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Biolase epic 10 User Manual

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EPIC 10 User Manual P/N 5400321 Rev. H

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Summary of Contents for Biolase epic 10

  • Page 1: User Manual

    User Manual EPIC 10 User Manual P/N 5400321 Rev. H...

  • Page 2: Table Of Contents

    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 ....................
  • Page 3 4.2 Operation - Turn on the Epic 10 ..................19 4.3 Settings Screen .......................20 4.4 Pairing the Footswitch to the Laser console ..............20 4.5 Control Button .........................22 4.6 Entering READY or STANDBY Modes ................22 4.7 READY Mode ........................22 4.8 Wireless Footswitch ......................23 4.9 Peak Power Display ......................23...
  • Page 4 Pre-programmed Settings for Dental Procedures ...............33 7.4 Table of Pre-Programmed Settings ..................34 7.5 Teeth Whitening Procedure .....................35 7.6 Pain Therapy ........................35 Pain Therapy – Adverse Effects ..................36 Pain Therapy – Warnings and Precautions ................36 Recommended Use ......................37 Using the Deep Tissue Handpiece ..................37 Using the Whitening/Contour Handpiece ................37 8.

  • Page 5: Introduction

    When used and maintained properly, the Epic 10 will prove a valuable addition to your practice. Please contact BIOLASE Customer Service at 1-800-321-6717 in the U.S. for any service needs.

  • Page 6: Packaging

    7. DC power supply and power cord (one (1) US and one (1) International) 8. User Manual 9. Welcome Kit (Welcome Letter, BIOLASE store information, Quick Setup Guide, Guide to Online Training & Product Registration Card, Limited Warranty Information) 10. Laser Warning Sign 11.

  • Page 7: Equipment Description

    2. EQUIPMENT DESCRIPTION 2.1 GENERAL The Epic 10 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,...

  • Page 8: Surgical Delivery System

    2.4 SURGICAL DELIVERY SYSTEM NOTE: All fiber optic cables, Handpieces & tips are shipped non-sterile. The Epic 10 Delivery System with surgical Handpiece consists of: • Re-useable Fiber Optic Assembly • Re-useable Surgical Handpiece (Figures 2.9) • Disposable Tips (Appendix A) The fiber optic cable is detachable from the console.

  • Page 9: Single-Use Tips

    Figure 2.2: Fiber Optic Access Plug Figure 2.3: Optical Access Port 2.6 SINGLE-USE TIPS The tips are single-use accessories and are provided in three core diameters: 200μm, 300μm, and 400μm, in different lengths (see Appendix A). Tips are single-use only to avoid cross-contamination and are designed to withstand only a single sterilization cycle;...
  • Page 10 Tip Assembly Figure 2.4: Insert the fiber tip into the handpiece (only when the handpiece is connected to the fiber) and twist clockwise until snug Figure 2.5: Remove the fiber Tip by twisting the tip counterclockwise Correct Bend Incorrect Bend Figure 2.6: When installing the tip, make sure it is Figure 2.7: Bending the tip cannula seated properly (thread correctly)

  • Page 11: Surgical Handpiece Assembly

    2.7 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. Fiber Shaft Protective Cap Handpiece Figure 2.8: Connecting the Handpiece to the fiber optic assembly Figure 2.9: Surgical Handpiece Assembly fully assembled ►...

  • Page 12: Whitening/Contour Handpiece (Optional Accessory)

    2.8 WHITENING/CONTOUR HANDPIECE (OPTIONAL ACCESSORY) NOTE: The Whitening/Contour Handpiece is reusable and equipped with a disposable non- sterile protective shield for single patient use. The Handpiece is non-sterile and requires disinfection before and after each patient treatment. This Handpiece cannot be sterilized in the autoclave. For disinfection instructions refer to Section 8.

  • Page 13: Deep Tissue Handpiece (Optional Accessory)

    2.9 DEEP TISSUE HANDPIECE (OPTIONAL ACCESSORY) The Deep Tissue Handpiece is reusable and equipped with a disposable non-sterile protective shield for single patient use. The Handpiece is non-sterile and requires disinfection before and after each patient treatment. This Handpiece cannot be sterilized in the autoclave.

  • Page 14: Safety

    However, the possibility of electromagnetic or other interference may still exist. Relocating the device may help to eliminate the interference. Always ensure that the proper laser parameters are set before the Epic 10 laser CAUTION: is used in a clinical setting.

  • Page 15: 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. System Monitor The system monitors the emergency stop switch, remote key, wireless footswitch connection, and output power.

  • Page 16: Power Switch

    READY mode. The aiming beam will illuminate to indicate that the system is ready for use. Wireless Footswitch The Epic 10 will not emit laser energy until the user presses down on the Footswitch while the laser is in READY mode. The footswitch is designed to work using wireless technology.

  • Page 17: Remote Interlock

    Two (2) AAA batteries are required to power the footswitch (included). (For instructions on how to replace the footswitch batteries, see Section 4.) The footswitch is protected by a metal cover. To access, first press down on the cover to unlatch it.

  • Page 18: Emergency Stop

    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.

  • Page 19: Operation Instructions

    DC Power: Connect the power cord of the power supply to the laser console and plug into a wall outlet o Rechargeable Battery: The Epic 10 is shipped with the battery pack already installed; to charge the battery pack, connect the power cord of the DC power supply to the laser console and plug into a wall outlet.

  • Page 20: Operation - Turn On The Epic 10

    Turn the Power Switch at the rear of the console to the ON (I) position. The “BIOLASE” logo screen will appear (Figure 4.1). After three (3) seconds the Epic 10 “Welcome” screen will be displayed (Figure 4.2).

  • Page 21: Settings Screen

    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...
  • Page 22 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.

  • Page 23: Control Button

    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).

  • Page 24: Wireless Footswitch

    If the aiming beam is not on, turn off the laser console, then remove and re-install the trunk fiber (see Section 2.6). If the aiming beam is still not on, turn off the laser console and call Biolase Service. 4.8 WIRELESS FOOTSWITCH The wireless footswitch is powered by two (2) AAA batteries.
  • Page 25 Duty Cycle PULSE DURATION (on) PULSE INTERVAL (off) MODE (Time On / Time off) 10 microseconds 40 microseconds 100 microseconds 200 microseconds 1 millisecond 1 millisecond 20 milliseconds 20 milliseconds *CP = Comfort Pulse; P3 = Pulsed Mode which is the standard for most diode lasers currently available to the dental market Figure 4.13 Operating the laser at a shorter pulse duration typically results in lower tissue...

  • Page 26: Using The Epic 10 Touch Screen Display

    4.11 USING THE EPIC 10 TOUCH SCREEN DISPLAY Figure 4.15 Epic™10 User Manual pg. 25 5400321 Rev H...

  • Page 27: Procedures Button

    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.

  • Page 28: Specifications

    5. SPECIFICATIONS 5.1 GENERAL 5.7 in (W) x 4.4 in (H) x 6.5 in (L) Dimension (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...

  • Page 29: Other Light Sources

    Pulse Interval 0.01ms – 20ms Pulse Repetition Rate Up to 20kHz (for reference) Spot size Surgical Handpiece 400µm (maximum in contact mode) Deep Tissue Handpiece 30mm diameter = 7.1cm area Whitening Handpiece Rectangular 35mm x 8mm = 2.8cm NOHD 4.77 meters Beam Divergence 8 - 22°...

  • Page 30: Contraindications, Warnings & Precautions

    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.

  • Page 31: Suction

    Suction Use high-speed suction as required to maintain a clear field of vision during treatment. Do not use the Epic 10 if you cannot clearly see the treatment site. Plume Removal Special care must be taken to prevent infection from the laser plume generated by vaporization of virally or bacterially infected tissue.

  • Page 32: Clinical Applications

    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.

  • Page 33: Soft Tissue Surgery And Other Dental Use

    7.3 SOFT TISSUE SURGERY AND OTHER DENTAL USE Tip Initiation: Parameters and Method ( Not required if using pre-initiated tips Most soft tissue surgical procedures require initiation of the fiber tip. The TIP INITIATION screen will appear (in READY mode) if tip initiation is recommended and the system will automatically go to the settings shown in Figure 7.1 based on the tip used;...

  • Page 34: Pre-Programmed Settings For Dental Procedures

    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 to scroll for additional procedures.

  • Page 35: Table Of Pre-Programmed Settings

    7.4 TABLE OF PRE-PROGRAMMED SETTINGS Peak Avg. Pulse Pulse Duty Preset Name Indications for Use Mode Power Power Interval Length Cycle Type Initiated? Reduction of gingival Gingivectomy/Gingivoplasty hypertrophy, 5.0 W 1.0 W 0.04 ms 0.01 ms Vestibuloplasty Tissue retraction for impression, Gingival Troughing 2.0 W...

  • Page 36: Teeth Whitening Procedure

    Figure 7.7 LaserWhite™ 20 Whitening Gel Kit (BIOLASE PN 7400030) 7.6 PAIN THERAPY The Epic 10 diode laser is designed to provide near-infrared laser energy to a tissue surface for the purpose of temporary pain relief when applied with the Whitening/Contour or Deep Tissue Handpiece.

  • Page 37: Pain Therapy - Adverse Effects

    Fitzpatrick Skin Type Scale Highly sensitive, always burns, never tans. Example: Red hair with TYPE I freckles Very sun-sensitive, burns easily, tans minimally. Example: Fair-skinned, TYPE II fair-haired Caucasians Sun-sensitive skin, sometimes burns, slowly tans to light brown. TYPE III Example: Darker Caucasians Minimally sun-sensitive, burns minimally, always tans to moderate brown.

  • Page 38: Recommended Use

    • Do not treat open wounds. • Muscle tissue closer to the skin surface may experience a higher absorption of heat; carefully monitor skin temperature and reduce power as necessary. • Excessive fatty tissue is known to transmit heat without much attenuation; reduce power. •...

  • Page 39: Maintenance

    8.1 DAILY MAINTENANCE Use the peel-off clear covers for the laser console supplied with the system. Use disinfectant to wipe down the front panel and handpiece holder of the Epic 10 system after each procedure. Do not use bleach or abrasive cleansers.

  • Page 40: Manual Cleaning Of The Surgical Handpiece

    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.

  • Page 41: Disinfecting The Whitening/Contour Handpiece

    Type of Sterilizer Temperature Min Time Drying Time 121°C ( 250°F) 30 minutes Gravity Displacement 15 – 30 minutes 132°C (270°F) 15 minutes 132°C (270°F) Dynamic-Air-Removal (Pre-Vacuum) 4 minutes 20 - 30 minutes 134°C (EU only) 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.

  • Page 42: Changing The Wireless Footswitch Batteries

    Screws to remove Battery cover Figure 8.2: Battery Cover/Bottom of Console Figure 8.3: Battery Pack/Connector Wire Only use the battery pack supplied by BIOLASE. The battery pack is a separate NOTE: accessory (BIOLASE p/n 6400457). 8.4 CHANGING THE WIRELESS FOOTSWITCH BATTERIES The wireless footswitch is powered by two AAA batteries.

  • Page 43: Transportation

    Remove the batteries from the footswitch if the Epic 10 is not likely to be used CAUTION: for some time. The Epic 10 is shipped inside a custom shipping box. Please save and store the box in a cool, dry place for use when transporting the laser, or for long-term storage. Epic™10 User Manual pg.

  • Page 44: Calibration

    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.
  • Page 45 SCREEN REASON MESSAGE Error 1 THERMISTOR OPEN THERMISTOR OPEN CALL BIOLASE SERVICE Error 2 THERMISTOR SHORTED THERMISTOR SHORTED 5-10 SHUTDOWN ALLOW MINUTES FOR LASER Error 3 SYSTEM TOO HOT TEMPERATURE TO COOL DOWN LASER CURRENT Error 4 OUTPUT IS OUT OF SPECS...
  • Page 46 SCREEN REASON MESSAGE 5-10 ALLOW MINUTES FOR LASER ARNING TEMPERATURE HIGH SYSTEM IS HOT TO COOL DOWN ARNING BATTERY IS LOW BATTERY IS LOW PLUG IN DC SUPPLY BATTERY NOT ARNING BATTERY NOT CONNECTED PLUG IN THE BATTERY CONNECTED FOOTSWITCH BATTERY BATTERY ON THE FOOTSWITCH ARNING REPLACE FOOTSWITCH BATTERY...

  • Page 47: Appendix A - Tip Guide

    APPENDIX A – TIP GUIDE All Biolase tips for diode lasers are sold non-sterile and are for single-use NOTE: only. See Section 8.2 for sterilization instructions. Epic™10 User Manual pg. 46 5400321 Rev H...

  • Page 48: Appendix B - Labeling

    APPENDIX B – LABELING Symbols Description Product ID Label Location: Bottom of laser console Manufacturer Date of Manufacture Catalog/Part Number Product Serial Number Refer to User Manual Type B Applied Part: The applied part is not conductive to the patient. FDA Compliance Label: Indicates the device complies with FDA laser standards.
  • Page 49 Warning Label: Indicates there is the risk of possible exposure to both infrared and visible laser radiation. Location: Back of laser console 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...
  • Page 50 Emergency Laser Stop Switch: The switch used in emergencies to stop laser output. Location: Right side of Laser Console DO NOT REUSE For single use only. WEEE (Waste Electrical and Electronic) Recycle Lithium Ion battery as regulated. Do not throw in trash bin. DC Power, USB, Remote Interlock Label: Identifies input ports Power Input Rating:...
  • Page 51 Atmospheric Pressure Limitations Fragile: Handle with care Keep Dry Humidity Limitations Temperature Limitations This End UP Epic™10 User Manual pg. 50 5400321 Rev H...

  • Page 52: Appendix C - Safety Precautions For Lithium-Ion Battery Packs

    APPENDIX C – SAFETY PRECAUTIONS FOR LITHIUM-ION 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: •...
  • Page 53 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.
  • Page 54 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.

  • Page 55: Appendix D - Accessories

    APPENDIX D – 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 clear Handpiece covers (30-pack)

  • Page 56: Appendix E - Electromagnetic Compatibility

    Portable and mobile Radio Frequency (RF) communications equipment can affect medical electrical equipment. Accessories: Medical grade power cord, maximum length 3ft (1 meter), Biolase p/n 2400043. Footswitch: Wireless, Biolase p/n 6400146 The use of accessories, other than those specified, except those supplied or sold by Biolase, Inc.
  • Page 57 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Epic diode laser is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic diode laser should assure that it is used in such an environment. IEC 60601 Continuous Electromagnetic environment -...
  • Page 58 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY (Continued) The model Epic laser is intended for use in the electromagnetic environment specified below. The customer or the user of the model Epic laser should assure that it is used in such an environment. IEC 60601 Continuous Electromagnetic environment -...
  • Page 59 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EPIC DIODE LASER The Epic diode laser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Epic diode laser can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Epic diode laser as recommended below, according to the maximum output power of the communications equipment.

  • Page 60: Appendix F - Wireless Equipment Compliance Statement

    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.
  • Page 61 WaterLase iPlus™. Made in the USA Copyright © 2014 BIOLASE, Inc. All rights reserved. EPIC, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece, ComfortPulse, WaterLase, and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE, Incorporated in the United States and/or other countries.

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