DDC POLYLASE LP Operator's Manual

Pulsed dual output laser

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POLYLASE LP PULSED DUAL OUTPUT

Caution: In the United States, federal law restricts this device to sale to or on the order of a physician or

any practitioner licensed by state law to use or order the use of this device.

Document Number 4000-002M

See Revision History page for revision of this manual.

Manufactured by

LASER

Operator's Manual

311 Woods Avenue, Oceanside, NY 11572

Tel.: (516) 594-1533

ã2019 by DDC Technologies, Inc.

Table of Contents

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Summary of Contents for DDC POLYLASE LP

Page 1 POLYLASE LP PULSED DUAL OUTPUT LASER Operator’s Manual Caution: In the United States, federal law restricts this device to sale to or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Page 2 Contacting DDC Technologies, Inc. In the United States: DDC Technologies, Inc. 311 Woods Avenue, Oceanside, NY 11572 Tel.: (516) 594-1533 (516) 770-0441 Customer Service email: sales@ddctech.com - 1 -...
Page 3 Revision History Document Number 4000-002M Rev. 1-12 Document Number 4000-002M Rev. 1-17 Document Number 4000-002M Rev. 2-19 Prepared by: Joseph Buscarello Document No.: UM 4000-002M Reviewed by: Dmitry Donskoy Current Revision: 2-19 Approved by: Dmitry Donskoy Effective Date: 9/10/19 - 2 -...
Page 4: Table Of Contents
Chapter 1: Introduction General Description Operator Training Indications for Use Patient Exclusion Criteria Warnings Precautions Complications/Adverse Effects Operator Guidelines Symbols Used in this Manual...
Page 5: General Description
General Description The POLYLASE LP Pulsed Dual Output Alexandrite and Nd:YAG Laser is designed to deliver precise fluences of long pulses of laser energy at 755 nm and 1064 nm wavelength to a predetermined target site to effect the elimination of unwanted hair.
Page 6 Figure 1-1. POLYLASE LP Dual Output Laser - 2 -...
Page 7: Operator Training
In-service training in the use of the POLYLASE LP Pulsed Dual Output Laser will be provided near the time of the initial system installation. Clinical techniques described here are presented only as a reference based on clinical experience with the device and other laser devices reported in the published literature.
Page 8: Patient Exclusion Criteria
• Should bleeding result at any time during the use of the POLYLASE LP Pulsed Dual Output Laser contact cooling handpiece, discontinue use immediately and quarantine the handpiece. Contact you DDC Technologies Customer Service Representative for further instructions.
Page 9: Precautions
Precautions Clinical studies have shown that both treatment effectiveness and inflammatory response to injury of the skin is exposure dose (FLUENCE) related; higher fluence level result in greater effectiveness and also higher inflammatory response. Begin treatment with a conservative exposure dose. If more tissue reaction is desired, increase the energy level in 2-5 J/cm²...
Page 10: Operator Guidelines
POLYLASE LP Pulsed Dual Output Laser, and improve the care of patients who choose this method of hair removal. For more information regarding training on the use of the POLYLASE LP Pulsed Dual Output Laser, please refer to page 1-2 of this Operator’s Manual.
Page 11: Symbols Used In This Manual
Symbols Used in this Manual Danger Indicates an imminent situation in which the possibility of exposure to hazardous laser radiation may occur that could result in serious injury to the operator, patient, or staff. 4000-001A Danger Indicates an imminent situation in which the possibility of exposure to electrical shock or a fire hazard could result in serious injury to the operator, patient, or staff.
Page 12 Chapter 2: Safety Overview Optical Safety Considerations Electrical Fire Laser Safety Information...
Page 13: Overview
All persons operating the POLYLASE LP Pulsed Dual Output Laser and all who are in the vicinity of the laser must be aware of the potential hazards of the POLYLASE LP Pulsed Dual Output Laser output. Be certain all personnel carefully review the safety precautions pertaining to the POLYLASE LP Pulsed Dual Output Laser.
Page 14: Optical
Laser warning signs must be posted at all entrances wherever the POLYLASE LP Laser is in use. An ANSI approved laser safety sign is provided with each laser system, and additional signs may be purchased directly from Customer Support.
Page 15: Electrical
Although the POLYLASE LP Pulsed Dual Output Laser has many safety features in its design, certain precautions must be observed: No one should attempt to operate the POLYLASE LP Pulsed Dual Output Laser with any panel removed. This may expose personnel to dangerous high voltages and potentially dangerous optical radiation.
Page 16: Fire
A safety self-surveillance system monitors appropriate electrical, temperature, contact and other variables and notifies the user of abnormalities by generating an error or warning message. Fire The potential for fire hazards exist because of the nature of laser treatment. The absorption of emitted laser energy, no matter how brief, may raise the temperature of any material.
Page 17 The POLYLASE LP Laser is a long pulse dual output Alexandrite and Nd:YAG laser operating at 755 nanometers (nm) and 1064 nm in the near-infrared (IR) light spectrum. The laser light is emitted from the end of an optical fiber with a cooled handpiece. When the laser is directed to the tissue being treated there is little chance of health care worker exposure.
Page 18 Chapter 3: System Description Overview Wavelength POLYLASE LP System Specifications Components Optical Laser Head Power Supply Unit System Control Electronics Module Cooling System Optical Delivery System Laser Handpiece Fiber Support Arm Controls and Indicators Main Control Panel 3-11 Required Labels...
Page 19: Overview
Overview The POLYLASE LP Laser provides the hair removal market with a solid-state laser for use in hair removal applications requiring the precise delivery of laser treatment energy to a predetermined target site. The design for the POLYLASE LP Laser incorporates a number of features that provide high reliability, versatility, compact size and superior performance.
Page 20: Wavelength
Wavelength The POLYLASE LP Dual Output Alexandrite and Nd:YAG Laser emits laser radiation at 755 nanometers and 1064 nanometers (nm) wavelength. The beam is aligned and delivered to the treatment area via an optical fiber with attached handpiece device. POLYLASE LP System Specifications...
Page 21: Components
Components The POLYLASE LP Laser consists of the following components: Optical Laser Head, Power Supply Unit, System Control Electronics Module, Internal Cooling System, Delivery System with Handpiece. Optical Laser Head The optical laser head consists of an optical rail with two flashlamp pump chambers that house the Alexandrite and Nd:YAG crystal and xenon flashlamps;...
Page 22: Laser Handpiece
Laser Handpiece The laser handpiece is equipped with the distance gauge, which provides fixed laser beam spot size on the treatment area. The spot size and the fluence level can be changed from the laser control panel. The motorized zoom lens position is electronically recognized by the system and is reflected as the Laser Beam Spot Size (Beam Size) on the LCD display.
Page 23 Fiber Cable Distance Gauge Umbilical Trigger Button Spot Size Display Window Protective Window Holder Cooling Air Supply Nozzle Zimmer Adaptor Channel Figure 3-2. Laser Handpiece Components - 5 -...
Page 24: Fiber Support Arm
Fiber Support Arm The fiber support arm is intended to support the beam delivery system so that the conduit is kept clear of the operation area, as well as providing support for the conduit while in use. It is recommended to use the handpiece while the fiber conduit is attached to the fiber support arm.
Page 25: Controls And Indicators
Controls and Indicators The POLYLASE LP Laser is equipped with features designed specifically to provide safe and reliable operation to laser users. All laser personnel should become familiar with the location (see Figures) and operation of the safety features discussed below and on the following pages.
Page 26 Figure 3-5. Front and side of the POLYLASE LP Laser - 8 -...
Page 27 External (door) Main power switch interlock connector Foot switch connector Main power cable Figure 3-6. Rear of the POLYLASE LP Laser - 9 -...
Page 28 Component Description Optical Fiber Cable Laser light pulses are delivered via a fiber optic cable. Laser Handpiece The handpiece provides accurate laser beam delivery to the treatment area. Different spot sizes can be generated by motorized zoom lens and provide fixed laser beam diameter on the skin, helping to maintain desired energy density (Fluence) during treatment.
Page 29: Main Control Panel
Main Control Panel Figure 3-7. Control Panel – Parameter Setting (Edit) Screen Control Description Parameter Setting Buttons Serve to display current device settings: Beam Size (mm); Duration (pulse width, ms); Frequency (Hz)-pulse repetition frequency. By pressing the corresponding button the Parameter can be selected for editing.
Page 30: Required Labels
Required Labels Government regulations require that certain labels appear on the POLYLASE LP Laser and be reproduced in this manual. Located on front lower panel of laser system DANGER DANGER (4000-001D) VISIBLE and/or INVISIBLE LASER RADIATION AVOID EYE OR SKIN...
Page 31 Danger Laser Radiation Label Laser Warning Label (4000-001D) (4000-003D) Figure 3-8. Labels, front of the POLYLASE LP Laser - 13 -...
Page 32 Figure 3-9. Labels, rear of the POLYLASE LP Laser Laser Aperture Label (4000-001A) Figure 3-10. Handpiece Label - 14 -...
Page 33 Laser Safety Door Sign Order P/N 4000-010D This sign should be posted outside of the room where the POLYLASE LP Laser is located. It serves as an informative warning to those who wish to enter the room that there are potential hazards related to the device and what level of precaution they should consider before entering.
Page 34 Chapter 4: Installation Customer’s Responsibilities Manufacturer’s Responsibilities Facilities Requirements Electrical Requirements Ambient Temperature Air Quality Space Requirements Footswitch Connection Beam Delivery System Connection...
Page 35: Customer's Responsibilities
However, certain experienced customers and authorized specially trained distributors can successfully perform device installation on their own. Please, refer to POLYLASE LP: Brief Installation Guide attached to this Manual for step-by – step installation instructions. Manufacturer’s Responsibilities Installation of the laser system is performed by a qualified laser engineer.
Page 36: Facilities Requirements
20 A electrical service. It is recommended that the electrical supply to the equipment be independently fused and switched by a 20 A circuit breaker, mounted at a convenient height in the operating area. This will enable the POLYLASE LP Laser to be electronically isolated for maintenance purposes.
Page 37: Space Requirements
The POLYLASE LP Laser is moved easily from room to room. Make sure that adequate space and appropriate electrical hookups are available in each room where its use is anticipated.
Page 38: Beam Delivery System Connection
Beam Delivery System Connection Fiber Support Arm Installation Before attaching the beam delivery system, it is important to install the fiber support arm (fiber support pole) to the back of the machine. This arm provides support for the fiber conduit and handpiece both while in use and in standby. The black adjustment knobs on the arm (see Figure 3-3) can be loosened in order to position the arm segments in the desired positions.
Page 39 Chapter 5: System Operation Control System Before Beginning Operating Instructions Start-Up Edit Mode (Setting Parameters) Ready Mode Session Complete Handpiece Cleaning Cleaning the Laser Console 5-11 Other System Features 5-11 Handpiece Vein Mode 5-11 Handpiece Manual Mode 5-12 System Sounds 5-12 Error Messages And Troubleshooting 5-13...
Page 40: Control System
Control System The POLYLASE LP Laser is a microprocessor-controlled system designed to be “user- friendly” while providing highly reliable laser output. The touch screen color LCD display shows important operating data, instructions for use and messages to the user.
Page 41: Before Beginning
Before Beginning Before you turn on the laser, ensure that the location of the POLYLASE LP Laser does not interfere with other objects (including the door) in the room. There should be at least two feet (61 cm) of free air space around all sides of the system.
Page 42: Operating Instructions
Operating Instructions Main power switch Foot switch connector Water Drain Outlet External (door) interlock connector Main power cable Figure 5-2 (a). Rear panel controls and connectors (bottom) - 3 -...
Page 43 Air Cooler Switch Air Compressor Switch Fiber Cable Connector Air Hose Connector Handpiece Cable Connector Figure 5-2 (b). Rear panel controls and connectors (top) - 4 -...
Page 44: Start-Up
Key Switch Figure 5-3. Front control panel (key on) To activate the POLYLASE LP Laser: Insert the laser key and rotate clockwise. (See Figure 5-3) After the system is turned on and software self-test procedure is complete, the Laser Output Selection screen will be displayed.
Page 45: Edit Mode (Setting Parameters)
The laser beam spot size can only be changed from the touch-screen control panel. This function works only in Edit mode. Three spot sizes (10 mm, 12 mm and 16 mm) are available in the POLYLASE LP handpiece. The currently selected spot size is displayed - 6 -...
Page 46 in the BEAM SIZE window on the LCD display. It is also displayed on the handpiece LED spot size indicator. Note: handpiece LED spot size indicator always displays actual handpiece state, i.e. it will display previously used spot size until Save button is pressed and the zoom lens moves to new position.
Page 47: Ready Mode
Ready Mode Figure 5-5. Ready Mode Screen When in Ready mode, please ensure that everyone in the treatment room is wearing proper eye protection. For more information regarding eye safety, please see Chapter 2, Laser Safety Information. Press Save or Ready button to switch the laser from Edit to Ready mode. The screen will change to Ready mode.
Page 48: Session Complete
Note: After extended use the optical surface of protective window can be damaged, despite of regular cleaning. This is normal. If extensive damages can be seen on the window surface, replace it with the new one. Please, contact DDC Technologies Customer service department and ask for Part #W-1064-0501 (Nd:YAG) or #W-755- 0501 (Alexandrite) to order.
Page 49 Figure 5-6. Handpiece protective window is located inside the snap-in holder between distance gauges. - 10 -...
Page 50: Cleaning The Laser Console
In order to switch the laser back to Hair Removal mode, press and hold Vein button for at least 3 sec. WARNING! Polylase LP does not have automatic recognition of the optional VEIN OBJECTIVE. Please, remember to switch the laser into Vein Mode every time you use the OBJECTIVE.
Page 51: Handpiece Manual Mode
HANDPIECE MANUAL MODE In some situations the Polylase LP laser handpiece detection system can be turned off. This is useful when handpiece-related errors happen in the system and operator needs to complete the treatment session. In order to start the laser in handpiece Manual Mode, on the laser controller Start Screen press and hold “Handpiece Mode”...
Page 52: Error Messages And Troubleshooting
ERROR MESSAGES AND TROUBLESHOOTING The POLYLASE LP Laser has a number of internal interlock circuits and sensors that control the status of the laser. If the system detects an interlock error or inappropriate value of the monitoring parameter, the Error Message will appear in the Message area on the LCD display.
Page 53 Improper operation of the Restart the laser. If the Shutter Error: Please, laser resonator shutter. problem persists, turn the restart the laser. system OFF and call Customer Service for assistance. There is insufficient water Check water level in the Error: No water flow. flow in the cooling system.
Page 54: Laser Controller Errors
Laser Controller Errors When the error of this category takes place, the following error messages are possible: Error Message Possible Cause Recommended Operator Action Laser Controller There is no response from The software will Communication Error laser Main Controller through automatically reset the error COM port within required when communication between...
Page 55: Flashlamp Service
Flashlamp Service The POLYLASE LP Laser will eventually need to have a certain internal component known as a “flashlamp” replaced. The replacement of the flashlamp is covered under the standard warranty and extended service contracts, however it does necessitate a visit of a field service technician.