters of the chosen library, a popup window will quickly
appear to ask you whether you want to save the revised
parameters or not.

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SOLARI  Chapter 5. Operation

5.4 Use of the Handpiece


1. Hold the handpiece horizontally to the target tissue as shown in Figure
5.10.

2. Bring the handpiece tip into light contact with the treatment area.

3. Press the finger switch to emit the light through the handpiece tip.

Correct Incorrect

Figure 5.10 How to place the handpiece on the skin

CAUTION
Before using the handpiece for any procedure, make sure that
there is no debris or residue on the handpiece tip. A dirty
handpiece tip may cause a loss of energy and produce less
effective results during treatment. Any damage incurred as a
result of failure to perform this routine maintenance will void
the warranty. Ref. Chapter 6

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SOLARI  Chapter 5. Operation

5.5 Setup
The items available in the setup mode are the H/P(Handpiece) Total Shot Count
indicator, H/P Temperature Check Mode indicator, Advanced Mode indicator,
Service button, Volume indicator and Return button.

Enter the setup mode by pressing setup button on the top of the normal operation
mode screen.

Figure 5.11 Setup mode

H/P Total Shot Count


This Handpiece Total Shot Count button displays the number of times
which light has been emitted by pressing the finger switch.

慮 H/P Temperature Check Mode


If the H/P Temperature Check Mode button is set to “Enable”, the system
limits emission of the light energy to the temperature range selected. If the
H/P Temperature Check Mode button is set to “Disable”, there is no
limitation on system emission of pulsed light.

旅 Advanced Mode
If the Advanced Mode button is set to “Enable”, you may set the
parameters in the advanced mode operation or if the Advanced Mode
button is set to “Disable”, you may set the parameters in the normal mode
operation.

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SOLARI  Chapter 5. Operation

5.6 Turning off the System


5.6.1 Normal turn-off
1. Securely stow the handpiece and turn the key counterclockwise back
to the OFF position.

2. Hang the handpiece on the hanger or put the handpiece in its cradle.

OFF

Figure 5.12 Turning off the key switch

3. Remove the key from the key switch in order to prohibit unauthorized
persons from using the device.

4. Flick the main power circuit breaker located on the main power
module at the lower rear of the device to the OFF (O) position in
order to shut off the main power supply.

5. If the device is not going to be used for a prolonged period of time,


please remove the power cord from the wall outlet.

5.6.2 Emergency turn-off


The operator should use the emergency stop button only in the case of an
emergency only. Pressing the emergency stop button consequently stops
the device immediately.
When the emergency situation has been dealt with, to restart the device,
first turn the key switch to the OFF position and set the main power circuit
breaker to the OFF (O) position. Then turn the emergency stop button
clockwise until it pops back out. When ready, restart the system as in
Section 5.3.1 above.

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SOLARI  Chapter 5. Operation

WARNING
 DO NOT leave the device unattended while it is running!
After using the device, remove the key from the key switch
to prevent random access by unauthorized persons.

 The emergency stop switch stops SOLARI IPL system


immediately. Do NOT use this switch to turn off the device
in normal operation: use the key switch to turn off the
device.

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SOLARI  Chapter 6. Maintenance & Management

Chapter 6. Maintenance
& Management
6.1 Overview
Chapter 6 describes maintenance guidelines, including periodic inspection
needed to maintain performance, and information on message codes to be
used in self-testing mechanisms for the device.

CAUTION
When inspecting the device, first turn off the power and then
disconnect the power cord. Attempting to inspect the device
while the electrical power is on may result in severe damage to
the device or severe injury to the user.

The SOLARI IPL system is designed so that maintenance and management


of the device are minimized. However, to guarantee the most effective
results the exterior of the device and the handpiece tip should be kept
thoroughly clean at all times.

6.2 Cleaning the System Main Body


 Soak a soft pad in a non-corrosive cleansing liquid such as isopropyl
alcohol or ethanol 90% pure or higher and gently wipe down the
surface areas of the device.

 Wipe down the device again with a clean, dry pad or let it naturally air
dry.

CAUTION
Do not apply cleansing liquid directly to the system main body
as it may damage or harm the system to malfunction.

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SOLARI  Chapter 6. Maintenance & Management

6.3 Cleaning the Handpiece


The handpiece unit should remain clean at all times. Follow the cleaning
procedure below after cleaning your hands.

Handpiece
tip

Figure 6.1 Cleaning the handpiece tip

1. Prepare a soft, lint-free dry cloth and soak it in reagent quality


alcohol.

2. Use the cloth to clean the entire area of the handpiece and
handpiece tip.

3. After thoroughly cleaning the handpiece and handpiece tip, shine


a light onto the handpiece tip to check for cleanliness.

4. When not using the handpiece, hang it on the hanger or put in the
handpiece cradle.

CAUTION
 The handpiece tip should be thoroughly and properly
cleaned before applying it to the treatment area. Failure to
do so may result in damage to the tip or negatively affect
clinical treatment.

 Failure to properly maintain or manage the condition of


handpiece tip may result in accumulation of foreign bodies
on its surface, resulting in damage to the handpiece
system.

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SOLARI  Chapter 6. Maintenance & Management

6.4 Cleaning the Interchangeable Filters


The interchangeable filters should remain clean at all times. Follow the
cleaning procedure below after cleaning your hands.

1. Hold the handpiece with one hand, and then carefully take out the
interchangeable filter from the handpiece with the other hand.

Figure 6.2 Taking out the filter out of the handpiece

2. To clean all foreign bodies from the filter after each use, wipe off any
residue from the filter surface with cotton swabs saturated in 90%
alcohol, working from the center to the left, then from the center to the
right.

Figure 6.3 Cleaning the used filter with a swab

3. After thoroughly cleaning the filter, shine a light onto the filter to check
for cleanliness.

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SOLARI  Chapter 6. Maintenance & Management

6.5 Separating the Handpiece


1. Press the buttons on both sides of handpiece connector.

2. Then pull the handpiece connector upwards.

Figure 6.4 Separating the handpiece

WARNING
Do not apply any liquids directly to the system main body while
separating the handpiece as it may damage, harm or cause the
system to malfunction.

CAUTION
In order to prevent any damage to the handpiece connector,
never insert the connector using excessive strength.

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SOLARI  Chapter 6. Maintenance & Management

6.6 Keeping the handpiece


When the handpiece is not actually in use during any treatment procedure
or after treatment is complete, please follow this 2-step procedure.

1. Stow the handpiece securely in the handpiece cradle located on the


top of the system main body. See Figure 6.5

Figure 6.5 Putting the handpiece in the handpiece cradle

2. After securely stowing the handpiece, hang the handpiece cable on


the handpiece cable hanger if it has been removed from the hanger
during a procedure. The cable may also be left in the hanger during
a procedure.

Figure 6.6 Hanging the handpiece cable on the handpiece cable


hanger

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SOLARI  Chapter 6. Maintenance & Management

6.7 Refilling the Cooling (Distilled) Water Tank


6.7.1 Cooling water indicator
The window indicating the distilled water level window is located on the
left side of the system main body. The cooling water level is indicated by a
ball floating in the indicator tube. When a status message (CODE 06)
appears on the screen, the operator should refill the distilled water tank.

6.7.2 How to refill the cooling water tank

1. Prepare the funnel, tube and fresh distilled water for use.

2. Take off the water level window by unscrewing the upper and lower
securing screws (See Figure 6.7, left panel) with a screwdriver, and
remove the plate to reveal the indicator tube.
Securing
Screw

Ball
Proper water
level

Indicator
Securing tube
Screw

Figure 6.7 Removing the window over the water level indicator

3. As shown in Figure 6.8, pull out the upper nipple of the indicator tube by
pushing the valve of the upper inlet.

4. Pull out the lower nipple of the indicator tube by pushing the valve of the
lower inlet. At this time, because the small amount of distilled water
inside the indicator tube will flow out, put a piece of cloth or tissue
under the lower nipple.

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SOLARI  Chapter 6. Maintenance & Management

Upper

Lower
Figure 6.8 Disconnecting the indicator tube

5. As shown in Figure 6.9, insert the plain tube with the funnel into the
upper inlet, and then insert the nipple of the funnel tube into the lower
inlet.

Figure 6.9 Inserting the funnel and the tube into the tank

6. While holding the funnel upright, slowly pour distilled water into it
(Figure 6.10). As the distilled water flows into the tank, the air inside the
tank is forced out through the upper tube. If the distilled water does not
flow smoothly into the tank, hold the funnel up higher.

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SOLARI  Chapter 6. Maintenance & Management

Figure 6.10 Pouring distilled water into the funnel

7. Once the cooling water tank is filled with distilled water to the top, pull
out the funnel and the plain tube from the tank inlets.

8. Reconnect the indicator tube to the tank by pushing the tube nipples into
tank inlets. The indicator tube will then fill up with distilled water to the
water level of the tank, shown by the level of the ball. It is important that
the ball now indicate the proper water level as shown in Figure 6.7
above.

Figure 6.11 Reconnecting the indicator tube to the tank

9. Reattach the water level window by replacing the plate and securing it
with the upper and lower screws using a screwdriver. Do not overtighten
the screws.

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SOLARI  Chapter 6. Maintenance & Management

6.8 Troubleshooting

6.8.1 When the device fails to turn on.


 Check that the power cord is correctly inserted into the main power
outlet.

 Check that the main power circuit breaker is flipped to the ON (I)
position.

 Check that the key switch is fully in the ON position.

 Check the condition of the fuse inside the device.

6.8.2 When the device is powered on but no light energy is emitted


from the handpiece.
 Check that the handpiece connector is correctly inserted into its socket.

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

 Check that the handpiece is correctly inserted.

CAUTION
If the light energy is not emitted for a long period of time, turn
off the device at the key switch and wait two minutes before
turning it on again. If the problem persists, do not attempt to
disassemble the device or take any other unauthorized actions
by yourself. Always contact an authorized Lutronic distributor
or Lutronic Corporation for assistance.

6.8.3 When light energy is emitted, but the output power appears
inadequate.
 Check whether the handpiece tip is damaged or dirty. If foreign
substances are found, clean the handpiece tip before using it again. Ref.
6.3 Cleaning handpiece

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

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SOLARI  Chapter 6. Maintenance & Management

6.9 Status Messages


The system is continuously self-monitored and will notify the user of any
problem by displaying a message code, one example of which is seen in
Figure 6.12.

Figure 6.12 Status message for Code 01


When an error occurs, the corresponding message code will be displayed
on the control panel as shown in Figure 6.12. In case of an error, emission
of light energy will stop immediately.

The following is the list of message codes:

▼ The following message codes do not mean the system has broken
down, but the problem can be resolved by the operator following the
instructions given below.
Possible Cause for
Message Code Actions to Take
Errors
Turn off the device and reset the
CODE 01 Emergency Switch on emergency switch, and then restart the
device in 2 min.
Turn off the device at the key switch.
CODE 02 Simmer Off Before restarting the device, wait for 2
minutes.
Turn off the device, close the side
CODE 03 Door open cover, and then restart the device in 2
minutes.
Turn off the device at the key switch,
check that the side cover is properly
CODE 04 Check Interlock
closed, and then restart the device in 2
minutes.

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SOLARI  Chapter 6. Maintenance & Management

Refill the cooling water tank according


CODE 05 Check Water Flow
to the instructions. (Ref. 6.5)

Check the water level and fill with


CODE 06 Check Water Level
distilled water as required.

CODE 07 Check Handpiece Check the handpiece

Turn off the system and request


CODE 08 Check Communication
assistance from Lutronic Corporation.

Turn off the system and contact your


CODE 09 Check Safety local Lutronic distributor for inspection
before using the device.

Turn off the device. Before restarting


CODE 10 Check Discharge
the device, wait for 2 minutes.

Press the READY button. Then the


CODE 11 Check Full Charge
SOLARI IPL system will operate.

DANGER
If error messages continue to appear, in some cases the
operator may continue to use the machine temporarily, but
must contact the Lutronic corporation customer service
department as soon as possible to restore stable use.

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

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SOLARI  Chapter 6. Maintenance & Management

6.10 Requests for Periodic After-sales service


For more detailed information on periodic service for this device, contact
your authorized Lutronic distributor or contact Lutronic Corporation for
assistance.

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SOLARI  Chapter 7. Clinical Information

Chapter 7. Clinical Information

7.1 Overview
The following clinical information has been developed from materials
recommended or proposed by doctors who have a lot of experience in using the
SOLARI IPL system or is based on excerpts from the relevant medical literature
and is intended only as a general guide. 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 SOLARI IPL System every operator should read the contents of
this manual very carefully and be fully familiar with all relevant items. Every
operator of the SOLARI IPL System is advised to attend a recognized training
course on photobiological basis of laser covering laser-related physics, safety
issues on laser and observation of patients. Specially recommended materials
intended for training clinicians are already available in the ‘ANSI Z136.4
standard’ publication. However, operators should always refer to the latest
literature relevant to modern clinical practice. If you wish to obtain more detailed
information, please contact Lutronic Corporation by dialing 82-31-908-3440 or
sending an email inquiry to edu@lutronic.com. Also we recommend that you visit
our educational website edu.lutronic.com for more details about operation video.

7.2 Clinical Guide

Introduction to the SOLARI IPL System System


SOLARI IPL System stands for Intense Pulsed Light (IPL).
SOLARI IPL System Intense pulsed light treatment (often called phototherapy) is a
non-laser, non-ablative skin rejuvenation technology that delivers light energy
(heat) to the skin's deeper layers (the dermis) while leaving its surface layer
(epidermis) essentialy intact.
The main difference between SOLARI IPL System Intense Pulsed Light treatments
and laser treatments is a broader frequency which results in greater absorption of
pigment in hair follicles and blood vessels depending on the setting.
The primary goal of SOLARI IPL System Intense Pulsed Light is to make the skin
tone or color more even.

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SOLARI  Chapter 7. Clinical Information

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SOLARI  Chapter 7. Clinical Information

7.3 Clinical Applications

The SOLARI is applicable for many indications and can be applied to any of the
following indications:
 Inflammatory Acne

 Pigmented Lesions

 Vascular Lesions

 Hair removal

 Skin rejuvenation

7.4 Contraindications
Physicians/Therapists should be aware that certain conditions and/or medicines can
cause photosensitivity. A list of conditions/medicines known to be photosensitisers
is given below. The list should not be regarded as exhaustive or complete and care
should be taken to confirm the safety of light treatment before exposure. If a
particular medication is not listed in the table below, please refer to the drug
manufacturer’s data sheet for any precautions and contra indications relating to
photosensitivity and contraindications relating to photosensitivity.

Photosensitivity denotes a reaction to normally harmless amounts of UVA and /or


visible right

SOLARI IPL system (IPL) Light delivers energy in the IR with no UV or visible
components.

Photosensitivity can also be caused by:

• Certain perfumes or plant materials such as St John’s Wort in contact with the
skin.
• Metabolic disorders such as porphyria and other light induced rashes. So, the
treatment is not recommended.
• Autoimmune disease (self allergy), such as lupus erythematosus.
• Albinism.

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SOLARI  Chapter 7. Clinical Information

7.5 Possible side effects of treatment


 Discomfort
When a pulse is triggered, it may cause various degrees of discomfort. Some
describe the sensation as stinging.
A burning sensation may last for up to an hour agter treatment. Most patients
are able to tolerate this discomfort, but some people may require a topical
anesthetic.

 Damage to natural skin texture


A crust or blister may form, which may take from five to ten days to heal.

 Change of pigmentation
There may be a change of pigmentation in the treated area. Most cases of hypo-
or hyper-pigmentation occur on people with darker skin, of when the treated
area has been exposed to sunlight before or after treatment.

 Scarring
There is a very small chance of scarring, such as enlarged hypertrophic scars. In
very rere cases, abnormal,large,raised keloid scars may appear. To reduce the
chance of scarring, it is important to carefully follow all post-treatment
instructions.

 Bruising
A blue-purple bruise(purpura) may appear on the treated area. It may last from
five to fifteen days. As the bruise fades, there may be rust-brown discoloration
of this skin, which fades in one to three months.

IMPORTANT
Be sure to choose the relevant cut-off filter for purpose of treatment,
carefully use as guidelines.

IMPORTANT
As the recommended treatment values for each symptom and/or effects
are standards to be used for consultative purposes only, we recommend
adjusting such values for patients depending on each patient's special
circumstances and treatment history. Lutronic shall not be liable for any
injuries, problems or issues that arise as a result of negligence or
inexperience in using the product supplied by Lutronic Corporation,
rather than as a result of any actual defect on the product itself as
supplied by Lutronic Corporation.

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SOLARI  Chapter 8. Warranty

Chapter 8. Warranty

8.1 Overview
Chapter 8 describes unpaid services available for those properly using the
system and exclusions from such unpaid services provided by the warranty
of this product.

8.2 Unpaid Services

 If the SOLARI IPL system has been properly used and after sales-
service has been applied for, the user is eligible for unpaid services up
to one year from the date of purchase, as guaranteed by Lutronic
Corporation.
 Free complimentary service includes maintenance of the main body of
the system and remote interlock, but not of the consumable
components, such as the flash lamp and sapphire block (handpiece tip),
all of which are excluded.
 If Lutronic Corporation receives a request for parts/labor during the
warranty period, such requests will be handled in a prompt manner.
Depending on the condition of the system to be repaired, Lutronic
Corporation may decide to repair or replace the system. Repairwill be
carried out either on the premises of Lutronic’s headquarters or the
location where the system is installed.
 If it is necessary to recall the system for the purpose of adjustment or
inspection, Lutronic Corporation will provide the information that our
customer requests or allow them to rent a temporary device.

 The SOLARI IPL system will be calibrated every 1 year during the
warranty period. The calibration will be covered under the warranty
plan and will be performed by Lutronic Inc. service department.

WARNING
In order to maintain the coverage of unpaid services, only
service persons formally authorized by Lutronic Corporation

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SOLARI  Chapter 8. Warranty

should be allowed to configure, modify or inspect the system. If


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

8.3 Exclusion of unpaid services within the period of the


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

 If the handpiece is pulled with excessive force so as to move the


system and results in damage to the main body, the system is then
no longer eligible for unpaid services covered by this letter of
warranty. To avoid this problem, always move the system using the
handle provided, and never by pulling on the handpiece.

 If the system is used, modified or disassembled for purposes other


than those initially intended, then the user forfeits coverage by
warranty and is ineligible for any unpaid services under the
warranty.

 The consumable accessories provided for convenience of use do


not belong to the system per se.

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SOLARI  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 regarding the condition of the system or its
marketability for any sort of purpose.

Practice name: ___________________________

Physician : ____________________________

Address:
_____________________________________________________________

Tel: ________________________ Fax: _________________________

E-mail: _____________________________

Model: __________________

Serial No.: ____________________

Date of purchase: ________________

Expiration Date of Warranty: ____________________

Sales Agent: ______________________ Tel. : ____________________

Date of installation: ______________________

Important! To validate this warranty, please completely fill out the above
items and email it or fax it to 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
Phone: 82-31-908-3440 Fax: 82-31-907-3440
Homepage: www.lutronic.com
E-mail: office@lutronic.com

Revision 1.1 / 4100133711 Ch8-3/3

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