BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA
949.361.1200
888.424.6527
biolase.com
User Manual
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
mt-procons.com
Delight Your Patients, Faster.
Rx Only.
®
Made in the USA
©2014 BIOLASE, Inc. All rights reserved. Subject to change without notice.
EPIC_X_UM_Cover_5400577_RevA.indd 1
5400577 Rev A
5400577 Rev A
11/13/2014 7:26:33 AM
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 .................................................................................................. 6
2.5 Fiber Optic Connection ..................................................................................................... 7
2.6 Single-Use Tips ................................................................................................................ 8
2.7 Surgical Handpiece Assembly .......................................................................................... 9
2.8 Whitening/Contour Handpiece (Optional Accessory) .......................................................10
2.9 Deep Tissue Handpiece (Optional Accessory) .................................................................11
3. Safety ..................................................................................................................................12
3.1 Precautions .....................................................................................................................12
3.2 Safety Instructions ...........................................................................................................12
3.3 Safety Features ...............................................................................................................13
Energy Monitor ..................................................................................................................13
System Monitor ..................................................................................................................13
Power Switch .....................................................................................................................13
Access Key Code...............................................................................................................14
Control Button ....................................................................................................................14
Wireless Footswitch ...........................................................................................................14
Remote Interlock ................................................................................................................14
Emergency Stop ................................................................................................................15
Functional Display..............................................................................................................15
3.4 Safety Classification ........................................................................................................15
4. Operating Instructions........................................................................................................16
4.1 System setup ...................................................................................................................16
User Manual
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4.2 Operation - Turn on the EPIC X .......................................................................................17
4.3 Settings Screen ...............................................................................................................17
4.4 Pairing the Footswitch to the Laser console.....................................................................18
4.5 Control Button .................................................................................................................19
4.6 Entering READY or STANDBY Modes ............................................................................19
4.7 READY Mode ..................................................................................................................19
4.8 Wireless Footswitch .........................................................................................................20
4.9 Peak Power Display ........................................................................................................20
4.10 Pulse Mode Selection ....................................................................................................20
4.11 Using the EPIC X Touch Screen Display .......................................................................22
4.12 Procedures Button .........................................................................................................23
4.13 Turn the Laser Console Off............................................................................................23
5. Specifications .....................................................................................................................24
5.1 General ...........................................................................................................................24
5.2 Electrical ..........................................................................................................................24
5.3 Laser ...............................................................................................................................24
5.4 Other Light Sources
6. Contraindications, Warnings & Precautions
6.1 Contraindications .............................................................................................................26
6.2 Warnings and Precautions ...............................................................................................26
Prescription Statement .......................................................................................................26
Eyewear .............................................................................................................................26
Anesthesia .........................................................................................................................26
Adjacent Structures............................................................................................................26
Suction ...............................................................................................................................26
Plume Removal..................................................................................................................27
Clinical Use ........................................................................................................................27
Training ..............................................................................................................................27
7. Clinical Applications ...........................................................................................................28
7.1 Introduction......................................................................................................................28
7.2 Indications for Use ...........................................................................................................28
7.3 Soft Tissue Surgery and Other Dental Use ......................................................................29
Tip Initiation: Parameters and Method (Not required if using pre-initiated tips) ...................29
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Pre-programmed Settings for Dental Procedures ...............................................................30
7.4 Table of Pre-Programmed Settings..................................................................................31
7.5 Teeth Whitening Procedure .............................................................................................32
7.6 Pain Therapy ...................................................................................................................32
Pain Therapy – Adverse Effects .........................................................................................33
Pain Therapy – Warnings and Precautions ........................................................................33
Recommended Use ...........................................................................................................34
Using the Deep Tissue Handpiece .....................................................................................34
8. Maintenance .......................................................................................................................35
8.1 Daily Maintenance ...........................................................................................................35
8.2 Cleaning and Sterilization Procedures .............................................................................35
Cleaning and Disinfecting Instructions-Surgical Handpiece, Reusable Fiber Optic Cable ..35
Manual Cleaning of the Surgical Handpiece: ......................................................................35
Steam Sterilization for Surgical Handpiece, Single Use Tips ..............................................36
Disinfecting the Whitening/Contour Handpiece ..................................................................37
Disinfecting the Deep Tissue Handpiece ............................................................................37
8.3 Installing/Replacing the Console Battery Pack .................................................................37
8.4 Changing the Wireless Footswitch Batteries ....................................................................38
8.5 Transportation .................................................................................................................38
8.6 Storage ............................................................................................................................38
9. Calibration ...........................................................................................................................39
10. Software Specification .....................................................................................................39
11. Troubleshooting ...............................................................................................................39
Appendix A – Tip Guide and Accessories ................................................................................41
Appendix B – Labeling ............................................................................................................42
Appendix C – Safety Precautions for Lithium-Ion Battery Packs ..............................................44
Appendix D – Electromagnetic Compatibility ...........................................................................46
Appendix E – Wireless Equipment Compliance Statement ......................................................50
User Manual
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5400577 Rev A
The EPIC™ X 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 X 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 X 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.
User Manual
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5400577 Rev A
1.1 SYSTEM PARTS LIST
The EPIC X 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 (Fiber Optic Assembly installed)
4. Assorted Surgical Tips
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. Welcome Kit (Welcome Letter, User Manual , BIOLASE store information, Quick Setup
Guide, Guide to Online Training & Product Registration Card, Limited Warranty Information)
9. Laser Warning Sign
10. Tip Initiation Kit
11. Remote Interlock cable
12. Philips-head screwdriver (for installing Footswitch batteries)
13. Footswitch
14. 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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5400577 Rev A
2.1 GENERAL
The EPIC X system consists of three components:
Wireless
Footswitch
Delivery System
Base Console
Fiber Optic Assembly
Handpiece
Tip
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
Activates the controls and display; places the
unit into STANDBY or READY mode.
LED Indicator
LED Indicator
Amber indicates unit is in STANDBY mode.
Green indicates unit is in READY mode.
LED
Indicator
Blinking green indicates the emission of
laser power.
Blinking blue indicates pairing between the
footswitch and laser console is active
Fiber Storage Channel
Control Button
Figure 2.1: Control Panel (Front View)
2.4 SURGICAL DELIVERY SYSTEM
NOTE:
All fiber optic cables, Handpieces & tips are shipped non-sterile.
The EPIC X Delivery System with surgical Handpiece consists of:
•
Re-useable Fiber Optic Assembly (Figure 2.8)
•
Re-useable Surgical Handpiece (Figure 2.9)
•
Disposable Tips (Appendix A)
User Manual
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5400577 Rev A
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.
NOTE:
2.5 FIBER OPTIC CONNECTION
The EPIC X ships with the fiber optic cable already attached.
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.
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).
Make sure you hear the fiber optic “click” into place; if you do not hear it “click,” remove the
fiber optic and reinstall it.
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 caught
or pinched between the housing and the fiber optic access plug.
Figure 2.2: Fiber Optic Access Plug
User Manual
Figure 2.3: Optical Access Port
pg. 7
5400577 Rev A
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).
CAUTION:
CAUTION:
Tips are single-use only to avoid cross-contamination and are designed to withstand
only a single sterilization cycle; they must be disposed of after use in a biohazard
medical waste Sharps container.
Always visually inspect the tip prior to use to make sure it is free of debris or 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 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:
To provide proper laser operation, do not connect tips when the handpiece is disconnected
from the fiber.
Tip Assembly
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
User Manual
pg. 8
5400577 Rev A
Correct Bend
Incorrect Bend
Figure 2.6: When installing the tip, make sure it is
seated properly (thread correctly)
WARNING:
Figure 2.7: Bending the tip cannula
When the aiming beam is not present or has a significantly asymmetrical shape:
►For tips that require initiation: change the tip
►For tips that do not require initiation: change the tip; press
requirement.
to bypass initiation
2.7 SURGICAL HANDPIECE ASSEMBLY
► Connect the Handpiece to the fiber optic assembly by pushing 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 assembled
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5400577 Rev A
► 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
2.8 WHITENING/CONTOUR HANDPIECE (OPTIONAL ACCESSORY)
NOTE:
The Whitening/Contour Handpiece is reusable and equipped with a disposable non-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 is
completed.
Figure 2.11: Whitening/Contour Handpiece
Figure 2.12: Disposable Non-Sterile Shield
2
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.
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5400577 Rev A
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 disinfection before and
after each patient treatment. This Handpiece cannot be 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 is
completed.
Spacer
Red Cap Dust
Cover
Handpiece
Disposable
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).
Figure 2.14
Place protective shield over the adjustable spacer (Figure 2.15).
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.
Figure 2.16
The Handpiece is now ready to use.
To remove the Handpiece, press and hold both buttons at the base of the Fiber Shaft and pull the
Handpiece away from the shaft.
User Manual
pg. 11
5400577 Rev A
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 X laser is used
in a clinical setting.
LASER
WARNING:
User Manual
Always ensure that the protective laser eyewear is appropriate for the laser
wavelength.
pg. 12
5400577 Rev A
•
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.
Power Switch
The laser console can be switched ON (I) or OFF (O) using the Power Switch on the back of the console.
Power Switch
DC Power
Remote Interlock
Figure 3.1: Power Switch, DC Power Input, Remote Interlock
User Manual
pg. 13
Figure 3.2: Power Supply Module with cord
5400577 Rev A
Use only the Power Supply Module supplied with the EPIC X laser system (BIOLASE
Part Number 2400129).
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:
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 X 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.
Two (2) AAA batteries are required to power the footswitch (included). (For instructions on how 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
Cover
Footswitch
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.
User Manual
pg. 14
5400577 Rev A
Figure 3.4: Remote Interlock Connector
Figure 3.5: Emergency Laser Stop (Left Profile View)
Emergency Stop
Press the red Emergency Laser Stop button (Figure 3.5) 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.
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
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5400577 Rev A
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 X will work using either DC power or the rechargeable battery pack:
NOTE:
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 X 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.
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.
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 2.8).
•
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 .
LASER
WARNING:
User Manual
Never point the laser at a person’s eyes.
pg. 16
5400577 Rev A
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 X
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 X “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); 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.
Laser Console Battery
Strength Indicator
Wireless Signal
Strength Indicator
Settings Button
Figure 4.4: Home Screen
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:
User Manual
pg. 17
5400577 Rev A
Language
Selection
Aiming Beam
Volume
Service Mode
(5 levels of
brightness
adjustment)
(5 levels of sound
adjustment)
(accessible only
by authorized
BIOLASE
Service)
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
To re-establish pairing, take the following steps:
1. Go to the Settings menu on the laser console display by pressing the Settings button
the “Wireless” icon
; select
.
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
.
Figure 4.7
3. The message that “PAIRING WILL NOW BEGIN” will appear
(Figure 4.8); press the green check mark to continue
.
Figure 4.8
User Manual
pg. 18
5400577 Rev A
4. To complete the pairing process, turn the footswitch over and
press the Pairing Button
for four (4) seconds (Figure 4.9).
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.
Figure 4.10
5b. If pairing has not occurred, the Wireless screen will
appear again indicating that pairing was not successful
(Figure 4.11); press the green button to repeat
steps 3 and 4.
Figure 4.11
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 (Figure 2.1) is a multi-functional button. 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.
User Manual
pg. 19
5400577 Rev A
NOTE:
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 either
instance, remove the Handpiece and confirm the beam is actually on by 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 reinstall the trunk fiber (see Section 2.6). If the aiming beam is still not on, turn off the laser
console and call Biolase Service.
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:
When the footswitch is not in use, it will go into SLEEP mode to conserve battery power. It
automatically reactivates when it is pressed.
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
(Figure 4.14).
User Manual
pg. 20
5400577 Rev A
Duty Cycle
Mode*
Pulse Duration (on)
Pulse Interval (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%
(Time On/Time off)
*CP = Comfort Pulse; P3 = Pulsed Mode which is the standard for most diode lasers currently available
to the dental market
Figure 4.13
NOTE:
Operating the laser at a shorter pulse duration typically results in lower tissue temperature.
Peak
Power
Average
Power
User Manual
Figure 4.14
pg. 21
5400577 Rev A
4.11 USING THE EPIC X TOUCH SCREEN DISPLAY
Figure 4.15
User Manual
pg. 22
5400577 Rev A
4.12 PROCEDURES BUTTON
The EPIC X has the ability to store up to 20 pre-set procedures; EPIC X is factory-installed with 14 preprogrammed procedural presets and 6 empty slots for custom pre-sets. All of them can be customized to
your preference.
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
to and select the pre-set you wish to overwrite (Figure 4.16).
on the HOME screen; scroll
2. Press and hold the banner on the selected procedure for two (2) seconds (Figure 4.17). The
parameters for that procedure will be changed and saved (the laser console will beep when the
adjusted settings are saved).
Figure 4.16
Figure 4.17
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:
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.
•
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.
User Manual
pg. 23
5400577 Rev A
5.1 GENERAL
Dimension
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)
Weight
2.5 lbs / 1kg
5.2 ELECTRICAL
Operating Voltage
100V - 240V ~ at 1.5A
Frequency
50/60Hz
External Fuses
None
Main Control
Power Switch
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
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
User Manual
pg. 24
5400577 Rev A
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 = 7.1cm area
Whitening Handpiece
Rectangular 35mm x 8mm = 2.8cm
2
NOHD
4.77 meters
Beam Divergence
8 - 22° per side angle
Standard Fiber Cable Length
5 feet (1.524 meters)
2
5.4 OTHER LIGHT SOURCES
Aiming Beam
User Manual
Laser diode, max 1 mW, 625 nm – 670 nm, Class 2
pg. 25
5400577 Rev A
6.1 CONTRAINDICATIONS
All clinical procedures performed with EPIC X 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 X 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.
Suction
Use high-speed suction as required to maintain a clear field of vision during treatment. Do not use the
EPIC X if you cannot clearly see the treatment site.
User Manual
pg. 26
5400577 Rev A
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:
User Manual
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
pg. 27
5400577 Rev A
7.1 INTRODUCTION
To efficiently remove tissues it is imperative to understand the nature of the EPIC X 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 X device may be appropriate for incision, excision, vaporization, ablation and coagulation
of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the
following specific indications:

Excisional and incisional biopsies

Vestibuloplasty

Exposure of unerupted teeth

Tissue retraction for impression

Fibroma removal

Laser soft tissue curettage

Frenectomy


Frenotomy

Gingival troughing for crown impressions
Laser removal of diseased, infected,
inflamed and necrosed soft tissue within the
periodontal pocket

Gingivectomy


Gingivoplasty

Gingival incision and excision

Hemostasis and coagulation

Implant recovery
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.)

Incision and drainage of abscess


Leukoplakia
Light activation for bleaching materials for
teeth whitening

Operculectomy

Laser-assisted whitening/bleaching of teeth

Oral papillectomies


Pulpotomy

Pulpotomy as an adjunct to root canal
therapy

Reduction of gingival hypertrophy

Soft tissue crown lengthening

Treatment of canker sores, herpetic and
aphthous ulcers of the oral mucosa
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.
User Manual
pg. 28
5400577 Rev A
7.3 SOFT TISSUE SURGERY AND OTHER DENTAL USE
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.
Tip Diameter (µm)
(Preset) Power (W)
Mode
400
1.4
CW
300
1.4
CW
200
Tip initiation not required when used for
recommended procedures
Figure 7.1
●
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 the 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;
a white flash will be visible or the tip will glow (Figure 7.4).
Figure 7.4
● Repeat initiation process as needed to ensure the tip is initiated.
After tip initiation is completed, press the check mark to access the screen for the selected procedure.
Figure 7.5
CAUTION:
User Manual
If the laser console is in “READY” mode, the laser will fire if the footswitch is
activated.
pg. 29
5400577 Rev A
Pre-programmed Settings for Dental Procedures
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 scroll for additional procedures.
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.
The Procedure Pre-Sets installed at the factory are based on clinical recommendations and
feedback from experienced laser dentists.
NOTE:
300μm tips are recommended for removing thin tissue layers. 400μm tips are 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 treatment area and
adjust parameters accordingly.
User Manual
pg. 30
5400577 Rev A
7.4 TABLE OF PRE-PROGRAMMED SETTINGS
Preset Name
Indications for Use
Mode
Peak
Power
Avg.
Power
Pulse
Interval
Pulse
Length
Duty
Cycle
Tip
Type
Tip
Initiated?
1
Gingivectomy/Gingivoplasty
Reduction of gingival
hypertrophy,
Vestibuloplasty
CP0
5.0 W
1.0 W
0.04 ms
0.01 ms
20%
E4
Yes
2
Troughing
Tissue retraction for
impression, Gingival
troughing for crown
impressions
CP2
2.0 W
1.0 W
1.0 ms
1.0 ms
50%
E4
Yes
3
Curettage
Laser soft tissue
curettage
CP1
2.4 W
0.8 W
0.2 ms
0.1 ms
30%
E4
Yes
4
Excision
Fibroma removal,
Excisional and incisional
biopsies, Gingival incision
and excision,
Operculectomy, Oral
papillectomies, Incision
and drainage of abscess
CP1
2.7 W
0.9 W
0.2 ms
0.1 ms
30%
E4
Yes
5
Frenectomy/Frenotomy
Frenectomy/Frenotomy
CP2
2.0 W
1.0 W
1.0 ms
1.0 ms
50%
E4
Yes
6
Implant Recovery
Implant Recovery
CP2
2.4 W
1.2 W
1.0 ms
1.0 ms
50%
E4
Yes
7
Perio Pockets
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.)
CP2
1.6 W
0.8 W
1.0 ms
1.0 ms
50%
E3
No
8
Pulpotomy(*)
Pulpotomy, Pulpotomy as
an adjunct to root canal
CW
0.1 W
0.1 W
N/A
N/A
N/A
E4
Yes
9
Crown Lengthening
Soft tissue crown
lengthening
CP1
2.7 W
0.9 W
0.2 ms
0.1 ms
30%
E4
Yes
10
Infected Pockets
Laser removal of
diseased, infected,
inflamed and necrosed
soft tissue within the
periodontal pocket
CP2
1.6 W
0.8 W
1.0 ms
1.0 ms
50%
E4
Yes
11
Endo (*)
Pulpotomy, Pulpotomy as
an adjunct to root canal
CW
0.1 W
0.1 W
N/A
N/A
N/A
E2
No
12
Hemostasis
Hemostasis
CW
0.5 W
0.5W
N/A
N/A
N/A
E4
Yes
13
Aphthous Ulcers
Treatment of canker
sores, herpetic and
aphthous ulcers of the
oral mucosa, Leukoplakia
CW
0.7 W
0.7 W
N/A
N/A
N/A
E4
No
14
Exposure of Unerupted Teeth
Exposure of unerupted
teeth
CP2
1.8 W
0.9 W
N/A
N/A
N/A
E4
Yes
15-17
Custom 1-3
N/A
CW
0.1 W
0.1 W
N/A
N/A
N/A
E4
Yes
18-20
Custom 4-6
N/A
CW
0.1 W
0.1 W
N/A
N/A
N/A
E4
No
(*)Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and
Pulpotomy as an adjunct to root canal therapy.
Figure 7.6
User Manual
pg. 31
5400577 Rev A
7.5 TEETH WHITENING PROCEDURE
The following items are required to perform teeth whitening with the EPIC X laser:
EPIC X 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 X 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.
User Manual
pg. 32
5400577 Rev A
Fitzpatrick Skin Type Scale
TYPE I
Highly sensitive, always burns, never tans. Example: Red hair with freckles
TYPE II
Very sun-sensitive, burns easily, tans minimally. Example: Fair-skinned, fair-haired
Caucasians
TYPE III
Sun-sensitive skin, sometimes burns, slowly tans to light brown. Example: Darker Caucasians
TYPE IV
Minimally sun-sensitive, burns minimally, always tans to moderate brown.
Example: Mediterranean-type Caucasians
TYPE V
Sun-insensitive skin, rarely burns, tans well. Example: Some Hispanics, some Blacks
TYPE VI
Sun-insensitive never burns, deeply pigmented. Example: Darker Blacks
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.
•
Do not treat open wounds.
•
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.
User Manual
pg. 33
5400577 Rev A
•
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:
o
Power output
o
Range of movement of the Handpiece
o
Power output
o
Patient skin type
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:
To avoid potential patient discomfort and/or skin damage, it is advisable to use a test spot
prior to the initial treatment to assess the suitability of the selected settings for the individual
patient.
Using the Deep Tissue Handpiece
If holding the Handpiece in a constant location, adjust the settings on the screen to the recommended
initial power settings for therapeutic effect, 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.
User Manual
pg. 34
5400577 Rev A
WARNING:
No modification of this equipment is allowed.
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 X system after each procedure. Do not use
bleach or abrasive cleansers.
8.2 CLEANING AND STERILIZATION PROCEDURES
The contamination control suggested for the EPIC X Surgical Handpiece and tips is the steam sterilization
method. However, before sterilization, the EPIC X reusable Handpiece should be carefully cleaned per
the following procedure.
Handpiece and tips must be cleaned and sterilized prior to initial use.
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.
Handpieces are reusable and must be cleaned and sterilized between patients to
avoid cross-contamination.
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 X 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.
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).
User Manual
pg. 35
5400577 Rev A
3. Prepare any commercially available surgical instrument detergent/enzymatic cleaning solution with
®
a pH of 7.0, such as Enzol or similar enzymatic presoak and cleaner, per the 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.
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.
NOTE:
Always perform the procedure immediately after cleaning and prior to use and only use FDAcleared (USA) or CE-marked (Europe) sterilization accessories, i.e., sterilization pouch and
autoclave tray.
•
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 recommended in
Figure 8.1.
Type of Sterilizer
Temperature
Minimum
Time
121°C ( 250°F)
30 minutes
Gravity Displacement
Drying Time
15 – 30 minutes
132°C (270°F)
15 minutes
132°C (270°F)
Dynamic-Air-Removal (Pre-Vacuum)
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.
User Manual
pg. 36
5400577 Rev A
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 cross-contamination.
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 cross-contamination..
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 screwdriver included with the laser system (Figure 8.2).
2. To remove the battery, grip the battery at the top and pull the cable away from the 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.
Screws to
remove Battery
Figure 8.2: Batter Cover/Bottom of Console
User Manual
Figure 8.3: Battery Pack/Connector Wire
pg. 37
5400577 Rev A
NOTE:
Only use the battery pack supplied by BIOLASE. The battery pack is a separate accessory
(BIOLASE p/n 6400457).
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.
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:
To ensure the longevity of the battery power, only BIOLASE-supplied batteries are
recommended as replacements (BIOLASE p/n 6400463); these are industrial-grade batteries
which under normal use have a longer life than conventional AAA batteries.
8.5 TRANSPORTATION
The EPIC X 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 X 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.
Make sure the distal end of the Handpiece shaft is protected from dirt with the
protective tip plug and Handpiece.
CAUTION:
Remove the batteries from the footswitch if the EPIC X is not likely to be used
for some time.
The EPIC X 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.
User Manual
pg. 38
5400577 Rev A
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 1-800-321-6717 or your Authorized
Service Representative to schedule an appointment.
BIOLASE respects the intellectual property of others, and we ask our users to do the same. EPIC X
software is protected by copyright and other intellectual property laws.
This product contains proprietary, copyrighted software developed by BIOLASE, Inc. All rights reserved in
the USA and other countries.
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:
For any on-screen message not listed in Figure 11.1, re-power the laser console; if the
message does not clear, call BIOLASE Service at 1-800-321-6717 or your authorized
Service Representative
Screen
Reason
Message
Fix
Warning 1
Temperature high
System is hot
Allow 5-10 minutes for
laser to cool down
Warning 2
Battery is low
Battery is low
Plug in DC supply
Warning 3
Battery not connected
Battery not connected
Plug in the battery
Warning 4
Footswitch battery is
low
Battery on the footswitch
is low
Replace footswitch
battery
Warning 5
Footswitch
Footswitch held
Release footswitch
Alert 1
Wireless not paired
No wireless connection
Re-establish pairing
(see sec 4)
Alert 2
System must be in
ready mode to lase
System is not in ready
mode
Press the control button
in any procedure screen
Figure 11.1
User Manual
pg. 39
5400577 Rev A
Screen
Error 1
Reason
Message
Thermistor open
Fix
Thermistor open
Call Biolase service
Error 2
Thermistor shorted
Thermistor shorted
Error 3
Shutdown temperature
System too hot
Allow 5-10 minutes for
laser to cool down
Error 4
Laser current high/low
Output is out of specs
Call Biolase service
Error 5
Footswitch shorted
FS is partially pressed or
damaged
Press/release footswitch
or call Biolase service
Error 6
ON/OFF button stuck
Key stuck
Press front key
Error 7
Flash corrupted
Memory corrupted
Call Biolase service
Error 8
No fiber
Fiber not inserted
Plug in trunk fiber
Error 9
Lost footswitch
communication
Wireless interference
Reposition console or
footswitch to improve
communication
Error 10
Emergency switch
E-switch pressed
Press E-switch again
Error 11
Remote interlock
Remote interlock open
Check remote interlock
closed
Error 12
Battery critically low
Battery is critically low
Plug in dc supply
Error 13
Internal error
Internal error occurred
Restart unit
Error 14
Footswitch battery
Footswitch battery
critically low
Replace footswitch
battery
Figure 11.2
User Manual
pg. 40
5400577 Rev A
Tip
Name
Diameter
(µm)
Length
(mm)
Qty
Application
Part Number
E4-4
400µm
4
30
Surgical
7400016
E4-7
400µm
7
15
Perio
E4-9
400µm
9
15
Perio
7400019
Combo Pack
15 x E4-7,
15 x E4-9
E3-4
300µm
4
30
Surgical
7400017
E3-7
300µm
7
15
Perio
E3-9
300µm
9
15
Perio
7400020
Combo Pack
15 x E3-7,
15 x E3-9
E2-4
200µm
4
30
Surgical
7400018
E2-14
200µm
14
30
Endo
7400021
E2-20
200µm
20
20
Endo
7400015
4
mm
7mm
9mm
4
mm
7mm
9mm
4
mm
14mm
20mm
All Biolase tips for diode lasers are sold non-sterile and are for single-use only. See
Section 8.2 for sterilization instructions.
NOTE:
Biolase p/n
Description
Biolase p/n
Description
6400479
Surgical Handpiece (2-pack)
7400030
Laserwhite 20 Whitening Gel Kit
(pack of 5)
2400040
Laser Safety Glasses (Clinician)
6400311
Deep-Tissue Handpiece
6400058
Remote Interlock Plug
6400310
Deep Tissue Handpiece protective
covers (qty. 20)
2400129
Power Cord with Power Supply
6400465
Peel-off clear screen covers
(qty. 20)
6400573
Wireless Footswitch
6400457
Lithium-ion battery pack for console
6400107
Tip Initiation Kit
6400463
Battery Pack (2 x AAA)
7400022
Whitening/Contour Handpiece
6400437
Trunk Fiber Assembly
6400180
Disposable shields for Whitening
Handpiece (30-pack)
User Manual
pg. 41
5400577 Rev A
CONSOLE
Product ID Label
Location: Bottom of laser console
Warning Label:
Indicates there is the risk of
possible exposure to both infrared
and visible laser radiation.
Location: Back of laser console
Manufacturer
Laser Warning:
Indicates the system
contains a laser.
Location: Back of
Laser Console
DC Power, USB, Remote Interlock Label:
Identifies input ports
User Manual
Date of
Manufacture
Fiber Warning:
Indicates the laser
aperture is at the end of
the fiber.
Location: Back of Laser
Console
Power Input Rating:
12 Volts Direct Current, 5 amps
pg. 42
Catalog/Part
Number
Product Serial
Number
Emergency Laser Stop
Switch:
The switch used in
emergencies to stop laser
output.
Location: Right side of
Laser Console
Refer to User
Manual
FCC and IC Label:
Lists Federal Communication
Commission and Industry
Canada registration numbers.
Location: Bottom of Laser
Console
Mini USB Input:
For external programming
Type B Applied
Part: The applied
part is not
conductive to the
patient
FDA Compliance Label:
Indicates product complies
with FDA performance
standards.
Location: Bottom of Laser
Console
Remote Interlock:
Input for Remote Interlock Connector
5400577 Rev A
FOOTSWITCH
IPX6
Footswitch Product ID Label
Location: Bottom of footswitch
FCC Compliance Notice:
The footswitch and laser console comply
with Part 15 of FCC Rules regarding
unlicensed transmissions.
Location: Bottom of Footswitch
FCC and IC Label:
Lists Federal Communication
Commission and Industry Canada
registration numbers.
Location: Bottom of Footswitch
BATTERY PACK
TIPS
DO NOT REUSE
For single use only.
Ingress Protection Code:
The footswitch is water-resistant,
protected against splashes of water.
WEEE (Waste Electrical and
Electronic)
Recycle Lithium Ion battery as
regulated. Do not throw in trash bin.
PACKAGING
Prescription Statement: Federal
Law restricts this device to sale by
or on the order of a dentist or
physician or other licensed medical
practitioner.
Atmospheric
Pressure
Limitations
User Manual
Keep Dry
Fragile:
Handle with care
pg. 43
Humidity
Limitations
Temperature
Limitations
5400577 Rev A
This End UP
When using the battery:
WARNING
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.
CAUTION
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.
2. When the battery is worn out, insulate the terminals with adhesive tape or similar 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.
User Manual
pg. 44
5400577 Rev A
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:
WARNING
1. Be sure to follow the rules listed below while charging the battery. Failure to do so may cause the
battery to become hot, rupture, or ignite and cause serious injury.
•
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.
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:
WARNING
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.
CAUTION
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.
User Manual
pg. 45
5400577 Rev A
CAUTION:
Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the
EMC information provided in the following tables.
Portable and mobile Radio Frequency (RF) communications equipment can affect
medical electrical equipment.
Accessories: Medical grade power cord, maximum length 3ft (1 meter), Biolase p/n 2400043.
Footswitch: Wireless, Biolase p/n 6400146
WARNING:
The use of accessories, other than those specified, except those supplied or 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.
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
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
Compliance
Group 1
Electromagnetic environment - guidance
The EPIC diode laser uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
Class A
Class A
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.
Class A
IEC 61000-3-3
User Manual
pg. 46
5400577 Rev A
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
Electrostatic
discharge (ESD)
IEC 60601
test level
Continuous
level
± 6 kV contact
± 6 kV contact
± 8kV air
± 8kV air
± 2 kV for power
supply lines
± 2 kV for power
supply lines
Main power quality should be that of a
typical commercial or hospital
environment.
± 1 kV for
input/output lines
N/A
N/A
± 1 kV differential
mode
± 1 kV differential
mode
Mains power quality should be that of a
typical commercial or hospital
environment.
± 2kV common
mode
± 2kV common
mode
<5% Ur
(>95% dip in UT)
for 0.5 cycle
<5% Ur
(>95% dip in UT)
for 0.5 cycle
40% Ur
(60% dip in UT) for
5 cycles
40% Ur
(60% dip in UT) for
5 cycles
70% Ur
(30% dip in Ur) for
25 cycles
70% Ur
(30% dip in Ur) for
25 cycles
<5% Ur
(>95% dip in Ur) for
5 seconds
<5% Ur
(>95% dip in Ur) for
5 seconds
3 A/m
3 A/m
IEC 61000-4-2
Electrical fast
transient/burst
Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, relative humidity
should be at least 50%.
IEC61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
IEC 61000-4-11
Power frequency
(50-60 Hz)
magnetic field
Mains power quality should be that of a
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.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
IEC 61000-4-8
NOTE: Ur is the A.C. mains voltage prior to applications of the test level.
User Manual
pg. 47
5400577 Rev A
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
Conducted RF
3 Vrms
3V
IEC 61000-4-6
150 kHz to 80 GHz
3Vm
Radiated RF
3V/m
IEC61000-4-3
80 MHz to 2.5 GHz
Electromagnetic environment guidance
Portable and mobile RF
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 distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
a
electromagnetic site survey, should be
less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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
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.
B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
User Manual
pg. 48
5400577 Rev A
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
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
the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter W
Separation distance according to frequency of transmitter M
150kHz to 80Mhz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
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.
NOTE 1 – At 80 MHz and 800 MHZ, the separation distance for 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.
User Manual
pg. 49
5400577 Rev A
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.
User Manual
pg. 50
Conforms to:
AAMI
ES60601-1
IEC60601-1
IEC60601-2-22
IEC62366
IEC80601-2-60
IEC60825-1
Certified to:
CSA C22.2
No. 60601-1
5400577 Rev A
BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA
949.361.1200
888.424.6527
biolase.com
User Manual
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
mt-procons.com
Delight Your Patients, Faster.
Rx Only.
®
Made in the USA
©2014 BIOLASE, Inc. All rights reserved. Subject to change without notice.
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