User Manual
Contents
1. Dental Excisional and incisional biopsies Soft Tissue Exposure of unerupted teeth Fibroma 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 Treatment of canker sores herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty 32 5400003 REV R 12 10 CAUTION Use caution when operating above an average power of 1 0 W pulsed or CW mode Closely observe tissue effects for changes in tissue color and depth of penetration and cut For procedures performed within enclosed spaces e g pockets channels interproximal use caution when operating above an average power of 0 5 W SPECIALTY APPLICATION Periodontal Laser soft tissue curettage Procedures Laser removal of diseased infected inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement removal of diseased infected inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index gingival bleeding index probe depth attachment loss and tooth mobility Whitening Light activation for bleaching materials for teeth whitening Laser assisted whitening bleaching of tee2. All clinical procedures performed with ez ase 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 that might contraindicate a local procedure Such conditions may include allergy to local or topical anesthetics heart disease lung disease bleeding disorders sleep apnea and immune system deficiency or any medical conditions or medications that may contraindicate use of certain light laser type sources associated with this device Medical clearance from patient s physician is advisable when doubt exists regarding treatment WARNINGS AND PRECAUTIONS Prescription Statement Federal law restricts this device to sale by or under the order of a dentist or physician or licensed practitioner Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 810 15 nm or 940 15 nm Anesthesia In soft tissue cases anesthesia may not be required patients should be closely monitored for signs of pain or discomfort at all times If such signs are present adjust settings apply anesthesia or cease treatment if required Adjacent Structures ezlase is designed to remove soft tissues Therefore al
3. WARNING Do not aim the laser at metallic or reflective surfaces such as surgical instruments or dental mirrors If aimed directly at these surfaces the laser beam will reflect and create a potential hazard SAFETY FEATURES Energy Monitor The current monitor measures and verifies power output Power deviations of more than 2096 from the selected value will cause the display to show the error message DIODE CALIBRATION 6 5400003 REV 12 10 The unit will not operate until the system is reset by pressing any key on the keypad If the error messages persist please contact Biolase Service at 1 800 321 6717 System Monitor The system monitors emergency stop switch remote key footswitch connection or 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 Power Switch The unit can be switched ON or OFF using toggle switch at the back panel Figure 1 Power Switch Figure 2 Power Supply CAUTION Use only the Power Module supplied with the ezlase system BIOLASE part number 6400005 Key Access Electronic key prevents unauthorized use of the system It is activated every time system is turned off with the Power Switch NOTE Turning the laser off by pressing the ON OFF button on the front panel does not re set the key access Turn Power Switch OFF only when system will not
4. Engraved 44 5400003 REV 12 10 A 5 EMERGENCY LASER STOP SWITCH Location Left Side LASER A 6 WARNING LABEL IEC 60825 1 2001 EN 60601 2 22 1995 VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT International Units Only OR SCATTERED RADIATION CLASS 4 LASER PRODUCT 4 5 W MAX C W 810 15 nm 10 0 W 940 15 nm 3 mW MAX C W 630 670 nm CAUTION LASER RADIATION WHEN OPEN 0018 Location Back Panel Figure 11 THIS PRODUCT COMPLIES WITH FDA 7 COMPLIANCE LABEL PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR Location Bottom side Figure 11 DEVIATIONS PURSUANT TO LASER NOTICE NO 50 DATED 26 JULY 2001 5200101 REV B APPENDIX B SPARE PARTS AND ACCESSORIES DESCRIPTION 6400007 2400040 6400058 6400005 6400062 6400053 6400091 2400078 6400105 6400109 6400107 7400022 7400023 7400024 7400030 6400173 SINGLE USE TIPS Surgical 7400018 7400017 7400016 Perio 7400020 7400019 7400021 46 5400003 REV 12 10 Handpiece Laser Safety Glasses Remote Interlock Plug Power Supply Footswitch Footswitch charging cable Peel off clear covers qty 30 Goggles Safety Handpiece with Box Technical Training DVD Tip Initiation Kit 940 only Whitening Handpiece Wall Mount Battery Pack LaserWhite 20 Whitening Gel Kit pack of 5 ezlase Window Cleaning Kit 200 um core diameters
5. INTERVAL button to adjust pulse interval Press right arrow to increase pulse interval and left arrow to decrease Laser OFF time allows tissue cooling generally with less thermal effect Fig 24 PULSE E 20 PROCEDURES Button Figure 25 The system has 15 pre sets to be programmed by the dentist All of them can be customized to your preference Ten of the fifteen pre sets have been labeled for specific clinical indications Please refer to the indications for use section for review of the clinical indications In order to customize parameters for the particular clinical procedure gt Adjust parameters on the main Menu gt Select PROCEDURES Mode gt Press and hold for 2 seconds the selected Procedure Parameters will be changed and memorized for that Procedure 26 5400003 REV R 12 10 MENU Button Figure 26 By pressing the MENU button you can get access to several system settings gt Aiming Beam 5 levels of brightness adjustment gt Beep Sound 3 levels of sound adjustment gt Service Mode accessible only by authorized Biolase Service Hepresentatives BIOLASE 0 MENU SETTINGS PROCEDURES 2 0W 50 50 PRESETS GINGIVECTOMY TROUGHING S SERVICE CURETTAGE Fig 25 Fig 26 TURN THE UNIT OFF Place handpiece back on handpiece holder CAUTION Verify that fiber optic tubing assembly is not twisted once the handpiece is returned to the holder The fiber m
6. disconnect the footswitch cable at either end when the laser is firing WARNING Before turning off the power switch at the rear of the ezlase device disconnect the footswitch cable at either end Note that the power switch must be turned ON when charging the footswitch WARNING When aiming beam is not present or has significantly different shape than shown in Figure 20 and 21 change the tip and inspect clean the protective window see Section 8 23 POWER Buttons Figures 8 and 19 Press POWER arrows to adjust power level Press right arrow to increase power level or press left arrow to decrease power level Average Power Display This icon is shown only when the system is in the pulsed mode and presents the calculated value of the average power based on the Power setting Pulse Length and Pulse Interval LASER MODE Button LASER MODE Button graphically indicates whether system is in Continuous Mode or in Pulsed Mode Only when the system is in Pulsed Mode both Pulse Length and Pulse Interval active displays are present as well as Average Power window They are not shown in Continuous Mode In Continuous Mode laser power is constantly delivered when in Ready Mode and footswitch is activated In Pulsed Mode laser radiation is delivered in repetitive pulses controlled by Pulse Length and Pulse Interval settings One touch of the Laser MODE button will allow switching between Pulsed and Continuous Modes PULSE MOD
7. qty 30 300 um core diameters qty 30 400 um core diameters qty 30 300 um core diameters qty 30 400 um core diameters qty 30 200 um core diameters qty 30 APPENDIX C ezlase LIMITED WARRANTY For warranty information refer to separate equipment warranty EZ IASE BIOLASE 9 0 05 5 0 20 5 PULSE INTERVAL PULSELENGTH BIOLASE BIOLASE biolase com NASDAQ USA BIOLASE Technology Inc 4 Cromwell Irvine CA 92618 949 361 1200 Europe MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 www mt procons com 2007 BIOLASE9 5400003 REV R 12 10 EZIASE om
8. E f 0 20 ms ENERGY START PULSEINTERVAL Fig 22 Fig 23 UE gt H 0 05 ms ENERGY TOTAL 24 5400003 REV R 12 10 ENERGY Button Figure 22 ENERGY function can be used when total amount of laser energy in Joules Power Watts x Time Seconds needs to be calculated Press the ENERGY button to enter the Energy Mode and toggle the unit between ENERGY TOTAL ENERGY START and OFF functions ENERGY TOTAL allows the user to pre set the amount of laser energy to be delivered when footswitch is pressed Laser stops when energy counts to zero and value re sets This way it works as a timer For example if 10J is entered and laser power is set at 1W laser will stop firing after 10 seconds ENERGY START allows to calculate the total amount of laser energy delivered to the tissue It can be re set to zero from this screen or by going to Standby mode PULSE LENGTH Button Figure 23 While in the Pulse Mode press PULSE LENGTH button to adjust pulse length Press right arrow to increase pulse length and the left arrow to decrease Laser ON time is when the actual energy is applied Longer generally more thermal effect less bleeding Press PULSE LENGTH again to exit to the Main Menu with modified setting Press BACK to exit to the Main Menu This action will not change any settings PULSE INTERVAL Button Figure 24 While in the Pulse Mode press PULSE
9. STRUCTIONS Follow these safety instructions before and during treatments gt All operatory entrances must be marked with an appropriate laser warning sign included with shipment gt Do not operate in the presence of explosive or flammable materials Flammable anesthetics or oxidizing gases such as nitrous oxide N2O and oxygen should be avoided Solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before laser is used Attention should also be drawn to the danger of ignition of endogenous gases gt All persons present in the operatory must wear protective laser eyewear CAUTION Periodically inspect laser eyewear for pitting and cracking NOTE For replacement or additional protective laser eyewear please contact your authorized dealer gt Do not look directly into the beam or at specular reflections gt Never direct or point the beam at anyone s eyes gt Press STANDBY Standby button on the control panel before turning off unit gt Always press STANDBY on the control panel before exchanging handpieces or disposable tips gt Move the toggle switch located on rear panel to OFF position before leaving unit unattended DANGER Do not open unit housing at anytime Danger from optical radiation may exist WARNING Be aware that the metal plastic cannula on the tips may become hot during use Avoid contact of the cannula with any tissue
10. Section8 38 Annual Maintenance 38 Daily Maintenance 38 Contamination Control Procedures 38 Cleaning Instructions for Handpiece and Fiber Optic 39 Steam Sterilization for Handpiece and Single Use Tips 39 Cleaning the ez ase Whitening Handpiece 40 le et e i a 40 5 41 Section9 CALIBRATION 41 Calibration 41 Section 10 SOFTWARE SPECIFICATION 41 Section 11 TROUBLESHOOTING 42 Appendix A 5 44 B SPARE PARTS AND ACCESSORIES 46 C ezlase LIMITED WARRANTY 47 2 5400003 REV R 12 10 INTRODUCTION The 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 ezlase utilizes a solid state diode as a semiconductor source of invisible infrared radiation The energy is delivered to the treatment site via flexible fiber connected at one end to the laser source and the other end to the handpiece Various types of the single use tips were designed and optimized for different applications The device is activated by means of footswitch The ezlase is a p
11. Spool Holder Installation 104 19 w buna W PIN EE A EM Turn the ezlase ON OFF EE s es be y es READY STANDBY 5 Navigation Wheel c LL POWER BUNGKS 2555 x wo wea foe Average Power LASER MODE ENERGY Button PULSE LENGTH BURON arearen errenten PULSE INTERVAL PROCEDURES dare ee MENU nc ae qur the OFF us iai icon suwa use DR CR D aa SPECIFICATIONS CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Contraindications Warnings and Precautions Prescription Statement Eyewear Anesthesia Adjacent Structures ua 2 2 2 ERB Was a Plume Removal ClinicalUse 31 lC 31 Section7 CLINICAL APPLICATIONS 32 la NG OM P 32 Table of Indications for 5 32 Whitening System Procedure 34 Pain Therapy Procedure 35 Recommended Pre sets 36
12. area middle area where main of the spot laser power is applied 22 5400003 REV R 12 10 Footswitch When footswitch is pressed and the laser fires the LASER FIRING icon will flash and a beeper will sound indicating that laser energy is present An amber LED will be lit as well on the top of the front panel When the footswitch is not pressed the LASER FIRING icon will go blank indicating that laser energy is not present NOTE Charge footswitch battery for 4 hours when first connected Power switch should be ON Before disconnecting the footswitch cord after each charging re cycle power by turning power switch OFF and ON to re set wireless communication When the unit is on standby mode press down on footswitch and hold Then unplug footswitch cord from the unit While holding down the footswitch blinking Blue LEDs confirm presence of wireless comunication The cable can be removed from the footswitch at this point Footswitch will operate for about 1 week without re charge so long as power switch is maintained in the position If you have more than one ezlase unit in your facility you must observe the following precautions WARNING DO NOT establish wireless communication with more than one ezlase footswitch combination simultaneously Instead establish wireless communication sequentially one pair at a time See note above for instructions on establishing wireless communication WARNING DO NOT
13. ative 40 5400003 REV R 12 10 STORAGE The ez ase should be stored in a cool dry place when not in use Storage temperature 15 C 35 59 F 95 relative humidity 1096 7096 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 CAUTION Make sure the distal end of the Handpiece shaft is protected from dirt with the protective tip plug and Handpiece The ez ase was shipped inside a custom shipping box Please save and store the box in a cool dry place SECTION 9 CALIBRATION CALIBRATION SCHEDULE Calibration procedure is recommended to be performed every 12 months in order to maintain the required accuracy of output power versus displayed power Annual calibrations can be performed ata certified depot repair facility Call Biolase Service at 1 800 321 6717 or your Authorized Service Representative to schedule an appointment SECTION 10 SOFTWARE SPECIFICATION Biolase respects the intellectual property of others and we ask our users to do the same ez ase software is protected by copyright and other intellectual property laws This product includes software developed by Biolase Technology Copyright 92007 Biolase Technology 41 SECTION 11 TROUBLESHOOTING Table 1 shows the list of Error messages which can be fixed by the user in most cases If Corrective Action does not help re power the laser If the Er
14. ay break if it is twisted gt Press the ON OFF button to turn display OFF gt Switch the Power Switch to OFF position if laser system will not be used for a long period of time gt Put the fiber cable on the spool 2f SECTION 5 ezlase SPECIFICATIONS GENERAL Dimensions Weight ELECTRICAL Operating Voltage Frequency External Fuses Main Control On Off Controls Remote Interruption LASER Laser Classification Medium Wavelength 28 5400003 REV R 12 10 W x H x D 3 5 x 7 0 x 2 5 8 5 x 18 x 6cm 2 lbs 1 0 kg 100 to 240 at 2A 50 60 Hz Power Switch Keypad Button Emergency Stop Remote Interlock Connector IV 4 GaAlAs InGaAsP 810 15 nm or 940 15 nm Max Output Power Power Accuracy Power Modes Pulse Length Pulse Interval Pulse Repetition Rate Fiber Tips Diameter NOHD Beam Divergence Fiber Cable Length OTHER LIGHT SOURCES Aiming Beam 7 Watts Q 940nm 4 5 Watts 810nm 20 Continuous Pulse Modulation 0 06 ms 10 sec 0 06 ms 10 sec up to 10 KHz for reference 200 300 400 um 11 8 meters 8 22 degrees per side angle 5 feet 1 524 meters Laser Diode max 3 mW 630 670nm class 3B The following ComfortPulse length and interval settings will result in the ranges specified 0 05 ms 0 07 ms 0 10 ms 0 14 ms 0 20 ms 0 28 ms SECTION 6 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS CONTRAINDICATIONS
15. be in use for a long period of time READY Button Once the power switch key access and ON OFF Key are set to the ON position the READY button on the keypad must be pressed to enable the footswitch The aiming beam will be lit to indicate that the system is ready for use Footswitch The ezlase will not emit laser energy until the user presses down on the footswitch The footswitch is designed to work using wireless technology One full charge of the battery will allow approximately one week of regular operation When the battery is low a permanent cable should be connected to resume operation For charging unit must be turned ON It takes 4 hours of charging time for full battery capacity NOTE is recommended to recharge the battery overnight every week Figure 4 Footswitch Cable Figure 3 Wireless Footswitch 8 5400003 REV 12 10 Remote Interlock This feature allows the device to be connected to a remote sensor which will ____ prevent its operation when triggered i e Figure 5 Remote Interlock by opening a door The electric cable from connector this connector should be wired to a normally closed switch which will turn the laser OFF when the switch is open This feature is overridden when the plug is not connected Emergency Stop Press the red Emergency Laser Stop button to instantly turn off the unit Press Laser Stop button again to RESET Functional Display The System Colo
16. conditions stated with the indications for use Affected muscles and or joints have to be exposed to an adequate level of therapeutic energy over a short period of time to be effective Two main therapeutic power settings are recommended for these treatments gt P1 2 75 W place the handpiece in contact with the skin and apply laser energy for 10 minutes continuously gt P2 5 50 W place the handpiece approximately 2 3mm away from the skin surface non contact Exposure time remains the same at 10 minutes continuously Patients should be monitored for discomfort If discomfort is reported at any time during the treatment there are several options a decrease the power setting to 2 75W or b defocus the energy by moving the handpiece further away from the skin or stop treatment Some patients may require more than one laser application or series of treatments before significant improvement is reported Repeat as necessary and monitor progress of the patient s condition throughout the treatment 35 RECOMMENDED PRE SETS WARNING Always use clinical judgment when selecting power pulse length and pulse interval parameters to ensure optimal clinical results The recommended settings apply only to the 300 and 400 um tips To set your ezlase system to the Pre Set values make the necessary changes on the main screen Enter the Procedures menu by selecting the Procedure button Scroll to the desired procedure na
17. dpiece and 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 ez ase Fiber optic Delivery System Wear protective latex gloves when handling the contaminated delivery system To clean fiber cable wipe the entire cable including shaft with cotton gauze and chemical disinfectant Keep window intact If window is dirty clean with the cotton swab moistened with alcohol To clean the handpiece gt Carefully remove tip from the handpiece and dispose in a sharps container gt Carefully remove the handpiece from the fiber optic cable see Section 3 gt Wipe entire handpiece outer surface with cotton gauze and chemical disinfectant gt Soak gauze in chemical disinfectant and then wrap handpiece in gauze gt Leave handpiece wrapped in gauze for 10 minutes gt Remove disinfectant gauze and wipe handpiece dry with dry gauze Steam Sterilization for Handpiece and Single Use Tips Before sterilization the handpiece must be cleaned and disassembled The process of thermal sterilization with saturated steam under pressure is carried out in an autoclave To perform this procedu
18. ezlase it s 50 easy User Manual 5 Section 1 Section 2 Section 3 INTRODUCTION 3 4 Installation 6 oua rir dae var se 4 Facility Requirements 4 Electrical SUDDly ace E RE we 4 Environmental Requirements 4 SAFETY aca cR RR E DRE cul AC 5 eui J uyu 5 Salety Instrictlols 33 sessi eana XE pas agua 5 Safety Features 6 Energy spe D 6 System Power Switch 7 KEY Dm 7 READY 8 HD 8 Remote 9 Emergency SIOP 9 Functional DISDlay ce 2322 nxor ipe RR Rar Rn 9 Safety Classification 9 EQUIPMENT DESCRIPTION 10 CIC PPP 10 P r 8 10 Surgical Delivery System 10 eziase Surgical Handpiece Assembly 10 eziase Single use Tips 16 edis L e uz Sasa EE Sa 16 eziase Whitening 17 5400003 REV R 12 10 Section 4 Section 5 Section 6 OPERATING INSTRUCTIONS System Setup Optional
19. fter each patient use It is recommended to dispose of them in a sharps container Tips should be steam sterilized prior to use For instructions on cleaning and sterilization of the handpiece and tips refer to Section 8 ezlase Surgical Handpiece Assembly To disconnect handpiece from the fiber optic assembly 1 Take the handpiece body in one hand amp the shaft in another Figure 14 2 Push two buttons on the handpiece shaft 3 pull handpiece with the ring to seperate To connect the Handpiece to the Fiber optic cable push the handpiece on the fiber shaft until it clicks on and is secured at connected position 10 5400003 REV R 12 10 FRONT PANEL Figure A Fig 8 Item Item Description 1 ON OFF Turns the controls and display on and off 2 READY Allows energy delivery when footswitch is pressed 3 READY LED Indicates unit is in READY mode 4 STANDBY Does not allow energy delivery 5 STANDBY LED Indicates unit is in STANDBY mode 6 EMISSION LED Indicates emitting of the laser power 7 WIRELESS Indicates communication with footswitch 8 NAVIGATION WHEEL Allows to select functions and adjust parameters BIOLASE EZ IASE 7 BIOLASE 7 0 W 0 5 ENERGY START PULSEINTERVAL Figure A Figure B MAIN MENU Figure B Item Item Description 1 AVERAGE POWER DISPLAY Indicates average power delivered 2 MAXIMUM POWER DISPLAY Indicates maximum allowable delive
20. h a disposable non sterile protective cover for single patient use The handpiece requires cleaning before and after each patient treatment For instructions on cleaning the handpiece refer to section 8 ezlase Whitening Handpiece LaserWhite 20 Disposable Shield The area of Laser Energy Output is 35mm x 8mm 2 8 cm Spot Size To disconnect the handpiece from the fiber optic assembly 1 Take the handpiece body in one hand amp the shaft in another Figure 13 2 Push two buttons on the handpiece shaft 3 Pull handpiece with the ring to separate To connect the Handpiece to the Fiber optic cable push the handpiece on the fiber shaft until it clicks on and is secured 17 Fiber Shaft Protective Window EF lt Handpiece e o Figure 14 Disconnecting the Handpiece push both buttons Tip Assembly m Figure 15 Disconnecting the fiber Tip twist first counter clockwise mm Right Figure 17 Bending the tip canula SECTION 4 OPERATING INSTRUCTIONS SYSTEM SETUP gt Place unit in a clean dry and well ventilated area gt Verify power switch is in OFF position gt Connect power cord to power connector on the unit and plug into wall outlet CAUTION Do not cover or block ventilation channels These channels provide air flow path to cool unit CAUTION Do not bend fiber optic cable sharply or the fiber will break gt Remove protective ti
21. he Right gt arrow and Enter buttons on the Navigation Wheel to select the numbers gt System will go to the Main Menu If code is selected wrong re enter the code gt Disconnect and press the footswitch Blue LEDs will light to confirm presence of wireless communication BIOLASE BIOLASE 21 ON OFF Button Press ON OFF button At this time the unit will go to sleep mode or turns ON and performs self diagnostic 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 At this time system fan will turn ON and pressing the footswitch will activate laser radiation There is a 2 sec delay between switching to READY mode and ability of system to emit a laser beam This is evidenced by the delay in the appearance of the red aiming beam Navigation Wheel The Navigation Wheel can be used instead of the touch screen General approach to navigate is e Up and Down arrow buttons are used to scroll between functions Left and Right arrow buttons are used to increase decrease values e Enter button is used to select function or enter the value Fig 20 Fig 21 When the tip When footswitch is straight the is pressed laser aiming beam power is applied will look like a and beam circle outlining will fill the the
22. l requirements Always start treatment at the lowest power setting for that specific indication and increase as required Closely observe and monitor clinical effects and use your judgment to determine clinical parameters and approach for the treatment Make appropriate power pulse length and interval adjustments to compensate for varying tissue compositions density and thickness BIOLASE assumes no responsibility for parameters techniques methods or results Training Only licensed professionals who have successfully completed the 2 in service training provided by a Biolase Laser Specialist or Authorized Representative 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 31 SECTION 7 CLINICAL APPLICATIONS INTRODUCTION To efficiently remove tissues it is important to understand the nature of the ez ase device Please review this section carefully practice on model tissues and attend diode laser training seminars before using this device in a clinical situation TABLE OF INDICATIONS FOR USE Use of the ezlase device may be appropriate for the following indications for use EINA ANAKIN gt gt wy Ka o ALI Y
23. me and press and hold the button for 3 seconds when the new values are saved NOTES 1 These pre sets are recommendations based on clinical feedback from experienced laser dentists 2 300 um tips are recommended for removing thin tissue layers 400 um tips are recommended for removing fibrous tissue 3 Always use your clinical judgement when selecting power pulse length and pulse interval parameters to ensure optimal clinical results At all times observe clinical effects and adjust parameters accordingly 36 5400003 REV R 12 10 Ul S135M00d 9608 M 80 9 55 G3L1O035NI ONINS3HLONIT 9004 SU G 0 SW 90 M60 7 enssi 0 NMOHD 14 ejqejreAe you AWOLOd1Nd enssi sul OI sul OI M 80 pue jo STH OOd Oldid z AH3AOO3H sul Q L su Q Buunp 1ue duu jo eunsodx3 INV1dWI enssi enbul SWOQ L Sul Q L M 0 qng JO AINOLO3N3H8HH sdoig 10 senss suu 9 0 SU 670 8 HOS JO NOISIOX3 enssi pesoJooN SU GO SW 9 0 MOL JO ADVLLAYND SsuoisseJduJ UMOID Su 0 sw 071 0 Jo ONIHDNOYL Guuno1uooey 9118UIS0 SW 90 0 SW 0c 0 MO 10 enssi o14yd
24. ngths Appendix B WARNING DO NOT autoclave more than once To connect the tip insert it into the handpiece orifice and tighten by turning clockwise Bend the metal canula according to the procedure requirements NOTE 7o provide proper laser operation connect tips after the handpiece 15 connected CAUTION Do not bend tips with sharp angle it will break the tip Figure 1 7 If the red aiming beam is not present in READY mode replace the tip INITIATION ezlase 940 parameters and procedures LASER PARAMETERS uU M 400 1 4 E PROCEDURAL STEPS 300 1 0 SUGGESTIONS Do not push the tip into the block surface Allow it to sink in with its own weight Steps above may be repeated on the same tip if the initiation is lost Step 1 Set the ezlase to the appropriate setting for the particular tip using the table above as a guide Step 2 Touch the ezlase tip to the surface of the initiation block without firing Step 3 Fire the laser allowing the tip to sink into the block Pull the tip out when the metal canula touches the block still firing until just before the tip is out of the block Step 4 Fire the laser into the air once you will see a white flash or the tip will glow Hepeat Steps 1 4 to ensure the tip Is initiated 16 5400003 REV R 12 10 ezlase Whitening Handpiece Optional NOTE The Handpiece is reusable and equipped wit
25. ospedA H AINOLO3AIDNIO Ov 6 95879 5145 3dd HON4INNOIH8 SECTION 8 MAINTENANCE ANNUAL MAINTENANCE The ez ase should be serviced annually by a qualified trained and certified technician Annual calibrations can be performed at a certified depot repair facility Call Biolase Service at 1 800 321 6717 or your Authorized Service Representative to schedule an appointment Please contact Biolase Service at 1 800 321 6717 or your Authorized Representative to discuss Extended Service Contracts and Annual maintenance options DAILY MAINTENANCE Use disinfectant to wipe down the front panel of the ez ase system after each procedure Use peel off clear covers supplied with the system Do not use bleach or abrasive cleansers Check and clean if necessary the protective window of the fiberoptic shaft with cotton swab moistened with alcohol Check and Clean window CONTAMINATION CONTROL PROCEDURES The contamination control suggested for the ez ase handpiece and tips are the steam sterilization method However before sterilization the ez ase reusable handpiece should be carefully cleaned per the following procedure NOTE The fiber optic cable and Handpiece and single use tips are delivered from the manufacturer as non sterile NOTE Tips are designed to withstand a single sterilization cycle and should be disposed of after single use in a sharps container 38 5400003 REV R 12 10 Cleaning Instructions for Han
26. p plug and handpiece from fiber shaft gt Verify visually that protective window is clean If not blow off any residue or dirt with compressed air For better results use cotton swab moistened with alcohol gt Carefully connect the Handpiece Figure 13 gt Insert the selected tip and tighten it clockwise until snug gt Wind excess fiber optic cable on to fiber spool clockwise gt Place handpiece in handpiece holder Figure 12 CAUTION Tips are designed for single patient use only Use a new tip each time ez ase is used WARNING Never point the fiber optic at the eyes WARNING Never operate the laser without a fiber tip attached WARNING persons present in the operatory MUST wear protective laser eyewear when laser is in operation 19 OPTIONAL SPOOL HOLDER INSTALLATION gt Slide Spool Holder into the rear of the ezlaseT gt Route fiber cable through the bottom of the Spool Holder gt Spool the fiber cable in a clockwise direction in Spool Holder 20 5400003 REV R 12 10 Turn ON the ezlase gt Connect power cord to power connector on the unit and plug into wall outlet gt Connect footswitch cable to the unit and to the footswitch gt Turn power switch to ON position ezlase Welcome screen will be displayed gt Enter the three digit key access code using the touch screen or system navigation wheel Access Key Code is 123 gt Also you can use t
27. r TFT Display with Touch Screen and LED indicators on the control panel show the functional conditions of the system SAFETY CLASSIFICATION The following safety classifications are applicable to the device Figure 6 Emergency Laser Stop gt Laser Radiation Class 4 gt Type of protections against electrical shock Class 1 gt Degree of protection against electrical shock Type B Applied Part gt Not protected against water ingress Ordinary Equipment gt Not suitable for use in presence of flammable anesthetic mixture gt Operation Mode Continuous Operation SECTION 3 EQUIPMENT DESCRIPTION GENERAL The eziase consists of two permanently connected components gt Console gt Delivery System CONSOLE Figures 8 12 Console has Control Panel Touch Screen and Keypad in front and disconnectable Base attached at the bottom back part of the Console SURGICAL DELIVERY SYSTEM NOTE fiber optic cables handpieces amp tips are shipped non sterile The ezlase Delivery System with surgical handpiece consists of gt Fiber Optic Assembly gt Handpiece Figures 13 14 gt ezlase Disposable Tips Figures 15 16 17 NOTE The fiber optic cable is permanently attached to the ez ase Console The Handpiece is a reusable accessory The Handpiece will require cleaning and sterilization before and after each patient treatment Tips are intended for single use only and should be disposed a
28. re follow these step by step instructions gt Place the handpiece or tip inside a single wrap self seal autoclave pouch Remove autoclave tray and place pouch s on the tray 39 gt Place tray in the autoclave chamber and sterilize using a clinic validated cycle The recommended autoclave cycle for the is Temperature 250 F 12190 Pressure 15 PSI 1 bar Time cycle 20 minutes gt At the completion of the autoclave cycle remove the tray and let the handpiece and or tip cool and dry Although Biolase Technology has Validated the parameters for the recommended autoclave sterilization procedure it is the responsibility of the customer user to properly validate his or her autoclave sterilizer CLEANING THE EZLASE WHITENING HANDPIECE The 2 Whitening Handpiece is sold together with disposable protective caps The handpiece and protective cap are not autoclavable The protective cap is intended for one time use only and therefore cannot be cleaned and reused To clean the Whitening Handpiece wipe down the handpiece with gauze and isopropyl alcohol TRANSPORTATION The ez ase is susceptible to damage if not handled properly The unit should ALWAYS be handled carefully and never banged jarred jolted dropped or knocked Do not transport the unit unless it is completely packaged inside of its shipping box If you have any questions regarding transportation please call your local Represent
29. red power 3 POWER up down Allows adjustment of delivered optical power 4 MENU Selects user function 5 PROCEDURES Selects pre set procedure parameters 6 PULSE LENGTH up down Allows adjustment of laser ON time 7 PULSE INTERVAL up down Allows adjustment of laser OFF time 8 LASER MODE Allows switching and indicates laser operation mode continuous or pulsed 9 ENERGY DISPLAY Allows setting and displays amount of laser energy that has been delivered or to be delivered Fig 9 Power Switch Emergency Stop Service Connector Remote Interlock Connector Footswitch Connector Power Connector Stand Fig 10 Handpiece Fiber Spool Fig 11 Regulatory Compliance and Description Labels See Appendix A Power Switch G3 X A Fiber Outlet located on bottom THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO 50 DATED 26 JULY 2001 5200191 REV B Compliance Label Fig 12 ezlase sao Tag Control Panel BIOLRSE DNE 5 6 W NA Standby 7 0 OM MEI 0 05 ms 0 20 ms PULSEINTERVAL PULSELENGTH imi Touch Screen pc Handpiece Handpiece Holder BIOLASE ezlase Single Use Tips The ezlase tips are single use accessories which are provided in three core diameters 200um 300um and 400um and different le
30. rescription device that is indicated for professional use by dentists and hygenists under the supervision of a dentist The use of this device requires proper clinical and technical training This manual provides instructions for dental professionals that have completed the appropriate training by an authorized Biolase Laser Specialist CANADA This device must be installed and operated according to the guidelines of CAN CSA Z386 92 Laser safety in a health care facility When used and maintained properly the ez ase will prove a valuable addition to your practice Please contact Biolase Service at 800 321 6717 for any service needs This refers only to states that allow hygienists to use a class medical laser device on patients 4 SECTION 1 INSTALLATION INSTALLATION INSTRUCTIONS Upon request your local authorized representative will unpack and install the 2 Refer to the Quick Start guide for step by step installation instructions The ez ase system includes the following Console Delivery System One Handpiece one Fiber Assembly attached to the Console User Manual 3 pairs of Laser Safety Glasses Goggle Footswitch with cord Power Supply with Cord Remote interlock assembly gt gt gt gt p Peel off clear covers gt Single use tips gt Tip Initiation Kit 940 only gt Technical Training DVD 1 Handpiece with box Use proper care prior to transporting
31. ror is still not cleared after re powering please call Service at 800 321 6717 or your Biolase Authorized Representative Table 1 REASON Footswitch not available Footswitch shorted Remote Interlock Open Remote Interlock Open Emergency Pressed Emergency Pressed Diode Current Error Output is out of Specs Thermistor Error Thermistor Error Overtemperature System too hot 42 5400003 REV 12 10 NOTE For all Error Messages not listed in the table re power the system and if the Error is not cleared call Biolase Service at 800 321 6717 or your Biolase Authorized Representative FIX CORRECTIVE ACTION 1 Press READY button Footswitch not in Ready mode 2 Connect Footswitch cable 3 Charge Footswitch battery 1 Disconnect Interlock Check Remote Interlock l 2 Close Interlock switch Press E Switch again Press E Switch again Calibration Error Call Service for laser calibration Call Service for laser Call Biolase re calibration Wait to cool down Wait for 5 10 min for laser to cool down APPENDIX A LABELS A 1 IDENTIFICATION BIOLRSE 4 Cromwell Irvine CA 92618 taal sn Location Back Panel Figure 11 6 EAA CAN CSA C 222 60111 5400016 Made in the USA b A 2 FOOTSWITCH EN Location Back Panel Left Side Engraved LASER APERTURE Location Back Panel Right Side A 4 REMOTE INTERLOCK Location Left Side Figure 9
32. th Pain Therapy Temporary relief of minor muscle and joint pain and stiffness or muscle spasm minor arthritis pain or muscle spasm minor sprains and strains and minor muscular back pain the temporary increase in blood circulation the temporary relaxation of muscle BIOLASE assumes no responsibility for parameters techniques methods or results Physicians must use their own clinical judgment and professionalism in determining all aspects of treatment technique proper power settings interval duration etc 33 TOOTH WHITENING PROCEDURE The following items are required to perform teeth whitening gt ezlase 940nm diode laser gt Whitening Handpiece sold separately gt LaserWhite 20 Whitening Gel Kit sold in packs of 5 Detailed step by step instructions and contraindications precautions and warnings for tooth whitening are provided with the LaserWhite 20 Whitening Gel Kit Tooth whitening can only be performed with the ezlase 940nm diode laser The ezlase 810nm diode laser has not been validated for use with the Whitening Handpiece for teeth whitening at this time 34 5400003 REV R 12 10 PAIN THERAPY PROCEDURE Requires the ezlase Whitening Handpiece The ezlase 940nm diode laser in conjunction with the ezlase Whitening is designed to provide near infrared laser energy to tissue for the purpose of elevating the temperature and providing for temporary relief of pain
33. the unit Refer to section 8 in this manual for instructions FACILITY REQUIREMENTS Electrical Supply 100 240V gt 1 5 50 60Hz Environmental Requirements gt Temperature 20 25 gt Humidity 15 9596 5400003 REV R 12 10 SECTION 2 SAFETY PRECAUTIONS Failure to comply with precautions and warnings described herein may lead to exposure to dangerous optical radiation sources Please comply with all safety instructions and warnings CAUTION Federal law restricts this device to sale by or under the order of a dentist or physician or other licensed practitioner 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 designed and tested to meet the requirements of electromagnetic electrostatic and radio frequency interference standards However the possibility of electromagnetic or other interference may still exist Relocating of the device may help to eliminate the interference CAUTION Laser delivery settings entered in the standby mode be retained in memory once the unit is put into the ready mode and will become the default settings Always ensure that the proper laser settings set before the 2 product is used in a clinical setting SAFETY IN
34. ways 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 Exercise extreme caution when using this device in areas such as pockets 30 5400003 REV R 12 10 cavities or channels such as 3rd molar sockets where critical structures i e nerves vessels could be damaged Do not proceed with using the laser if visibility is limited 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 suction as required to maintain a clear field of vision during treatment Do not use the 2 if you cannot clearly see the treatment site Plume Removal Special care must be taken to prevent infection from the laser plume generated by vaporization of virally or bacterially infected tissue Ensure that appropriate protective equipment including high speed suction to remove the plume appropriately filtered masks and other protective equipment is used at all times during the laser procedure Clinical Use Use your clinical judgment to determine all aspects of treatment including but not limited to the laser treatment protocol technique power settings pulse duration and interval settings mode of operation as well as the accessories e g tip type and other procedura
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