(Rev 1.1) SOLARI - Operation Manual - 4100133711
(Rev 1.1) SOLARI - Operation Manual - 4100133711
(Rev 1.1) SOLARI - Operation Manual - 4100133711
SOLARI
Square Pulse Technology
Operator’s Manual
0434
CAUTION : Users must read this manual carefully and thoroughly before using
this product.
No part of this manual may be re-manufactured or copied in any form without the
written consent of Lutronic Corporation.
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
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
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 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
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
List of Figures
Chapter 1. Overview
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).
Manufacturer
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.
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.
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.
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).
(A) (B)
3PL#33
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.
Never allow any type of liquid to enter the system main body of the
SOLARI IPL system. This may lead to electrical shock.
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.
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.
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.
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.
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.
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.
(1) OFF
Key Switch OFF
Status: Power is shut off.
(2) ON
Key Switch ON
Status: Power is on.
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.
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.
If the back panel is opened while the system is in operation, the system
will stop operating immediately and show a message code.
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
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
Figure 2.8 Caution label for refilling the cooling water tank
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.
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.
420nm
640nm
Handpiece 510nm
Filters
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.
WARNING
Never look at the handpiece tip directly when the finger switch
is depressed. It could result in serious eye injuries and/or
blindness.
Prompt and accurate control of the driving device for the SOLARI
IPL system.
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.
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.
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.
Each vertical side of the device should be at least 12 inches (30 cm)
away from any wall.
Length of the
1027mm Handpiece
Cable : 1800mm
570mm
367mm
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.
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.
- Operating conditions
- Non-operating conditions
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.
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
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.
External
grounding
Figure 4.7 The main power module shown with the system interlock
connector connected.
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.
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.”
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.
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
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.
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.
旅 Cooling Temperature
求
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) ( , ).
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.
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.
“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.
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.
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.
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.
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.
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.
Jog wheel
a b
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.
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.
1. Enter the library mode by pressing the Library button located on the top
left of the normal operation mode screen.
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.
1. Enter the setup mode by pressing setup button on the top of the normal
operation mode screen.
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
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.
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.
b c
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
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
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.
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
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
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.
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.
2. Hang the handpiece on the hanger or put the handpiece in its cradle.
OFF
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.
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.
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.
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.
Handpiece
tip
2. Use the cloth to clean the entire area of the handpiece and
handpiece tip.
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.
1. Hold the handpiece with one hand, and then carefully take out the
interchangeable filter from the handpiece with the other hand.
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.
3. After thoroughly cleaning the filter, shine a light onto the filter to check
for cleanliness.
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.
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.
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.
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.
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.
6.8 Troubleshooting
Check that the main power circuit breaker is flipped to the ON (I)
position.
Check to see that the remote interlock is properly inserted into its
socket.
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.
▼ 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.
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.
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.
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.
SOLARI IPL system (IPL) Light delivers energy in the IR with no UV or visible
components.
• 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.
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.
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.
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
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.
Physician : ____________________________
Address:
_____________________________________________________________
E-mail: _____________________________
Model: __________________
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