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Biolase Epic Q User Manual

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Epic
Q User Manual
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Summary of Contents for Biolase Epic Q

  • Page 1 Epic Q User Manual...
  • Page 2 Control Button ..........................13 Fiber Delivery System ........................13 Surgical Handpiece ........................13 Wireless Footswitch ........................14 6. SAFETY WITH THE EPIC Q ................... 15 6.1 Safety Instructions ......................... 15 6.2 Safety Classification ........................16 6.3 Safety Features ..........................17 Energy Monitor ..........................
  • Page 3 7.11 Wireless Footswitch ........................26 7.12 Peak Power Display ........................27 7.13 Pulse Mode Selection ........................27 7.14 Using the EPIC Q Touch Screen Display ..................28 7.15 Procedures Button ........................29 7.16 Turn the Laser Console Off ......................29 8.
  • Page 4 Contents 9.4 Installing/Replacingthe Console Battery pack ................37 9.5 Changing the Wireless Footswitch Batteries ................. 38 9.6 Transportation ..........................39 9.7 Storage ............................39 10. CALIBRATION ......................40 11. SOFTWARE SPECIFICATION ..................40 12. TROUBLESHOOTING ....................41 APPENDIX A- TIP GUIDE ....................43 APPENDIX B –...
  • Page 5 The EPIC Q 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 6 Indications for Use The EPIC Q device is indicated for incision, excision, vaporization, ablation and coagulation of oral soft- tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: • Excisional and incisional biopsies •...
  • Page 7 Contraindications, Warnings, and Precautions 3.1 CONTRAINDICATIONS All clinical procedures performed with EPIC Q 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 and exercise caution for general medical conditions that might contraindicate a local procedure;...
  • Page 8 Contradictions, Warnings, and Precautions ADJACENT STRUCTURES EPIC Q is designed to remove soft-tissues. Therefore, always be aware of adjacent structures and substructures during use. Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues. Do not direct energy toward hard-tissue such as tooth or bone. Do not direct energy towards amalgam, gold or other metallic surfaces.
  • Page 9 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 16.5 x 11.2) • Weight 3.5 lbs / 1.6 kg 4.2 ELECTRICAL • Operating voltage 100V - 240V ~ at 1.5A •...
  • Page 10 Equipment Descriptions 5.1 SYSTEM COMPONENTS The EPIC Q laser system includes the following: 1. Laser Console with Fiber Optic Cable 2. Peel-off Screen Protectors (qty. 30) 3. Assorted Surgical Tips 4. Surgical Handpiece (qty. 2) 5. Laser Safety Goggles (qty. 3) 6.
  • Page 11 Equipment Descriptions 5.2 GENERAL The EPIC Q system consists of three components: Base Console Fiber Delivery System LED Indicators LED Indicators Control Button Fiber Storage Channel Wireless Footswitch Figure 5.1 Epic Q User Manual...
  • Page 12 Equipment Descriptions 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 5.1). CONTROL BUTTON: Activates the controls and console display;...
  • Page 13 Equipment Descriptions WIRELESS FOOTSWITCH The EPIC Q laser will only emit laser energy when the user presses down on the Footswitch while the laser is in Ready mode. It is Cover designed to work using wireless technology and is powered by two AAA batteries which are installed prior to shipment from the factory;...
  • Page 14 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 Q laser is used in a clinical procedure. •...
  • Page 15 Safety with the Epic Q 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 instruments or dental mirrors. If aimed directly at these surfaces the laser beam will reflect creating a potential hazard.
  • Page 16 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 17 Safety with the Epic Q WIRELESS FOOTSWITCH The EPIC Q 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 and is paired to the laser console at the factory.
  • Page 18 OFF (O) at the power switch, the battery will still charge, but at a slower rate. 7.2 THE FIBER OPTIC CABLE The Epic Q ships with the Fiber Optic Cable built into the laser console and cannot be disconnected from the console.
  • Page 19 Installation and Set-Up 7.3 SETUP REQUIREMENTS CAUTION: The surgical Handpiece is not sterile when shipped and MUST be sterilized prior to initial use, and cleaned and sterilized between patients. To connect the Handpiece to the Fiber Optic Cable, push the Handpiece onto the fiber shaft, without twisting, until it clicks into place and is secured (Figures 7.1, 7.2).
  • Page 20 Installation and Set-Up Figure 7.2: Surgical Handpiece Assembly fully assembled To disconnect the Handpiece from the Fiber Optic Cable (Figure 7.3): 1. Take the Handpiece body in one hand and the shaft in the other, 2. Pushing the two buttons on the fiber shaft, 3.
  • Page 21 Installation and Set-Up Figure 7.5: Remove the fiber Tip by twisting the Tip counterclockwise CAUTION: For proper laser operation, do not connect the Tip when the Handpiece is not connected to the fiber. Figure 7.7: Bending the Tip cannula Figure 7.6 : Installing the Tip CAUTION: Be aware that the metal cannula on the Tips may become hot during use.
  • Page 22 Turn the power switch at the rear of the console to the ON ( I ) position. After three (3) seconds the EPIC Q Welcome screen will be displayed. •...
  • Page 23 Installation and Set-Up Aiming Beam Volume Language Selection Wireless Menu Service Mode Restore Factory Defaults Figure 7.10 7.7 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE Verify that the Footswitch and laser console are paired; a blue LED indicator light on the laser console will blink when pairing is established.
  • Page 24 Installation and Set-Up To re-establish pairing, take the following steps: Go to the settings menu on the laser console display by pressing the settings icon; select the “Wireless” icon. A screen will appear indicating that pairing of the Footswitch to the laser console has been lost (Figure 7.12);...
  • Page 25 Installation and Set-Up 7.9 ENTERING READY OR STANDBY MODES Press and release the Control button to place the laser console into either Ready or Standby mode (the mode is displayed in the lower right hand corner of the console). The laser console will only emit laser energy when the Footswitch is pressed, and the laser console is set to Ready mode.
  • Page 26 Installation and Set-Up 7.12 PEAK POWER DISPLAY This number is shown only when the system is in Pulse mode and presents the value of the peak power based on the power setting and Pulse mode. 7.13 PULSE MODE SELECTION Pulse mode selection graphically indicates whether the system is in Continuous mode or in Pulse mode. In Continuous mode, laser power is constantly delivered when the laser console is in Ready mode and the wireless Footswitch is activated.
  • Page 27 Installation and Set-Up 7.14 USING THE EPIC Q TOUCH SCREEN DISPLAY Figure 7.28 Epic Q User Manual...
  • Page 28 7.15 PROCEDURES BUTTON The EPIC Q has the ability to store up to 20 pre-set procedures; EPIC Q 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 29 Clinical Applications 8.1 OVERVIEW To efficiently treat tissues, it is imperative to understand the nature of the EPIC Q 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 30 Clinical Applications After Tip initiation is completed, press the check mark to access the screen for the selected procedure. Figure 8.5 Figure 8.6 CAUTION: If the laser console is in Ready mode, the laser will fire if the Footswitch is activated. PRE-PROGRAMMED SETTINGS FOR DENTAL PROCEDURES To access the pre-programmed procedure values: Go to the procedures menu by pressing the Soft-tissue icon on the Home screen.
  • Page 31 Clinical Applications 8.3 TABLE OF PRE-PROGRAMMED SURGICAL SETTINGS Peak Avg. Pulse Pulse Duty Preset name Indications for Use Mode power Power Interval Length Cycle Gingivectomy/ Reduction of gingival CP20 5.0 W 1.0 W 0.04 ms 0.01 ms Gingivoplasty hypertrophy, vestibuloplasty Tissue retraction for impression, gingival Troughing...
  • Page 32 Clinical Applications 8.3 TABLE OF PRE-PROGRAMMED SURGICAL SETTINGS (CONTINUED) Peak Avg. Pulse Pulse Duty Preset name Indications for Use Mode power Power Interval Length Cycle Soft-tissue crown Crown Lengthening CP33 2.7 W 0.9 W 0.2 ms 0.1 ms lengthening Laser removal of diseased, infected, inflamed and Infected Pockets CP50...
  • Page 33 Use disinfectant to wipe down the front panel and Handpiece Holder of the EPIC Q system after each procedure. Do not use bleach or abrasive cleansers.
  • Page 34 Maintenance 7. Rinse the Handpiece under running lukewarm tap water (22-43°C) for a minimum of 10 seconds and then dry with a lint-free cloth. 8. Visually inspect the Handpiece for any residual soil. If necessary, repeat steps 5 - 7 until all residual soil is removed.
  • Page 35 4. Repeat as needed using a new lint free cotton or foam swab each time until Figure 9.3 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 Q User Manual...
  • Page 36 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 4400287). Epic...
  • Page 37 AAA batteries. 9.6 TRANSPORTATION The EPIC Q is susceptible to damage if not handled properly. The unit should ALWAYS be handled carefully and never banged, jarred, jolted, dropped, or knocked.
  • Page 38 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 Q 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 39 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 Q software is protected by copyright and other intellectual property laws. This product contains proprietary, copyrighted software developed by BIOLASE, Inc.
  • Page 40 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 41 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 cool Error 3 Shutdown temperature System too hot down Error 4 Laser current high/low...
  • Page 42 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 Name Diameter Application Part Number (mm) E4-4 400µm...
  • Page 43 Power Cord (International) 6400573 Wireless Footswitch 6400107 Tip Initiation Kit 6400465 Peel-off Clear Screen Protectors (qty. 30) 4400287 Lithium-Ion Battery Pack for Console 2400203 Battery Pack (2 x AAA) 5400419 Laser Warning Sign 4400553 Epic Protective Case Epic Q User Manual...
  • Page 44 Appendix C Contents Labelig PRODUCT IDENTIFICATION LABEL: Epic Q LOCATION: 7410008 Bottom of laser console Label shown is an example only MANUFACTURER CATALOG/PART NUMBER PRODUCT SERIAL NUMBER DATE OF MANUFACTURE LASER WARNING: Indicates the system contains a laser LOCATION: Back of Laser Console.
  • Page 45 Appendix C Contents 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: Bottom of laser console FCC AND IC LABEL: MODEL: EPIC X Federal Communication Commission and Industry FCC ID: G2OEPIC...
  • Page 46 LOCATION: Outer carton (shipping box). HUMIDITY LIMITATIONS LOCATION: Outer carton (shipping box). ATMOSPHERIC PRESSURE LIMITATIONS LOCATION: Outer carton (shipping box). SYSTEM SHIPPING LABEL: EPIC Q LOCATION: Outer carton (shipping box). 7410008 Label shown is an example only Epic Q User Manual...
  • Page 47 RADIATION. AVOID EYE OR SKIN EXPOSURE TO DIRECT AND/OR SCATTERED RADIATION. Semiconductor Diode, 940nm +/-10nm, 3W max 5mW max @ 625-670nm Aiming Beam BIOLASE. 27042 Towne Centre Drive, Suite 270 Foothill Ranch, CA 92610-2811 USA EYE PROTECTION REQUIRED CLASS IV LASER PRODUCT TITLE...
  • Page 48 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 Appendix D Safety-Lithium-Ion Battery Packs WHEN CHARGING THE BATTERY: WARNING: 1. Be sure to follow the rules listed below while charging the battery. Failure to do so may cause the battery to become hot, rupture, or ignite and cause serious injury. •...
  • Page 50 EMISSIONS or decreased IMMUNITY of the EPIC Q diode laser system. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS The EPIC Q is intended for use in the electromagnetic environment specified below. The customer or the user of the EPIC Q should assure it is used in such an environment.
  • Page 51 Electromagnetic Compability GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY The EPIC Q is intended for use in the electromagnetic environment specified below. The customer or the user of the EPIC Q should assure that it is used in such an environment.
  • Page 52 GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY (continued) The EPIC Q is intended for use in the electromagnetic environment specified below. The customer or the user of the EPIC Q should assure that it is used in such an environment.
  • Page 53 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND THE EPIC Q The EPIC Q is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EPIC Q can help prevent electromagnetic interferences by...
  • Page 54 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 55 PAGE IS LEFT BLANK INTENTIONALLY...
  • Page 56 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.