Diolase Plus™
Contents
1. 10 COMO PANG ls ER re aus 11 Unit THO AUN OS ars acta 12 PACCOS SONGS nissan ia states 12 Delivery SY Ste sess ste nade EO o Eom 15 Delivery System Assembly saiua a 15 Directions for Cleav ing Diolase Plus Fiber After Each Procedure 16 Operating Instructions cccceseeeeseeeseeseeenneeseeenseeseenseeeseoees 19 MAS A a 19 OPIO a al 19 Turn On the Diolase PluS ota ire 19 ON OFF BUNOM aaa dd 19 READY STANDBY BUtOFIS ica 20 LASER FIRING o di each 20 MODE BIOS vai dae 20 POWER Buttons ss 20 PULSE DURATION Buttons 20 PULSE INTERVAL ButtonS oococcccnnncncncnnnnnccnncononononanononononononcnnnnnos 20 FUNCTION Key ns 20 PRESET Buttons idee boost pr ac eve EpL s niess 20 iir toe nb OP e sioe did 21 Section 5 Section 6 Section 7 Section 8 Section 9 Appendix SPECIFICATION Sica 22 General adan lada iodo ds 22 A Re m a re 22 A NS Sr E EEE A NN ne 22 Our Lig 99uleBS arora 22 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 23 COopitralhdicalloliS EAN ntm cena nue teen 23 Warnings and PrecautiOnS ccccocccccccnncoccnnccnnnnononnnonanononannnnnnnnnnnnnnnonnnos 23 CLINICAL APPLICATIONS 1 eene enean nnn nnns 24 A a a arlean 24 Fable Gf Indications Tor US ss a gente 24 MAINTENANCE unicidad ttes 25 PAU IVAN TICS ce farsi site nos 25 Daly Maintenance nn name E S 25 Contamination Control Proced2. Laser Aperture Name Plate 5000910 Rev 06 04 Diolase Plus User Manual APPENDIX C SPARE PARTS AND ACCESSORIES BIOLASE DESCRIPTION e Handpiece Fiber Optic Assembly Laser Safety Glasses Key Remote Interlock Plug Power Cord Footswitch Laser Radiation Danger Sign e Prescription eyewear may be available Please contact your local authorized BIOLASE dealer for additional information 2004 Biolase Technology Inc All Rights Reserved ENS APPENDIX D LIMITED WARRANTY BIOLASE Technology Inc warrants for a period of twelve 12 months from the shipment to the original purchaser user the Diolase Plus Laser system serial number It is warranted to be free from defects in materials and workmanship under normal use and service and fit for the ordinary use for which designed if operated by a trained and competent operator and properly serviced and maintained This limited warranty applies only to the original purchaser user of the equipment and only so long as the equipment is used in the country to which it was originally shipped by BIOLASE Technology Inc or by its authorized distributor This warranty does not cover maintenance of parts that fail due to normal use including but not limited to the Fiber optic cable and Handpiece This warranty is null and void if the user attempts to service the equipment other than performing the maintenance described in the Operator Manual or if service is performed by p
3. One beep will sound to indicate that the system is ready for use Footswitch The Diolase Plus will not emit laser energy until the user pressed down on the footswitch The variable footswitch works like a rheostat The amount of energy emitted from the fiber will be proportional to the amount the footswitch is pressed The footswitch may also be selected to function as a switch See Section 4 Function Key Figure 3 Footswitch Domestic Emergency Stop Press the red emergency stop button to instantly turn off the unit Rotate and release button to RESET Do not use the emergency stop for normal stops Figure 5 Emergency Stop BUTTON 5000910 Rev A 06 04 Diolase Plus User Manual Remote Interlock This feature allows the device to be connected to the remote sensor which will prevent its operation when triggered i e by opening door This feature may be overridden by inserting the remote interlock plug Functional Display The System Text Display and the Light Emitting Diode LED indicators on the control panel show the functional conditions of the system Safety Questions Please direct any safety questions to an authorized representative Safety Classification The following safety classifications are applicable to the device Laser Radiation Class 4 Type of protections against electrical shock Class 1 Degree of protection against electrical shock Type B Applied Part Not protected against wa
4. Remove the service plug and re insert the remote plug Calibration Schedule This Procedure will be required every 12 months in order to maintain the required accuracy of the output power versus displayed power 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual APPENDIX A LABELS THIS PRODUCT CONFORMS TO THE PROVISIONS OF 21 CFR CHAPTER 1 SUBCHAPTER J B81 Cale Amanecer San Clemente GA 92573 Manufactured Date _ Model Number Serial Number Made In The U S_A 3000417 REN ELECTRICAL RATINGS 5000440 REVA 5000910 Rev A 06 04 A 1 Certification Location Back Panel see figure 13 A 2 Identification Location Back Panel see figure 13 A 3 Keyswitch On Off Location Back Panel around keyswitch see figure 13 A 4 Electrical Rating Location Back Panel see figure 13 A 5 Footswitch Location Back Panel see figure 13 Diolase Plus User Manual A 6 Remote Interlock Location Back Panel see figure 13 9000439 REVA A 7 Danger L lon VISIBLE AND INVISIBLE LASER RADIATION ocatio AVOID EYE OR SKIN EXPOSURE TO DIRECT MM LLL ltt Front Panel see figure 9 16 0 W Maximum 2ms 9595 CW 815 15 nm CLASS IV LASER PRODUCT Domestic use Rex A 8 Laser Aperature Location Front Panel see figure 14 A 9 Name Plate 1 Location Front Panel see figure 14 A 10 Lifting Label Location On top s
5. To perform this procedure follow these step by step instructions e Place the handpiece and interchangeable heads inside a single wrap self seal autoclave pouch e Remove autoclave tray and place pouch s on the tray e Place tray inside the autoclave chamber and set controls to the following values Temperature 250 F 121 Pressure 15 PSI 1 bar Time cycle 20 minutes e Atthe completion of the autoclave cycle remove the tray and let the handpiece fiber optic cable and interchangeable heads cool and dry e Assemble the handpiece to the fiber optic cable and attach delivery system to unit for the next patient CAUTION DO NOT place or stack other devices on top of the fiber optic cable Transportation The Diolase Plus is susceptible to misalignment if not handled properly The unit should ALWAYS be handled carefully and never banged jarred jolted dropped or knocked Do not place the unit into a pick up truck van or other moving machine for transportation unless it is completely packaged inside of its shipping box If you have any questions regarding transportation please call your local Dealer Storage The Diolase Plus should be stored in a cool dry place when not in use Cover the unit when not in use for extended periods of time Store the system in a place where it will not be accidentally bumped or banged The Diolase Plus was shipped inside a custom shipping box Please save and store the box in a cool d
6. e Place unit in a clean dry and well ventilated area e Verify circuit breaker is in OFF position e Connect key into key switch verify it is in the OFF position e Verify Emergency Stop Button is disengaged Up position e Connect footswitch e Connect remote interlock e Connect power cord to power connector on unit and plug into wall outlet CAUTION Do not cover or block ventilation channels These channels provide air flow path to cool unit WARNING Never point fiber optic at eyes WARNING All persons present in the operatory must wear protective Eyewear when laser is in operation Operation Turn On the Diolase Plus e Turn circuit breaker to ON position e System Status Display shows message Rotate key clockwise to ON position ON OFF Button Press ON OFF button The unit will turn on and begin a self diagnostic routine During this routine the following will automatically occur e Memory test e Memory OK e 3second delay Warm up mode If during the self diagnostic routine the diode laser temperature is below 18 C 64 F the system will go into warm up mode Follow the instructions on the display 1 First press the READY key 2 Press and hold the footswitch until the system stops 3 The LASER FIRING icon will flash and beeper will sound until the system is sufficiently warmed up It may take up to two minutes The hand piece should be left in the holder with the fiber pointing down NOTE While output powe
7. upon request Handpiece Base Handle Head 30P Accessories Adapter To be used with Disposable Bendable Tip Diolase Plus Handpiece Kit See Figure 11 The fiber optic cable handpiece and head are reusable accessories that require cleaning and sterilization before and after each patient treatment For instructions on cleaning and sterilization of the fiber optic cable handpiece and head refer to section 8 Fiber optic cable is not autoclavable unless labeled as autoclavable Diolase Plus Surgical Handpiece Assembly To connect handpiece to fiber optic assembly 1 OP Ot en Se no Loosen Handpiece Base from Handpiece Handle See Figure 10a Slide fiber through Handpiece Base Handle and Head Adjust fiber so it protrudes approximately 2 inches Strip and cleave fiber See Figure 10b Adjust to desired length See Figure 10c Gently tighten Handpiece Base to secure Handpiece to the Fiber Optic Assembly See Figure 10d To disassemble Handpiece from Fiber optic cable See Figure 10 1 e 1 2 NOTE Loosen Handpiece Base Slide Handpiece off of fiber optic cable To change Handpiece Head See Figure 10 Disassemble Handpiece from Fiber optic cable Change Handpiece head by holding handle and rotating head For unit set up instructions refer to Section 4 Operating Instructions 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 5 Specificatio
8. Diode arrays as well as all relevant electronic circuits will be calibrated Please contact your authorized representative to discuss Extended Service Contracts and Annual maintenance options Daily maintenance Use disinfectant to wipe down the front panel of the Diolase Plus system after each procedure Do not use bleach or abrasive cleansers Contamination Control Procedures The contamination control suggested for the Diolase Plus fiber optic cable handpiece and interchangeable heads is the steam sterilization method However before sterilization the Diolase Plus reusable accessories handpiece fiber optic cable and interchangeable heads should be carefully cleaned per the following procedure NOTE Fiber optic cable is delivered from manufacturer as non sterile Cleaning Instructions for the Diolase Plus Surgical Handpiece and the Fiber Optic Cable The cleaning process is intended to remove blood protein and other potential contaminants from the surfaces and crevices of reusable accessories This process may also reduce the quantity of particles microorganisms and pyrogens present Cleaning should be performed prior to sterilization and must be conducted only by qualified office personnel trained to perform the procedure and handle the Diolase Plus Fiber optic Delivery System Wear protective latex gloves when handling the contaminated delivery system To disconnect the delivery system follow the instruction
9. Diolase Plus A SOFT TISSUE LASER User Manual BIOLASE 2004 Biolase Technology Incorporated All Rights Reserved BIOLASE Diolase Plus User Manual BIOLASE the BIOLASE logo Diolase Diolase Plus and the Diolase Plus logo are either registered trademarks or trademarks of BIOLASE Incorporated in the United States and or other countries BIOLASE Technology Inc 981 Calle Amanecer San Clemente CA 92673 USA NoPainDentistry com NASDAQ BLTI BIOLASE Europe GmbH Paintweg 10 92685 Floss Germany 5000910 Rev A 06 04 Contents Section 1 Section 2 Section 3 Section 4 INTFOGUICTION pui LE 5 Installation of the Diolase Plus 5 Installation IAStTUCUONS o doo de Re doeet cU entm du pate po E io eua 5 FAC Requirements 5 Electrical Suppl 5 Environmental Requirements eese nnne 5 Safety with the Diolase Plus 6 TEC AIN mm 6 Safety Instructions 6 Safety Features ss 7 miae Mere N 7 Circuit Breaker arrasado aia 7 System Monto pieces aut a 7 EY SWING Mtra dia 7 READ dise esmas colla IT 8 POOLS Wicca a 8 EIMGLQENCY oO ios 8 Remote Mea E 9 FUNCIONA DIS ao 9 Sale QUES ONS SR M de 9 Satety i e 9 Equipment Description sees 10 A UU NE 10 ONS OO act sage cases
10. Energy Monitor The energy monitor measures and verifies power output Power deviations of more than 20 from the selected value will cause the display to show either error message DIODE CALIBRATION or LASER POWER The unit will not operate until the system is reset by pressing any key on the keypad If error messages persist please contact your authorized service representative Circuit Breaker The circuit breaker serves as a line switch to separate the unit from the main power supply 0 OFF ON Figure 1 Circuit Breaker ON OFF System Monitor The system monitors the emergency stop switch remote key footswitch attachment fiber attachment and output power An error in any one of these will stop the system the text display will indicate the type of error Operation will not resume until the error is cleared and the text once again displays Biolase Technology Keyswitch The unit can be switched ON key in horizontal position only with the proper key The key cannot be removed while in the ON position Always turn the key off vertical position and remove the key when not in use Figure 2 Keyswitch Oorr ON 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 2 Safety READY Button Once the circuit breaker keyswitch and ON OFF switch are set to the ON position the READY button on the keypad must be pressed to enable the footswitch
11. ITY OR FITNESS FOR A PARTICULAR PURPOSE BIOLASE TECHNOLOGY INC SHALL HAVE NO LIABILITY WHATSOEVER FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF ANY DEFECT IMPROPER USE OR UNAUTHORIZED SERVICE OR REPAIR Prior to return of a unit or any portion thereof BIOLASE Technology Inc MUST be consulted to avoid unnecessary shipping If return of the equipment is deemed necessary a Return Authorization Number will be assigned This number must be recorded on the outside of the shipping container APPENDIX E LIMITED LIABILITY BIOLASE TECHNOLOGY INC WILL NOT BE LIABLE FOR INCIDENTAL CONSEQUENTIAL INDIRECT OR SPECIAL DAMAGES OF ANY KIND INCLUDING BUT NOT LIMITED TO DAMAGES FOR LOSS OF REVENUE LOSS OF BUSINESS OR BUSINESS OPPORTUNITY OR OTHER SIMILAR FINANCIAL LOSS ARISING OUT OF OR IN CONNECTION WITH THE PERFORMANCE USE OR INTERRUPTED USE OF THE Diolase Plus SYSTEM S OR ANY BIOLASE MATERIALS 5000910 Rev A 06 04
12. e duration Press up arrow to increase pulse duration or press down arrow to decrease pulse duration PULSE INTERVAL Buttons While in the repeat pulse mode press PULSE INTERVAL arrows to adjust pulse interval Press up arrow to increase pulse interval or press down arrow to decrease pulse interval FUNCTION Key Select Pulse Counter Pulse Count e Use Aiming Beam Up Down buttons to Set number of pulses e Pulses Delivered Display displays selection When energized counter will count down pulses as delivered Select Footswitch Operation Footswitch Oper e Use Aiming Beam Up Down buttons to toggle between variable and On Off operation of footswitch Select Display Brightness Disp Brightness e Use Aiming Beam Up Down buttons to change display LEDs brightness Select Beep ON OFF e Use Aiming Beam Up Down buttons to turn On Off BEEPER PRESET Buttons Press a preset button to recall saved power mode duration and interval settings To store values in a preset press and hold the desired preset button for 2 3 seconds until its LED flashes 5000910 Rev A 06 04 Diolase Plus User Manual Turn the unit OFF e Press the STANDBY button e Place handpiece back on handpiece holder CAUTION Verify that fiber optic tubing assembly is not twisted once handpiece is returned to holder Fiber may break if it is twisted e Press the ON OFF button e Turn key to OFF position e Switch circuit breaker to OFF po
13. ee figure 14 2004 Biolase Technology Inc All Rights Reserved A 11 Emergency Stop Label Location On top see figure 14 A 12 Control Panel Location On top see figure 14 A 13 Warning label International Units Only Location Front Panel see figure 14 5000910 Rev A 06 04 Diolase Plus User Manual A 14 Ground International Units Only Location Next to E1 ground terminal LBOO 20 0009 A 15 CSA Certification Label International Units Only Location Back Panel see figure 13 C US 207461 5000444 REVB A 16 CE Certification Label C C Location Back Panel see figure 13 u 0050 9000252 REV B APPENDIX B SIGNS B 1 Laser Radiation Danger Sign Location At Operating Entrance VISIBLE and or INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION 16 0 Wi Maximum 2ms 355 Of 815 4 15 nm CLASS IV LASER PRODUCT EYE PROTECTION REQUIRED 2004 Biolase Technology Inc All Rights Reserved ES Figure 13 Back View with Labels International units Certification Keyswitch On Off TENET 3BIOLRSE N Identification Key CE Certification Label A N E A Remote Interlock Label Electrical Ratings Foothswitch Label Figure 14 Front View with Labels International units Handle Emergency Stop Label Control Panel Laser Aperture Label Danger Label
14. ersons who are not trained and authorized to do so by BIOLASE Technology Inc If the unit is found to be defective within the period specified above after examination by an authorized service representative and BIOLASE Technology Inc is satisfied that the failure was due to defective materials and or workmanship BIOLASE Technology Inc will repair or at its option replace the defective parts without charge BIOLASE Technology Inc reserves the right to make such an examination and to make the necessary repair replacement in its own factory at any authorized repair station or at the purchaser user s place of installation In the event the user does not cooperate with BIOLASE in providing service BIOLASE is released of all liabilities to the purchaser user Any shipping charges incurred shall be paid by the purchaser user of the equipment Disposable or consumable items are not covered by this warranty The handpiece and fiber optic cable are warranted for 90 days against defects in workmanship and materials BIOLASE will not be responsible or obligated to purchaser user for loss of revenues incurred by the purchaser user due to the product requiring service THE EXPRESS WARRANTY ABOVE IS THE SOLE WARRANTY OBLIGATION OF BIOLASE TECHNOLOGY INC AND REMEDY PROVIDED ABOVE IN LIEU OF ANY OTHER REMEDIES THERE ARE NO OTHER AGREEMENTS GUARANTEES OR WARRANTEES ORAL OR WRITTEN EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTY OR MERCHANTABIL
15. fety Glasses Power cord Remote interlock plug 5000910 Rev A 06 04 Figure 10 Figure 10 Figure 7 8 and 9 Figure 10 Figure 9 Figure 8 Figure 9 10 Figure 7 and 9 Figure 10 Figure 8 Figure 9 and 14 Figure 8 Figure 10 Figure 8 Figure 13 Figures 7 and 8 Figure 3 and 4 Figure 8 Not Shown Not Shown Figure 8 Figure 7 Side View Handpice Delivery System Connection Fiber Optic Assembly Ventilation Channel Handpiece Holder Figure 8 Back View Emergency Stop Key Switch Key ae ucu Ventilation Channel Circuit Breaker Main ELECTRICAL RATINGS 100 240V 50 60 Hz 360 VA MAL Power Connector Remote Interlock Plug Footswitch Connector 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 5 Specifications Figure 9 Front View Domestic Unit Emergency Stop Control Panel gt Pal Handle wen Spool Handpiece Sdandpiacs Holder Laser Aperture Danger Label Domestic Unit Dio ARA DG Fiber Optic Assembly 5000910 Rev A 06 04 Delivery System NOTE sterile The fiber optic cable handpiece and heads See Figure 6 are shipped non The Feed through Delivery System consists of NOTE NOTE Fiber Optic Assembly See Figure 10 The standard fiber optic cable assembly is a 400um fiber Other sizes are available
16. for delivery system assembly presented in Section 3 Together with steam sterilization fiber optic cable can be disinfected per following instructions High level Disinfection Instructions for the Fiber Optic Cable e Transport the delivery system to a decontamination sterilization work area e Take the fiber and strip 1 0 off from distal end of fiber using the fiber cleaver Make sure that the part that has debris is removed entirely Dispose of the contaminated fiber tip accordingly e Prepare the Sporox Sterilizing and Disinfecting Solution and submerge approximately 30cm 12 inches of the fiber s distal end into the solution For high level of disinfecting immerse the fiber end for 30 minutes at 20 C 68 F e After this process is completed thoroughly rinse and dry the fiber e For disposal of the Sporox please follow the manufacture s instructions 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 8 Maintenance Steam Sterilization for Diolase Plus Surgical Handpiece Before sterilization the handpiece must be cleaned and disassembled For cleaning follow the procedures described above See Section 9 3 1 To disassemble the handpiece from the fiber optic cable carefully loosen the handpiece base and slide handpiece off of fiber optic cable See Section 4 3 2 The process of thermal sterilization with saturated steam under pressure is carried out in an autoclave
17. g button saves selected values Toggles between continuous repeat pulse and single emission modes Resets pulse counter to zero Indicates total pulses delivered Indicates currently selected mode continuous repeat pulse single Indicates interval between pulses Indicates length of each pulse Indicates system errors or status Allows energy delivery Indicates unit is in READY mode Does not allow energy delivery Indicates unit is in STANDBY mode Figure 6 Control Panel Actual Power Laser Firing Icon Max Power Display 3 E Grp 5 Power OnO Switch 1 Up Down Buttons standby LED 23 standby Button 22 6 Aiming Beam Up Down Buttons Ready LED 21 Ready Button 20 Aiming Beam Intensity System Status 19 Bar Display Display a Function Button Pulse Duration Display Pulse Duration Interval Up Down Buttons Display 10 Pulse Interval Up Down Buttons Mode lcon 116 11 Preset LEDs 1 4 Pulse Counter 15 Display 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 5 Specifications Unit Features Base Delivery System Emergency stop Fiber Optic Cable Fiber spool Footswitch connector Handle Handpiece holder Head Keyswitch Laser aperture Main Circuit Breaker Male Connector Power connector Remote Interlock connector Ventilation channels Accessories Footswitch Key Laser Sa
18. hat might contraindicate a local procedure Such conditions may include allergy to local or topical anesthetics heart disease lung disease bleeding disorders sleep apnea or an immune system deficiency Medical clearance from patient s physician is advisable when doubt exists regarding treatment e Patients with snoring difficulties possibly due to alcohol consumption or being overweight are not candidates for Laser Assisted Uvulopaletoplasty LAUP unless other treatments have been attempted NOTE LAUP procedures should be performed by ENT trained professionals only Warnings Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 815 15 nm Anesthesia In soft tissue cases anesthesia may not be required patients should be closely monitored for signs of pain or discomfort If such signs are present adjust settings apply anesthesia or cease treatment if required Adjacent Structures Diolase Plus is designed to remove soft tissues Therefore always be aware of adjacent structures and substructures during treatments Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues Do not direct energy towards hard tissues such as tooth or bone Do not direct energy towards amalgam gold or other metallic surfaces Do not direct energy towards cements or other filling materials Suction Use high speed suct
19. igned and tested to meet the requirements of electromagnetic electrostatic and radio frequency interference testing However the possibility of electromagnetic or other interference may still exist Safety Instructions Follow these safety instructions before and during treatments e All operatory entrances must be marked with an appropriate warning sign See Appendix B 1 e Do not operate in the presence of explosive or flammable materials e All persons present in the operatory must wear protective eyewear CAUTION Periodically inspect eyewear for pitting and cracking Note For replacement additional or prescription protective eyewear please contact your authorized representative e Do not look directly into the beam or at specular reflections e Never direct or point the beam at anyone s eyes e Remove or cover all highly reflective items in the treatment area e Press STANDBY Standby button on the control panel before turning off unit e Always press STANDBY on the control panel before exchanging handpieces or removing the fiber optic connector from the unit e Move the circuit breaker located on rear panel to OFF 0 position and remove the key before leaving unit unattended DANGER Do not open unit housing at anytime Danger from high voltage may exist NOTE Please be aware that metal plastic cannulas may become hot during use Avoid contact of cannulas with tissues 5000910 Rev A 06 04 Safety Features
20. ion as required to maintain a clear field of vision during treatment Do not use the Diolase Plus if you cannot clearly see the treatment site Training Only licensed professionals who have successfully completed a Diolase Plus training seminar and have read and understood this User Manual should use this device BIOLASE assumes no responsibility for parameters techniques methods or results Physicians must us their own clinical judgment and professionalism in determining all aspects of treatment technique proper power settings interval duration etc LAUP Candidates considering LAUP treatment should be advised that this treatment could affect vocalization 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 7 Specifications Section 7 CLINICAL APPLICATIONS Introduction To efficiently remove tissues it is imperative to understand the nature of the Diolase Plus device Diolase Plus operates unlike traditional devices and the technique must be practiced and perfected to ensure efficient operation Please study this section carefully practice on model tissues and attend a quality diode laser training seminar before using this device in a clinical situation Table of Indications for Use Use of Diolase Plus may be appropriate for the following indication for use Specialty Application Dental Excisional and incisional biopsies Soft Tissue Exposure of unerupted teeth Fibr
21. ions or require assistance section 1 INSTALLATION Installation Instructions Upon request your local authorized representative will unpack and install the Diolase Plus The Diolase Plus system includes the following e Console e Delivery System Handpiece and Fiber Assembly e User Manual e 3 Safety Goggles e Footswitch e Power Cord e Carbide fiber scriber e Micro fiber stripper 400um e Laser Radiation Danger Sign e Accessory Pouch includes remote interlock plug ground clip key Use proper care prior to transporting the unit Refer to Section 8 in this manual for instructions Misalignment of optical components may occur during transportation Facility Requirements Electrical Supply 100 240V 1 5 3A 50 60Hz Environmental Requirements Temperature 20 25 C Humidity 15 95 Relative 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 2 Safety Section 2 SAFETY Precautions Failure to comply with precautions and warnings described herein may lead to exposure to dangerous voltage levels or optical radiation sources Please comply with all safety instructions and warnings CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure DANGER Do not use this unit if you suspect it of functioning improperly or other than described herein CAUTION _ This unit has been des
22. ns Directions for Cleaving Diolase Plus Fiber The Diolase Plus fiber should be cleaved after each procedure To cleave the fiber refer to the following steps 1 Loosen the proximal end of the handpiece Fig 10a by unscrewing the Handpiece Base 2 Pull 2 3 inches of fiberoptic cable from the Handpiece Head through the Handpiece 3 Select a fiber stripper that corresponds to the fiber diameter size 4 Insert approximately 1 inch of the fiberoptic cable into the stripper Squeeze the stripper handles to get a firm purchase on the fiberoptic cable while keeping a firm grip on the fiberoptic cable pull the stripper away from the handpiece in a smooth motion to ensure that the jacket is cleanly removed 5 Use a diamond carbide cleaver to cut the used end of the fiber Place the fiber against a flat surface Position the edge of the cleaver approximately 1 4 inch from the end of the fiber and make a scratch around half the circumference of the fiber Make sure that the edge of the cleaver is always perpendicular to the fiber during scratching 6 Hold the end of the fiber above the scratch between thumb and forefinger and pull the end of the fiber away until the end section breaks off If the fiber end is removed properly by pulling in the direction perpendicular to the end surface of the fiber the fiber should end in a flat surface 7 Verify the cleave quality by aiming the fiber at a flat surface and observing the shape of the sp
23. oma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sulcular debridement removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index gingival bleeding index probe depth attachment loss and tooth mobility Treatment of aphthous ulcers Vestibuloplasty ENT Laser assisted Uvulopaletoplasty LAUP For LAUP this laser is effective for cutting ablation coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring This procedure is for ENT professionals only BIOLASE assumes no responsibility for parameters techniques method s or results Physicians must use their own clinical judgment and professionalism in determining all aspects of treatment technique proper power settings interval duration etc 5000910 Rev A 06 04 Section 8 MAINTENANCE Annual Maintenance The Diolase Plus should be serviced annually by a qualified trained and certified technician During the annual visit the system
24. ot created by the visible aiming beam If the visible spot is a full circle then the power output is optimal If the circle is distorted then repeat only the cleaving procedure presented in steps 5 and 6 until you obtain a perfect circle beam 8 After the fiber is successfully cleaved pull the fiber back through the Handpiece adjust fiber See Figure 10 end to desired lenght Tighten the Handpiece Base until snug Ensure that the fiber isn t loose by pulling lightly on the fiberoptic cable at the proximal end Figure 10 Feed through Delivery System Base Handle N Head Handpiece Fiber Optic Cable Connector Protective Cap A ff q an i y p Al EE osmmn SS MD and Male Connector Eau s EA SMA Connector CH 31313231313 AAA e 5000910 Rev A 06 04 Figure 10a Loosen Hanapiece Base Turn counter clockwise to loosen base CEBIOLASE Fiber optic Base Handle Head Assembly Figure 10b Strip and Cleave gu IOLASE Strip amp cleave fiber Figure 10c Adjust Fiber Length Figure 10d Tighten Handpiece Base Turn clockwise to tighten base 2004 Biolase Technology Inc All Rights Reserved Diolase Plus User Manual Section 5 Specifications Figure 11 Diolase Plus Handpiece Kit Handpiece Disposable Bendable Tip Adaptor DEBEBIB 5000910 Rev A 06 04 Section 4 OPERATING INSTRUCTIONS Unit Setup
25. r is negligible wear protective glasses during the warm up The warm up mode will not function at temperatures below 5 C 41 F as a Thermistor Error will appear on the display Do not leave the system in an uncontrolled environment where the temperature might drop significantly i e the trunk of a car If this happens the system should be Diolase Plus User Manual 2004 Biolase Technology Inc All Rights Reserved ECS Section 5 Specifications left to warm up indoors for ten to fifteen minutes before the warm up mode is activated READY STANDBY Buttons Unit will only emit laser energy when footswitch is pressed and unit is set to READY mode Values may be adjusted in both modes In READY mode values may be changed only when footswitch is released Press READY button LASER FIRING Icon When footswitch is pressed and laser fires the LASER FIRING icon will flash and beeper will sound indicating that laser energy is present When footswitch is not pressed the LASER FIRING icon will go blank indicating laser energy is not present MODE Buttons Press the MODE button to toggle the unit between continuous repeat pulse and single modes POWER Buttons Press POWER arrows to adjust power level Press up arrow to increase power level or press down arrow to decrease power level PULSE DURATION Buttons While in the repeat pulse or single pulse mode press PULSE DURATION arrows to adjust puls
26. ry place 5000910 Rev A 06 04 Section 9 CALIBRATION Calibrating Power NOTE Calibration is to be performed only by trained personnel It is necessary periodically to calibrate the Diolase Plus Laser System In order to do this the following equipment is required e An Optical power meter recently calibrated e Diolase Plus Laser e Handpiece with polished tip e Service Plug Turn on the Diolase Plus Laser following previously described procedures Arrange a fixture such that the handpiece tip is pointing at 3 toward the optical power meter and the beam does not overfill the sensing diameter Remove the remote plug from the rear of the Diolase Plus and insert the service plug Push any key to clear the Remote Error display and set the output power to 0 5 watt Be certain the pulse mode is continuous Push the Ready key and depress the footswitch to the maximum The optical power meter will indicate the power delivered Use the Aiming Beam keys to increase or decrease the diode current until the power output displayed on the optical power meter is 0 5 watt Release the footswitch and push Counter Reset to store this value of diode current Set the output power to 1 0 watt and repeat the procedure using Aiming Beam keys to adjust the diode current When the optical power meter indicates 1 0 watt 10 release the footswitch push Counter Reset Repeat at each power setting 1 10 watts
27. sition e Remove key from the unit and place in secured area 2004 Biolase Technology Inc All Rights Reserved DE Section 5 Specifications Section 5 Diolase Plus SPECIFICATIONS General Dimensions Weight Electrical Operating Voltage Current Rating Frequency External Fuses Main Control On Off Controls Remote Interruption Laser Classification Medium Wavelength Power Accuracy Power Modes Pulse Duration Pulse Interval Delivery Fiber Diameter Mode Max Output Power Range Other Light sources Aiming Beam 5000910 Rev A 06 04 W x H x D 8 5 x 9 0 x 12 5 22 x 23 x 32cm 13 lbs 6 kg 90 to 132 VAC 180 264 VAC 3A 1 5A 47 63 Hz 47 63 Hz None Circuit Breaker Keyswitch Keypad Button Emergency Stop Remote Interlock Connector IV 4 GaAlAs 815 15nm 20 Continuous Repeat Pulse Single Pulse 20 ms 9 9 sec 20 ms 9 9 sec 200 1000 um Multimode 7 watts out of a 600 um or 400 um fiber LED max 5 mW 630 670nm section 6 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Contraindications e All clinical procedures performed with Diolase Plus must be subjected to the same clinical judgment and care as with traditional techniques Patient risk must always be considered and fully understood before clinical treatment The clinician must completely understand the patient s medical history prior to treatment Exercise caution for general medical conditions t
28. ter ingress Ordinary Equipment Not suitable for use in presence of flammable anesthetic mixture Operation Mode Continuous Operation 2004 Biolase Technology Inc All Rights Reserved 9 Section 5 Specifications Section 3 EQUIPMENT DESCRIPTION General The Diolase Plus consists of two components e Console e Delivery System Console The Console Elements are the e Control Panel e Unit Features e Accessories Control Panel See Figure 6 Item Item 1 ON OFF 2 ACTUAL POWER DISPLAY 3 LASER FIRING ICON 4 MAXIMUM POWER DISPLAY 5 POWER up down 6 AIMING BEAM up down 7 AIMING BEAM INTENSITY 8 FUNCTION 9 PULSE DURATION up down 10 PULSE INTERVAL up down 11 PRESET LEDs 12 PRESET 13 MODE 14 COUNTER RESET 15 PULSE COUNTER DISPLAY 16 MODE ICON 17 INTERVAL DISPLAY 18 PULSE DURATION DISPLAY 19 SYSTEM STATUS DISPLAY 20 READY 21 READY LED 22 STANDBY 23 STANDBY LED 5000910 Rev A 06 04 Item Description Turns the unit on and off Indicates average power delivered Flashes when laser energy is delivered Indicates maximum allowable delivered power Allows adjustment of maximum delivered optical power Allows adjustment of aiming beam intensity Indicates aiming beam intensity Selects user function Allows adjustment of pulse length Allows adjustment of pulse interval Indicates which preset is currently selected Allows for selection of system presets Holdin
29. ure ccccoccncccnncnncccnccnncconcnnnnnncnnnononnnananons 25 cleaning nds eee 25 High level Disinfection Instructions for the Fiber Optic Cable 25 Steam Sterilization for Diolase Plus Surgical Handpiece 26 TRANS DONATION be CT EA 26 LONG NM T pU A 26 CALIBRA THON e nue 27 Calibrating Power sis 27 Calibration Schedules en se Radar tordre 27 Ae LABELS are a a 28 BSO NO 31 C SPARE PARTS AND ACCESSORIES 33 D LIMITED WARRANT Y 0 cccccsscssensensensenseneenseeeeeeeeeeeeenees 34 INTRODUCTION The Diolase Plus Dental Soft Tissue Laser is a surgical device at the cutting edge of technology designed for a wide variety of oral soft tissue procedures The Diolase Plus utilizes a solid state diode as a laser energy source and the energy is delivered to the operating area by means of a delivery system consisting of flexible fiber connecting the laser source and the handpiece The device is activated by means of a footswitch The Diolase Plus is intended for use by dentists in oral soft tissue procedures The use of this device requires proper clinical and technical training This manual provides instructions for professionals that have completed the appropriate training When used and maintained properly the Diolase Plus will prove a valuable addition to your practice Please contact your authorized representative if you have any quest
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