PICO+4
The premium pico- and nanosecond platform
The premium pico- and nanosecond platform
Operator s manual
CAUTION : Users must read this manual carefully and thoroughly before
using this product.
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PICO+4
The premium pico- and nanosecond platform
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 user’s 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:
[email protected]
Lutronic Corporation Lutronic Center, 219, Sowon-ro, Deogyang-gu, Goyang-si, Gyeonggi-do, Korea
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Tel: +82-31-908-344 0 Fax: +82-31-907- 3440 Web site: www.lutronic.com E-mail:
[email protected]
PICO+4
The premium pico- and nanosecond platform
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 2. Safety Precautions 2.1 Overview
1/18
2.2 Safety for the Treatment Room
3/18
2.3 General Precautions for Users, staff and patients
5/18
2.3.1 Precautionary items for the handpiece prior to procedure
5/18
2.3.2 Precautionary items for moving the system in the
5/18
treatment room
2.3.3 Caution for replacing the handpiece tip
5/18
2.4 Cautions regarding Electrical Hazards
6/18
2.5 Protecting the eyes
7/18
2.6 Precautions against Fire Hazards 2.7 Safety system for the PICO+4 Laser System
8/18 9/18
2.7.1 Operation button and Password
9/18
2.7.2 Emergency Stop Button
10/18
2.7.3 Warning sound and signal of the laser radiation
10/18
2.7.4 Remote interlock
10/18
2.7.5 Door interlock
11/18
2.8 Main International standards Applied to PICO+4 Laser System
12/18
2.9 Safety labels for PICO+4 Laser System
13/18
2.9.1 Caution Label of Emergency Stop
14/18
2.9.2 Caution Label for Handpiece Cable Insertion
14/18
2.9.3 Caution Label for Refilling Cooling Water
14/18
2.9.4 Warning Label of Handle Use 2.9.5 Handpiece case Label
14/18 15/18
2.9.6 Danger Label of Laser Radiation Path
15/18
2.9.7 Warning Label against Electrical Shock
15/18
2.9.8 Danger Label regarding Exposure to Laser
15/18
2.9.9 Danger Label regarding Laser Radiation Output
16/18
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2.9.10 Remote Interlock Label
16/18
2.9.11 Footswitch Label
16/18
2.9.12 Grounding Label
16/18
2.9.13 Power Cable Label
17/18
2.9.14 Laser Aperture Label
17/18
2.9.15 Name Plate Label
17/18
Chapter 3. System Description 3.1 Overview
1/6
3.2 System Specifications
1/6
3.3 Components of the PICO+4 Laser System
2/6
3.3.1 System Main Body
3/6
3.3.2 Handpiece & Articulated arm
4/6
3.3.3 Footswitch & System Inlet
5/6
3.4 System Software
6/6
Chapter 4. Installation 4.1 Overview
1/9
4.2 Installation Component List 4.3 Conditions for Installation
1/9 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
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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
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5.3.1 STEP 1: Turning on the System
6/18
5.3.2 STEP 2: Operation Mode
8/18
5.3.3 Use of Handpiece
13/18
5.4 Setup
15/18
5.4.1 Checking Shot Count
15/18
5.4.2 Adjusting Sound Volume of GUI
15/18
5.4.3 Use of Calibration Function
16/18 16/18
5.5 Turning off the System 5.5.1 Normal Turn-Off
18/18
5.5.2 Emergency Turn-off
18/18
Chapter 6. Maintenance & Management 6.1 Overview
1/12
6.2 Cleaning the System Main Body
1/12
6.3 Cleaning Handpiece
2/12
6.3.1 Cleaning Normal Handpiece
2/12
6.3.2 Cleaning Gold Toning+ Handpiece
4/12
6.3.3 Cleaning RuVY Touch+ Handpiece
5/12
6.4 Keeping the Articulated Arm 6.5 Refilling Cooling(Distilled) Water
6/12 7/12
6.5.1 Time for refilling cooling(distilled) water: 6.5.2 How to refill cooling water
7/12 7/12
6.6 Troubleshooting
10/12
6.6.1 When the device fails to turn ON.
10/12
6.6.2When the device is powered on but no laser fails to be radiated.
10/12
6.6.3 When the laser beam radiates with insufficient output power.
10/12
6.7 Status Message
11/12
6.8 Request for Periodic A/S
12/12
Chapter 7. Clinical Guidance 7.1 Overview
1/3
7.2 Education and Training
1/3
7.3 Consultation
2/3
7.4 Contraindications
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Chapter 8. Warranty 8.1 Overview
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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
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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 Figure 2.6 Locations of Labels on the Front
10/18 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 Figure 2.18 Grounding Label
16/18 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
Figure 3.1 Main Components of the PICO+4 Laser System
2/6
Figure 3.2 Articulated Arm and Handpieces
4/6
Figure 3.3 Foot Switch and System Inlet
5/6
Figure 4.1 Dimensions of the PICO+4 Laser System
2/9
Figure 4.2 Connecting the handpiece to the articulated arm Figure 4.3 Connecting the articulated arm cable connector and the handpiece
5/9 5/9
cable connector Figure 4.4 Connecting the articulated arm cable
6/9
Figure 4.5 Connected System Inlet
7/9
Figure 4.6 Main Power button
8/9
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Figure 5.1 Control Panel of PICO+4 Laser System
1/18
Figure 5.2 Pressing the main power switch
6/18
Figure 5.3 Pressing the operation button
6/18
Figure 5.4 Loading screen and password input screen
7/18
Figure 5.5 Control Panel for Normal Handpiece
8/18
Figure 5.6 Control Panel for Focused Dots Handpiece Figure 5.7 Control Panel for RuVY Touch+ Handpiece
9/18 10/18
Figure 5.8 Control Panel for Gold Toning+ Handpiece
11/18
Figure 5.9 Setting Parameter to Save
13/18
Figure 5.10 Setting the spot size on the handpiece
13/18
Figure 5.11 Correct way to hold Handpiece
14/18
Figure 5.12 Incorrect contacting the Handpiece with Skin
14/18
Figure 5.13 Setup mode
15/18
Figure 5.14 Location of the calibration port (A),
16/18
Articulated arm equipped in the calibration port (B) Figure 5.15 Progress of calibration
16/18
Figure 6.1 Separated Handpiece Figure 6.2 Cleaning the window and tip of handpiece
2/12 2/12
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Figure 6.3 Separated Gold Toning Handpiece
4/12
Figure 6.4 Cleaning the window and tip of Gold Toning+ handpiece
4/12
Figure 6.5 Mount Gold Toning + handpiece Tip
4/12
+
Figure 6.6 RuVY Touch Handpiece
5/12 +
Figure 6.7 Cleaning the window and tip of RuVY Touch Handpiece
5/12
Figure 6.8 Fixing the tube of the articulated arm
6/12
Figure 6.9 Fixing the end of the articulated arm
6/12
Figure 6.10 Tube for injecting cooling water
7/12
Figure 6.11 Method to open the inlet for cooling water(A), Opened inlet(B)
7/12
Figure 6.12 Location of the installed tube for injecting cooling water (A),
8/12
Installed tube (B) Figure 6.13 Injecting cooling water (A), Cooling water leaking from the end of
8/12
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.
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 user’s 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 notconstitute comply with the injury instructions in and this manual may severely to bothgiven device user.
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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
a
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 patient’s 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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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
in
the
European
Community 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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Chapter 2. Safety Precautions
Chapter 2. Safety Precautions 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 system’s 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 system’s operation when Revision 0.0 /4100160200
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Chapter 2. Safety Precautions
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
B
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 into theis laser aperture of the handpiece while the main powerdirectly of the system 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 PICO4 laser system This system complies with the following international standards for the safety of doctors and patients. Standard/
Title
Ratification
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
Medical Device Directive Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment 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
2007 1990;A1;1993;A2; 1995; A13;1996 2007
2010
Medical electrical equipment – 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
2012
Medical devices - Application of risk management to medical devices
2012
Graphical symbols for use in the labeling of Medical devices
2008
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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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Chapter 2. Safety Precautions
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.
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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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Chapter 3. System Description
Chapter 3. System Description 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
pico nano pico nano pico nano pico nano
1064 532 Pulse Energy
595 660
1064 pico focused dots nano 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 RuVY Touch+Handpiece Display system Protective Eyewear Optical Density Cooling System
Dye Handpiece
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
Chapter 3. System Description
+
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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Chapter 3. System Description
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
Functions
This includes the operation button and the emergency stop button which controls the System Control Module
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.
Power Supply
Converts the commonly-used power supply (AC220~230V) to the level of electric power that the device requires and provides it for each module.
Laser Module
Generates the laser beam of a wavelength of the 1064 nm and 532 nm. Displays information of the current status and
Control Panel
the parameter. The of eachvalue buttonofiseach explained in detail in function Chapter 5.
Handle and Casters
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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3.3.2 Handpiece & Articulated arm 1
2
Articulated Arm
3 Handpiece
4
5
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 system’s 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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Chapter 4. Installation
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.
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
[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
Operator s manual
1vol.
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Chapter 4. Installation
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
1078 mm
483 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 20 C 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 ~ 55°C (23 ~ 131°F)
-
Relative Humidity : 90% at 35°C (95°F) non-condensing 32% at 55°C (137°F) 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.
Handpiece cable connector
Articulated arm 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
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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.
2.
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.
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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Chapter 5. Operation
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. 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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Chapter 5. Operation
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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Chapter 5. Operation
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/cm 2). 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
Spot size at 0.2cm(2mm) and Pulse energy at 0.1J Fluence: 0.1 x 0.1 x = 0.0314 cm2 2 2 0.1(J) / 0.0314(cm )= 3.184J/cm
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. Revision 0.0 /4100160200
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Chapter 5. Operation
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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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Chapter 5. Operation
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 b utton (
,
) to set the pulse rate of laser
beam. 5. Press the Fluence bu tton(
,
) 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. Revision 0.0 /4100160200
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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 button when it is ready to begin. 7. When the message for checking the spot size pops up, check the set spot size and click the “Yes” button. 8. Press the Aiming Beam button(
,
) to set the brightness of
aiming beam in Ready status. 9. 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. Revision 0.0 /4100160200
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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.
+
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
5.
,
).”
Press the Pulse Rate button (
,
) to set the pulse rate of laser
beam 6.
Press the Fluence button(
,
) to set the energy of laser beam
to the per unit area. 7.
Press the Pulse Width button (
8.
width of laser beam. After setting the desired treated parameters on the control panel,
9.
or
) to set the pulse
press the Standby button when it is ready to begin. When the message for checking the spot size pops up, check the set spot size and click the “Yes” button.
10. Press the Aiming Beam button(
,
) to set the brightness of
aiming beam in Ready status. 11. 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. Revision 0.0 /4100160200
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+
Operating Gold Toning Handpiece +
- Applicable Handpiece : Gold Toning Handpiece
+
Figure 5.8 Control Panel for Gold Toning Handpiece
1.
Make sure that Gold Toning+ 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 “ ”
3. 4.
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
,
).
5.
Press the Pulse Rate button ( beam.
,
6.
Press the Fluence button ( to the per unit area.
) to set the energy of laser beam
7.
Press the Pulse Width b utton ( or ) to set the pulse width of laser beam. After setting the desired treated parameters on the control panel,
8.
,
) to set the pulse rate of laser
press the Standby button when it is ready to begin. 9.
When the message for checking the spot size pops up, check the set spot size and click the “Yes” button.
10. Press the Aiming Beam button (
,
)to set the brightness of
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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.
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.
NOTE
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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.
NOTE
1
1 2
Figure 5.10 Setting the spot size on the handpiece
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. 2. 3.
Hold the handpiece slightly vertically as shown in Figure 5.11. Contact the handpiece tip with treatment area slightly. 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 w indow. 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 arm’s 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. Revision 0.0 /4100160200
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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
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 window’s 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 window’s 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 headpiece’s 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.
+
2.
Figure 6.3 Separated Gold Toning Handpiece 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 handpiece’s groove and main body’s 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 ofRuVY 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 Coo ling (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.)
(A)
(B)
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 ins ufficient 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
Chapter 6. Maintenance & Management CODE 10
Faulty Safety Shutter (not open)
CODE 21
Shutter Voltage Low
CODE 06
Faulty 532 Module (not removed)
CODE 05
Faulty 532 Module (not inserted)
CODE 08
Faulty Nano Module (not removed)
CODE 07
Faulty Nano Module (not inserted)
CODE 31
Faulty LD Current
CODE 03
Check Water Flow
CODE 32 CODE 36
Faulty AC Contactor Simmer Off
CODE 37
Check Cooling System (Water)
CODE 46
Faulty Temperature Communication
CODE 12
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)
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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Chapter 7. Clinical Guidance
Chapter 7. Clinical Guidance 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 [email protected]. 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 patient’s 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 patient’s 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
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
alcohol or drug
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 Lutronic’s headquarters or the location where the system is installed.
If it is necessary to recall the system for the purpose of adjustment or inspection, Lutronic will provide the information that our customer requests or allow them to rent a temporary device.
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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 with purposes other than srcinally or not in compliance the instructions given in intended 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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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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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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This letter of warranty can replace any form of implicit or explicit w arranty 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: [email protected]
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