Biolase Epic 10 User Manual

User Manual

EPIC 10 User Manual P/N 5400321 Rev. H

Table of Contents ....................................................................................................................... 1

Introduction ................................................................................................................................ 4

1.Packaging ............................................................................................................................... 5

1.1 System Parts List .............................................................................................................. 5

1.2 Facility Requirements ....................................................................................................... 5

2. Equipment Description ........................................................................................................... 6

2.1 General ............................................................................................................................ 6

2.2 Base Console ................................................................................................................... 6

2.3 Control Panel .................................................................................................................... 6

2.4 Surgical Delivery System .................................................................................................. 7

2.5 Fiber Optic Connection ..................................................................................................... 7

2.6 Single-Use Tips ................................................................................................................ 8

2.7 Surgical Handpiece Assembly .........................................................................................10

2.8 Whitening/Contour Handpiece (Optional Accessory) .......................................................11

2.9 Deep Tissue Handpiece (Optional Accessory) .................................................................12

3. Safety....................................................................................................................................13

3.1 Precautions .....................................................................................................................13

3.2 Safety Instructions ...........................................................................................................13

3.3 Safety Features ...............................................................................................................14

Energy Monitor ..................................................................................................................14

System Monitor ..................................................................................................................14

Power Switch .....................................................................................................................15

Access Key Code ...............................................................................................................15

Control Button ....................................................................................................................15

Wireless Footswitch ...........................................................................................................15

Remote Interlock ................................................................................................................16

Emergency Stop ................................................................................................................17

Functional Display ..............................................................................................................17

3.4 Safety Classification ........................................................................................................17

4. Operation Instructions ...........................................................................................................18

4.1 System setup ...................................................................................................................18

Epic™10 User Manual pg. 1 5400321 Rev H

4.2 Operation - Turn on the Epic 10 .......................................................................................19

4.3 Settings Screen ...............................................................................................................20

4.4 Pairing the Footswitch to the Laser console .....................................................................20

4.5 Control Button .................................................................................................................22

4.6 Entering READY or STANDBY Modes ............................................................................22

4.7 READY Mode ..................................................................................................................22

4.8 Wireless Footswitch .........................................................................................................23

4.9 Peak Power Display ........................................................................................................23

4.10 Pulse Mode Selection ....................................................................................................23

4.11 Using the Epic 10 Touch Screen Display ......................................................................25

4.12 Procedures Button .........................................................................................................26

4.13 Turn the Laser Console Off............................................................................................26

5. Specifications ........................................................................................................................27

5.1 General ...........................................................................................................................27

5.2 Electrical ..........................................................................................................................27

5.3 Laser ...............................................................................................................................27

5.4 Other Light Sources .........................................................................................................28

6. Contraindications, Warnings & Precautions ..........................................................................29

6.1 Contraindications .............................................................................................................29

6.2 Warnings and Precautions ...............................................................................................29

Prescription Statement .......................................................................................................29

Eyewear .............................................................................................................................29

Anesthesia .........................................................................................................................29

Adjacent Structures ............................................................................................................29

Suction ...............................................................................................................................30

Plume Removal..................................................................................................................30

Clinical Use ........................................................................................................................30

Training ..............................................................................................................................30

7. Clinical Applications ..............................................................................................................31

7.1 Introduction ......................................................................................................................31

7.2 Indications for Use ...........................................................................................................31

7.3 Soft Tissue Surgery and Other Dental Use ......................................................................32

Tip Initiation: Parameters and Method (Not required if using pre-initiated tips) ...................32

Epic™10 User Manual pg. 2 5400321 Rev H

Pre-programmed Settings for Dental Procedures ...............................................................33

7.4 Table of Pre-Programmed Settings ..................................................................................34

7.5 Teeth Whitening Procedure .............................................................................................35

7.6 Pain Therapy ...................................................................................................................35

Pain Therapy – Adverse Effects .........................................................................................36

Pain Therapy – Warnings and Precautions ........................................................................36

Recommended Use ...........................................................................................................37

Using the Deep Tissue Handpiece .....................................................................................37

Using the Whitening/Contour Handpiece ...........................................................................37

8. Maintenance .........................................................................................................................38

8.1 Daily Maintenance ...........................................................................................................38

8.2 Cleaning and Sterilization Procedures .............................................................................38

Cleaning and Disinfecting Instructions-Surgical Handpiece, Reusable Fiber Optic Cable ..38

Manual Cleaning of the Surgical Handpiece: ......................................................................39

Steam Sterilization for Surgical Handpiece, Single Use Tips ..............................................39

Disinfecting the Whitening/Contour Handpiece ..................................................................40

Disinfecting the Deep Tissue Handpiece ............................................................................40

8.3 Installing/Replacing the Console Battery Pack .................................................................40

8.4 Changing the Wireless Footswitch Batteries ....................................................................41

8.5 Transportation .................................................................................................................42

8.6 Storage ............................................................................................................................42

9. Calibration .............................................................................................................................43

10. Software Specification .........................................................................................................43

11. Troubleshooting ..................................................................................................................43

APPENDIX A – Tip Guide .........................................................................................................46

APPENDIX B – Labeling ...........................................................................................................47

APPENDIX C – Safety Precautions for Lithium-Ion Battery Packs ............................................51

APPENDIX D – Accessories .....................................................................................................54

APPENDIX E – Electromagnetic Compatibility ..........................................................................55

APPENDIX F – Wireless Equipment Compliance Statement .....................................................59

Epic™10 User Manual pg. 3 5400321 Rev H

INTRODUCTION

The Epic™ 10 diode 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 single use, disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.

This is a prescription device that is indicated for professional use only by licensed medical and dental practitioners. The use of this device requires proper clinical and technical training. This manual provides instructions for those 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 Customer Service at 1-800-321-6717 in the U.S. for any service needs. If you are located outside the USA, please contact your BIOLASE-authorized distributor.

Epic™10 User Manual pg. 4 5400321 Rev H

1.PACKAGING

NOTE:

The laser ships with the lithium ion battery pack already installed.

Use proper care when transporting the unit. Refer to Section 8 in this User Manual for instructions.

WARNING:

No modification of this equipment is allowed.

Electrical Supply (100-240V ~):

1.5A, 50/60Hz

Environmental Requirements:

Temperature: 20-25 ºC Humidity: 15-95%, Non-condensing

1.1 SYSTEM PARTS LIST

The Epic 10 laser system includes the following:

1. Laser Console (lithium ion battery pack already installed)

2. Screen Protectors box (Peel-off clear screen cover - qty. 30)

3. Deliver y System (installed)

4. Assorted Surgical Tips

5. Surgical Handpiece box (contains two (2) Surgical Handpieces)

6. Three (3) pairs of protective laser eyewear (two (2) pairs of doctor safety glasses, one (1) pair of darker patient safety glasses)

7. DC power supply and power cord (one (1) US and one (1) International)

8. User Manual

9. Welcome Kit (Welcome Letter, BIOLASE store information, Quick Setup Guide, Guide to Online Training & Product Registration Card, Limited Warranty Information)

10. Laser Warning Sign

11. Tip Initiation Kit

12. Remote Interlock cable

13. Philips-head screwdriver (for installing Footswitch batteries)

14. Footswitch

15. AAA batteries (2)

NOTE:

1.2 FACILITY REQUIREMENTS

Epic™10 User Manual pg. 5 5400321 Rev H

2. EQUIPMENT DESCRIPTION

Figure 2.1: Control Panel (Front View)

LED Indicator

Control Button

Fiber Storage Channel

2.1 GENERAL

The Epic 10 system consists of three components:

● Base Console

● Delivery System

● Wireless Footswitch

2.2 BASE CONSOLE

The Console has a Display Panel (Touch Screen and Control Button) in front. It can be powered by an external mains power supply or an internal replaceable lithium ion battery pack, 14.4V,

2.9 Ah.

2.3 CONTROL PANEL

ITEM ITEM DESCRIPTION

CONTROL

Button

LED

Indicator

Activates the controls and display; places the unit into STANDBY or READY mode.

Amber indicates unit is in ST ANDBY mode.

Green indicates unit is in READY mode.

Blinking green indicates the emission of laser power.

Blinking blue indicates pairing between the footswitch an d laser console is active

Epic™10 User Manual pg. 6 5400321 Rev H

2.4 SURGICAL DELIVERY SYSTEM

NOTE:

All fiber optic cables, Handpieces & tips are shipped non-sterile.

The fiber optic cable is detachable from the console. The Handpiece is a Re-usable

the Handpiece and tips Refer to Section 8.

Do not connect or disconnect the fiber while the laser console is turned on. Only connect or disconnect the fiber when the laser console is turned off.

Make sure you hear the fiber optic “click” into place; if you do not hear it “click,” remove the fiber optic and reinstall it.

The Epic 10 Delivery System with surgical Handpiece consists of:

• Re-useable Fiber Optic Assembly

• Re-useable Surgical Handpiece (Figures 2.9)

• Disposable Tips (Appendix A)

accessory and will require cleaning and sterilization prior to each patient treatment.

NOTE:

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

2.5 FIBER OPTIC CONNECTION

The Epic10 ships with the fiber optic cable already attached.

CAUTION:

To disconnect the fiber optic cable from the laser console, make sure the laser console is turned off and the cable is completely unwound from the console base, grab the fiber optic

access plug and slowly pull it straight back from the optical access port (Figure 2.3). To re-install the fiber optic cable, make sure the laser console is turned off. The fiber optic

cable is attached to the console by inserting the optical access plug (Figure 2.2) into the optical access port (Figure 2.3).

NOTE:

For storage, wind the cable in the fiber storage channel around the base of the console in a counterclockwise direction (Figure 2.1).

CAUTION:

Do not bend the fiber optic at a sharp angle, as it is can break. Make sure it is not ca ught or pinched between the housing and the fiber optic access plug.

Epic™10 User Manual pg. 7 5400321 Rev H

Figure 2.2: Fiber Optic Access Plug

Figure 2.3: Optical Access Port

Tips are single-use only to avoid cross-contamination and are designed to

damage.

Be aware that the metal/plastic cannula on the tips may become hot during use. Avoid contact of the cannula with any tissue.

To provide proper laser operation, do not connect tips when the handpiece is disconnected from the fiber.

2.6 SINGLE-USE TIPS

The tips are single-use accessories and are provided in three core diameters: 200μm, 300μm, and 400μm, in different lengths (see Appendix A).

withstand only a single sterilization cycle; they must be disposed of after use in

CAUTION:

a biohazard medical waste Sharps container. Always visually inspect the tip prior to use to make sure it is free of debris or

CAUTION:

To connect the tip, first connect the handpiece to the fiber, then insert the tip firmly into the distal end of the handpiece as far as it will go, and tighten by turning clockwise (Figure 2.4). Bend the metal cannula according to the specific procedure requirements (Figure 2.7).

Remove the fiber tip by twisting the tip counterclockwise (Figure 2.5).

NOTE:

Epic™10 User Manual pg. 8 5400321 Rev H

Tip Assembly

When the aiming beam is not present or has a significantly asymmetrical shape:

Figure 2.4: Insert the fiber tip into the handpiece (only when the handpiece is connected to the fiber) and

twist clockwise until snug

Figure 2.5: Remove the fiber Tip by twisting the tip counterclockwise

Figure 2.6: When installing the tip, make sure it is seated properly (thread correctly)

►For tips that require initiation: change the tip

WARNING:

►For tips that do not require initiation: change the tip; press

initiation requirement.

Correct Bend

Incorrect Bend

Figure 2.7: Bending the tip cannula

to bypass

Epic™10 User Manual pg. 9 5400321 Rev H

2.7 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.

Fiber Shaft Protective Cap

Handpiece

Figure 2.8: Connecting the Handpiece to the fiber optic assembly

Figure 2.9: Surgical Handpiece Assembly fully assemb led

► Disconnect the handpiece from the fiber optic assembly (Figure 2.10) by

1. Taking the handpiece body in one hand and the shaft in the other,

2. Pushing the two buttons on the Fiber Shaft,

3. Pulling the handpiece with the ring to separate.

Figure 2.10: Disconnect the Handpiece from the fiber optic assembly by pressing both buttons at the

base of the Fiber Shaft

Epic™10 User Manual pg. 10 5400321 Rev H

2.8 WHITENING/CONTOUR HANDPIECE (OPTIONAL ACCESSORY)

NOTE:

The Whitening/Contour Handpiece is reusable and equipped with a disposable non-

is completed.

sterile protective shield for single patient use. The Handpiece is non-sterile and requires disinfection before and after each patient treatment. This Handpiece cannot be sterilized in the autoclave. For disinfection instructions refer to Section 8.

Always wipe the disposable shield with alcohol prior to use. The disposable shield is for single-use only to avoid cross-contamination. Dispose of when treatment session

Figure 2.11: Whitening/Contour Handpiece

Figure 2.12: Disposable Non-Sterile Shield

The area of Laser Energy Output for the Whitening/Contour Handpiece is 35mm x 8mm =

2.8cm

Spot Size.

To connect the Handpiece to the fiber optic cable, push the Handpiece onto the fiber shaft until it clicks on and is secured.

To disconnect the Handpiece from the fiber optic assembly:

• Take the Handpiece body in one hand and the shaft in another.

• Press both buttons at the base of the Fiber Shaft.

• Pull the Handpiece from the ring to separate.

Epic™10 User Manual pg. 11 5400321 Rev H

2.9 DEEP TISSUE HANDPIECE (OPTIONAL ACCESSORY)

The Deep Tissue Handpiece is reusable and equipped with a disposable non-sterile

is completed.

Handpiece

Disposable

Red Cap Dust

Cover

protective shield for single patient use. The Handpiece is non-sterile and requires disinfection before and after each patient treatment. This Handpiece cannot be

NOTE:

sterilized in the autoclave. For instructions on disinfecting the Handpiece, refer to

section 8. Always wipe the disposable shield with alcohol prior to use. The disposable shield is

for single-use only to avoid cross-contamination. Dispose of when treatment session

Shield

Figure 2.13: Deep Tissue Handpiece

Remove Red Cap Dust Cover from the Deep Tissue Handpiece.

Slide Handpiece over shaft until it clicks into place (Figure 2.14).

Place protective shield over the adjustable spacer (Figure 2.15).

Loosen the Lock Ring and set the Spacer at the desired spot size Detent Location (Figure 2.16). Tighten the Lock Ring.

The Handpiece is now ready to use.

Figure 2.14

Figure 2.15

Figure 2.16

To remove the Handpiece, press and hold both buttons at the base of the Fiber Shaft and pull the Handpiece away from the shaft.

Epic™10 User Manual pg. 12 5400321 Rev H

3. SAFETY

NOTE:

For replacement or additional protective laser eyewear, please contact BIOLASE.

CAUTION:

Periodically inspect laser eyewear for pitting and cracking.

LASER WARNING:

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

Do not use this unit if you suspect it of functioning improperly or other than described herein.

This unit has been designed and tested to meet the requirements of

Relocating the device may help to eliminate the interference.

3.1 PRECAUTIONS

Failure to comply with precautions and warnings described in this User Manual may lead to exposure to dangerous optical radiation sources. Please comply with all safety instructions and warnings.

3.2 SAFETY INSTRUCTIONS

Follow these safety instructions before and during treatments:

• When the laser is in use, all operatory entrances must be marked with an appropriate

warning sign (one (1) included).

• Do not operate in the presence of explosive or flammable materials. Flammable anesthetics or oxidizing gases such as nitrous oxide (N 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 t o the danger of ignition of endogenous gases.

O) and oxygen should be avoided.

All persons present in the operatory must wear protective laser eyewear.

WARNING:

CAUTION:

electromagnetic, electrostatic, and radio frequency interference standards. However, the possibility of electromagnetic or other interference may still exist.

Always ensure that the proper laser parameters are set before the Epic 10 laser is used in a clinical setting.

Epic™10 User Manual pg. 13 5400321 Rev H

LASER WARNING:

Always ensure that the protective laser eyewear is appropriate for the laser wavelength.

LASER WARNING:

Do not open unit housing at any time. Danger from optical radiation may exist.

Do not aim the laser at metallic or reflective surfaces, such as surgical beam will reflect and create a potential hazard.

Be aware that the metal / plastic cannula on the tips may become hot during use. Avoid contact of the cannula with any tissue.

• Do not look directly into the beam or at specular reflections.

• Never direct or point the beam at a person’s eyes.

• Always place the system into STANDBY mode (by pressing the Control Button while in

READY mode) before exchanging Handpieces or disposable tips.

• Toggle the ON/OFF switch (located on the rear of the console) to the OFF (O) position before leaving unit unattended.

LASER WARNING:

instruments or dental mirrors. If aimed directly at these surfaces the laser

CAUTION:

3.3 SAFETY FEATURES

Energy Monitor

The energy 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: “LASER CURRENT HIGH/LOW”.

The laser console will not operate until the system first clears the error and then goes into READY mode. If the error message persists, please contact BIOLASE Service at 1-800-321-6717.

System Monitor

The system monitors the emergency stop switch, remote key, wireless footswitch connection, and output power. 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.

Epic™10 User Manual pg. 14 5400321 Rev H

Power Switch

Use only the Power Supply Module supplied with the Epic 10 laser system (BIOLASE Part Number 2400129).

Placing the laser in sleep mode by pressing and holding the Control button on the only when the system will not be in use for a long period of time.

Power Switch

DC Power

Remote Interlock

The laser console can be switched ON (I) or OFF (O) using the Power Switch on the back of the console.

Figure 3.1: Power Switch, DC Power Input, Remote

Interlock

Figure 3.2: Power Supply Module with cord

CAUTION:

Access Key Code

The Access Key Code prevents unauthorized use of the system. It is activated every time the system is turned on with the Power Switch (refer to Section 4 for code).

NOTE:

front panel does not re-set the Access Key Code. Turn the Power Switch OFF (O)

Control Button

Once the power switch is set to the ON (I) position, enter the access key code. After setting the desired parameters for a procedure, press the CONTROL button on the control panel to enter into READY mode. 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 while the laser is in READY mode. The footswitch is designed to work using wireless technology.

Epic™10 User Manual pg. 15 5400321 Rev H

Two (2) AAA batt eries are required to power the footswitch (included). (For instructions on how

Figure 3.4: Remote Interlock Connector

Cover

Footswitch

to replace the footswitch batteries, see Section 4.) The footswitch is protected by a metal cover. To access, first press down on the cover to

unlatch it. Now the footswitch can be pressed to fire the laser

Figure 3.3: Footswitch

Remote Interlock

This feature allows the laser to be connected to a remote sensor which prevents it from firing when the sensor is triggered. To install the Remote Interlock, insert the plug (a) at the end of the connector into the rear of the laser console (Figure 3.1) and attach the two wires (b) at the other end to a door switch; the laser will stop immediately when the connection to the door switch is deactivated (when the door is opened).

To override this feature, don’t connect the plug.

Epic™10 User Manual pg. 16 5400321 Rev H

Emergency Stop

Press the red Emergency Laser Stop button to instantly turn off the laser console. The error screen will display an “Emergency Switch Error” message and the amber LED will begin flashing. To clear the error, press the Emergency Laser Stop button again; in 2 to 5 seconds the amber LED will stop flashing and the system will automatically go into STANDBY mode.

Figure 3.5: Emergency Laser Stop (Left Profile View)

Functional Display

The System Color Display with Touch Screen and LED indicators on the control panel show the functional conditions of the system.

3.4 SAFETY CLASSIFICATION

The following safety classifications are applicable to the device:

• Laser Radiation – Class 4

• Aiming Beam – Class 2

• Type of protections against electrical shock – Class 2

• 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 Wave and Pulse Mode

• Wireless Footswitch – IPX6

Epic™10 User Manual pg. 17 5400321 Rev H

4. OPERATION INSTRUCTIONS

To fully charge the battery, plug the power supply in and then turn the laser console

rate.

Do not connect or disconnect the fiber while the laser console is turned on. Only connect or disconnect the fiber when the laser console is turned off.

Do not cover or block ventilation channels. These channels provide an air-flow path to cool the unit.

Do not bend the fiber optic at a sharp angle, as it is can break. Make sure it is not caught or pinched between the housing and the fiber optic access plug.

4.1 SYSTEM SETUP

• Place the unit in a clean, dry, and well-ventilated area.

• Verify power switch is in the OFF (O) position.

• Epic 10 will work using either DC power or the rechargeable battery pack:

o DC Power: Connect the power cord of the power supply to the laser console and plug

into a wall outlet

o Rechargeable Battery: The Epic 10 is shipped with the battery pack already installed;

to charge the battery pack, connect the power cord of the DC power supply to the laser console and plug into a wall outlet. Before first use, fully charge the battery ( at least 3 hours). Once the battery is charged, unplug the power cord from the wall outlet and the laser console. The laser console will run on battery power alone.

ON (I) at the Power Switch. The laser console will start to charge and the unit will go

NOTE:

into sleep mode (with the screen off) after 5 minutes; if the power supply is plugged in but turned OFF (O) at the Power Switch, the battery will still charge, but at a sl ower

CAUTION:

• Remove protective cap from the end of the fiber shaft (see Figure 2.8).

• Carefully connect the Handpiece to the fiber optic assembly (see Figure 2.9).

• Insert the selected tip and tighten it clockwise until snug (see Figure 2.4).

• Wind any excess fiber optic cable onto the fiber spool counterclockwise around the base

of the console (see Figure 2.1).

• The Handpiece is now ready to use. To store the Handpiece, place it in the Handpiece holder located at the top of the laser console .

Epic™10 User Manual pg. 18 5400321 Rev H

LASER WARNING:

Never point the laser at a person’s eyes.

LASER WARNING:

All persons present in the operatory must wear protective eyewear when the laser is in use.

Figure 4.1

Figure 4.2

Figure 4.3

Figure 4.4: Home Screen

Wireless Signal

Laser Console Battery Settings Button

Never operate the laser without a fiber tip attached.

4.2 OPERATION - TURN ON THE EPIC 10

Ensure that the battery has enough charge for operation, or connect the power supply cord to the power connector on the laser console and plug the cord into a wall outlet.

Turn the Power Switch at the rear of the console to the O N (I) position. The “BIOLASE” logo screen will appear (Figure 4.1). After three (3) seconds the Epic 10 “Welcome” screen will be displayed (Figure 4.2).

• Enter the three digit access code using the touch screen. The Access Key Code is 888. (If the incorrect code is entered, an ‘X’ appears briefly in the window (Figure 4.3); press the ‘X’ or wait 3 seconds to revert back to the Welcome screen; re-enter the correct code.

• The system will go to the HOME screen which identifies three procedure categories to choose from: Soft Tissue, Whitening, Pain Therapy.

Strength Indicator

Epic™10 User Manual pg. 19 5400321 Rev H

Strength Indicator

4.3 SETTINGS SCREEN

Figur e 4.6

Pressing the Settings button on the HOME screen accesses the Settings screen; this screen allows the user to make changes to several system settings:

Language Selection

Aiming Beam (5 levels of brightness adjustment)

Volume (5 levels of sound adjustment)

Service Mode (accessible only by authorized BIOLASE Service

Representatives)

Restore to Factory Default Settings

Wireless Menu - Access to Pairing Screens

Figure 4.5

4.4 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE

Verify that the footswitch and laser console are paired; a blue LED indicator light on the laser console will blink when pairing is established. The laser and footswitch are shipped already

paired. However, if pairing is not confirmed, an “ ” will appear in the pairing icon located in the upper left hand corner of the touchscreen (Figure 4.6).

Epic™10 User Manual pg. 20 5400321 Rev H

To re-establish pairing, take the following steps:

Figure 4.7

Figure 4.8

Figure 4.9

Figure 4.10

1. Go to the Settings menu on the laser console display by pressing the Settings button and select the “Wireless” icon .

2. A screen will appear indicating that pairing of the

footswitch to the laser console has been lost (Figure 4.7); press the green PAIR button.

3. The message that “PAIRING WILL NOW BEGIN” will

appear; press the green check mark to continue

(Figure 4.8).

4. To complete the pairing process, turn the footswitch over

and press the Pairing Button for four (4) seconds (Figure 4.9).

5a. The Wireless screen will appear indicating that pairing was successful and that the footswitch and laser console are now paired (Figure 4.10). Proceed to step 6.

Epic™10 User Manual pg. 21 5400321 Rev H

5b. If pairing has not occurred, the Wireless screen will

Figure 4.11

appear again indicating that pairing was not successful (Figure 4.11); press the green button to repeat

steps 3 – 5a.

6. Press the Settings button to return to the Settings menu;

press the arrow on the bottom left of the Settings screen to return to the Home screen (Figure 4.12).

Figure 4.12

4.5 CONTROL BUTTON

The CONTROL button on the front of the laser console is a multi-functional button (Figure 2.1). Pressing and holding the Control Button for approximately two (2) seconds will allow the transition from STANDBY or READY mode to SLEEP mode. Note that you will not be allowed to go into READY mode unless you have chosen a treatment module on the HOME screen first.

4.6 ENTERING READY OR STANDBY MODES

Press and release the Control Button to place the laser console into either READY or STANDBY mode. The laser console will only emit laser energy when the footswitch is pressed and the laser console is set to READY mode. While in READY or STANDBY mode, mode setting and/or power setting values may be changed only when the laser is not firing. If the laser is firing (i.e., the footswitch is engaged), the ability to change the settings is blocked. (“READY” or “STANDBY” is displayed in the lower right hand corner of the display screen).

4.7 READY MODE

When entering READY mode, the laser console fan will turn on and pressing the footswitch will activate laser radiation. There is a two (2) sec delay between switching to READY mode and the ability of the laser console to emit a laser beam.

Epic™10 User Manual pg. 22 5400321 Rev H

The aiming beam is on only when the laser is in READY mode or when adjusting the

brightness of the beam while in Settings mode. If the aiming beam is not visible in

aiming beam is still not on, turn off the laser console and call Biolase Service.

When the footswitch is not in use, it will go into SLEEP mode to conserve battery power. It automatically reactivates when it is pressed.

either instance, remove the handpiece and confirm the beam is actually on by

NOTE:

shining the end of the trunk fiber on a plain, non-reflective surface. DO NOT look directly at the output end of the trunk fiber. If the aiming beam is not on, turn off the laser console, then remove and re-install the trunk fiber (see Section 2.6). If the

4.8 WIRELESS FOOTSWITCH

The wireless footswitch is powered by two (2) AAA batteries. When the wireless footswitch is pressed in READY mode and the laser fires, a beeping sound

indicates that laser energy is present. A green LED will begin flashing and a blue LED will light at the top corners of the laser console, confirming the footswitch and laser are paired.

In the top left corner of most screens is a Signal Strength Indicator which displays the signal strength between the laser console and the footswitch (strongest is five (5) bars). Pressing and releasing the footswitch while in Standby mode will update this indicator. Although the unit will work with a signal level as low as one (1) bar, a weaker signal level will make the connection between the footswitch and laser console more vulnerable to wireless (RF) interference from other sources, such as cell phones or microwaves. To improve the signal strength, reposition either the footswitch or the laser console until the signal indicator achieves the strongest possible level for optimal operation.

NOTE:

4.9 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.

4.10 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.

In Pulse Mode, laser power is delivered in repetitive pulses, controlled by the Pulse Length and Pulse Interval settings.

Pressing the Pulse Mode button will allow switching between Pulsed and Continuous Modes (Figur e 4.14).

Epic™10 User Manual pg. 23 5400321 Rev H

MODE*

Operating the laser at a shorter pulse duration typically results in lower tissue temperature.

Average

Power

Peak

Power

PULSE DURATION (on) PULSE INTERVAL (off)

Duty Cycl e

(Time On / Time off)

CP0 10 microseconds 40 microseconds 20% CP1 100 microseconds 200 microseconds 33% CP2 1 millisecond 1 millisecond 50%

P3 20 milliseconds 20 milliseconds 50%

*CP = Comfort Pulse; P3 = Pulsed Mode which is the standard for most diode lasers currently available

to the dental market

Figure 4.13

NOTE:

Figure 4.14

Epic™10 User Manual pg. 24 5400321 Rev H

4.11 USING THE EPIC 10 TOUCH SCREEN DISPLAY

Figure 4.15

Epic™10 User Manual pg. 25 5400321 Rev H

4.12 PROCEDURES BUTTON

Figure 4.16

Verify that the fiber optic tubing assembly is not twisted once the Handpiece is returned to the holder. The fiber may break if it is twisted.

The Epic 10 has the ability to store up to 20 pre-set procedures; Epic 10 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.

In order to customize the parameters (e.g., power, pulse duration, interval, etc.) for a particular clinical procedure:

1. Go to the PROCEDURES menu by pressing the Soft Tissue icon on the HOME screen; scroll to the pre-set you wish to overwrite (Figure 4.16).

2. Press and hold the selected procedure for two (2) seconds. The parameters for that procedure will be changed and saved (the laser console will beep when the adjusted settings are saved).

4.13 TURN THE LASER CONSOLE OFF

• Wind the fiber cable onto the fiber spool counterclockwise around the base of the console.

• Place the Handpiece onto the Handpiece holder.

CAUTION:

Epic™10 User Manual pg. 26 5400321 Rev H

• Press the CONTROL button on the front of the console for more than 2 seconds to turn the display off.

• Press the Power Switch at the rear of the laser console to the OFF (O) position if the laser system will not be used for a long period of time.

5. SPECIFICATIONS

5.7 in (W) x 4.4 in (H) x 6.5 in (L) (14.5 cm x 11.2 cm x 16.5 cm)

Operating Voltage

100V - 240V ~ at 1.5A

Laser Classification

IV (4)

Medium

InGaAsP Semi-conductor diode

Wavelength

940 ± 10nm

Max Power Output

10W

Power Accuracy

± 20%

Power Modes

Continuous, Pulse Modulation

Fiber Tips Diameter

200µm, 300 µm, 400µm

Pulse Duration

0.01ms – 20ms

5.1 GENERAL

Dimension

Weight 2.5 lbs / 1kg

5.2 ELECTRICAL

Frequency 50/60Hz External Fuses None Main Control Power Swit ch Remote Interruption Remote Interlock Disable Control Emergency Stop Button Battery Lithium Ion Rechargeable, 14.4V, 2.9Ah DC Power Supply Module 12V DC, 5A

5.3 LASER

Epic™10 User Manual pg. 27 5400321 Rev H

Pulse Interval

0.01ms – 20ms

Pulse Repetition Rate

Up to 20kHz (for reference)

Spot size Surgical Handpiece

400µm (maximum in contact mode)

Deep Tissue Handpiece

30mm diameter = 7.1cm2 area

Whitening Handpiece

Rectangular 35mm x 8mm = 2.8cm2

NOHD

4.77 meters

Beam Divergence

8 - 22° per side angle

Standard Fiber Cable Length

5 feet (1.524 meters)

Aiming Beam

Laser diode, max 1 mW, 625 nm – 670 nm, Class 2

5.4 OTHER LIGHT SOURCES

Epic™10 User Manual pg. 28 5400321 Rev H

6. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS

6.1 CONTRAINDICATIONS

All clinical procedures performed with Epic 10 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. 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.

6.2 WARNINGS AND PRECAUTIONS

Prescription Statement

Federal Law restricts this device to sale by or on the order of a dentist or physician or other licensed medical 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 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. 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 third 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.

Epic™10 User Manual pg. 29 5400321 Rev H

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.

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 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.

LASER WARNING:

Never point the laser at a person’s eyes. All persons present in the operatory must wear protective eyewear when the laser is in operation

Epic™10 User Manual pg. 30 5400321 Rev H

7. CLINICAL APPLICATIONS

o Excisional and incisional biopsies

o Vestibuloplasty

7.1 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.

7.2 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:

o Exposure of unerupted teeth o Fibroma removal o Frenectomy o Frenotomy o Gingival troughing for crown impressions o Gingivectomy o Gingivoplasty o Gingival incision and excision o Hemostasis and coagulation o Implant recovery o Incision and drainage of abscess o Leukoplakia o Operculectomy o Oral papillectomies o Pulpotomy o Pulpotomy as an adjunct to root canal

therapy

o Reduction of gingival hypertrophy o Soft tissue crown lengthening o Treatment of canker sores, herpetic and

aphthous ulcers of the oral mucosa

o Tissue retraction for impression o Laser soft tissue curettage o Laser removal of diseased, infected,

inflamed and necrosed soft tissue within the periodontal pocket

o 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.)

o Light activation for bleaching materials for

teeth whitening

o Laser-assisted whitening/bleaching of

teeth

o 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.

Epic™10 User Manual pg. 31 5400321 Rev H

7.3 SOFT TISSUE SURGERY AND OTHER DENTAL USE

Tip Diameter (µm)

(Preset) Power (W)

Mode

400

1.4

300

1.4

200

Tip initiation not required when used for recommended procedures

Figure 7.1

After tip initiation is completed, press the check mark to access the screen for the selected procedure.

Figure 7.5

If the laser console is in “READY” mode, the laser will f ire if the footswitch is activated.

Tip Initiation: Parameters and Method (

Not required if using pre-initiated tips)

Most soft tissue surgical procedures require initiation of the fiber tip. The TIP INITIATION screen will appear (in READY mode) if tip initiation is recommended and the system will

automatically go to the settings shown in Figure 7.1 based on the tip used; while in the TIP INITIATION screen, initiate the tip by following the steps outlined below.

● Touch the tip to the surface of the initiation block, without activating the laser (don’t press down on the footswitch (Figure 7.2).

Figure 7.2

● Press the footswitch to activate the laser, allowing the tip to sink into the block. Pull the tip out when t he metal cannula touches the block, still firing until just before the tip is out of the block (Figure 7.3).

Figure 7.3

● Press the footswitch to activate the laser into the air once, you will see a white flash or the tip will glow (Figure 7.4).

● Repeat initiation process as needed to ensure the tip is initiated.

CAUTION:

Epic™10 User Manual pg. 32 5400321 Rev H

Figure 7.4

Pre-programmed Settings for Dental Procedures

The Procedure Pre-Sets installed at the factory are based on clinical

treat ment area and adjust parameters accordingly.

To access the pre-programmed procedure values:

1. Go to the Procedures menu by pressing the Soft Tissue icon on the Home screen.

2. Press the button associated with the desired procedure.

3. Press the up and down arrows

To store your personal preferred settings for any procedure:

A. Follow steps 1 and 2 above. B. Enter the new values. C. Touch and hold the Procedure name for more than 2 seconds; you will hear a beeping

sound confirming the settings are saved.

recommendations and feedback from experienced laser dentists.

300μm tips are recommended for removing thin tissue layers. 400μm tips are

NOTE:

recommended for removing fibrous tissue. 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 300μm and 400μm tips. At all times observe the clinical effects on the

to scroll for additional procedures.

Epic™10 User Manual pg. 33 5400321 Rev H

7.4 TABLE OF PRE-PROGRAMMED SETTINGS

Peak

Power

Avg.

Power

Pulse

Interval

Pulse

Length

Duty

Cycle

Tip

Type

Tip

Initiated?

Reduction of gingival

Vestibuloplasty

Tissue retrac tion for

impressions

Laser soft tissue

curettage

Fibroma rem oval,

and drainage of abscess

Frenectomy/Frenotomy

CP2

2.0 W

1.0 W

1.0 ms

50%

YES

Implant Recovery

CP2

2.4 W

1.2 W

1.0 ms

50%

YES

Sulcular debridement

loss and tooth mobili ty.)

Pulpotomy, P ulpotomy as

an adjunct to root canal

Soft tissue crown

lengthening

Laser remov al of

periodontal pocket

Hemostasis

0.5 W

0.5W

N/A

YES

Treatment of canker

oral mucosa, Leukoplakia

Exposure of uneru pt ed

teeth

15-17

Custom 1-3

N/A

0.1 W

N/A

YES

18-20

Custom 4-6

N/A

0.1 W

N/A

Preset Name Indications for Use Mode

1 Gingivectomy/Gingivoplasty

2 Troughing

3 Curettage

4 Excision

7 Perio Pockets

8 Pulpotomy(*)

hypertrophy,

impression, Gingival

troughing for crown

Excisional and incisional

biopsies, Gingival inci sion

and excision,

Operculectomy, Oral

papillectomies, Incision

(removal of dise ased, infected, infl am ed an d necrosed soft tissue in

the periodontal pocket to

improve clinical indices including gin giv al ind ex , gingival ble eding index,

probe depth, att achm ent

CP0 5.0 W 1.0 W 0.04 ms 0.01 ms 20% E4 YES

CP2 2.0 W 1.0 W 1.0 ms 1.0 ms 50% E4 YES

CP1 2.4 W 0.8 W 0.2 ms 0.1 ms 30% E4 YES

CP1 2.7 W 0.9 W 0.2 ms 0.1 ms 30% E4 YES

CP2 1.6 W 0.8 W 1.0 ms 1.0 ms 50% E3 NO

CW 0.1 W 0.1 W N/A N/A N/A E4 YES

9 Crown Lengthening

10 Infected Pocket s

11 Endo (*)

13 Aphthous Ulcers

14 Exposure of Unerupted Teeth

diseased, infected,

inflamed and necr os ed

soft tiss ue w ithin the

Pulpotomy, P ulpotomy as

an adjunct to root canal

sores, herpetic and

aphthous ulcers of the

CP1 2.7 W 0.9 W 0.2 ms 0.1 ms 30% E4 YES

CP2 1.6 W 0.8 W 1.0 ms 1.0 ms 50% E4 YES

CW 0.1 W 0.1 W N/A N/A N/A E2 NO

CW 0.7 W 0.7 W N/A N/A N/A E4 NO

CP2 1.8 W 0.9 W N/A N/A N/A E4 YES

(*)Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and Pulpotomy as an adjunct to root canal therapy.

Figure 7.6

Epic™10 User Manual pg. 34 5400321 Rev H

7.5 TEETH WHITENING PROCEDURE

The following items are required to perform teeth whitening with the Epic 10 laser: Epic 10 diode laser

Whitening/Contour Handpiece (Optional Accessory). LaserWhite™ 20 Whitening Gel Kit, BIOLASE p/n 7400030, sold separately in packs of five

(Figure 7.7). Detailed step-by-step instructions, contraindications, precautions, and warnings for teeth

whitening are provided with the LaserWhite™ 20 Whitening Gel Kit. Please read the instructions carefully before proceeding.

Figure 7.7 LaserWhite™ 20 Whitening Gel Kit (BIOLASE PN 7400030)

7.6 PAIN THERAPY

The Epic 10 diode laser is designed to provide near-infrared laser energy to a tissue surface for the purpose of temporary pain relief when applied with the Whitening/Contour or Deep Tissue Handpiece. The pain therapy procedure is the process by which tissue temperature is elevated for the temporary relief of minor pain, the temporary increase in local blood circulation, and the temporary relaxation of muscle, as stated in the Indications for Use.

Affected muscles and/or joints have to be exposed to an adequate level of therapeutic energy over a short period of time to provide effective therapeutic effects. Some patients may require more than one laser application or a series of treatments before significant improvement is reported. Repeat the therapy as necessary and monitor the progress of the patient’s condition throughout the treatment.

Refer to the Fitzpatrick Skin Type Scale when performing pain therapy procedures. The diode wavelength has increased absorption in melanin in the skin, causing greater heating of the skin surface of patients with a higher melanin concentration (darker skin types). Patients with higher melanin content in their skin may feel more discomfort during treatment, which may be alleviated by moving the Handpiece, defocusing the energy, or decreasing the power setting.

Epic™10 User Manual pg. 35 5400321 Rev H

Fitzpatrick Skin Type Scale

TYPE I

Highly sensitive, always burns, never tans. Example: Red hair with freckles

Very sun-sensitive, burns easily, tans minimally. Example: Fair-skinned, fair-haired Caucasians

Sun-sensitive skin, sometimes burns, slowly tans to light brown. Example: Darker Caucasians

Minimally sun-sensitive, burns minimally, always tans to moderate brown. Example: Mediterranean-type Caucasians

Sun-insensitive skin, rarely burns, tans well. Example: Some Hispanics, some Blacks

TYPE VI

Sun-insensitive, never burns, deeply pigmented. Example: Darker Blacks

TYPE II

TYPE III

TYPE IV

TYPE V

Figure 7.8

Pain Therapy – Adverse Effects

Some reddening of the skin at the treatment site is normal due to increased circulation; however, in very rare cases burning or blistering of the skin may occur. Immediately stop treatment, rinse the area with cool water or place a cold pack to the affected area for at least 5 minutes, then apply a burn ointment or spray. DO NOT USE ICE

Patients should be monitored for discomfort and visual skin changes. Redness has been associated with increased temperature at the site of application and increased absorption properties of the skin. If discomfort or redness of the skin occurs at any time during the treatment, you have the following options:

o Move the handpiece relative to the affected anatomy o Defocus the energy by moving the Handpiece further away from the skin o Decrease the power setting o Stop treatment

Pain Therapy – Warnings and Precautions

• Scar tissue has been associated with poor circulation and reduced cooling through heat transport by blood; power settings may have to be reduced to avoid overheating.

• Patients with tender or sensitive skin may be hypersensitive to heat; reduce power as necessary to ensure comfort during treatment.

• Patients with swelling and/or inflammation may be sensitive to heat; reduce power as necessary to ensure comfort during treatment.

Epic™10 User Manual pg. 36 5400321 Rev H

• Do not treat open wounds.

o Power output

o Range of movement of the handpiece

o Distance from the skin surface

o Patient skin type

To avoid potential patient discomfort and/or skin damage, it is advisable to use a test the individual patient.

• Muscle tissue closer to the skin surface may experience a higher absorption of heat; carefully monitor skin temperature and reduce power as necessary.

• Excessive fatty tissue is known to transmit heat without much attenuation; reduce power.

• Different implant materials will respond differently to laser energy and heat; be aware of

any implants and their location; avoid direct exposure to laser energy or heat at the site of the implant.

• Avoid treatment of sites that have tattoos.

• Do not apply ointment, creams, lotions or heating lotion patches at, or in close proximity

to, the treatment area.

• Do not apply therapies prior to treatment that could change body temperature, such as ultrasound, ice/heat pack, electrical stimulation, or heating patches.

• Do not apply treatment over articles of clothing.

Recommended Use

There are four main variables that impact the safety and effectiveness of pain therapy procedures:

Safety and effectiveness are described by elevating the skin temperature in the treatment area utilizing the settings recommended below. Use personal clinical judgment with consideration of the Fitzpatrick Skin Type Scale when selecting procedure parameters; monitor the patient and adjust the settings as necessary for effectiveness and patient comfort.

NOTE:

spot prior to the initial treatment to assess the suitability of the selected settings for

Using the Deep Tissue Handpiece

If holding the Handpiece in a constant location, set the screen to the recommended initial power settings for therapeutic effect at 4.0W delivered over 10 minutes (600 seconds) of continuous treatment (CW), with the spacer set at a 30mm spot size. Always monitor patient response; adjust power and/or distance as needed for patient comfort.

Using the Whitening/Contour Handpiece

If holding the Handpiece in a constant location, change the settings on the screen to 5.5W CW when approximately 3mm from the skin surface, or 2.75W CW in contact with the skin, applying laser energy for 10 minutes (600 seconds) continuously. Always monitor patient response.

Epic™10 User Manual pg. 37 5400321 Rev H

8. MAINTENANCE

WARNING:

No modification of this equipment is allowed.

Handpiece and tips must be cleaned and sterilized prior to initial use.

patients to avoid cross-contamination.

8.1 DAILY MAINTENANCE

Use the peel-off clear covers for the laser console supplied with the system. Use disinfectant to wipe down the front panel and handpiece holder of the Epic 10 system after each procedure. Do not use bleach or abrasive cleansers.

8.2 CLEANING AND STERILIZATION 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.

Tips are single-use only to avoid cross-contamination and are designed to

CAUTION:

withstand a single sterilization cycle; they must be disposed of after use in a biohazard medical waste Sharps container.

Handpieces are reusable and must be cleaned and sterilized between

Cleaning and Disinfecting Instructions-Surgical Handpiece, 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 pathogens 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 disinfect the fiber cable, wipe the entire cable, including the shaft, with an appropriate

disinfecting solution, such as Cavicide™ or a similar quaternary ammonium compound product (containing 20% alcohol or less), and follow the manufacturer’s instructions. Avoid getting any liquid or debris near the distal end of the fiber cable.

Epic™10 User Manual pg. 38 5400321 Rev H

Manual Cleaning of the Surgical Handpiece:

Cleaning must be performed within a maximum of 1 hour after the procedure and always prior to sterilization.

1. After use, carefully remove the tip from the handpiece and dispose of in a biohazard medical waste Sharps container.

2. Carefully remove the handpiece from the fiber optic cable (see Section 2).

3. Prepare any commercially available surgical instrument detergent/enzymatic cleaning

solution with a pH of 7.0, such as Enzol manufacturer’s instructions. (Follow the manufacturer’s instructions for disposal of used solution.)

4. Rinse the Handpiece under running lukewarm tap water (22 – 43°C) for a minimum of 10 seconds to remove gross soil.

5. Wrap the handpiece in a piece of gauze that has been soaked in the cleaning solution; leave it wrapped in the gauze for a minimum of 10 minutes.

6. Unwrap the handpiece from the gauze and use a soft-bristled brush dipped in the cleaning solution to gently scrub it for at least 15 seconds.

or similar enzymatic presoak and cleaner, per the

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.

Steam Sterilization for Surgical Handpiece, Single Use Tips

The steam sterilization process is intended to destroy infectious microorganisms and pathogens.

Always perform the procedure immediately after cleaning and prior to use and only

NOTE:

• Place the handpiece and fiber tips in separate single-wrap, self-seal autoclave pouches.

• Place on an autoclave tray; do not stack other instruments on top of the pouches.

• Place the tray inside the autoclave chamber and set the appropriate cycle as

use FDA-cleared (USA) or CE-marked (Europe) sterilization accessories, i.e., sterilization pouch and autoclave tray.

recommended in Figure 8.1.

Epic™10 User Manual pg. 39 5400321 Rev H

Type of Sterilizer Temperature Min Time Drying Time

Gravity Displacement

Dynamic-Air-Removal (Pre-Vacuum)

121°C ( 250°F) 30 minutes

15 – 30 minutes

132°C (270°F) 15 minutes

132°C (270°F)

4 minutes 20 - 30 minutes

134°C (EU only)

Figure 8.1

• Once the cycle is completed, remove the tray and let each sterilized item cool and dry.

The handpiece and tips must remain in the sterilization pouches until used in order to maintain sterility.

• For instructions on how to reassemble the handpiece, please refer to section 2.7.

Disinfecting the Whitening/Contour Handpiece

The Whitening Handpiece is sold with disposable non-sterile protective shields. The Handpiece and clear protective shield are not autoclavable. The clear protective

shields are intended for one-time use only and should never be reused to prevent crosscontamination.

To disinfect the Whitening Handpiece, wipe down the Handpiece with gauze and isopropyl alcohol. Always wipe the disposable shield with alcohol prior to use. Dispose of after single use.

Disinfecting the Deep Tissue Handpiece

The Deep Tissue Handpiece is sold with non-sterile, disposable protective shields. The Handpiece and clear protective shield are not autoclavable. The clear protective

shields are intended for single-time use only and should never be reused to prevent crosscontamination.

To disinfect the Deep Tissue Handpiece, wipe the entire outer surface of the Handpiece with cotton gauze and isopropyl alcohol or a mild chemical disinfectant.

Always wipe the disposable shield with alcohol prior to use. Dispose of after one-time use.

8.3 INSTALLING/REPLACING THE CONSOLE BATTERY PACK

1. To install or replace the battery pack, remove the battery cover on the underside of the console using the Phillips s c re wdriver included with the laser system (Figure 8.2).

Epic™10 User Manual pg. 40 5400321 Rev H

2. To remove the battery, grip the battery at the top and pull the cable away from the

Figure 8.3: Battery Pack/Connector Wire

Only use the battery pack supplied by BIOLASE. The battery pack is a separate accessory (BIOLASE p/n 6400457).

Screws to remove

connector (Figure 8.3). Do not tug or wrench the cable from the connector.

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 place the battery into the compartment (Figure 8.3).

4. Replace the battery cover on the bottom of the unit, using a standard Phillips screwdriver.

5. Connect the power cord of the DC power supply to the unit and plug into a wall outlet. Before first use, you should fully charge the battery (at least three (3) 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. (See Section 4.1)

6. Recycle the used Lithium Ion battery as regulated. Do not throw it in a trashbin.

Battery cover

NOTE:

8.4 CHANGING THE WIRELESS FOOTSWITCH BATTERIES

The wireless footswitch is powered by two AAA batteries. When the batteries are low, a warning message will appear on the touchscreen indicating that the batteries need to be replaced. To replace the batteries, unscrew the battery cover on the underside of the footswitch (Section 4), remove the old batteries, and install the new ones, replacing the cover when done. Dispose of the used batteries as regulated; do not throw them in a trash bin.

Do not press/push/touch the Pairing Button (Figure 8.4) while changing the batteries, as this will disrupt the pairing of the laser console and footswitch.

Epic™10 User Manual pg. 41 5400321 Rev H

To ensure the longevity of the battery power, only BIOLASE-supplied batteries are batteries which under normal use have a longer life than conventional AAA batteries.

Make sure the distal end of the Handpiece shaft is protected from dirt with the protective tip plug and Handpiece.

Remove the batteries from the footswitch if the Epic 10 is not likely to be used for some time.

Pairing Button (Internal View)

Figure 8.4

Replacing the batteries may disrupt the pairing of the laser console and footswitch. If you find the wireless communication has been interrupted, reestablish pairing by following the instructions provided in Section 4.

NOTE:

recommended as replacements (BIOLASE p/n 6400463); these are industrial-grade

8.5 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 its shipping box. If you have any questions regarding transportation please call BIOLASE Service at 1-800-321-6717.

8.6 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:

The Epic 10 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.

Epic™10 User Manual pg. 42 5400321 Rev H

9. CALIBRATION

For any on-screen message not listed in Figure 11.1, re-power the laser console; if authorized Service Representative

Calibration procedure is recommended to be performed every twenty-four (24) months in order to maintain the required accuracy of output power versus displayed power. Bi-annual calibrations can be performed at a certified depot repair facility. Call BIOLASE Service at 1-800321-6717 or your Authorized Service Representative to schedule an appointment.

10. SOFTWARE SPECIFICATION

BIOLASE respects the intellectual property of others, and we ask our users to do the same. Epic 10 software is protected by copyright and other intellectual property laws.

11. TROUBLESHOOTING

Should any of the on-screen messages listed in Figure 11.1 and Figure 11.2 appear, follow the troubleshooting instructions for the specific message as noted below.

NOTE:

the message does not clear, call BIOLASE Service at 1-800-321-6717 or your

Epic™10 User Manual pg. 43 5400321 Rev H

SCREEN

COMMUNICATION

MESSAGE

REASON

FIX

Error 1

Error 2

Error 3

Error 4

ERROR 5

ERROR 6

ERROR 7

ERROR 8

ERROR 9

THERMISTOR OPEN THERMISTOR OPEN

CALL BIOLASE SERVICE

THERMISTOR SHORTED THERMISTOR SHORTED

SHUTDOWN TEMPERATURE

LASER CURRENT

/LOW

HIGH

FOOTSWITCH SHORTED

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

SYSTEM TOO HOT

OUTPUT IS O U T OF SPECS CALL BIOLASE SERVICE

FS IS PARTIALLY PRESSED OR DAMAGED

WIRELESS INTER F ER EN CE

ALLOW 5-10 MINUTES FOR LASER TO COOL DOWN

PRESS/RELEASE FOOTSWITCH OR CALL BIOLASE SERVICE

REPOSITION CONSOLE OR FOOTSWITCH TO IMPROVE

ERROR 10

ERROR 11

ERROR 12

ERROR 13

ERROR 14

EMERGENCY SWITCH E-SWITCH PRESSED PRESS E-SWITCH AGAIN

REMOTE INTERLOCK REMOTE INTERLOCK OPEN

BATTERY CRITICALLY LOW

INTERNAL ERROR INTERNAL ERROR OCCURRED RESTART UNIT

FOOTSWITCH BATTERY

BATTERY IS CRITICALLY LOW PLUG IN DC SUPPLY

FOOTSWITCH BATTERY CRITICALLY LOW

CHECK REMOTE INTERLOCK CLOSED

REPLACE FOOTSWITCH BATTERY

Figure 11.1

Epic™10 User Manual pg. 44 5400321 Rev H

READY MODE TO LASE

ANY PROCEDURE SCREEN

SCREEN

WARNING 1

WARNING 2

WARNING 3

WARNING 4

WARNING 5

ALERT 1

ALERT 2

MESSAGE

TEMPERATURE HIGH SYSTEM IS HOT

BATTERY IS LOW BATTERY IS LOW PLUG IN DC SUPPLY

BATTERY NOT CONNECTED

FOOTSWITCH BATTERY IS LOW

FOOTSWITCH FOOTSWITCH HELD RELEASE FOOTSWITCH

WIRELESS NOT PAIRED NO WIRELESS CONNECTION

SYSTEM MUST BE IN

REASON

ALLOW 5-10 MINUTES FOR LASER TO COOL DOWN

BATTERY NOT CONNECTED PLUG IN THE BATTERY

BATTERY ON THE FOOTSW ITCH IS LOW

REPLACE FOOTSWITCH BATTERY

RE-ESTABLISH PAIRING

(SEE SEC 4)

SYSTEM IS NOT IN READY MODE

PRESS THE CONTROL BUTTON IN

FIX

Figure 11.2

Epic™10 User Manual pg. 45 5400321 Rev H

APPENDIX A – TIP GUIDE

NOTE:

All Biolase tips for diode lasers are sold non-sterile and are for single-use only. See Section 8.2 for sterilization instructions.

Epic™10 User Manual pg. 46 5400321 Rev H

APPENDIX B – LABELING

Symbols

Description

Product ID Label

Location: Bottom of laser console

Manufacturer

Date of Manufacture

Catalog/Part Number

Product Serial Number

Refer to User Manual

Type B Applied Part:

The applied part is not conductive to the

patient.

FDA Compliance Label:

Indicates the device complies with FDA laser

standards.

Epic™10 User Manual pg. 47 5400321 Rev H

Warning Label:

FCC Compliance Notice:

Location: Bottom of Footswitch

Indicates there is the risk of possible

exposure to both infrared and visible laser

radiation.

Location: Back of laser console

The footswitch and laser console comply with

Part 15 of FCC Rules regarding unlicensed

transmissions.

FCC and IC Label:

Lists Federal Communication Commission

and Industry Canada registration numbers.

Location: Bottom of Console

FCC and IC Label:

Lists Federal Communication Commission

and Industry Canada registration numbers.

Location: Bottom of Footswitch

IPX6

Ingress Protection Code:

The footswitch is water-resistant, protected

against splashes of water.

Laser Warning:

Indicates the system contains a laser.

Location: Back of Laser Console

Fiber Warning:

Indicates the laser aperture is at the end of

the fiber.

Location: Back of Laser Console

Epic™10 User Manual pg. 48 5400321 Rev H

Emergency Laser Stop Switch:

The switch used in emergencies to stop laser

output.

Location: Right side of Laser Console

DO NOT REUSE

For single use only.

WEEE (Waste Electrical and Electronic)

Recycle Lithium Ion battery as regulated. Do

not throw in trash bin.

DC Power, USB, Remote Interlock Label:

Identifies input ports

Power Input Rating:

12 Volts Direct Current, 5 amps

Mini USB Input:

Input for Remote Interlock Connector which,

operatory and activated, wil l shut of f the

For external programming

Remote Interlock:

when applied to the access door of the

laser.

Prescription Statement:

Federal Law restricts this device to sale

by or on the order of a dentist or

physician or other licensed medical

practitioner.

Epic™10 User Manual pg. 49 5400321 Rev H

Atmospheric Pressure Limitations

Fragile:

Handle with care

Keep Dry

Humidity Limitations

Temperature Limitations

This End UP

Epic™10 User Manual pg. 50 5400321 Rev H

APPENDIX C – SAFETY PRECAUTIONS FOR

WARNING

CAUTION

LITHIUM-ION BATTERY PACKS

When USING the BATTERY

1. Misusing the battery may cause the battery to get hot, rupture, or ignite and cause serious injury. Be sure to follow the safety rules listed below:

• Do not place the battery in fire or heat the battery.

• Do not install the battery backwards so that the polarity is reversed.

• Do not connect the positive terminal and the negative terminal of the battery to each

other with any metal object (such as a wire).

• Do not carry or store the batteries together with necklaces, hairpins, or other metal

objects.

• Do not pierce the battery with nails, strike the battery with a hammer, step on the

battery, or otherwise subject it to strong impacts or shocks.

• Do not solder directly onto the battery.

• Do not expose the battery to water or salt water, or allow the battery to get wet.

2. Do not disassemble or modify the battery. The battery contains safety and protection devices which, if damaged, may cause the battery to generate heat, rupture, or ignite.

3. Do not place the battery on or near fires, stoves, or other high-temperature locations. Do not place the battery in direct sunshine or use or store the battery inside cards in hot weather. Doing so may cause the battery to generate heat, rupture, or ignite. Using the battery in this manner may also result in a loss of performance and a shortened life expectancy.

1. If the device is to be used by small children, the caregiver should explain the contents of the user’s manual to the children. The caregiver should provide adequate supervision to ensure that the device is being used as explained in the user’s manual.

Epic™10 User Manual pg. 51 5400321 Rev H

2. When the battery is worn out, insulate the terminals with adhesive tape or similar

WARNING

materials before disposal.

3. Immediately discontinue use of the battery if, while using, charging, or storing the battery, the battery emits an unusual smell, feels hot, changes color, changes shape, or appears abnormal in any other way. Contact your sales location or BIOLASE if any of these problems are observed.

4. Do not place the batteries in microwave ovens, high-pressure containers, or on induction cookware.

5. In the event that the battery leaks and the fluid gets into one’s eye(s), do not rub the eye(s). Rinse well with water and immediately seek medical care. If left untreated, the battery fluid could cause damage to the eye.

WHEN CHARGING the Battery

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.

• When charging the battery, either use a specified battery charger or otherwise

ensure that the battery charging conditions specified are met.

• Do not attach the batteries to a power supply plug or directly to a car’s cigarette

lighter.

• Do not place the batteries in or near fire, or into direct sunlight. When the battery

becomes hot, the built-in safety equipment is activated, preventing the battery from charging further, and heating the battery can destroy the safety equipment and can cause additional heating, breaking, or ignition of the battery.

2. Do not continue charging the battery if it does not recharge within the specified charging time. Doing so may cause the battery to become hot, rupture, or ignite.

Epic™10 User Manual pg. 52 5400321 Rev H

CAUTION

WARNING

CAUTION

The temperature range over which the battery can be charged is 0°C to 45°C. Changing the battery at temperatures outside of this range may cause the battery to become hot or to break. Charging the battery outside of this temperature range may also harm the performance of the battery or reduce the battery’s life expectancy.

When DISCHARGING the Battery

Do not discharge the battery using any device except for the specified device. When the battery is used in devices aside from the specified device it may damage the performance of the battery or reduce its life expectancy, and if the device causes an abnormal current to flow, it may cause the battery to become hot, rupture, or ignite and cause serious injury.

The temperature range over which the battery can be discharged is -20°C to 60°C. Use of the battery outside of this temperature range may damage the performance of the battery or may reduce its life expectancy.

Epic™10 User Manual pg. 53 5400321 Rev H

APPENDIX D – ACCESSORIES

BIOLASE p/n

Description

6400479

Surgical Handpiece (2-pack)

2400040

Laser Safety Glasses (Clinician)

6400058

Remote Interlock Plug

2400129

Power Cord with Power Supply

6400146

Wireless Footswitch

6400107

Tip initiation kit

7400022

Whitening/Contour Handpiece

6400180

Whitening Handpiece clear Handpiece covers (30-pack)

7400030

LaserWhite 20 Whitening Gel Kit (pack of 5)

6400311

Deep-Tissue Handpiece

6400310

Deep-Tissue Handpiece protective covers (qty. 20)

6400465

Peel-off clear screen covers (qty. 30)

6400457

Lithium ion battery pack for console

6400463

Battery Pack, (2 x AAA)

6400437

Trunk Fiber Assembly

Epic™10 User Manual pg. 54 5400321 Rev H

APPENDIX E – ELECTROMAGNETIC

Medical electrical equipment needs special precautions regarding

The use of accessories, other than those specified, except those supplied or

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Epic diode laser is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic diode laser should assure it is used in such an environment.

Emissions Test

Compliance

Electromagnetic environment - guidance

The Epic diode laser uses RF energy only for its internal

COMPATIBILITY

electromagnetic compatibility (EMC) and needs to be installed and put into

CAUTION:

Accessories: Medical grade power cord, maximum length 3ft (1 meter), Biolase p/n 2400043. Footswitch: Wireless, Biolase p/n 6400146

service according to the EMC information provided in the following tables. Portable and mobile Radio Frequency (RF) communications equipment can

affect medical electrical equipment.

WARNING:

sold by Biolase, Inc. as replacement parts for internal or external components, may result in increased EMMISSIONS or decreased IMMUNITY of the Epic diode laser system.

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Group 1

Class A

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Epic diode laser is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/flicker emissions

Class A

IEC 61000-3-3

Epic™10 User Manual pg. 55 5400321 Rev H

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Epic diode laser is intended for use in the electromagnetic environment specified below. The customer or the user of the Epic diode laser should assure that it is used in such an environment.

Immunity test

IEC 60601

test level

Continuous

level

Electromagnetic environment -

guidance

Electrostatic

IEC 61000-4-2

± 6 kV contact

Floors should be wood, concrete or

should be at least 50%.

Electrical fast

± 2 kV for power

input/output lines

± 2 kV for power

Main power quality should be that of a Surge

± 1 kV differential

mode

± 1 kV differential

mode

Mains power quality should be that of a

Voltage dips, short

<5% U

5 seconds

<5% U

5 seconds

Mains power quality should be that of a

Power frequency

IEC 61000-4-8

3 A/m

Power frequency magnetic fields

NOTE: Ur is the A.C. mains voltage prior to applications of the test level.

discharge (ESD)

transient/burst IEC61000-4-4

IEC 61000-4-5

interruptions and voltage variations on power supply input lines.

IEC 61000-4-11

± 8kV air

supply lines

± 1 kV for

mode ± 2kV common

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles

70% U (30% dip in U

) for

25 cycles <5% Ur

(>95% dip in U

) for

± 8kV air

supply lines

N/A

mode ± 2kV common

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles

70% U (30% dip in U

) for

25 cycles <5% Ur

(>95% dip in U

) for

ceramic tile. If floors are covered with synthetic material, relative humidity

typical commercial or hospital environment.

N/A

typical commercial or hospital environment.

typical commercial or hospital environment. If the user of the Epic diode laser requires continued operation during power mains interruptions, it is recommended that the Epic diode laser be powered from an uninterrupted power supply.

(50-60 Hz) magnetic field

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Epic™10 User Manual pg. 56 5400321 Rev H

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY (Continued)

The model Epic laser is intended for use in the electromagnetic environment specified below. The customer or the user of the model Epic laser should assure that it is used in such an environment.

Immunity test

IEC 60601

test level

Continuous

level

Electromagnetic environment -

guidance

Conducted RF

3 Vrms

3 V

Portable and mobile RF

NOTE 1 – At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone and

B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

IEC 61000-4-6

Radiated RF IEC61000-4-3

150 kHz to 80 GHz

3V/m 80 MHz to 2.5 GHz

3Vm

communications equipment should be used no closer to any part of the Epic diode laser, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800MHz to 2.5GHZ

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d 8s the recommended separation d is tanc e in meters (m).

Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey,

should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Epic diode laser is used exceeds the applicable RF compliance level above, the Epic diode laser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Epic diode laser.

Epic™10 User Manual pg. 57 5400321 Rev H

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EPIC DIODE LASER

The Epic diode laser is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the Epic diode laser can help prevent

the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter M

150kHz to 80Mhz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation

NOTE 1 – At 80 MHz and 800 MHZ, the separation distance for the higher frequency range applies.

electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Epic diode laser as recommended below, according to

Rated maximum output power of

transmitter W

distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

d = 1.2√P

d = 2.3√P

NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Epic™10 User Manual pg. 58 5400321 Rev H

APPENDIX F - WIRELESS EQUIPMENT

Conforms to:

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. 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.

CAUTION: Federal Law restricts this device to sale by or on the order

of a dentist or physician or other licensed medical practitioner.

Epic™10 User Manual pg. 59 5400321 Rev H

AAMI ES60601-1 IEC60601-1 IEC60601-2-22 IEC62366 IEC80601-2-60 IEC60825-1 Certified to: CSA C22.2 No. 60601-1

BIOLASE, Inc. 4 Cromwell Irvine, CA 92618 USA

949.361.1200

888.424.6527 biolase.com

About BIOLASE

Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine

and dentistry that feature proprietary and patented technologies for

minimally invasive surgeries, reducing pain and improving clinical

results.

MT Promedt Consulting GmbH Altenhofstrasse 80 D-66386 St. Ingbert/Germany +49 6894 581020 mt-procons.com

Only BIOLASE combines the leading laser technology – continuously

improved through ongoing clinical R&D and engineering – with

unmatched training, practice integration support and service.

BIOLASE leads the global dental laser market with over 21,000 lasers in

use today and the most complete family of dental lasers – from diode

lasers to the most advanced all-tissue laser, the WaterLase iPlus™.

Made in the USA

Copy right © 201 4 BIOLA SE, Inc. All r ights res erved. EP IC, iLase, e zLase, ezTip , LaserWh ite, Deep Ti ssue Handpie ce,

ComfortP ulse, WaterLase, and WaterLase iPlus are either trademark s or registered tra demarks of BIOLASE,

Incor porated in t he United Stat es and/or other c ountries . All other tr ademarks ar e proper ty of their re gistered

owner s. Subjec t to change wit hout notic e.

EPIC 10 User Manual P/N 5400321 Rev. H

Biolase Epic 10 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

INTRODUCTION

1.PACKAGING

1.1 SYSTEM PARTS LIST

1.2 FACILITY REQUIREMENTS

2. EQUIPMENT DESCRIPTION

2.1 GENERAL

2.2 BASE CONSOLE

2.3 CONTROL PANEL

2.4 SURGICAL DELIVERY SYSTEM

2.5 FIBER OPTIC CONNECTION

2.6 SINGLE-USE TIPS

2.7 SURGICAL HANDPIECE ASSEMBLY

2.8 WHITENING/CONTOUR HANDPIECE (OPTIONAL ACCESSORY)

2.9 DEEP TISSUE HANDPIECE (OPTIONAL ACCESSORY)

3. SAFETY

3.1 PRECAUTIONS

3.2 SAFETY INSTRUCTIONS

3.3 SAFETY FEATURES

Energy Monitor

System Monitor

Power Switch

Access Key Code

Control Button

Wireless Footswitch

Remote Interlock

Emergency Stop

Functional Display

3.4 SAFETY CLASSIFICATION

4. OPERATION INSTRUCTIONS

4.1 SYSTEM SETUP

4.2 OPERATION - TURN ON THE EPIC 10

4.3 SETTINGS SCREEN

4.4 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE

4.5 CONTROL BUTTON

4.6 ENTERING READY OR STANDBY MODES

4.7 READY MODE

4.8 WIRELESS FOOTSWITCH

4.9 PEAK POWER DISPLAY

4.10 PULSE MODE SELECTION

4.11 USING THE EPIC 10 TOUCH SCREEN DISPLAY

4.12 PROCEDURES BUTTON

4.13 TURN THE LASER CONSOLE OFF

5. SPECIFICATIONS

5.1 GENERAL

5.2 ELECTRICAL

5.3 LASER

5.4 OTHER LIGHT SOURCES

6. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS

6.1 CONTRAINDICATIONS

6.2 WARNINGS AND PRECAUTIONS

Prescription Statement

Eyewear

Anesthesia

Adjacent Structures

Suction

Plume Removal

Clinical Use

Training

7. CLINICAL APPLICATIONS

7.1 INTRODUCTION

7.2 INDICATIONS FOR USE

7.3 SOFT TISSUE SURGERY AND OTHER DENTAL USE

Pre-programmed Settings for Dental Procedures

7.4 TABLE OF PRE-PROGRAMMED SETTINGS

7.5 TEETH WHITENING PROCEDURE

7.6 PAIN THERAPY

Pain Therapy – Adverse Effects

Pain Therapy – Warnings and Precautions

Recommended Use

Using the Deep Tissue Handpiece

Using the Whitening/Contour Handpiece

8. MAINTENANCE

8.1 DAILY MAINTENANCE

8.2 CLEANING AND STERILIZATION PROCEDURES

Cleaning and Disinfecting Instructions-Surgical Handpiece, Reusable Fiber Optic Cable