Biolase EPIC EPIC 10 Dental Soft Tissue Laser User Manual 5400321 50912x

Biolase, Inc. EPIC 10 Dental Soft Tissue Laser 5400321 50912x

Users Manual

User Manual
2 | Page 5400321Rev. X: DRAFT 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 .......................................................................................................... 7 Power Switch ............................................................................................................. 7 Access Key Code....................................................................................................... 8 CONTROL Button ...................................................................................................... 8 Wireless Footswitch...................................................................................................8 Remote Interlock........................................................................................................ 8 Emergency Stop ........................................................................................................ 9 Functional Display...................................................................................................... 9 Safety Classification ...................................................................................................... 9 Section 3: Equipment Description ................................................................. 10 General........................................................................................................................10 Base Console .............................................................................................................. 10 Control Panel...............................................................................................................10 Main Menu and Procedures Screen ............................................................................ 11 Re-usable Surgical Delivery System ........................................................................... 13 Fiber Optic Connection................................................................................................13 Single Use Tips............................................................................................................ 14 Surgical Handpiece Assembly.....................................................................................14 Whitening/Contour Handpiece..................................................................................... 16 Deep Tissue Handpiece (Optional).............................................................................. 17 Classical “Feed-Through” Fiber Handpiece (Optional) ................................................ 18
3 | Page 5400321Rev. X: DRAFT 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 ........................................................................................... 23 Operational Algorithm .............................................................................................. 24 PROCEDURES Button ............................................................................................ 25 SETTINGS Screen................................................................................................... 25 Turn the Unit OFF .................................................................................................... 25 Section 5: Specifications................................................................................ 26 Section 6: Contraindications, Warnings and Precautions........................... 27 Contraindications.........................................................................................................27 Warnings and Precautions........................................................................................... 27 Section 7: Clinical Applications ..................................................................... 29 Introduction.................................................................................................................. 29 Table of Indications for Use.........................................................................................29 Dental .......................................................................................................................... 30 Pre-programmed Settings for Dental Procedures.................................................... 30 Table of Recommended Pre-programmed Settings ................................................31 Tooth Whitening Procedure.....................................................................................32 Pain Therapy Procedures............................................................................................33 Using the Whitening/Contour Handpiece................................................................. 33 Deep Tissue Handpiece .......................................................................................... 34 Section 8: Maintenance................................................................................... 35 Annual Maintenance....................................................................................................35 Daily Maintenance ....................................................................................................... 35 Contamination Control Procedures.............................................................................. 35
4 | Page 5400321Rev. X: DRAFT 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 ........................................................... 37 Installing or Changing the Console Battery Pack..................................................... 37 Transportation.......................................................................................................... 38 Storage .................................................................................................................... 38 Section 9: Calibration.................................................................................... 39 Section 10: Software Specification................................................................ 39 Section 11: Troubleshooting .......................................................................... 39 Appendix A - Labels........................................................................................ 40 Appendix B – Spare Parts and Accessories .................................................. 42 Appendix C – Limited Warranty……………………….………………………….. 43
5 | Page 5400321Rev. X: DRAFT INTRODUCTION The EPIC 10 Dental Soft Tissue Laser is a surgical and therapeutic device at the cutting edge of technology, designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain. The EPIC 10 utilizes a solid state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via flexible fiber, connected at one end to the laser source and the other end to the handpiece. Various types of the single use tips were designed and optimized for different applications. The device is activated by means of a wireless footswitch. The EPIC 10 is a prescription device that is indicated for professional use by dentists and hygienists (where local law allows) under the supervision of a dentist. The use of this device requires proper clinical and technical training. This manual provides instructions for dental professionals that have completed the appropriate training. 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.”
6 | Page 5400321Rev. X: DRAFT Section 1: INSTALLATION Installation Instructions The EPIC 10 system includes the following:  Console (includes rechargeable battery pack) NOTE: For instructions on how to install or change the battery pack, see Section 8.  Re-usable Delivery System (1 surgical handpiece; 1 whitening handpiece, 1 re-usable, detachable fiber assembly, (optional) 1 deep tissue handpiece) or  (optional) Classical Delivery System (1 “feed-through” fiber assembly, 1 corresponding handpiece, 1 fiber stripper, 1 fiber scribe)  User Manual CD  3 pairs of protective laser eyewear  Wireless Footswitch with two AAA batteries (FCC I.D. No. G20EPIC)  Power Supply with Cord  Remote interlock assembly  Peel-off clear cover pack (qty. 30)  Tip Initiation Kit  Tips Starter Kit (single-use)  Quick Reference DVD  Window Cleaning Kit  Warning Sign NOTE: Use proper care prior to transporting the unit. Refer to section 8 in this Manual for instructions. Facility Requirements Electrical Supply (100-240V)  1.5 - 3A, 50/60Hz Environmental Requirements  Temperature: 20-25 ºC  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.
7 | Page 5400321Rev. X: DRAFT Section 2: SAFETY Precautions Failure to comply with precautions and warnings described herein may lead to exposure to dangerous optical radiation sources. Please comply with all safety instructions and warnings. CAUTION: Federal Law restricts this device to sale by or under the order of a dentist or physician or other licensed practitioner. CAUTION: Use of controls or adjustments or performance of procedures other than those specified herein my result in hazardous radiation exposure. DANGER: Do not use this unit if you suspect it of functioning improperly or other than described herein. CAUTION: This unit has been designed and tested to meet the requirements of electromagnetic, electrostatic, and radio frequency interference standards. However, the possibility of electromagnetic or other interference may still exist. Relocating the device may help to eliminate the interference. CAUTION: Always ensure that the proper laser parameters are set before the EPIC 10 product is used in a clinical setting. Safety Instructions Follow these safety instructions before and during treatments:  All operatory entrances must be marked with an appropriate warning sign (included with shipment).  Do not operate in the presence of explosive or flammable materials. Flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided. Solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before laser is used. Attention should also be drawn to the danger of ignition of endogenous gases.  All persons present in the operatory must wear protective laser eyewear. CAUTION: Periodically inspect laser eyewear for pitting and cracking. CAUTION: Always ensure that the protective laser eyewear is appropriate for the laser wavelength. NOTE: For replacement or additional protective laser eyewear, please contact your authorized dealer  Do not look directly into the beam or at specular reflections.  Never direct or point the beam at anyone's eyes.  Always place the system into STANDBY mode (by pressing the control button on the control panel while in READY mode) before exchanging handpieces or disposable tips.
8 | Page 5400321Rev. X: DRAFT  Move the toggle switch (located on rear of console) to OFF position before leaving unit unattended. DANGER: Do not open unit housing at anytime. Danger from optical radiation may exist. WARNING: Be aware that the metal / plastic cannula on the tips may becom hot during use. Avoid contact of the cannula with any tissue. ` WARNING: Do not aim the laser at metallic or reflective surfaces, such as surgical instruments or dental mirrors. If aimed directily at these surfaces the laser beam will reflect and create a potential hazard. Safety Features Energy Monitor The current monitor measures and verifies power output. Power deviations of more than ± 20% from the selected value will cause the display to show the error message: “DIODE CALIBRATION”. 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. An error in any one of these will stop the system. The text display will indicate the type of error. Operation will not resume until the error is cleared. Power Switch The unit can be switched ON or OFF using a toggle switch at the back panel. Figure 1: Power Switch Figure 2: Power Supply with cord
9 | Page 5400321Rev. X: DRAFT 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. NOTE: Turning the laser off by pressing and holding the Control button on the front panel does not re-set the Access Key Code. Turn the Power Switch OFF only when the system will not be in use for a long period of time. CONTROL Button Once the power switch is set to the ON position the access key code is activated. The CONTROL button on the control panel must be pressed to enable the footswitch. 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 in READY mode. The footswitch is designed to work using wireless technology. Two AAA batteries are required to power the footswitch (operating voltage – 2 to 3.2 volts). Figure 3: Footswitch Remote Interlock This feature allows the device to be connected to the remote sensor which will prevent its operation when triggered (e.g., by opening door). The electric cable from this connector should be wired to the normally closed switch, sensing the opening of a door and turning the laser OFF when switch is open. This feature is overridden when the plug is not connected. Figure 4: Remote Interlock connector
10 | Page 5400321Rev. X: DRAFT 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 show the functional conditions of the system. Safety Classification The following safety classifications are applicable to the device:  Laser Radiation – Class 4  Type of protections against electrical shock – Class 1  Degree of protection against electrical shock – Type B Applied Part  Not protected against water ingress – Ordinary Equipment  Not suitable for use in presence of flammable anesthetic mixture  Operation Mode – Continuous Operation  Wireless Footswitch – IPX6
11 | Page 5400321Rev. X: DRAFT Section 3: EQUIPMENT DESCRIPTION General The EPIC 10 system consists of three components:  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 Control Panel (See Figure 7) ITEM # ITEM ITEM DESCRIPTION 1 CONTROL BUTTON (a) Turns the controls and display on and off Places unit into STANDBY or READY mode 2 LED INDICATOR (b) Amber indicates unit is in STANDBY or READY mode. Blinking green indicates emission of laser power. Blinking blue indicates wireless connection is active Figure 7: Control Panel (a) (b) (b)
12 | Page 5400321Rev. X: DRAFT Main Menu and Procedures Screen (See Figure 8) ITEM # ITEM ITEM DESCRIPTION 1 HOME Selects procedure categories 2 PROCEDURES SCREEN Selects pre-set procedures parameters Figure 8: Main Menu and Procedures Screen Figure 9: Left Side View
13 | Page 5400321Rev. X: DRAFT Figure 10: Right Side View Figure 10: Back View Figure 12: Front View
14 | Page 5400321Rev. X: DRAFT Re-usable Surgical Delivery System NOTE: All fiber optic cables, handpieces & tips are shipped non-sterile. The EPIC 10 Re-Useable Delivery System with surgical handpiece consists of:  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. The Handpiece is a reusable accessory. The Handpiece will require cleaning and sterilization prior to each patient treatment. Tips are intended for single-use only and must be disposed of after each patient use. Proper tip disposal in a biohazard medical waste sharps container is required. Tips must be steam sterilized prior to use. For instructions on cleaning and sterilization of the handpiece and tips Refer to Section 8. Fiber Optic Connection The fiber optic cable is attached to the console by inserting the optical access plug (Figure 13) into the optical access port (Figure 14). For storage, the cable can be wound in the fiber storage channel around the base of the console in either a clockwise or counterclockwise direction (Figure 15). Figure 13: Optical Access Plug Figure 14: Optical Access Port
15 | Page 5400321Rev. X: DRAFT 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). WARNING: Always autoclave before tip initiation. Do not autoclave more than once. Tips are single-use only. To connect the tip, insert it into the handpiece orifice and tighten by turning clockwise. Bend the metal cannula according to the specific procedure requirements. NOTE: To provide proper laser operation, do not connect tips when the handpiece is disconnected. CAUTION: Do not bend tips with sharp angle - it will break the tip (Figure 17). If the red aiming beam is not present in READY mode - replace the tip. 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.  To disconnect handpiece from fiber optic assembly: 1. Take handpiece body in one hand and the shaft in another (See Figure 14) 2. Push two buttons on the handpiece shaft 3. Pull handpiece with the ring to separate.
16 | Page 5400321Rev. X: DRAFT 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 Figure 20: Bending the tip cannula Whitening/Contour Handpiece
17 | Page 5400321Rev. X: DRAFT NOTE: The handpiece is reusable and equipped with a disposable non-sterile 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. NOTE: The Whitening/Contour Handpiece is compatible only with the Re-useable Fiber Optic Cable Assembly. It is not compatible with the Classical (Feed-Through) Fiber. Whitening/Contour Handpiece Disposable Shield The area of Laser Energy Output is 35mm x 8mm = 2.8cm2 Spot Size. To disconnect the handpiece from the fiber optic assembly: 1. Take the handpiece body in one hand and the shaft in another. 2. Push two buttons on the handpiece shaft. 3. Pull handpiece with the ring to separate. To connect the Handpiece to the fiber optic cable, push the handpiece on the fiber shaft until it clicks on and is secured. Deep Tissue Handpiece (Optional)
18 | Page 5400321Rev. X: DRAFT NOTE: The handpiece is reusable and equipped with a disposable non-sterile 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. NOTE: The Deep Tissue Handpiece is compatible only with the Re-useable Fiber Optic Cable Assembly. It is not compatible with the Classical (Feed- Through) Fiber. Deep Tissue Handpiece 1) Remove Red Dust Cover from Deep Tissue Handpiece 2) Slide handpiece over monocoil shaft until it clicks into place. 3) Place protective cover over the adjustable spacer 4) Loosen the Lock Ring and set the spacer at the desired spot size detent location. Tighten the Lock Ring. 5) Place handpiece into the handpiece holder. To remove handpiece, press and hold the buttons on the side of the shaft and pull handpiece away from shaft. Classical “Feed-Through” Fiber Handpiece (Optional)
19 | Page 5400321Rev. X: DRAFT 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. WARNING: All fiber optic cables, handpieces, and heads are shipped non-sterile. These are reusable accessories that require cleaning and sterilization before and after each patient treatment. For instructions on cleaning and sterilization of the fiber optic cable, handpiece, and head, refer to Section 8. Fiber optic cable is not autoclavable unless it is labeled as “autoclavable.” Cleaving the Fiber The fiber should be cleaved after each procedure. 1) Loosen the proximal end of the handpiece by unscrewing the handpiece base. 2) Pull 2-3 inches of fiber optic cable from the handpiece head through the handpiece. 3) Select a fiber stripper that corresponds to the fiber diameter size. 4) Insert approximately 1 inch of the fiber optic cable into the stripper. Squeeze the stripper handles to get a firm purchase on the fiber optic cable, and while doing so pull
20 | Page 5400321Rev. X: DRAFT 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. Make sure that the edge of the cleaver is always perpendicular to the fiber during scratching. 6) Hold the end of the fiber above the scratch between thumb and forefinger and pull the end of the fiber away until the end section breaks off. If the fiber end is removed properly by pulling in the direction perpendicular to the end surface of the fiber, the fiber should end in a flat surface. 7) Verify the cleave quality by aiming the fiber at a flat surface and observing the shape of the spot created by the visible aiming beam. If the visible spot is a full circle, then the power output is optimal; if the circle is distorted, then repeat only the cleaving procedure presented in steps 5 and 6 until you obtain a perfect circle beam. 8) After the fiber is successfully cleaved, pull the fiber back through the handpiece until just the fiber tip protrudes from the fiber end of the handpiece head. Tighten the handpiece base until snug. Ensure that the fiber isn’t loose by pulling tightly on the fiber optic cable at the proximal end. Tip Initiation: Parameters and procedures
21 | Page 5400321Rev. X: DRAFT ■ Laser Parameters: Tip Diameter (µm) Power (W) Mode 400 1.4 CW 300 1.0 CW ■ 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. Pull the tip out when the metal canula touches the block, still firing until just before Step 4) Fire the laser into the air once, you will see a white flash or the tip will glow. Repeat steps 1 – 4 to ensure the tip is initiated. Section 4: OPERATING INSTRUCTIONS
22 | Page 5400321Rev. X: DRAFT System Setup  Place unit in a clean, dry and well-ventilated area.  Verify power switch is in OFF position  Connect power cord to power connector on the unit and plug into wall outlet to charge the rechargeable battery. Before first use, it is recommended to fully charge the battery (at least 2 hours). Once the battery is charged, unplug the power cord from the wall outlet and the console. The unit will run on battery power alone.  Connect chosen fiber to the console CAUTION: Do not cover or block ventilation channels. These channels provide air-flow path to cool unit. CAUTION: Do not bend fiber optic cable sharply or fiber will break.  Remove protective tip and handpiece from fiber shaft (See Fig. 14)  Verify visually that protective window is clean. If not – blow off any residue or dirt with compressed air. For better results, use a non-linting cotton swab soaked with alcohol.  Carefully connect the Handpiece (See Figure 13)  Insert the selected tip and tighten it clockwise until snug.  Wind excess fiber optic cable onto the fiber spool around the base of the console.  Place handpiece in handpiece holder. (See Figure 12)  If using the classical “feed-through” fiber handpiece, make sure the fiber connector is free of dirt and dust. If not – clean with a cotton swab soaked with alcohol. WARNING: Never point fiber optic at eyes. WARNING: Never operate the laser without a fiber tip attached. WARNING: All persons present in the operatory must wear protective eyewear when laser is in operation. Operation Turn On the EPIC 10  Ensure that the battery has enough charge for operation, or connect power cord to power connector on the unit and plug into wall outlet.  Turn power switch at the rear of the base of the console to ON position. The EPIC 10 Welcome screen will be displayed.
23 | Page 5400321Rev. X: DRAFT 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.  Verify wireless communication with the footswitch; a blue LED indicator light on the console will blink when communication is established. The laser and footswitch are shipped already paired. However, if the wireless communication is not confirmed by the indicator light, take the following steps to establish pairing: 1. Go to the Settings menu on the console display and select “Wireless” icon. 2. In the “Wireless” menu, press “Connect” to initiate pairing; blue LED will start blinking, indicating that the laser console and footswitch are communicating. 3. While holding the footswitch, press and hold the Reset switch on the bottom of the footswitch. 4. While holding the footswitch, press and hold the foot pedal. 5. Release the Rest switch. 6. Release the foot pedal. 7. A message will appear on the console display indicating that pairing has been successful, or unsuccessful. If unsuccessful, repeat steps 1-6. CONTROL Button Pressing and holding the Control Button for 2 seconds will cause the system to enter SLEEP mode, or move out of SLEEP mode to STANDBY mode, or go from STANDBY mode to READY mode; this button will also turn the system ON. Entering READY or STANDBY Modes A quick press of the Control Button will place the system into either READY or STANDBY mode. The unit will only emit laser energy when the footswitch is pressed and the unit is set to READY mode. Values may be adjusted in both modes. In READY mode, values may be changed only when footswitch is released. READY Mode When entering READY mode, the system fan will turn ON and pressing the footswitch will activate laser radiation. There is 2 sec delay between switching to READY mode and the ability of the system to emit a laser beam. This is evidenced by the delay in the appearance of the red aiming beam.
24 | Page 5400321Rev. X: DRAFT Figure 23 When the tip is straight, the aiming beam will look like a circle, outlining the area where main laser power is applied. Figure 24 When the tip is bent, the aiming beam will look like a spot, and the main laser power is applied in the middle area of the spot. Wireless Footswitch The wireless footswitch is powered by 2 standard AAA batteries. When the wireless footswitch is pressed in READY mode and the laser fires, a beeper will sound indicating that laser energy is present. A green LED will be visible on the top right of the front panel. When the footswitch is not pressed, the green light will not appear. PEAK POWER Display This number is shown only when the system is in the pulsed mode and presents the value of the peak power based on the Power setting, and Pulse Mode. PULSE Mode Selection Pulse Mode selection graphically indicates whether the system is in Continuous Mode or in Pulsed Mode. In Continuous Mode laser power is constantly delivered when in Ready Mode and the wireless footswitch is activated. In Pulsed Mode, laser power is delivered in repetitive pulses, controlled by Pulse Length and Pulse Interval settings. Pressing the Pulse MODE button will allow switching between Pulsed and Continuous Modes. WARNING: When aiming beam is not present or has significantly different shape, change the tip and inspect / clean the protective window. NOTE: When the footswitch is not in use, it will go into “sleep” mode to conserve battery power. It automatically reactivates when it is pressed.
25 | Page 5400321Rev. X: DRAFT Operational Algorithm of the EPIC 10
26 | Page 5400321Rev. X: DRAFT PROCEDURES Button The EPIC 10 has 20 pre-set procedures, 14 with pre-programmed procedural presets and 6 empty slots for custom pre-sets. All of them can be customized to your preference. In order to customize parameters for the particular clinical procedure:  Adjust parameters on the main Pre-Programmed Procedure menu  Select PROCEDURES Mode  Press and hold the selected Procedure for 2 seconds. Parameters will be changed and saved for that Procedure (you will hear a beeping sound when the adjusted settings are saved). Figure 25 SETTINGS Screen By pressing the Settings icon on the main screen, you can access several system settings:  Language Selection  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. CAUTION: Verify that fiber optic tubing assembly is not twisted once the handpiece is returned to the holder. The fiber may break if it is twisted.  Press the CONTROL button to turn display OFF.  Switch the Power Switch at the rear of the base of the console to OFF position, if the laser system will not be used for a long period of time.  Wind the fiber cable onto the fiber spool around the base of the console.
27 | Page 5400321Rev. X: DRAFT 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 ● External Fuses None ● Main Control Power Switch ● On / Off Controls Control Button, Emergency Stop ● Remote Interruption Remote Interlock Laser ● Laser Classification IV (4) ● Medium InGaAsP ● Wavelength 940 ± 10nm ● Max Output Power 10 Watts ● Power Accuracy ± 20% ● Power Modes Continuous, Pulse Modulation ● Pulse Duration ● Pulse Interval ● Pulse Repetition Rate 0.01 ms – 10 sec 0.01 ms – 10 sec Up to 20KHz (for reference) ● Fiber Tips Diameter 200, 300, 400 µm ● Spot size ◦ Surgical Handpiece Maximum 400 µm ◦ Deep Tissue Handpiece 30 mm diameter = 7.1 cm2 area ◦ Whitening Handpiece Rectangular 35 mm x 8 mm = 2.8 cm ● NOHD 4.77 meters ● Beam Divergence 8 – 22 degrees per side angle ● Standard Fiber Cable Length 5 feet (1.524 meters) ● Feed-Through Fiber Cable Length 8 feet (2.438 meters) Other Light Sources ● Aiming Beam Laser Diode, max 1 mW, 635 nm ± 10nm
28 | Page 5400321Rev. X: DRAFT 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. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease (including pacemakers), lung disease, bleeding disorders, sleep apnea or an immune system deficiency, or any medical conditions or medications that may contraindicate use of certain light/laser type sources associated with this device. Medical clearance from patient's physician is advisable when doubt exists regarding treatment. Warnings and Precautions Prescription Statement Federal law restricts this device to sale by or under the order of a licensed medical or dental practitioner. Eyewear Doctor, patient, assistant and all others inside the operatory must wear appropriate laser eyewear protection for the diode laser wavelength of 940 ± 10nm. Anesthesia In soft tissue cases anesthesia may not be required, but patients should be closely monitored for signs of pain or discomfort at all times. If such signs are present, adjust settings, apply anesthesia or cease treatment if required. Adjacent Structures EPIC 10 is designed to remove soft tissues. Therefore, always be aware of adjacent structures and substructures during treatments. Be extremely careful not to inadvertently penetrate or ablate underlying or adjacent tissues. Do not direct energy towards hard tissues such as tooth or bone. Do not direct energy towards amalgam, gold or other metallic surfaces. Do not direct energy towards cements or other filling materials. Exercise extreme caution when using this device in areas such as pockets, cavities or channels such as 3rd molar sockets, where critical structures (i.e. nerves, vessels) could be damaged. Do not proceed with using the laser if visibility is limited in these areas. 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. Ensure that appropriate protective equipment (including high-speed suction to remove the plume, appropriately filtered masks, and other protective equipment) is used at all times during the laser procedure. Section 6: CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS
29 | Page 5400321Rev. X: DRAFT Clinical Use Use your clinical judgment to determine all aspects of treatment including, but not limited to, the laser treatment protocol, technique, power settings, pulse duration and interval settings, mode of operation as well as the accessories (e.g. tip type) and other procedural requirements. Closely observe and monitor clinical effects and use your judgment to determine clinical parameters and approach for the treatment. Make appropriate power, pulse length, and interval adjustments to compensate for varying tissue compositions, density, and thickness. Always start treatment at the lowest power setting for that specific indication and increase as required. BIOLASE assumes no responsibility for parameters, techniques, methods or results. 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. NOTE: 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.
30 | Page 5400321Rev. X: DRAFT Section 7: CLINICAL APPLICATIONS 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. Table of Indications for Use Use of the EPIC 10 device may be appropriate 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 ►Exposure of unerupted teeth ►Fibroma removal ►Frenectomy ►Frenotomy ►Gingival troughing for crown impressions ►Gingivectomy ►Gingivoplasty ►Gingival incision and excision ►Hemostasis ►Implant recovery ►Incision and drainage of abscess ►Leukoplakia ►Operculectomy ►Oral papillectomies ►Pulpotomy ►Pulpotomy as an adjunct to root canal therapy ►Reduction of gingival hypertrophy ►Soft tissue crown lengthening ►Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ►Vestibuloplasty ►Tissue retraction for impression ►Laser soft tissue curettage ►Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket ►Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) ►Light activation for bleaching materials for teeth whitening ►Laser-assisted whitening/bleaching of teeth ►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; the temporary relaxation of muscle.
31 | Page 5400321Rev. X: DRAFT DENTAL Pre-programmed Settings for Dental Procedures WARNING: Always use clinical judgment when selecting power, pulse, length, and 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: a) Follow steps 1 and 2 above b) Enter the new values c) Press and hold the Procedure button for 2 seconds; you will hear a beeping sound confirming the settings are saved. NOTE: 1. These pre-sets are recommendations based on clinical feedback from experienced laser dentists. 2. 300µm tips are recommended for removing thin tissue layers. 400µm tips are recommended for removing fibrous tissue. 3. Always use your clinical judgment when selecting power, pulse length, and pulse interval parameters to ensure optimal clinical results. At all times observe clinical effects and adjust parameters accordingly.
32 | Page 5400321Rev. X: DRAFT PRE-PROGRAMMED SETTINGS PROCDURE NAME MODE PEAK POWER AVERAGE POWER PULSE INTERVAL PULSE LENGTH DUTY CYCLE TIP TYPE INITIATION 1 GINGIVECTOMY CP0 5.0W 1.0W 0.04 ms 0.01 ms 20% E4 YES 2 TROUGHING CP2 2.0 W 1.0 W 1.0 ms 1.0 ms 50% E4 YES 3 CURETTAGE CP1 2.4 W 0.8 W 0.2 ms 0.1 ms 30% E4 YES 4 EXCISION CP1 2.7 W 0.9 W 0.2 ms 0.1 ms 30% E4 YES 5 FRENECTOMY CP2 2.0 W 1.0 W 1.0 ms 1.0 ms 50% E4 YES 6 IMPLANT RECOVERY CP2 2.5 W 1.25 W 1.0 ms 1.0 ms 50% E4 YES 7 PERIO POCKETS CP2 1.6 W 0.8 W 1.0 ms 1.0 ms 50% E3 NO 8 PULPOTOMY(*) CW 0.10W 0.10W N/A N/A N/A E4 YES 9 CROWN LENGTHENING CP1 2.7 W 0.9 W 0.2 ms 0.1 ms 30% E4 YES 10 INFECTED POCKETS CP2 1.6 W 0.8 W 1.0 ms 1.0 ms 50% E4 YES 11 ENDO(*) CW 0.10 W 0.10 W N/A N/A N/A E2 NO 12 HEMOSTASIS CW 0.50W 0.50W N/A N/A N/A E4 YES 13 APHTHOUS ULCERS CW 0.70W 0.70W N/A N/A N/A E4 NO 14 EXPOSURE OF UNERUPTED TEETH CP2 1.80W 0.90W 1.0ms 1.0ms 50% E4 YES 15 CUSTOM 1 - 6 (*) Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and Pulpotomy as an adjunct to root canal therapy.
33 | Page 5400321Rev. X: DRAFT 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™ 20 Whitening Gel Kit. Please read the instructions carefully before proceeding.
34 | Page 5400321Rev. X: DRAFT PAIN THERAPY NOTE: Follow the Fitzpatrick Skin Type Scale noted below when performing pain therapy procedures. Select the appropriate clinical parameter and reduce power as necessary for patient comfort. Fitzpatrick Skin Type Scale TYPE I Highly sensitive, always burns, never tans. Example: Red hair with freckles TYPE II Very sun-sensitive, burns easily, tans minimally. Example: Fair-skinned, fair-haired Caucasians TYPE III Sun-sensitive skin, sometimes burns, slowly tans to light brown. Example: Darker Caucasians TYPE IV Minimally sun-sensitive, burns minimally, always tans to moderate brown. Example: Mediterranian-type Caucasians TYPE V Sun-insensitive skin, rarely burns, tans well. Example: Some Hispanics, some Blacks TYPE VI Sun-insensitive, never burns, deeply pigmented. Example: Darker Blacks 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. Affected muscles and/or joints have to be exposed to an adequate level of therapeutic energy over a short period of time to be effective. Two main therapeutic power settings are recommended for these treatments: ► 2.75W CW: place the handpiece in contact with the skin and apply laser energy for 10 minutes continuously. ► 5.50W CW: place the handpiece approximately 2 – 3mm away from the skin surface (non-contact). Exposure time remains the same at 10 minutes continuously. Patients should be monitored for discomfort. If discomfort is reported at any time during the treatment, there are several options: a) Decrease the power setting to 2.75W; or b) Defocus the energy by moving the handpiece further away from the sking; or c) Stop treatment.
35 | Page 5400321Rev. X: DRAFT Using the Deep Tissue Handpiece: Recommended Clinical Settings TYPE II Set Power to 4.0W CW for 2 minutes, followed by Power at 3.25W for 3 minutes and then set Power to 2.75W for the remaining 5 minutes TYPE III Set Power to 4.5W CW for 2 minutes, reduce Power to 4.0W for the remaining 8 minutes TYPE IV Set Power to 4.0W CW for 2 minutes, reduce Power to 3.5W for the remaining 8 minutes TYPE V Set Power to 3.5W CW for 2 minutes, reduce Power to 3.0W for the remaining 8 minutes. TYPE I Less common, settings are not available TYPE VI Less common, settings are not available NOTE: Some patients may require more than one laser application or a series of treatments before significant improvement is reported. Repeat this therapy as necessary and monitor progress of the patient’s condition throughout the the treatment.
36 | Page 5400321Rev. X: DRAFT Section 8: MAINTENANCE Annual Maintenance The EPIC 10 should be serviced annually by a qualified, trained, and certified technician. 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. Daily Maintenance Use peel-off clear covers 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. Check and clean the protective window of the fiber optic shaft with cotton swab wet in alcohol. Contamination Control Procedures The contamination control suggested for the EPIC 10 surgical handpiece and tips is the steam sterilization method. However, before sterilization, the EPIC 10 reusable handpiece should be carefully cleaned per the following procedure. NOTE: The fiber optic cable and Handpiece are delivered from the manufacturer as non-sterile. NOTE: Tips are designed to withstand a single sterilization cycle and must be disposed of after single use in a biohazard medical waste sharps container. Cleaning Instructions for the Surgical Handpiece, the Classical (Feed-Through) Fiber Handpiece, and the Reusable Fiber Optic Cable The cleaning process is intended to remove blood, protein and other potential contaminants from the surfaces and crevices of reusable accessories. This process may also reduce the quantity of particles, microorganisms and pyrogens present. Cleaning should be performed prior to sterilization and must be conducted only by qualified office personnel trained to perform the procedure and handle the EPIC 10 Fiber optic Delivery System. Wear protective latex gloves when handling the contaminated delivery system. To clean the fiber cable, wipe the entire cable, including the shaft, with cotton gauze and chemical disinfectant. Keep the window intact. If the window is dirty, clean with a cotton swab wet with alcohol.
37 | Page 5400321Rev. X: DRAFT To clean the handpiece: ► Carefully remove tip from the handpiece and dispose of in a biohazard medical waste sharps container. ► Carefully remove the handpiece from the fiber optic cable (see Section 3). ► Wipe entire handpiece outer surface with cotton gauze and chemical disinfectant. ► Soak gauze in a chemical disifectant, and then wrap the handpiece in the gauze. ► Leave the handpiece wrapped in the soaked gauze for 10 minutes. ► Remove the handpiece from the soaked gauze and wipe with dry gauze. Steam Sterilization for Handpiece, Single Use Tips, Tip Initiation Block Before sterilization, the handpiece must be cleaned and disassembled. The process of thermal sterilization with saturated steam under pressure is carried out in an autoclave. To sterilize the handpiece, tips, and tip initiation block, follow these step-by-step instructions: ► Place the handpiece, tips, and tip initiation block in separate single wrap, self-seal autoclave pouches. ► Remove autoclave tray and place pouch(s) on the tray. ► Place tray inside the autoclave chamber and sterilize using a clinic-validated cycle. The recommended autoclave cycle for the EPIC 10 is: Temperature: 250°F (121°C) Pressure: 15 PSI (1 bar) Time cycle: 20 minutes ► 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. Cleaning the Whitening/Contour Handpiece The Whitening Handpiece is sold together with disposable protective caps. The handpiece and protective cap are not autoclavable. The protective cap is intended for one-time use only and therefore cannot be cleaned and reused. To clean the Whitening Handpiece, wipe down the handpiece with gauze and isopropyl alcohol. Cleaning the Deep-Tissue Handpiece
38 | Page 5400321Rev. X: DRAFT The Deep-Tissue Handpiece is sold with non-sterile disposable protective covers. The protective covers are intended for one-time use only and therefore cannot be cleaned and reused. To clean the Deep-Tissue Handpiece, wipe the entire outer surface of the handpiece with cotton gauze and isopropyl alcohol or a mild chemical disinfectant. Disinfection of the Classical (Feed-Through) Fiber Optic Cable ► Take the fiber and strip 1.0” off from the distal end using the fiber cleaver. Make sure that the part that has debris is removed entirely. Dispose of the contaminated fiber tip in a properly labeled biohazard medical waste sharps container. ► Prepare a Sporox Sterilizing and Disinfecting Solution and submerge approximately 30cm (12 inches) of the fiber’s distal end into the solution. For a high level of disinfection, immerse the fiber end for 30 minutes at 20° C (68° F). ► After this process is completed, thoroughly rinse and dry the fiber. For disposal of the Sporox, follow the manufacturer’s instructions. Changing the Wireless Footswitch Batteries The wireless footswitch is powered by two standard AAA batteries. To replace the battery, unscrew the battery cover on the underside of the footswitch, remove the old battery, and install the new one, replacing the cover when done. 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). Figure 26: Battery Cover/Bottom of Console
39 | Page 5400321Rev. X: DRAFT 2. To remove the battery, grip the battery at the top and pull the cable away from the connector (Figure 27). Figure 27: Battery Pack/Connector Wire 3. To install the battery, insert the connector wire from the battery to the unit, making sure the red wire is on the left, and gently drop the battery into the compartment (Figure 27). 4. Replace the battery cover on the bottom of the unit, using a Phillips screwdriver (Figure 26). 5. Connect power cord to power connector on the unit and plug into wall outlet to charge battery (at least 2 hours). Once the battery is charged, unplug the power cord from the wall outlet and the console. 6. Dispose of the used battery pack as appropriate for your location. Transportation The EPIC 10 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 of its shipping box. If you have any questions regarding transportation please call your local Representative. Storage The EPIC 10 should be stored in a cool dry place when not in use. Storage temperature 15°C-35°C (59°F-95°F), relative humidity 10%-70%, non-condensing. 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. CAUTION: Make sure the distal end of the Handpiece shaft is protected from dirt with the protective tip plug and Handpiece. CAUTION: Remove battery pack if the Epic 10 is not likely to be used for some time The EPIC 10 was shipped inside a custom shipping box. Please save and store the box in a cool dry place.
40 | Page 5400321Rev. X: DRAFT Section 9: CALIBRATION Calibration Schedule Calibration procedure is recommended to be performed every 12 months in order to maintain the required accuracy of output power versus displayed power. 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. 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. Section 11: TROUBLESHOOTING Below is the list of the Error messages, which in most cases can be fixed by the user. If Corrective Action did not help, re-power the laser. If Error is not cleared after re-powering, please call for system Service. NOTE: For all Error Messages not listed in the table, re-power the system and if Error is not cleared, call for system Service. Error/Warning Description Reason Fix Thermistor Open Thermistor Open Thermistor Shorted Thermistor Shorted Call Biolase Service Shutdown Temperature System too hot Allow 5-10 mins for laser to cool down Laser Current High/ Low Output is of specs Call Biolase Service FS shorted in Standby FS not in Ready mode Enter Ready mode ON/OFF button Stuck Key stuck Press Front key Flash Corrupted Memory Corrupted Call Biolase Service No Fiber Fiber not inserted Plug in Trunk Fiber Lost Footswitch Communication No wireless connect Re-establish pairing (see Sec 4) Emergency Switch E-Switch Pressed Press E-Switch Again Remote Interlock Remote interlock open Check Remote Interlock closed Warning Temp High System is hot Allow 5-10 mins for laser to cool down Warning Battery Low Battery is low Plug in DC supply Warning Battery Not Connected Battery not connected Plug in Battery
41 | Page 5400321Rev. X: DRAFT 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
42 | Page 5400321Rev. X: DRAFT A.6 Remote Interlock Location: Rear of Laser Console A.9 Compliance label Location: Bottom of laser console 5400017 A.7 Emergency Laser Stop Switch Location: Left side of laser console A.8 Warning label Location: Rear top cover of laser console THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO. 50 DATED 26 JULY 2001 5200191 REV. B
43 | Page 5400321Rev. X: DRAFT 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 LaserWhite 20 Whitening Gel Kit (pack of 5) 6400311 Deep-Tissue Handpiece (Optional) 6400310 Deep-Tissue Handpiece protective covers (qty. 20) TBD Peel-off clear covers (qty. xx) 6000562 Classical (Feed-Through) Fiber Handpiece (Optional) TBD Classical (Feed-Through) Fiber 6400457 Lithium ion battery pack for console SINGLE-USE TIPS: Surgical: 7400018 200 m core diameters (qty. 30) 7400017 300m core diameters (qty. 30) 7400016 400m core diameters (qty. 30) Perio: 7400020 300m core diameters (qty. 30) 7400019 400m core diameters (qty. 30) Endo: 7400015 EZTIP Endo Kit, E2, 20mm 7400021 200 m core diameters (qty. 30)
44 | Page 5400321Rev. X: DRAFT 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:  Reorient or relocate the receiving antenna.  Increase the separation between the equipment and receiver.  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.  Consult the dealer or an experienced radio/TV technician for help.
45 | Page 5400321Rev. X: DRAFT biolase.com NASDAQ: BLTI USA BIOLASE® Technology, Inc. 4 Cromwell Irvine, CA 92618 949.361.1200 Europe MT Promedt Consulting GmbH Altenhofstrasse 80 D-66386 St. Ingbert Germany +49 6894 581020 www.mt-procons.com ©2012. BIOLASE® 5400321 Rev. X: DRAFT EC REP

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