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PICO 4
The premium pico- and nanosecond platform
Operators manual
CAUTION : Users must read this manual carefully and thoroughly before
using this product.
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.
Lutronic Inc.
Tel: 888-588-7644
850 Auburn Court
E-mail:
Fremont, CA 94538
officeusa@lutronic.com
USA
Lutronic Corporation Tel: +82-31-908-3440
Lutronic Center, 219, Fax: +82-31-907-3440
Sowon-ro, Deogyang-gu, Web site: www.lutronic.com
Goyang-si, Gyeonggi-do, E-mail: office@lutronic.com
Korea
Table of Contents
Chapter 1. Overview
1.1 Introduction to the System 1/3
1.2 Symbols used in this Manual and the Device 2/3
Chapter 4. Installation
4.1 Overview 1/9
4.2 Installation Component List 1/9
4.3 Conditions for Installation 2/9
4.3.1 Space Requirements 2/9
4.3.2 Electrical Requirements 3/9
4.3.3 Environmental Requirements 4/9
4.4 Installation of the Device 5/9
4.4.1 STEP 1: Connecting the Handpiece 5/9
4.4.2 STEP 2: Connecting the Accessories 7/9
4.4.3 STEP 3: Final Check-up and Fixing the Device 8/9
4.4.4 STEP 4: Supplying Main Power 8/9
4.5 Moving the Device 9/9
4.5.1 Moving the Device in the Treatment Room 9/9
4.5.2 Moving the Device to a Remote Location 9/9
Chapter 5. Operation
5.1 Overview 1/18
5.2 Checking of the Caution and Inspection Items 5/18
5.3 Operation of the PICO+4 Laser System 6/18
Chapter 8. Warranty
8.1 Overview 1/5
8.2 Unpaid Services 1/5
8.3 Exclusion to unpaid service within the period of the warranty 3/5
8.4 Consumable Items Not Covered Under the Warranty 4/5
List of Figures
Figure 2.1 Warning Sign for Laser-Beam Radiation 3/18
Figure 2.2 Laser Protective Goggles for the Physician (A) / for the Patient(B) 4/18
Figure 2.3 Position of the operation button 9/18
Figure 2.4 Emergency Stop Button 10/18
Figure 2.5 Remote Interlock 10/18
Figure 2.6 Locations of Labels on the Front 13/18
Figure 2.7 Caution Label of Emergency Stop 13/18
Figure 2.8 Caution Label for Handpiece Cable Insertion 14/18
Figure 2.9 Caution Label for Refilling Cooling Water 14/18
Figure 2.10 Warning Label of Handle Use 14/18
Figure 2.11 Handpiece case label 15/18
Figure 2.12 Danger Label of Laser Radiation Path 15/18
Figure 2.13 Warning Label of Electrical Shock 15/18
Figure 2.14 Danger Label of Exposure to Laser 15/18
Figure 2.15 Danger Label of Laser Radiation Output 16/18
Figure 2.16 Remote Interlock Label 16/18
Figure 2.17 Foot switch Label 16/18
Figure 2.18 Grounding Label 16/18
Figure 2.19 Power Cable Label 17/18
Figure 2.20 Laser Aperture Label 17/18
Figure 2.21 Name Plate Label 17/18
Figure 2.22 Locations of Labels on the Back 18/18
Chapter 1. Overview
The PICO+4 is the medical laser system which should perform for
the following intended use, emitting the wavelength of 1064 nm,
532 nm, 595 nm, 660 nm with its articulated arm, handpiece and
footswitch.
WARNING
Improper handling and/or manipulation of the device in a way
that does not comply with the instructions given in this
manual may constitute severely injury to both device and
user.
Symbols Description
Consult accompanying documents. This symbol
advises the reader to consult the accompanying
documents.
This symbol indicates that the operational voltage
of this product exceeds the danger limits set out in
the Protective Regulations for Electrical Shocks
(IEC 417 /878-03-01).
CE Marking
Manufacturer
2.1 Overview
This chapter provides the basic safety and precautionary items regarding
laser-generating devices. The items will also serve to inform users of the
electrical safety and laser beam characteristics of the system.
All persons involved in the PICO+4 laser system operation (e.g. operator,
patient, and staff) should be aware of all the potential dangers and the
safety regulations of the system. The system should not be handled
without proper knowledge and training. The operator or the staff should
inform patients of precautions prior to treatment.
3. The PICO+4 laser system automatically detects the spot size of the
handpiece and displays the information on the Touch LCD screen.
DANGER
The PICO+4 laser system is in compliance with the US Federal
Regulation (21. CFR 1040.10 and 1040.11) of the CDRH (Center
for Devices and Radiological Health), which is governed by the
FDA (Food and Drug Administration). In terms of the CDRH
standards, the PICO+4 laser system is deemed CLASS 4. This
is the most powerful class of lasers used for medical
applications and requires that extra precautions be taken when
using this system.
1064/532 nm 595/660 nm
A B
Figure 2.2 Laser Safety Goggles
for the Physician (A) / for the Patient(B)
DANGER
The PICO+4 laser system uses near infrared laser beam which
is invisible to the naked eye. All persons in the operating area
must wear safety goggles at all times during the procedure.
Exposure to the laser beam may result in serious injury
including loss of eyesight. Goggles should protect eyes
against laser beam. The protective eyewear should be
pursuant to the ANSI standard. Inappropriate or inadequate
protection may cause damage to the eyes. Even with safety
goggles are worn, all users are cautioned against the inherent
risk of dealing with laser devices.
Even if proper safety goggles are worn, looking directly into the laser
aperture of the handpiece could pose an eye hazard.
Never allow any type of liquid to enter the main body of the PICO+4
laser system. This may lead to electrical shock.
The user should not clean the handpiece or repair this instrument while
electrical power is being supplied to this instrument.
The user should check that the supply voltage in the treatment room is
suitable for the device before connecting the power plug to the wall
socket.
WARNING
Persons other than service engineers authorized by Lutronic
Corporation should not attempt to remove the external cover
or disassemble the system. Exposure to dangerous laser
beams, high voltage or current generated by this system may
occur.
All persons involved with the laser operation should wear goggles
with protection from laser beams (optical density of 5 or higher
@1064nm, 532nm, 595nm, 660nm) or glasses with side protection that
is pursuant to the ANSI standard. Simple goggles made of glass that
does not have any safety functions may be penetrated by the laser
beam.
The laser beam may reflect off the smooth surfaces such as surgical
tools. Therefore, all tools irrelevant to the procedure should be moved
to a safe place before performing the procedure.
A direct or scattered ray of laser(1064nm, 532nm, 595nm, 660nm)
may cause unrecoverable damage to the retina as it comes in contact
with eyes.
Although proper laser safety goggles are worn, all persons should not
look directly into the laser aperture of the handpiece while the main
power of the system is turned on.
Patients are also required to wear the proper eye protection.
DANGER
Never look directly into the laser aperture or at the end of the
handpiece when power is applied to the system. It could result
in serious eye injury and/or blindness even though laser safety
goggles are worn. Never direct the rays of laser beam to any
object other than necessary targets. Regardless of its color,
the laser beam reflected from the surface may cause damage
at any time.
Before using the laser, make sure all solvent, adhesives and cleaning
liquids have fully evaporated.
DANGER
Operator should be especially careful when using the laser
beam near flammable material. For instance, if the laser beam
hits an anesthetic, gaseous material such as nitric acids or
oxygen, or flammable material such as alcohol or cotton, it
may cause fire.
WARNING
One should never direct the rays of a laser beam at any target
other than skin. This may lead to ignition of the object.
After pressing the power-on button on the front of the body, enter the
password on the GUI screen.
Operation
button
CAUTION
Only authorized and properly trained persons should operate this
system. In order to prevent any unauthorized person from using the
device, the user should not inform others of the password.
You may install a remote interlock device to the door of the treatment
room to halt the system immediately if unauthorized persons enter the
treatment room in the middle of a treatment.
If the back panel while the system is in operation, the system will stop
operating immediately and generate a message code.
Standard/
Title Ratification
Regulation
2007/47/EC
(amended from Medical Device Directive 2007
93/42/EEC)
1990;A1;1993;A2;
EN 60601-1 Medical electrical equipment
1995;
IEC 60601-1 Part 1: General requirements for safety
A13;1996
Medical electrical equipment
EN 60601-1-2 Part1-2: General requirements for safety Collateral
2007
IEC 60601-1-2 standard: Electromagnetic
compatibility - Requirements and Tests
Medical electrical equipment Part 1-6
EN 60601-1-6 General requirements for basic safety and
2010
IEC 60601-1-6 essential performance
- Collateral Standard: Usability
Medical electrical equipment
EN 60601-2-22 1996
Part 2: Particular requirements for the safety of
IEC 60601-2-22 1995
diagnostic and therapeutic laser equipment
Safety of laser products
EN 60825-1
Part 1: Equipment classification, 2007
IEC 60825-1
requirements and user's guide
Graphical symbols for use in the labeling of
EN 15223-1 2012
Medical devices
Medical devices - Application of risk
EN ISO 14971 2012
management to medical devices
Graphical symbols for use in the labeling of
EN 980 2008
Medical devices
Biological evaluation of medical devices Part 1:
EN ISO 10993-1 Evaluation and testing within a risk management 2009/AC:2010
process
Medical device software-Software life cycle
EN 62304 2006
processes
Medical devices - Application of usability
EN 62366 2008
engineering to medical devices
Information Supplied by the manufacturer of
EN1041 2008
medical devices
US Federal Performance Standards 21CFR
21CFR/FDA 1040.10 and 1040.11 for Class IV Laser Product _
CAUTION
Physicians and staff should be fully aware of the locations and
the meaning of all the safety labels attached to the system.
3.1 Overview
This chapter provides a general description of the PICO+4 laser system,
including its main components, system control, and technical specifications.
Articulated
arm
Weight
balance
Handpiece
Control
Panel
Calibration port
Handle
System
Main Body
Operation Foot Switch
Button
Emergency
Stop Button
Caster
Components Functions
This includes the operation button and the
emergency stop button which controls the
overall operation of the entire system. The
System Control 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.
Generates the laser beam of a wavelength of
Laser Module
the 1064 nm and 532 nm.
Displays information of the current status and
Control Panel the value of each parameter. The function of
each button is explained in detail in Chapter 5.
The four casters may move in all four
directions. The handle on the back may be
used to easily move and direct the casters. The
Handle and Casters
front two casters additionally have locking
devices to allow the operator to station the
device firmly and safely in a fixed position.
Articulated 2
Arm
3
Handpiece
The beam delivery system begins at the post mount. Here, the infrared and
visible laser beam exits the laser optical system. The laser beam will then enter
the articulated arm and the 7 mirrors attached inside the arm reflect and deliver
the beam.
The articulated arm contains an aiming beam system with 655nm wavelength
to visually show where the tip of handpiece is directing to for treatment area.
Handpieces can be easily interchanged with the laser systems articulated arm
depending on the purpose of clinical operation. The handpiece tip should be
replaced before each clinical operation to avoid danger of infection between
patients and treatments.
Power Cord
Remote
Foot Switch Socket
Interlock
Socket
External
Ground
CAUTION
When moving the PICO+4 laser system, the foot switch must be
detached from the device. This will prevent severe damage to
the connector or disconnection from the wiring in the foot
switch.
Prompt and accurate control of the driving device for the PICO+4
laser system.
The initial screen on the control panel stores the status of the most
recent operation performed; thus the panel information may appear
different each time the system is run.
Chapter 4. Installation
4.1 Overview
Chapter 4 describes the installation method for PICO+4 laser system as
well as the optimal environment for using this device. Only persons
authorized or trained by Lutronic Corporation may move or install the
device.
Each vertical side of the device should be at least 12 inches (30 cm)
away from the wall.
1820 mm
1119 mm
483 mm 1078 mm
The wall socket outlet should include at least two terminal units
and grounding terminals.
Check the output power of the outlet within the wall. Output
should be a single phase, AC220~230V and 50/60Hz outlet.
Please confirm this condition before connecting the device power
plug to the outlet.
Never use instantaneous big current around the device and the
place where the electromagnetic wave exposure is serious.
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.
Atmosphere
Temperature/relative humidity
1. Take off the protective cap covering the end of the articulated arm.
2. Hold the end of the articulated arm steadily. Carefully insert the
handpiece to the end by screwing the end of the articulated arm to the
side as the arrow shown in Figure 4.2 until the handpiece is connected
firmly. Be sure that the handpiece is securely fastened.
Figure 4.3 Connecting the articulated arm cable connector and the
handpiece cable connector
CAUTION
In case of connection and disconnection of the handpiece
cable, the operator must follow the instructions below in order
to prevent any breakage of the connectors.
CAUTION
Because the cable socket on top of the device may get
damaged, Never put excessive strength to the connector
socket.
1. Remote interlock
Insert the remote interlock into the socket of the system inlet
located at the lower back of the system main body. Insert the
remote interlock into the socket, pulling the metallic part of the
interlock back; a resulting frictional sound indicates that the
interlock has fitted into the socket correctly.
The remote interlock is not designed for other types of socket. Use
of excessive force while attempting to insert interlock into an
inappropriate socket may cause damages. Please be careful at all
times.
2. Footswitch
Insert the footswitch connector in the socket of the main power
module located in the lower rear side of the device. While pulling
the metallic part of the footswitch connector back, insert the
connector into the socket; a frictional sound will result indicating
that the footswitch connector has fitted into the socket hole
correctly.
2. Depress the caster brakes located on all the four casters of the device
to lock the position of the device. (To move the device again, please
be sure to release all breaks.)
CAUTION
Before moving the device, the handpiece, articulated arm,
power cord and the footswitch must first be secured. Use the
moving handle to transport the device to a desired location.
Be sure to use slow, cautious motions and speed. Fix all the
casters to secure the device in its desired location.
2. Connect the power plug for the main power cord to the outlet on the
wall.
CAUTION
When the device is not used, make sure that the status of main
power switch is in the (O) position. Furthermore, if the device
is left unused for a long period of time, please remove the
main power cord from the wall outlet and the main power
socket of the device.
Using the moving handle to transport the device, move the device to a
location that is compliant to the 4.3 Conditions for Installation and
reinstall the device according to 4.4 Installation of the Device.
CAUTION
When moving the device to a remote location, contact your
Lutronic Corporation distributor to do so safely and efficiently.
This will prevent potential damages or breakage of the device
and potential physical injuries to the operator and staff.
WARNING
Never use the footswitch hanger to move the device. Such
improper use of the footswitch causes internal system
complications. Problems and complications resulting in
misuse will result in voiding of warranty.
Chapter 5. Operation
5.1 Overview
This chapter contains detailed operating instructions, cautions and warning
items for the PICO+4 laser system.
The control panel allows the user to set optimum parameters of the
treatment beam. The control panel also displays useful information about
the system during operation. While the system is operating, functions are
continuously monitored by a micro-controller and displayed to the
operator.
1. Shot Count
This function shows the laser shot number emitted since the system is
turned on. The laser shot emitted by pressing the footswitch is counted
cumulatively as far as it is not initialized by pressing the Reset button. The
shot count can be reset by pushing the reset ( ) button.
2. Wavelength
The PICO+4 laser system has four kinds of wavelength (1064nm, 532nm,
595nm and 660nm). Wavelength can be automatically selected only by
connecting its handpiece to articulated arm. In terms of Zoom Headpiece
and Pico Toning Collimated Handpiece, the user can select one of two
kinds of wavelength (1064 nm, 532 nm).
3. Spot Size
This function displays the spot size of the laser beam at the end of the
handpiece. The fluence display depends on the pulse energy and the beam
spot size.
532 mode
Zoom Handpiece : 0.9/1.5/ 2.3/ 3.3/ 4.3/ 5.3 mm
Pico Toning Collimated Handpiece : 4.3/ 5.3/ 6.5/ 8.0/ 9.0 mm
595 mode
Gold Toning+ Handpiece : 2 mm, 5mm
660 mode
RuVY Touch+ Handpiece : 2mm, 3mm
5. Fluence
The fluence is displayed in joules per square centimeter (J/cm2). The
fluence is computed by dividing the pulse energy into joules by the spot
area in square centimeters. The fluence is adjustable using (up) and
(down) buttons on the right side. This display is valid for fluence at
the tissue. The spot area and the fluence depend on which handpiece is
being used.
6. Pulse Width
The pulse width is defined as the duration of each pulse. The user can
choose between Pico Pulse Width and Nano Pulse Width.
7. Aiming Beam
The aiming beam of the device allows adjustment of its brightness from
level 0 to level 10 in the ready status by using (Up) & (Down)
buttons in the lower part of the screen. When the device is on, the latest
condition is set, and the user can adjust the brightness appropriate for the
treatment condition in Ready status.
9. Memory
This button allows user to enter Memory mode and save parameters in a
memory. Additionally, users can recall a memory by pressing one of the
memories in the mode.
10. Setup
This button allows users to carry out calibration and adjust volume of the
GUI and check shot count of 595nm / 660 nm wavelength.
Are the casters for the device properly fixed in order to prevent
the device from moving?
Are there any objects nearby that can reflect light, such as a
mirror, installed in the treatment room?
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 into
the laser aperture or at the end of the handpiece when power
is applied. Serious eye injury and/or blindness could result.
2. Press the operation button located on the front of the system. The
operation button will light and the cooling pump will start running.
CAUTION
When the warm-up process for the device is not completed, the
current status can be checked through the message on the screen.
The device should only be used after the message screen
disappears.
NOTE
When restarting the system, the control panel recalls and
displays the most resent used parameters.
NOTE
RuVY Touch+ Handpiece and Gold Toning+ Handpiece have a
finite lifetime. The Dye element must be replaced when the laser
starts to become ineffective during treatment.
DANGER
Never look directly into the laser aperture or at the end of
the handpiece when power is applied. It could result in
serious eye injury and/or blindness.
NOTE
If the spot size of the handpiece does not match the spot
size of the control panel, the spot size display window on
the control panel will continue blinking until both of them
match, and the device will remain in Standby status.
5. 3. 3 Use of Handpiece
Automatic Spot Size Setup
The spot size on the control panel is set automatically by adjusting the
spot size regulator located at the handpiece. For the automatic sensing,
the operator must make sure that its cable is correctly connected to the
port of the articulated arm.
NOTE
To use this mode, the operator must make sure its cable
is connected with the port of the articulated arm
When changing the wavelength or other handpiece, the
fluence on the control panel is set automatically at the
minimum parameter.
Use of Handpiece
1. Hold the handpiece slightly vertically as shown in Figure 5.11.
2. Contact the handpiece tip with treatment area slightly.
3. During the treatment, be careful not to change the spot size by
touching the spot size regulator of the handpiece.
Correct
Figure 5.11 Correct way to hold Handpiece
Incorrect Incorrect
CAUTION
Before using the handpiece during operation, make sure
there is no debris or residue on the lens and window. A dirty
lens and window can cause a loss of energy and produce
less effective results during treatment. Incurred damages as
a result of failure to perform this routine maintenance will
void the warranty. Ref. Chapter 6
For the automatic spot size setup, make sure that the cable
of the handpiece is connected to the relevant port of the
arm.
5.4 Setup
5.4.1 Checking Shout Count
1. Enter Setup mode by pressing Setup button at bottom of Operation
mode screen.
2. User Shot Count and 595nm/ 660nm Shot Count can be checked at
the upper of the screen. For reference, User Shot Count is the total
number of times that laser emits outwards by the user and 595nm /
660nm Shot Count is the total number of times that only 595 nm or
660 nm laser emits outwards by the user.
(A) (B)
WARNING
If the beam mode is a round shape without any deleted
parts, you may start calibration, otherwise please contact
your local Lutronic distributor.
3. Flick the main power switch located on the rear of the device to (O) in
order to shut off the main power supply.
4. To prevent any incident caused by unauthorized use, the password
should be known only by a doctor and staff member in charge of
handling the device.
5. If the device will be idle for a prolonged period of time, please remove
the power cord from the outlet.
2. To restart the device, turn the emergency stop button clockwise until it
stops, and then turn the device.
Chapter 6. Maintenance
& Management
6.1 Overview
Chapter 6 describes maintenance guidelines, including periodic inspection
needed to maintain performance, and information on error codes to be used
in self-testing mechanisms for the device.
CAUTION
When inspecting the device first turn off the power and then
disconnect the power cord. Attempting to inspect the device
while the electrical power is on may result in severe damage to
the device or the user.
Wipe down the device again with a clean, dry pad or let it naturally air
dry.
CAUTION
Do not apply cleansing liquid directly to the system main body
as it may damage, harm or cause the system to malfunction.
1. Remove the handpiece tip from the handpiece, hold the handpiece
body with one hand and pull the handpiece tip with the other hand.
Do not use excessive force.
Handpiece Tip
Handpiece Body
7. When not using the handpiece, wipe the handpiece with dried cotton
cloths and keep it in the handpiece case.
NOTE
If cleansing protocol fails to eliminate alien substances, then :
CAUTION
The handpiece tip should be thoroughly and properly
cleaned before applying it to treatment area of a patient.
Failure to do so may result in damages or negatively affect
clinical treatment.
Figure 6.4 Cleaning the window and the tip of Gold Toning+ Handpiece
3. After thoroughly cleaning the handpiece, shine a light onto the window
of the handpiece to examine it and check for cleanliness.
5. When not using the handpiece, wipe the handpiece with dried cotton
cloths and keep it in the handpiece case.
2. To clean the window from alien substances, hold the handpiece body and wipe
the tip using a cotton swab saturated in 90% alcohol thoroughly. Repeat the
same procedure to clean the window.
Figure 6.7 Cleaning the Window and Tip of RuVY Touch+ Handpiece
3. After thoroughly cleaning the handpiece, shine a light onto the window of the
handpiece to examine it and check for cleanliness.
4. When not using the handpiece, wipe the handpiece with dried cotton cloths
and keep it in the handpiece case.
1. Fix the tube of the articulated arm in its hook shown in Figure 6.8
2. Cover the end of the articulated arm with the protective cap. Fix the
end of the articulated arm, with the handpiece connected, in its hook.
See Figure 6.9
CAUTION
In refilling cooling water, only distilled water of PH7.0 can be
used. In cases where other liquids or additives (e.g. tap water,
underground water, bleaching agent) are injected to the
device, it is likely to cause reduced performance.
2. Prepare cooling water (distilled water, PH 7.0) and a tube for injecting
cooling water, which is supplied when installing the device.
3. Open the lid of the hole for injecting cooling water located on the back of
the device by turning it clockwise.
(A) (B)
Figure 6.11 Method to open the inlet for cooling water (A),
Opened inlet (B)
4. Push the tube for injecting cooling water to the tube installation part on the
lower part of the back of the device until you hear pop.
(A) (B)
Figure 6.12 Location of the installed tube for injecting cooling water (A),
Installed tube (B)
5. While injecting cooling water into the hole of the inlet, stop injecting the
water when it leaks from the end of the tube. (It indicates that the cooling
water is filled to the appropriate level.)
(B)
(A)
6. Detach the tube from the device by pushing the upper part (metal part) as
shown in Figure 6.14.
Figure 6.14 Method to detach the tube for injecting cooling water
7. Lock the lid of the inlet for cooling water by turning it clockwise.
6.6 Troubleshooting
Check whether the main power switch is flipped to the ON (I) position.
CAUTION
If the laser beam does not radiate for a long period of time,
turn off the device and wait two minutes before turning it on
again. If the problem persists, do not disassemble the device
or take any inadequate or unauthorized actions of your own.
Always contact an authorized Lutronic distributor or Lutronic
Corporation for assistance.
6.6.3 When the laser beam radiates with insufficient output power.
If the problem persists after taking the above actions, contact your
authorized Lutronic distributor or Lutronic Corporation for assistance.
Message
Possible Cause for Errors Actions to Take
Code
Contact your local Lutronic
CODE 30 Faulty Power Module distributor for inspection
and use it.
Turn off the device and
CODE 01 Emergency Switch on restore the emergency
switch. Restart the device.
Refill cooling water
according to the
CODE 33 Check Water Level
instruction. (Ref. 6.5)
Restart the device
CODE 51 Check Cooling System (Head)
Contact your local Lutronic
CODE 35 Faulty Simmer Trigger
distributor for inspection
CODE 42 Water Leakage
and use it.
CODE 09 Faulty Safety Shutter (not closed)
CAUTION
The operator is advised to take proper actions for the nature of
each message code. If the error persists after taking proper
action, contact your authorized Lutronic distributor or Lutronic
Corporation for assistance. If a person not formally authorized
by Lutronic Corporation opens the cover of the device or takes
any improper actions, the warranty will be voided. Fatal
damage to the device severe physical injury may occur.
7.1 Overview
The following clinical guide is compiled from reports and information
provided by medical doctors with experience of using the PICO+4 laser
system and from published clinical reports and professional literature.
7.3 Consultation
Physicians should provide patients with detailed information regarding the
nature of their problem area, the treatment options, risks, benefits,
potential complications and anticipated outcomes. Written consent of the
patient should also be obtained prior to commencing a laser treatment
program. During consultation, a clinical history should be established with
specific and detailed attention paid to any contraindications. It is
recommended that:
7.4 Contraindications
Take special attention and precautions when treating patients with the
following symptoms or conditions.
IMPORTANT
As the recommended treatment values for each symptoms
and/or effects are standards to be used for consultative
purposes only, we recommend adjusting such values for
patients depending on each patient's special circumstances
and treatment history. Lutronic Corporation shall not be liable
for any injuries, problems or issues that arise as a result of
negligence or inexperience in using the product supplied by
Lutronic Corporation, rather than as a result of any actual
defect on the product itself as supplied by Lutronic
Corporation
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.
WARNING
In order to maintain the coverage of unpaid services, only
service persons formally authorized by Lutronic 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
finalized and cannot be overridden.
CAUTION
The user is required to be fully aware of this manual as charged
guarantee may ensue regardless of the warranty period unless a
request is made for repair due to damage to the device.
Handpiece window
Flash lamp
Laser protective goggle
RuVY Touch+ Handpiece
Gold Toing+ Handpiece
This letter of warranty can replace any form of implicit or explicit warranty
agreed by interested parties. However, the sales agent shall not provide
any kind of warranty for the condition of the system or its marketability for
purposes of any sort.
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 below within fifteen days of the
installation.
Lutronic Corporation.
E-mail: office@lutronic.com