Biolase Epic X User Manual
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Biolase Epic X User Manual

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Summary of Contents for Biolase Epic X

  • Page 1 User Manual...

  • Page 3: Table Of Contents

    Suction ............................14 Plume Removal .......................... 14 Treatment, Technique and Settings .................... 14 Clinical Environment ........................14 6 SAFETY WITH THE EPIC X ..................15 6.1 Safety Instructions ........................16 6.2 Safety Classification ........................16 6.3 Safety Features .......................... 17 Energy Monitor ........................... 17...
  • Page 4 7.14 Wireless Footswitch ........................29 7.15 Peak Power Display ........................30 7.16 Pulse Mode Selection ......................... 30 7.17 Using the Epic X Touch Screen Display ..................31 7.18 Procedures Button ........................32 7.19 Turn the Laser Console Off ......................32 8 CLINICAL APPLICATIONS ....................
  • Page 5 Pre-Initiated ............................51 APPENDIX B- ACCESSORIES ..................52 APPENDIX C- LABELING ....................53 APPENDIX D- SAFETY PRECAUTIONS FOR LITHIUM-ION BATTERY PACKS .... 57 APPENDIX E- ELECTROMAGNETIC COMPATIBILITY ............ 59 APPENDIX F- WIRELESS EQUIPMENT COMPLIANCE STATEMENT ......63 Epic X User Manual...

  • Page 6: Introduction

    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.

  • Page 7: Indications For Use

    • 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 X User Manual...

  • Page 8: Specifications

    30 mm diameter = 7.1 cm area. • Whitening Handpiece Rectangular 35mm x 8mm = 2.8cm • NOHD 2.7 meters. • Beam Divergence 8- 22° per side angle. • Standard Fiber Cable Length 5 feet (1.524 meters). 3.4 OTHER LIGHT SOURCES • Aiming Beam Laser diode, max 1 mW, 625 nm – 670 nm, Class 2. Epic X User Manual...

  • Page 9: Equipment Description

    Equipment Description 4.1 SYSTEM COMPONENTS The Epic X laser system includes the following: Laser Console (Lithium Ion Battery Pack Already Installed). 2. Screen Protectors Box (Peel-off Clear Screen Cover - qty. 30). Fiber Optic Cable Assembly (Installed). Assorted Surgical Tips. Surgical Handpiece (2). Laser Protective Eyewear (3). DC Power Supply and Power Cord (1).

  • Page 10: General

    Equipment Description 4.2 GENERAL The Epic X system consists of three components: Base Console Fiber Delivery System LED Indicators LED Indicators Control Button Fiber Storage Channel Handpiece Fiber Optic Assembly Wireless Footswitch Figure 4.1 Epic X User Manual...

  • Page 11: Base Console

    The surgical Handpiece is re-usable and detachable from the fiber (Figure 4.3). It is the conduit through which laser energy flows from the laser, through the Fiber Optic Cable, to the Tip. WHITENING HANDPIECE (OPTIONAL Figure 4.3 The Whitening/Contour Handpiece is a re-usable Handpiece which can be used for teeth whitening and comes equipped with disposable non-sterile shields for single-patient use (Figure 4.4). Figure 4.4 Epic X User Manual...

  • Page 12: Deep Tissue Handpiece (Optional)

    The shields are applied to the spacer and discarded after one-time use. WIRELESS FOOTSWITCH The Epic X laser will only emit laser energy when the user presses down on the Footswitch while the laser is in Ready Figure 4.5 mode. It is designed to work using wireless technology and is powered by two AAA batteries which are installed prior to shipment from the factory;...

  • Page 13: Contraindications, Warnings, And Precautions

    Contraindications, Warnings, and Precautions 5.1 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 prior to treatment and exercise caution for general medical conditions that might contraindicate a local procedure;...

  • Page 14: Adjacent Structures

    Contraindications, Warnings, and Precautions 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 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...

  • Page 15: Safety With The Epic X

    Safety with the Epic X Failure to comply with the 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. WARNING: No modification of this equipment is allowed. Symbol warns of laser beam hazard. Always wear appropriate eye protection. Symbol indicates laser aperture is at the end of the Fiber Optic Cable; when attached to the laser console, visible and/or invisible laser radiation is emitted from this aperture.

  • Page 16: Safety Instructions

    • Always place the system into Standby mode (by pressing the control button while in Ready mode) before exchanging Handpieces or disposable Tips. • Always ensure that the proper laser parameters are set before the Epic X laser is used in a clinical procedure. • Toggle the ON/OFF switch (located on the rear of the console) to the OFF (O) position before leaving the unit unattended.

  • Page 17: Safety Features

    “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 Figure 6.1: Power Switch, DC or your BIOLASE-authorized service representative. Power Input, Remote Interlock...

  • Page 18: Wireless Footswitch

    Safety with the Epic X 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. 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...

  • Page 19: Installation And Setup

    • Verify the power switch is in the OFF (O) position. • Epic X will work using either DC power or its rechargeable battery pack DC Power: Connect the power cord of the power supply to the laser console and plug into a wall outlet.

  • Page 20: Surgical Handpiece Assembly

    (Figures 7.3, 7.4). If no click is audible, disconnect the Handpiece and then re-install it. Protective Cap Fiber Shaft Handpiece Collar Figure 7.3: Connecting the Handpiece to the Fiber Optic Cable assembly Figure 7.4: Surgical Handpiece Assembly fully assembled Epic X User Manual...

  • Page 21: Single-Use Tips

    CAUTION: Be aware that the metal/plastic cannula on the Tips may become hot during use. Avoid contact of the cannula with any tissue. To connect the Tip, remove the protective cap from the end of the fiber shaft, 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 7.6). Bend the metal cannula according to the specific procedure requirements (Figure 7.9). Remove the fiber Tip by twisting the Tip counterclockwise (Figure 7.7) Figure 7.6: Insert the fiber Tip into the Handpiece (only when the Handpiece is connected to the fiber) and twist clockwise until snug Epic X User Manual...
  • Page 22 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 operate the laser without a fiber Tip attached to the Handpiece. Never point the laser at a person’s eyes. All persons present in the operatory must wear protective eyewear when the laser is in use. Epic X User Manual...

  • Page 23: Connecting The Whitening Handpiece (Optional Accessory)

    Handpiece to separate. When the Whitening Handpiece is connected, the pain therapy application is disabled (Figure 7.11). Figure 7.11 NOTE: Refer to the individual Instructions for Use included with the Whitening Handpiece packaging for additional details. Epic X User Manual...

  • Page 24: Connecting The Deep_Tissue Handpiece (Optional Accessory)

    A disposable, single-use non-sterile protective shield attaches to the Handpiece to avoid cross- contamination between patients. Always wipe the disposable shield with alcohol prior to use. Discard when the treatment session is completed. Fiber Spacer Optic Cable Disposable Shield Handpiece Figure 7.12: Deep Tissue Handpiece Epic X User Manual...
  • Page 25 Clean any debris that appears on the lens using a cotton swab moistened with isopropyl alcohol. Figure 7.15 Figure 7.16 NOTE: Refer to the individual Instructions for Use included with the Whitening Handpiece packaging for additional details. Epic X User Manual...

  • Page 26: Operation-Turn On The Epic X

    Turn the power switch at the rear of the console to the ON ( I ) position. The “BIOLASE” logo screen will appear. After three (3) seconds the Epic X “Welcome” screen will be displayed. • Enter the three digit access code using the touch screen.

  • Page 27: Settings Screen

    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 "x" will appear in the pairing icon located in the upper left hand corner of the touchscreen. (Figure 7.20) Figure 7.20 Epic X User Manual...

  • Page 28: Control 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. Figure 7.25 Figure 7.26 Epic X User Manual...

  • Page 29: Entering Ready Or Standby Modes

    NOTE: If the Footswitch is pressed while the system is in Standby mode, the screen will display a message indicating "System must be in Ready mode to lase." Press the control button to switch to Ready mode. When the Footswitch is not in use, it will go into Sleep mode to conserve battery power. It automatically reactivates when pressed. Epic X User Manual...

  • Page 30: Peak Power Display

    *CP = Comfort pulse; P3 = Pulsed mode which is the standard for most diode lasers currently available to the dental market Figure 7.27 NOTE: Operating the laser at a shorter pulse duration typically results in lower tissue temperature. Peak Power Average Power Figure 7.28 Epic X User Manual...

  • Page 31: Using The Epic X Touch Screen Display

    Installation and Set-Up 7.17 USING THE EPIC X TOUCH SCREEN DISPLAY Figure 7.29 Epic X User Manual...

  • Page 32: Procedures Button

    Installation and Set-Up 7.18 PROCEDURES BUTTON The Epic X has the ability to 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.

  • Page 33: Clinical Applications

    Tip is out of the block (Figure 8.3). Figure 8.2 Figure 8.3 • Press the Footswitch to activate the laser into the air once; a white flash will be visible or the Tip wil glow (Figure 8.4). • Repeat initiation process as needed to ensure the Tip is initiated. Figure 8.4 Epic X User Manual...

  • Page 34: Pre-Programmed Settings For Dental 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. At all times observe the clinical effects on the treatment area and adjust parameters accordingly. Epic X User Manual...

  • Page 35: Table Of Pre-Programmed Settings

    Perio Pockets 1.6 W 0.8 W 1.0 ms 1.0 ms clinical indices gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) Pulpotomy, pulpotomy as an Pulpotomy(*) 0.1 W 0.1 W adjunct to root canal Epic X User Manual...
  • Page 36 0.9 W Unerupted Teeth Custom 0.1 W 0.1 W Custom 0.1 W 0.1 W (*) Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and Pulpotomy as an adjunct to root canal therapy. Epic X User Manual...

  • Page 37: Teeth Whitening

    Gel Kit (BIOLASE PN 7400063) 8.5 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 applied with the Deep Tissue Handpiece. The pain therapy procedure elevates tissue temperature 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.

  • Page 38: Preset Values

    If discomfort or redness of the skin occurs at any time during the treatment, you have the following options: • 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. Epic X User Manual...

  • Page 39: Pain Therapy-Warning And Precautions

    • Do not apply treatment over articles of clothing. • Do not apply any numbing agents to the affected area as they could reduce the patient's pain sensitivity and response to any treatment discomfort. Epic X User Manual...

  • Page 40: Recommended Use

    NOTE: To avoid potential patient discomfort and/or skin damage, it is advisable to use a test spot prior to the initial treatment to assess the suitability of the selected settings for the individual patient. Epic X User Manual...

  • Page 41: Maintenance

    9.1 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.

  • Page 42: Step 2- Sterilization Process- Surgical Handpiece

    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. To re-connect the Handpiece to the Fiber Optic Cable, push the Handpiece onto the fiber shaft without twisting until it clicks into place and is secured, as described in Section 7.3. Epic X User Manual...

  • Page 43: Step 3- Disinfecting The Fiber Optic Cable

    Cavicide™ or a similar quaternary ammonium compound product (containing 20% alcohol or less), and follow the manufacturer’s instructions • Always wipe the disposable shield with alcohol prior to use. Discard after one-time use Epic X User Manual...

  • Page 44: Fiber Optic Lens Inspection And Cleaning

    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. 4. Replace the battery cover on the bottom of the unit, using a standard Phillips screwdriver. Epic X User Manual...

  • Page 45: Installing/Replacing The Console Battery Pack

    Figure 9.6 Figure 9.7 NOTE: Only use the battery pack supplied by BIOLASE. The battery pack is a seperate accessory (BIOLASE P/N 6400457). 9.5 CHANGING THE WIRELESS FOOTSWITCH BATTERIES The wireless Footswitch is powered by two AAA batteries.

  • Page 46: Transportation

    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. 9.7 STORAGE The Epic X should be stored in a cool, dry place when not in use under the following environmental conditions: • Storage temperature: 15°C-35°C (59°F-95°F). • Relative humidity: 10%-70%, non-condensing.

  • Page 47: Calibration

    Software Specification 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.

  • Page 48: Troubleshooting

    Troubleshooting NOTE: For any on-screen message not listed in Figure 12.1, re-power the laser console; if the message does not clear, call BIOLASE Service at 1-800-321-6717 or your Authorized Service Representative. Screen Message Reason Allow 5-10 minutes for laser to...
  • Page 49 Check remote interlock closed Error 12 Battery critically low Battery is critically low Plug in DC supply Error 13 Internal error Internal error occurred Restart unit Footswitch battery Error 14 Footswitch battery Replace Footswitch battery critically low Figure 12.2 Epic X User Manual...

  • Page 50: Appendix A Tip Guide

    Surgical 7400016 7410003/ E4-7 400µm Perio 7400019 E4-9 400µm Perio 7410019 E3-4 300µm Surgical 7400017 7410002/ E3-7 300µm Perio 7400020 E3-9 300µm Perio 7400020 E2-4 200µm Surgical 7400018 E2-14 200µm Endo 7400021 E2-20 200µm Endo 7400015 Epic X User Manual...

  • Page 51: Pre-Initiated

    7400067 PI4-7 400µm Perio 7400068 PI4-9 400µm Perio 7400069 NOTE: All BIOLASE tips for diolde lasers are sold non-sterile and are for single-use only. See section 9 in this User Manual for cleaning and streilization instructions. Epic X User Manual...

  • Page 52: Appendix B Accessories

    Laserwhite 20 Whitening Gel Kit (5-pack) 7420001 Deep Tissue Handpiece 6400310 Deep Tissue Handpiece Disposable Shields (qty. 20) 6400465 Peel-off Clear Screen Covers (qty. 20) 6400457 Lithium-Ion Battery Pack for Console 6400463 Battery Pack (2 x AAA) 6400437 Fiber Optic Cable 5400386 Laser Warning Sign Epic X User Manual...

  • Page 53: Appendix C Labeling

    EMERGENCY LASER STOP SWITCH: The switch used in emergencies to stop laser output. LOCATION: Right side of laser console. LASER APERTURE WARNING: Indicates visible and/or invisible laser radiation is emitted from this aperture. LOCATION: Back of laser console. Epic X User Manual...
  • Page 54 The Footswitch and laser console comply with Part 15 of FCC Rules regarding unlicensed transmissions. LOCATION: Bottom of Footswitch. FOOTSWITCH PRODUCT ID LABEL: Wireless Footswitch LOCATION: Bottom of Footswitch. INGRESS PROTECTION CODE: IPX6 The Footswitch is water-resistant, protected splashes of water. Epic X User Manual...
  • Page 55 FRAGILE: HANDLE WITH CARE LOCATION: Outer carton (shipping box). KEEP DRY LOCATION: Outer carton (shipping box). TEMPERATURE LIMITATIONS +60 C -20 C LOCATION: Outer carton (shipping box). TEMPERATURE HUMIDITY LIMITATIONS LOCATION: Outer carton (shipping box). ATMOSPHERIC PRESSURE LIMITATIONS 106kPa 50kPa LOCATION: Outer carton (shipping box). ATMOSPHERIC PRESSURE SYSTEM SHIPPING LABEL: LOCATION: Outer carton (shipping box). Epic X User Manual...
  • Page 56 • ALL PRINT’S IN PANTONE BLACK C, EXCEPT DANGER LOGO AND STARBURST WHICH ARE PANTONE RED C. DC POWER, USB, REMOTE INTERLOCK LABEL: Identifies input ports POWER INPUT RATING: 12 Volts Direct Current, 5 amps MINI USB INPUT: For external programing REMOTE INTERLOCK: Input for Remote Interlock Connector Epic X User Manual...

  • Page 57: Appendix D- Safety Precautions For Lithium-Ion Battery Packs

    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.
  • Page 58 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 X User Manual...

  • Page 59: Appendix E- Electromagnetic Compatibility

    EMMISSIONS or decreased IMMUNITY of the Epic X diode laser system. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Epic X diode is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic X diode should assure it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance...
  • Page 60 Appendix E Electromagnetic Compatibility GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Epic X diode is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic X diode should assure that it is used in such an environment. IEC 60601 Immunity test Continuous level Electromagnetic environment - guidance...
  • Page 61 Appendix E Electromagnetic Compatibility GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Epic X is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic X should assure that it is used in such an environment. IEC 60601 Immunity test Continuous level Electromagnetic environment - guidance test level...
  • Page 62 Appendix E Electromagnetic Compatibility GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Epic X diode is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic X diode should assure that it is used in such an environment. IEC 60601 Immunity test Continuous level Electromagnetic environment - guidance test level A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone...

  • Page 63: Appendix F- Wireless Equipment Compliance Statement

    • 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 INTERFERENCE CAUSING EQUIPMENT REGULATIONS. 9800165 Conforms to AAMI ES60601-1 IEC60601-1 IEC60601-2-22 IEC62366 IEC60601-2-60 IEC60825-1 Certified to: CSA CSS-S No.60601-1 Epic X User Manual...
  • Page 64 BIOLASE, INC. 4 Cromwell Irvine, CA 92618 USA Telephone: (888) 424-6527 Telephone: (949) 361-1200 Fax: (949) 273-6687 Service: (800) 321-6717 MADE IN THE USA Copyright ©2018 BIOLASE, Inc. All rights reserved. Epic X™ software copyright ©2016 BIOLASE, Inc. Rx Only 400620 Rev. B...

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