Delight Your Patients, Faster.
Contents
1. 2 7 SURGICAL HANDPIECE ASSEMBLY gt Connect the Handpiece to the fiber optic assembly by pushing the Handpiece onto the fiber shaft until it clicks on and is secured Fiber Shaft Protective Cap Figure 2 9 Surgical Handpiece Assembly fully assembled epic ARKAADIA pg 9 5400577 Rev B 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 2 8 WHITENING CONTOUR HANDPIECE OPTIONAL ACCESSORY 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 the 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 8cm Spot Size To connect the Hand2. 4 2 Operation Turn on the EPIC A 17 A SOUINGS ClO E 17 4 4 Pairing the Footswitch to the Laser CONSOIE ccccsecceccceeecseeceeecececeeeceeeceeseesseeesaeess 18 e ere TE 0 EE 19 4 6 EREECHEN 19 Ar READY NOTO E 19 4 8 NV ICS ee ILC EE 20 4 9 Peak Power DISDIAY enee 20 4 10 Pulse Mode Selection cccccceccceccscsececaeeecceeeeceeeeccecescecescuaeesseeesceeescenescseeeseeeesoees 20 4 11 Using the EPIC X Touch Screen Display ccccccceceseececeeeeeeeeeeseeeeseeeeseeeesseeeeseeesaaees 22 AA POCS dieS BUON aes cerccencee eegoeen tae caeunt E E G 23 4 13 Turn the Laser Console On 23 o 81219 lee 24 SORE A AN EE E E A E E E E 24 22 ECO ee E E E OR ee E EE 24 Eege 24 5 4 Other ele Ee ee 25 6 Contraindications Warnings amp Precautions ssssssssssssssnsnnnnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 26 SC SOM elle lettre e GE 26 6 2 Warnings later 26 Prescription Giatement 26 Fy SWC EE 26 PVCS TNC Sl aces n E E ye eames aaeanmaesa 26 POY OT WUC WS geed 26 UL CMOS eege 26 PEI rn e E 27 Tales kU EE 27 PE AIC O A A E EE E A E T E 27 Ke a ele ler dea 28 Tl alt dee Lee EE 28 Ace MCN AMON IS WOW EE 28 7 3 Soft Tissue Surgery and Other Dental Uee ce ccceccccececeeeeeceeeeceeeeeseeeeseeeeseeeessaeeesaes 29 Tip Initiation Parameters and Method Not required if using pre initiated pel 29 GDKO eae pg 2 5400577 Rev B Pre programmed Settings for Dental Drocecdures 30 7 4 Table of Pre P
3. 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 screens is a Signal Strength Indicator alll 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 NOTE When the footswitch is not in use it will go into SLEEP mode to conserve battery 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
4. maintain the required accuracy of output power versus displayed power Bi 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 10 Software Specification BIOLASE respects the intellectual property of others and we ask our users to do the same EPIC X 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 the NOTE Service Representative message does not clear call BIOLASE Service at 1 800 321 6717 or your authorized Screen Message Pi Reason KS Fix Allow 5 10 minutes for Warning 1 Temperature high System is hot asa to coo doni Warning 2 Battery is low Battery is low Plug in DC supply Warning 3 Battery not connected Battery not connected Plug in the battery Warni Footswitch battery is Battery on the footswitch Replace footswitch arning 4 low is low battery Warning 5 Footswitch Footswitch held Release footswitch Re establ
5. supply lines 1 kV for input output lines 1 kV differential mode 2kV common mode 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 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 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 hospital 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 mains voltage prior to applications of the test level pg 47 54
6. 11 Endo an adjunct to root canal CW 0 1W 0 1W N A N A N A E2 No 12 Hemostasis Hemostasis CW 0 5 W 0 5W N A N A N A E4 Yes Treatment of canker sores herpetic and 13 Aphthous Ulcers aphthous ulcers of the CW 0 7 W 0 7 W N A N A N A E4 No oral mucosa Leukoplakia 14 Exposure of Unerupted Teeth ee CP2 1 8 W 0 9W N A N A N A E4 Yes 15 17 Custom 1 3 N A CW 0 1W 0 1W N A N A N A E4 Yes 18 20 Custom 4 6 N A CW 0 1W 0 1W N A N A N A E4 No Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and Pulpotomy as an adjunct to root canal therapy epic User Manual Figure 7 6 pg 31 5400577 Rev B 7 5 TEETH WHITENING PROCEDURE The following items are required to perform teeth whitening with the EPIC X laser EPIC X 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 X diode laser is designed to provide near infrared laser energy to a tissue surface for the purpose of temporary pain relief when applie
7. battery pack 14 4V 2 9 Ah 2 3 CONTROL PANEL Item Item Description CONTROL Activates the controls and display places the LED Indicator LED Indicator Button unit into STANDBY or READY or SLEEP mode NG Amber indicates unit is in STANDBY mode Green indicates unit is in READY mode LED Blinking green indicates the emission of Indicator laser power Blinking blue indicates pairing between the footswitch and laser console is active Fiber Storage Channel Control Button Figure 2 1 Control Panel Front View 2 4 SURGICAL DELIVERY SYSTEM The EPIC X Delivery System with surgical Handpiece consists of e Re useable Fiber Optic Assembly Figure 2 8 e Re useable Surgical Handpiece Figure 2 9 e Disposable Tips Appendix A epicX User Manual pg 6 5400577 Rev B The fiber optic cable is detachable from the console The Handpiece is a re usable accessory 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 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 EPIC X ships with the fiber optic cable already attached CAUTION Do not connect or disconnect the fiber while the laser console is tur
8. 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 ewe pg 11 5400577 Rev B 3 Safety 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 operatory entrances must be marked with an appropriate warning sign one 1 included e Do not operate in the presence of explosive or flammable materials Flammable anesthetics or oxidizing gases such as nitrous oxide N20 and oxygen O2 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 those WARNING specified herein may result in hazardous radiation exposure Do not use this unit if you Suspect It of functioning improperly or ot
9. 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 must be disposed of after use in a CAREA 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 X 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 Manual Cleaning of the Surgical Handpiece Cleaning must be performed within a maximum of 1 hour after the procedur
10. 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 Suction Use high speed suction as required to maintain a clear field of vision during treatment Do not fire the laser if you cannot clearly see the treatment site ig ee pg 26 5400577 Rev B 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 Make appropriate power pulse length and interval adjustments to compensate for varying tissue comp
11. 00577 Rev B GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY Continued The model EPIC laser is intended for use in 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 nu ae test level level guidance Conducted RF 3 Vrms 3 V Portable and mobile RF communications equipment should be IEC 61000 4 6 150 kHz to 80 GHz 3Vm used no 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 d 1 2VP 80 MHz to 800 MHz d 2 3VP 800MHz to 2 5GHZ Where P is the maximum output power rating of the transmitter in watts 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 C 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 re
12. 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 lf 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 cannot resume until the error is cleared Power Switch The laser console can be switched ON I 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 Interlock Figure 3 2 Power Supply Module with cord Eig ee pg 13 5400577 Rev B Use only the Power Supply Module supplied with the EPIC X laser system BIOLASE CAUTION 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 the necessary code Placing the laser in sleep mode by pressing and holding the Control button on the front panel NOTE does not re set the Access Key Code Turn the P
13. 400577 Rev B APPENDIX B Labeling CONSOLE asl BIOLASE 4 Cromwell Irvine CA 92618 USA EPIC X 7400073 EJ mum YYYY MM om e GI A CE Rx Only Lion Rechargeable pany Battery 14 4 V 2 9 Ah 5400351 Rev D ECIREF MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert GERMANY Made in the USA 5400585 Rev A Type B Applied Part The applied part is not conductive to the patient Refer to User Manual Product Serial Number Catalog Part Number Date of Manufacture Product ID Label Location Bottom of laser console THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO 50 DATED 24 JUNE 2007 MODEL EPIC X FCC ID G2OEPIC Warning Label Indicates there is the risk of possible exposure to both infrared and visible laser radiation Location Back of laser console Laser Warning Indicates the system contains a laser Location Back of Laser Console Emergency Laser Stop Switch The switch used in emergencies to stop laser output Location Right side of Laser Console Fiber Warning Indicates the laser aperture is at the end of the fiber Location Back of Laser Console IC 10338A EPIC OOSA Kee A FCC and IC Label Lists Federal Communication Commission and Industry Canada registration numbers Location Bottom of Laser Console P N 5400341 FDA Compliance Label Indic
14. 5400577 Rev B APPENDIX A Tip Guide and Accessories Diameter Length D Hart Tip Name um mm Qty Application Number ba E4 4 400um 4 30 Surgical 7400016 ll 7400019 a E4 7 A00um 7 15 Perio Combo Pack C o 15 x E4 7 E4 9 400um 9 15 Perio 15 x E4 9 C ae E3 4 300um 4 30 Surgical 7400017 a gt 7400020 Ve E3 7 300um 7 15 Perio Combo Pack G f 15 x E3 7 enn E3 9 300um 9 15 Perio 15 x E3 9 Ss E2 4 200um 4 30 Surgical 7400018 CC mm E214 200um 14 30 Endo 7400021 20mm F2 20 200um 20 20 Endo 7400015 Part No Description Part No Description 6400479 Surgical Handpiece 2 pack Eer JEDES 5 pack 2400040 Laser safety glasses Clinician 6400311 Deep Tissue Handpiece Deep Tissue Handpiece protective 6400058 Remote Interlock plug 6400310 covers aty 20 2400129 Power cord with power supply 6400465 Peel off clear screen covers qty 20 6400573 Wireless footswitch 6400457 Lithium ion battery pack for console 6400107 Tip initiation kit 6400463 Battery pack 2 x AAA 7400022 Whitening Contour Handpiece 6400437 Trunk Fiber assembly Disposable shields for Whitening 6400180 Handpiece 30 pack 5400386 Laser warning sign o Use Manta pg 41 5
15. Emergency Laser Stop Left Profile View Emergency Stop Press the red Emergency Laser Stop button Figure 3 5 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 Functional Display The System Color Display with Touch Screen and LED indicators on the control panel show the functional conditions of the system 3 4 SAFETY CLASSIFICATION The following safety classifications are applicable to the device e Laser Radiation Class A 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 ig ee pg 15 5400577 Rev B 4 Operating 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 X 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 Rech
16. GH BIOLASE Table of Contents Table OS ONS E 1 Val ele Lei de EE 4 DoT ACA INN assis E es eae AA A E teria jane saag A E 5 Web Sy SUSU AS ES ce ene greece gee cece teense eerie EE E E A 5 1 2 Facility IC GUI CIM E E 5 2 QUI IGM 1 CSTD OA serseri i ester sasencecsareedencenean Ea EREE 6 CN fe 6 WE 6 2 2 BaSe e Ee UE 6 E a O19 9 169 4 ees f Me ee enn EE ene ere enn ene ee een ene eee ee 6 2 4 Surgical Delivery System 0n000n000no0ann0annoanoaneonnnrnnnrnnrrrnrernrernnrnnrrnnrrnnerenrrrnrrrnrernnernnenne 6 SEENEN ee 7 20 n roe E 8 2 7 Surgical Handpiece Assembly cccsccccseececeececseseeceeeeseeceeeeeeeseecesseeeeseeeeseeeseeeesseeeesaaees 9 2 8 Whitening Contour Handpiece Optional Accessory ccccsececeeeeeececeeeeeeeseeeseneeseeeeans 10 2 9 Deep Tissue Handpiece Optional ACCessonm 11 Eege 12 ith ee Een aca rnorni seiko rdcerio ris catiamea E acd eenoreciusenomuuancnmmanncmouaesonss 12 3 2 Safety HS IC ere 12 RB DIOL EE 13 EMCI OY MOTION EE 13 Dy Sle lial WO ne 13 Bel ee en ogc atosaees seose dese or E E teas os 13 Access E alte gt ete nee ne Se nee eee ee ee ee eee ee 14 Eiere dure e rE E E S E E E E 14 WirelgsS eet e RE 14 Remote INSHIOC I wactcacetacecatnidatamicdaiwedbtamietwnutaneasbiienmanncadniniahracneaancadsintaanmncinerarentehstioteniientul 14 See TO EE 15 SilgteuteluzlREltei VE 15 Oe ale Ly aS SIH Cau OM WE 15 el leie geo Kiel E 16 AOT E 16 GDKO eee pg 1 5400577 Rev B
17. H x 6 5 in L 14 5 cm x 11 2 cm x 16 5 cm Dimension 2 5 lbs 1kg 5 2 ELECTRICAL Operating Voltage 100V 240V at 1 5A Frequency 50 60Hz External Fuses None Main Control Power Switch Remote Interruption Remote Interlock Disable Control Emergency Stop Button Battery Lithium lon Rechargeable 14 4V 2 9Ah DC Power Supply Module 12V DC 5A 5 3 LASER Laser Classification IV 4 Medium InGaAsP Semi conductor diode Wavelength 940 10nm Max Power Output 10W Power Accuracy 20 Power Modes Continuous Pulse Modulation Fiber Tips Diameter 200um 300 um 400um Pulse Duration 0 01ms 20ms epicx User Manual pg 24 5400577 Rev B Pulse Interval 0 01ms 20ms Pulse Repetition Rate Up to 20kHz for reference Surgical Handpiece 400um maximum in contact mode Deep Tissue Handpiece 30mm diameter 7 1cm area NOHD 4 77 meters Beam Divergence 8 22 per side angle Standard 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 ene pg 25 5400577 Rev B 6 Contraindications Warnings amp Precautions 6 1 CONTRAINDICATIONS All clinical procedures performed with EPIC X must be subjected to the same clinical judgment and care used 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 pri
18. 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 Tip Diameter um ines SE Mode 400 1 4 CW 300 1 4 CW 200 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 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 a white flash will be visible 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 dl TIP INITIATION T dl GINGIVECTOMY it L TIP 5 0 MODE PLEASE e POWER l INITIATE l KL THE TIP es LU Lo Use only new and clean tips d D J o READY IO Figure 7 5 If th
19. argeable Battery The EPIC X 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 charge and the unit will go 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 Do not connect or disconnect the fiber while the laser console is turned on Only ea connect or disconnect the fiber when the laser console is turned off Do not cover or block ventilation channels These channels provide an air flow path to eA cool the unit Do not bend the fiber optic at a sharp angle as it is can break Make sure it is not anon 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 cabl
20. as been lost Figure 4 7 press the green Ze x PAIR button ER O Figure 4 7 3 The message that PAIRING WILL NOW BEGIN will appear Figure 4 8 press the green check mark to continue O e e Figure 4 8 epic ewe pg 18 5400577 Rev B PRESS FOR 4 SECONDS 4 To complete the pairing process turn the footswitch over and ZA press the Pairing Button for four 4 seconds Figure 4 9 Figure 4 9 5a The Wireless screen will appear indicating that pairing e g was successful and that the footswitch and laser console y are now paired Figure 4 10 Proceed to step 6 O Figure 4 10 5b If pairing has not occurred the Wireless screen will appear again indicating that pairing was not successful x0 Figure 4 11 press the green button to repeat Q steps 3 and A ASi KC Figure 4 11 mill SETTINGS it 6 Press the Settings button to return to the Settings menu press GE the arrow on the bottom left of the Settings screen to return to the Home screen Figure 4 12 MOD Figure 4 12 4 5 CONTROL BUTTON The CONTROL button on the front of the laser console Figure 2 1 is a multi functional button 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 r
21. ates product complies with FDA performance standards Location Bottom of Laser Console Remote Interlock Power Input Rating Input for Remote Interlock Connector 12 Volts Direct Current 5 amps Mini USB Input For external programming 5400577 Rev B DC Power USB Remote Interlock Label Identifies input ports epi User Manual pg 42 FOOTSWITCH aad BIOLASE MT Promedt Consulting GmbH 4 Cromwell Altenhofstrasse 80 Irvine CA 92618 USA D 66386 St Ingbert GERMANY EPIC X FOOTSWITCH his device oNOTICE of f 6400573 na Dor s gege to i Gecken MODEL EPIC A two conditions 1 this device may not FCC ID G20EPIC 1 A A WM cause harmful interference and 2 this YYYY MM device must accept any interference IC 10338A EPIC received including interference that may IPX6 cause undesired operation K 5400583 Rev A f Made in the USA FCC Compliance Notice FCC and IC Label Ingress Protection Code The footswitch and laser console comply Lists Federal Communication The footswitch is water resistant with Part 15 of FCC Rules regarding Commission and Industry Canada protected against splashes of water unlicensed transmissions registration numbers Location Bottom of Footswitch Location Bottom of Footswitch Footswitch Product ID Label Location Bottom of footswitch TIPS BATTERY REV 8 WEEE Waste Electrical and DO NOT REUSE Electronic For single use only Recycle Lithium lon battery as regulate
22. customer or the user of the EPIC diode laser should assure it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance Ean 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 User Manual pg 46 5400577 Rev B GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The EPIC diode laser is intended for use in the electromagnetic environment specified 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 Surge 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 NOTE Uris the A C epig User Manual IEC 60601 test level 6 kV contact 8kV air 2 kV for power
23. d Do not throw in trash bin PACKAGING EEJ 90 En Rx Only AC kk e 4400417 Rev A JON CONDENSING TEMPERATURE THIS END UP FRAGILE RELATIVE HUMIDITY Prescription Statement Federal Law restricts this device to sale by Atmospheric or on the order of a dentist or Pressure Keep Dry physician or other licensed medical Limitations practitioner Fragile Humidity Temperature Handle with care Limitations Limitations This End UP epic Manual pg 43 5400577 Rev B APPENDIX C Safety Precautions for Lithium lon Battery Packs When using the battery WARNING 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 not carry 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 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 batte
24. d 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 application 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 setting ig ee pg 32 5400577 Rev B Fitzpatrick Skin Type Scale TYPE Highly sensitive always burns never tans Example Red hair with freckles TYPE II Very sun sensitive burns easily tans minimally Example Fair skinned fair haired Caucasians TYPE Ill Sun sensitive skin s
25. e EPIC X diode laser system 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 X utilizes a solid state diode as a semiconductor source for invisible infrared radiation The energy is delivered to the treatment site via a 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 X will prove a valuable addition to your 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 SOFT TISSUE WHITENING PAIN THERAPY Big ee pg 4 5400577 Rev B 1 Packaging 1 1 SYSTEM PARTS LIST The EPIC X laser system includes the following Laser console lithium ion battery pack already installed Screen protectors box Pee
26. e 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 2 Carefully remove the Handpiece from the fiber optic cable see Section 2 eigen pg 35 5400577 Rev B 3 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 soll 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 fora 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 o
27. e laser console is in READY mode the laser will fire if the footswitch is CAUTION activated epic Te pg 29 5400577 Rev B Pre programmed Settings for Dental Procedures To access the pre programmed procedure values 1 Goto the Procedures menu by pressing the Soft Tissue con on the Home screen 2 Press the button associated with the desired procedure A 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 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 ene pg 30 5400577 Rev B 7 4 TABLE OF PRE PROGRAMMED SETTINGS er Peak Avg Pulse Pulse Duty Tip Tip HESS AHI Jolie ouen er be
28. e onto the fiber spool counterclockwise around the base of the console see Figure 2 1 Ben Eggs ba D D D D e d W The Handpiece is now ready to use To store the Handpiece place it in the Handpiece holder located at the top of the laser console LASER WARNING Never point the laser at a person s eyes ioe ee pg 16 5400577 Rev B LASER WARNING Never operate the laser without a fiber tip attached LASER All persons present in the operatory must wear protective eyewear when the WARNING laser is in use 4 2 OPERATION TURN ON THE EPIC X 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 X Welcome screen will be displayed Figure 4 2 WELCOME WELCOME e D j X E X ef 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 X or wait 3 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 Wire
29. e 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 SSES Intertek D I Conforms to AAMI ES60601 1 of a dentist or physician or other licensed medical practitioner ee S IEC62366 IEC80601 2 60 IEC60825 1 Certified to CSA C22 2 No 60601 1 CAUTION Federal Law restricts this device to sale by or on the order ig ee pg 50 5400577 Rev B BIOLASE Inc 4 Cromwell Irvine CA 92618 USA 949 361 1200 888 424 6527 biolase com MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 mt procons com Made in the USA 2014 BIOLASE Inc All rights reserved Subject to change without notice 5400577 Rev B
30. ed 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 pg 28 VW V WV 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 5400577 Rev B 7 3 SOFT TISSUE SURGERY AND OTHER DENTAL USE Tip Initiation Parameters and Method
31. elease 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 i e 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 GDKO ee pg 19 5400577 Rev B 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 shining the end of the trunk fiber on a plain non reflective surface DO NOT look directly at the output end of the trunk fiber If the aiming beam is 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
32. flection 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 eam pg 48 5400577 Rev B RECOMMENDED SEPARATION DISTANCES 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 Rated maximum Separation distance according to
33. frequency of transmitter M output power of 150kHz to 80Mhz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d 1 2VP d 1 2VP d 2 3VP 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 E 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 pg 49 5400577 Rev B epic User Manual APPENDIX E Wireless Equipment 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 interferenc
34. gevity of the battery power only BIOLASE supplied batteries are NOTE recommended as replacements BIOLASE p n 6400463 these are industrial grade batteries which under normal use have a longer life than conventional AAA batteries 8 5 TRANSPORTATION The EPIC X 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 call BIOLASE Service at 1 800 321 6717 8 6 STORAGE The EPIC X should be stored in a cool dry place when not in use storage temperature 15 C 35 C 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 by installing the Handpiece and protective tip plug CAUTION Remove the batteries from the footswitch if the EPIC Xis not likely to be used for some time The EPIC X 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 User Manual pg 38 5400577 Rev B 9 Calibration Calibration procedure is recommended to be performed every twenty four 24 months in order to
35. he battery fluid could cause damage to the eye When charging the battery WARNING 1 Be 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 e Do not attach the batteries to a power supply plug or directly to a car s 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 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 become 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 u
36. her than described WARNING herein 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 the device may help to eliminate the interference CAUTION Always ensure that the proper laser parameters are set before the EPIC X laser is used in a clinical setting CAUTION LASER Always ensure that the protective laser eyewear is appropriate for the laser WARNING wavelength epic ee pg 12 5400577 Rev B e Do not look directly into the beam 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 the unit unattended LASER D WARNING Do not open console housing at any time Danger from optical radiation may exist LASER 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 WARNING l create a potential hazard Be aware that the metal plastic cannula on the tips may become hot during use Avoid CAUTION contact of the cannula with any tissue 3
37. hield 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 and 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 2 To remove the battery grip the battery at the top and pull the cable away from the connector Figure 8 3 Do not tug or wrench the cable from the connector 3 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 ho
38. ish pairing Alert 1 Wireless not paired No wireless connection see sec 4 Alert 2 System must be in System is not in ready Press the control button ready mode to lase mode in any procedure screen epic User Manual Figure 11 1 pg 39 5400577 Rev B Screen Message EN Reason Fix Error 1 Thermistor open Thermistor open Call Biolase service Error 2 Thermistor shorted Thermistor shorted Allow 5 10 minutes for Error 3 Shutdown temperature System too hot aserto cool down Error 4 Laser current high low Output is out of specs Call Biolase service l FS is partially pressed or Press release footswitch Ste Footswitch SONER damaged or call Biolase service Error 6 ON OFF button stuck Key stuck Press front key Error 7 Flash corrupted Memory corrupted Call Biolase service Error 8 No fiber Fiber not inserted Plug in trunk fiber L stfooiswiich Reposition console or Error 9 communica oh Wireless interference footswitch to improve communication Error 10 Emergency switch E switch pressed Press E switch again Error 11 Remote interlock Remote interlock open ECK TEMPIE INIENOGK closed Error 12 Battery critically low Battery is critically low Plug in dc supply Error 13 Internal error Internal error occurred Restart unit Error 14 Footswitch battery Footswitch battery Replace footswitch critically low battery epic User Manual Figure 11 2 pg 40
39. izing 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 spot NOTE prior to the initial treatment to assess the suitability of the selected settings for the individual patient Using the Deep Tissue Handpiece If holding the Handpiece in a constant location adjust the settings on the screen to the recommended initial power settings for therapeutic effect 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 eebe pg 34 5400577 Rev B 6 Maintenance WARNING No modification of this equipment is allowed 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 X system after each procedure Do not use bleach or abrasive cleansers 8 2 CLEANING AND STERILIZATION PROCEDURES The contamination control suggested for the EPIC X Surgical Handpiece and tips is the steam sterilization method However before sterilization the EPIC X reusable Handpiece should be MANUALLY cleaned per
40. l off clear screen cover qty 30 Delivery System Fiber Optic Assembly installed Assorted Surgical tips Surgical Handpiece box 2 pack Three 3 pairs of protective laser eyewear DC power supply and power cord one 1 US and one 1 International Welcome Kit Welcome Letter User Manual BIOLASE store information Quick Setup Guide Guide to Online Training amp Product Registration Card Limited Warranty Information 9 Laser warning sign 10 Tip initiation kit 11 Remote Interlock cable 12 Philips head screwdriver for installing Footswitch batteries 13 Footswitch 14 AAA batteries 2 Sa ot OY ee i a NOTE The laser ships with the lithium ion battery pack already installed NOTE Use proper care when transporting the unit Refer to Section 8 in this User Manual for instructions WARNING No modification of this equipment is allowed 1 2 FACILITY REQUIREMENTS e Electrical Supply 100 240V 1 5A 50 60Hz e Environmental Requirements Temperature 20 25 C Humidity 15 95 Non condensing epicx User Manual pg 5 5400577 Rev B 2 Equipment Description 2 1 GENERAL The EPIC X system consists of three components Wireless Footswitch Base Console Delivery System Fiber Optic Assembly Handpiece Tip 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
41. 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 Figure 4 14 ig ee pg 20 5400577 Rev B Duty Cycle Mode Pulse Duration on Pulse Interval off 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 ts 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 ieee mill GINGIVECTOMY alll PULSE MODE m Ga x BZA V Average Power Figure 4 14 epic ewe pg 21 5400577 Rev B 4 11 USING THE EPIC X TOUCH SCREEN DISPLAY epig BIOLASE all PROCEDURES Semer Em doe ae Y al TIP INITIATION ii ail PULSE MODE WEEN d Ip SELECTION i o epic User Manual SERVICE RESTORE RESTORE ALL SETTINGS This will set the laser to factory settings LA WIRELESS Figure 4 15 pg 22 SE WHITENING 5400577 Rev B 4 12 PROCEDURES BUTTON The EPIC X has the ability to
42. less Signal Laser Console Battery Strength Indicator Strength Indicator SOFT TISSUE wW G PAIN THERAPY Settings Button _ _ c Figure 4 4 Home Screen 4 3 SETTINGS SCREEN Pressing the Settings button 0 on the HOME screen accesses the Settings screen this screen allows the user to make changes to several system settings epic User Manual pg 17 5400577 Rev B alll SETTINGS T MO Liao Bam N LETN RF ff P N eil O 9y mm Language Aiming Beam Volume Service Mode Restore to Wireless Menu Selection 5 levels of 5 levels of sound accessible only Factory Access to brightness adjustment by authorized Default Pairing Screens Service Figure 4 5 4 4 PAIRING THE FOOTSWITCH TO THE LASER JB1 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 xi will appear in the pairing icon located in the upper left hand corner of the touchscreen Figure 4 6 SOFT TISSUE WHITENING PAIN THERAPY O Figure 4 6 To re establish pairing take the following steps 1 Go to the Settings menu on the laser console display by pressing the Settings button O select pi the Wireless icon Px WIRELESS 2 A screen will appear indicating that pairing of the footswitch to a the laser console h
43. ned 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 NOTE Make sure you hear the fiber optic click into place if you do not hear it click remove the fiber optic and reinstall it For storage wind the cable in the fiber storage channel around the base of the console in a counterclockwise direction Figure 2 1 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 PS a aw NS 7 SA Figure 2 2 Fiber Optic Access Plug Figure 2 3 Optical Access Port epic User Manual pg 7 5400577 Rev B 2 6 SINGLE USE TIPS The tips are single use accessories and are provided in three core diameters 200um 300um and 400un in different lengths see Appendix A Tips are single use only to avoid cross contamination and are designed to withstand only a single sterilization cycle they must be di
44. nly use FDA NOTE cleared USA or CE marked Europe sterilization accessories e sterilization pouch and autoclave tray e Place the Handpiece and fiber tips in separate single wrap self seal autoclave pouches 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 Minimum Time Drying Time Type of Sterilizer Temperature 121 C 250 F 30 minutes Gravity Displacement 15 30 minutes 132 C 270 15 minutes 132 C 270 F Dynamic Air Removal Pre Vacuum 4 minutes 20 30 minutes 134 C EU 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 e For instructions on how to reassemble the Handpiece please refer to section 2 7 ig ee pg 36 5400577 Rev B 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 s
45. ometimes burns slowly tans to light brown Example Darker Caucasians Minimally sun sensitive burns minimally always tans to moderate brown TYPE IV l Example Mediterranean type Caucasians TYPE V Sun insensitive skin rarely burns tans well Example Some Hispanics 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 circulation 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 O epig User Manual Move the handpiece relative to the affected anatomy Defocus the energy by moving the Handpiece further away from the skin Decrease the power setting Stop treatment Therapy Warnings and Precautions 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 overhea
46. or 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 and implantable defibrillators 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 X is designed to remove soft tissues Therefore always be aware of adjacent structures and substructures during use Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues Do not direct energy toward hard tissue such as tooth or bone Do not direct energy
47. ositions 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 LASER Never point the laser at a person s eyes All persons present in the WARNING operatory must wear protective eyewear when the laser is in operation epic ene pg 27 5400577 Rev B 7 Clinical Applications 7 1 INTRODUCTION To efficiently remove tissues it is imperative to understand the nature of the EPIC X 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 X 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 VV VV VV VV VV VV NV V VV WV V WV epic User Manual Excisional and incisional biopsies Exposure of unerupt
48. ower 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 X 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 Two 2 AAA batteries 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 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 e when the door is opened pice ewe pg 14 5400577 Rev B Figure 3 4 Remote Interlock Connector Figure 3 5
49. piece to the fiber optic cable push the Handpiece onto the fiber shaft until it clicks on 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 ewe pg 10 5400577 Rev B 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 on disinfecting the Handpiece 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 the treatment session is completed Red Cap Dust Cover Handpiece Disposable 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 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 Figure 2 16 The Handpiece is now
50. rate Power Power Interval Length Cycle Type Initiated Reduction of gingival 1 Gingivectomy G ingivoplasty hypertrophy CPO 5 0 W 10W 0 04ms 0 01ms 20 E4 Yes Vestibuloplasty Tissue retraction for impression Gingival 5 2 Troughing troughing for crown CP2 2 0 W 1 0 W 1 0 ms 1 0 ms 50 E4 Yes impressions Laser soft tissue 0 3 Curettage curettage CPL 2 4 W 0 8 W 0 2 ms 0 1 ms 30 E4 Yes Fibroma removal Excisional and incisional biopsies Gingival incision 4 Excision and excision CPI 2 1 W 0 9 W 0 2 ms 0 1 ms 30 E4 Yes Operculectomy Oral papillectomies Incision and drainage of abscess 5 Frenectomy F renotomy Frenectomy F renotomy CP2 2 0 W 1 0W 1 0 ms 1 0 ms 50 E4 Yes 6 Implant Recovery Implant Recovery CP2 2 4W 1 2 W 1 0 ms 1 0 ms 50 E4 Yes Sulcular debridement removal of diseased infected inflamed and necrosed soft tissue in the periodontal pocket to 5 7 Perio Pockets improve clinical indices CP2 1 6 W 0 8 W 1 0 ms 1 0 ms 50 E3 No including gingival index gingival bleeding index probe depth attachment loss and tooth mobility Pulpotomy Pulpotomy as 8 P ulpotomy an adjunct to root canal CW 0 1W 0 1W N A N A N A E4 Yes Soft tissue crown f 9 Crown Lengthening lengthening CPI 2 1 W 0 9 W 0 2 ms 0 1 ms 30 E4 Yes Laser removal of diseased infected 10 Infected Pockets inflamed and necrosed CP2 1 6 W 0 8 W 1 0 ms 1 0 ms 50 E4 Yes Soft tissue within the periodontal pocket Pulpotomy Pulpotomy as
51. rogrammed Gettngs 31 E RRE e Ra UE alle tele elt 32 LO Pan Leet 32 Pain Therapy Adverse E 33 Pain Therapy Warnings and Hrecautons 33 Breil Ewe RE 34 Using the Deep Tissue e Eeler 34 EE 35 Sal Daily Wali ul e 35 8 2 Cleaning and Sterilization Procedures snanunennnennnenoennnsnnnsnnnsnrrsnrrnrrrnnrrsnrrnrersnrrnneene 35 Cleaning and Disinfecting Instructions Surgical Handpiece Reusable Fiber Optic Cable 35 Manual Cleaning of the Surgical Handoiece 35 Steam Sterilization for Surgical Handpiece Single Use fe 36 Disinfecting the Whitening Contour Handpiece s ensneneeenenensnerernrnsrrrsrrrsrrrnrrrnrrrnrrerrrene 37 Disinfecting the Deep Tissue HANDPIECE ccceccceeeseecceeccececeeeceeeceeecseeceesesseeeseeesaeees 37 8 3 Installing Replacing the Console Battery Pack or 8 4 Changing the Wireless Footswitch Batteries ccccccececcseeeeeeeeeeeeeeeeeeeseeeeseeeeneeeenaaees 38 SO EIERE 38 BO UO E EEEE TE EEE EE A EAE E AE E E vecmocormpousacttacmmeaemenicaces 38 d elle le p E 39 10 ONENESS CIN CANON E 39 Mis Kr el Die Lee ln Le DEE 39 Appendix A Tip Guide and ee 41 eieiei B Laal ME 42 Appendix C Safety Precautions for Lithium lon Battery Dacks 44 Appendix D Electromagnetic Compatibility cccccccccccsssssssssseeeceeeeeeeceeeeseeseseseneeeseeeeeees 46 Appendix E Wireless Equipment Compliance Giaiement 50 ig ee pg 3 5400577 Rev B Introduction Th
52. ry 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 Ifthe 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 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 batteries in microwave ovens high pressure containers or on induction cookware pig ee pg 44 5400577 Rev B 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 t
53. sed 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 pic ee pg 45 5400577 Rev B APPENDIX D Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the CAUTION EMC information provided in the following tables Portable and mobile Radio Frequency RF communications equipment can affect medical electrical equipment Accessories Medical grade power 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 sold by WARNING 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
54. sposed of after use in a biohazard CAUTION medical waste Sharps container Always visually inspect the tip prior to use to make sure it is free of debris or damage i Be aware that the metal plastic cannula on the tips may become hot during use CAUTION 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 To provide proper laser operation do not connect tips when the handpiece is disconnected NOTE from the fiber Tip Assembly Figure 2 4 Insert the fiber tip into the Handpiece only when the Handpiece is connected to the fiber and twist Clockwise until snug Figure 2 5 Remove the fiber Tip by twisting the tip counterclockwise ig ee pg 8 5400577 Rev B Correct Bend x 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 For tips that require initiation change the tip WARNING gt For tips that do not require initiation change the tip press to bypass initiation requirement
55. store up to 20 pre set procedures EPIC X is 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 To customize the parameters e g power pulse duration interval etc for a particular clinical procedure 1 Go to the PROCEDURES menu by pressing the Soft Tissue icon 4 on the HOME screen scroll to and select the pre set you wish to overwrite Figure 4 16 2 Press and hold the banner on the selected procedure for two 2 seconds Figure 4 17 The parameters for that procedure will be changed and saved the laser console will beep when the adjusted settings are saved AOO all GINGIVECTOMY EJ oroc Y g 4 FRENECTOMY re Figure 4 16 Figure 4 17 4 13 TURN THE LASER CONSOLE OFF e Wind the fiber cable onto the fiber spool counterclockwise around the base of the console gg e Place the Handpiece onto the Handpiece holder iii 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 pig ewe pg 23 5400577 Rev B 5 Specifications 5 1 GENERAL 5 7 in W x 4 4 in
56. ting Patients with tender or sensitive skin may be hypersensitive to heat reduce power as necessary to ensure comfort during treatment Patients with swelling and or inflammation may be sensitive to heat reduce power as necessary to ensure comfort during treatment Do not treat open wounds Muscle tissue closer to the skin surface may experience a higher absorption of heat carefully monitor skin temperature and reduce power as necessary Excessive fatty tissue is known to transmit heat without much attenuation reduce power 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 pg 33 5400577 Rev B 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 Distance from the skin surface o Range of movement of the Handpiece o Patient skin type Safety and effectiveness are described by elevating the skin temperature in the treatment area util
57. urs 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 6 Recycle the used Lithium lon battery as regulated Do not throw it in a trash bin Screws to remove Battery Figure 8 2 Batter Cover Bottom of Console Figure 8 3 Battery Pack Connector Wire epic User Manual pg 37 5400577 Rev B Only use the battery pack supplied by BIOLASE The battery pack is a separate accessory NOTE 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 Pairing Button Internal View a li 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 lon
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