User Manual
Contents
1. 29 Prescription Statement 29 zr Y YY ass 29 e E Rege prie 29 ________ _ __ _ 6___ ____ 6 29 30 Plume TACO uuu uu 30 6 2 u E 30 _____ 30 Ts SMMC all ADDIIGSHONS uuu 31 LA ON TP 31 r WICC ATOMS 31 7 3 Soft Tissue Surgery and Other Dental Use 32 Tip Initiation Parameters and Method Not required if using pre initiated tips 32 Epic 10 User Manual pg 2 5400321 Rev H Pre programmed Settings for Dental Procedures 33 7 4 Table of Pre Programmed SettingsS nnne 34 5 Teeilh Whitening TP FOCCOUN 35 LO PRN ir 35 Pain Therapy Adverse Ell e018_ u u u a 36 Pain Therapy Warnings and Precautions 36 Recommended Use 37 Using the Deep Tissue Handpiece a nnns 372. Figure 2 4 Insert the fiber tip into the handpiece only when the handpiece is connected to the fiber and twist clockwise until snug Correct Bend Incorrect Bend Figure 2 6 When installing the tip make sure it is Figure 2 7 Bending the tip cannula seated properly thread correctly When the aiming beam is not present or has a significantly asymmetrical shape gt tips that require initiation change the tip WARNING gt tips that do not require initiation change the tip press to bypass initiation requirement Epic 10 User Manual pg 9 5400321 Rev H 2 7 SURGICAL HANDPIECE ASSEMBLY gt connect the Handpiece to the fiber optic assembly push the Handpiece on the fiber shaft until it clicks on and is secured at connected position Fiber Shaft Protective Cap Handpiece gt c Figure 2 8 Connecting the Handpiece to the fiber optic assembly Figure 2 9 Surgical Handpiece Assembly fully assembled gt Disconnect the handpiece from the fiber optic assembly Figure 2 10 by 1 Taking the handpiece body in one hand and the shaft in the other 2 Pushing the two buttons on the Fiber Shaft 3 Pulling the handpiece with the ring to separate Figure 2 10 Disconnect the Handpiece from the fiber optic assembly by pressing both buttons at the base of the Fiber Shaft Epic M10 User Manual 5400321 Rev H 2 8 WHITENING CONTOUR HANDPIECE OPTIONAL ACCES
3. COMPLIANCE STATEMENT This statement applies only to the wireless portion of the device This equipment has been tested and found to comply with the limits 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 in accordance with 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 can be determined 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 e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help CAUTION Federal Law restricts this device to sale by or on the order Ell He of a dentist or physician or other licensed medical practitioner Intertek 9800165 Conforms to AAMI ES60601 1 IEC60601 1 IEC60601 2 22 IEC62366 80601 2 60 IEC60825 1 Certified to CSA C22 2 No 60
4. the footswitch is engaged the ability to change the settings is blocked READY or STANDBY is displayed in the lower right hand corner of the display screen 4 7 READY MODE When entering READY mode the laser console fan will turn on and pressing the footswitch will activate laser radiation There is a two 2 sec delay between switching to READY mode and the ability of the laser console to emit a laser beam Epic 10 User Manual pg 22 5400321 Rev H The aiming beam is on only when the laser is in READY mode or when adjusting the brightness of the beam while in Settings mode If the aiming beam is not visible in either instance remove the handpiece and confirm the beam is actually on by NOTE shining the end of the trunk fiber on plain non reflective surface DO NOT look directly at the output end of the trunk fiber If the aiming beam 15 not on turn off the laser console then remove and re install the trunk fiber see Section 2 6 If the aiming beam is still not on turn off the laser console and call Biolase Service 4 8 WIRELESS FOOTSWITCH The wireless footswitch is powered by two 2 AAA batteries When the wireless footswitch is pressed in READY mode and the laser fires a beeping sound indicates that laser energy is present A green LED will begin flashing and a blue LED will light at the top corners of the laser console confirming the footswitch and laser are paired In the top left corner of most scre
5. Safety Precautions for Lithium lon Battery Packs 51 APPENDIX D ACCCSSONES T E aaa o4 APPENDIX E Electromagnetic Compatibility 55 APPENDIX F Wireless Equipment Compliance Statement 59 Epic 10 User Manual pg 3 5400321 Rev H INTRODUCTION The Epic 10 diode laser is a surgical and therapeutic device at the cutting edge of technology designed for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing temporary relief of minor pain The Epic 10 utilizes a solid state diode as a semiconductor source for 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 single use disposable tips are designed and optimized for different applications The device is activated by means of a wireless footswitch This is a prescription device that is indicated for professional use only by licensed medical and dental practitioners The use of this device requires proper clinical and technical training This manual provides instructions for those professionals that have completed the appropriate training When used and maintained properly the Epic 10 will prove a valuable addition to y
6. 6 Recycle the used Lithium lon battery as regulated Do not throw it in a trashbin 7 Screws to remove Battery cover Figure 8 2 Battery Cover Bottom of Console Figure 8 3 Battery Pack Connector Wire NOTE Only use the battery pack supplied by BIOLASE The battery pack is a separate accessory BIOLASE p n 6400457 8 4 CHANGING THE WIRELESS FOOTSWITCH BATTERIES The wireless footswitch is powered by two AAA batteries When the batteries are low a warning message will appear on the touchscreen indicating that the batteries need to be replaced To replace the batteries unscrew the battery cover on the underside of the footswitch Section 4 remove the old batteries and install the new ones replacing the cover when done Dispose of the used batteries as regulated do not throw them in a trash bin Do not press push touch the Pairing Button Figure 8 4 while changing the batteries as this will disrupt the pairing of the laser console and footswitch Epic 10 User Manual pg 41 5400321 Rev H Pairing Button Internal View Figure 8 4 Replacing the batteries may disrupt the pairing of the laser console and footswitch If you find the wireless communication has been interrupted reestablish pairing by following the instructions provided in Section 4 To ensure the longevity of the battery power only BIOLASE supplied batteries are NOTE recommended as replacements BIOLASE p n 6400463 these are indus
7. 0 01 5 20 Vestibuloplasty Tissue retraction for 2 Troughing 1015 105 50 impressions Laser soft tissue 0 Curettage curettage 0 2 ms 0 1 ms 30 Fibroma removal Excisional and incisional biopsies Gingival incision 4 Excision and excision 0 2 ms 0 1 ms 30 Operculectomy Oral papillectomies Incision and drainage of abscess HM Frenectomy F renotomy Frenectomy F renotomy CP2 20W 108 10 1015 ImplantRecovery Recovery Implant Recovery 022 4W 1 12 W 1 1015 50 _ Sulcular debridement removal of diseased infected inflamed and necrosed soft tissue the periodontal pocket to Perio Pockets improve clinical indices 1 0 ms 1 0 ms 50 including gingival index gingival bleeding index probe depth attachment loss and tooth mobility E Preset Indications for Use Mode Reduction of gingival Gingivectomy G ingivoplasty Pulpotomy Pulpotomy as m FUOD an adjunct to root canal 5 N A Soft tissue crown Laser removal of diseased infected inflamed and necrosed 1 0 ms 1 0 ms 5096 soft tissue within the periodontal pocket P ulpotomy Pulpotomy as Hemostasis Hemostasis Treatment of canker sores herpetic and 13 Aphthous Ulcers aphthous ulcers of the oral mucosa Leukoplakia poe fat fe fe a Minimum defaults provided for user setting of Endodontic Procedures such as and
8. Figure 4 14 Epic 10 User Manual pg 23 5400321 Rev H PULSE DURATION PULSE INTERVAL off Duty Cycle Time On Time off CPO 10 microseconds 40 microseconds 20 CP1 100 microseconds 200 microseconds 33 CP2 1 millisecond 1 millisecond 50 P3 20 milliseconds 20 milliseconds 50 CP Comfort Pulse P3 Pulsed Mode which is the standard for most diode lasers currently available to the dental market Figure 4 13 NOTE Operating the laser at a shorter pulse duration typically results in lower tissue temperature Peak rower GINGIVECTOMY PULSE MODE 5 0 MODE POWER emp ls BIS 1 2 1 0 10815 1005 Tem d JIUL x tor B CW 2 ms Figure 4 14 Epic 10 User Manual pg 24 5400321 Rev H 4 11 USING THE EPIC 10 TOUCH SCREEN DISPLAY WELCOME BIOLASE GINGIVECTOMY 2 TROUGHING 3 CURETTAGE SOFT PAIN Tissue WHITENING THERAPY 4 EXCISION PLEASE INITIATE THE TIP 5 NEW AND CLEAN TIPS 5 0 MODE POWER 4 1 0 t 2 O Restore all Settings This will set the laser to factory settings A Gs Gai CPO CP1 CP2 BH M x RESTORE P3 CW Figure 4 15 Epic 10 User Manual POWER 70 e ENERGY TIP POWER 1200 p 4 0 TIME 7 40 sms 5400321 Rev H 4 12 PROCEDURES BUTTON The Epic 10 has the ability to store up to 20 pre set procedures Epic 10 is
9. epic 10 User Manual TABLE CONTENTS oO COC l 1 qc m 4 IN HG ACMA O Aa SS 5 cee E E 5 1 2 Facility Reguirem enis 5 2 Equipment Description 6 PARCI E E E 6 COINS ON Ot srs cra scans cesses antes 6 OMI Ol HM MTM NNI UM 6 3 4 iO O 7 20 auToO T EERE 7 ZO gt 13 e tiri u uuu 8 2 7 urgical HardpleeesASSeImbly _____ 10 2 8 Whitening Contour Handpiece Optional Accessory 11 2 9 Deep Tissue Handpiece Optional Accessory 12 SN M T 13 SN Miele RENTRER 13 13 u 14 OY MODO Uc Tm 14 9 a iama apuqa anaq 14 5 SWINGIN T 15 POCOSS 15 E Emm 15 Wireless Footswitch t 15 NN ERI IEEE UT MM 16 EMGS TE MU RUE 17 Functional DIS DIAY 17 SES AIO EE SIN NETT 17 4 Operation at il edo ERR 18 S eli ibo osa 18 Epic M10 User Manual
10. Operating Voltage Frequency External Fuses Main Control Remote Interruption Disable Control Battery DC Power Supply Module 5 3 LASER Laser Classification Medium Wavelength Max Power Output Power Accuracy Power Modes Fiber Tips Diameter Pulse Duration Epic M10 User Manual 5 in W x 4 4 in H x 6 5 in L 14 5 cm x 11 2 cm x 16 5 2 5 lbs 1kg 100V 240V at 1 5A 50 60Hz None Power Switch Remote Interlock Emergency Stop Button Lithium lon Rechargeable 14 4V 2 9Ah 12V DC 5A IV 4 InGaAsP Semi conductor diode 940 10nm 10W 20 Continuous Pulse Modulation 200um 300 um 400 0 01ms 20ms pg 27 5400321 Rev H Pulse Interval 0 01ms 20ms Pulse Repetition Rate Up to 20kHz for reference Spot size Surgical Handpiece 400um maximum in contact mode Deep Tissue Handpiece 30mm diameter 7 1 area Whitening Handpiece Rectangular 35mm x 8mm 2 8cm NOHD 4 77 meters Beam Divergence 8 22 per side angle otandard Fiber Cable Length 5 feet 1 524 meters 5 4 OTHER LIGHT SOURCES Aiming Beam Laser diode max 1 mW 625 nm 670 nm Class 2 Epic 10 User Manual pg 28 5400321 Rev H 6 CONTRAINDICATIONS WARNINGS 8 PRECAUTIONS 6 4 CONTRAINDICATIONS All clinical procedures performed with Epic 10 must be subjected to the same clinical judgment and care used with traditional techniques Patient risk must always be considered and fully und
11. Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation 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 Epic M10 User Manual pg 31 Vestibuloplasty Tissue retraction for impression Laser soft tissue curettage 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 Light activation for bleaching materials for teeth whitening Laser assisted whitening bleaching of teeth Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis pain or muscle spasm minor sprains and strains and minor muscular back pain the temporary increase in local blood circulation the temporary relaxation of muscle 5400321 Rev H 7 3 SOFT TISSUE S
12. Pulpotomy as an adjunct to root canal therapy 10 Infected Pockets Figure 7 6 Epic 10 User Manual pg 34 5400321 Rev H 7 5 TEETH WHITENING PROCEDURE The following items are required to perform teeth whitening with the Epic 10 laser Epic 10 diode laser Whitening Contour Handpiece Optional Accessory LaserWhite 20 Whitening Gel Kit BIOLASE p n 7400030 sold separately in packs of five Figure 7 7 Detailed step by step instructions contraindications precautions and warnings for teeth whitening are provided with the LaserWhite 20 Whitening Gel Kit Please read the instructions carefully before proceeding laserwhite 20 Whitening Gel Kit waterlase dentistry Figure 7 7 LaserWhite 20 Whitening Gel Kit BIOLASE PN 7400030 7 6 PAIN THERAPY The Epic 10 diode laser is designed to provide near infrared laser energy to a tissue surface for the purpose of temporary pain relief when applied with the Whitening Contour or Deep Tissue Handpiece The pain therapy procedure is the process by which tissue temperature is elevated for the temporary relief of minor pain the temporary increase in local blood circulation and the temporary relaxation of muscle as stated in 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 provide effective therapeutic effects Some patients may require more than one laser applic
13. 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 All persons present in the operatory must wear protective laser eyewear NOTE For replacement or additional protective laser eyewear please contact BIOLASE CAUTION Periodically inspect laser eyewear for pitting and cracking LASER Use of controls or adjustments or performance of procedures other than WARNING _ those specified herein may result in hazardous radiation exposure WARNING Do not use this unit if you suspect it of functioning improperly or other than described herein This unit has been designed and tested to meet the requirements of CAUTION electromagnetic electrostatic and radio frequency interference standards I However the possibility of electromagnetic or other interference may still exist Relocating the device may help to eliminate the interference Always ensure that proper laser parameters set before the Epic 10 laser CAUTION is used in clinical setting Epic 10 User Manual pg 13 5400321 Rev H LASER Always ensure that the protective laser eyewear is appropriate for the WARNING laser wavelength e Do not look directly into the beam
14. factory installed with 14 pre programmed procedural presets and 6 empty slots for custom pre sets All of them can be customized to your preference In order to customize the parameters e g power pulse duration interval etc for a particular clinical procedure 3 1 Go to the PROCEDURES menu by pressing the Soft Tissue icon M on the HOME screen scroll to the pre set you wish to overwrite Figure 4 16 2 Press and hold the selected procedure for two 2 seconds The parameters for that procedure will be changed and saved the laser console will beep when the adjusted settings are saved GINGIVECTOMY PROCEDURES GINGIVECTOMY MODE EN POWER TROUGHING 1 0 x CURETTAGE EXCISION Figure 4 16 4 13 TURN THE LASER CONSOLE OFF Wind the fiber cable onto the fiber spool counterclockwise around the base of the console LX e Place the Handpiece onto the Handpiece holder 4a Eh CAUTION Verify that the fiber optic tubing assembly is not twisted once the Handpiece is returned to the holder The fiber may break if it is twisted e Press the CONTROL button on the front of the console for more than 2 seconds to turn the display off e Press the Power Switch at the rear of the laser console to the OFF O position if the laser system will not be used for a long period of time Epic 10 User Manual pg 26 5400321 Rev H 5 SPECIFICATIONS 5 1 GENERAL Dimension Weight 5 2 ELECTRICAL
15. not resume until the error is cleared Epic 10 User Manual pg 14 5400321 Rev H Power Switch The laser console can be switched ON 1 or OFF O using the Power Switch on the back of the console Power Switch DC Power Remote Interlock Figure 3 1 Power Switch DC Power Input Remote Figure 3 2 Power Supply Module with cord Interlock CAUTION Use only the Power Supply Module supplied with the Epic 10 laser system BIOLASE Part Number 2400129 Access Key Code The Access Key Code prevents unauthorized use of the system It is activated every time the system is turned on with the Power Switch refer to Section 4 for code Placing the laser in sleep mode by pressing and holding the Control button on the NOTE front panel does not re set the Access Key Code Turn the Power Switch OFF O only when the system will not be in use for a long period of time Control Button Once the power switch is set to the ON I position enter the access key code After setting the desired parameters for a procedure press the CONTROL button on the control panel to enter into READY mode The aiming beam will illuminate to indicate that the system is ready for use Wireless Footswitch The Epic 10 will not emit laser energy until the user presses down on the Footswitch while the laser is in READY mode The footswitch is designed to work using wireless technology Epic 10 User Manual pg 15 5400321 Rev H Two 2 AAA batt
16. or otherwise subject it to strong impacts or shocks e Do not solder directly onto the battery e Do not expose the battery to water or salt water or allow the battery to get wet 2 Do not disassemble or modify the battery The battery contains safety and protection devices which if damaged may cause the battery to generate heat rupture or ignite 3 Do not place the battery on or near fires stoves or other high temperature locations Do not place the battery in direct sunshine or use or store the battery inside cards in hot weather Doing so may cause the battery to generate heat rupture or ignite Using the battery in this manner may also result in a loss of performance and a shortened life expectancy CAUTION 1 If the device is to be used by small children the caregiver should explain the contents of the user s manual to the children The caregiver should provide adequate supervision to ensure that the device is being used as explained in the user s manual Epic M10 User Manual pg 51 5400321 Rev H 2 When the battery is worn out insulate the terminals with adhesive tape or similar materials before disposal 3 Immediately discontinue use of the battery if while using charging or storing the battery the battery emits an unusual smell feels hot changes color changes shape or appears abnormal in any other way Contact your sales location or BIOLASE if any of these problems are observed 4 Do not place the batter
17. pg 1 5400321 Rev H 4 2 Operation Turn on the Epic 10 19 SONGS SCC CUM TET 20 4 4 Pairing the Footswitch to the Laser console 20 d SCONTO 22 4 6 Entering READY or STANDBY Modes 22 Ax READY 22 4 8 Wireless FOOIS WIC eucacacatuaaiactousadacnsiecnuacswiasiitecnsieunwsonnnatuasdanmswacsanatuaninageleclleiunlesnalniuniesaiteseaiesit 23 lt lan an ieai Ea a iE 23 4 10 Pulse Mode 23 4 11 Using the Epic 10 Touch Screen Display 25 T I2 PIOCOOUI SS ON u 26 4 13 Turn the Laser Console Olf a r nnns 26 Se SOO CIN 27 SHEE ______________ 27 Te 27 erect 27 ___________ _____ 28 6 Contraindications Warnings amp Precautions 29 O ITE AON S 29 6 2 Warnings and Precautions Face UA e
18. 601 1 Epic M10 User Manual pg 59 5400321 Rev H BIOLASE Inc 4 Cromwell Irvine CA 92618 USA SAS 851 72100 888 424 6527 biolase com MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 mt procons com 0482 About BIOLASE Founded in 1986 BIOLASE Inc specializes in lasers for medicine and dentistry that feature proprietary and patented technologies for minimally invasive surgeries reducing pain and improving clinical results Only BIOLASE combines the leading laser technology continuously improved through ongoing clinical R amp D and engineering with unmatched training practice integration support and service BIOLASE leads the global dental laser market with over 21 000 lasers in use today and the most complete family of dental lasers from diode lasers to the most advanced all tissue laser the WaterLase iPlus Made in the USA Copyright 2014 BIOLASE Inc All rights reserved EPIC iLase ezLase ezTip LaserWhite Deep Tissue Handpiece ComfortPulse WaterLase and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE Incorporated in the United States and or other countries All other trademarks are property of their registered owners Subject to change without notice
19. NCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EPIC DIODE LASER The Epic diode laser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Epic diode laser can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Epic diode laser as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter M Rate cimaximum 150kHz to 80Mhz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter W 1 2NP d 1 2NP d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHZ the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Epic 10 User Manual pg 58 5400321 Rev H APPENDIX WIRELESS EQUIPMENT
20. S IS PARTIALLY PRESSED OR DAMAGED KEY STUCK MEMORY CORRUPTED FIBER NOT INSERTED WIRELESS INTERFERENCE E SWITCH PRESSED REMOTE INTERLOCK OPEN BATTERY IS CRITICALLY LOW INTERNAL ERROR OCCURRED FOOTSWITCH BATTERY CRITICALLY LOW Figure 11 1 CALL BIOLASE SERVICE ALLOW 5 10 MINUTES FOR LASER TO COOL DOWN CALL BIOLASE SERVICE PRESS RELEASE FOOTSWITCH OR CALL BIOLASE SERVICE PRESS FRONT KEY CALL BIOLASE SERVICE PLUG IN TRUNK FIBER REPOSITION CONSOLE OR FOOTSWITCH TO IMPROVE COMMUNICATION PRESS E SWITCH AGAIN CHECK REMOTE INTERLOCK CLOSED PLUG IN DC SUPPLY RESTART UNIT REPLACE FOOTSWITCH BATTERY Epic 10 User Manual 5400321 Rev H SCREEN WARNING 1 WARNING 2 WARNING 3 WARNING 4 WARNING 5 ALERT 2 MESSAGE TEMPERATURE HIGH BATTERY IS LOW BATTERY NOT CONNECTED FOOTSWITCH BATTERY IS LOW FOOTSWITCH WIRELESS NOT PAIRED SYSTEM MUST BE IN READY MODE TO LASE REASON SYSTEM IS HOT BATTERY IS LOW BATTERY NOT CONNECTED BATTERY ON THE FOOTSWITCH IS LOW FOOTSWITCH HELD NO WIRELESS CONNECTION SYSTEM IS NOT IN READY MODE Figure 11 2 ALLOW 5 10 MINUTES FOR LASER TO COOL DOWN PLUG IN DC SUPPLY PLUG IN THE BATTERY REPLACE FOOTSWITCH BATTERY RELEASE FOOTSWITCH RE ESTABLISH PAIRING SEE SEC 4 PRESS THE CONTROL BUTTON IN ANY PROCEDURE SCREEN Epic 10 User Manual 5400321 Rev H APPENDIX A TIP GUIDE Diamete
21. SORY NOTE The Whitening Contour Handpiece is reusable and equipped with a disposable non sterile protective shield for single patient use The Handpiece is non sterile and requires disinfection before and after each patient treatment This Handpiece cannot be sterilized in the autoclave For disinfection instructions refer to Section 8 Always wipe the disposable shield with alcohol prior to use The disposable shield is for single use only to avoid cross contamination Dispose of when treatment session is completed Figure 2 11 Whitening Contour Handpiece Figure 2 12 Disposable Non Sterile Shield The area of Laser Energy Output for the Whitening Contour Handpiece is 35mm x 8mm 2 8 Spot Size To connect the Handpiece to the fiber optic cable push the Handpiece onto the fiber shaft until it clicks and is secured To disconnect the Handpiece from the fiber optic assembly e Take the Handpiece body in one hand and the shaft in another e Press both buttons at the base of the Fiber Shaft e Pull the Handpiece from the ring to separate Epic 10 User Manual pg 11 5400321 Rev H 2 9 DEEP TISSUE HANDPIECE OPTIONAL ACCESSORY The Deep Tissue Handpiece is reusable and equipped with a disposable non sterile protective shield for single patient use The Handpiece is non sterile and requires disinfection before and after each patient treatment This Handpiece cannot be sterilized in the autoclave For instructions o
22. TURN ON THE EPIC 10 Ensure that the battery has enough charge for operation or connect the power supply cord to the power connector on the laser console and plug the cord into a wall outlet Turn the Power Switch at the rear of the console to the ON I position The BIOLASE logo screen will appear Figure 4 1 After three 3 seconds the Epic 10 Welcome screen will be displayed Figure 4 2 WELCOME WELCOME BIOLASE Figure 4 1 Figure 4 2 Figure 4 3 e Enter the three digit access code using the touch screen The Access Key Code is 888 If the incorrect code is entered an X appears briefly in the window Figure 4 3 press the or wait seconds to revert back to the Welcome screen re enter the correct code e The system will go to the HOME screen which identifies three procedure categories to choose from Soft Tissue Whitening Pain Therapy gt PAIN SOFT tissue WHITENING THERAPY Laser Console Battery Wireless Signal Strength Indicator Strength Indicator Settings Button x Figure 4 4 Home Screen Epic 10 User Manual pg 19 5400321 Rev H 4 3 SETTINGS SCREEN Pressing the Settings button on the HOME screen accesses the Settings screen this screen allows the user to make changes to several system settings Language Selection Aiming Beam 5 levels of brightness adjustment SETTINGS Volume 5 levels of sound adjustment Service Mode accessible only by auth
23. URGERY AND OTHER DENTAL USE Initiation Parameters and Method not required if using pre initiated tips Most soft tissue surgical procedures require initiation of the fiber tip The TIP INITIATION screen will appear in READY mode if tip initiation is recommended and the system will automatically go to the settings shown in Figure 7 1 based on the tip used while in the TIP INITIATION screen initiate the tip by following the steps outlined below Preset Power W Tip Diameter um 400 Tip initiation not required when used for recommended procedures Figure 7 1 e Touch the tip to the surface of the initiation block without activating the laser don t press down on the footswitch Figure 7 2 96 Figure 7 2 e Press the footswitch to activate the laser allowing the tip to sink into the block Pull the tip out when the metal cannula touches the block still firing until just before the tip is out of the block Figure 7 3 Figure 7 3 e Press the footswitch to activate the laser into the air once you will see a white flash or the tip will glow Figure 7 4 Figure 7 4 e Repeat initiation process as needed to ensure the tip is initiated After tip initiation is completed press the check mark to access the screen for the selected procedure TIP INITIATION GINGIVECTOMY PLEASE 5 0 MODE INITIATE y gt LIE THE 1 0 w A USE ONLY NEW AND CLEAN TIPS e s Figure 7 5 If
24. Using the Whitening Contour Handpiece 37 FIO 38 38 8 2 Cleaning and Sterilization 38 Cleaning and Disinfecting Instructions Surgical Handpiece Reusable Fiber Optic Cable 38 Manual Cleaning of the Surgical Handpiece 39 Steam Sterilization for Surgical Handpiece Single Use 39 Disinfecting the Whitening Contour HandDpiece 40 Disinfecting the Deep Tissue HandDpiece 40 8 3 Installing Replacing the Console Battery Pack 40 8 4 Changing the Wireless Footswitch Batteries 41 Bor PAMSOOMAUOMMN DE 42 O ste 10 6 CNN 42 br ili eee ene E TM 43 10 Software Specification a a ra rrrssrsssrsss ssa 43 11 T olibBIGehie0l0gu 43 APPENDIX RUN UU 46 APPENDIX B au EEN 47 APPENDIX C
25. ation however in very rare cases burning or blistering of the skin may occur Immediately stop treatment rinse the area with cool water or place a cold pack to the affected area for at least 5 minutes then apply a burn ointment or spray DO NOT USE ICE Patients should be monitored for discomfort and visual skin changes Redness has been associated with increased temperature at the site of application and increased absorption properties of the skin If discomfort or redness of the skin occurs at any time during the treatment you have the following options o Move the handpiece relative to the affected anatomy o Defocus the energy by moving the Handpiece further away from the skin o Decrease the power setting o Stop treatment Pain Therapy Wamings and Precautions e Scar tissue has been associated with poor circulation and reduced cooling through heat transport by blood power settings may have to be reduced to avoid overheating e Patients with tender or sensitive skin may be hypersensitive to heat reduce power as necessary to ensure comfort during treatment e Patients with swelling and or inflammation may be sensitive to heat reduce power as necessary to ensure comfort during treatment Epic 10 User Manual pg 36 5400321 Rev H e Do not treat open wounds e Muscle tissue closer to the skin surface may experience a higher absorption of heat carefully monitor skin temperature and reduce power as necessary e Excessive fatty t
26. ation or a series of treatments before significant improvement is reported Repeat the therapy as necessary and monitor the progress of the patient s condition throughout the treatment Refer to the Fitzpatrick Skin Type Scale when performing pain therapy procedures The diode wavelength has increased absorption in melanin in the skin causing greater heating of the skin surface of patients with a higher melanin concentration darker skin types Patients with higher melanin content in their skin may feel more discomfort during treatment which may be alleviated by moving the Handpiece defocusing the energy or decreasing the power seiting Epic 10 User Manual pg 35 5400321 Rev H Fitzpatrick Skin Scale Highly sensitive always burns never tans Example Red hair with freckles Very sun sensitive burns easily tans minimally Example Fair skinned TYPE Il fair haired Caucasians Sun sensitive skin sometimes burns slowly tans to light brown TYPE 111 i Example Darker Caucasians Minimally sun sensitive burns minimally always tans to moderate brown TYPE IV Example Mediterranean type Caucasians Sun insensitive skin rarely burns tans well Example Some Hispanics TYPE V some Blacks TYPE VI Sun insensitive never burns deeply pigmented Example Darker Blacks Figure 7 8 Pain Therapy Adverse Effects Some reddening of the skin at the treatment site is normal due to increased circul
27. cord maximum length 3ft 1 meter Biolase p n 2400043 Footswitch Wireless Biolase p n 6400146 The use of accessories other than those specified except those supplied or WARNING sold by Biolase Inc as replacement parts for internal or external components may result in increased EMMISSIONS or decreased IMMUNITY of the Epic diode laser system GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Epic diode laser is intended for use in the electromagnetic environment specified below The customer _ the user of the Epic diode laser should assure it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The Epic diode laser uses RF energy only for its internal RF emissions function Therefore its RF emissions are very low and are Group 1 not likely to cause any interference in nearby electronic CISPR 11 equipment RF emissions Class A CISPR 11 Harmonic emissions The Epic diode laser is suitable for use in all Class A establishments other than domestic and those directly IEC 61000 3 2 connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Class A IEC 61000 3 3 Epic M10 User Manual pg 55 5400321 Rev H GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Epic diode laser is intended for use in the electromagnetic environment s
28. d clear protective shield are not autoclavable The clear protective shields are intended for single time use only and should never be reused to prevent cross contamination To disinfect the Deep Tissue Handpiece wipe the entire outer surface of the Handpiece with cotton gauze and isopropyl alcohol or a mild chemical disinfectant Always wipe the disposable shield with alcohol prior to use Dispose of after one time use 8 3 INSTALLING REPLACING THE CONSOLE BATTERY PACK 1 To install or replace the battery pack remove the battery cover on the underside of the console using the Phillips screwdriver included with the laser system Figure 8 2 Epic 10 User Manual pg 40 5400321 Rev H 2 remove the battery grip the battery the top and pull the cable away from the connector Figure 8 3 Do tug or wrench the cable from the connector To install the battery insert the connector wire from the battery to the unit making sure the red wire is on the left and gently place the battery into the compartment Figure 8 3 4 Replace the battery cover on the bottom of the unit using a standard Phillips screwdriver 5 Connect the power cord of the DC power supply to the unit and plug into a wall outlet Before first use you should fully charge the battery at least three 3 hours Once the battery is charged unplug the power cord from the wall outlet and the console The unit will run on battery power alone See Section 4 1
29. e and the unit will go NOTE into sleep mode with the screen off after 5 minutes if the power supply is plugged in but turned OFF O at the Power Switch the battery will still charge but at a slower rate CAUTION Do not connect or disconnect the fiber while the laser console is turned on Only connect disconnect the fiber when the laser console is turned off CAUTION Do not cover or block ventilation channels These channels provide an air flow path to cool the unit CAUTION Do not bend the fiber optic at a sharp angle as it is can break Make sure it is not caught or pinched between the housing and the fiber optic access plug e Remove protective cap from the end of the fiber shaft See Figure 2 8 e Carefully connect the Handpiece to the fiber optic assembly see Figure 2 9 e Insert the selected tip and tighten it clockwise until snug see Figure 2 4 e Wind any excess fiber optic cable onto the fiber spool counterclockwise around the base of the console see Figure 2 1 4a he Handpiece is now ready to use To store the Handpiece place it in the Handpiece holder located at the top of the laser console Epic 10 User Manual pg 18 5400321 Rev H LASER WARNING Never point the laser at a person s eyes LASER WARNING Never operate the laser without a fiber tip attached LASER All persons present in the operatory must wear protective eyewear when WARNING the laser is in use 4 2 OPERATION
30. e appropriate power pulse length and interval adjustments to compensate for varying tissue compositions density and thickness Always start treatment at the lowest power setting for that specific indication and increase as required BIOLASE assumes no responsibility for parameters techniques methods or results Training Only licensed professionals who have reviewed and understood this User Manual should use this device 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 Never point the laser at a person s eyes All persons present in the operatory must wear protective eyewear when the laser is in operation LASER WARNING Epic 10 User Manual pg 30 5400321 Rev H 7 CLINICAL APPLICATIONS 7 1 INTRODUCTION To efficiently remove tissues it is imperative to understand the nature of the Epic 10 device Please review this section carefully practice on model tissues and attend a diode laser training session before using this device in a clinical situation 7 2 INDICATIONS FOR USE Use of the Epic 10 device may be appropriate for incision excision vaporization ablation and coagulation of oral soft tissues including marginal and inter dental gingival and epithelial lining of free gingiva and the following specific indications
31. emove the handpiece from the fiber optic cable see Section 2 Prepare any commercially available surgical instrument detergent enzymatic cleaning solution with a pH of 7 0 such as Enzol or similar enzymatic presoak and cleaner per the manufacturer s instructions Follow the manufacturer s instructions for disposal of used solution 4 Rinse the Handpiece under running lukewarm tap water 22 43 C for a minimum of 10 seconds to remove gross 01 5 Wrap the handpiece in a piece of gauze that has been soaked in the cleaning solution leave it wrapped in the gauze for a minimum of 10 minutes 6 Unwrap the handpiece from the gauze and use a soft bristled brush dipped in the cleaning solution to gently scrub it for at least 15 seconds 7 Rinse the handpiece under running lukewarm tap water 22 43 C for a minimum of 10 seconds and then dry with a lint free cloth 8 Visually inspect the handpiece for any residual soil If necessary repeat steps 5 7 until all residual soil is removed Steam Sterilization for Surgical Handpiece Single Use Tips The steam sterilization process is intended to destroy infectious microorganisms and pathogens Always perform the procedure immediately after cleaning and prior to use and only NOTE use FDA cleared USA or CE marked Europe sterilization accessories i e sterilization pouch and autoclave tray e Place the handpiece and fiber tips in separate single wrap self seal autoclave pouch
32. ens is a Signal Strength Indicator E which displays the signal strength between the laser console and the footswitch strongest is five 5 bars Pressing and releasing the footswitch while in Standby mode will update this indicator Although the unit will work with a signal level as low as one 1 bar a weaker signal level will make the connection between the footswitch and laser console more vulnerable to wireless RF interference from other sources such as cell phones or microwaves To improve the signal strength reposition either the footswitch or the laser console until the signal indicator achieves the strongest possible level for optimal operation When the footswitch is not in use it will go into SLEEP mode to conserve battery NOTE m power It automatically reactivates when it is pressed 4 9 PEAK POWER DISPLAY This number is shown only when the system is in pulse mode and presents the value of the peak power based on the Power Setting and Pulse Mode 4 10 PULSE MODE SELECTION Pulse Mode selection graphically indicates whether the system is in Continuous Mode or in Pulse Mode In Continuous Mode laser power is constantly delivered when the laser console is in Ready Mode and the wireless footswitch is activated In Pulse Mode laser power is delivered in repetitive pulses controlled by the Pulse Length and Pulse Interval settings Pressing the Pulse Mode button will allow switching between Pulsed and Continuous Modes
33. epot repair facility Call BIOLASE Service at 1 800 321 6717 or your Authorized Service Representative to schedule an appointment 10 SOFTWARE SPECIFICATION BIOLASE respects the intellectual property of others and we ask our users to do the same Epic 10 software is protected by copyright and other intellectual property laws This product contains proprietary copyrighted software developed by BIOLASE Inc All rights reserved in the USA and other countries 11 TROUBLESHOOTING Should any of the on screen messages listed in Figure 11 1 and Figure 11 2 appear follow the troubleshooting instructions for the specific message as noted below For any on screen message not listed in Figure 11 1 re power the laser console if NOTE the message does not clear BIOLASE Service at 1 800 321 6717 or your authorized Service Representative Epic M10 User Manual pg 43 5400321 Rev H SCREEN Error 1 Error 2 Error 3 Error 4 ERROR 5 ERROR 6 ERROR 7 ERROR 9 ERROR 10 ERROR 11 ERROR 12 ERROR 13 ERROR 14 MESSAGE THERMISTOR OPEN THERMISTOR SHORTED SHUTDOWN TEMPERATURE LASER CURRENT HIGH LOW FOOTSWITCH SHORTED ON OFF BUTTON STUCK FLASH CORRUPTED NO FIBER LOST FOOTSWITCH COMMUNICATION EMERGENCY SWITCH REMOTE INTERLOCK BATTERY CRITICALLY LOW INTERNAL ERROR FOOTSWITCH BATTERY REASON THERMISTOR OPEN THERMISTOR SHORTED SYSTEM TOO HOT OUTPUT IS OUT OF SPECS F
34. eries are required to power the footswitch included For instructions on how to replace the footswitch batteries see Section 4 The footswitch is protected by a metal cover To access first press down on the cover to unlatch it Now the footswitch can be pressed to fire the laser Cover Footswitch Figure 3 3 Footswitch Remote Interlock This feature allows the laser to be connected to a remote sensor which prevents it from firing when the sensor is triggered To install the Remote Interlock insert the plug a at the end of the connector into the rear of the laser console Figure 3 1 and attach the two wires b at the other end to a door switch the laser will stop immediately when the connection to the door switch is deactivated when the door is opened To override this feature don t connect the plug Epic 10 User Manual pg 16 5400321 Rev H Emergency Stop Press the red Emergency Laser Stop button to instantly turn off the laser console The error screen will display an Emergency Switch Error message and the amber LED will begin flashing To clear the error press the Emergency Laser Stop button again in 2 to 5 seconds the amber LED will stop flashing and the system will automatically go into STANDBY mode Figure 3 5 Emergency Laser Stop Left Profile View Functional Display The System Color Display with Touch Screen and LED indicators on the control panel show the functional conditions of the
35. erstood 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 including pacemakers lung disease bleeding disorders sleep apnea or an 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 6 2 WARNINGS AND PRECAUTIONS Prescription Statement Federal Law restricts this device to sale by or on the order of a dentist or physician or other licensed medical practitioner Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 940 10nm Anesthesia In soft tissue cases anesthesia may not be required but 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 Epic 10 is designed to remove soft tissues Therefore always be aware of adjacent structures and substructures during use Be extremely careful not to inadvertently penetrate ablate underlying or adjacent tissues Do
36. es e Place on an autoclave tray do not stack other instruments on top of the pouches e Place the tray inside the autoclave chamber and set the appropriate cycle as recommended in Figure 8 1 Epic 10 User Manual pg 39 5400321 Rev H of Sterilizer Temperature Min Time Drying Time 121 C 250 F 30 minutes Gravity Displacement 15 30 minutes 132 C 270 F 15 minutes 132 270 F Dynamic Air Removal Pre Vacuum 4 minutes 20 30 minutes 134 C only Figure 8 1 e Once the cycle is completed remove the tray and let each sterilized item cool and dry The handpiece and tips must remain in the sterilization pouches until used in order to maintain sterility For instructions on how to reassemble the handpiece please refer to section 2 7 Disinfecting the Whitening Contour Handpiece The Whitening Handpiece is sold with disposable non sterile protective shields The Handpiece and clear protective shield are not autoclavable The clear protective shields are intended for one time use only and should never be reused to prevent cross contamination To disinfect the Whitening Handpiece wipe down the Handpiece with gauze and isopropyl alcohol Always wipe the disposable shield with alcohol prior to use Dispose of after single use Disinfecting the Deep Tissue Handpiece The Deep Tissue Handpiece is sold with non sterile disposable protective shields The Handpiece an
37. ies in microwave ovens high pressure containers or on induction cookware 5 Inthe event that the battery leaks and the fluid gets into one s eye s do not rub the eye s Rinse well with water and immediately seek medical care If left untreated the battery fluid could cause damage to the eye WHEN CHARGING the Battery WARNING 1 sure to follow the rules listed below while charging the battery Failure to do so may cause the battery to become hot rupture or ignite and cause serious injury e When charging the battery either use a specified battery charger or otherwise ensure that the battery charging conditions specified are met Do not attach the batteries to a power supply plug or directly to a cigarette lighter e Do not place the batteries in or near fire or into direct sunlight When the battery becomes hot the built in safety equipment is activated preventing the battery from charging further and heating the battery can destroy the safety equipment and can cause additional heating breaking or ignition of the battery 2 Do not continue charging the battery if it does not recharge within the specified charging time Doing so may cause the battery to become hot rupture or ignite Epic 10 User Manual pg 52 5400321 Rev H CAUTION The temperature range over which the battery can be charged is 0 C to 45 C Changing the battery at temperatures outside of this range may cause the battery to beco
38. issue is known to transmit heat without much attenuation reduce power e Different implant materials will respond differently to laser energy and heat be aware of any implants and their location avoid direct exposure to laser energy or heat at the site of the implant e Avoid treatment of sites that have tattoos e Do not apply ointment creams lotions or heating lotion patches at or in close proximity to the treatment area e Do not apply therapies prior to treatment that could change body temperature such as ultrasound ice heat pack electrical stimulation or heating patches e Do not apply treatment over articles of clothing Recommended Use There are four main variables that impact the safety and effectiveness of pain therapy procedures o Power output o Range of movement of the handpiece o Distance from the skin surface o Patient skin type Safety and effectiveness are described by elevating the skin temperature in the treatment area utilizing the settings recommended below Use personal clinical judgment with consideration of the Fitzpatrick Skin Type Scale when selecting procedure parameters monitor the patient and adjust the settings as necessary for effectiveness and patient comfort To avoid potential patient discomfort and or skin damage it is advisable to use a test NOTE spot prior to the initial treatment to assess the suitability of the selected settings for the individual patient Using the Deep Tissue Hand
39. me hot or to break Charging the battery outside of this temperature range may also harm the performance of the battery or reduce the battery s life expectancy When DISCHARGING the Battery WARNING Do not discharge the battery using any device except for the specified device When the battery is used in devices aside from the specified device it may damage the performance of the battery or reduce its life expectancy and if the device causes an abnormal current to flow it may cause the battery to become hot rupture or ignite and cause serious injury CAUTION The temperature range over which the battery can be discharged is 20 C to 60 C Use of the battery outside of this temperature range may damage the performance of the battery or may reduce its life expectancy Epic 10 User Manual pg 53 5400321 Rev H APPENDIX D ACCESSORIES 6400479 Surgical Handpiece 2 pack 2400040 Laser Safety Glasses Clinician 6400457 Lithium ion battery pack for console Epic 10 User Manual pg 54 5400321 Rev H APPENDIX ELECTROMAGNETIC Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into CAUTION service according to the EMC information provided in the following tables Portable and mobile Radio Frequency RF communications equipment can affect medical electrical equipment Accessories Medical grade power
40. n disinfecting the Handpiece refer to NOTE section 8 Always wipe the disposable shield with alcohol prior to use The disposable shield is for single use only to avoid cross contamination Dispose of when treatment session is completed Spacer Cap Dust Handpiece Cover Disposable gt Shield Figure 2 13 Deep Tissue Handpiece Remove Red Cap Dust Cover from the Deep Tissue Handpiece Slide Handpiece over shaft until it clicks into place Figure 2 14 A Figure 2 14 Place protective shield over the adjustable spacer Figure 2 15 Figure 2 15 Loosen the Lock Ring and set the Spacer at the desired spot size Detent Location Figure 2 16 Tighten the Lock Ring Wa x Figure 2 16 The Handpiece is now ready to use To remove the Handpiece press and hold both buttons at the base of the Fiber Shaft and pull the Handpiece away from the shaft Epic 10 User Manual pg 12 5400321 Rev H 3 3 1 PRECAUTIONS Failure to comply with precautions and warnings described in this User Manual may lead to exposure to dangerous optical radiation sources Please comply with all safety instructions and warnings 3 2 SAFETY INSTRUCTIONS Follow these safety instructions before and during treatments e When the laser is in use all entrances must be marked with an appropriate DANGER warning sign one 1 included e Do not operate in the presence of
41. nal programming Remote Interlock Input for Remote Interlock Connector which when applied to the access door of the operatory and activated will shut off the laser Prescription Statement Only Federal Law restricts this device to sale ly by or on the order of a dentist or 4400417 Rev C physician or other licensed medical practitioner Epic 10 User Manual pg 49 5400321 Rev H Atmospheric Pressure Limitations 50 ATMOSPHERIC PRESSURE Fragile Handle with care FRAGILE F E F F l KEEP DRY Keep Dry Humidity Limitations 1058 NON CONDENSING RELATIVE HUMIDITY 60 Temperature Limitations TEMPERATURE This End UP THIS END UP Epic 10 User Manual pg 50 5400321 Rev H APPENDIX SAFETY PRECAUTIONS FOR LITHIUM ION BATTERY PACKS When USING the BATTERY 1 Misusing the battery may cause the battery to get hot rupture or ignite and cause serious injury Be sure to follow the safety rules listed below e Do not place the battery in fire or heat the battery e Do not install the battery backwards so that the polarity is reversed e Do not connect the positive terminal and the negative terminal of the battery to each other with any metal object such as a wire e Do notcarry or store the batteries together with necklaces hairpins or other metal objects e Do not pierce the battery with nails strike the battery with a hammer step on the battery
42. not direct energy toward hard tissue 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 Exercise extreme caution when using this device in areas such as pockets cavities or channels such as third molar sockets where critical structures i e nerves vessels could be damaged Do not proceed with using the laser if visibility is limited in these areas Epic M10 User Manual pg 29 5400321 Rev H Suction Use high speed suction as required to maintain a clear field of vision during treatment Do not use the Epic 10 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 procedural requirements Closely observe and monitor clinical effects and use your judgment to determine clinical parameters and approach for the treatment Mak
43. or at specular reflections e Never direct or point the beam at a person s eyes e Always place the system into STANDBY mode by pressing the Control Button while in READY mode before exchanging Handpieces or disposable tips e Toggle the ON OFF switch located on the rear of the console to the OFF O position before leaving unit unattended LASER Do not open unit housing at any time Danger from optical radiation may WARNING exist 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 LASER WARNING Be aware that the metal plastic cannula on the tips may become hot during use Avoid contact of the cannula with any tissue CAUTION 3 3 SAFETY FEATURES 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 the error message LASER CURRENT HIGH LOW The laser console will not operate until the system first clears the error and then goes into READY mode If the error message persists please contact BIOLASE Service at 1 800 321 6717 System Monitor The system monitors the emergency stop switch remote key wireless footswitch connection 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
44. orized BIOLASE Service Representatives Restore to Factory Default Settings Wireless Menu Access to Pairing Screens Figure 4 5 4 4 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE Verify that the footswitch and laser console are paired a blue LED indicator light on the laser console will blink when pairing is established The laser and footswitch are shipped already paired However if pairing is not confirmed an EB will appear in the pairing icon located in the upper left hand corner of the touchscreen Figure 4 6 is o PAIN SOFT WHITENING THERAPY TISSUE Figure 4 6 Epic 10 User Manual pg 20 5400321 Rev H re establish pairing take following steps 1 Go to the Settings menu on the laser console display by pressing the Settings button and select the Wireless icon WIRELESS 2 Ascreen will appear indicating that pairing of the lt Cz footswitch to the laser console has been lost Figure 4 7 press the green button Figure 4 7 WIRELESS 3 The message that PAIRING WILL NOW BEGIN will appear press the green check mark to continue PAIRING WILL NOW BEGIN EXISTING CONNECTION WILL RESET CONTINUE Figure 4 8 Figure 4 8 WIRELESS 4 To complete the pairing process turn the footswitch over PRESS FOR 4 SECONDS and press the Pairing Button for four 4 seconds Figure 4 9 WIRELESS The Wirele
45. ory and will require cleaning and sterilization prior to each patient treatment Tips are intended for single use only and must be disposed of after each patient use NOTE Mo I I Proper tip disposal in a biohazard medical waste Sharps container is required Tips must be steam sterilized prior to use For instructions on cleaning and sterilization of the Handpiece and tips Refer to Section 8 2 5 FIBER OPTIC CONNECTION The Epic10 ships with the fiber optic cable already attached CAUTION Do not connect or disconnect the fiber while the laser console is turned on Only connect or disconnect the fiber when the laser console is turned off To disconnect the fiber optic cable from the laser console make sure the laser console is turned off and the cable is completely unwound from the console base grab the fiber optic access plug and slowly pull it straight back from the optical access port Figure 2 3 To re install the fiber optic cable make sure the laser console is turned off The fiber optic cable is attached to the console by inserting the optical access plug Figure 2 2 into the optical access port Figure 2 3 sure you hear the fiber optic click into place if you do not hear it click NOTE remove the fiber and reinstall it For storage wind the cable in the fiber storage channel around the base of the console counterclockwise direction Figure 2 1 CAUTION Do not bend
46. our practice Please contact BIOLASE Customer Service at 1 800 321 6717 in the U S for any service needs If you are located outside the USA please contact your BIOLASE authorized distributor BIO Hsc Epic M10 User Manual pg 4 5400321 Rev H 1 PACKAGING 1 1 SYSTEM PARTS LIST The Epic 10 laser system includes the following Laser Console lithium ion battery pack already installed Screen Protectors box Peel off clear screen cover qty 30 Delivery System installed Assorted Surgical Tips Surgical Handpiece box contains two 2 Surgical Handpieces Three 3 pairs of protective laser eyewear two 2 pairs of doctor safety glasses one 1 pair of darker patient safety glasses DC power supply and power cord one 1 US and one 1 International User Manual 9 Welcome Kit Welcome Letter BIOLASE store information Quick Setup Guide Guide to Online Training amp Product Registration Card Limited Warranty Information 10 Laser Warning Sign 11 Tip Initiation Kit 12 Remote Interlock cable 13 Philips head screwdriver for installing Footswitch batteries 14 Footswitch 15 AAA batteries 2 ot a us irn NOTE The laser ships with the lithium ion battery pack already installed Use proper care when transporting the unit Refer to Section 8 in this User NOTE Manual for instructions WARNING modification of this equipment is allowed 1 2 FACILITY REQUIREMENTS Electrical Suppl
47. pecified below The customer or the user of the Epic diode laser should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC61000 4 4 ourge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 common lt 5 Ur gt 95 dip in UT for 0 5 cycle 40 Ur 60 dip in UT for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 seconds 3 A m Continuous level 6 kV contact 8kV air 2 kV for power supply lines N A 1 kV differential mode 2kV common mode lt 5 U r gt 95 dip in UT for 0 5 cycle 40 Ur 60 dip in UT for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 seconds 3 A m Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material relative humidity should be at least 50 Main power quality should be that of a typical commercial or hospital environment N A Mains power quality should be that of a typical commercial or hos
48. piece If holding the Handpiece in a constant location set the screen to the recommended initial power settings for therapeutic effect at 4 0W delivered over 10 minutes 600 seconds of continuous treatment CW with the spacer set at a 30mm spot size Always monitor patient response adjust power and or distance as needed for patient comfort Using the Whitening Contour If holding the Handpiece in a constant location change the settings on the screen to 5 5W CW when approximately 3mm from the skin surface or 2 75W CW in contact with the skin applying laser energy for 10 minutes 600 seconds continuously Always monitor patient response Epic 10 User Manual pg 37 5400321 Rev H 8 8 1 DAILY MAINTENANCE Use the peel off clear covers for the laser console supplied with the system Use disinfectant to wipe down the front panel and handpiece holder of the Epic 10 system after each procedure Do not use bleach or abrasive cleansers 8 2 CLEANING AND STERILIZATION PROCEDURES The contamination control suggested for the Epic 10 Surgical Handpiece and tips is the steam sterilization method However before sterilization the Epic 10 reusable Handpiece should be carefully cleaned per the following procedure Handpiece and tips must be cleaned and sterilized prior to initial use Tips are single use only to avoid cross contamination and are designed to withstand a single sterilization cycle they m
49. pital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Epic diode laser requires continued operation during power mains interruptions it is recommended that the Epic diode laser be powered from an uninterrupted power supply Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the A C mains voltage prior to applications of the test level Epic 10 User Manual 5400321 Rev H GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY Continued The model Epic laser is intended for use the electromagnetic environment specified below The customer or the user of the model Epic laser should assure that it is used in such an environment IEC 60601 Continuous Electromagnetic environment Immunity test test level level guidance Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment should be IEC 61000 4 6 150 kHz to 80 GHz used closer to any part of the Epic diode laser including cables than the recommended separation distance Radiated RF 3V m calculated from the equation applicable to the frequency of the transmitter IEC61000 4 3 80 MHz to 2 5 GHz Recommended separation distance d 1 2VP 1 2 80 MHz to 800 MHz d 22 3 P 800MHz to 2 5GHZ Where P is the maximum output power rating of the transmitter in wa
50. r Length TM Surgical 7400016 7400019 15 Perlo Combo Pack 400um 15 x E4 7 400um Perio 15 x E4 9 300um Surgical 7400017 7400020 Combo Pack 15 x Perio 15 x E3 9 7400018 30 Surgical 30 7400021 20 7400015 Biolase tips for diode lasers are sold non sterile and are for single use only See Section 8 2 for sterilization instructions NOTE Epic M10 User Manual pg 46 5400321 Rev H APPENDIX LABELING BIOLRSE fel Promedt Consulting GmbH 4 Cromwell Altenhofstrasse 80 Irvine CA 92618 USA D 66386 St Ingbert GERMANY EPIC 10 P ID L 7400049 roduct abe 747 YYYY MM Location Bottom of laser console CDR 9 Rx Only Date of Manufacture Catalog Part Number Product Serial Number Refer to User Manual Type B Applied Part The applied part is not conductive to the patient THIS PRODUCT COMPLIES WITH FDA FDA Compliance Label PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR Indicates the device complies with FDA laser DEVIATIONS PURSUANT LASER NOTICE 50 DATED 24 JUNE 2007 standards 5400341 Epic 10 User Manual pg 47 5400321 Rev H Warning Label Indicates there is the risk of possible exposure to both infrared and visible laser radiation Location Back of laser console NOTICE FCC Compliance Notice footswitch laser console comply with ules Operation i
51. s subject to the following two conditions 1 this device may not Part 15 of FCC Rules regarding unlicensed cause harmful interference and 2 this transmissions device must accept any interference received including interference that may PNE Location Bottom of Footswitch FCC and IC Label MODEL EPIC 10 Lists Federal Communication Commission FCC ID G20EPIC and Industry Canada registration numbers IC 10338A EPIC 5400365 Location Bottom of Console FCC and IC Label MODEL EPIC 10 Lists Federal Communication Commission ID G2OEPIC 1 and Industry Canada registration numbers IG 10338A EPIC 5400540 Location Bottom of Footswitch Ingress Protection Code The footswitch is water resistant protected against splashes of water Laser Warning Indicates the system contains a laser Location Back of Laser Console Fiber Warning Indicates the laser aperture is at the end of the fiber Location Back of Laser Console Epic 10 User Manual pg 48 5400321 Rev H Emergency Laser Stop Switch The switch used in emergencies to stop laser output Location Right side of Laser Console DO NOT REUSE For single use only WEEE Waste Electrical and Electronic Recycle Lithium lon battery as regulated Do not throw in trash bin DC Power USB Remote Interlock Label Identifies input ports Power Input Rating 12 Volts Direct Current 5 amps Mini USB Input For exter
52. ss screen will appear indicating that pairing X gt was successful and that the footswitch and laser console Figure 4 10 Proceed step 6 o Figure 4 10 Epic 10 User Manual pg 21 5400321 Rev H WIRELESS amp 56 If pairing has not occurred the Wireless screen will gt appear again indicating that pairing was not successful lt Ham Ls Figure 4 11 B the green button to repeat steps 3 5a SETTINGS 6 Press the Settings button to return to the Settings menu press the arrow on the bottom left of the Settings screen to return to the Home screen Figure 4 12 Figure 4 12 4 5 CONTROL BUTTON The CONTROL button on the front of the laser console is a multi functional button Figure 2 1 Pressing and holding the Control Button for approximately two 2 seconds will allow the transition from STANDBY or READY mode to SLEEP mode Note that you will not be allowed to go into READY mode unless you have chosen a treatment module on the HOME screen first 4 6 ENTERING READY OR STANDBY MODES Press and release the Control Button to place the laser console into either READY or STANDBY mode The laser console will only emit laser energy when the footswitch is pressed and the laser console is set to READY mode While in READY or STANDBY mode mode setting and or power setting values may be changed only when the laser is not firing If the laser is firing
53. system 3 4 SAFETY CLASSIFICATION The following safety classifications are applicable to the device e Laser Radiation Class 4 e Aiming Beam Class 2 e Type of protections against electrical shock Class 2 e Degree of protection against electrical shock Type B Applied Part e Not protected against water ingress Ordinary Equipment e Not suitable for use in presence of flammable anesthetic mixture e Operation Mode Continuous Wave and Pulse Mode e Wireless Footswitch IPX6 Epic 10 User Manual pg 17 5400321 Rev H 4 OPERATION INSTRUCTIONS 4 1 SYSTEM SETUP e Place the unit in a clean dry and well ventilated area e Verify power switch is in the OFF O position e Epic 10 will work using either DC power or the rechargeable battery pack o DC Power Connect the power cord of the power supply to the laser console and plug into a wall outlet o Rechargeable Battery The Epic 10 is shipped with the battery pack already installed to charge the battery pack connect the power cord of the DC power supply to the laser console and plug into a wall outlet Before first use fully charge the battery at least 3 hours Once the battery is charged unplug the power cord from the wall outlet and the laser console The laser console will run on battery power alone To fully charge the battery plug the power supply in and then turn the laser console ON I at the Power Switch The laser console will start to charg
54. the fiber optic at a sharp angle as it is can break Make sure it is not caught or pinched between the housing and the fiber optic access plug Epic 10 User Manual pg 7 5400321 Rev H 6 2 Figure 2 2 Fiber Optic Access Plug Figure 2 3 Optical Access Port 2 6 SINGLE USE TIPS The tips are single use accessories and are provided in three core diameters 200 300um and 400 in different lengths see Appendix Tips are single use only to avoid cross contamination and are designed to withstand only a single sterilization cycle they must be disposed of after use in CAUTION biohazard medical waste Sharps container Always visually inspect the tip prior to use to make sure it is free of debris or damage Be aware that the cannula on the tips may become hot during CAUTION use Avoid contact of the cannula with any tissue To connect the tip first connect the handpiece to the fiber then insert the tip firmly into the distal end of the handpiece as far as it will go and tighten by turning clockwise Figure 2 4 Bend the metal cannula according to the specific procedure requirements Figure 2 7 Remove the fiber tip by twisting the tip counterclockwise Figure 2 5 provide proper laser operation do not connect tips when the handpiece is NOTE disconnected from the fiber Epic 10 User Manual pg 8 5400321 Rev H Assembly B iz zen Imm
55. the laser console is in READY mode the laser will fire if the footswitch CAUTION is activated 5400321 Rev H Epic 10 User Manual pg 32 Pre programmed Settings for Dental Procedures To access the pre programmed procedure values a 1 Goto the Procedures menu by pressing the Soft Tissue icon M on the Home screen 2 Press the button associated with the desired procedure 3 Press the up and down arrows to scroll for additional procedures To store your personal preferred settings for any procedure A Follow steps 1 and 2 above B Enter the new values C Touch and hold the Procedure name for more than 2 seconds you will hear a beeping sound confirming the settings are saved The Procedure Pre Sets installed at the factory are based on clinical recommendations and feedback from experienced laser dentists 300um tips are recommended for removing thin tissue layers 400um tips are NOTE recommended for removing fibrous tissue 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 300um and 400mm tips At all times observe the clinical effects on the treatment area and adjust parameters accordingly Epic 10 User Manual pg 33 5400321 Rev H 7 4 TABLE OF PRE PROGRAMMED SETTINGS Peak Avg Pulse Pulse Duty Tip Power Power Interval Length Cycle mu m hypertrophy 0 04ms
56. trial grade batteries which under normal use have a longer life than conventional AAA batteries 8 5 TRANSPORTATION The Epic 10 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 its shipping box If you have any questions regarding transportation please BIOLASE Service at 1 800 321 6717 8 6 STORAGE The Epic 10 should be stored in a cool dry place when not in use Storage temperature 15 35 59 F 95 F relative humidity 10 70 non condensing 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 Make sure the distal end of the Handpiece shaft is protected from dirt with the CAUTION protective tip plug and Handpiece Remove the batteries from the footswitch if the Epic 10 is not likely to be used for some time CAUTION The Epic 10 is shipped inside a custom shipping box Please save and store the box in a cool dry place for use when transporting the laser or for long term storage Epic 10 User Manual pg 42 5400321 Rev H 9 CALIBRATION Calibration procedure is recommended to be performed every twenty four 24 months in order to maintain the required accuracy of output power versus displayed power Bi annual calibrations can be performed at a certified d
57. tts W according to the transmitter manufacturer and d 8s the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A Field strengths from fixed transmitters such as base stations for radio cellular cordless telephone and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Epic diode laser is used exceeds the applicable RF compliance level above the Epic diode laser should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Epic diode laser B Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m Epic 10 User Manual pg 57 5400321 Rev H RECOMMENDED SEPARATION DISTA
58. ust be disposed of after use ina cO biohazard medical waste Sharps container Handpieces are reusable and must be cleaned and sterilized between patients to avoid cross contamination Cleaning and Disinfecting Instructions Surgical Handpiece Reusable 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 pathogens 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 Epic 10 fiber optic delivery system Wear protective latex gloves when handling the contaminated delivery system To disinfect the fiber cable wipe the entire cable including the shaft with an appropriate disinfecting solution such as Cavicide or a similar quaternary ammonium compound product containing 20 alcohol or less and follow the manufacturer s instructions Avoid getting any liquid or debris near the distal end of the fiber cable Epic 10 User Manual pg 38 5400321 Rev H Manual Cleaning of the Surgical Handpiece Cleaning must be performed within a maximum of 1 hour after the procedure and always prior to sterilization 1 After use carefully remove the tip from the handpiece and dispose of in a biohazard medical waste Sharps container Carefully r
59. y 100 240V 1 5A 50 60Hz Environmental Requirements Temperature 20 25 C Humidity 15 95 Non condensing Epic 10 User Manual pg 5 5400321 Rev H 2 EQUIPMENT DESCRIPTION 2 1 GENERAL The Epic 10 system consists of three components e Base Console e Delivery System e Wireless Footswitch 2 2 BASE CONSOLE The Console has a Display Panel Touch Screen and Control Button in front It can be powered by an external mains power supply or an internal replaceable lithium ion battery pack 14 4V 2 9 Ah 2 3 CONTROL PANEL ITEM ITEM DESCRIPTION CONTROL Activates the controls and display places Button the unit into STANDBY or READY mode Amber indicates unit is in STANDBY mode Green indicates unit is in READY mode LED sciet Blinking green indicates the emission of laser power Blinking blue indicates pairing between the footswitch and laser console is active LED Indicator LED Indicator Fiber Storage Channel Control Button Figure 2 1 Control Panel Front View Epic M10 User Manual 5400321 Rev H 2 4 SURGICAL DELIVERY SYSTEM NOTE All fiber optic cables Handpieces amp tips are shipped non sterile The Epic 10 Delivery System with surgical Handpiece consists of e Re useable Fiber Optic Assembly e Re useable Surgical Handpiece Figures 2 9 e Disposable Tips Appendix A The fiber optic cable is detachable from the console The Handpiece is a Re usable access
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