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Epic Hygiene User Manual

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Summary of Contents for Biolase Epic Hygiene

  • Page 1 Epic Hygiene User Manual...
  • Page 2 PAGE LEFT BLANK...
  • Page 3: Table Of Contents

    Base Console ..........................13 Control Button..........................13 Fiber Delivery System .........................13 Handpiece ...........................13 Wireless Footswitch ........................14 6 SAFETY WITH THE EPIC HYGIENE ................15 6.1 Safety Instructions ........................15 6.2 Safety Classification........................16 6.3 Safety Features .......................... 17 Epic Hygiene User Manual...
  • Page 4 7.11 Wireless Footswitch ........................26 7.12 Peak Power Display ........................27 7.13 Pulse Mode Selection ........................27 7.14 Using the Epic Hygiene Touch Screen Display ................28 7.15 Procedures Button ........................29 7.16 Turn the Laser Console Off ......................29 8 CLINICAL APPLICATIONS ....................
  • Page 5 APPENDIX C - ACCESSORIES ..................43 APPENDIX D- LABELING ....................44 APPENDIX E - SAFETY - LITHIUM-ION BATTERY PACKS ..........48 APPENDIX F - ELECTROMAGNETIC COMPATIBILITY ........... 50 APPENDIX G - WIRELESS EQUIPMENT COMPLIANCE STATEMENT ......54 Epic Hygiene User Manual...
  • Page 6: Introduction

    Epic Hygiene 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

    Contraindications, Warnings, and Precautions 3.1 CONTRAINDICATIONS All clinical procedures performed with Epic Hygiene 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. Practitioners 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 8: Eyewear

    Prior to use, inspect the eyewear for pitting and/or cracking. Replace if damaged; do not use. CAUTION: The specifications for the protective eyewear provided with the Epic Hygiene laser system are marked on the side of the glasses. Always check the eyewear specifications marked on the glasses to ensure they offer the required protection for the specific laser wavelength.
  • Page 9: Treatment, Technique And Settings

    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 the specific indication and increase as required. BIOLASE assumes no responsibility for parameters, techniques, methods or results.
  • Page 10: Specifications

    • Beam Divergence 8 - 22° per side • Standard Fiber Cable Length 5 feet (1.5 meters) 4.4 OTHER LIGHT SOURCES Laser diode, max 1 mW, 625 nm – 670 nm, Class 2 • Aiming Beam Epic Hygiene User Manual...
  • Page 11: Equipment Description

    Equipment Description 5.1 SYSTEM COMPONENTS The Epic Hygiene laser system includes the following: Laser Console Peel-off Screen Protectors (qty. 25) Fiber Optic Cable (Installed) Assorted Tips Handpiece (qty. 2) Laser Protective Eyewear (qty. 3) DC Power Supply Module Power Cord (qty. 1)
  • Page 12: General

    Equipment Description 5.2 GENERAL The Epic Hygiene system consists of three components: Base Console Fiber Delivery System LED Indicators LED Indicators Control Button Fiber Storage Channel Handpiece Fiber Optic Cable Wireless Footswitch Figure 5.1 Epic Hygiene User Manual...
  • Page 13: Base Console

    The Handpiece (Figure 5.3) is re-usable. It is a conduit for delivering the optical energy produced by the laser to the treatment site and must be cleaned and sterilized between patients to avoid cross-contamination (See Section 9). Figure 5.3 Epic Hygiene User Manual...
  • Page 14: Wireless Footswitch

    Equipment Description WIRELESS FOOTSWITCH The Epic Hygiene laser will only emit laser energy when the user presses down on the Footswitch Cover while the laser is in Ready 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 15: Safety With The Epic Hygiene

    • 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 Hygiene laser is used in a procedure.
  • Page 16: Safety Classification

    Safety with the Epic Hygiene LASER WARNING: DO NOT open the console housing at any time. Danger from optical radiation may exist. CAUTION: DO NOT position this equipment so that it is difficult to pull the plug from the power source.
  • 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 or your BIOLASE-authorized service representative. Figure 6.1: Power Switch, DC...
  • Page 18: Wireless Footswitch

    The system color display with touch screen and LED indicators on the control panel shows the functional conditions of the system. Figure 6.5: Emergency Laser Stop CAUTION: Use only the DC Power Supply Module supplied with the Epic Hygiene laser system. (BIOLASE P/N 2400075) Epic Hygiene User Manual...
  • Page 19: Installation And Setup

    7.2 CONNECTING THE FIBER OPTIC CABLE The Epic Hygiene ships with the Fiber Optic Cable already connected to the laser console. CAUTION: Do not connect or disconnect the fiber cable while the laser console is turned ON.
  • Page 20: 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 Figure 7.4: Handpiece Assembly fully assembled Epic Hygiene User Manual...
  • Page 21: Single-Use Tips

    (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 Hygiene User Manual...
  • Page 22 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 Hygiene User Manual...
  • Page 23: Operation -Turn On The Epic Hygiene

    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 Hygiene “Welcome” screen will be displayed.
  • Page 24: 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 over the pairing icon located in the upper left hand corner of the touchscreen. Figure 7.20 Epic Hygiene User Manual...
  • Page 25: Control Button

    (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. Figure 7.25 Figure 7.26 Epic Hygiene User Manual...
  • Page 26: Entering Ready Or Standby Modes

    ALERT 2, indicating the system is not in Ready mode. 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 Hygiene User Manual...
  • Page 27: Peak Power Display

    (Figure 7.28). By pressing the "X" on the bottom left of the screen the user may cancel the Pulse mode selected. Figure 7.27 NOTE: Operating the laser at a shorter pulse duration typically results in lower tissue temperature. Figure 7.28 Epic Hygiene User Manual...
  • Page 28: Using The Epic Hygiene Touch Screen Display

    Installation and Set-Up 7.14 USING THE Epic Hygiene TOUCH SCREEN DISPLAY Figure 7.29 Epic Hygiene User Manual...
  • Page 29: Procedures Button

    Installation and Set-Up 7.15 PROCEDURES BUTTON The Epic Hygiene has the ability to store up to 12 pre-set procedures. The laser has 6 pre-programmed procedural presets installed and 6 empty slots for custom use. Pre-programmed settings can be customized to your preference.
  • Page 30: Clinical Applications

    Clinical Applications 8.1 OVERVIEW To efficiently treat tissues, it is imperative to understand the nature of the Epic Hygiene 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 within the applicable scope of practice.
  • Page 31: Maintenance

    Use disinfectant to wipe down the front panel and Handpiece Holder of the Epic Hygiene system after each procedure. Do not use bleach or abrasive cleansers.
  • Page 32: Step 1- Cleaning Process - Handpiece

    1. Place the Handpiece and fiber Tips in separate single-wrap, self-seal autoclave pouches. 2. Place on an autoclave tray; do not stack other instruments on top of the pouches. 3. Place the tray inside the autoclave chamber and set the appropriate cycle as recommended in Figure 9.1. Epic Hygiene User Manual...
  • Page 33: Step 3- Disinfecting The Fiber Optic Cable

    Always disinfect the fiber between patients by wiping it completely 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. DO NOT AUTOCLAVE. Epic Hygiene User Manual...
  • Page 34: Fiber Optic Lens Inspection And Cleaning

    4. Repeat as needed using a new Mirocbrush each time until no residue appears on the swab. Figure 9.4 CAUTION: If blemishes appear below or inside the lens, contact BIOLASE or your authorized service representative to order a replacement lens. Figure 9.5 Epic Hygiene User Manual...
  • Page 35: Installing/Replacing The Console Battery Pack

    6. Dispose of the used Lithium Ion battery as regulated. Do not discard in a trash bin. Figure 9.6 NOTE: Only use the battery pack supplied by BIOLASE. The battery pack is a separate accessory (BIOLASE P/N 6400457). Epic Hygiene User Manual...
  • Page 36: Changing The Wireless Footswitch Batteries

    Figure 9.7 battery cover screws Figure 9.8 pairing button (internal view) NOTE: To ensure the longevity of the battery power, only BIOLASE-supplied batteries are recommended as replacements (BIOLASE p/n 2400203); these are industrial-grade batteries which under normal use have a longer life than conventional AAA batteries.
  • Page 37: Transportation

    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. The Epic Hygiene 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.
  • Page 38: Calibration

    Service at 1-800-321-6717 or your Authorized Service Representative to schedule an appointment. Software Specification BIOLASE respects the intellectual property of others, and we ask our users to do the same. Epic Hygiene software is protected by copyright and other intellectual property laws. This product contains proprietary, copyrighted software developed by BIOLASE, Inc.
  • Page 39: 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...
  • Page 40 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 Hygiene User Manual...
  • Page 41: Appendix A - Tip Guide

    Appendix A Tip Guide NOTE: All BIOLASE tips for diode lasers are sold non-sterile and are for single-use only. See Section 9 in this User Manual for cleaning and sterilization instructions. NON-INITIATED Length (mm) Part Number Name Diameter E4-4 400µm...
  • Page 42: Appendix B Tip Initiation

    Tip will glow (Figure 3). 4. Repeat initiation process as needed to ensure the Tip is initiated. Figure 2 Figure 3 Please follow local/state regulations to ensure the procedures are within your scope of practice. Epic Hygiene User Manual...
  • Page 43: Appendix C - Accessories

    Power Cord (U.S.) 6400541 Wireless Footswitch Tip Initiation Kit 6400107 6400465 Peel-off Clear Screen Protectors (qty. 30) 6400457 Lithium-Ion Battery Pack for Console 2400203 Battery Pack (2 x AAA) Fiber Optic Cable 6400437 5400110 Laser Warning Sign Epic Hygiene User Manual...
  • Page 44: Appendix D Labeling

    The applied part is not conductive to the patient EMERGENCY LASER STOP SWITCH: The switch used in emergencies to stop laser output LOCATION: Left side of laser console FIBER WARNING: Indicates the system contains a laser LOCATION: Back of laser console Epic Hygiene User Manual...
  • Page 45 The Footswitch and laser console comply with Part 15 of FCC Rules regarding unlicensed transmissions LOCATION: Bottom of Footswitch INGRESS PROTECTION CODE: IPX6 The Footswitch is water-resistant, protected from splashes of water SINGLE USE ONLY – DO NOT REUSE Epic Hygiene User Manual...
  • Page 46 LOCATION: Outer carton (shipping box) TRANSPORTATION TEMPERATURE LIMITATIONS LOCATION: Outer carton (shipping box) HUMIDITY LIMITATIONS LOCATION: Outer carton (shipping box) ATMOSPHERIC PRESSURE LIMITATIONS LOCATION: Outer carton (shipping box) SYSTEM SHIPPING LABEL LOCATION: Outer carton (shipping box) Epic Hygiene User Manual...
  • Page 47 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 Epic Hygiene User Manual...
  • Page 48: Appendix E Safety - 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 49 • 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 Hygiene User Manual...
  • Page 50: Appendix F Electromagnetic Compatibility

    DC Power Supply Module, BIOLASE p/n 2400075 Wireless Footswitch, BIOLASE p/n 6400541 WARNING: The use of accessories other than those supplied or sold by BIOLASE, Inc. as replacement parts for internal or external components may result in increased EMISSIONS or decreased IMMUNITY of the Epic Hygiene diode laser system.
  • Page 51 Appendix F Electromagnetic Compatibility Epic Hygiene User Manual...
  • Page 52 Appendix F Electromagnetic Compatibility Epic Hygiene User Manual...
  • Page 53 Appendix F Electromagnetic Compatibility Epic Hygiene User Manual...
  • Page 54: Appendix G Wireless Equipment Compliance Statement

    • 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 Epic Hygiene User Manual...
  • Page 55 PAGE LEFT BLANK...
  • Page 56 ©2019 BIOLASE, Inc. All rights reserved. Epic Pro, Epic X, Epic Hygiene, 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.

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