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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: [email protected]

Содержание POLYLASE MX

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...

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: ...0 002M Rev 1 17 Document Number 4000 002M Rev 2 19 Document Number 4000 002M Rev 1 20 Document Number 4000 002M Rev 2 20 Prepared by Joseph Buscarello Document No UM 4000 002M Reviewed by Dmitry Donsk...

Страница 4: ...n 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 Us...

Страница 5: ...etermined 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...

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

Страница 7: ...nce 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 train...

Страница 8: ...l 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 MX Pulsed...

Страница 9: ...ient 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 Hy...

Страница 10: ...rtant 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 o...

Страница 11: ...s 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 operato...

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: ...iced 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 M...

Страница 14: ...d access to the room Laser warning signs must be posted at all entrances wherever the POLYLASE MX Laser is in use An ANSI approved laser safety sign is provided with each laser system and additional s...

Страница 15: ...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 Electri...

Страница 16: ...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...

Страница 17: ...ions 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 l...

Страница 18: ...pply 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 Air Filters 3 7 Controls and Indicators 3 8 Main Control Pa...

Страница 19: ...er 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...

Страница 20: ...5 100 ms user selectable 0 5 100 ms user selectable Max Average Power 120 W 120W Pulse Repetition Rate Single Shot 5 Hz Single Shot 10 Hz Beam Delivery Optical fiber 10 feet 3 m length Optical fiber 1...

Страница 21: ...th 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 User Interface C...

Страница 22: ...protects the 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 le...

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: ...it 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 A...

Страница 25: ...he horizontal filter is 7 6 x 10 There is a mesh screen on one side of the filter and the direction of air flow is marked as shown in Figure 3 5 Figure 3 5 Air Filter Flow Direction In order to access...

Страница 26: ...itch disconnects the system from the power source when put in OFF position see Fig 3 8 Display Touch screen Color LCD display prompts the user to enter and initiate important operating parameters Emer...

Страница 27: ...9 Figure 3 7 Front and side of the POLYLASE MX Laser...

Страница 28: ...10 Figure 3 8 Rear of the POLYLASE MX Laser Main power cable Main power switch Foot switch connector External door interlock connector...

Страница 29: ...ntain 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 see Fig 3 8 Foot...

Страница 30: ...12 Main Control Panel Figure 3 9 Control Panel Parameter Setting Edit Screen...

Страница 31: ...ty and is shown as Joules cm2 Fluence can be changed the same way as other parameters see above Memory Selection Buttons Serve to recall pre set Operating Parameters stored for each combination of Ski...

Страница 32: ...tem 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...

Страница 33: ...15 Figure 3 10 Labels front of the POLYLASE MX Laser Figure 3 11 Labels rear of the POLYLASE MX Laser...

Страница 34: ...16 Figure 3 12 Handpiece Label Laser Aperture Label 4000 001A...

Страница 35: ...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 Rep...

Страница 36: ...sponsibilities 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...

Страница 37: ...bilities 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 block...

Страница 38: ...erature 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 th...

Страница 39: ...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...

Страница 40: ...he 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...

Страница 41: ...5 12 Session Complete 5 12 Handpiece Cleaning 5 12 Cleaning the Laser Console 5 13 Other System Features 5 14 Handpiece Vein Mode 5 14 Handpiece Manual Mode 5 15 System Sounds 5 15 Error Messages And...

Страница 42: ...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 guidel...

Страница 43: ...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 ou...

Страница 44: ...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 45: ...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 46: ...wer line is plugged into the wall receptacle Turn on the Main Power Switch located at rear of the unit by switching it to the ON position See Figure 5 2 Figure 5 3 a Front control panel key on Figure...

Страница 47: ...e or Nd YAG laser output see Fig 5 3 b 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 see F...

Страница 48: ...indow The Spot Size can be selected by pressing correspondent round Spot Size button Fluence Setting arrow buttons and slide serve to set Fluence on the target After user presets desired fluence level...

Страница 49: ...ed Spot Size Button on the laser control 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...

Страница 50: ...s with too sensitive skin It is not recommended to use this mode for treatment of areas with very fine thin hair Example To select and then adjust the Fluence setting for the patient with Skin Type 3...

Страница 51: ...andpiece Unless the footswitch or the handpiece trigger button is depressed it is not possible to fire the laser in this mode It is not possible to change parameters while in Ready mode To enter Stand...

Страница 52: ...selected combination of Fluence Beam Size and Frequency results in the average power that can not be supported by the laser power supply This is normal Pulse Counter displays number of laser pulses f...

Страница 53: ...delines and requires cleaning of the output protective window by an alcohol swab in between patients This window is located inside the snap in holder at the handpiece output aperture between two dista...

Страница 54: ...dically with a clean cloth wetted with a spray cleaner do not use acetone to clean any Laser Console parts Dry with a clean dry cloth DO NOT spray or pour any type of cleaning agent directly onto the...

Страница 55: ...on the footer toolbar on the Edit screen see Fig 5 4 and 5 8 The laser is always in Hair mode by default after system start up therefore normally this button has the name Vein displayed on it In order...

Страница 56: ...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 patie...

Страница 57: ...w 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...

Страница 58: ...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 servic...

Страница 59: ...in 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 with...

Страница 60: ...se of any other coolant can damage the system and will void manufacturer s warranty To replace coolant water 1 Drain the old water using Water Drain Valve at the laser rear panel see Fig 5 2 a Use the...

Страница 61: ...20 Calibration Procedure SOP3 should be performed by qualified trained technician after any service or repair work...

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