Biolase epic V series User manual

EPIC V-Series User Manual P/N 5400430 Rev. A
Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine
and dentistry that feature proprietary and patented technologies for
performing minimally invasive surgeries, reducing pain and improving
clinical results.
Only BIOLASE combines the leading laser technology – continuously
improved through ongoing clinical R&D and engineering – with
unmatched training, practice integration support and service.
About BIOLASE
BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA
949.361.1200
888.424.6527
biolase.com
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
[phone]
mt-procons.com
Copyright © BIOLASE, Inc. All rights reserved. EPIC, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece,
ComfortPulse, WaterLase, and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE,
Incorporated in the United States and/or other countries. All other trademarks are property of their registered
owners. Subject to change without notice.
User Manual
EPIC V-Series User Manual P/N 5400430 Rev. A
Made in the USA
EPIC_V-Series_UserManual_5400430_RevA_Cover.indd 1 6/24/2013 9:20:03 AM

TABLE OF CONTENTS
TABLE OF CONTENTS............................................................................................................. 0
Introduction................................................................................................................................ 3
1.Packaging............................................................................................................................... 4
1.1 System Parts List.............................................................................................................. 4
1.2 Facility Requirements....................................................................................................... 4
2. Equipment Description........................................................................................................... 5
2.1 General ............................................................................................................................ 5
2.2 Base Console................................................................................................................... 5
2.3 Control Panel.................................................................................................................... 5
2.4 Surgical Delivery System.................................................................................................. 6
2.6 Fiber Optic Connection..................................................................................................... 6
2.7 Single-Use Tips................................................................................................................ 7
2.8 Surgical Handpiece Assembly.......................................................................................... 7
2.9 Deep Tissue Handpiece (Optional Accessory).................................................................10
3. Safety....................................................................................................................................11
3.1 Precautions .....................................................................................................................11
3.2 Safety Instructions...........................................................................................................11
3.3 Safety Features...............................................................................................................12
Energy Monitor ..................................................................................................................12
System Monitor..................................................................................................................12
Power Switch.....................................................................................................................13
Access Key Code...............................................................................................................13
Control Button....................................................................................................................13
Wireless Footswitch...........................................................................................................13
Remote Interlock................................................................................................................14
Emergency Stop ................................................................................................................14
Functional Display..............................................................................................................15
3.4 Safety Classification........................................................................................................15
4. Operation Instructions...........................................................................................................16
4.1 System setup...................................................................................................................16
4.2 Operation - Turn on the EPIC V-Series............................................................................17

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4.3 Settings Screen...............................................................................................................18
4.4 Pairing the Footswitch to the Laser console.....................................................................18
4.5 Control Button .................................................................................................................20
4.6 Entering READY or STANDBY Modes ............................................................................20
4.7 READY Mode..................................................................................................................20
4.8 Wireless Footswitch.........................................................................................................21
4.9 Peak Power Display ........................................................................................................21
4.10 Pulse Mode Selection....................................................................................................21
4.11 Using the EPIC V-Series Touch Screen Display............................................................23
4.12 Procedures Button.........................................................................................................24
4.13 Turn the Laser Console Off............................................................................................24
5. Specifications........................................................................................................................25
5.1 General ...........................................................................................................................25
5.2 Electrical..........................................................................................................................25
5.3 Laser...............................................................................................................................25
5.4 Other Light Sources.........................................................................................................26
6. Contraindications, Warnings & Precautions ..........................................................................27
6.1 Contraindications.............................................................................................................27
6.2 Warnings and Precautions...............................................................................................27
Prescription Statement.......................................................................................................27
Eyewear.............................................................................................................................27
Anesthesia.........................................................................................................................27
Adjacent Structures............................................................................................................27
Suction...............................................................................................................................28
Plume Removal..................................................................................................................28
Clinical Use........................................................................................................................28
Training..............................................................................................................................28
7. Clinical Applications..............................................................................................................29
7.1 Introduction......................................................................................................................29
7.2 Indications for Use...........................................................................................................29
7.3 Soft Tissue Surgery and Dental Use................................................................................29
Tip Initiation: Parameters and Method................................................................................29
Pre-programmed Settings for Dental Soft Tissue and Surgical Procedures........................31

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7.4 Table of EPIC V-Series Pre-Programmed Settings..........................................................32
7.5 Pain Therapy...................................................................................................................33
Recommended Use...........................................................................................................33
Pre-Progammed Settings for Pain Therapy........................................................................34
Pain Therapy - Warnings and Precautions.........................................................................34
Using the Deep Tissue Handpiece.....................................................................................35
8. Maintenance .........................................................................................................................36
8.1 Daily Maintenance...........................................................................................................36
8.2 Cleaning and Sterilization Procedures.............................................................................36
Cleaning and Disinfecting Instructions for the Surgical Handpiece, and the Reusable Fiber
Optic Cable........................................................................................................................36
To Clean the Surgical Handpiece:......................................................................................37
Steam Sterilization for Surgical Handpiece, Single Use Tips, Tip Initiation Block...............37
Cleaning the Deep Tissue Handpiece................................................................................37
8.3 Installing/Replacing the Console Battery Pack.................................................................38
8.4 Changing the Wireless Footswitch Batteries....................................................................38
8.5 Transportation.................................................................................................................39
8.6 Storage............................................................................................................................39
9. Calibration.............................................................................................................................40
9.1 Calibration Schedule .......................................................................................................40
10. Software Specification.........................................................................................................40
11. Troubleshooting ..................................................................................................................40
APPENDIX A – Definition of Symbols on Labeling....................................................................42
APPENDIX B – Safety Precautions for Lithium-Ion Battery Packs.............................................46
When USING the Battery.......................................................................................................46
WHEN CHARGING the Battery.............................................................................................47
When DISCHARGING the Battery.........................................................................................48
Appendix C - Spare Parts & Accessories..................................................................................49
System Accessories..............................................................................................................49
Single Use Tips.....................................................................................................................49
Appendix D - Wireless Equipment Compliance Statement........................................................51

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INTRODUCTION
The EPIC™ V-Series diode laser is a surgical and therapeutic device at the cutting edge of
technology, designed for a wide variety of dental and surgical soft tissue procedures, as well as
for use in providing temporary relief of minor pain in domestic animals (i.e., dogs, cats, birds,
and horses).
The EPIC™ V-Series 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.
The EPIC V-Series is restricted to sale by or on the order of a licensed veterinarian and its use
requires proper clinical and technical training. This manual provides instructions for those
professionals who have completed the appropriate training.
When used and maintained properly, the EPIC V-Series will prove a valuable addition to your
practice. Please contact BIOLASE Customer Service at 1-800-321-6717 in the USA and
Canada for any service needs. If you are located outside the U.S., please contact your
BIOLASE-authorized distributor for any service needs.
CANADA: This device must be installed and operated according the guidelines of CAN/CSA-
Z386-92 “Laser safety in a health care facility.”
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1.PACKAGING
1.1 SYSTEM PARTS LIST
The EPIC V-Series 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. Delivery System box
4. Tips box
5. Surgical Handpiece box (contains two (2) Surgical Handpieces)
6. Three (3) pairs of protective laser eyewear)
7. DC power supply and power cord (one (1) US and one (1) International)
8. User Manual (Hard Copy only)
9. Welcome Kit (Welcome Letter, BIOLASE store information, Quick Setup Guide,
Guide to Online Training & Product Registration Card, Tip User Guide, Limited
Warranty Information)
10. 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:
The laser ships with the lithium ion battery pack already installed.
NOTE:
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.
1.2 FACILITY REQUIREMENTS
Electrical Supply (100-240V ~):
1.5A, 50/60Hz
Environmental Requirements:
Temperature: 20-25 ºC
Humidity: 15-95%, Non-condensing

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2. EQUIPMENT DESCRIPTION
2.1 GENERAL
The EPIC V-Series system consists of three components:
● Base Console
● Delivery System
● Wireless Footswitch
2.2 BASE CONSOLE
The Console has a Display Panel (Touch Screen and Control Button) in front. It can be powered
by an external mains power supply or an internal replaceable lithium ion battery pack, 14.4V,
2.9 Ah.
2.3 CONTROL PANEL
ITEM ITEM DESCRIPTION
CONTROL
Button
Turns the controls and display on and
off; places the unit into STANDBY or
READY or SLEEP mode
LED
Indicator
•Amber indicates unit is in
STANDBY mode.
•Green indicates unit is in READY
mode.
•Blinking green indicates the
emission of laser power.
•Blinking blue indicates pairing
between the footswitch and laser
console is active
Figure 2.1: Control Panel (Front View)
LED Indicator
LED Indicator
Control Button

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2.4 SURGICAL DELIVERY SYSTEM
NOTE:
All fiber optic cables, Handpieces & tips are shipped non-sterile.
The EPIC V-Series Re-Useable Delivery System with surgical Handpiece consists of:
•Re-useable Fiber Optic Assembly
•Re-useable Surgical Handpiece (Figures 2.4, 2.5)
•Disposable Tips (See Figures 2.7, 2.8, 2.9, 2.10)
NOTE:
The fiber optic cable is detachable from the console. The Handpiece is a Re-usable
accessory and 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.
2.6 FIBER OPTIC CONNECTION
Only install the fiber optic cable while 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).
CAUTION:
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.
For storage, wind the cable in the fiber storage channel around the base of the console in a
counterclockwise direction (Figure 2.7).
CAUTION: 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.
To disconnect the fiber optic cable from the laser console, make sure 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.
NOTE:
Make sure you hear the fiber optic “click” into place; if you do not hear it “click,”
remove the fiber optic and reinstall it.

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Figure 2.2: Fiber Optic Access Plug
Figure 2.3: Optical Access Port
2.7 SINGLE-USE TIPS
The tips are single-use accessories and are provided in three core diameters: 200μm, 300μm,
and 400μm, in different lengths (see Appendix C).
CAUTION:
Tips are single-use only to avoid cross-contamination and are designed
to withstand a single sterilization cycle; they must be disposed of after
use in a biohazard medical waste Sharps container.
To connect the tip, insert it firmly into the distal end of the Handpiece as far as it will go, then
tighten by turning clockwise (Figure 2.7). Bend the metal cannula according to the specific
procedure requirements (Figure 2.10).
NOTE:
To provide proper laser operation, do not connect tips when the Handpiece is
disconnected.
2.8 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 the Handpiece from fiber optic assembly:
•Take the Handpiece body in one hand and the shaft in another
•Push the two buttons on the Fiber Shaft
•Pull the Handpiece with the ring to separate.
► Remove the fiber tip by twisting the tip counterclockwise.

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Fiber Shaft Protective Cap
Handpiece
Figure 2.4: Connecting the Handpiece to the fiber optic assembly
Figure 2.5: Surgical Handpiece Assembly fully assembled
Figure 2.6: Disconnect the Handpiece from the fiber optic assembly by pressing both buttons at the
base of the Fiber Shaft
Tip Assembly
Figure 2.7: Insert the fiber tip into the Handpiece and twist clockwise until snug
Figure 2.8: Remove the fiber Tip by twisting the tip counterclockwise

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Correct Bend
Incorrect Bend
Figure 2.9: When installing the tip, make sure it is
seated properly (thread correctly) Figure 2.10: Bending the tip cannula
WARNING:
When the aiming beam is not present or has a significantly different shape,
change the tip.

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2.9 DEEP TISSUE HANDPIECE (OPTIONAL ACCESSORY)
NOTE:
The Deep Tissue Handpiece is reusable and equipped with a disposable non-sterile
protective shield for single patient use. The Handpiece is non-sterile and requires
cleaning before and after each patient treatment. This Handpiece cannot be
sterilized in the autoclave. For instructions on cleaning 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
is completed.
Figure 2.15: Deep Tissue Handpiece
•Remove Red Cap Dust Cover from the Deep Tissue Handpiece.
The Handpiece is now ready to use.
To remove the Handpiece, press and hold the buttons on the side of the Fiber Shaft and pull the
Handpiece away from the shaft.
•Slide Handpiece over shaft until it clicks into place
(Figure 2.16).
Figure 2.16
•Place protective shield over the adjustable spacer
(Figure 2.17).
Figure 2.17
•Loosen the Lock Ring and set the Spacer at the desired spot
size Detent Location (Figure 2.18). Tighten the Lock Ring.
Figure 2.18
Handpiece
Spacer
Disposable
Shield
Red Cap Dust
Cover

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3. SAFETY
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 (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.
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.
WARNING:
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 V-Series laser is used in a clinical setting.

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LASER
WARNING:
Always ensure that the protective laser eyewear is appropriate for the
laser wavelength.
•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:
Do not open unit housing at any time. Danger from optical radiation may
exist.
LASER
WARNING:
Do not aim the laser at metallic or reflective surfaces, such as surgical
instruments or dental mirrors. If aimed directly at these surfaces the laser
beam will reflect and create a potential hazard.
CAUTION:
Be aware that the metal / plastic cannula on the tips may become hot during
use. Avoid contact of the cannula with any tissue.
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.

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Power Switch
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:
Use only the Power Supply Module supplied with the EPIC V-Series laser system
(BIOLASE Part Number 2400129).
Access Key Code
The Access Key Code prevents unauthorized use of the system. It is activated every time
system is turned on with the Power Switch (refer to Section 4 for code).
NOTE:
Placing the laser in sleep mode by pressing and holding the Control button on the
front panel does not re-set the Access Key Code. Turn the Power Switch OFF (O)
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 (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 V-Series 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.
Power Switch
DC Power
Remote Interlock

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Two (2) AAA batteries are required to power the footswitch (included). (For instructions on how
to replace the footswitch batteries, see Section 4.)
Figure 3.3: Footswitch
Remote Interlock
This feature allows the laser console to be connected to the remote sensor, preventing its
operation when triggered (e.g., by opening door). The electric cable from this connector should
be wired to the normally closed switch, sensing the opening of a door and turning the laser
console off when the switch is open.
To override this feature, don’t connect the plug.
Figure 3.4: Remote Interlock Connector
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.

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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 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

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4. OPERATION INSTRUCTIONS
4.1 SYSTEM SETUP
•Place the unit in a clean, dry, and well-ventilated area.
•Verify power switch is in the OFF (O) position.
•EPIC V-Series will work using either DC power or the rechargeable battery pack:
oDC Power:Connect the power cord of the power supply to the laser console and plug
into a wall outlet
oRechargeable Battery: The EPIC V-Series 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.
NOTE:
To fully charge the battery, plug the power supply in and then turn the laser console
ON (I) at the Power Switch. The laser console will start to charge and the unit will go
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 slower
rate.
•Connect the fiber to the laser console (see Section 2).
CAUTION:
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.
CAUTION:
Do not cover or block ventilation channels. These channels provide an air-
flow path to cool the unit.
CAUTION:
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.
•Remove protective cap from the end of the fiber shaft (see Figure 2.4).
•Carefully connect the Handpiece to the fiber optic assembly (see Figure 2.5).
•Insert the selected tip and tighten it clockwise until snug (see Figure 2.7).
•Wind any excess fiber optic cable onto the fiber spool counterclockwise around the base
of the console.
•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 .

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LASER
WARNING:
Never point the laser at a person’s eyes.
LASER
WARNING:
Never operate the laser without a fiber tip attached.
LASER
WARNING:
All persons present in the operatory must wear protective eyewear when
the laser is in use.
4.2 OPERATION - TURN ON THE EPIC V-SERIES
•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 ON (I) position. The “BIOLASE”
logo screen will appear (Figure 4.1). After three (3) seconds the EPIC V-Series “Welcome”
screen will be displayed (Figure 4.2).
Figure 4.1
Figure 4.2
Figure 4.3
•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) and then
the screen reverts 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.
Figure 4.4: Home Screen
Wireless Signal
Strength Indicator
Laser Console Battery
Strength Indicator
Settings Button

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4.3 SETTINGS SCREEN
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).
Figure 4.6