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4000-001A

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.

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.

Caution

Indicates a potentially hazardous situation that, if not avoided, could
result in damage to the equipment and serious injury to the operator,
patient, or staff.

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Содержание POLYLASE LP

Страница 1: ...s 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 311 Woods Avenue Oceanside NY 11572 Tel 516 594 1533 ã2019 by DDC Technologies Inc ...

Страница 2: ... 1 Contacting DDC Technologies Inc In the United States DDC Technologies Inc 311 Woods Avenue Oceanside NY 11572 USA Tel 516 594 1533 516 770 0441 Customer Service email sales ddctech com ...

Страница 3: ...00 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 ...

Страница 4: ...on General Description 1 1 Operator Training 1 3 Indications for Use 1 3 Patient Exclusion Criteria 1 4 Warnings 1 4 Precautions 1 5 Complications Adverse Effects 1 5 Operator Guidelines 1 6 Symbols Used in this Manual 1 7 ...

Страница 5: ...determined laser beam spot sizes on the patient s skin during treatment Once a foot switch is depressed light is administered to the treatment area by placing the distal end of the handpiece in contact with tissue The POLYLASE LP Pulsed Dual Output Laser is microprocessor based to ensure optimal flexibility and user friendly control of the laser system A touch screen control panel with color LCD d...

Страница 6: ... 2 Figure 1 1 POLYLASE LP Dual Output Laser ...

Страница 7: ...ance at specialty specific courses presented during academy or college meetings All practitioners handling lasers including physicians nurses and other allied professionals should also complete a training program which may include subjects such as basic laser physics laser safety tissue interaction laser operating procedures laser set up procedures potential hazards and hands on experience In serv...

Страница 8: ...al or mechanical epilation 6 weeks prior to laser treatment Hypersensitivity to hydroquinone if applicable Warnings Patients should be cautioned in any of these situations apply The POLYLASE LP Pulsed Dual Output Laser is designed for treatment to intact skin only Do not treat around the outer cantus of the eye Closing the eye is not sufficient protection from Alexandrite and Nd YAG laser light th...

Страница 9: ...tient to be treated Complications Adverse Effects In clinical studies involving the long pulse Alexandrite and Nd YAG laser treatments the following minor complication were observed in some patients Hypopigmentation or hyperpigmentations may occur Note There complications have been rated as both transient and minor and appear to resolve spontaneously within several weeks or month after laser treat...

Страница 10: ...ortant to recognize that it is generally intra epidermal and will usually heal without scarring Vesicles should be treated conservatively with gentle cleansing and application of a topical antibiotic ointment until they have completely healed If vesiculation or nikolsky s sign is encountered the energy fluence should be reduced until these reactions are no longer produced If vesiculation occurs at...

Страница 11: ...us injury to the operator patient or staff 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 Caution Indicates a potentially hazardous situation that if not avoided could result in damage to the equipment and serious injury to the operator patient or staff ...

Страница 12: ...Chapter 2 Safety Overview 2 1 Optical 2 2 Safety Considerations 2 2 Electrical 2 3 Fire 2 4 Laser Safety Information 2 4 ...

Страница 13: ...viced by qualified technicians who have received appropriate training on the laser from DDC Technologies Inc and who are familiar with the safety considerations discussed in this section The POLYLASE LP Pulsed Dual Output Laser has been designed for the safest possible operation and maintenance However any laser system can cause injury if it is not properly installed operated moved and serviced Th...

Страница 14: ...ed access to the room 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 All personnel in the treatment room during operation or service including the person being treated shall wear the appropriate eye protection befor...

Страница 15: ...r all windows with nonflammable window covering in the operating area Always ensure that the handpiece is in proper contact with the area to be treated prior to the delivery of each laser pulse 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 L...

Страница 16: ...e combustion of any flammable material Avoid using combustible materials such as gauze and drapes in the treatment area When they are required these materials may be made fire retardant by keeping them moist with water or saline Clothing should be kept well away from the area of treatment Simple and effective means of extinguishing a small fire should be kept on hand during each procedure A CO2 fi...

Страница 17: ...tions in Appendix B of ANSI Z136 1 the NHZ for this laser has a radius of approximately 11 meters or 36 feet This means that there is a potential for exposure above the ANSI MPE within 36 feet of the laser during operation maintenance or service Since this distance is larger than most installations in which the laser is to be used it would be safe to assume that the entire operating room or theate...

Страница 18: ...ead 3 3 Power Supply Unit 3 3 System Control Electronics Module 3 3 Cooling System 3 3 Optical Delivery System 3 3 Laser Handpiece 3 4 Fiber Support Arm 3 6 Controls and Indicators 3 7 Main Control Panel 3 11 Required Labels 3 12 Chassis Labels 3 12 Location of Chassis Labels 3 13 Peripheral Devices Contained with System 3 15 ...

Страница 19: ...ber of features that provide high reliability versatility compact size and superior performance The system is micro processor based to ensure maximum safety flexibility in function and ease of use The touch screen control panel see Figure 3 1 displays Sequential use instructions Key operating data System status information This information is shown on a color LCD display which is mounted on the fr...

Страница 20: ...er Pulse Width 0 5 100 ms user selectable 0 5 100 ms user selectable Max Average Power 100 W 120W Pulse Repetition Rate Single Shot 5 Hz Single Shot 10 Hz Beam Delivery Optical fiber 10 feet 3 m length Optical fiber 10 feet 3 m length Optical Fiber core diameter 1000 µm 1000 µm Handpiece Spot Size 10 mm 12 mm or 16 mm dia Optional 14 16 and 20 mm 10 mm 12 mm or 16 mm dia Max Energy Fluence 16 mm s...

Страница 21: ...h pulse forming network PFN electrical circuit and power distribution system with power factor corrector PFC System Control Electronics The system control electronics consists of the touch screen control panel with User Interface Controller mini PC Main System Controller microprocessor PC board with touch screen control pad system controls interlocks and sensors Cooling System This system uses sel...

Страница 22: ...main focusing lens from contamination during treatment The collimating lens inside the handpiece changes the laser beam divergence out of the fiber and in combination with imaging zoom lens provides fixed laser beam spot size at the certain distance from the handpiece Fiber Cable Umbilical Jacket Contains optical fiber electrical cables and cooling air tubing The reinforced umbilical jacket protec...

Страница 23: ... 5 Figure 3 2 Laser Handpiece Components Distance Gauge Fiber Cable Umbilical Protective Window Holder Cooling Air Supply Nozzle Spot Size Display Window Zimmer Adaptor Channel Trigger Button ...

Страница 24: ...uit is attached to the fiber support arm The arm is capable of swinging to a convenient location or locking in place by tightening the fiber support clamp on the rear of the machine see Fiber Support Arm and Fiber Attachment section of Chapter 4 for more details By keeping the handpiece attached to the arm it will also prevent accidental dropping of the hand piece Figure 3 3 Fiber Support Arm Comp...

Страница 25: ... system from the power source when put in OFF position Display Touch screen Color LCD display prompts the user to enter and initiate important operating parameters Emergency Off Button A large red circular push button switch that disables the laser power supply Note The EMERGENCY OFF button will remain depressed until it is rotated clockwise and pulled up Key power Switch A key switch that activat...

Страница 26: ... 8 Figure 3 5 Front and side of the POLYLASE LP Laser ...

Страница 27: ... 9 Figure 3 6 Rear of the POLYLASE LP Laser Main power cable Main power switch Foot switch connector External door interlock connector ...

Страница 28: ...skin helping to maintain desired energy density Fluence during treatment Rear Panel The power cord and footswitch cable are attached at this panel as well as Alexandrite and Nd YAG beam delivery systems Footswitch Depressing the footswitch activates the laser permitting it to fire when the laser is in READY mode Control Panel The control panel with touch screen LCD display shows the system status ...

Страница 29: ... Size settings Fluence is a measure of energy density and is shown as Joules cm2 Message Prompt Area Place to display current system status as well as Help and Error messages The numerical Edit Keypad is also displayed in this area when there are no system messages Memory Selection Buttons Serve to recall pre set Operating Parameters stored in each of 5 Memory Buttons Save Button Serves to switch ...

Страница 30: ...stem 4000 001D Located on output end of handpiece 4000 001A Located on front and rear panels of laser system 4000 003D Located on rear panel of laser system 4000 001S LASER APERTURE 4000 001A 4000 001A DANGER CLASS IV LASER PRODUCT VISIBLE and or INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION DANGER 70J max 1 100 msec 1064 nm and 755 nm ...

Страница 31: ... 13 Figure 3 8 Labels front of the POLYLASE LP Laser Danger Laser Radiation Label 4000 001D Laser Warning Label 4000 003D ...

Страница 32: ... 14 Figure 3 9 Labels rear of the POLYLASE LP Laser Figure 3 10 Handpiece Label Laser Aperture Label 4000 001A ...

Страница 33: ... Order P N CKL12BFW01 The laser is powered up by turning the supplied key in the switch located on the upper front console One key is included with each system Operator s Manual Order P N 4000 002M Replacement or additional copies of this manual are available Everyone who works with the POLYLASE LP Laser should read and familiarize themselves with the contents of this manual One is included with e...

Страница 34: ...esponsibilities 4 1 Manufacturer s Responsibilities 4 1 Facilities Requirements 4 2 Electrical Requirements 4 2 Ambient Temperature 4 2 Air Quality 4 2 Space Requirements 4 3 Footswitch Connection 4 3 Beam Delivery System Connection 4 4 ...

Страница 35: ...ibilities Installation of the laser system is performed by a qualified laser engineer NOTE Initial installation and test can be a lengthy process the room where the laser will be housed should be blocked off for about one day to allow adequate time for this procedure Upon arrival the DDC Technologies Service Technician will complete the following Uncrate the POLYLASE LP Laser System and position i...

Страница 36: ...perature warning message and system shut off due to overheating condition may take place The laser will generate approximately 3500 watts of heat into the room when operating at full power Therefore the air conditioner you select for the laser room must be able to accommodate this additional heat If the coolant water is colder than 15 C the laser controller will not allow starting the laser and wi...

Страница 37: ... 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 If the system is moved care must be taken to ensure that the optical fiber cables and laser handpieces are not damaged Footswitch Connection Check to see that the footswitch cable is firmly connected to the footswitch receptacle input on the ba...

Страница 38: ...the knobs in place to keep the arm rigid For installation position the arm as shown in Figure 4 2 Screw the attachment knob all the way into the fiber support holder The pole should rest in the groove of the clamp already installed on the rear of the machine Once the pole is installed attach the second piece Fiber Support Clamp 2 see Fig 4 2 with 4 M3 screws Tightening the M3 screws all the way wi...

Страница 39: ...5 9 Handpiece Cleaning 5 9 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 System Interlock Errors 5 13 System Faults 5 13 Laser Controller Errors 5 15 Flashlamp Service 5 16 Coolant Water Replacement 5 16 Calibration Schedule 5 16 Chapter Summary 5 17 ...

Страница 40: ...e training criteria is the responsibility of the practitioner or institution it is recommended that minimal training include education on laser physics laser safety laser interaction with tissue guidelines for use in specific applications and hands on training with appropriate models Control System The POLYLASE LP Laser is a microprocessor controlled system designed to be user friendly while provi...

Страница 41: ... covered in the standard warranty or service contract Do not have the main cable stretched so tightly that it puts unnecessary strain on the cable and its terminations Be sure that the main cable is out of pedestrian traffic around the system Ensure that protective eyewear appropriate for the Alexandrite Nd YAG Laser system OD 7 at 755 nm and 1064 nm is readily available to be put on before the sy...

Страница 42: ... 3 Operating Instructions Figure 5 2 a Rear panel controls and connectors bottom External door interlock connector Main power cable Main power switch Foot switch connector Water Drain Outlet ...

Страница 43: ... 4 Figure 5 2 b Rear panel controls and connectors top Handpiece Cable Connector Fiber Cable Connector Air Hose Connector Air Compressor Switch Air Cooler Switch ...

Страница 44: ...he Laser Output Selection screen will be displayed Press corresponding button on the touch screen to select Alexandrite or Nd YAG laser output see Fig 5 3 At this moment the cooling system pump will start and laser lamp s will ignite After the system has completed a start up cycle laser will stay in Edit mode In this mode laser operating parameters can be modified by the operator and the laser ene...

Страница 45: ...nd laser switches to Ready mode with these parameters selected To modify parameters stored in each of 5 memory settings the Keypad Buttons must be used With Parameter buttons Fluence Duration Frequency and Beam Size operator can select parameter that he wishes to change The selected parameter will be displayed on highlighted green background The selected parameter value can be changed by pressing ...

Страница 46: ...e is too high and can not be achieved with currently selected Duration Note Pulse Duration settings range is always limited by selected Fluence i e some pulse widths may not be available at certain combinations of Fluence and Beam Size settings This is normal LONG PULSE MODE All pulses with Durations above 10 ms Nd YAG and 7 ms Alexandrite are stretched i e consist of a train of shorter pulses spa...

Страница 47: ...to change parameters while in Ready mode To enter Edit mode from Ready mode press Edit button When you are ready to begin laser treatment press footswitch At this moment laser energy will be delivered to the treatment area The frequency display in the Parameter Settings area will show laser Pulse Repetition Frequency PRF in Hz In the Single Shot mode the only one laser pulse will be delivered when...

Страница 48: ...indow by an alcohol swab in between patients This window is located inside the snap in holder at the handpiece output aperture between two distance gauges and should be cleaned during extended use to reduce dirt accumulation Products such as standard alcohol prep pads or Q tips soaked with acetone or methanol may be used to clean the laser handpiece protective window between patients Always finish...

Страница 49: ... 10 Figure 5 6 Handpiece protective window is located inside the snap in holder between distance gauges ...

Страница 50: ... Nd YAG laser When this optional objective is installed the user has to switch the laser into Vein Mode The handpiece mode selection button is located next to Beam Size selection window see Fig 5 4 The laser is always in Hair Removal mode by default after system start up therefore normally this button has name Hair displayed on it In order to switch to Vein Mode press and hold Hair button for at l...

Страница 51: ...s made to start the laser in Manual Mode the operator is responsible for the correct selection of the handpiece spot size on the laser controller screen that will match the actual handpiece output beam spot size Failure to do so may result in severe skin burns due to incorrect Fluence settings or other injuries to the patient Do not use the laser in handpiece Manual Mode without need and arrange f...

Страница 52: ...ow 25 C Remove the side panels and check if the system heat exchanger under main fan in clean from dust Clean with vacuum cleaner if necessary System Faults When the error of this category takes place the system controller automatically turns off the high voltage power supply clears the LCD screen and displays corresponding error message This procedure takes place after each SYSTEM FAULT and does ...

Страница 53: ...r The measured Output Fluence was more than 20 higher than pre set by the operator Restart the laser If the problem persists call Customer Service for assistance Overcharge Error Please call for service The measured charge on the capacitor bank was more than 10 higher than ordered by controller Critical system fault Please call Customer Service for assistance Charger Overheat Error Please call for...

Страница 54: ...ain Controller through COM port Restart the laser If the problem persists call Customer Service for assistance Handpiece Error There was no response from the handpiece to User Interface Controller within required timeout period May also indicate handpiece zoom lens movement malfunction The software will automatically reset the error when communication between controller and handpiece is re establi...

Страница 55: ... a Use the Water Drain Plug supplied with the laser to release the shut off drain valve 2 Remove laser left side panel Locate white water tank in the middle of the compartment Pull the strap that holds water tank lid to the side Remove the lid and refill water tank from top with fresh distilled water Fill the tank to 4 5 volume Start the laser and let it run for 1 min then turn it off and add wate...

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