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Biolase Epic T Series User Manual

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Summary of Contents for Biolase Epic T Series

  • Page 1 ne Color Full Color en, laser etch, etc.) (print, web, etc.) User Manual...
  • Page 2 Page Left Blank...

  • Page 3: Table Of Contents

    Contents 1 INTRODUCTION ......................6 2 INDICATIONS FOR USE ....................7 3 CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS .........7 3.1 Contraindications .......................... 7 3.2 Warnings and Precautions ......................7 Prescription Statement ......................... 7 Training ............................7 Eyewear ............................8 Treatment, Technique and Settings ....................8 Clinical Environment ........................
  • Page 4 Contents Remote Interlock ......................... 16 Emergency Stop ......................... 16 Functional Display ........................16 7 INSTALLATION AND SETUP ..................17 7.1 System Setup ..........................17 Facility Requirements........................17 7.2 Connecting the Fiber Optic......................17 Connecting/Disconnecting the Deep-Tissue Handpiece ............18 Operation - Turn on the Epic T ....................20 Home Screen ..........................
  • Page 5 Contents 10 CALIBRATION ....................... 33 11 SOFTWARE SPECIFICATION ..................33 12 TROUBLESHOOTING ....................33 APPENDIX A- ACCESSORIES ..................36 APPENDIX B- LABELING ....................37 APPENDIX C- SAFETY - LITHIUM-ION BATTERY PACKS ..........41 APPENDIX D- ELECTROMAGNETIC COMPATIBILITY ............ 43 APPENDIX E- WIRELESS EQUIPMENT COMPLIANCE STATEMENT ......47 Epic T User Manual...

  • Page 6: Introduction

    It is effective for chronic and acute musculoskeletal conditions, including back and neck pain, injuries from accidents, and athletic injuries to muscles and joints. Epic T Series 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

    Indications for Use The Epic T Series diode laser is intended for topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation;...

  • Page 8: Eyewear

    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. CLINICAL ENVIRONMENT Only use this device in clinical environments that observe proper standard aseptic techniques.

  • Page 9: Specifications

    Specifications 4.1 GENERAL • Dimension (W x L x H) 5.7 in x 6.5 in x 4.4 in (14.5 cm x 11.2 cm x 16.5 cm) 2.5 lbs / 1 kg • Weight 4.2 ELECTRICAL 100V - 240V ~ at 1.5A • Operating voltage • Frequency 50 / 60 Hz None • External Fuses Main Power Switch (ON/OFF Control Button). • Main control •...

  • Page 10: Equipment Description

    Equipment Description 5.1 SYSTEM COMPONENTS The Epic T laser system includes the following: Laser Console Screen Protectors Box (Peel-off Clear Screen Cover - qty. 25) Fiber Optic Cable (Installed) Laser Protective Eyewear (qty. 3) Deep Tissue Handpiece (qty. 1; packaged/shipped separately) Deep Tissue Handpiece Disposable Shields (qty. 20; packaged/shipped separately) DC Power Supply Module Power Cord (U.S.) (qty.

  • Page 11: General

    Equipment Description 5.2 GENERAL The Epic T system consists of three components: Handpiece Fiber Optic Assembly Spacer Wireless Footswitch Figure 4.1 Epic T User Manual...

  • Page 12: Base Console

    Equipment Description BASE CONSOLE The base console is portable, contains the diode laser and all the elements which power the laser, and has a touchscreen which allows the user to navigate from screen to screen, select procedures, enter and/or change settings, etc. (Figure 4.1). CONTROL BUTTON Activates the controls and display;...

  • Page 13: Safety With The Epic T

    Safety with the Epic T 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: Use of controls or adjustments or performance of procedures other than those specified in this User Manual may result in hazardous radiation exposure. 6.1 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...

  • Page 14: Safety Classification

    Safety with the Epic T LASER WARNING: DO NOT open the console housing at any time. Danger from optical radiation may exist. DO NOT aim the laser at metallic or reflective surfaces, such as surgical insturments or mirrors. If aimed directly at these surfaces the laser beam will reflect creating a potential hazard.

  • 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 or your BIOLASE-authorized service representative. Figure 6.1:...

  • Page 16: 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 T laser system. (BIOLASE P/N 2400075) Epic T User Manual...

  • Page 17: Installation And Setup

    Installation and Set-Up NOTE: The laser ships with the lithium ion battery pack already installed. FACILITY REQUIREMENTS Electrical Supply: 100V-240V ~ at 1.5A, 50/60Hz Environmental: Temperature 15-35 ºC (59-95 ºF), Humidity 10-90%, non-condensing • Place the unit in a clean, dry, and well-ventilated area; do not cover or block the ventilation channels. These channels provide an air-flow path to cool the unit.

  • Page 18: Connecting/Disconnecting The Deep-Tissue Handpiece

    Installation and Set-Up 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 Cable access plug and slowly pull it straight back from the optical access port (Figure 7.1). To re-install the Fiber Optic Cable, make sure the laser console is turned off.
  • Page 19 Installation and Set-Up Fiber Shaft Protective Cap Figure 7.5 • Connect the Deep Tissue Handpiece to the Fiber Optic Cable by sliding it over the fiber shaft until it clicks into place and is secured (Figure 7.5). If no click is audible, disconnect the Handpiece and then re-install it.

  • Page 20: Operation - Turn On The Epic T

    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 T “Welcome” screen will be displayed.

  • Page 21: Settings Screen

    Installation and Set-Up 7.6 SETTINGS SCREEN Pressing the Settings button on the HOME screen accesses the Settings screen; the user may make changes to the following system settings: Figure 7.10 7.7 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE Verify that the Footswitch and laser are paired; a blue LED indicator light on the laser console will blink when pairing is established.

  • Page 22: Control Button

    Installation and Set-Up To re-establish pairing, take the following steps: 1. Go to the settings menu on the laser console display by pressing the settings icon; select the “Wireless” icon. 2. A screen will appear indicating that pairing of the Footswitch to the laser console has been lost (Figure 7.12);...

  • Page 23: Entering Ready Or Standby Modes

    Fiber Optic Cable. If the aiming beam is not on, turn off the laser console, then remove and re-install the Fiber Optic Cable assembly. If the aiming beam is still not on, turn off the laser console and call a Biolase-authorized service representative. 7.11 WIRELESS FOOTSWITCH The wireless Footswitch is powered by two (2) AAA batteries.

  • Page 24: Using The Epic T Touch Screen Display

    Installation and Set-Up 7.12 USING THE EPIC T TOUCH SCREEN DISPLAY Figure 7.18 Epic T User Manual...

  • Page 25: Turn The Laser Console Off

    Installation and Set-Up 7.13 TURN THE LASER CONSOLE OFF • Wind the fiber Optic 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 Cable is not twisted once the Handpiece is returned to the holder.

  • Page 26: Clinical Application

    Clinical Applications 8.1 OVERVIEW Please review this section carefully before using this device in a clinical situation. The Epic T 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 27: Pain Therapy - Adverse Effects

    Clinical Applications 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. Maximum Recommended Fitzpatrick Skin Type Scale Power / Exposure Always burns, never tans (pale white;...

  • Page 28: Pain Therapy - Warnings And Precautions

    Clinical Applications Patients suffering from general neurovascular conditions, such as neurodegeneration associated with Type II diabetes, may have reduced sensitivity to pain affecting their response to discomfort during treatment. Refer to Section "Contraindications, Warnings, and Precautions" for additional information. PAIN THERAPY – WARNINGS AND PRECAUTIONS • Scar tissue has been associated with poor circulation and reduced cooling through heat transport by blood;...

  • Page 29: Maintenance

    CAUTION: This device contains no user-serviceable parts other than what is described in this manual. Any attempt to modify or repair the laser by anyone other than an authorized BIOLASE technician or BIOLASE-trained representative may lead to exposure to laser radiation and collateral radiation and will void the product warranty.

  • Page 30: Fiber Cable Lens Inspection And Cleaning

    Maintenance 9.4 FIBER CABLE LENS INSPECTION AND CLEANING LENS INSPECTION PROCEDURE The lens is at the distal end of the Fiber Optic Cable (Figure 9.1); this is where debris may accumulate over time with use. To inspect the lens, take the following steps: CAUTION: DO NOT inspect the lens while the laser system is powered on;...

  • Page 31: Changing The Wireless Footswitch Batteries

    Do not discard in a trash bin. Figure 9.5 Figure 9.6 NOTE: Only use the battery pack supplied by BIOLASE. The battery pack is a seperate accessory (BIOLASE P/N 6400457). 9.6 CHANGING THE WIRELESS FOOTSWITCH BATTERIES The wireless Footswitch is powered by two AAA batteries.

  • Page 32: Transportation

    The Epic T 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. 9.8 STORAGE The Epic T should be stored in a cool, dry place when not in use under the following environmental conditions: •...

  • Page 33: Calibration

    Software Specification BIOLASE respects the intellectual property of others, and we ask our users to do the same. Epic T 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 34: 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 35 Troubleshooting Screen Message Reason Error 1 Thermistor open Thermistor open Call BIOLASE service Error 2 Thermistor shorted Thermistor shorted Call BIOLASE service Allow 5-10 minutes for laser to Error 3 Shutdown temperature System too hot cool down Error 4 Laser current high/low...

  • Page 36: Appendix A Accessories

    Appendix A Accessories PART NO. DESCRIPTION 2400277 Laser Safety Glasses Remote Interlock Plug 6400058 DC Power Supply Module 2400075 2400043 Power Cord (U.S.) 2400055 Power Cord (International) 6400522 Wireless Footswitch Deep-Tissue Handpiece 6400311 Deep-Tissue Handpiece Disposable Shields (qty. 20) 6400310 6400465 Peel-off Clear Screen Covers (qty.

  • Page 37: Appendix B Labeling

    Appendix B Labeling PRODUCT IDENTIFICATION LABEL: LOCATION: Bottom of laser console. MANUFACTURER CATALOG/PART NUMBER PRODUCT SERIAL NUMBER DATE OF MANUFACTURE LASER WARNING: Symbol warns of laser beam hazard. Always wear appropriate eye protection. LOCATION: Back of Laser Console. TYPE BF APPLIED PART: The applied part is not conductive to the patient.
  • Page 38 Appendix B Labeling CERTIFICATION: This device complies with FDA laser standards. LOCATION: Bottom of laser console. WARNING LABEL: Indicates there is the risk of possible exposure to both infrared and visible laser radiation. LOCATION: Back of laser console FCC AND IC LABEL: Federal Communication Commission and Industry Canada registration numbers. LOCATION: Bottom of laser console.
  • Page 39 Appendix B Labeling SINGLE USE ONLY – DO NOT REUSE WEEE (WASTE ELECTRICAL AND ELECTRONIC): Recycle lithium ion battery as regulated. Do not throw in trash bin. THIS END UP LOCATION: Outer carton (shipping box). FRAGILE: HANDLE WITH CARE LOCATION: Outer carton (shipping box). KEEP DRY LOCATION: Outer carton (shipping box).
  • Page 40 Appendix B Labeling LASER WARNING SIGN Included Welcome Kit; must placed outside of the operatory whenever the laser system is in use. DC POWER, USB, REMOTE INTERLOCK LABEL: Identifies input ports POWER INPUT RATING: Approved: ____________________ Date: ____________________ 12 Volts Direct Current, 5 4 Cromwell, Irvine, CA 92618 SIGN, DANGER, amps...

  • Page 41: Appendix C 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 42 Appendix C Safety-Lithium-Ion Battery Packs WHEN CHARGING THE BATTERY: WARNING: WARNING: CAUTION: WHEN DISCHARGING THE BATTERY: WARNING: CAUTION: Epic T User Manual...

  • Page 43: Appendix D Electromagnetic Compatibility

    DC Power Supply Module, BIOLASE p/n 2400075 Wireless Footswitch, BIOLASE p/n 6400522 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 T diode laser system.
  • Page 44 Appendix D Electromagnetic Compatibility Epic T User Manual...
  • Page 45 Appendix D Electromagnetic Compatibility Epic T User Manual...
  • Page 46 Appendix D Electromagnetic Compatibility Epic T User Manual...

  • Page 47: Appendix E Wireless Equipment Compliance Statement

    Appendix E Wireless Equipment Compliance Statement This statement applies only to the wireless portion of the device. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
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  • Page 49 WaterLase iPlus™. (silk screen Made in the USA ©2019 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, Full Color (print, web, etc.)

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