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Biolase epic V series User Manual

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User Manual
EPIC V-Series User Manual P/N 5400430 Rev. A

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  • Page 1 User Manual EPIC V-Series User Manual P/N 5400430 Rev. A...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS TABLE OF CONTENTS ......................0 Introduction ..........................3 1.Packaging ..........................4 1.1 System Parts List ......................4 1.2 Facility Requirements ....................... 4 2. Equipment Description ......................5 2.1 General ..........................5 2.2 Base Console ........................5 2.3 Control Panel ........................5 2.4 Surgical Delivery System ....................
  • Page 3 4.3 Settings Screen .......................18 4.4 Pairing the Footswitch to the Laser console ..............18 4.5 Control Button .........................20 4.6 Entering READY or STANDBY Modes ................20 4.7 READY Mode ........................20 4.8 Wireless Footswitch ......................21 4.9 Peak Power Display ......................21 4.10 Pulse Mode Selection ....................21 4.11 Using the EPIC V-Series Touch Screen Display ............23 4.12 Procedures Button ......................24 4.13 Turn the Laser Console Off....................24...
  • Page 4 7.4 Table of EPIC V-Series Pre-Programmed Settings ............32 7.5 Pain Therapy ........................33 Recommended Use ......................33 Pre-Progammed Settings for Pain Therapy ................34 Pain Therapy - Warnings and Precautions .................34 Using the Deep Tissue Handpiece ..................35 8. Maintenance .........................36 8.1 Daily Maintenance ......................36 8.2 Cleaning and Sterilization Procedures ................36 Cleaning and Disinfecting Instructions for the Surgical Handpiece, and the Reusable Fiber Optic Cable ........................36...

  • Page 5: Introduction

    When used and maintained properly, the EPIC V-Series will prove a valuable addition to your practice. Please contact BIOLASE Customer Service at 1-800-321-6717 in the USA and Canada for any service needs. If you are located outside the U.S., please contact your BIOLASE-authorized distributor for any service needs.

  • Page 6: Packaging

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

  • Page 7: Equipment Description

    2. EQUIPMENT DESCRIPTION 2.1 GENERAL The EPIC V-Series 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.

  • Page 8: Surgical Delivery System

    2.4 SURGICAL DELIVERY SYSTEM NOTE: All fiber optic cables, Handpieces & tips are shipped non-sterile. The EPIC V-Series 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) The fiber optic cable is detachable from the console.

  • Page 9: Single-Use Tips

    Fiber Figure 2.3: Optical Access Port Figure 2.2: Optic Access Plug 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 C). Tips are single-use only to avoid cross-contamination and are designed CAUTION: to withstand a single sterilization cycle;...
  • Page 10 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...
  • Page 11 Correct Bend Incorrect Bend Figure 2.9: When installing the tip, make sure it is Figure 2.10: Bending the tip cannula seated properly (thread correctly) When the aiming beam is not present or has a significantly different shape, WARNING: change the tip. EPIC™...

  • Page 12: 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 cleaning before and after each patient treatment. This Handpiece cannot be sterilized in the autoclave.

  • Page 13: Safety

    • 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 Use of controls or adjustments or performance of procedures other than WARNING: those specified herein may result in hazardous radiation exposure.

  • Page 14: 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 15: Power Switch

    Remote Interlock Use only the Power Supply Module supplied with the EPIC V-Series laser system CAUTION: (BIOLASE Part Number 2400129). 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).

  • Page 16: 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.) 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).

  • Page 17: Functional Display

    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: •...

  • Page 18: Operation Instructions

    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 V-Series will work using either DC power or the rechargeable battery pack: o 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 V-Series is shipped with the battery pack already...

  • Page 19: Operation - Turn On The Epic V-Series

    • 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 V-Series “Welcome”...

  • Page 20: 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 21 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 22: 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 23: Wireless Footswitch

    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.
  • Page 24 Peak Power Average Power Figure 4.13 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 4.14 Operating the laser at a shorter pulse duration typically results in lower tissue...

  • Page 25: Using The Epic V-Series Touch Screen Display

    4.11 USING THE EPIC V-SERIES TOUCH SCREEN DISPLAY Figure 4.15 EPIC™ V Series User Manual pg. 23 5400430 Rev A...

  • Page 26: Procedures Button

    4.12 PROCEDURES BUTTON The EPIC V-Series comes with 12 Soft Tissue procedural presets already installed and 4 empty slots for custom pre-sets, as well as one factory-installed preset for Surgical. All presets can be customized to your preference. In order to customize the parameters for a particular clinical procedure: 1.

  • Page 27: 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 28: Other Light Sources

    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) Deep Tissue Handpiece 30 mm diameter = 7.1 cm area NOHD 4.77 meters Beam Divergence 8 - 22°...

  • Page 29: Contraindications, Warnings & Precautions

    6. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS 6.1 CONTRAINDICATIONS All clinical procedures performed with EPIC V-Series 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 30: Suction

    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.

  • Page 31: Clinical Applications

    7. CLINICAL APPLICATIONS 7.1 INTRODUCTION To efficiently remove tissues it is imperative to understand the nature of the EPIC V-Series 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 V-Series device may be appropriate for incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and...
  • Page 32 Tip Diameter (µm) (Preset) Power (W) Mode Tip initiation not required when used for recommended procedures Figure 7.2 ● Touch the tip to the surface of the initiation block, without activating the laser (don’t press down on the footswitch (Figure 7.3). Figure 7.3 ●...

  • Page 33: Pre-Programmed Settings For Dental Soft Tissue And Surgical Procedures

    Pre-programmed Settings for Dental Soft Tissue and Surgical Procedures To access the pre-programmed procedure values: 1. Go to the Procedures menu by pressing the Soft Tissue icon or the Surgical icon on the Home screen. 2. Press the button associated with the desired procedure. 3.

  • Page 34: Table Of Epic V-Series Pre-Programmed Settings

    7.4 TABLE OF EPIC V-SERIES PRE-PROGRAMMED SETTINGS PEAK AVERAGE PULSE PULSE DUTY PROCDURE NAME MODE POWER POWER INTERVAL LENGTH CYCLE TYPE INITIATION GINGIVECTOMY 5.0W 1.0W 0.04ms 0.01ms TROUGHING 2.0W 1.0W 1.0ms 1.0ms CURETTAGE 2.4 W 0.80W 0.20ms 0.10ms EXCISION 2.7 W 0.90W 0.20ms 0.10ms...

  • Page 35: Pain Therapy

    7.5 PAIN THERAPY The EPIC V-Series 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. The pain therapy procedure is the process by which tissue temperature is elevated 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 36: Pre-Progammed Settings For Pain Therapy

    • 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 Pre-Progammed Settings for Pain Therapy The Epic V comes from the factory already programmed with 12 settings specific to the type of animal being treated.

  • Page 37: Using The Deep Tissue Handpiece

    • 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. • Different implant materials will respond differently to laser energy and heat; be aware of any implants and their location;...

  • Page 38: Maintenance

    8. MAINTENANCE WARNING: No modification of this equipment is allowed. 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 V-Series system after each procedure.

  • Page 39: To Clean The Surgical Handpiece

    To Clean the Surgical Handpiece: • Carefully remove the tip from the Handpiece and dispose of it in a biohazard medical waste Sharps container. • Carefully remove the Handpiece from the fiber optic cable (see Section 3). • Wipe the entire Handpiece outer surface with cotton gauze and a detergent/enzymatic cleaning solution such as Klenzyme®...

  • Page 40: Installing/Replacing The Console Battery Pack

    Screws to remove Battery cover Figure 8.1: Battery Cover/Bottom of Console Figure 8.2: 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 41: Transportation

    Section 4. To ensure the longevity of the battery power, only BIOLASE-supplied batteries are NOTE: recommended as replacements (BIOLASE p/n 6400463); these are industrial-grade batteries which under normal use have a longer life than conventional AAA batteries.

  • Page 42: Calibration

    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 V-Series 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 43 System too hot down Error 4 Laser Current High/ Low Output is out of specs Call BIOLASE Service FS is partially pressed or Press/Release FS or call Biolase Error 5 FS shorted in Standby is damaged Service Error 6 ON/OFF button Stuck...

  • Page 44: Appendix A - Definition Of Symbols On Labeling

    APPENDIX A – DEFINITION OF SYMBOLS ON LABELING Symbols Description 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. EPIC™ V Series User Manual pg.
  • Page 45 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 FCC Compliance Notice: The footswitch and laser console comply with Part 15 of FCC Rules regarding unlicensed transmissions.
  • Page 46 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 47 Prescription Statement: Federal Law restricts this device to sale by or on the order of a licensed veterinarian; for Canine, Feline, Equine, and Avian use. Atmospheric Pressure Limitations Fragile: Handle with care Keep Dry Humidity Limitations Temperature Limitations This End UP EPIC™...

  • Page 48: Appendix B - Safety Precautions For Lithium-Ion Battery Packs

    APPENDIX B – 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 49: When Charging The Battery

    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 50: When Discharging The Battery

    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.

  • Page 51: Appendix C - Spare Parts & Accessories

    APPENDIX C - SPARE PARTS & ACCESSORIES SYSTEM ACCESSORIES BIOLASE p/n Description 6400007 Surgical Handpiece 2400040 Laser Safety Glasses (Clinician) 6400058 Remote Interlock Plug 2400129 Power Cord with Power Supply 6400506 Wireless Footswitch 6400107 Tip initiation kit 6400311 Deep-Tissue Handpiece 6400310 Deep-Tissue Handpiece protective covers (qty.
  • Page 52 Endo: BIOLASE p/n Description 7400015 EZTIP Endo Kit, E2, 20mm 7400021 200 µm core diameters (qty. 30) EPIC™ V Series User Manual pg. 50 5400430 Rev A...

  • Page 53: Appendix D - Wireless Equipment Compliance Statement

    APPENDIX D - 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 54 Made in the USA Copyright © 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.

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