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1. Plug the power cord into a standard AC grounded power outlet 100 240 VAC Connect the power cord to the proper receptacles on the rear of the laser Please note that the wide flat connector to the left of the DC outlet is for factory use only The battery powered wireless foot pedal is composed of a supporting plastic base that is connected to the pedal In order to power the food pedal you must insert the provided AA batteries Before inserting the batteries make sure the laser is completely turned off and that the laser Is nat plugged in Laserin use Battery low Battery compartment 1 Turn the foot pedal upside down to locate the battery slot 2 Remove the lid and insert the batteries 3 Close the battery lid The foot pedal has two LED indicator lights located on the top surface of the foot pedal The green LED indicates that the foot pedal is being depressed and the laser Is firing The amber LED light indicates that the foot pedal battery is low and needs to be replaced NOTE Keep extra AA batteries in your office inventory because the battery should be replaced after approximately 100 hours of continued operation NOTE Some models come with a foot pedal safety shroud installed separately Push the power button on the rear of the laser to the ON position You will be Instructed to input a software lock to protect against unqualified use Using the keypad on screen type in 1 2 3 4 You w
2. 10 nm All laser safety glasses goggles have a wavelength for indicated use stamped into the lens or eyepiece Care must be taken to assure that everyone in the operations area is wearing the appropriate glasses Protective eye wear is marked with optical density gt 10 at 808 nm The laser beam from a laser diode is usually not visible to the human eye but it can seriously damage retinal tissue DO NOT look directly into the laser beam aperture or into the working end of the optical fiber Reflected laser light may also cause retinal damage The reflection hazard exists several feet from the reflection point Avoid aiming the laser beam in the direction of reflective surfaces Laser System Safety Features The S13 diode laser provides the following safety features for both the user and the patient Audible Lasing Signal An audible signal high pitch beeping sounds whenever the activation foot switch is depressed This feature can be adjusted at the Tools section Laser Firing Delay There is a brief delay between depressing the foot switch and the onset of laser activation This allows the user adequate time to react if the foot switch Is inadvertently depressed Software Key Lock The laser system is equipped with a software key switch to protect against unqualified use and cannot be turned ON until the correct password is used Remote Interlock The remote interlock feature gives you the option of installing the l
3. Continuous 10W Troughing Contact Initiated Continuous 08W Vestibuloplasty Contact Initiated Continuous 10W 2 Laser Operation Procedure It is imperative that you follow steps A through H to ensure that you are protecting yourself the patient and staff and to assure that you are using the laser instrument according to the manufacturer s specifications AA Place appropriate laser caution signs at all entrances to the operatory B Verify that the connectors for the power cord optional and Unifiber at the rear panel are properly secured C Prepare appropriate wavelength specific 0D gt 10 at 808 nm eyewear Make sure the operator assistants and patient are all wearing protective eyewear D Turn the laser on by pressing the blue power button located at the back left panel of the device 1 Set laser operating parameters manually or use the pre set procedures 2 To use pre set procedures select the Presets button at the bottom of the screen Navigate to the desired procedure and select it The laser will set all parameters to the proper settings 3 Ifyou need to adjust any of the operation settings click the Tools button at the bottom of the screen This allows you to change the aiming light brightness beeping volume voice confirmation volume and the brightness of the screen and remote interlock system aint ees al a u 4 The battery level is displayed on the top ri
4. tip and discard it in a Sharps container Standby mode Section 6 Labels amp Symbols Aperture Label Certification Label A Located on back of device Laser Aperture Located underneath device a Explanatory Label oe Teton back older manual for use Dispose of properly Gane BR peared A cn ECIREP cngrsenate Bethe a 7 Fragile SN seriatnumber age REF sognnter Emergency laser ON OFF button stop button 15 Section 7 Warranty and Service Service and Maintenance We suggest that your practice establish an internal verification program for your laser Verification is recommended a minimum of once per year based on average usage You may purchase a calibrated hand held power meter approved for use with 808nm devices to check power output The appropriate safety goggles should be worn at all times when the laser is on The laser should be set in continuous wave mode The SL3 diode laser should be set at 0 5 1 0 15 20 and 2 5 Watts with the output checked at each level The output display should be within 20 of the meter reading If not rescore the fiber and te check Ifthe output display is outside the 20 tolerance return the unit to the manufacturer for recalibration There are no methods available for the user to adjust the calibration of the unit and the unit chassis must not be removed by the user for any reason SL3 Diode L
5. tissue procedures This device uses a Gallium Aluminum Arsenic GaAIAS diode for the active medium producing laser energy at 808 nanometer wavelength Laser technology has been steadily evolving allowing doctors to provide less invasive treatment for many dental procedures both preventative and restorative For a list of approved procedures please refer to page 12 All of the safety features warnings and precautions should be observed for the SL3 diode laser All of the Safety Warning Labels are described in detail on page 15 of this guide The SL3 diode laser is especially designed to be compact portable reliable and user friendly It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips The system may be utilized for a wide variety of surgi procedures and cosmetic Indications for Use The SL3 diode laser is intended to be used for oral soft tissue surgery including biopsies hemostatic assistance treatment of aphthous ulcers frenectomy gingival incision and excision gingivectomy gingivoplasty incising and draining of abscesses operculectomy removal of fibromas soft tissue crown lengthening sulcular debridement removal of diseased or inflamed soft tissue in the periodontal pocket and tissue retraction for impressions What s in the box La
6. void and nullify all warranties The Instrument is not to be serviced without specific written instructions from DenMat Any attempted service of the Instrument without these instructions will void the DenMat Warranty Warranty Evaluation amp Repair Service Subject to the determination set forth below if a repair is required during the Warranty Period DenMat shall authorize warranty repair or replacement at no cost to you Please contact our Customer Service Department TOLL FREE at 16 1 800 4DENMAT to request warranty repair service and obtain a Return Authorization RA number for shipping purposes Please ensure that the RA number is clearly marked on the box used to return the Instrument Itis recommended that you return your Instrument in its original shipping box Ifthe original shipping box is not available make sure that adequate packing is used to protect against shipping damage Make sure you buy insurance to protect your asset against shipping damage Please clearly state the reasons for return Note Returns without a return authorization number will be refused A return label will be provided with your RA number by our Customer Service Department Send Returns to DenMat Holdings LLC 1624W Central Ave Lompoc CA 93436 DenMat will inspect your Instrument and determine whether the damage and or failure are covered under the warranty Warranty repairs or replacement will be completed and the Instrument will be shipp
7. Manufactured for Denmat Holdings LLC 1017W Cental Ave Lompoc CA 93436 1 800 4DenMat 1 800 433 6628 y www denmat com DenMa aota Dent Halang LACAN Rights esened IO Central Ave Lompoc CA S3436 79700 08 40 CaviMipes isa registered trademark of MetrexResearh LLC SOFT TISSUE LASER SL3 User s Manual This manual must be read thoroughly and understood prior to using the laser system CAUTION Using the controls and adjustments or performing laser procedures other than as specified herein may result in hazardous radiation exposure Table of Contents Section 1 Introduction Introduction 1 Indications for Use What s in the box Section 2 Specifications Laser System Specifications 2 Laser System Description 2 LCD Screen Unifiber System Section 3 Safety Indications Standards Precautions Protective Eyewear Laser System Safety Features Section 4 System Set Up Unpacking What s in the box 8 Installation ssn Cleaning and Disinfection Transportation Preparing the Unifiber Hand Piece Assembly n Section 5 Operation Procedure Guide Laser Operation Procedure 13 Section Labels amp Symbols Section 7 Warranty and Service Service and Maintenance 16 SL3 Unit Warranty Compliance INTRODUCTION The SL3 diode laser is a Class IV soft tissue laser that can be used for a wide variety of soft
8. Period Our Customer Service Department will provide an RA The customer is responsible for freight charges to ship the Instrument to and from DenMat for non warranty service Returns without an RA will be refused A minimum Evaluation Fee will be charged for all repairs not covered by warranty Ifthe customer does not authorize the repair the customer is still responsible for payment of the minimum Evaluation Fee If the customer authorizes repair service D the minimum Evaluation Fee will be applied to the total repair costs Upon receipt of approval and acceptance of the repair and shipping costs DenMat will repair and ship the Instrument back within five 5 business days Terms amp Conditions 1 All prices subject to change without notice 2 Allprices subject to applicable sales tax 3 Refurbished units subject to availability 4 Returning parts after warranty period may be subject to an evaluation fee 5 All program information is based on the latest data available and Is subject to change For questions regarding defective product during the warranty period please call DenMat Customer Service or an authorized sales distributor Address DenMat Holdings LLC 1017 W Central Ave Lompoc CA 93436 1 800 4DENMAT Compliance FCC Statement This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must ac
9. SER STOP button de activates all lasing functions and puts the laser in stand by mode A warning message will be displayed Follow the screen instructions to de activate the warning message The laser output power is regulated in 30 steps by plus sign and minus sign buttons The LCD front panel screen indicates the level of output power in Watts delivered from the tip of the 400 im fiber when in continuous wave CW mode An operator can choose CW or Pulsed operation mode by pressing the CW or Pulse button on the LCD screen The SL3 diode laser uses an internal battery that is recharged when it is plugged in When fully charged the battery will last for 30 minutes in continuous use at maximum power The SL3 diode laser internal battery is not intended to be changed by the operator The laser energy is activated by a wireless foot pedal Depressing the foot switch activates the lasing process while releasing it stops the process The diode laser system is highly portable and self contained with built in safety features It is capable of producing the rated output power in a continuous wave mode for more than half an hour without interruption allowing completion of most surgical procedures In the pulsed mode the system delivers pulsed interrupted radiation at a repetition rate of 10 Hertz and a pulse width of 50 ms The SL3 diode laser uses disposable removable fiber tips to accurately deliver the
10. aser Unit Warranty The SL3 diode laser unit the Instrument manufactured by DenMat is warranted against defects arising from faulty materials or workmanship for a period of twenty four 24 months from the date of purchase the Warranty Period The limited warranties provided herein are expressly conditioned on the Instrument being used under normal conditions and in compliance with the instructions as stated in the Instrument User s Manual and Basic User s Guide The limited Warranties provided herein do not cover any damage that may occur as a result of misuse neglect adjustments or alterations to the Instrument The warranty offered by DenMat on the Instrument isa limited warranty and the sole liability of DenMat shall be to replace or repair the Instrument DenMat shall have no obligation or liability to refund any portion of the purchase price and shall have no liability for special exemplary consequential or punitive damages loss of profits damages to persons or injury in connection with the purchase or use of the Instrument The warranty does not include labor postage or delivery charges This warranty does not apply to the extemal finish of the console handpiece fiber power cord or foot pedal DenMat reserves the right to make changes in design or to modify such previously manufactured products at its sole discretion Use of products not specifically made by or authorized by DenMat for use with the Instrument will
11. aser in a dedicated room and be interlocked with the entrance door to the room In an interlocked installation the laser shuts off whenever the door is opened thereby protecting the eyes of the person entering the room The code to enable the remote interlock is 6 3 2 4 Once the interlock is activated and the proper hardware is connected the laser will shut off if the remote interlock sensor is triggered Press the power button to turn the laser back on Section 4 System Set Up Unpacking Immediately upon receipt ofthe SL3 diode laser system inspect all components for damage and for missing items Unpack all components carefully and verify the presence of all components on the packing slip Notify DenMat immediately if there are any missing components NOTE Please keep the shipping box during the laser warranty period for possible service upgrades or returns What s in the box Laser Safety Glasses 3 Unifiber with Hand Piece Introductory DVD Foot Pedal w 2 AA batteries Caution Sign Disposable Tips 10 Initiating Film Power Adapter User s Guide Installation Place the laser on a suitable table cart or shelf Remove the protective end cap from the laser port red or white cap Remove the plastic cap from the fiber FC connector Attach the Unifiber system into the laser port by turning it clockwise Wind the fiber cable ina clockwise direction around the spool behind the LCD screen as shown below
12. cept any interference received including interference that may cause undesired operation This product has been tested and complies with the specifications for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential Installation This equipment generates uses and can radiate radio frequency energy and if not installed and used according to the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which is found by turning the equipment off and on the user is encouraged to try to correct the Interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment or devices Connect the equipment to an outlet other than the receiver s Consult a dealer or an experienced RF technician for assistance FCC Caution Any changes or modifications not expressly approved by the party responsible for compliance could Void the user s authority to operate this equipment 18 Industry Canada Statement This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference an
13. d 2 this device must accept any interference including interference that may cause undesired operation of the device Ifyou have questions or comments about the contents of this User s Manual please call our toll free number for assistance 1 800 4DENMAT We want to make sure your experience in using our SL3 diode laser system is most gratifying 19 20 a
14. ear that protects your eyes from wavelengths other than 808nm do not provide proper protection for use with this laser Damage to the retina or cornea may be irreparable if exposed to direct reflected or scattered radiation Always wear protective eyewear when operating the laser WARNING For the safety of the operator DO NOT use the laser when the fiber is disconnected at the base connection port WARNING Never operate the laser without an attached optical fiber to avoid uncontrolled laser radiation WARNING This laser system is very sensitive to back reflections into the laser module which may damage or completely destroy the facet of the laser diode Never point the focused laser beam vertically on a reflecting surface WARNING Laser treatment may result in inadvertent exposure of adjacent tissues Undue exposure can result in damage to tissue vessel perforation and bleeding The practitioner should always set the laser system for minimal exposure to the patient Optimal parameters for laser surgery may be achieved by starting with the power as low as possible and increasing incrementally as necessary Power levels affect the precision of cutting rate of tissue removal and thermal damage to adjacent tissues WARNING The laser can ignite non metallic materials All combustible materials must be removed from the operations area or should be kept moist during the procedure WARNING The laser can ignite preparation solutions containin
15. ed back to you within five 5 business days of receipt of the Instrument Ifthe required repairs are not covered by the warranty due to in DenMat s determination misuse neglect adjustments or alterations to the Instrument or the applicable Warranty Period having ended you will be contacted within two 2 business days of receipt of the Instrument with a price quotation for the cost of repair s or cost of the replacement Upon receipt of your approval and acceptance of repair and shipping costs DenMat will repair and ship your Instrument back to you within five 5 business days Replacement Repair Program amp Services DenMat provides for the purchase of major Instrument components after the warranty periods have ended We guarantee the availability of replacement parts for a period of one year after sale of this product is discontinued should that occur Refurbished parts if available are offered to our customers at a lower cost Refurbished parts are those that have been returned to us remanufactured and inspected to ensure they meet the original performance standards for new components before being offered for resale DenMat provides a new warranty on all new or refurbished parts purchased The warranty periods for the newly purchased parts begin when the new or refurbished part is shipped Non Warranty Evaluation amp Repair Service Please contact our Customer Service Department to request repair service outside the Warranty
16. eet to guide you with the most conservative power of the following procedures The settings shown below are for your guidance only Procedure Technique Tip Mode Power Abscess Contact Initiated Continuous 10W Aphthous Ulcer Non contact Nor initiated Pulse TAW Biopsy Contact Initiated Continuous 10W Contouring Contact Initiated Continuous 10W Distal Wedge Contact Initiated Continuous 15W Draining Abscesses Contact Initiated Continuous 09W Expose Teeth Contact Initiated Continuous 10W Fibroma Contact Initiated Continuous 10W Frenectomy Contact Initiated Continuous 11W Gingivectomy Contact Initiated Continuous 10W Gingivitis Contact Initiated Continuous 04W GingWitis Therapy Contact Initiated Continuous 08W Gingivoplasty Contact Initiated Continuous 10W Hemostasis Contact Initiated Continuous 13W Herpetic Lesion Non contact Nonnitiated Pulse TEW Hypertrophic Tissue Contact Initiated Continuous 15W Implant Exposure Contact Initiated Continuous 14W Lesion Removal Contact Initiated Continuous 10W Operculectomy Contact Initiated Continuous 15W Ovate Pontic Contact Initiated Continuous 10W Periimplantitis Contact Initiated Continuous 10W Socket Treatment Non contact Nondinitiated Continuous 08W Sulcular Debridement Contact Initiated Continuous 08W Tissue Tag Contact Initiated Continuous 15W Tissue Welding Contact Initiated Continuous 06W TongueTie Contact Initiated
17. empt to remove the cover from the laser chassis for the purpose of repairing the laser Serious injury from an electrical shock or laser radiation could occur Removing the cover on the laser chassis wil void the warranty AX CAUTION Not using the proper disposable tip may cause damage to the internal components of the laser CAUTION Changes or modifications not expressly approved by DenMat could void the product warranty AX CAUTION The remote interlock feature is disabled by default so the laser is functional To use this feature it must be enabled through the Tools screen and additional hardware is required CAUTION Avoid prolonged exposure to the laser energy when working in and around the cervical areas of the tooth Due to the thin layer of enamel in this area the laser s energy may be absorbed by the hemoglobin in the pulp in which case pulpal hyperemia may occur Extended exposure to laser energy could lead to pain and possible pulpal necrosis AX CAUTION Use a high volume vacuum to remove the laser plume Provide high fitration masks for all personnel in the treatment area The laser plume may contain viable tissue particulates CAUTION The fiber optic cable is very fragile and can be damaged where itattaches to the rear panel Please be particularly careful when transporting or placing the unit near protruding objects so as not to damage the cable A CAUTION Do not touch the end of the fiber connecto
18. g alcohol acetone or other solvents DO NOT leave puddles of preparation solution in the operations area Vapors may build up under surgical drapes and create a safety hazard DO NOT place the footswitch in an area where it may be accidentally depressed When the laser is not in use remove the foot switch from the practitioner s immediate operations area WARNING Never use the laser system in the presence of flammable anesthetic gases The use of laser safe endotracheal tubes and other laser safe accessories is recommended Many materials not normally considered flammable could be ignited in the presence of high oxygen and nitrous gas mixtures An acute awareness of the buildup of the gases as a hazard should be maintained WARNING Avoid tissue splatter on the working end of the disposable tip as this will create localized heating which may cause the fiber tip to char and fail If back splatter occurs wipe the tip with alcohol gauze Allow alcohol to evaporate before continuing the lasing process DO NOT Use any power supply other than the one supplied by DenMat with your laser Part number 041473 Precautions CAUTION US Federal law restricts this device to sale by or on the order of a physician DO NOT attempt to operate the laser system with any protective panels removed or if the fiber delivery system is improperly connected The system is equipped with an interlock device for the protective housing cover AX CAUTION Do not att
19. ght of the screen and demonstrates what percentage of battery life is left We recommend plugging in the unit if the battery level falls below 25 5 Once the correct procedure settings have been selected the laser is ready to use Ensure that the proper safety eyewear is wor and depress the foot pedal to activate the laser energy Releasing your foot off of the pedal will cause the laser to stop fring E Ifthe procedure requires an initiated tip increase the laser output power to its value of 0 6 Watts by pressing the Plus Sign button With the tip of the fiber touch a piece of initiating film dull side is best and depress the foot switch to activate the laser An audible high pitch tone will be heard indicating activation of the laser power When laser emission begins move the tip back and forth over the surface melting the film onto the tip There will be a rapid melting vaporization of the film The fiber tip should now be dark F The operator may now proceed with tissue treatment in accordance with developed treatment protocols G In order to prevent accidental firing press the Standby Active button on screen When the laser is not in use After all sterilizing procedures are completed press the ACTIVE button and proceed to the next procedure this laser system does not require warm up time H When treatment has been completed de activate the laser and push the power button to shut the laser off Remove the disposable
20. h appropriate end caps and place the Unifiber into its shipping box 2 Disconnect the power supply from the rear of the laser 3 Carefully repack the laser and attachments into the appropriate shipping cartons 10 AX CAUTION Do not allow the laser system to be exposed to temperatures below 0 C 22 F AX caution keep the end of the handpiece clean Do not allow dust or particles to contaminate the end Preparing the Unifiber Hand Piece Assembly The Unifibersystem is composed of an aluminum autoclavable handpiece inner plastic optics and disposable tip Please do not under any circumstances autoclave the inner optics sleeve Doing so will permanently damage your Unifiber Hand Piece Connect the inner optics inside the aluminum handle and screw it completely shut Insert the disposable tip onto the aluminum handle until the magnet sucks the tip in place Attach the end of the fiber into the fiber port on the back of the unit s display panel Wrap the fiber around the oval fiber storage plate There is a rubber ring under the plate to keep the fiber from unraveling Leave enough fiber unwrapped to reach the patient The hand piece is now ready for the procedure AX caution Do not try to detach the fiber from the hand piece loclenut or optics Inner optics A E Disposable tip u Section 5 Operation Procedures Guide In order to better assist you with your procedures needs we created a spreadsh
21. ill see a visual verification that the password has been accepted The panel LCD screen should now read 0 0 acai Se ale wl The pamcote a neared Pesse ty again gt Cleaning and Disinfection The SL3 diode laser system is not supplied in sterile condition nor must it be sterilized before use The disposable plastic tips are supplied non sterile and should be wiped with CaviWipest or similar product prior to use There is no re use or re sterilization procedure indicated After a used tip is taken off the handpiece discard itin an infectious waste container SHARPS The aluminum handpiece shell is autoclavable and must be sterilized after each use We recommend a steam sterilization method performed at 121 C 250 F at 103 4 kPa 15 PSI for a minimum of 20 minutes NOTE The LCD screen is not routinely contaminated by the procedure but the entire front panel should be covered with a protective clear adhesive barrier film replaceable after each patient In the event that the screen is touched without protective film it should be wiped down with CaviWipes or equivalent product and re covered with a new protective plastic cover Transportation In the event that the laser system is to be relocated this does not include moving within the facility place the system into an appropriate shipping carton 1 Unwind the Unifiber from the rear panel and disconnect it Cover all fiber connectors wit
22. laser energy Please refer to page 11 for more information on the disposable tips LCD Screen The SL3 diode laser is equipped with a touch screen allowing the user to perform selections of various settings The screen graphics are intuitive allowing the user to select options quickly and easily An example of the main touch screen display is shown in the pictures below For a complete list ofall the features on the Main Display screen see page 12 Unifiber System Flexible fiberoptic cables are the most widely accepted delivery systems for diode laser power In the diode laser system the 400 um diameter single core quartz fiber is mounted into standard FC connectors The fiber optic cable is coated in a steel metal offering superior protection and preventing damage to delicate fibers The SL3 diode laser uses a Unifiber system to deliver diode laser power This consists of an autoclavable aluminum handpiece shell with internal optics The hand piece is paired with disposable non sterile fiber tips that can be easily removed and replaced in between procedures For information on setting up the unifiber system please refer to page 11 Section 3 Safety Indications Testing Standards The SL3 diode laser has been tested to the standards applicable to medical lasers luding IEC s 60825 60601 1 60601 1 2 60601 2 22 and the Food and Drug Administration s Laser Performance Standard 21 CFR 1040 10 and 1040 11 Please
23. r or place it on a dusty dirty surface prior to connecting to the rear panel If contamination occurs wipe the connector end with lint free soft tissue dampened with 75 80 ethanol or Isopropyl alcohol Make sure it s dry and then attach the connector to the laser port Ad CAUTION This device should be protected against unqualified use when notin use DO limit access to the operation area to personnel who are trained in the principles of laser safety The laser system has a remote interlock option that can be activated if necessary DO NOT attempt to defeat the system s interlock or access the enclosures as they are designed for your protection DO NOT attempt repairs of this system Service and maintenance should only be performed by a qualified SL3 diode laser Service Technician AX caution avoid inadvertent laser firing Turn the laser OFF when notin use foran extended period of time NOTE As the aiming beam passes down the same delivery system as the working beam it provides a good method of checking the integrity of the delivery system Ifthe aiming beam spot is not present at the distal end of the delivery system its intensity is reduced or it looks diffused this is a possible indication of a damaged delivery system Protective Eyewear All personnel in the operation area including the patient must wear eye protection Contact lenses are not viable protection Eye protection must be specific to the wavelength in use 808
24. review all labels prior to using the laser Familiarity with the American National Standards Institute 2136 3 Document and or Laser Institute Safety Manual is strongly recommended Note The laser must be installed and operated according to CAN CSA 2386 92 Laser safety in health care facilities The labels on the unit are required under these standards for safety purposes and should not be removed Labels A caution Laser in Use Each treatment area should have a Laser in Use warning sign posted at the entrance to the treatment area This signage serves to warn people not to enter the treatment area without proper safety eyewear when the laser isin use AX caution The Nominal Ocular Hazard Distance s NOHD as defined by IEC EN 60825 1 2007 03 Ed 2 0 for this device has been determined to be 143 0cm and 93 0mm for the eye and skin respectively Proper protection and safeguards forthe eyes and skin should be in place within these distances of the laser aperture Class 4 Laser Product Aiming Beam Laser Pulse Duration Beam Divergence 808nm 10nm 3 0 Watts 650nm 10nm SmW max Warnings WARNING Laser Radiation Avoid exposure to the eyes or skin from direct or scattered radiation DO NOT place any part of the body in direct line with the laser beam WARNING Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure WARNING Eyew
25. ser Power Adapter Initiating Film Unifiber with Hand Piece Safety Glasses 3 User s Guide Foot Pedal w 2 AA batteries Introductory DVD Disposable Tips 10 Caution Sign a s 5 Section 2 Specifications LASER SYSTEM SPECIFICATIONS SEE 17 7 cm wide x 13 cm high x 14 cm deep 7 x52 x 5 5 Weight 1 36 kg 3 lbs Wavelength 808 10 nm Operation modes Continuous Wave amp Pulsed at 10 Hz Output power 3 0W 20 Pulse width 50 ms Calibration External power meter Fiber optic port Standard FT type connector compatible with 400 um ameter single core quartz fiber cable Aiming beam 650 10 nm red diode laser 5 mW maximum Input power Laser Device 9v 3 5A Footswitch AA Cells 1 5V Power supply 100 240 VAC 1 0 A max 50 60 Hz Class 1 Handling storage Between 0 50 C 32 122 F conditions Protection type BF part Footpedal protection IPX1 Laser System Description The laser system is contained within a compact lightweight molded plastic housing consisting of a laser diode assembly with a self contained cooling system a flat LCD screen connected to an interface PCB and power controller PCB The base system has two physical buttons The first button Is a mechanical ON OFF button located on the rear left side of the unit The second power button is a red LASER STOP button located on the left side The LA

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