Manual de Plataforma de Nanosegundos

PICO+4
The premium pico- and nanosecond platform
PICO 4
Operators manual
CAUTION : Users must read this manual carefully and thoroughly before
using this product.
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PICO+4
Copyright 2015 Lutronic Corporation. All rights reserved. (2016.01)

No part of this publication may be reproduced, stored in a retrieval
system, or transmitted in any form by any means, electrical, mechanical
or otherwise without the written permission of Lutronic Corporation.
Use of this manual

This manual is designed so that users of PICO+4 laser system may easily
understand the characteristics of this device as a medical instrument, the
safety system of the device and the method for use. In order to use this
device properly and safely, users must be fully aware of all the details
given in this users manual. Users should be trained and educated
properly before using this device.
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.
850 Auburn Court
Fremont, CA 94538
USA
Tel: 888-588-7644
E-mail:
officeusa@lutronic.com
Lutronic Corporation
Lutronic Center, 219,
Sowon-ro, Deogyang-gu,
Goyang-si, Gyeonggi-do,
Korea
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Tel: +82-31-908-3440
Fax: +82-31-907-3440
Web site: www.lutronic.com
E-mail: office@lutronic.com
PICO+4
Table of Contents
Chapter 1. Overview
1.1 Introduction to the System
1.2 Symbols used in this Manual and the Device
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Chapter 2. Safety Precautions

2.1 Overview
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2.2 Safety for the Treatment Room

2.3 General Precautions for Users, staff and patients
2.3.1 Precautionary items for the handpiece prior to procedure
2.3.2 Precautionary items for moving the system in the
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treatment room
2.3.3 Caution for replacing the handpiece tip

2.4 Cautions regarding Electrical Hazards
2.5 Protecting the eyes
2.6 Precautions against Fire Hazards
2.7 Safety system for the PICO+4 Laser System
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2.7.1 Operation button and Password

2.7.2 Emergency Stop Button
2.7.3 Warning sound and signal of the laser radiation
2.7.4 Remote interlock
2.7.5 Door interlock
2.8 Main International standards Applied to PICO+4 Laser System
2.9 Safety labels for PICO+4 Laser System
2.9.1 Caution Label of Emergency Stop
2.9.2 Caution Label for Handpiece Cable Insertion
2.9.3 Caution Label for Refilling Cooling Water
2.9.4 Warning Label of Handle Use
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2.9.5 Handpiece case Label

2.9.6 Danger Label of Laser Radiation Path
2.9.7 Warning Label against Electrical Shock
2.9.8 Danger Label regarding Exposure to Laser
2.9.9 Danger Label regarding Laser Radiation Output
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2.9.10 Remote Interlock Label

2.9.11 Footswitch Label
2.9.12 Grounding Label
2.9.13 Power Cable Label
2.9.14 Laser Aperture Label
2.9.15 Name Plate Label
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Chapter 3. System Description

3.1 Overview
3.2 System Specifications
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3.3 Components of the PICO+4 Laser System

3.3.1 System Main Body
3.3.2 Handpiece & Articulated arm
3.3.3 Footswitch & System Inlet
3.4 System Software
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Chapter 4. Installation
4.1 Overview
4.2 Installation Component List
4.3 Conditions for Installation
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4.3.1 Space Requirements

4.3.2 Electrical Requirements
4.3.3 Environmental Requirements
4.4 Installation of the Device
4.4.1 STEP 1: Connecting the Handpiece
4.4.2 STEP 2: Connecting the Accessories
4.4.3 STEP 3: Final Check-up and Fixing the Device
4.4.4 STEP 4: Supplying Main Power
4.5 Moving the Device
4.5.1 Moving the Device in the Treatment Room
4.5.2 Moving the Device to a Remote Location
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Chapter 5. Operation
5.1 Overview
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5.2 Checking of the Caution and Inspection Items

5.3 Operation of the PICO+4 Laser System
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5.3.1 STEP 1: Turning on the System

5.3.2 STEP 2: Operation Mode
5.3.3 Use of Handpiece
5.4 Setup
5.4.1 Checking Shot Count
5.4.2 Adjusting Sound Volume of GUI
5.4.3 Use of Calibration Function
5.5 Turning off the System
5.5.1 Normal Turn-Off
5.5.2 Emergency Turn-off
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Chapter 6. Maintenance & Management

6.1 Overview
6.2 Cleaning the System Main Body
6.3 Cleaning Handpiece
6.3.1 Cleaning Normal Handpiece

6.3.2 Cleaning Gold Toning+ Handpiece
6.3.3 Cleaning RuVY Touch+ Handpiece
6.4 Keeping the Articulated Arm
6.5 Refilling Cooling(Distilled) Water
6.5.1 Time for refilling cooling(distilled) water:
6.5.2 How to refill cooling water
6.6 Troubleshooting
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6.6.1 When the device fails to turn ON.

6.6.2 When the device is powered on but no laser fails to be radiated.
6.6.3 When the laser beam radiates with insufficient output power.
6.7 Status Message
6.8 Request for Periodic A/S
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Chapter 7. Clinical Guidance

7.1 Overview
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7.2 Education and Training

7.3 Consultation
7.4 Contraindications
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Chapter 8. Warranty
8.1 Overview
8.2 Unpaid Services
8.3 Exclusion to unpaid service within the period of the warranty
8.4 Consumable Items Not Covered Under the Warranty
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List of Figures
Figure 2.1 Warning Sign for Laser-Beam Radiation
Figure 2.2 Laser Protective Goggles for the Physician (A) / for the Patient(B)
Figure 2.3 Position of the operation button
Figure 2.4 Emergency Stop Button
Figure 2.5 Remote Interlock
Figure 2.6 Locations of Labels on the Front
Figure 2.7 Caution Label of Emergency Stop
Figure 2.8 Caution Label for Handpiece Cable Insertion
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Figure 2.9 Caution Label for Refilling Cooling Water

Figure 2.10 Warning Label of Handle Use
Figure 2.11 Handpiece case label
Figure 2.12 Danger Label of Laser Radiation Path
Figure 2.13 Warning Label of Electrical Shock
Figure 2.14 Danger Label of Exposure to Laser
Figure 2.15 Danger Label of Laser Radiation Output
Figure 2.16 Remote Interlock Label
Figure 2.17 Foot switch Label
Figure 2.18 Grounding Label
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Figure 2.19 Power Cable Label

Figure 2.20 Laser Aperture Label
Figure 2.21 Name Plate Label
Figure 2.22 Locations of Labels on the Back
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Figure 3.1 Main Components of the PICO+4 Laser System

Figure 3.2 Articulated Arm and Handpieces
Figure 3.3 Foot Switch and System Inlet
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Figure 4.1 Dimensions of the PICO+4 Laser System

Figure 4.2 Connecting the handpiece to the articulated arm
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Figure 4.3 Connecting the articulated arm cable connector and the handpiece
cable connector
Figure 4.4 Connecting the articulated arm cable
Figure 4.5 Connected System Inlet
Figure 4.6 Main Power button
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PICO+4
Figure 5.1 Control Panel of PICO+4 Laser System

Figure 5.2 Pressing the main power switch
Figure 5.3 Pressing the operation button
Figure 5.4 Loading screen and password input screen
Figure 5.5 Control Panel for Normal Handpiece
Figure 5.6 Control Panel for Focused Dots Handpiece
Figure 5.7 Control Panel for RuVY Touch+ Handpiece
Figure 5.8 Control Panel for Gold Toning+ Handpiece
Figure 5.9 Setting Parameter to Save
Figure 5.10 Setting the spot size on the handpiece
Figure 5.11 Correct way to hold Handpiece
Figure 5.12 Incorrect contacting the Handpiece with Skin
Figure 5.13 Setup mode
Figure 5.14 Location of the calibration port (A),
Articulated arm equipped in the calibration port (B)
Figure 5.15 Progress of calibration
Figure 6.1 Separated Handpiece
Figure 6.2 Cleaning the window and tip of handpiece
+
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Figure 6.3 Separated Gold Toning Handpiece

Figure 6.4 Cleaning the window and tip of Gold Toning+ handpiece
Figure 6.5 Mount Gold Toning+ handpiece Tip
Figure 6.6 RuVY Touch+ Handpiece
Figure 6.7 Cleaning the window and tip of RuVY Touch+ Handpiece
Figure 6.8 Fixing the tube of the articulated arm
Figure 6.9 Fixing the end of the articulated arm
Figure 6.10 Tube for injecting cooling water
Figure 6.11 Method to open the inlet for cooling water(A), Opened inlet(B)
Figure 6.12 Location of the installed tube for injecting cooling water (A),
Installed tube (B)
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Figure 6.13 Injecting cooling water (A), Cooling water leaking from the end of
the tube (B)
Figure 6.14 Method to detach the tube for injecting cooling water
Figure 6.15 Status Message for Code 01
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PICO 4
Chapter 1. Overview
Chapter 1. Overview
1.1 Introduction to the system
The PICO+4 laser system is produced in accordance with international
standards for manufacturing medical devices in order to guarantee the
users safety and durability of use. This device is designed for
convenience and for prolonged use. The PICO+4 laser system only
requires users to exert basic maintenance and repair efforts on a periodic
basis.
LCD Touch Screen is applied to the control panel so that users

may easily adjust parameters for optimal settings. The software
included provides device and clinical information to the users.
The 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.
The pulsed beam is directed to the treatment zone by means of an

articulated arm fixed to a handpiece. When the beam contacts
human tissue, the energy of the beam is absorbed into the tissue,
resulting in a very rapid and highly localized temperature increase
to target tissue.
The PICO+4 Laser System is indicated for use in surgical

applications requiring ablation, vaporization, excision, incision,
and coagulation of soft tissue.
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.
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Chapter 1. Overview
1.2 Symbols used in this manual and the device

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).
Indicates radiation
radiation.
DANGER
WARNING
WARNING
CAUTION
IMPORTANT
hazard
against
laser
Indicates the potential danger for users, patients or

staff members of direct exposure to laser beam
radiation.
Warns users, patients or staff members that they
may be severely injured if directly exposed to
laser beam radiation.
Warns against possible danger and risk of
electrical shock that may result in severe injury to
the device and/or relevant persons. Electrical
complications may cause damage and/or fire
during exposure to laser radiation.
Cautions against the possible risk of electrical
shocks that may result in severe damage to the
device and/or persons. Electrical complications
may cause damage and/or fire during exposure to
laser radiation.
Indicates that prior to any procedure with the
Nd:YAG laser system, the operator should check
the patients individual circumstances and
treatment history to get good clinical efficacy.
This symbol indicates that the product
specifications comply with Class B of the
Protective Regulations for electrical shocks (IEC
417 / 878-02-02).
This symbol indicates that the POWER is OFF,
which complies with the Protective Regulations
for electrical shocks (IEC 417 / 5008).
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Chapter 1. Overview
This symbol indicates that the POWER is ON and

is in compliance with the Protective Regulations
for electrical shocks (IEC 417 / 5007).
Indicates the need for separate collection for
electrical and electronic equipment in compliance
with the Waste Electrical and Electronic
Equipment (WEEE) Directive. This symbol
indicates that electrical and electronic equipment
wastes must not be disposed as unsorted
municipal waste and must be collected separately.
Please contact the manufacturer or an authorized
disposal company to decommission your
equipment according to local regulations)
This symbol indicates that the product is a laser
generating instrument. This product is in
compliance with EN(IEC) 60601-2-22 and
operates at a pulse repetition frequency.
NOTE
Indicates important items to be noted during the

use of this device.
Authorized representative
Community
in
the
European
CE Marking
Manufacturer
The use of mobile telephones or similar
appliances is not allowed while the laser system is
working.
On account of the possible risk of interference
from electromagnetic radiation while the laser
system is in operation, persons with heart
pacemakers may not be present in the room.
Pregnant women should also not be present in the
laser room during operation of the device.
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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.
The PICO+4 laser system is designed to ensure optimal safety for
operators, staff and patients and is equipped with the safety system
described below:
1. This system utilizes a Fast-Acting fuse at 250V/15A which
protects the system from possible current and voltage
complications. The Safety Extra Low Voltage (SELV) method is
employed in this system. The fuse installed in the inner area of the
PICO+4 laser system successfully blocks unwanted power surges.
2. Upon successfully starting the system, by pressing the operation
button located on the front panel, the safety-related parts of this
laser system will run in safe operation.
The system automatically runs in a supervisory mode,
continuously monitoring the entire procedure in order to
notify the user of the systems safety status.
The software installed in the PICO+4 laser system will block
any laser beam radiation immediately after an error occurs.
An message code will be promptly displayed to notify the
operator.
3. The PICO+4 laser system automatically detects the spot size of the
handpiece and displays the information on the Touch LCD screen.
4. A remote interlock device will halt the systems operation when
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no plug is connected to the remote interlock. To install an

interlock system to a location, please contact Lutronic Corporation
customer support.
5. In Ready status, the laser beam will radiate only if the
footswitch is depressed.
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.
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2.2 Safety for Treatment Room

Before performing a procedure, the operator and staff handling the
system should check the following items:
1.
All warning signs should be attached to the door of the treatment

room. Warning signs are provided by Lutronic Corporation. Any
missing signs should be replaced before installing and operating
the PICO+4 laser system. (Figure 2.1)
Figure 2.1 Warning Sign for Laser-Beam Radiation

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

essential to the procedure and who are well trained in the required
safety precautions.
3.
All present during a procedure should be fully aware of the

technical details of the system. If necessary, all persons should be
able to halt the system in case of an emergency.
4.
No hazardous reflective objects (i.e. mirrors), should be allowed

in the operation room.
5.
All present during a procedure must wear safety goggles. Safety

goggles (L-702YGII : for 532nm, 1064nm / DY2 : for 595nm,
660nm) is provided by Lutronic Corporation. Please contact
Lutronic Corporation to inquire about reordering when needed.
6.
Common power supply must be AC220~230V in order to use and

operate the PICO+4 laser system safely.
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1064/532 nm
595/660 nm
A
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.
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2.3 General Precautions for Users, Staff and Patients

2.3.1 Precautionary Items for the Handpiece Prior to the Procedure
The handpiece must be cleaned before each procedure. Thorough
maintenance protocol should be reviewed before cleaning the
handpiece. Any alien substances on the internal lens and tip of the
handpiece should be removed using alcohol of 90% or higher in order
to maintain energy efficiency. Ref. Chapter 6
Even if proper safety goggles are worn, looking directly into the laser
aperture of the handpiece could pose an eye hazard.
2.3.2 Precautionary Items for Transporting the System in the

Treatment Room
The PICO+4 laser system weighs about 142kg. Mishandling of the
system may cause damage to the system internally and externally both,
possibly adversely affecting its performance. In particular, in cases
where the entrance has a threshold, it is necessary to move the device
very carefully.
The system is designed in such a way that its center of mass is
optimized to facilitate convenient moving of the system. Handle it
with extreme care.
Do not attempt to move the instrument while holding the articulated
arm and/or the handpiece. Attempting to do so will disrupt the center
of mass and may cause the instrument to fall over resulting in damages
to system and surrounding persons. User must use the moving handle
located back of the main system to move the instrument.
2.3.3 Caution for Replacing the Handpiece

When handling the handpiece for purposes other than lasing during a
procedure, be sure not to press down on the footswitch. This kind of
manipulation or replacing the handpiece requires that it remain in a
vertical position and in a safe location at all times.
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2.4 Cautions regarding Electrical Hazards
The PICO+4 laser system is an instrument that uses a voltage source of

AC220~230V and thus contains high voltage components. Removing
the protection cover from the main body may result in high risk of
severe electrical shock.
Some residual electrical power may remain within the electrical

components of the PICO+4 laser system after blocking the power
supply. Persons other than those who are authorized and trained by
Lutronic Corporation may not disassemble this instrument or inspect
the inner components, as this will void the warranty.
Never allow any type of liquid to enter the main body of the PICO+4
laser system. This may lead to electrical shock.
Only use power cables with grounding pins provided by Lutronic
Corporation. If the power cable is damaged or worn out, contact
Lutronic Corporation or an authorized Lutronic distributor to replace
the cable. Do not attempt to use or operate this system with inferior or
alternative cables.
The user should not clean the handpiece or repair this instrument while
electrical power is being supplied to this instrument.
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.
As an electrical medical device, this device is designed to be suitable
for the international standard IEC 60601-1-2; however, the user should
install and use the device in consideration of unintentional
electromagnetic waves from outside.
WARNING
Persons other than service engineers authorized by Lutronic
Corporation should not attempt to remove the external cover
or disassemble the system. Exposure to dangerous laser
beams, high voltage or current generated by this system may
occur.
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2.5 Protecting the Eyes

The PICO+4 laser system produces near infrared rays that are invisible
to the naked eye. Users and patients must wear safety goggles at all
times. Eye exposure, during procedures, to the laser beam may result
in severe injury or even loss of eyesight.
All persons involved with the laser operation should wear goggles
with protection from 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.
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2.6 Precautions against Fire Hazards

Laser may ignite most non-metallic objects..
Various types of covers and gowns commonly used in procedures

should be made of material that is flame resistant. Avoid using
materials saturated with oxygen.
Be especially careful when using the laser beam near flammable

material. For instance, if the laser beam hits anesthetic, gaseous
materials such as nitric oxide or oxygen, or flammable material such
as alcohol or cotton, it may cause a fire.
Before using the laser, make sure all solvent, adhesives and cleaning
liquids have fully evaporated.
A fire extinguisher should be placed near the laser-generating device

at all times.
Never operate this system while it is covered.
DANGER
Operator should be especially careful when using the laser
beam near flammable material. For instance, if the laser beam
hits an anesthetic, gaseous material such as nitric acids or
oxygen, or flammable material such as alcohol or cotton, it
may cause fire.
WARNING
One should never direct the rays of a laser beam at any target
other than skin. This may lead to ignition of the object.
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2.7 Safety System for the PICO+4 laser system

This system includes safety devices fully compliant with international
standards to secure the safety of operator, staff and patients.
2.7.1 Operation button and Password

The PICO+4 laser system can be operated only by pressing the
operation button and inputting the password supplied by the Lutronic
Corporation on the GUI screen.
In order to prevent any unauthorized person from using the device,

the user should not inform others of the password.
After pressing the power-on button on the front of the body, enter the
password on the GUI screen.
Operation
button
(1) Power Off

1
(2) Power ON
Figure 2.3 Operation button

2
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.
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2.7.2 Emergency Stop Button
In case of an emergency, laser emission

can be stopped immediately by pressing
the emergency stop button.
To restore operation, rotate the button

clockwise (in the direction of the
arrows) until it pops out again and
follow the normal startup sequence. See
Chapter 5 for startup procedure. Press
the operation button which power is
shut off and then follow the normal
startup procedure.
Figure 2.4. Emergency

stop button
This emergency stop button should not be used as part of a normal

operation procedure. Because it may lead to a electrical damage in the
system. Always use the operation button to turn on or off the instrument
in normal situations.
2.7.3 Warning Sound and Signal of the Laser Radiation

Pressing the ready button will alert an alarm sound for 3 seconds to let
all present know that the system is ready to emit laser beam.
Once laser emits by depressing the foot switch, the word Lasing
blinks to warn users of lasing in progress.
2.7.4 Remote Interlock

When a remote interlock to the socket located on the back of the
PICO+4 laser systems, the electrical circuitry will be closed and the
system can start its normal operation. If the remote interlock device is
not attached to the connector, then the system will not operate.
You may install a remote interlock device to the door of the treatment
room to halt the system immediately if unauthorized persons enter the
treatment room in the middle of a treatment.
Figure 2.5 Remote Interlock
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2.7.5 Door Interlock

The door interlock located on the back top of the system stops
operating if the back panel is left open.
If the back panel while the system is in operation, the system will stop
operating immediately and generate a message code.
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2.8 Main International Standards Applied to PICO+4 laser

system
This system complies with the following international standards for the safety
of doctors and patients.
Standard/
Regulation
2007/47/EC
(amended from
93/42/EEC)
EN 60601-1
IEC 60601-1
EN 60601-1-2
IEC 60601-1-2
EN 60601-1-6
IEC 60601-1-6
EN 60601-2-22
IEC 60601-2-22
EN 60825-1
IEC 60825-1
EN 15223-1
EN ISO 14971
EN 980
EN ISO 10993-1
Title
Medical Device Directive
Medical electrical equipment
Part 1: General requirements for safety
Part1-2: General requirements for safety Collateral
standard: Electromagnetic
compatibility - Requirements and Tests
Medical electrical equipment Part 1-6
General requirements for basic safety and
essential performance
- Collateral Standard: Usability
Ratification
2007
1990;A1;1993;A2;
1995;
A13;1996
2007
2010

Part 2: Particular requirements for the safety of
diagnostic and therapeutic laser equipment
1996
1995
Safety of laser products

Part 1: Equipment classification,
requirements and user's guide
2007
Graphical symbols for use in the labeling of

Medical devices
Medical devices - Application of risk
management to medical devices
Graphical symbols for use in the labeling of
Medical devices
Biological evaluation of medical devices Part 1:
Evaluation and testing within a risk management
process
2012
2012
2008
2009/AC:2010
EN 62304
Medical device software-Software life cycle

processes
2006
EN 62366
Medical devices - Application of usability

engineering to medical devices
2008
Information Supplied by the manufacturer of

medical devices
2008
EN1041
US Federal Performance Standards 21CFR

1040.10 and 1040.11 for Class IV Laser Product
MFDS
Electromagnetic waves safety test standard for

medical device
MFDS
Electrical/mechanical safety test standard for

medical device
21CFR/FDA
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2.9 Safety Labels for PICO+4 Laser System

Pursuant to domestic and international standards, various types of safety
and system information labels are attached to the appropriate locations.
CAUTION
Physicians and staff should be fully aware of the locations and
the meaning of all the safety labels attached to the system.
Figure 2.6 Locations of Labels on the Front
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2.9.1 Caution Label of Emergency Stop

The emergency stop button is used for immediate stop of the laser
equipment in case of emergency. The label is located next to the
emergency stop button on the front of the system
Figure 2.7 Caution Label of Emergency Stop
2.9.2 Caution Label for Handpiece Cable Insertion

The label informs users of the proper way to insert the handpiece cable to
the cable socket installed on the arm port to prevent breakage.
Figure 2.8 Caution Label for Handpiece Cable Insertion
2.9.3 Caution Label for Refilling Cooling Water

The label instructs the user on refilling the water tank, so it can be done
properly and independently.
Figure 2.9 Caution Label for Refilling Cooling Water
2.9.4 Warning Label of Handle Use

The label states that the handle of the front system should not be used to
move the system because lifting the system may cause system operation
damage.
Figure 2.10 Warning Label of Handle Use

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2.9.5 Handpiece case label

The label indicates how to open handpiece case located on the top of main
system.
Figure 2.11 Handpiece case label
2.9.6 Danger Label of Laser Radiation Path

The label indicates the laser beam radiation and its path.
Figure 2.12 Danger Label of Laser Radiation Path
2.9.7 Warning Label against Electrical Shock

The label warns of electrical shock and exposure to high voltage in the
instance that the panel is opened or removed. Only authorized and trained
persons may open or remove the cover.
Figure 2.13 Warning Label of Electrical Shock
2.9.8 Danger Label regarding Exposure to Laser

This warning label states that the eyes or skin should not be exposed to
direct or scattered rays of the laser beam due to possible severe injury.
Figure 2.14 Danger Label of Exposure to Laser
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2.9.9 Danger Label regarding Laser Radiation Output

This label identifies the class of the laser beam (CLASS 4). It indicates
laser output information, such as, the radiation time for maximum pulses,
the danger items for the wavelength and the medium of transmission for
proper safety.
VISIBLE AND INVISIBLE LASER RADIATION

AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
MAX. Nd:YAG Laser Energy : 0.8J
Pulse Duration :750ps, 2ns
Nd:YAG Wavelength : 1064 / 660 / 595 / 532nm
CLASS IV LASER PRODUCT
Figure 2.15 Danger Label of Laser Radiation Output
2.9.10 Remote Interlock Label

This label indicates that laser emission is performed only if remote interlock
is connected its socket.
Figure 2.16 Remote Interlock Label
2.9.11 Footswitch Label

This label indicates that laser emission is performed only if the footswitch is
depressed.
Figure 2.17 Footswitch Label
2.9.12 Grounding Label

This symbol indicates that this product adopts equi-phase grounding which
complies with the protective regulations for electrical shocks.
Figure 2.18 Grounding Label

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2.9.13 Power Cable Label

This label warns users of the precaution when connecting the main power
cord to a wall outlet.
Figure 2.19 Power Cable Label
2.9.14 Laser Aperture Label

This label indicates the location of laser Aperture.
Figure 2.20 Laser Aperture Label
2.9.15 Nameplate Label

This label indicates the product name, model name, laser class and other
electrical specifications of the PICO+4 laser system.
Figure 2.21 Nameplate Label
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Figure 2.22 Locations of Labels on the Back
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3.1 Overview
This chapter provides a general description of the PICO+4 laser system,
including its main components, system control, and technical specifications.
3.2 System Specifications

Performance
System Specification
Laser wavelength
Aiming beam
Laser Medium
Laser delivery system
1064/532/595/660 nm
Diode laser (655nm/Red, 5mW)
Nd:YAG
Articulated Arm
Max. 600mJ
Max. 800mJ
1064
532
Pulse Energy
595
660
pico
nano
pico
nano
pico
nano
pico
nano
pico
nano
1064
focused dots
pico
Pulse Width
nano
Pulse Rate
CDRH Class
Applied Part Class
Classifications
MDD Class
FDA Class
Zoom Handpiece
Normal
Handpiece
Pico Toning Collimated

Handpiece
Focused Dot Handpiece
Gold Toning+Handpiece
Dye Handpiece
RuVY Touch+Handpiece
Display system
Protective Eyewear Optical Density
Cooling System
Electrical rating
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Max. 300mJ
Max. 110mJ
Max. 90mJ
Max. 600mJ
Max. 800mJ
750 ps
2 ns
S1, 1, 2, 5, 10(Hz)
Class IV
B
Class IIb
Class II
1~6mm (1064nm)
/ 0.9~5.3mm (532nm)
6~10mm (1064nm)
/ 4.3~9.0mm (532nm)
7.4 x 7.4 (mm)
2, 5 mm
2, 3 mm
Touch LCD Display
>5 (1064, 532, 595, 660nm)
Air + Water Cooling
Single phase
AC220~230V
(Fuse 250V/20A) 50/60Hz,
Power consumption: 3.0kVA
PICO 4
3.3 Components of PICO+4 Laser System

The PICO+4 laser system is largely composed of three main components
System main body
- Dimensions(mm): 483(W) x 1078(L) x 1820(H)
Laser delivery system (Articulated arm and Handpiece)
Foot switch
Articulated
arm
Weight
balance
Handpiece
Control
Panel
Calibration port
Handle
System
Main Body
Operation
Button
Foot Switch
Emergency
Stop Button
Caster
Figure 3.1 Main Components of the PICO+4 Laser System
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3.3.1 System Main Body

The system main body is an essential part for device operation. It is
composed of components and modules necessary for controlling and
operating the device. The system main body is organized as follows.
Components
System Control Module
Power Supply
Laser Module
Control Panel
Handle and Casters
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Functions
This includes the operation button and the
emergency stop button which controls the
overall operation of the entire system. The
control module receives input signals from
other modules and sends output signals to
execute the proper operation of the system.
Converts the commonly-used power supply
(AC220~230V) to the level of electric power
that the device requires and provides it for
each module.
Generates the laser beam of a wavelength of
the 1064 nm and 532 nm.
Displays information of the current status and
the value of each parameter. The function of
each button is explained in detail in Chapter 5.
The four casters may move in all four
directions. The handle on the back may be
used to easily move and direct the casters. The
front two casters additionally have locking
devices to allow the operator to station the
device firmly and safely in a fixed position.
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PICO 4
3.3.2 Handpiece & Articulated arm

1
Articulated
Arm
Handpiece
4
Figure 3.2 Articulated arm and Handpieces

No.
1
2
3
4
5
Handpiece name
Zoom Handpiece
Pico Toning Collimated Handpiece
Gold Toning+ Handpiece
RuVY Touch+ Handpiece
Focused Dots 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.
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3.3.3 Footswitch & System Inlet

Main Power Switch
Power Cord
Remote
Interlock
Socket
Foot Switch Socket
External
Ground
Figure 3.3 Footswitch and System Inlet

The footswitch is designed with a metal cover to satisfy firmness,
weight and safety to prevent unwanted malfunctions pursuant to the
international standard IEC60601-2-22.
The footswitch complies with the international standard IEC60529 and
is categorized as IP8 according to the dustproof and waterproof ratings.
The footswitch should be connected to the footswitch socket located on
the system inlet of the backside of the device.
When the Ready button is pressed, the footswitch is then in control of
laser emission. Laser beam will be emitted from the handpiece as long
as the foot switch is depressed. The micro-controller continuously
monitors the foot switch to ensure that the laser fires only when the foot
switch is depressed. If the foot switch is not connected to the system
main body, the laser beam will not fire.
CAUTION
When moving the 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.
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3.4 System Software

The software installed in the PICO+4 laser system provides the optimal
environment for clinical operations. It is programmed for the following
purposes:
Selection and application of optimal and individual clinical
parameters for each patient.
Prompt and accurate control of the driving device for the PICO+4
laser system.
Ability to consistently monitor the device in order to secure the
safety of operator, staff and patients.
Generating an accurate amount of laser radiation by checking the
varying output of the laser beam due to use.
The initial screen on the control panel stores the status of the most
recent operation performed; thus the panel information may appear
different each time the system is run.
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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.
4.2 Installation Component List

Before installing the system, check the following list of installation
components.
Items
Qty
PICO+4 laser system body (including articulated arm)
1unit
[Optional] Zoom Handpiece
1unit
Pico Toning Collimated Handpiece
1unit
[Optional] Gold Toning Handpiece

+
1unit
[Optional] RuVY Touch Handpiece
1unit
[Optional] Focused Dots Handpiece
1unit
Foot switch
1unit
Remote interlock
1unit
Laser radiation warning sign (For the treatment room)
1unit
Laser protection goggles for operator (for 1064/532nm)
1unit
Laser protection goggles for operator (for 595/660nm)
1unit
Laser protection goggles for patient
1unit
Operators manual
1vol.
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4.3 Conditions for Installation

4.3.1 Space Requirements
The entire area of the device is shown in Figure 4.1. To maintain optimal
efficiency, the surrounding space indicated below should be allocated when
installing the device.
Before installation, be sure to first survey and consider the
appropriateness of the intended location and space.
Each vertical side of the device should be at least 12 inches (30 cm)
away from the wall.
Maximum distance is encouraged when placing the device near or
next to another medical device, or any other device that generates
heat.
1820 mm
1119 mm
483 mm
1078 mm
Figure 4.1 Dimensions of PICO+4 Laser System

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4.3.2 Electrical Requirements

Electric power supplied to PICO+4 laser system should satisfy the
following requirements in order to maintain optimal efficiency and
electrical safety.
The wall socket outlet should include at least two terminal units
and grounding terminals.
Check the output power of the outlet within the wall. Output
should be a single phase, AC220~230V and 50/60Hz outlet.
Please confirm this condition before connecting the device power
plug to the outlet.
After confirming the wall outlet in the treatment room complies
with the power consumption of the device, the operator should run
the device.
A 250V/20A fuse is used to protect the device from exceeding
voltage. If the fuse is open-circuited, contact the Lutronic
Corporation customer service department for proper actions to be
taken.
For the safety of patients, operator, staff members, as well as
electrical safety, connect the external ground terminal of the
device to the separate ground terminal in the operating room.
Please contact Lutronic Corporation customer service department
to ensure safe grounding during installation.
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.
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4.3.3 Environmental Requirements

The environment for using PICO+4 laser system should satisfy the
following requirements:
Atmosphere
-
Use of the device in a strong corrosive or acidic atmosphere

may lead to corrosion of the electrical cord, the electrical
components or the laser module.
Air-borne dust particles should be kept to a minimum. Such

fine particles of dust may severely damage the device once it
has entered into the electrical components or the laser
modules.
Temperature/relative humidity
-
The optimal temperature for storing the device is a range of

50F (10C) to 104F (40C). The optimal temperature for
using the device is a range of 20C to 30C. Atmosphere is a
range of 80kPa ~ 106kPa.
Relative humidity should remain between 30% and 70%, and

install the device in an airy place in order to keep proper
humidity according to the temperature.
Maximum altitude : Standard commercial shipping altitude

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

32% at 55C (137F) non-condensing
Places unsuitable for use:

-
humid, damp places

in direct sunlight
dusty locations without proper ventilation
near salt
near chemical substances or gas
uneven or unstable ground
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4.4 Installation of the Device

4.4.1 STEP 1: Connecting the Handpiece
1. Take off the protective cap covering the end of the articulated arm.
2. Hold the end of the articulated arm steadily. Carefully insert the
handpiece to the end by screwing the end of the articulated arm to the
side as the arrow shown in Figure 4.2 until the handpiece is connected
firmly. Be sure that the handpiece is securely fastened.
Figure 4.2 Connecting the handpiece to the articulated arm

3. Hold the handpiece cable connector and articulated arm cable
connector. Check the arrows on the two connectors in a beeline and
connect them each other as shown in Figure 4.3.
Articulated arm
Cable connector
Handpiece cable
connector
Figure 4.3 Connecting the articulated arm cable connector and the
handpiece cable connector
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CAUTION
In case of connection and disconnection of the handpiece
cable, the operator must follow the instructions below in order
to prevent any breakage of the connectors.
When connecting the handpiece cable connector and the
articulated arm cable connector, it is required to hold the
black parts, which are the end of the connectors, and
check the arrows on the two connectors.
When separating the handpiece cable connector and the
articulated arm cable connector, it is required to hold the
metal parts, which are the front of the connectors, and
separate them slightly.
4.
Connect the articulated arm cable connector to its socket located on

the left top of the back of the system as shown in Figure 4.4.
Figure 4.4 Connecting the articulated arm cable
CAUTION
Because the cable socket on top of the device may get
damaged, Never put excessive strength to the connector
socket.
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4.4.2 STEP 2: Connecting the Accessories

1. Remote interlock
Insert the remote interlock into the socket of the system inlet
located at the lower back of the system main body. Insert the
remote interlock into the socket, pulling the metallic part of the
interlock back; a resulting frictional sound indicates that the
interlock has fitted into the socket correctly.
The remote interlock is not designed for other types of socket. Use
of excessive force while attempting to insert interlock into an
inappropriate socket may cause damages. Please be careful at all
times.
2.
Footswitch
Insert the footswitch connector in the socket of the main power
module located in the lower rear side of the device. While pulling
the metallic part of the footswitch connector back, insert the
connector into the socket; a frictional sound will result indicating
that the footswitch connector has fitted into the socket hole
correctly.
The footswitch connector is not designed for another type of
socket. Use of excessive force while attempting to insert the
footswitch into an inappropriate socket may cause damage. Please
be careful at all times.
Remote
Interlock
Footswitch Socket
Figure 4.5 Connected System Inlet
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4.4.3 STEP 3: Final Check-up and Fixing the Device

1. Position the device in a place that satisfies the requirements of 4.3
Conditions for Installation for the installation space.
2. Depress the caster brakes located on all the four casters of the device
to lock the position of the device. (To move the device again, please
be sure to release all breaks.)
CAUTION
Before moving the device, the handpiece, articulated arm,
power cord and the footswitch must first be secured. Use the
moving handle to transport the device to a desired location.
Be sure to use slow, cautious motions and speed. Fix all the
casters to secure the device in its desired location.
4.4.4 STEP 4: Supplying Main Power

1. Make sure that the status of main power switch is in the (O) position
indicating that the main power is off and not running.
2. Connect the power plug for the main power cord to the outlet on the
wall.
Figure 4.6 Main Power button
CAUTION
When the device is not used, make sure that the status of main
power switch is in the (O) position. Furthermore, if the device
is left unused for a long period of time, please remove the
main power cord from the wall outlet and the main power
socket of the device.
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4.5 Moving the Device

When moving the device in the treatment room or to a remote location,
first carefully check the following items. Only persons authorized and
trained by Lutronic Corporation may move the device. All other persons
must explicitly read and follow the instructions below.
4.5.1 Moving the Device in the Treatment Room
To move the device safely, repeat steps shown in 4.4 Installation of

the Device in the reverse order.
Using the moving handle to transport the device, move the device to a
location that is compliant to the 4.3 Conditions for Installation and
reinstall the device according to 4.4 Installation of the Device.
4.5.2 Moving the Device to a Remote Location

When moving the device to a remote location, contact your Lutronic
Corporation distributor for safe and efficient transportation.
CAUTION
When moving the device to a remote location, contact your
Lutronic Corporation distributor to do so safely and efficiently.
This will prevent potential damages or breakage of the device
and potential physical injuries to the operator and staff.
WARNING
Never use the footswitch hanger to move the device. Such
improper use of the footswitch causes internal system
complications. Problems and complications resulting in
misuse will result in voiding of warranty.
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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.
Please refer to Figure 5.1 for the following information.
Figure 5.1 Control Panel of PICO+4 Laser System
1. Shot Count
This function shows the laser shot number emitted since the system is
turned on. The laser shot emitted by pressing the footswitch is counted
cumulatively as far as it is not initialized by pressing the Reset button. The
shot count can be reset by pushing the reset (
) button.
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2. 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).
Wavelength recognized in installing the handpiece
Zoom Handpiece : 532 nm, 1064 nm
Pico Toning Collimated Handpiece : 532 nm, 1064 nm
Gold Toning+ Handpiece : 595 nm
RuVY Touch+ Handpiece : 660 nm
Focused Dots Handpiece : 1064 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.
Range of Spot size
1064 mode
Zoom Handpiece : 1/ 2/ 3/ 4/ 5/ 6 mm
Pico Toning Collimated Handpiece : 6/ 7/ 8/ 9/ 10 mm
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
1064 focused dots mode

Focused Dots Handpiece : 7.4 * 7.4 mm
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4. Pulse Rate (Hz)

The pulse repetition rate is defined as the number of pulses that are emitted
in one second. The pulse rate can be adjusted by using the push button on
the right. The pulse rate can be set at 1, 2, 5 as well as 10 Hz and Single
Shot (S1).
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.
Derivation of the equation:
Area of Laser Radiation: (Spot size[cm] /2) x (Spot size[cm] /2) x
Fluence(J/cm2)= Laser output / Area of laser radiation
<Example> Spot size at 0.2cm(2mm) and Pulse energy at 0.1J
Fluence: 0.1 x 0.1 x = 0.0314 cm2
0.1(J) / 0.0314(cm2)= 3.184J/cm2
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.
Range of Pulse Width
Nano : 2 ns
Pico : 750 ps
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.
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8. Standby & Ready

This button allows the laser system to shift from Standby to Ready.
As the button is pressed, the current status of the system is displayed
below the button.
Standby status allows users to set parameters. And the laser
beam will not radiate even though the footswitch is depressed.
This is the default status of the device.
Ready status means that the laser is ready to radiate. Once
Standby button is pressed, pops up message for checking Spot
size. Pressing the YES button, warning sounds for 3 seconds
and laser does not emit even if the footswitch is depressed. Status
button blinks changing its color to orange.
Once laser emission starts by depressing the footswitch in the
Ready status, Status button blinks changing its color to orange.
And the word Lasing is displayed blinking upper the button.
Ready status reverts automatically to Standby status if the foot
switch is not pressed for 1 minute.
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.
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5.2 Checking Caution and Inspection Items

Prior to performing a treatment procedure, please check the
following items. Pay close attention to the cautionary items presented
in Chapter 2. Safety Precautions
Does the user acknowledge and understand the user manual?
Are the handpiece window and system main body clean?
Is the device installed properly according to the conditions
expressed in Chapter 4. Installation?
Are the casters for the device properly fixed in order to prevent
the device from moving?
Are there any objects nearby that can reflect light, such as a
mirror, installed in the treatment room?
Is everyone in the treatment room wearing laser protection
goggles or glasses with side protection in accordance with the
ANSI standard?
Is the patient wearing protective goggles?
Is the power plug connected to an outlet that is of the appropriate
energy, that is the local power supply in the treatment room is
AC220~230V with proper grounding?
Are the footswitch and remote interlock properly connected to the
back of the body? Did the user check the connection of
accessories (handpiece, etc.) suitable for each mode?
Did the user check that the emergency stop button and remote
interlock operate correctly and the spot size which is set in the
handpiece is displayed properly on the screen?
Is the device operated by a doctor?
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.
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5.3 Operation of the PICO+4 Laser System

5.3.1 STEP 1: Turning on the System
1. Flick the main power switch, located at the back of the system, to the
ON (I) position.
Figure 5.2 Pressing the main power switch

2. Press the operation button located on the front of the system. The
operation button will light and the cooling pump will start running.
[Power OFF]
[Power ON]
Figure 5.3 Pressing the operation button
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.
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3. The control panel displays password input pops up as shown Figure

5.4 and input password to allow the system to enter the operation
mode.
Figure 5.4 loading screen and password input screen
NOTE
When restarting the system, the control panel recalls and
displays the most resent used parameters.
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5.3.2 STEP 2: Operation Mode

Operating with Normal Handpiece
- Applicable Handpiece : Zoom Handpiece, Pico Toning Collimated Handpiece
Figure 5.5 Control Panel for Normal Handpiece

1. Press one (532nm or 1064nm) of the Wavelength buttons
to
adjust spot size.
2. Turn the Spot Size regulator at the handpiece clockwise or
counterclockwise to adjust spot size.
3. Check that the Spot Size on the screen is the same as the spot
size set in the handpiece.
4. Press the Pulse Rate
button ( , ) to set the pulse rate of laser
beam.
5. Press the Fluence
button( , ) to set the energy of laser beam
to the per unit area.
6. Press the Pulse Width
button (
or
) to set the pulse
width of laser beam.
7. After setting the desired treated parameters on the control panel,
press the Standby
button when it is ready to begin.
8. When the message for checking the spot size pops up, check the set
spot size and click the Yes button.
9. Press the Aiming Beam
button ( ,
) to set the brightness of
aiming beam in Ready status.
10. With the footswitch depressed, contact the handpiece to the
treatment area. Upon pressing the footswitch, the laser beam will
begin to radiate according to the current set pulse rate.
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Operating with Focused Dots Handpiece

- Applicable Handpiece: Focused Dots Handpiece
Figure 5.6 Control Panel for Focused Dots Handpiece

1. Make sure that Focused Dots Handpiece is properly connected to
the articulated arm.
2. Once the cable is connected correctly, the system recognizes and
the
control
panel
displays
the
Wavelength
and the Spot size

7.4 for Focused
Dots Handpiece.
3. Press the Pulse Rate
button ( , ) to set the pulse rate of
laser beam
4. Press the Fluence
button( , ) to set the energy of laser
beam to the per unit area.
5. Press the Pulse Width
button (
or
) to set the
pulse width of laser beam.
6. After setting the desired treated parameters on the control panel,
press the Standby
7. When the message for checking the spot size pops up, check the
set spot size and click the Yes button.
button( ,
) to set the brightness of
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Operating with RuVY Touch+ Handpiece

+
- Applicable Handpiece : RuVY Touch Handpiece
Figure 5.7 Control Panel RuVY Touch+ Handpiece

1.
2.
3.
4.
5.
6.
7.
8.
9.
Make sure that RuVY Touch+ Handpiece is properly connected to the

articulated arm.
Once the cable is connected correctly, the system recognizes and the
control panel displays the Wavelength
.
Adjust the spot size (2mm, 3mm) by pulling or pushing the spot size
adjustment part of the handpiece.
Set the size same as the spot size set in the handpiece by pushing
the Spot Size ( ) button , ).
Press the Pulse Rate
button (
beam
Press the Fluence
button( ,
) to set the pulse rate of laser
) to set the energy of laser beam
Press the Pulse Width

button (
or
) to set the pulse
width of laser beam.
After setting the desired treated parameters on the control panel,
press the Standby
When the message for checking the spot size pops up, check the set

button( , ) to set the brightness of
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Operating Gold Toning + Handpiece

+
- Applicable Handpiece : Gold Toning Handpiece
Figure 5.8 Control Panel for Gold Toning+ Handpiece

1.
2.
3.
4.
5.
6.
7.
8.
9.
Make sure that Gold Toning+ Handpiece is properly connected to the

articulated arm.
Once the cable is connected correctly, the system recognizes and the
control panel displays the Wavelength
Set the spot size of the handpiece by installing the 2mm or 5mm tip.
Set the size same as the spot size set in the handpiece by pushing the
Spot Size ( ) button , ).
Press the Pulse Rate button ( , ) to set the pulse rate of laser
beam.
Press the Fluence button ( , ) to set the energy of laser beam
Press the Pulse Width button (
or
) to set the pulse width
of laser beam.
After setting the desired treated parameters on the control panel,
press the Standby
When the message for checking the spot size pops up, check the set

button ( , )to set the brightness of
begin to radiate according to the current set pulse rate
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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.
Never leave the device unattended when it is turned on.
Secure the device against unauthorized use.
NOTE
If the spot size of the handpiece does not match the spot
size of the control panel, the spot size display window on
the control panel will continue blinking until both of them
match, and the device will remain in Standby status.
Changing pulse rate and fluence in Ready status is
permissible; however, if other parameters including the spot
size of the handpiece are changed in Ready status, the
device will revert to Standby status.
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5. 3. 3 Use of Handpiece
Automatic Spot Size Setup
The spot size on the control panel is set automatically by adjusting the
spot size regulator located at the handpiece. For the automatic sensing,
the operator must make sure that its cable is correctly connected to the
port of the articulated arm.
Figure 5.9 Automatic Spot Size Setup
Adjusting spot size on the handpiece

The spot size regulator is built-in the
zoom handpiece and Pico Toning
collimated handpiece. The positive
numbers are available at 1064 nm and
the figures in parentheses are the spot
sizes at 532 nm.
1. To adjust the spot size of the
handpieces, hold the regulator and
pull it down as shown in Figure 5.10.
2. And rotate it to the left or the right in
order to show the spot size to set as
shown in Figure 5.10.
1
2
Figure 5.10 Setting the

spot
size
on
the
handpiece
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.
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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
Figure 5.12 Incorrect contacting the Handpiece with Skin
CAUTION
Before using the handpiece during operation, make sure
there is no debris or residue on the lens and window. A dirty
lens and window can cause a loss of energy and produce
less effective results during treatment. Incurred damages as
a result of failure to perform this routine maintenance will
void the warranty. Ref. Chapter 6
For the automatic spot size setup, make sure that the cable
of the handpiece is connected to the relevant port of the
arm.
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5.4 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.
Figure 5.13 Setup mode
5.4.2 Adjusting Sound Volume of GUI

Alarm Sound and Lasing Sound are the function to adjust sound of the
GUI. It can be adjusted at the range of 1 ~ 20 step by pressing the up &
down button (
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5.4.3 Use of Calibration Function

Calibration allows the operator to check the current energy condition of
the device by following the three steps below.
1. After changing to standby status, open the calibration port cover on
the front of the device.
2. After inserting the articulated arm which does not set the handpiece
to the calibration port, turn and fix the articulated arms handpiece
connection part.
(A)
(B)
Figure 5.14 Location of the calibration port (A),

Articulated arm equipped in the calibration port (B)
3. Change to the Set-up mode by pressing the
(Setup) button
on the right side of the LCD screen and press the

button on the lower left side.
4. By pressing the Start button, calibration starts and the progress
status is shown as a percentage.
Figure 5.15 Progress of calibration

5. When 100% is marked on the progress, calibration is completed.
6. Separate the articulated arm from the calibration port.
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WARNING
If the beam mode is a round shape without any deleted

parts, you may start calibration, otherwise please contact
your local Lutronic distributor.
You may start a calibration if the articulated arm is

connected into the calibration port. In case of the
articulated arm is disconnected during calibration, its
operation stops shortly.
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5.5 Turning off the System

5.5.1 Normal Turn-Off
1. Position the handpiece in a safe place and press the operation button to
OFF position.
2. Hang the handpiece on its hook installed on the articulated arm.
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.
5.5.2 Emergency Turn-Off

1. The operator should use the emergency stop button in case of an
emergency only. Pressing the emergency stop button consequently
stops the device immediately.
2. To restart the device, turn the emergency stop button clockwise until it
stops, and then turn the device.
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Chapter 6. Maintenance
& Management
6.1 Overview
Chapter 6 describes maintenance guidelines, including periodic inspection
needed to maintain performance, and information on error codes to be used
in self-testing mechanisms for the device.
CAUTION
When inspecting the device first turn off the power and then
disconnect the power cord. Attempting to inspect the device
while the electrical power is on may result in severe damage to
the device or the user.
The PICO+4 laser system is designed so that maintenance and management
of the device is minimized. However, to guarantee the most effective results
the exterior of the device and the handpiece window, including its tip,
should be cleaned thoroughly at all times.
6.2 Cleaning the System Main Body
Soak a soft pad in a non-corrosive cleansing liquid such as Isopropyl

alcohol or ethanol 90% or higher and gently wipe the surface areas of
the device.
Wipe down the device again with a clean, dry pad or let it naturally air
dry.
CAUTION
Do not apply cleansing liquid directly to the system main body
as it may damage, harm or cause the system to malfunction.
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6.3 Cleaning Handpiece

6.3.1 Cleaning Normal Handpiece
The handpiece unit should remain clean at all items. Follow the cleaning
procedure below after cleaning your hands.
1. Remove the handpiece tip from the handpiece, hold the handpiece
body with one hand and pull the handpiece tip with the other hand.
Do not use excessive force.
Handpiece Tip
Handpiece Body
Figure 6.1 Separated Handpiece

2. Obtain a soft, lint-free dry cloth and soak it in alcohol. Thus
saturated, use the cloth to clean the entire area of the handpiece
except its window at the end of the handpiece body.
3. To eliminate the area of all alien substances, use a cotton swab
saturated in 90% alcohol to wipe out the area thoroughly.
4. Be sure to also remove debris on the inner side of handpiece tip
using the same method. When using cotton swab to wipe out alien
substances, do not exert excessive pressure on the window as this
may damage the natural coating of the windows surface.
Figure 6.2 Cleaning the window & tip of handpiece

5. After thoroughly cleaning the handpiece, shine a light onto the
window of the handpiece to examine it and check for cleanliness.
6. Reassemble the handpiece in reverse order of the disassembling
step.
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7. When not using the handpiece, wipe the handpiece with dried cotton
cloths and keep it in the handpiece case.
NOTE
If cleansing protocol fails to eliminate alien substances, then :
Soak a lens paper or cotton swab in ethanol. Allow one

drop of ethanol to fall onto the top of the window and sit
for 3 to 5 seconds.
When the alien substances are thoroughly soaked, use a

cotton swab to remove the substances.
CAUTION
The handpiece tip should be thoroughly and properly

cleaned before applying it to treatment area of a patient.
Failure to do so may result in damages or negatively affect
clinical treatment.
When using cotton swab to wipe out alien substances, do

not exert excessive pressure on the window as this may
damage the natural coating of the windows surface.
Failure to properly maintain or manage the condition of

the window of the handpiece may result in accumulation
of alien substances on its surface, causing damages to
the headpieces optical system.
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6.3.2 Cleaning Gold Toning+ Handpiece

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.
Figure 6.3 Separated Gold Toning+ Handpiece

2. To clean the window from alien substances, hold the handpiece body
and wipe the tip using a cotton swab saturated in 90% alcohol
thoroughly. Repeat the same procedure to clean the window
Figure 6.4 Cleaning the window and 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.
4. Thoroughly cleaning the handpiece, after setting the location of the
handpieces groove and main bodys pin in a horizontal line, complete
assembly of the part by pushing it to the end in the direction of an
arrow.
Figure 6.5 Mount Gold Toning+ Handpiece Tip

5. When not using the handpiece, wipe the handpiece with dried cotton
cloths and keep it in the handpiece case.
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6.3.3 Cleaning RuVY Touch+ Handpiece

1. RuVY Touch+ Handpiece tip can be cleaned without being separated.
Figure 6.6 RuVY Touch+ Handpiece

2. To clean the window from alien substances, hold the handpiece body and wipe
the tip using a cotton swab saturated in 90% alcohol thoroughly. Repeat the
same procedure to clean the window.
Figure 6.7 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.
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6.4 Keeping the Articulated Arm

When the system is not in use for over 12 hours, store the articulated arm
by following the below instructions:
1. Fix the tube of the articulated arm in its hook shown in Figure 6.8
Figure 6.8 Fixing the tube of the articulated arm

2. Cover the end of the articulated arm with the protective cap. Fix the
end of the articulated arm, with the handpiece connected, in its hook.
See Figure 6.9
Figure 6.9 Fixing the end of the articulated arm
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6.5 Refilling Cooling (Distilled) Water

6.5.1 Time for refilling cooling (distilled) water:
When any device status message (CODE 33) pops up on the control panel
screen with regard to the level of cooling water during treatment, refill
the cooling water by following 6.5.2 How to refill cooling (distilled)
water.
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.
6.5.2 How to refill cooling water :

1. Turn off the main power for safety.
2. Prepare cooling water (distilled water, PH 7.0) and a tube for injecting
cooling water, which is supplied when installing the device.
Figure 6.10 Tube for injecting cooling water

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)
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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)
Figure. 6.13 Injecting cooling water (A),

Cooling water leaking from the end of the tube (B)
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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.
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6.6 Troubleshooting
6.6.1 When the device fails to turn ON.
Check whether the power cord is correctly inserted into the main
power outlet.
Check whether the main power switch is flipped to the ON (I) position.
6.6.2 When the device is powered on but laser beam fails to be

radiated.
Check if the footswitch is correctly inserted into the socket.
Check to see if the remote interlock is properly inserted into the
socket.
CAUTION
If the laser beam does not radiate for a long period of time,
turn off the device and wait two minutes before turning it on
again. If the problem persists, do not disassemble the device
or take any inadequate or unauthorized actions of your own.
Always contact an authorized Lutronic distributor or Lutronic
Corporation for assistance.
6.6.3 When the laser beam radiates with insufficient output power.
Check whether the handpiece window is damaged or dirty. If alien
substances are found, clean the window before using it again. Ref. 6.3
Cleaning Handpiece
If the problem persists after taking the above actions, contact your
authorized Lutronic distributor or Lutronic Corporation for assistance.
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6.7 Status Message
Figure 6.15 Status Message for Code 01
When an error occurs, the corresponding message code will be

displayed on the control panel as shown in Figure 6.15.
In case of an error, the laser beam radiation will stop immediately.
The following is the list of message codes:
The following Message Codes do not mean the system is broken

down, but it can be resolved by the operator taking the instructed actions.
Message
Code
Possible Cause for Errors
CODE 30
Faulty Power Module
CODE 01
Emergency Switch on
CODE 33
Check Water Level
CODE 51
Check Cooling System (Head)
CODE 35
Faulty Simmer Trigger
CODE 42
Water Leakage
CODE 09
Faulty Safety Shutter (not closed)
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Actions to Take
Contact your local Lutronic
distributor for inspection
and use it.
Turn off the device and
restore the emergency
switch. Restart the device.
Refill cooling water
according to the
instruction. (Ref. 6.5)
Restart the device
Contact your local Lutronic
distributor for inspection
and use it.
PICO 4
CODE 10
Faulty Safety Shutter (not open)
CODE 21
Shutter Voltage Low
CODE 06
Faulty 532 Module (not removed)
CODE 05
CODE 08
CODE 07
CODE 31
Faulty 532 Module (not inserted)

Faulty Nano Module (not removed)
Faulty Nano Module (not inserted)
Faulty LD Current
CODE 03
Check Water Flow
CODE 32
Faulty AC Contactor
CODE 36
Simmer Off
CODE 37
CODE 12
Check Cooling System (Water)

Faulty Temperature
Communication
Faulty Attenuator (not removed)
CODE 11
Faulty Attenuator (not inserted)
CODE 61
Faulty MO Security
CODE 47
Faulty Calibration Communication
CODE 50
Faulty Temperature Control
CODE 55
"Faulty Temperature Voltage
CODE 56
Faulty Calibration Voltage
CODE 52
Check Heating System (Water)
CODE 53
Check Heating System (Head)
CODE 46
CAUTION
The operator is advised to take proper actions for the nature of
each message code. If the error persists after taking proper
action, contact your authorized Lutronic distributor or Lutronic
Corporation for assistance. If a person not formally authorized
by Lutronic Corporation opens the cover of the device or takes
any improper actions, the warranty will be voided. Fatal
damage to the device severe physical injury may occur.
6.8 Requests for Periodic A/S

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

Before using the PICO+4 laser system, operators should ensure that they
are completely familiar with this manual and that they understand
everything in it. The system is intended for use by qualified clinical
professionals. Operators are advised to attend a Lutronic Corporation
authorized training session on the use of the PICO+4 laser system, receive
training in basic laser related safety, and gain hands-on clinical experience
before using the system.
A Nd:YAG Laser course includes didactic lectures on: laser physics, laser
safety, and hands-on sessions. Live patient observation followed by a
preceptorship is highly recommended. Specific recommendations for
laser safety training can be found in the relevant international standards
such as the ANSI Z136.4, CA and CE Standards, as published by the
relevant Standards authorities. For more information on training please
contact Lutronic Corporation by dialing +82-31-908-3440 or sending an email to office@lutronic.com. Also we recommend to click on website
edu.lutronic.com for more details about operation video.
Users should stay current with published literature on the clinical use of
lasers.
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7.3 Consultation
Physicians should provide patients with detailed information regarding the
nature of their problem area, the treatment options, risks, benefits,
potential complications and anticipated outcomes. Written consent of the
patient should also be obtained prior to commencing a laser treatment
program. During consultation, a clinical history should be established with
specific and detailed attention paid to any contraindications. It is
recommended that:
All patients should have a full consultation prior to treatment
The consultation should be used to screen out unsuitable patients
for reasons of skin type, skin condition, or any other clinical
contraindications
The patient should be provided with an informational literature
explaining expectations and after care, a medical history
questionnaire and consent form.
The consultant should discuss the patients medical history,
treatment requests, anesthetic requirements and projected
treatment cost.
The following key points must be communicated to the patient
prior to commencing treatment program:
- Multiple treatments may be required
-
The effectiveness of treatment is related to skin color, skin

type and other factors
the laser type being used and its appropriateness for

patients skin type
Patient comments should be recorded

The patient should be given the opportunity to ask questions and,
only when satisfied, asked to sign a consent form.
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7.4 Contraindications
Take special attention and precautions when treating patients with the
following symptoms or conditions.
Allergic response to topical anesthetics, antibiotics, or other
medications
Healing disorders such as those caused by diabetes mellitus,
connective tissue disease, radiation therapy, or chemotherapy
Seizure disorder caused by bright light
Patients with psychoneurosis and/or a history of
abuse
alcohol or drug
Patients with unrealistic expectations regarding to the outcome of

the treatment
Patients who are unable or unwilling to follow post treatment
guidelines
Cancerous or pre-malignant lesions
Patient have a history of keloid formation
Patient has been tanning recently
IMPORTANT
As the recommended treatment values for each symptoms
and/or effects are standards to be used for consultative
purposes only, we recommend adjusting such values for
patients depending on each patient's special circumstances
and treatment history. Lutronic Corporation shall not be liable
for any injuries, problems or issues that arise as a result of
negligence or inexperience in using the product supplied by
Lutronic Corporation, rather than as a result of any actual
defect on the product itself as supplied by Lutronic
Corporation
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Chapter 8. Warranty
Chapter 8. Warranty
8.1 Overview
Chapter 8 describes unpaid services available for those properly using the
system and exclusions from such unpaid services provided by the warranty
of this product.
8.2 Unpaid Services

If the PICO+4 laser system has been properly used and applied for after
sales-service, the user is eligible for unpaid services up to one year from
the date of purchase, as guaranteed by Lutronic Corporation.
Free complimentary service includes maintenance of the main body of
the system, foot switch, articulated arm, and remote interlock, but not of
the consumable components, such as the handpiece window, flash
lamp, goggle, all of which are excluded.
If Lutronic Corporation receives a request for parts/labor during the
warranty period, such requests will be handled in a prompt manner.
Depending on the condition of the system to be repaired, Lutronic
Corporation may decide to repair or replace the system either on the
premises of Lutronics headquarters or the location where the system is
installed.
If it is necessary to recall the system for the purpose of adjustment or
inspection, Lutronic will provide the information that our customer
requests or allow them to rent a temporary device.
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Chapter 8. Warranty
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.
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Chapter 8. Warranty
8.3 Exclusion to unpaid service within the period of the

warranty
If the operational procedures and cautionary items specified in this manual
are not properly followed, altered, or neglected in any manner, the
purchaser will not be eligible for unpaid services. Please pay close attention
to the items below while using the system.
Damage caused by disassembling, remodeling, or careless use
(flooding, damage, etc.) by a consumer
Damage caused by repairs carried out by an unauthorized service agent.
ONLY service agent officially authorized by Lutronic Corporation or a
designated affiliate should repair this equipment
Damage caused by using parts not designated by Lutronic Corporation
or not complying with the method of disinfection
Damage caused by not following procedures for operating the device or
safety precautions stipulated in this manual or not complying with
precautions
Damage caused by natural disasters (fire, salt damage, flood damage,
lightning strike, etc.)
If the handpiece is pulled with excessive force so as to move the system
and results in damages to the articulated arm or the main body, the
system is then no longer eligible for unpaid services covered by this
letter of warranty.
If the system is used, modified or disassembled for purposes other than
those initially intended, then the user forfeits coverage by warranty and
is ineligible for any unpaid services under warranty.
Replacement or repair of consumable parts, such as the handpiece
window, flash lamp, and goggle are not covered under the terms of the
warranty
The accessories provided for convenience of use, not belongs to the
system.
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PICO 4
Chapter 8. Warranty
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.
8.4. Consumable Items Not Covered Under the Warranty
Handpiece window
Flash lamp
Laser protective goggle
RuVY Touch+ Handpiece
Gold Toing+ Handpiece
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PICO 4
Chapter 8. Warranty
This letter of warranty can replace any form of implicit or explicit warranty
agreed by interested parties. However, the sales agent shall not provide
any kind of warranty for the condition of the system or its marketability for
purposes of any sort.
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 below within fifteen days of the
installation.
Lutronic Corporation.
Lutronic Center, 219, Sowon-ro, Deogyang-gu, Goyang-si, Gyeonggi-do, Korea
E-mail: office@lutronic.com
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Manual de Plataforma de Nanosegundos

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PICO+4

The premium pico- and nanosecond platform

using this product.

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The premium pico- and nanosecond platform

Copyright 2015 Lutronic Corporation. All rights reserved. (2016.01)

Use of this manual

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The premium pico- and nanosecond platform

Chapter 2. Safety Precautions

2.2 Safety for the Treatment Room

2.3.3 Caution for replacing the handpiece tip

2.7.1 Operation button and Password

2.9.5 Handpiece case Label

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The premium pico- and nanosecond platform

2.9.10 Remote Interlock Label

Chapter 3. System Description

3.3 Components of the PICO+4 Laser System

4.3.1 Space Requirements

5.2 Checking of the Caution and Inspection Items

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The premium pico- and nanosecond platform

5.3.1 STEP 1: Turning on the System

Chapter 6. Maintenance & Management

6.3.1 Cleaning Normal Handpiece

6.6.1 When the device fails to turn ON.

Chapter 7. Clinical Guidance

7.2 Education and Training

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The premium pico- and nanosecond platform

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The premium pico- and nanosecond platform

Figure 2.9 Caution Label for Refilling Cooling Water

Figure 2.19 Power Cable Label

Figure 3.1 Main Components of the PICO+4 Laser System

Figure 4.1 Dimensions of the PICO+4 Laser System

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The premium pico- and nanosecond platform

Figure 5.1 Control Panel of PICO+4 Laser System

Figure 6.3 Separated Gold Toning Handpiece

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LCD Touch Screen is applied to the control panel so that users

The pulsed beam is directed to the treatment zone by means of an

The PICO+4 Laser System is indicated for use in surgical

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1.2 Symbols used in this manual and the device

Indicates the potential danger for users, patients or

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This symbol indicates that the POWER is ON and

Indicates important items to be noted during the

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Chapter 2. Safety Precautions

Chapter 2. Safety Precautions

Chapter 2. Safety Precautions

no plug is connected to the remote interlock. To install an

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Chapter 2. Safety Precautions

2.2 Safety for Treatment Room

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

Figure 2.1 Warning Sign for Laser-Beam Radiation

Access to the treatment room should be restricted to personnel

All present during a procedure should be fully aware of the

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