User Manual
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| Document Description | User Manual |
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| Date Submitted | 2014-01-10 00:00:00 |
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| Document Author: | John Bernhard |
BIOLASE, Inc. 4 Cromwell Irvine, CA 92618 USA 949.361.1200 888.424.6527 biolase.com 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&D and engineering – with unmatched training, practice integration support and service. BIOLASE leads the global dental laser market with over 24,000 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. Conforms to: AAMI ES60601-1 IEC60601-1 IEC6060-2-22 IEC62366 IEC80601-2-60 IEC60825-1 Certified to: CSA C22-2 No. 60601-1 User Manual Made in the USA © 2013 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. EPIC 10 User Manual P/N 5400525 Rev. B 5400525 Rev A, User Manual Cover, EPIC 10 Canada.indd 1 EPIC 10 User Manual P/N 5400525 Rev. B 12/20/2013 10:24:46 AM TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................. 1 Introduction ................................................................................................................................ 4 1.Packaging ............................................................................................................................... 5 1.1 System Parts List.............................................................................................................. 5 1.2 Facility Requirements ....................................................................................................... 5 2. Equipment Description ........................................................................................................... 6 2.1 General ............................................................................................................................ 6 2.2 Base Console ................................................................................................................... 6 2.3 Control Panel.................................................................................................................... 6 2.4 Surgical Delivery System .................................................................................................. 7 2.6 Fiber Optic Connection ..................................................................................................... 7 2.7 Single-Use Tips ................................................................................................................ 8 2.8 Surgical Handpiece Assembly .......................................................................................... 8 2.9 Whitening/Contour Handpiece (Optional Accessory) .......................................................11 3. Safety....................................................................................................................................12 3.1 Precautions .....................................................................................................................12 3.2 Safety Instructions ...........................................................................................................12 3.3 Safety Features ...............................................................................................................13 Energy Monitor ..................................................................................................................13 System Monitor ..................................................................................................................13 Power Switch .....................................................................................................................14 Access Key Code...............................................................................................................14 Control Button ....................................................................................................................14 Wireless Footswitch ...........................................................................................................14 Remote Interlock ................................................................................................................15 Emergency Stop ................................................................................................................15 Functional Display..............................................................................................................16 3.4 Safety Classification ........................................................................................................16 4. Operation Instructions ...........................................................................................................17 4.1 System setup ...................................................................................................................17 4.2 Operation - Turn on the EPIC 10 Laser ..........................................................................18 EPIC™10 User Manual pg. 1 5400525 Rev B 4.3 Settings Screen ...............................................................................................................19 4.4 Pairing the Footswitch to the Laser console.....................................................................19 4.5 Control Button .................................................................................................................21 4.6 Entering READY or STANDBY Modes ............................................................................21 4.7 READY Mode ..................................................................................................................21 4.8 Wireless Footswitch .........................................................................................................22 4.9 Peak Power Display ........................................................................................................22 4.10 Pulse Mode Selection ....................................................................................................22 4.11 Using the EPIC 10 Touch Screen Display......................................................................24 4.12 Procedures Button .........................................................................................................25 4.13 Turn the Laser Console Off............................................................................................25 5. Specifications ........................................................................................................................26 5.1 General ...........................................................................................................................26 5.2 Electrical ..........................................................................................................................26 5.3 Laser ...............................................................................................................................26 5.4 Other Light Sources .........................................................................................................27 6. Contraindications, Warnings & Precautions ..........................................................................28 6.1 Contraindications .............................................................................................................28 6.2 Warnings and Precautions ...............................................................................................28 Prescription Statement .......................................................................................................28 Eyewear .............................................................................................................................28 Anesthesia .........................................................................................................................28 Adjacent Structures............................................................................................................28 Suction ...............................................................................................................................29 Plume Removal..................................................................................................................29 Clinical Use ........................................................................................................................29 Training ..............................................................................................................................29 7. Clinical Applications ..............................................................................................................30 7.1 Introduction......................................................................................................................30 7.2 Indications for Use ...........................................................................................................30 7.3 Soft Tissue Surgery and Other Dental Use ......................................................................31 Tip Initiation: Parameters and Method................................................................................31 Pre-programmed Settings for Dental Procedures ...............................................................32 EPIC™10 User Manual pg. 2 5400525 Rev B 7.4 Table of Pre-Programmed Settings..................................................................................33 7.5 Teeth Whitening Procedure .............................................................................................34 8. Maintenance .........................................................................................................................35 8.1 Daily Maintenance ...........................................................................................................35 8.2 Cleaning and Sterilization Procedures .............................................................................35 Cleaning and Disinfecting Instructions for the Surgical Handpiece, and the Reusable Fiber Optic Cable ........................................................................................................................35 Manual Cleaning of the Surgical Handpiece: ......................................................................36 Steam Sterilization for Surgical Handpiece, Single Use Tips ..............................................36 Cleaning the Whitening/Contour Handpiece.......................................................................37 8.3 Installing/Replacing the Console Battery Pack .................................................................37 8.4 Changing the Wireless Footswitch Batteries ....................................................................38 8.5 Transportation .................................................................................................................39 8.6 Storage ............................................................................................................................39 9. Calibration .............................................................................................................................40 9.1 Calibration Schedule .......................................................................................................40 10. Software Specification .........................................................................................................40 11. Troubleshooting ..................................................................................................................40 APPENDIX A – Tip Guide .........................................................................................................42 APPENDIX B – Labeling ...........................................................................................................43 APPENDIX C – Safety Precautions for Lithium-Ion Battery Packs ............................................46 When USING the BATTERY .................................................................................................46 WHEN CHARGING the Battery .............................................................................................47 When DISCHARGING the Battery .........................................................................................48 APPENDIX D - Spare Parts & Accessories ...............................................................................49 System Accessories ..............................................................................................................49 Single Use Tips .....................................................................................................................49 APPENDIX E – Electromagnetic Compatibility ..........................................................................51 APPENDIX F – Wireless Equipment Compliance Statement.....................................................54 EPIC™10 User Manual pg. 3 5400525 Rev B INTRODUCTION The EPIC™ 10 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. 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™ will prove a valuable addition to your practice. Please contact BIOLASE Customer Service at 1-800-321-6717 for any service needs. This device must be installed, operated, and maintained according the guidelines of CAN/CSAZ386-08 “Laser safety in health care facilities.” EPIC™10 User Manual pg. 4 5400525 Rev B 1.PACKAGING 1.1 SYSTEM PARTS LIST The EPIC 10 laser system (BIOLASE p/n 7400042C) includes the following: 1. Laser Console (lithium ion battery pack already installed) 2. Screen Protectors box (Peel-off clear screen cover - qty. 30) 3. Tips box 4. Surgical Handpiece box (contains two (2) Surgical Handpieces) 5. Three (3) pairs of protective laser eyewear (two (2) pairs of doctor safety glasses, one (1) pair of darker patient safety glasses) 6. DC power supply and power cord 7. User Manual 8. Welcome Kit (Welcome Letter, BIOLASE store information, Quick Setup Guide, 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) 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 Electrical Supply (100-240V ~): 1.5A, 50/60Hz Environmental Requirements: Temperature: 20-25 ºC Humidity: 15-95%, Non-condensing EPIC™10 User Manual pg. 5 5400525 Rev B 2. EQUIPMENT DESCRIPTION 2.1 GENERAL The EPIC 10 laser system consists of three components: ● Base Console ● Delivery System ● 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 CONTROL Button LED Indicator ITEM DESCRIPTION Turns the controls and display on and off; places the unit into STANDBY or READY or SLEEP mode • Amber indicates unit is in STANDBY mode. • Green indicates unit is in READY mode. • Blinking green indicates the emission of laser power. • Blinking blue indicates pairing between the footswitch and laser console is active LED Indicator LED Indicator Control Button Figure 2.1: Control Panel (Front View) EPIC™10 User Manual pg. 6 5400525 Rev B 2.4 SURGICAL DELIVERY SYSTEM NOTE: All fiber optic cables, handpieces & tips are shipped non-sterile. The EPIC 10 Re-Useable Delivery System with surgical Handpiece consists of: • Re-useable Fiber Optic Assembly • Re-useable Surgical Handpiece (Figures 2.4, 2.5) • Disposable Tips (See Figures 2.7, 2.8, 2.9, 2.10) NOTE: 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. 2.6 FIBER OPTIC CONNECTION The EPIC 10 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). NOTE: You should 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. EPIC™10 User Manual pg. 7 5400525 Rev B Figure 2.2: Fiber Optic Access Plug Figure 2.3: Optical Access Port 2.7 SINGLE-USE TIPS The tips are single-use accessories and are provided in three core diameters: 200μm, 300μm, and 400μm, in different lengths (see Appendix A). CAUTION: 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 a biohazard medical waste Sharps container. Always visually inspect the tip prior to use to make sure it is free of debris or damage. To connect the tip, insert it firmly into the distal end of the handpiece as far as it will go, then tighten by turning clockwise (Figure 2.7). Bend the metal cannula according to the specific procedure requirements (Figure 2.10). Remove the fiber tip by twisting the tip counterclockwise (Figure 2.8). To provide proper laser operation, do not connect tips when the handpiece is disconnected. NOTE: 2.8 SURGICAL HANDPIECE ASSEMBLY ► To 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 (Figures 2.4, 2.5). ► To disconnect the handpiece from fiber optic assembly (Figure 2.6): • Take the handpiece body in one hand and the shaft in another • Push the two buttons on the fiber shaft • Pull the handpiece with the ring to separate. EPIC™10 User Manual pg. 8 5400525 Rev B Fiber Shaft Protective Cap Handpiece Figure 2.4: Connecting the handpiece to the fiber optic assembly Figure 2.5: Surgical handpiece assembly fully assembled Figure 2.6: Disconnect the handpiece from the fiber optic assembly by pressing both buttons at the base of the fiber shaft Tip Assembly Figure 2.7: Insert the fiber tip into the handpiece and twist clockwise until snug Figure 2.8: Remove the fiber tip by twisting the tip counterclockwise EPIC™10 User Manual pg. 9 5400525 Rev B Correct Bend Incorrect Bend Figure 2.9: When installing the tip, make sure it is seated properly (thread correctly) WARNING: Figure 2.10: Bending the tip cannula When the aiming beam is not present or has a significantly different shape, change the tip. EPIC™10 User Manual pg. 10 5400525 Rev B 2.9 WHITENING/CONTOUR HANDPIECE (OPTIONAL ACCESSORY) NOTE: The Whitening/Contour Handpiece is reusable and equipped with a disposable nonsterile protective shield for single patient use. The handpiece is non-sterile and requires cleaning before and after each patient treatment. This handpiece cannot be sterilized in the autoclave. For instructions on cleaning 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 treatment session is completed. Figure 2.13: Whitening/Contour Handpiece Figure 2.14: Disposable Non-Sterile Shield The area of Laser Energy Output for the Whitening/Contour Handpiece is 35mm x 8mm = 2.8cm2 Spot Size. To connect the handpiece 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: • Take the handpiece body in one hand and the shaft in another. • Push two buttons on the fiber shaft. • Pull the handpiece from the ring to separate. EPIC™10 User Manual pg. 11 5400525 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: • When the laser is in use, all operatory entrances must be marked with an appropriate warning sign (one (1) included). • Do not operate in the presence of explosive or flammable materials. Flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided. Solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before laser is used. Attention should also be drawn to the danger of ignition of endogenous gases. • 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 WARNING: Use of controls or adjustments or performance of procedures other than 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. CAUTION: This unit has been designed and tested to meet the requirements of electromagnetic, electrostatic, and radio frequency interference standards. However, the possibility of electromagnetic or other interference may still exist. Relocating the device may help to eliminate the interference. CAUTION: Always ensure that the proper laser parameters are set before the EPIC 10 laser is used in a clinical setting. EPIC™10 User Manual pg. 12 5400525 Rev B LASER WARNING: Always ensure that the protective laser eyewear is appropriate for the laser wavelength. • Do not look directly into the beam or at specular reflections. • Never direct or point the beam at a person’s eyes. • Always place the system into STANDBY mode (by pressing the Control Button while in READY mode) before exchanging Handpieces or disposable tips. • Toggle the ON/OFF switch (located on the rear of the console) to the OFF (O) position before leaving unit unattended. LASER WARNING: Do not open unit housing at any time. Danger from optical radiation may exist. LASER WARNING: Do not aim the laser at metallic or reflective surfaces, such as surgical instruments or dental mirrors. If aimed directly at these surfaces the laser beam will reflect and create a potential hazard. CAUTION: Be aware that the metal / plastic cannula on the tips may become hot during use. Avoid contact of the cannula with any tissue. 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 not resume until the error is cleared. EPIC™10 User Manual pg. 13 5400525 Rev B 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 CAUTION: Figure 3.2: Power Supply Module with cord Use only the Power Supply Module (BIOLASE Part Number 2400129) supplied with the EPIC 10 laser system. Access Key Code The Access Key Code prevents unauthorized use of the system. It is activated every time system is turned on with the Power Switch (refer to Section 4 for code). NOTE: Placing the laser in SLEEP mode by pressing and holding the Control button on the 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 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. 14 5400525 Rev B Two (2) AAA batteries are required to power the footswitch (included). (For instructions on how to replace the footswitch batteries, see Section 4.) Figure 3.3: Footswitch Remote Interlock This feature allows the laser console to be connected to the remote sensor, preventing its operation when triggered (e.g., by opening door). The electric cable from this connector should be wired to the normally closed switch, sensing the opening of a door and turning the laser console off when the switch is open. To override this feature, don’t connect the plug. Figure 3.4: Remote Interlock Connector 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. EPIC™10 User Manual pg. 15 5400525 Rev B 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 system. 3.4 SAFETY CLASSIFICATION The following safety classifications are applicable to the device: • Laser Radiation – Class 4 • Aiming Beam – Class 2 • Type of protections against electrical shock – Class 1 • Degree of protection against electrical shock – Type B Applied Part • Not protected against water ingress – Ordinary Equipment • Not suitable for use in presence of flammable anesthetic mixture • Operation Mode – Continuous Wave and Pulse Mode • Wireless Footswitch – IPX6 EPIC™10 User Manual pg. 16 5400525 Rev B 4. OPERATION INSTRUCTIONS 4.1 SYSTEM SETUP • Place the unit in a clean, dry, and well-ventilated area. • Verify power switch is in the OFF (O) position. • EPIC will work using either DC power or the rechargeable battery pack: DC Power: Connect the power cord of the power supply to the laser console and plug into a wall outlet Rechargeable Battery: The EPIC 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. NOTE: • 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. Connect the fiber to the laser console (see Section 2). 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. 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. • Remove protective cap from the end of the fiber shaft (see Figure 2.4). • Carefully connect the handpiece to the fiber optic assembly (see Figures 2.4, 2.5). • Insert the selected tip and tighten it clockwise until snug (see Figure 2.7). • Wind any excess fiber optic cable onto the fiber spool counterclockwise around the base of the console. • 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 EPIC™10 User Manual pg. 17 5400525 Rev B LASER WARNING: Never point the laser at a person’s eyes. LASER WARNING: Never operate the laser without a fiber tip attached. LASER WARNING: All persons present in the operatory must wear protective eyewear when the laser is in use. 4.2 OPERATION - TURN ON THE EPIC 10 LASER • 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 “Welcome” screen will be displayed (Figure 4.2). Figure 4.1 Figure 4.2 Figure 4.3 • 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) and then the screen reverts back to the Welcome screen; re-enter the correct code.) • The system will go to the HOME screen which identifies two procedure categories to choose from: Soft Tissue, Whitening. Wireless Signal Strength Indicator Laser Console Battery Strength Indicator Settings Button Figure 4.4: Home Screen EPIC™10 User Manual pg. 18 5400525 Rev B 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) Volume (5 levels of sound adjustment) Service mode (accessible only by authorized 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 “ ” will appear in the pairing icon located in the upper left hand corner of the touchscreen (Figure 4.6). Figure 4.6 EPIC™10 User Manual pg. 19 5400525 Rev B To re-establish pairing, take the following steps: 1. Go to the Settings menu on the laser console display by pressing the Settings button and select the “Wireless” icon 2. A screen will appear indicating that pairing of the footswitch to the laser console has been lost (Figure 4.7); press the green PAIR button. Figure 4.7 3. The message that “PAIRING WILL NOW BEGIN” will appear; press the green check mark to continue (Figure 4.8). Figure 4.8 4. To complete the pairing process, turn the footswitch over and press the Pairing Button (Figure 4.9). for four (4) seconds Figure 4.9 5a. The Wireless screen will appear indicating that pairing was successful and that the footswitch and laser console are now paired (Figure 4.10). Proceed to step 6. Figure 4.10 EPIC™10 User Manual pg. 20 5400525 Rev B 5b. If pairing has not occurred, the Wireless screen will appear again indicating that pairing was not successful (Figure 4.11); press the green button to repeat steps 3 – 5a. Figure 4.11 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 (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. EPIC™10 User Manual pg. 21 5400525 Rev B 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 screens is a Signal Strength Indicator 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 will go into SLEEP mode when not in use 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, 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). MODE* PULSE DURATION (on) PULSE INTERVAL (off) Duty Cycle CP0 CP1 CP2 P3 10 microseconds 100 microseconds 1 millisecond 20 milliseconds 40 microseconds 200 microseconds 1 millisecond 20 milliseconds 20% 33% 50% 50% (Time On / Time off) *CP = Comfort Pulse; P3 = Pulsed Mode which is the standard for most diode lasers currently available to the marketplace Figure 4.13 EPIC™10 User Manual pg. 22 5400525 Rev B NOTE: Operating the laser at a shorter pulse duration typically results in lower tissue temperature. Peak Power Average Power Figure 4.14 EPIC™10 User Manual pg. 23 5400525 Rev B 4.11 USING THE EPIC 10 TOUCH SCREEN DISPLAY Figure 4.15 EPIC™10 User Manual pg. 24 5400525 Rev B 4.12 PROCEDURES BUTTON The EPIC 10 has the ability to store up to 20 pre-set procedures; EPIC 10 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. In order to customize the parameters for a particular clinical procedure: 1. Select PROCEDURES mode and scroll to the pre-set you wish to overwrite. 2. Adjust the operating parameters of the laser (e.g., power, pulse duration, interval, etc.). 3. Press and hold the name of the selected procedure (Figure 4.16) for approximately two (2) seconds. Parameters for that procedure will be changed and saved (the laser console will beep when the adjusted settings are saved). 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. • Place the handpiece onto the handpiece holder. 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. • Press the CONTROL button on the front of the console for more than 2 seconds to turn the display off. • 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. 25 5400525 Rev B 5. SPECIFICATIONS 5.1 GENERAL Dimension 5.7 in (W) x 4.4 in (H) x 6.5 in (L) (14.5 cm x 11.2 cm x 16.5 cm) Weight 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 Ion 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 200µm, 300 µm, 400µm EPIC™10 User Manual pg. 26 5400525 Rev B Pulse Duration 0.01 ms – 20 ms Pulse Interval 0.04 ms – 20 ms Pulse Repetition Rate Up to 20kHz (for reference) Spot size Surgical Handpiece 400 µm (maximum in contact mode) Whitening Handpiece Rectangular 35 mm x 8 mm = 2.8 cm2 NOHD 4.77 meters Beam Divergence 8 - 22° per side angle Standard Fiber Cable Length 5 feet (1.5 meters) 5.4 OTHER LIGHT SOURCES Aiming Beam EPIC™10 User Manual Laser diode, max 1 mW, 625 nm – 670 nm pg. 27 5400525 Rev B 6. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS 6.1 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 understood before clinical treatment. The clinician must completely understand the patient’s medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease (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 or ablate underlying or adjacent tissues. Do 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™10 User Manual pg. 28 5400525 Rev B Suction Use high-speed suction as required to maintain a clear field of vision during treatment. Do not use the EPIC 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. Make 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. EPIC™10 User Manual pg. 29 5400525 Rev B 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 laser 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: • Excisional and incisional biopsies • Vestibuloplasty • Exposure of unerupted teeth • Tissue retraction for impression • Fibroma removal • Laser soft tissue curettage • Frenectomy • • Frenotomy • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Gingival troughing for crown impressions • • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis and coagulation 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.) • Implant recovery • • Light activation for bleaching materials for teeth whitening Incision and drainage of abscess • • Laser-assisted whitening/bleaching of teeth 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™10 User Manual pg. 30 5400525 Rev B 7.3 SOFT TISSUE SURGERY AND OTHER DENTAL USE Tip Initiation: Parameters and Method 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; while in the TIP INITIATION screen, initiate the tip by following the steps outlined below. Tip Diameter (µm) (Preset) Power (W) Mode 400 300 200 1.4 1.4 CW CW Tip initiation not required when used for recommended procedures Figure 7.1 ● Review the table in Figure 7.1 to determine whether the tip requires initiation. ● Touch the tip to the surface of the initiation block, without activating the laser (Figure 7.2). Figure 7.2 ● 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 ● 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). ● Repeat initiation process as needed to ensure the tip is initiated. Figure 7.4 After tip initiation is completed, press the check mark to access the screen for the selected procedure. Figure 7.5 CAUTION: If the laser console is in “READY” mode, the laser will fire if the footswitch is activated. EPIC™10 User Manual pg. 31 5400525 Rev B LASER WARNING: 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 Pre-programmed Settings for Dental Procedures To access the pre-programmed procedure values: 1. Go to the Procedures menu by pressing the Soft Tissue icon on the Home screen. 2. Press the button associated with the desired procedure. 3. Press the up and down arrows CAUTION: to scroll for additional procedures. 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 300μm and 400μm tips. 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. NOTE: 300μm tips are recommended for removing thin tissue layers. 400μm tips are recommended for removing fibrous tissue. Always use your clinical judgment when selecting power, pulse length, and pulse interval parameters to ensure optimal clinical results. At all times observe the clinical effects on the treatment area and adjust parameters accordingly. EPIC™10 User Manual pg. 32 5400525 Rev B 7.4 TABLE OF PRE-PROGRAMMED SETTINGS Preset Name Indications for Use Mode Peak Power Avg. Power Pulse Interval Pulse Length Duty Cycle Tip Type Tip Initiated? Gingivectomy/Gingivoplasty Reduction of gingival hypertrophy, Vestibuloplasty CP0 5.0 W 1.0 W 0.04 ms 0.01 ms 20% E4 YES Troughing Tissue retraction for impression, Gingival troughing for crown impressions CP2 2.0 W 1.0 W 1.0 ms 1.0 ms 50% E4 YES Curettage Laser soft tissue curettage CP1 2.4 W 0.8 W 0.2 ms 0.1 ms 30% E4 YES Excision Fibroma removal, Excisional and incisional biopsies, Gingival incision and excision, Operculectomy, Oral papillectomies, Incision and drainage of abscess CP1 2.7 W 0.9 W 0.2 ms 0.1 ms 30% E4 YES Frenectomy/Frenotomy Frenectomy/Frenotomy CP2 2.0 W 1.0 W 1.0 ms 1.0 ms 50% E4 YES Implant Recovery Implant Recovery CP2 2.4 W 1.2 W 1.0 ms 1.0 ms 50% E4 YES Perio Pockets 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.) CP2 1.6 W 0.8 W 1.0 ms 1.0 ms 50% E3 NO Pulpotomy(*) Pulpotomy, Pulpotomy as an adjunct to root canal CW 0.1 W 0.1 W N/A N/A N/A E4 YES Crown Lengthening Soft tissue crown lengthening CP1 2.7 W 0.9 W 0.2 ms 0.1 ms 30% E4 YES 10 Infected Pockets Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket CP2 1.6 W 0.8 W 1.0 ms 1.0 ms 50% E4 YES 11 Endo (*) Pulpotomy, Pulpotomy as an adjunct to root canal CW 0.1 W 0.1 W 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 13 Aphthous Ulcers Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Leukoplakia CW 0.7 W 0.7 W N/A N/A N/A E4 NO 14 Exposure of Unerupted Teeth Exposure of unerupted teeth CP2 0.7 W 0.7 W N/A N/A N/A E4 YES 15-17 Custom 1-3 N/A CW 0.1 W 0.1 W N/A N/A N/A E4 YES 18-20 Custom 4-6 N/A CW 0.1 W 0.1 W 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. Figure 7.6 EPIC™10 User Manual pg. 33 5400525 Rev B 7.5 TEETH WHITENING PROCEDURE The following items are required to perform teeth whitening with the EPIC 10 laser: • EPIC 10 laser • Whitening/Contour Handpiece (Optional Accessory). • LaserWhite™ 20 Whitening Gel Kit, BIOLASE p/n 7400063, 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. Figure 7.7: LaserWhite™ 20 Whitening Gel Kit (BIOLASE PN 7400063) EPIC™10 User Manual pg. 34 5400525 Rev B 8. MAINTENANCE WARNING: Changes or modifications not expressly approved by Biolase could void the user’s authority to operate the equipment. 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 system after each procedure. Do not use bleach or abrasive cleansers. 8.2 CLEANING AND STERILIZATION PROCEDURES The contamination control suggested for the EPIC surgical handpiece and tips is the steam sterilization method. However, before sterilization, the EPIC reusable handpiece should be carefully cleaned per the following procedure. CAUTION: 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 biohazard medical waste Sharps container. Handpieces are reusable and must be cleaned and sterilized between patients to avoid cross-contamination. Cleaning and Disinfecting Instructions for the Surgical Handpiece, and the 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 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. 35 5400525 Rev B 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. 2. Carefully remove the handpiece from the fiber optic cable (see Section 2). 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 soil. 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. • Place the handpiece and fiber tips in separate single-wrap, self-seal autoclave pouches. • Place on an autoclave tray; do not stack other instruments on top of the pouches. • Place the tray inside the autoclave chamber and set the appropriate cycle as recommended in Figure 8.1. EPIC™10 User Manual pg. 36 5400525 Rev B Type of Sterilizer Temperature Min Time 121°C ( 250°F) 30 minutes 132°C (270°F) 15 minutes Gravity Displacement Drying Time 15 – 30 minutes 132°C (270°F) Dynamic-Air-Removal (Pre-Vacuum) 4 minutes 20 - 30 minutes 134°C (273°F) Figure 8.1 • 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. Cleaning 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 avoid crosscontamination. To clean 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. 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 8.1). 2. To remove the battery, grip the battery at the top and pull the cable away from the connector (Figure 8.2). 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 8.2). 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) 6. Recycle the used Lithium Ion battery as regulated. Do not throw it in a trashbin. EPIC™10 User Manual pg. 37 5400525 Rev B Screws to remove Battery cover Figure 8.1: Battery Cover/Bottom of Console NOTE: Figure 8.2: Battery Pack/Connector Wire 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 3), 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 8.3) while changing the batteries, as this will disrupt the pairing of the laser console and footswitch. Pairing Button (Internal View) Figure 8.3 Although replacing the batteries will not 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. NOTE: To ensure the longevity of the battery power, only BIOLASE-supplied batteries are recommended as replacements (BIOLASE p/n 6400463); these are industrial-grade EPIC™10 User Manual pg. 38 5400525 Rev B 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 call 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°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. CAUTION: Make sure the distal end of the handpiece shaft is protected from dirt with the protective tip plug and handpiece. CAUTION: Remove the batteries from the footswitch if the EPIC 10 is not likely to be used for some time. The EPIC 10 laser system 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. 39 5400525 Rev B 9. CALIBRATION 9.1 CALIBRATION SCHEDULE 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. 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 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 appear, follow the troubleshooting instructions for the specific message as noted below. NOTE: For any on-screen message not listed in Figure 11.1, re-power the laser console; if the message does not clear, call BIOLASE Service at 1-800-321-6717 or your authorized Service Representative EPIC™10 User Manual pg. 40 5400525 Rev B Title Error 1 Reason Message Thermistor Open Fix Thermistor Open Call BIOLASE Service Error 2 Thermistor Shorted Thermistor Shorted Error 3 Shutdown Temperature System too hot Allow 5-10 mins for laser to cool down Error 4 Laser Current High/ Low Output is out of specs Call BIOLASE Service Error 5 FS shorted in Standby FS is partially pressed or is damaged Press/Release FS 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 Error 9 Lost Footswitch Communication Wireless Interference Reposition console or FS to improve communication Error 10 Emergency Switch E-Switch Pressed Press E-Switch Again Error 11 Remote Interlock Remote interlock open Check Remote Interlock closed Error 12 Battery Critically Low Battery Critically Low Plug in DC supply Warning 1 Temp High System is hot Allow 5-10 mins for laser to cool down Warning 2 Battery Low Battery is low Plug in DC supply Warning 3 Battery Not Connected Battery not connected Plug in Battery Warning 4 FS Battery Low Battery on FS low Replace FS battery Alert 1 Wireless Not Paired No wireless connect Re-establish pairing (see Sec 4) Alert 2 System must be in READY mode to lase System is not in READY mode Press the Control Button in any procedure screen Figure 11.1 EPIC™10 User Manual pg. 41 5400525 Rev B APPENDIX A – TIP GUIDE Tip mm 7mm 9mm mm 7mm 9mm mm 14mm 20mm EPIC™10 User Manual Name Diameter (µm) Length (mm) Qty Part Number E4-4 400µm 30 7400016 E4-7 400µm 15 E4-9 400µm 15 E3-4 300µm 30 E3-7 300µm 15 E3-9 300µm 15 E2-4 200µm 30 7400018 E2-14 200µm 14 30 7400021 E2-20 200µm 20 20 7400015 pg. 42 7400019 Combo Pack 15 x E4-7, 15 x E4-9 7400017 7400020 Combo Pack 15 x E3-7, 15 x E3-9 5400525 Rev B APPENDIX B – LABELING Symbols Description Product ID Label Location: Bottom of laser console Refer to User Manual Type B Applied Part: The applied part is not conductive to the patient. FDA Compliance Label: Indicates the device complies with FDA laser standards. Warning Label: Indicates there is the risk of possible exposure to both infrared and visible laser radiation. Location: Back of laser console EPIC™10 User Manual pg. 43 5400525 Rev B FCC Compliance Notice: The footswitch and laser console comply with Part 15 of FCC Rules regarding unlicensed transmissions. Location: Bottom of Footswitch FCC and IC Label: Lists Federal Communication Commission and Industry Canada registration numbers. Ingress Protection Code: The footswitch is water-resistant, protected against splashes of water. IPX6 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 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. EPIC™10 User Manual pg. 44 5400525 Rev B WEEE (Waste Electrical and Electronic) Recycle Lithium Ion 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 external 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. EPIC™10 User Manual pg. 45 5400525 Rev B APPENDIX C – SAFETY PRECAUTIONS FOR LITHIUMION 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: • Do not place the battery in fire or heat the battery. • Do not install the battery backwards so that the polarity is reversed. • Do not connect the positive terminal and the negative terminal of the battery to each other with any metal object (such as a wire). • Do not carry or store the batteries together with necklaces, hairpins, or other metal objects. • 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. • Do not solder directly onto the battery. • 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. 2. When the battery is worn out, insulate the terminals with adhesive tape or similar materials before disposal. EPIC™10 User Manual pg. 46 5400525 Rev B 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. 5. In the 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. 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. • 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 car’s cigarette lighter. • 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. EPIC™10 User Manual pg. 47 5400525 Rev B 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. 48 5400525 Rev B APPENDIX D - SPARE PARTS & ACCESSORIES SYSTEM ACCESSORIES BIOLASE p/n Description 6400479 Surgical Handpiece (2-pack) 2400040 Laser Safety Glasses (Clinician) 6400058 Remote Interlock Plug 2400129 Power Cord with Power Supply 6400146 Wireless Footswitch 6400107 Tip initiation kit 7400022 Whitening/Contour Handpiece 6400180 Whitening Handpiece disposable shields (30-pack) 7400063 LaserWhite 20 Whitening Gel Kit (pack of 5) 6400465 Peel-off clear screen covers (qty. 30) 6400457 Lithium ion battery pack for console 6400463 Battery Pack, (2 x AAA) 6400437 Trunk Fiber Assembly SINGLE USE TIPS Surgical: BIOLASE p/n Description 7400018 200 µm core diameters (qty. 30) 7400017 300 µm core diameters (qty. 30) 7400016 400 µm core diameters (qty. 30) EPIC™10 User Manual pg. 49 5400525 Rev B Perio: BIOLASE p/n Description 7400020 300 µm core diameters (qty. 30) 7400019 400 µm core diameters (qty. 30) Endo: BIOLASE p/n Description 7400015 EZTIP Endo Kit, E2, 20mm 7400021 200 µm core diameters (qty. 30) EPIC™10 User Manual pg. 50 5400525 Rev B APPENDIX E – ELECTROMAGNETIC COMPATIBILITY GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The model Epic 10 is intended for use in the electromagnetic environment specified below. The customer or the user of the model Epic 10 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 60601 test level Continuous level Electromagnetic environment guidance ± 6 kV contact ± 6 kV contact ± 8kV air ± 8kV air ± 2 kV for power supply lines ± 2 kV for power supply lines Main power quality should be that of a typical commercial or hospital environment. ± 1 kV for input/output lines N/A Input/output that does not apply because the footswitch cable length is less than 3 meters. ± 1 kV differential mode ± 1 kV differential mode ± 2kV common mode ± 2kV common mode Mains power quality should be that of a typical commercial or hospital environment. <5% Ur (>95% dip in UT) for 0.5 cycle <5% Ur (>95% dip in UT) for 0.5 cycle 40% Ur (60% dip in UT) for 5 cycles 40% Ur (60% dip in UT) for 5 cycles 70% Ur 70% Ur (30% dip in Ur) for 25 cycles (30% dip in Ur) for 25 cycles <5% Ur (>95% dip in Ur) for 5 seconds <5% Ur (>95% dip in Ur) for 5 seconds 3 A/m 3 A/m IEC 61000-4-8 Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, relative humidity should be at least 50%. Mains power quality should be that of a typical commercial or hospital environment. If the user of the model Epic 10 requires continued operation during power mains interruptions, it is recommended that the model Epic 10 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: Ur is the A.C. mains voltage prior to applications of the test level. EPIC™10 User Manual pg. 51 5400525 Rev B GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY (Continued) The model Epic 10 is intended for use in the electromagnetic environment specified below. The customer or the user of the model Epic 10 should assure that it is used in such an environment. Immunity test IEC 60601 test level Conducted RF 3 Vrms IEC 61000-4-6 150 kHz to 80 GHz Radiated RF 3V/m IEC61000-4-3 80 MHz to 2.5 GHz Continuous level 3V 3Vm Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the model Epic 10, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800MHz to 2.5GHZ Wher 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,a should be less than the compliance level in each frequency range.b 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 10 is used exceeds the applicable RF compliance level above, the Epic 10 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Epic 10. B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. EPIC™10 User Manual pg. 52 5400525 Rev B RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EPIC 10 The Epic 10 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Epic 10can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Epic 10 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter M Rated maximum output power of transmitter W 150kHz to 80Mhz d = 1.2√P 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz d = 2.3√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 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. 53 5400525 Rev B APPENDIX F – 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 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: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. This Class [B] digital apparatus meets all requirements of the Canadian InterferenceCausing Equipment Regulations. EPIC™10 User Manual pg. 54 5400525 Rev B BIOLASE, Inc. 4 Cromwell Irvine, CA 92618 USA 949.361.1200 888.424.6527 biolase.com 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&D and engineering – with unmatched training, practice integration support and service. BIOLASE leads the global dental laser market with over 24,000 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. Conforms to: AAMI ES60601-1 IEC60601-1 IEC6060-2-22 IEC62366 IEC80601-2-60 IEC60825-1 Certified to: CSA C22-2 No. 60601-1 User Manual Made in the USA © 2013 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. EPIC 10 User Manual P/N 5400525 Rev. B 5400525 Rev A, User Manual Cover, EPIC 10 Canada.indd 1 EPIC 10 User Manual P/N 5400525 Rev. B 12/20/2013 10:24:46 AM
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