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Biolase epic 10 User Manual

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Summary of Contents for Biolase epic 10

  • Page 1 User Manual...

  • Page 2: Table Of Contents

    Contents Introduction......................4 Section 1: Installation ..................5 Installation Instructions ....................5 Facility Requirements ....................5 Electrical Supply ......................5 Environmental Requirements ..................5 Section 2: Safety....................6 Precautions........................6 Safety Instructions ......................6 Safety Features ......................7 Energy Monitor......................7 System Monitor ......................
  • Page 3 Tip Initiation: Parameters and Procedures ..............20 Section 4: Operating Instructions ..............21 System Setup ......................21 Operation ........................21 CONTROL Button ....................22 Entering READY/STANDBY Modes ................ 22 READY Mode......................22 Wireless Footswitch ....................23 AVERAGE POWER Display ..................23 PULSE Mode Selection ...................
  • Page 4 Cleaning Instructions (Surgical Handpiece, Classical “Feed-Through” Fiber Handpiece, Reusable Fiber Optic Cable) ..............35 Steam Sterilization (Handpiece, Single Use Tips, Tip Initiation Block) ....36 Cleaning the Whitening/Contour Handpiece............36 Cleaning the Deep Tissue Handpiece ..............37 Disinfection of the Classical “Feed-Through” Fiber Optic Cable......37 Changing the Wireless Footswitch Batteries ............

  • Page 5: Introduction

    When used and maintained properly, the EPIC 10 will prove a valuable addition to your practice. Please contact Biolase Service at 1-800-321-3717 for any service needs. CANADA: This device must be installed and operated according the guidelines of CAN/CSA-Z386-92 “Laser safety in a health care facility.”...

  • Page 6: Section 1: Installation

     Humidity: 15-95%, Non-condensing Changes or modifications not expressly approved by Biolase Technology, Inc. could void the user’s authority to operate the equipment. P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T...

  • Page 7: Section 2: Safety

    Relocating the device may help to eliminate the interference. Always ensure that the proper laser parameters are set before the CAUTION: EPIC 10 product is used in a clinical setting. Safety Instructions Follow these safety instructions before and during treatments: ...

  • Page 8: Safety Features

    The unit will not operate until the system is reset by pressing the “Next” button on the touchscreen and then going into READY mode. If the error messages persist, 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 9: Access Key Code

    CAUTION: Use only the Power Module supplied with the EPIC 10 system (Biolase Part Number 6400142). 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.

  • Page 10: Emergency Stop

    Emergency Stop Press the red Emergency Laser Stop button to instantly turn off the unit. The error √ screen will display an “Emergency Switch Error” message. Press the “ ” icon to clear the error and automatically set the system into STANDBY mode. Figure 5: Emergency Laser Stop Functional Display The System Color Display with Touch Screen and LED indicators on the control panel...

  • Page 11: Section 3: Equipment Description

    Section 3: EQUIPMENT DESCRIPTION General system consists of three components: EPIC 10  Console  Delivery System  Wireless Footswitch 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, 14.8V, 2.9 A/h...

  • Page 12: Main Menu And Procedures Screen

    Main Menu and Procedures Screen (See Figure 8) ITEM ITEM ITEM DESCRIPTION HOME Selects procedure categories PROCEDURES SCREEN Selects pre-set procedures parameters Figure 8: Main Menu and Procedures Screen Figure 9: Left Side View P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T 12 |...
  • Page 13 Figure 10: Right Side View Figure 10: Back View Figure 12: Front View P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T 13 |...

  • Page 14: Re-Usable Surgical Delivery System

    Re-usable Surgical Delivery System NOTE: All fiber optic cables, handpieces & tips are shipped non-sterile. Re-Useable Delivery System with surgical handpiece consists of: EPIC 10  Re-Useable Fiber Optic Assembly  Surgical Handpiece (Figures 13, 14)  Disposable Tips (See Figures 15, 16, 17) NOTE: The fiber optic cable is detachable from the console.

  • Page 15: Single Use Tips

    Figure 15: Fiber Storage Channel Single-use Tips The tips are single-use accessories, which are provided in three core diameters: 200m, 300m and 400m and different lengths (see Appendix B). Always autoclave before tip initiation. Do not autoclave more than WARNING: once.
  • Page 16 Figure 16: Surgical Handpiece Assembly Fiber Shaft Protective Window Handpiece Figure 17: Disconnecting the Handpiece(push both buttons) Tip assembly Figure 18: Disconnecting the fiber Tip (twist first counter clockwise) Figure 19: Tightening the fiber tips twist (only when Handpiece is connected to fiber) Bend Correct Incorrect...

  • Page 17: Whitening/Contour Handpiece

    The handpiece is reusable and equipped with a disposable non-sterile NOTE: protective shield for single patient use. The handpiece requires cleaning before and after each patient treatment. For instructions on cleaning the the handpiece, refer to section 8. The Whitening/Contour Handpiece is compatible only with the Re-useable NOTE: Fiber Optic Cable Assembly.

  • Page 18: Deep Tissue Handpiece (Optional)

    The handpiece is reusable and equipped with a disposable non-sterile NOTE: protective shield for single patient use. The handpiece requires cleaning before and after each patient treatment. For instructions on cleaning the the handpiece, refer to section 8. The Deep Tissue Handpiece is compatible only with the Re-useable Fiber NOTE: Optic Cable Assembly.

  • Page 19: Classical "Feed-Through" Fiber Handpiece (Optional)

    Classical “Feed-Through” Delivery System The Feed-Through Delivery System with Surgical Handpiece consists of a Fiber Optic Assembly with the following: ► Handpiece ► Base ► Handle ► Head (30°) NOTE: The standard fiber optic cable assembly is a 400µm fiber. Other sizes are available upon request.
  • Page 20 the stripper away from the handpiece in a smooth motion to ensure that the jacket is cleanly removed. 5) Use a diamond/carbide cleaver to cut the used end of the fiber. Place the fiber against a flat surface. Position the edge of the cleaver approximately ¼ inch from the end of the fiber, and make a scratch around half the circumference of the fiber.

  • Page 21: Tip Initiation: Parameters And Procedures

    Mode ■ Procedural Steps Step 1) Set the EPIC 10 to the appropriate setting for the particular tip, using the table above as a guide. Step 2) Touch the tip to the surface of the initiation block, without firing Step 3) Fire the laser, allowing the tip to sink into the block.

  • Page 22: System Setup

     Turn power switch at the rear of the base of the console to ON position. The EPIC 10 Welcome screen will be displayed. P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T...

  • Page 23: Control Button

    Figure 21 Figure 22  Enter the three digit key access code using the touch screen. The Access Key Code is 888. (If the proper code is not entered, re-enter the correct code.)  The system will go to the HOME screen, which identifies three procedure categories to choose from.

  • Page 24: Wireless Footswitch

    Figure 23 Figure 24 When the tip is When the tip is straight, the bent, the aiming aiming beam will beam will look look like a circle, like a spot, and outlining the the main laser area where main power is laser power is applied in the applied.

  • Page 25: Operational Algorithm

    Operational Algorithm of the EPIC 10 P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T 25 |...

  • Page 26: Procedures Button

     Aiming Beam (5 levels of brightness adjustment)  Beep Sound (3 levels of sound adjustment)  Service Mode (accessible only by authorized Biolase Service Representatives)  Restore Factory Default Settings Turn the Unit OFF  Place handpiece back on handpiece holder.

  • Page 27: Section 5: Specifications

    Section 5: SPECIFICATIONS General ● Dimensions 5.7 in (W) x 4.4 in (H) x 6.5 in (L) ● Weight 2.5 lbs / 1kg Electrical ● Operating Voltage 100V ± 10% and 230V ± 10% ~ at 2A ● Frequency 50-60Hz ●...

  • Page 28: Section 6: Contraindications, Warnings And Precautions

    Section 6: CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS Contraindications All clinical procedures performed with EPIC 10 must be subjected to the same clinical judgment and care as 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 29 Training Only licensed professionals who have 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 30: Section 7: Clinical Applications

    To efficiently remove tissues it is imperative to understand the nature of the device. EPIC 10 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 31: Dental

    DENTAL Pre-programmed Settings for Dental Procedures Always use clinical judgment when selecting power, pulse, length, and WARNING: pulse interval parameters to ensure optimal clinical results. The recommended settings apply only to the 300 µm and 400 µm tips. To access the pre-programmed procedure values: 1) Go to the Procedures menu by pressing the Procedures button 2) Press the button associated with the chosen procedure To store your personal preferred settings for any procedure:...

  • Page 32: Table Of Recommended Pre-Programmed Settings

    PRE-PROGRAMMED SETTINGS PROCDURE PEAK AVERAGE PULSE PULSE DUTY MODE INITIATION NAME POWER POWER INTERVAL LENGTH CYCLE TYPE GINGIVECTOMY 5.0W 1.0W 0.04 ms 0.01 ms TROUGHING 2.0 W 1.0 W 1.0 ms 1.0 ms CURETTAGE 2.4 W 0.8 W EXCISION 2.7 W 0.9 W FRENECTOMY 2.0 W...

  • Page 33: Tooth Whitening Procedure

    Tooth Whitening Procedure The following items are required to perform teeth whitening with the EPIC 10 laser: ► EPIC 10 diode laser ► Whitening/Contour Handpiece ► LaserWhite™ 20 Whitening Gel Kit (p/n 7400030 sold separately in packs of 5) Detailed step-by-step instructions, contraindications, precautions, and warnings for tooth whitening are provided with the LaserWhite™...

  • Page 34: Pain Therapy Procedures

    Using the Whitening/Contour Handpiece : Recommended Clinical Settings The EPIC 10 diode laser, in conjunction with the Whitening/Contour Handpiece, is designed to provide near-infrared laser energy to tissue for the purpose of elevating tissue temperature and providing for temporary relief of pain conditions as stated in the Indications for Use.

  • Page 35: Deep Tissue Handpiece

    Using the Deep Tissue Handpiece : Recommended Clinical Settings Set Power to 4.0W CW for 2 minutes, followed by Power at 3.25W for 3 TYPE II minutes and then set Power to 2.75W for the remaining 5 minutes Set Power to 4.5W CW for 2 minutes, reduce Power to 4.0W for the TYPE III remaining 8 minutes Set Power to 4.0W CW for 2 minutes, reduce Power to 3.5W for the...

  • Page 36: Section 8: Maintenance

    EPIC 10 Annual calibrations can be performed at a certified depot repair facility. Call Biolase Service at 1-800-321-6717 or your Authorized Service Representative to schedule an appointment. Please contact Biolase Service at 1-800-321-6717 or your Authorized Representative to discuss Extended Service Contracts and Annual maintenance options.

  • Page 37: Steam Sterilization (Handpiece, Single Use Tips, Tip Initiation Block)

    ► At the completion of the autoclave cycle, remove the tray and let each item sterilized cool and dry. Although Biolase Technology has validated the parameters for the recommended autoclave sterilization procedure, it is the responsibility of the customer/user to properly validate his or her autoclave sterilizer.

  • Page 38: Cleaning The Deep Tissue Handpiece

    Dispose of the used battery as appropriate. Installing/Replacing the Console Battery Pack NOTE: Only use the battery pack suppled by Biolase. The battery pack is a separate accessory (see Appendix B). 1. To install or replace the battery pack, remove the battery cover on the underside of the console using a Phillips screwdriver (Figure 26).

  • Page 39: Transportation

    Make sure the distal end of the Handpiece shaft is protected from dirt with the CAUTION: protective tip plug and Handpiece. Remove battery pack if the Epic 10 is not likely to be used for some time CAUTION: was shipped inside a custom shipping box. Please save and store the box in a EPIC 10 cool dry place.

  • Page 40: Calibration

    Authorized Service Representative to schedule an appointment. Section 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. This product includes software developed by Biolase Technology Copyright ©2012 Biolase Technology.

  • Page 41: Appendix A - Labels

    APPENDIX A - LABELS A.1 Identification Location: Bottom of laser console A.2 Footswitch [Engraved] A.3 Laser Aperture Location: Rear of laser console A.4 FCC Compliance Notice Location: Bottom of footswitch P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T 41 |...
  • Page 42 A.6 Remote Interlock Location: Rear of Laser Console A.7 Emergency Laser Stop Switch Location: Left side of laser console 5400017 A.8 Warning label Location: Rear top cover of laser console THIS PRODUCT COMPLIES WITH FDA A.9 Compliance label PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR Location: Bottom of laser console DEVIATIONS PURSUANT TO LASER...

  • Page 43: Appendix B - Spare Parts And Accessories

    APPENDIX B - SPARE PARTS AND ACCESSORIES DESCRIPTION 6400007 Surgical Handpiece 2400040 Laser Safety Glasses (Clinician) 2400078 Laser Safety Glasses (Patient) 6400058 Remote Interlock Plug 6400005 Power Cord with Power Supply 6400xxx Wireless Footswitch 6400107 Tip initiation kit 7400022 Whitening/Contour Handpiece (Optional) 6400180 Whitening Handpiece clear handpiece covers (30-pack) 7400030...

  • Page 44: Appendix C - Limited Warranty

    APPENDIX C – LIMITED WARRANTY For warranty information, refer to separate equipment warranty. This note applies only to the wireless portion of our 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.
  • Page 45 Altenhofstrasse 80 D-66386 St. Ingbert Germany +49 6894 581020 www.mt-procons.com ® ©2012. BIOLASE 5400321 Rev. X: DRAFT P a g e 5 4 0 0 3 2 1 R e v . X : D R A F T 45 |...

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