User Manual
Contents
INTRODUCTION ................................................................................................................... 6
1 OVERVIEW ....................................................................................................................... 7
2 INDICATIONS FOR USE .................................................................................................. 8
3 SPECIFICATIONS ........................................................................................................... 10
3.1 General .......................................................................................................................................... 10
3.2 Electrical ........................................................................................................................................ 10
3.3 Laser ............................................................................................................................................. 10
3.4 Other Light Sources ...................................................................................................................... 10
4 EQUIPMENT DESCRIPTION ......................................................................................... 11
4.1 System Components ..................................................................................................................... 11
4.2 General .......................................................................................................................................... 11
5 CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS ....................................... 14
5.1 Contraindications ........................................................................................................................... 14
5.2 Warnings and Precautions ............................................................................................................14
6 SAFETY WITH THE EPIC PRO ..................................................................................... 16
6.1 Safety Instructions ......................................................................................................................... 16
6.2 Safety Classication ...................................................................................................................... 17
6.3 Safety Features ............................................................................................................................. 18
7 INSTALLATION AND SETUP ......................................................................................... 20
7.1 Facility Requirements .................................................................................................................... 20
7.2 System Setup ................................................................................................................................ 20
7.3 Fiber Optic Cable .......................................................................................................................... 21
7.4 Surgical Handpiece Assembly ....................................................................................................... 22
7.5 Single-Use Tips ............................................................................................................................. 23
7.6 Whitening Handpiece (optional accessory) ................................................................................... 25
7.6.1 Whitening Gel ........................................................................................................................ 25
7.7 Pairing the Footswitch and Laser .................................................................................................. 26
Epic Pro User Manual
3
Contents
8 OPERATING INSTRUCTIONS ....................................................................................... 27
8.1 Epic Pro Interactive Display .......................................................................................................... 27
8.2 Icons-Denitions ............................................................................................................................ 27
8.3 System Start-up and Functions ..................................................................................................... 28
8.3.1 Login ...................................................................................................................................... 28
8.3.2 HOME Screen ....................................................................................................................... 29
8.3.3 Basic and Advanced .............................................................................................................. 29
8.3.4 Treatment Modes of Operation .............................................................................................. 30
8.3.5 Continuous Wave (CW) Mode ............................................................................................... 30
8.3.6 Automatic Power Control (APC) ............................................................................................31
8.3.7 Pulse Mode ............................................................................................................................ 32
8.3.8 Super Thermal Pulse ............................................................................................................. 33
8.3.9 QUICK START ....................................................................................................................... 34
8.3.10 Tip Selection ........................................................................................................................ 35
8.3.11 Tip Warning .......................................................................................................................... 36
8.3.12 Procedure Selection ............................................................................................................ 37
8.3.13 Creating Favorites Procedure .............................................................................................. 38
8.3.14 Selecting a Favorites Procedure ......................................................................................... 40
8.3.15 Ready Mode ...................................................................................................................... 40
8.3.16 Firing the Laser .................................................................................................................... 41
8.3.17 System Settings Menu ......................................................................................................... 42
8.3.18 System Information and Software Updates ......................................................................... 43
8.3.19 Service Mode ....................................................................................................................... 48
8.3.20 Export and Import of Settings and Favorites ....................................................................... 48
8.4 Turning the Epic Pro OFF ..............................................................................................................49
8.5 System Flow Chart ........................................................................................................................ 50
9 PRESETS ....................................................................................................................... 51
9.1 Restorative .................................................................................................................................... 51
9.2 Aesthetic ........................................................................................................................................ 52
9.3 Implant ........................................................................................................................................... 52
9.4 Perio .............................................................................................................................................. 52
9.5 Surgical ......................................................................................................................................... 53
9.6 Endo .............................................................................................................................................. 53
9.7 Oral Lesions .................................................................................................................................. 53
4
Epic Pro User Manual
Contents
10 CLEANING, DISINFECTION, AND STERILIZATION .................................................... 54
10.1 Cleaning the Console .................................................................................................................. 54
10.2 Cleaning and Sterilization Procedures, Handpiece and Fiber Tips .............................................54
10.3 Disinfecting the Fiber ................................................................................................................... 56
10.4 Disinfecting the Whitening Handpiece ......................................................................................... 56
11 MAINTENANCE AND CALIBRATION ........................................................................... 57
11.1 Annual Calibration ....................................................................................................................... 57
11.2 Changing the Wireless Footswitch Batteries ............................................................................... 57
11.3 Fiber Cable Lens Inspection and Cleaning .................................................................................. 58
11.3.1 Lens Inspection Procedure .................................................................................................. 58
11.3.2 Cleaning the Lens ................................................................................................................ 58
12 TROUBLESHOOTING ................................................................................................... 59
APPENDIX A – LABELS .................................................................................................... 62
APPENDIX B – TIP GUIDE ................................................................................................. 66
APPENDIX C: ACCESSORIES/SPARE PARTS ................................................................ 67
APPENDIX D – ELECTROMAGNETIC COMPATIBILITY .................................................. 68
APPENDIX E – WIRELESS EQUIPMENT COMPLIANCE STATEMENT .......................... 72
Epic Pro User Manual
5
Introduction
Congratulations on the addition of the Epic Pro diode laser system to your practice!
This User Manual is designed to help you become familiar with the operation and functions of the laser
system. Read it carefully before using the laser clinically, follow all safety instructions and cautions, and
always have it accessible for use as a reference.
We appreciate your commitment to better care and know your investment in this technology is a sound
foundation for the successful growth of your practice.
BIOLASE Team
6
Epic Pro User Manual
Overview
The Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral
soft-tissue procedures, and dental whitening.
Epic Pro utilizes a solid state diode as a semiconductor source for invisible infrared radiation.
The energy is delivered to the treatment site via a exible ber 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 prescription device is indicated for professional use only by licensed 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.
The device must be installed, operated, and maintained in according to the guidelines of
CAN/CSA – Z386-14
When used and maintained properly, the Epic Pro will prove a valuable addition to your practice. Please
contact BIOLASE Customer Service at 1-800-321-6717 in the U.S. for any service needs. If you are
located outside the USA, please contact your BIOLASE-authorized distributor.
Epic Pro User Manual
7
2 Indications for Use
The Epic Pro device with surgical laser operation (Automatic Power Control), used in contact or noncontact mode, is indicated for dental soft-tissue indications including incision, excision, vaporization,
ablation, hemostasis, or coagulation of intraoral and extra-oral soft-tissue (including marginal and
interdental gingiva and epithelial lining of free gingiva); examples include:
• Frenectomy
• Debridement of diseased epithelial lining
• Frenotomy
• Incisions and draining of abscesses
• Biopsy
• Tissue retraction for impressions
• Operculectomy
• Papillectomy
• Implant recovery/uncovery
• Vestibuloplasty
• Gingivectomy
• Excision of lesions
• Gingivoplasty
• Exposure of unerupted teeth/partially erupted teeth
• Gingival troughing
• Leukoplakia
• Crown lengthening
• Removal of hyperplastic tissues
• Removal of granulation tissue
• Laser-assisted ap surgery
• Sulcular debidement (removal of diseased or inamed soft-tissue in the periodontal pocket)
The Epic Pro device with surgical laser operation, used in contact or non-contact mode, is intended for
use in general surgery for incision/excision, vaporization, ablation and coagulation of soft-tissue.
8
Epic Pro User Manual
2 Indications for Use
The Epic Pro device with dental laser operation, used in contact or non-contact mode, is intended for
incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral softtissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include:
• Frenectomy
• Debridement of diseased epithelial lining
• Frenotomy
• Incisions and draining of abscesses
• Biopsy
• Tissue retraction for impressions
• Operculectomy
• Papillectomy
• Implant recovery/uncovery
• Vestibuloplasty
• Gingivectomy
• Excision of lesions
• Gingivoplasty
• Exposure of unerupted teeth/partially erupted teeth
• Gingival troughing
• Leukoplakia
• Crown lengthening
• Removal of hyperplastic tissues
• Removal of granulation tissue
• Laser-assisted ap surgery
• Hemostasis of donor site
• Pulpotomy
• Treatment of aphthous ulcers
• Pulpotomy as an adjunct to root canal therapy
• Sulcular debridement (removal of diseased or inamed soft-tissue in the periodontal pocket)
• Light activation of bleaching materials for teeth whitening
Epic Pro User Manual
9
3 Specications
3.1 GENERAL
• Dimension (W x L x H) 7.25in x 4.5in x 6.5in (18.4cm x 11.4cm x 16.5cm)
• Weight 4lbs (1.8kg)
3.2 ELECTRICAL
• Operating Voltage 100V-240V ~ at 1.2A/0.5A
• Frequency 50/60 Hz
• External Fuses None
• Main Control Main Power Switch
• Remote Interruption Remote Interlock Connector
• Disable Control Emergency Stop Button
3.3 LASER
• Laser Classication IV (4)
• Medium Semi-Conductor Diode
• Wavelength 940 ± 20nm
• Max Power Output 25W
• Power Accuracy ± 20%
• Power Modes Continuous, Pulse Modulation
• Fiber Tips Diameter 300µm, 400µm
• Pulse Duration 10µs-100ms
• Max. Energy Pulse 3.0J
• Pulse Repetition Rate Up to 20kHz (for reference)
• NOHD 4.77 meters
• Beam Divergence 0.22
• Standard Fiber Cable Length 6 feet (1.8 meters)
3.4 OTHER LIGHT SOURCES
• Aiming Beam Laser Diode, 5mW Max. C.W. @450-680nm, Class 3R
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Epic Pro User Manual
4 Equipment Description
4.1 SYSTEM COMPONENTS
The Epic Pro laser system includes the following:
1. Laser Console
2. Fiber Management Module
3. Fiber Optic Cable
4. Surgical Handpiece (2)
5. Assorted Surgical Tips (non-initiated and pre-initiated)
6. Wireless Footswitch
7. Protective Eyewear (3)
8. Power Supply/Adapter
9. Power Cord (1-US, 1-Int’l)
10. Disposable Screen Protectors (30)
11. Remote Interlock Connector
12. AAA Batteries (2-pack)
13. Welcome Kit (Includes User Manual and Laser Warning Sign)
WARNING: No modication of this equipment is allowed.
4.2 GENERAL
The Epic Pro laser system consists of three components:
1. Console and ber management module
2. Reusable ber delivery system (Fiber Optic Cable, reusable surgical Handpiece, ber Tips)
3. Wireless Footswitch
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11
4 Equipment Description
CONSOLE
The console, supported by a snap-on table base, is portable, contains the diode laser and all the
elements which power the laser. A touch screen Graphical User Interface (GUI) allows the user to
navigate from screen to screen, select procedures, enter and/or change settings, view system status,
etc. (Figure 4.1)
FIBER MANAGEMENT MODULE
This module is a separate component that clips onto the console. It provides a storage channel for the
ber and a holder for the Handpiece (Figure 4.1).
FIBER OPTIC CABLE
The Fiber Optic Cable transmits the laser radiation from the laser console through the Handpiece and
ber Tips to the target tissue.
SURGICAL HANDPIECE
Part of the delivery system, the surgical Handpiece is re-useable and detachable from the ber. It is the
conduit through which the laser energy ows from the Fiber Optic Cable to the Tip.
FIBER TIPS
Fiber Tips deliver the energy generated by the laser and transmitted through the Fiber Optic Cable to the
treatment site.
Power & Status
Indicator Light
Interactive Touch Screen
Emergency Stop Buttom
Fiber Management
Module & Handpiece Holder
12
Figure 4.1
Epic Pro User Manual
4 Equipment Description
WIRELESS FOOTSWITCH
Epic Pro is activated by a Footswitch designed to work using wireless technology. It is
powered by two (2) AAA batteries (Refer to section 11 for instructions on how to install/
replace the Footswitch batteries).
The Epic Pro laser will only emit laser energy when
the Footswitch is pressed while the laser is in
Ready mode.
The Footswitch and laser are shipped from the factory
already paired.
The Footswitch is protected by a metal cover. To
access, press down on the cover (Figure 4.2).
Three separate LED indicator lights are displayed on
the rear panel of the Footswitch.
LED Indicator Status
Cover
Footswitch
Figure 4.2
Amber Blinking or Solid
Blue Solid
Green Blinking The Footswitch batteries are low; replace the batteries.
Green Solid
Epic Pro User Manual
A critical error or short has occurred; the relevant error
message will appear on the tablet screen.
The Footswitch is connecting to the laser, or has successfully
paired with the laser.
ON: the Footswitch is pressed while paired to the laser;
OFF: the footswitch is not pressed, or the system is in Sleep
mode, or the batteries are dead.
13
5 Contraindications, Warnings, and Precautions
5.1 CONTRAINDICATIONS
All clinical procedures performed with Epic Pro must be subjected to the same clinical judgment
and care as with traditional techniques. Patient risk must always be considered and fully understood
before clinical treatment. The clinician must completely understand the patient’s medical history prior
to treatment and exercise caution for general medical conditions which might contraindicate a local
procedure; such conditions may include, but are not limited to, allergy to local or topical anesthetics,
heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deciency or
any medical conditions or medications that may contraindicate use of certain light/laser type sources
associated with this device. Medical clearance from the patient’s physician is advisable when
doubt exists regarding treatment. Epic Pro treatment may be contraindicated for patients suffering
from photodermatosis, photosensitive patients, and patients who are taking photosensitive drugs.
Conditions such as pregnancy or pacemakers are not known as contraindications for laser light energy.
5.2 WARNINGS AND PRECAUTIONS
PRESCRIPTION STATEMENT
U.S. Federal Law restricts this device to sale by or on the order of a dentist or dental specialist.
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.
EYEWEAR
Doctor, patient, assistant and all others inside or entering the operatory must wear appropriate laser
protection eyewear for the 940nm wavelength, OD 5 or greater (OD5+) whenever the laser is in user.
Prior to use, inspect eyewear for pitting and/or cracking. Do not use if damaged.
CAUTION: Always check eyewear specications as etched on the glasses themselves to
ensure they offer the protection required by the laser wavelength.
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.
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Epic Pro User Manual
5 Contraindications, Warnings, and Precautions
TREATMENT, TECHNIQUE, AND SETTINGS
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 clinic al ef fects and use your judgment to determine the clinic al parameters and approach for
the treatment; make appropriate power, pulse length, and interval adjustments to compensate for
varying tissue composition, density, and thickness. Always start treatment at the lowest power setting
for the specic indication and increase as required. BIOLASE assumes no responsibility for parameters,
techniques, methods, or results.
ADJACENT STRUCTURES
Epic Pro 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
lling 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 eld of vision during treatment. Do not use the
Epic Pro if you cannot clearly see the treatment site.
PLUME REMOVAL
CAUTION: Laser plume may contain viable tissue particulates.
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 ltered masks, and other protective gear is used at all times during
the laser procedure.
CLINICAL ENVIRONMENT
Only use this device in clinical environments that observe proper standard aseptic techniques with all
oral procedures.
Epic Pro User Manual
15
6 Safety with the Epic Pro
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.
WARNING: No modication of this equipment is allowed.
6.1 SAFETY INSTRUCTIONS
LASER WARNING: Emits invisible and/or visible laser radiation. Avoid eye or skin
exposure to direct or scattered radiation. Do not use the Laser System in any manner
other than as described in this User Manual; do not user the Laser System if you suspect
it is not functioning properly; do not use procedures other than those specied herein as it
may result in hazardous radiation exposure.
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 (included)
• Do not operate in the presence of explosive or ammable materials. Flammable anesthetics or
oxidizing gases such as nitrous oxide (N
and ammable solutions used for cleaning and disinfecting should be allowed to evaporate before
the laser is used. Attention should also be drawn to the danger of ignition of endogenous gases
• Doctor, patient, assistant, and all others in or entering the operatory must wear appropriate laser
protection eyewear. Always ensure that the laser protective eyewear is appropriate for the 940nm
wavelength (OD 5+). Prior to use always inspect the eyewear for pitting and/or cracking; do not
use if damaged
• Do not look directly into the beam or at specular reections
• Never direct or point the beam at a person’s eyes
• Always place the system into Standby mode before exchanging the ber delivery system,
Handpieces or disposable Tips
• Always ensure the proper laser parameters are set before the Epic Pro is used in a
clinical procedure
• Before leaving the unit unattended, return to the Home screen so the device cannot accidentally
emit laser energy. The laser can also be turned off at the power switch
O) and oxygen should be avoided. Solvents of adhesives
2
• Do not use the Epic Pro if the Fiber Optic Cable is damaged or broken
16
Epic Pro User Manual
6 Safety with the Epic Pro
LASER WARNING: Do not open the console housing at any time. Danger from optical
radiation may exist.
LASER WARNING: Do not aim the laser at metallic or reective surfaces, such as
surgical instruments or dental mirrors. If aimed directly at these surfaces the laser beam
will be reected and create a potential hazard.
CAUTION: This laser system 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: High temperatures produced in the normal use of this laser equipment may ignite
some materials (e.g., cotton wool when saturated with oxygen); solvents or adhesive and
ammable solutions used for cleaning and disinfecting should be allowed to evaporate before
the laser is activated.
CAUTION: Be aware that the metal / cannula on the Tips may become hot during use. Avoid
touching any tissue with the cannula.
6.2 SAFETY CLASSIFICATION
The following safety classications are applicable to the device:
• Laser Radiation – Class 4
• Aiming Beam – Class 3R
• Type of protection against electrical shock – Class 2
• Degree of protection against electrical shock – Type BF Class 1
• Not protected against water ingress – Ordinary Equipment
• Not suitable for use in presence of ammable anesthetic mixture
• Operation Mode – Continuous Wave and Pulse Modulation
• Wireless Footswitch – IPX6
Epic Pro User Manual
17
6 Safety with the Epic Pro
6.3 SAFETY FEATURES
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 side of the console
(Figure 6.1).
Power Switch
Power cord
SD Card Slot
USB Port (Service)
Remote Interlock
DC Power Supply
Figure 6.1
External Power
Supply/Adapter
Figure 6.2
18
CAUTION: Use only the power supply module and power cord supplied with the Epic Pro
laser system.
Epic Pro User Manual
6 Safety with the Epic Pro
ACCESS KEY CODE
The Access Key Code (888) prevents unauthorized use of the
system. It is activated every time the system is turned ON with the
Power Switch.
WIRELESS FOOTSWITCH
The Epic Pro 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.
REMOTE INTERLOCK
The Epic Pro console is equipped with a remote interlock feature
that links a door switch (optional) with the Epic Pro console and will
prevent the laser from ring when the sensor is triggered. To utilize
this safety feature, wire the remote interlock plug to a multi-conductor
wire and insert it into the opening at the side of the laser console
(Figure 6.3). Attach the other end of the wire to a door switch/
sensor; if the closed door is opened, the connection to the switch is
deactivated, immediately stopping the laser from ring. To override
this feature, don’t connect the plug to a door switch.
Figure 6.3
The remote interlock must be inserted into the console in order for the
laser to operate, whether or not the remote interlock function is used.
EMERGENCY STOP
Press the red Emergency Laser Stop button located on the bottom
left of the front panel to instantly turn off the laser console (Figure
6.4). The laser will immediately stop, the screen will go dark, and the
system will need to be completely powered OFF and then rebooted
to resume operation.
Figure 6.4
Epic Pro User Manual
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7 Installation and Set-Up
7.1 FACILITY REQUIREMENTS
• Electrical Supply (100-240V ~): 1.2A/0.5A, 50/60Hz
• Environmental Requirements: Temperature: 15-30 ºC
Humidity: 20-80%, Non-condensing
CAUTION: Do not position this equipment so that it is difcult to pull the plug from the power
source. To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
CAUTION: Do not stack this device with other equipment, as it could affect proper operation.
Always monitor this and any adjacent equipment to ensure they are operating normally.
7.2 SYSTEM SETUP
The Epic Pro is designed to be transportable between operatories using the built-in handle. Prior
to use, the laser must be properly set up as described in this user manual to ensure safe and
efcient functionality.
• Attach the base to the console by aligning the grooves on the bottom of the console to the grooves
on the base and then sliding the console from front to back until it clicks into place
• Press the lever of the ber management module and push it onto the right side of the console until
it clicks into place (Figure 7.1)
Handpiece
Lever-Fiber
Management Module
Fiber Optic Cable
Lever
20
Figure 7.1
Epic Pro User Manual
7 Installation and Set-Up
• Place the unit on a at surface in a clean, dry, and well-ventilated area
• Verify the power switch is in the OFF (O) position
• Connect the power supply/adapter to the laser console by orienting the
power supply plug as indicated by the symbol on the connector panel and
inserting it fully into the consoles power jack until snug (Figure 7.2). Plug
the power cord into the power supply and insert the distal end of the cord
into a wall outlet. Install the remote interlock, if used
CAUTION: Never touch the exposed pins and the patient simultaneously whenever the ber
management module is not attached to the console, but the laser is ON ( I ), to avoid electric
shock to the patient.
7.3 SURGICAL DELIVERY SYSTEM
CAUTION: The Fiber Optic Cable is detachable from the console; it cannot be autoclaved
but must always be disinfected between patients by following the procedure
outlined in section 10.3.
Figure 7.2
• Verify the power switch is in the OFF (O) position
• Remove the protective cap on the end of the ber connector
(the cap is reusable and needed when storing the ber)
• Attach the Fiber Optic Cable to the console by aligning the
center of the ber SMA connector with the center of the port
at the rear of the console, gently inserting the connector
into the port until snug, and turning it clockwise until secure
(Figure 7.3)
• To disconnect the Fiber Optic Cable from the console, turn
the SMA connector counterclockwise; when loose, pull
gently from the connector port
CAUTION: Do not connect or disconnect the ber while the laser is turned ON. Only
connect or disconnect the Fiber Optic Cable when the laser is turned OFF.
CAUTION: Never bend the Fiber Optic Cable at a sharp angle, as it can break the internal
optical ber.
Figure 7.3
CAUTION: Avoid direct contact with the proximal end of the Fiber Optic Cable SMA
connector. Contamination of the connector may result in laser damage.
Epic Pro User Manual
21
7 Installation and Set-Up
7.4 SURGICAL HANDPIECE ASSEMBLY
CAUTION: Handpieces are not sterile when sold and must be sterilized prior to initial use,
and cleaned and sterilized between patients. Refer to Section 10 for complete instructions on
cleaning and sterilization.
• Remove the protective red cap from the distal end of the ber shaft
• Connect the Handpiece to the Fiber Optic Cable assembly by pushing the Handpiece onto the ber
shaft until it clicks on and is secured (Figures 7.4, 7.5), without twisting
Fiber Shaft
Protective Cap
Handpiece
Collar
Figure 7.4: Connecting the Handpiece to the Fiber Optic Cable assembly
22
Figure 7.5: Surgical Handpiece Assembly fully assembled
Epic Pro User Manual
7 Installation and Set-Up
Disconnect the Handpiece from the Fiber Optic Cable assembly (Figure 7.6):
1. Take the Handpiece body in one hand and the shaft in the other,
2. Push the two buttons on the ber shaft,
3. Gently pull the Handpiece by the collar to separate it from the ber shaft without twisting.
Figure 7.6: Disconnecting the Handpiece from the Fiber Optic Cable
7.5 SINGLE-USE TIPS
Fiber Tips are single-use accessories available in 300μm and 400μm core diameters and in different
lengths; Tips are available non-initiated, for procedures that do not involve cutting tissue, such as
hemostasis, or pre-initiated, for all ablative procedures. The choice of which Tip to use is based on the
type of procedure/treatment mode. Refer to Section 9 for a details on procedures and related presets
and recommended Tips.
CAUTION: Tips are for one-time use only to avoid cross-contamination and are designed to
withstand only a single sterilization cycle. Always visually inspect the Tip prior to use to make
sure it is free of debris or damage
CAUTION: Be aware that the metal / cannula on the Tips may become hot during use. Avoid
touching any tissue with the cannula.
To connect the Tip, rst connect the Handpiece to the Fiber Optic Cable, then insert
the Tip rmly into the distal end of the Handpiece as far as it will go, and tighten by turning clockwise
until snug (Figure 7.7). Bend the metal cannula according to the specic procedure requirements
(Figure 7.10).
Remove the ber Tip by twisting it counterclockwise (Figure 7.8).
Epic Pro User Manual
23
7 Installation and Set-Up
CAUTION: To deliver proper laser operation, do not install Tips when the Handpiece is not
connected to the Fiber Optic Cable.
Figure 7.7: Insert the ber Tip into the Handpiece (only when the Handpiece is connected to
the Fiber Optic Cable) and twist clockwise until snug
Figure 7.8: Remove the ber Tip by twisting the Tip counterclockwise
Correct
Incorrect
Figure 7.9: Installing the Tip Figure 7.10: Bending
Correct
Incorrect
the Tip cannula
24
Epic Pro User Manual
7 Installation and Set-Up
7.6 WHITENING HANDPIECE (OPTIONAL ACCESSORY)
The Whitening Handpiece (Figure 7.11) is a reusable accessory intended for light activation of
bleaching materials in tooth whitening procedures.
It is equipped with disposable non-sterile protective
shields for single patient use (Figure 7.12) and
requires disinfection before and after each patient
treatment. This Handpiece cannot be
sterilized in the autoclave. Doing so will
damage its internal optics. For instructions on
how to disinfect the Whitening Handpiece, refer to
Section 10.
The disposable shield ts over the head of the Handpiece and must be
discarded after one-time use to avoid cross-contamination between
patients. Always wipe with alcohol prior to use.
Figure 7.11
The area of Laser Energy Output for the Whitening Handpiece is 35mm x
8mm = 2.8cm2 Spot Size.
Figure 7.12
To connect the Handpiece to the Fiber Optic Cable, push it onto the ber
shaft until it clicks on and is secured.
To disconnect the Handpiece from the Fiber Optic Cable:
• Take the Handpiece body in one hand and the shaft in another
• Press both buttons at the base of the ber shaft
• Gently pull the Handpiece from the collar without twisting to separate
7.6.1 WHITENING GEL
The Whitening Handpiece is designed to work with LaserWhite™ 20 Whitening Gel to achieve teeth
whitening. This item is sold separately, as a kit in packs of ve. 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 with the procedure.
Epic Pro User Manual
25
7 Installation and Set-Up
7.7 PAIRING THE FOOTSWITCH AND LASER
Epic Pro ships with the laser and Wireless Footswitch already
paired. However, if the wireless connection should fail at any
time, pairing will need to be re-established by taking the
following steps:
Make sure two (2) AAA fully charged batteries are installed in the
Footswitch.
Go to the System Settings Menu by pressing the Settings icon at
the bottom right of the screen. Select “Foot Pedal” and follow the
instructions displayed on the next series of screens.
1. Place the Footswitch on a at surface (Figure 7.13). Make
sure to wake-up the Footswitch if it has gone to sleep.
2. Use a coin or a at-head screw driver to loosen the battery
compartment cover on the side of the Footswitch without
completely removing it, until the blue LED turns off. If the
light stays on, loosen the compartment cover further, or
remove it altogether. Pairing will not be possible unless the
LED is off (Figure 7.14).
3. Release the Footswitch cover to expose the Footswitch
pedal; press down on the Footswitch pedal and hold.
4. While the Footswitch pedal is pressed, screw the battery
compartment cover back in place; continue pressing the
Footswitch pedal for an additional 5 seconds (Figure 7.15);
both the blue and green LEDs will turn on indicating the
Footswitch is ready to pair. Once the Footswitch Assembly
is ready to pair, you may release the Footswitch pedal
(Figure 7.16).
Figure 7.13
Figure 7.14
Figure 7.15
If pairing is successful, a “Pair Success” message appears on
the screen (only the blue LED will light up on the Footswitch);
press “Return to Home” to begin using the laser.
If the pairing operation times out, the screen will display the
message “Pairing Timed Out” and offer the option to “Try Again.”
If replacing an existing Footswitch, rst insert two (2) new AAA
batteries in the battery compartment, then follow the pairing
steps noted above.
26
Figure 7.16
Epic Pro User Manual
8 Operating Instructions
8.1 EPIC PRO INTERACTIVE DISPLAY
The Epic Pro interactive display allows for touch screen operation. All functions are activated by gently
touching the appropriate button on the display. Apply the disposable screen protector provided before
use to protect the screen from water and debris.
8.2 ICONS - DEFINITIONS
The Epic Pro Graphic User Interface (GUI) is the main part of the system control. It communicates
with the user through the interactive touchscreen display and is designed to provide easy and intuitive
interaction with the laser system while performing clinical procedures. Buttons on each screen allow
easy navigation of the GUI.
Favorites Home
Settings Back Button (Return to Previous Screen)
Advanced Mode Indicator Signal Strength Indicator (Wireless FS)
Settings modied and saved Settings modied but not saved
FS Battery Strength Indicator Decrease setting/Increase setting
System Information Service
Figure 8.1
Epic Pro User Manual
27
8 Operating Instructions
8.3 SYSTEM START-UP AND FUNCTIONS
Turn the power switch at the side of the console to the ON (I)
position. The system will boot up and display two screens in
quick succession – the rst displaying the “BIOLASE” logo
followed by one showing the Epic Pro name; after 3 seconds,
the system will display the “Welcome” screen.
8.3.1 LOGIN
Enter the three digit default access code (888) using the keypad
on the touchscreen. If the incorrect code is keyed, an “X”
appears in the window; wait 3 seconds for the “X” to clear, then
re-enter the correct code (Figure 8.3).
After logging in, the Epic Pro will display the Home Screen
(Figure 8.4).
Figure 8.2
While in the Login Screen, the Epic Pro cannot emit
laser energy.
CAUTION: Always check the aiming beam before
using the laser; the shape of the beam on a surface
should be symmetrical. This indicates that the
delivery system (Fiber Optic Cable, Handpiece) is
working properly. This check should be performed
with a non-initiated Tip only.
Figure 8.3
28
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8 Operating Instructions
8.3.2 HOME SCREEN
The HOME screen offers the user four operational options (Figure 8.4):
1. Quick Start: accesses the main treatment screen;
select the treatment parameters and start treatment
immediately.
2. Procedures: displays the Procedures menu; select from
a series of factory pre-programmed dental treatments and
settings.
3. Favorites: presents a list of the user’s favorite
procedures/settings; select the chosen procedure/settings
and begin treatment.
4. Settings: allows modication of user options and settings.
8.3.3 BASIC AND ADVANCED
Figure 8.4
The Epic Pro laser system offers two levels of operation, Basic and Advanced; usage is based on
specic procedure requirements and the user’s level of training and experience with the laser system.
• Basic: Only some of the pre-set parameters for any given procedure may be modied by the user
• Advanced: Allows the user to modify all the pre-set values for a procedure, even from a pre-set
procedure screen
The user may switch between levels by pressing the Advanced mode Indicator on the bottom right of
any procedure screen, or through the Settings menu.
Advanced
Mode
Epic Pro User Manual
Settings
Figure 8.5
29
8 Operating Instructions
8.3.4 TREATMENT MODES OF OPERATION
The Epic Pro soft-tissue laser is a versatile system that can be used for a variety of surgical and dental
soft-tissue procedures. It offers four treatment modes of operation:
• Continuous Wave (CW) Mode (Figure 8.6)
• Automatic Power Control (APC™) (Figure 8.7).
• Pulse Mode (Figure 8.8)
• Super Thermal Pulse (STP™) (Figure 8.9)
While on the main operating screen, the user has the option to toggle between treatment modes of
operation, i.e., APC, CW, Pulse and STP modes. Once a selection is made, the screen will display the
treatment parameter adjustment controls for the corresponding treatment mode.
NOTE: Whenever the mode is changed from the preset for a procedure, the banner at the top
of the screen will change from the procedure name to "Quick Start."
8.3.5 CONTINUOUS WAVE (CW) MODE:
CW treatment mode allows the user to adjust the power and the total time of ring, which can be set to
OFF to enable continuous ring with no time limit (Figure 8.6).
When CW is selected while in Basic user mode, the Epic Pro delivers continuous laser power output.
This can be increased or decreased incrementally by using the corresponding arrows, or by using the
slider at the bottom of the power window. The output power is adjustable from 0.1 to 25W.
The timer, or the length of time the laser will re continuously without stopping, can either be turned off,
or adjusted in increments up to 99 seconds.
30
Basic Mode
Figure 8.6
Epic Pro User Manual
8 Operating Instructions
8.3.6 AUTOMATIC POWER CONTROL (APC):
Epic Pro has a treatment mode of operation called Automatic Power Control (APC) in which the laser, in
continuous wave mode, converts light energy to thermal power at the tip (Figure 8.7). The cutting effect
in contact mode with a pre-initiated Tip is achieved not by the direct action of laser power, but rather by
the thermo-mechanical action of a "hot tip." Therefore, Tip temperature is a very important parameter
and is adjusted automatically to maintain a uniform temperature, resulting in constant and reliable
cutting, independent of speed of movement, tissue type, etc.
In the Advanced level of operation, the peak "not to exceed" upper power limit is adjustable from 3W to
25W. Thermal Level is adjusted automatically when Power Limit is modied within these parameters.
Advanced
Mode
Figure 8.7
CAUTION: APC procedures utilize only pre-initiated tips. Do not operate the Epic Pro
in APC mode with a non-initiated Tip; the system will not be able to reach the target
temperature and will temporarily operate at “Not to Exceed” power, which is much higher
than the power required for treatment, before displaying an error message.
CAUTION: The pulse width, peak and average power, and timer duration parameters are not
adjustable in the APC operating treatment mode.
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8 Operating Instructions
8.3.7 PULSE MODE:
When the Pulse operating treatment mode is selected, Epic Pro delivers repetitive pulses. The peak
laser power output can be increased or decreased by moving the power slider right or left. The peak
output power is adjustable from 3W up to 150W, depending on the Pulse duration selected (Figure 8.8).
In Pulse mode, pulse width (duration), peak power, average power, and the timer, or the length of time
the laser will re continuously without stopping, are all adjustable.
For each pulse duration (10μs – 100ms), there is a corresponding set of peak powers, and for each peak
power there is a corresponding average power setting.
When pulse width is adjusted, the corresponding default (minimum) peak power and (maximum) average
power are automatically selected and displayed by the system software.
32
Figure 8.8
Epic Pro User Manual
8 Operating Instructions
8.3.8 SUPER THERMAL PULSE:
In Super Thermal Pulse (STP) treatment mode, the device converts pulsed laser energy into pulses
of thermal power at the Tip, resulting in deeper penetration, more precise cutting, and less trauma to
tissue. These power bursts are emitted at a preset pulse width and repetition rate, while maintaining
a precise thermal level range at the tip. If the measured Tip temperature is higher than the desired
thermal level, the peak power of the laser pulses will be decreased to bring it down; if the measured Tip
temperature is lower than desired, the peak power will be increased accordingly. In this way, dynamic
control of the peak power ensures the stable temperature range of the Tip and, consequently, consistent
thermal effect on the target tissue.
CAUTION: STP procedures utilize only pre-initiated Tips. Do not operate the Epic Pro
in STP mode with a non-initiated Tip; the system will not be able to reach the target
temperature and will temporarily operate at “Not to Exceed” power, which is much higher
than the power required for treatment, before displaying an error message.
Epic Pro User Manual
Figure 8.9
33
8 Operating Instructions
8.3.9 QUICK START
Selecting Quick Start on the Home screen displays the main operating screen, with APC as the default
mode of operation (Figure 8.10). Quick Start allows the user to adjust treatment parameters, select the
treatment mode of operation (CW, APC, Pulse, or STP), choose a Tip suitable for the procedure, save
custom treatment settings, and, ultimately, re the laser using the displayed parameters. This screen
also offers the user the option to view system settings or procedure info, return to the previous screen,
or return to the Home screen. A graphical indicator displays the status of the wireless Footswitch
connection, while the laser defaults to Standby mode.
The main operating screen allows the user to toggle between APC, CW, Pulse, and STP modes, as
needed. Once a selection is made, the screen will display the treatment parameter adjustment controls
for the corresponding mode of operation for treatment.
Return to
Previous Screen
Home
Default
APC Mode
Tip
Selection
Wireless
Status
Save Settings
as Favorites
Advanced
Mode
Figure 8.10
34
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8 Operating Instructions
8.3.10 TIP SELECTION
From the main treatment screen, the user has the option of choosing a treatment Tip by pressing the
“Select Tip” button; the screen will display a selection of non-initiated and initiated Tips (Figure 8.11).
After Tip selection is completed, the system returns to the main operating screen which will now display
the Tip chosen (Figure 8.12)
If an attempt is made to re the laser without rst having selected a Tip, a message stating “Please
Select Tip” will appear on the screen and the laser will not re (Figure 8.13). Press the Select Tip button
and choose a Tip as described above, then press on the Footswitch to activate the laser.
In the Advanced level of operation, if a pre-initiated Tip is selected in APC or STP modes, the system
software returns to the main operating screen and displays a graph that plots the set Tip temperature
and real-time laser power during emission.
Figure 8.11
No Tip Selected
Epic Pro User Manual
Figure 8.12
Figure 8.13
35
8 Operating Instructions
The set Tip temperature and set power limit are displayed on the graph (Figure 8.14). While the laser is
emitting laser energy, the program will plot the Tip temperature feedback and real-time power value to
achieve the set Tip temperature.
Tip Temperature
Pre-initiated
Tip Selected
Feedback
Set Power
Feedback
Figure 8.14
CAUTION: Laser power output above the level shown on the touch screen may cause
unwanted tissue damage. The optical power output and pulse width must remain within
+/- 20% of the selected values while the laser is emitting energy.
8.3.11 TIP WARNING
In APC and STP modes, if a pre-initiated Tip inserted into the Handpiece is not properly initiated, the
Tip’s initiation has degraded after use, or a non-initiated Tip is inserted, a message will appear on the
screen when attempting to re the laser instructing the user to replace the Tip (Figure 8.15).
36
Figure 8.15
Epic Pro User Manual
8 Operating Instructions
8.3.12 PROCEDURE SELECTION
When Procedures is selected at the Home screen, seven treatment categories are displayed; the user is
able to select any one of these to access a specic pre-set procedure (Figure 8.16). However, settings
may be adjusted by the user, as needed, on the Main operation screen.
The recommended settings for each indication are preprogrammed at the factory and cannot be deleted.
However, they may be adjusted by the user, as needed, on the Main operating screen.
Once a pre-set procedure is chosen, the screen will display the treatment parameters, corresponding
mode (APC, CW, Pulse, or STP), and Tip selection established for treatment (Figure 8.17).
Epic Pro User Manual
Figure 8.16
Figure 8.17
37
8 Operating Instructions
8.3.13 CREATING A FAVORITES PROCEDURE
Any changes to the pre-programmed settings of a clinical procedure can be saved to Favorites by
pressing the heart button on the right side of the main operating screen (Figure 8.18):
• A full keyboard and text input eld are displayed; the input eld is limited to 30 characters, and may
be all alpha, all numeric, or a combination of the two. Type in a unique name for the procedure, or
leave as the default name set by the system
• Press Save. The settings are now stored in Favorites for use when needed. The program returns
to the main treatment screen with the new saved Favorite name displayed on the banner and the
Favorites button is highlighted (Figure 8.19)
• The customized procedure is now saved and can be accessed at any time from the Favorites screen
Select Save
Favorite Button
Favorites Locked
Select Save
Button
Figure 8.18
User Favorite Name
Displayed in Banner
Favorite Button
Highlighted
Figure 8.19
38
Epic Pro User Manual
8 Operating Instructions
If a Favorites procedure is selected, but any of the parameters that appear on the screen are changed,
the locked lock will change to an unlocked lock. The new settings may be saved by pressing the
Favorites icon at the bottom right of the display; the name of the procedure will remain the same unless
the modied settings are saved as a new Favorites.
To permanently delete a Favorites entry, press and hold the procedure name displayed on the screen
for 4 seconds. A screen requesting conrmation will always appear before the procedure is deleted
(Figure 8.20).
While in the Favorites selection screen, Epic Pro is in Standby and cannot emit laser energy.
Figure 8.20
Epic Pro User Manual
39
8 Operating Instructions
8.3.14 SELECTING A FAVORITES PROCEDURE
To access the Favorites screen, select Favorites on the Home screen; all custom procedures previously
saved will be displayed (Figure 8.21). This list is created solely by the user; it is empty by default when
the system is rst installed.
Select from the procedures listed. Once a selection is made, the Main operating screen is displayed
with the saved parameters ready for use. Navigate through the full list of Favorites by using the up and
down arrows.
Figure 8.21
8.3.15 READY MODE
Epic Pro will only emit laser energy when the Footswitch is pressed while the console is in Ready
mode. Press the Standby button on the bottom left of the screen to shift from Standby to Ready.
To return to Standby, press the Ready button on the bottom right of the screen.
Figure 8.22
40
Epic Pro User Manual
8 Operating Instructions
CAUTION: The aiming beam is on only when the laser is in Ready mode or when adjusting
the brightness of the beam through the Settings menu. If the aiming beam is not visible in
either instance, remove the Handpiece and conrm the beam is actually on by shining the
end of the Fiber Optic Cable on a plain, non-reective surface. DO NOT look directly at the
output end of the Fiber Optic Cable. If the aiming beam is not on, turn off the laser console,
then remove and re-install the Fiber Optic Cable (see Section 7.3). If the aiming beam is still
not detected, turn the laser console off and call BIOLASE Service.
LASER WARNING: Never point the laser at a person’s eyes. All persons present in the
operatory must wear appropriate protective eyewear when the laser is in use.
8.3.16 FIRING THE LASER
Pressing the wireless Footswitch while the laser is in Ready mode will cause the laser to re; a beeping
sound indicates that laser energy is present.
While the laser is ring, the main treatment screen disables all operator options, such as mode
and/or power setting adjustments, Tip selection, etc. The laser will continue to re until the Footswitch
is no longer pressed. Once the Footswitch is disengaged, the laser will stop emitting laser energy.
Press the Ready button to go to Standby.
Laser in Ready mode, foot pedal not pressed
Foot pedal pressed/ laser ring
Figure 8.23
Epic Pro User Manual
41
8 Operating Instructions
8.3.17 SYSTEM SETTINGS MENU
Pressing the Settings icon allows the user to make changes to the system parameters (Figure 8.24); this
menu can be reached from any screen displaying this Settings icon:
Adjust Pilot Aiming Beam
Adjust Sleep Timeout
Toggle Sort
Order Modes
Enter Wireless
Footswitch
Pairing Screen
Enter Language Selection
Adjust LCD Screen Brightness
Adjust System
Volume
Import User
Procedures
& Settings
Enter
Service Mode
Export User Procedures & Settings
Figure 8.24
42
Epic Pro User Manual
8 Operating Instructions
8.3.18 SYSTEM INFORMATION AND SOFTWARE UPDATES:
System information, such as the system serial number, software revision, GUI conguration, BootLoader
version, and hardware revision are displayed by pressing the system information icon located in the
upper right hand corner of any screen (Figure 8.25).
Figure 8.25
This screen also allows the user to implement the following changes (Figure 8.25.
Update Software: From time to time, BIOLASE may provide updated software with new
functionalities by supplying the user with a programmed SD card.
• Insert the card into the SD card slot and press the “Update Software” button to start the
upgrade process
• The screen will display a conrmation screen before initiating the update (Figure 8.26)
• If “Yes” is selected, the system will begin the update
• If “No” is selected, the system will revert to the System Information Screen
Epic Pro User Manual
Figure 8.26
43
8 Operating Instructions
If a valid application software le is detected on the SD card, the update is initiated. The system screen
will temporarily turn off. When completed, the system will reboot to the splash screen logo and Welcome
screen. The system beep is audible during the update process.
If no SD card is inserted, the SD card is improperly formatted, or the application software le on the
SD card is corrupted, the program will display an error message after the Update Software button is
selected by the operator (Figure 8.27). If this occurs, replace the SD card with a known good card and
a genuine copy of the application software le to be uploaded.
Figure 8.27
Update GUI: BIOLASE will provide the user with a programmed SD card whenever an update to the
GUI is necessary.
• Insert the card into the SD card slot and press the “Update GUI” button to start the upgrade process.
• The screen will display a conrmation screen before initiating the update (Figure 8.28).
• If “Yes” is selected, the system will begin the update.
• If “No” is selected, the system will revert to the System Information Screen
44
Figure 8.28
Epic Pro User Manual
8 Operating Instructions
If a valid GUI conguration le is detected on the SD card, the program will begin the update process.
The system screen will temporarily turn off and then reboot to a blue screen. The system memory is
erased and then replaced with the new GUI conguration le from the SD card. A status bar at the
bottom of the screen measures progress, while a number value on the top right corner displays the
percentage completed (Figure 8.29). When nished, the system will reboot to the splash screen logo
and Welcome screen. Updating the GUI takes approximately 20-25 minutes to complete.
Figure 8.29
If no SD card is inserted, the SD card is improperly formatted, or the GUI conguration le on the SD
card is corrupted, the program will display an error message after the Update GUI button is selected
by the operator (Figure 8.30. If this occurs, replace the SD card with a known good card and a genuine
copy of the GUI conguration le to be uploaded.
Figure 8.30
Epic Pro User Manual
45
8 Operating Instructions
Update Procedures: BIOLASE will provide the user with a programmed SD card if any updates to
the preset treatment parameters have made.
• Insert the card into the SD card slot and press the “Update Procedures” button to start the
upgrade process
• The screen will display a conrmation screen before initiating the update (Figure 8.31)
• If “Yes” is selected, the system will begin the update
• If “No” is selected, the system will revert to the System Information Screen
Figure 8.31
If a valid factory procedures conguration le is detected on the SD card, the program will begin
the software update. The system will display a blue screen briey, then display a status of “Update
Complete” when the routine is done. Upon completion, the system will reboot to the splash screen logo
and Welcome screen. Updating the factory procedures takes approximately 5 seconds to complete
(Figure 8.32).
Figure 8.32
46
Epic Pro User Manual
8 Operating Instructions
If no SD card is inserted, the SD card is improperly formatted, or the procedures conguration le on the
SD card is corrupted, the program will display an error message after the Update Procedures button is
selected by the operator (Figure 8.33). If this occurs, replace the SD card with a known good card and a
genuine copy of the factory procedures conguration to be uploaded.
Figure 8.33
CAUTION: Please contact BIOLASE Customer Care immediately if any of the above update
processes results in an error message.
Epic Pro User Manual
47
8 Operating Instructions
8.3.19 SERVICE MODE:
The Epic Pro software includes a service mode which is password-protected and may only be accessed
by trained service personnel. To return to the previous screen, press the “Back” button.
8.3.20 EXPORT AND IMPORT OF SETTINGS AND FAVORITES
Exporting settings to SD card: To preserve Favorite procedures and GUI settings when returning
the Epic Pro to the BIOLASE Service Center for repair, export the information to an external storage
device by inserting an Epic Pro SD card into the card slot on the left side of the console. Go to Settings
and select Export to begin the process. Before proceeding, a screen will appear which requires the user
to conrm the export command or cancel the operation (Figure 8.34). If cancel is selected, the system
will return to the Settings screen; if export is conrmed, the program will begin to download data to the
SD card.
While the export operation is in process, the screen will display a busy status followed by the results of
the export operation. A screen will appear either conrming the export was successful, or that it failed
(Figure 8.35). In either case, press OK to return to the main treatment screen.
48
Figure 8.34
Figure 8.35
Epic Pro User Manual
8 Operating Instructions
Importing settings from SD card: To transfer Favorites procedures and System settings to your
Epic Pro, insert the Epic Pro SD card containing the information into the card reader slot on the left side
of the console. Go to Settings and select Import to begin the process.
Before proceeding, a screen will appear which requires the user to conrm the import command or
cancel the operation (Figures 8.36). If cancel is selected, the program will return to the Settings screen;
if import is conrmed, the program will begin to download data to your Epic Pro console.
While the import operation is in process, the screen will display a busy status followed by the results of
the import operation. A screen will appear either conrming the export was successful, or that it failed
(Figure 8.37). In either case, press OK to return to the main treatment screen.
8.4 TURNING THE EPIC PRO OFF
To turn the Epic Pro off, return to the Home screen by pushing the Home icon, then press the Power
Switch on the side of the console to the OFF position (O).
Epic Pro User Manual
Figure 8.36
Figure 8.37
49
8 Operating Instructions
8.5 SYSTEM FLOW CHART
50
Figure 8.37
Epic Pro User Manual
9 Presets
The settings chosen for a procedure will contribute to its overall success. Recommended settings have
been pre-programmed into Epic Pro at the factory for different procedures in CW, APC, Pulse, and STP
treatment modes. These settings may be modied, within specic parameters, and saved as Favorites.
Always use clinical judgment when making adjustments to power, pulse repetition rate, and
treatment mode as may be nece ssary to compensate for variati ons in tissue composition, density,
and/or thickness.
NOTE: N/A means the parameter is not directly modiable by the user, but may be visible
on the screen.
9.1 RESTORATIVE
Treatment
Procedure
Regime
(Range)
Troughing STP 4
Soft-Tissue Crown
Lengthening
APC
Gingivoplasty STP 4
Thermal
Level
(Range)
2
(1- 5)
Power
Limit
(Range)
1.6 W
(1.6-3.6W)
Average
Power
(Range)
Pulse
Width
(Range)
Pulse
Energy
(Range)
N/A 0.1 ms N/A N/A
10W N/A N/A N/A N/A
5.6W
(3.2-6.4W)
N/A 1 ms N/A N/A
Timer
(Preset
Val ue)
Tip
Type
PI PRO 3
Pre-initiated
PI PRO 4
Pre-initiated
PI PRO 4
Pre-initiated
Epic Pro User Manual
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9 Presets
9.2 AESTHETIC
Procedure
Aesthetic
Contouring
Gingival
Contouring
Micro-
Coagulation
Teet h
Whitening
9.3 IMPLANT
Procedure
Treatment
Mode
(Range)
APC
APC
Thermal
Level
(Range)
2
(1- 5)
2
(1- 5)
Power
Limit
(Range)
Average
Power
(Range)
10W N/A N/A N/A N/A
10W N/A N/A N/A N/A
Pulse N/A N/A N/A N/A
CW N/A N/A
Treatment
Mode
(Range)
Thermal
Level
(Range)
Power
Limit
(Range)
7W
(3-7W)
Average
Power
(Range)
Pulse
Width
(Range)
Pulse
Energy
(Range)
3 J
(1.75-3.75)
Timer
(Preset
Val ue)
Single
Pulse
N/A N/A 30s
Pulse
Width
(Range)
Pulse
Energy
(Range)
Timer
(Preset
Val ue)
Tip
Type
PI PRO 4
Pre-initiated
PI PRO 4
Pre-initiated
E4
Non-initiated
Whitening
Handpiece
Tip
Type
Implant
Uncovering
Soft-Tissue
Contouring
9.4 PERIO
Procedure
Soft-Tissue
Pocket Reduction
Sulcular
Debridement
STP 6
STP 3
Treatment
Mode
(Range)
APC
Thermal
Level
(Range)
(1- 5)
(3.2-6.4W)
(3.2-6.4W)
2
Pulse N/A N/A
5.6W
5.6W
Power
Limit
(Range)
N/A 1 ms N/A N/A
6.4W 1 ms N/A N/A
Average
Power
(Range)
Pulse
Width
(Range)
Pulse
Energy
(Range)
Timer
(Preset
10W N/A N/A N/A N/A
2W
(1.6-3.6W)
2 ms
(1-10 m s)
N/A 10 s
Val ue)
PI PRO 4
Pre-initiated
PI PRO 4
Pre-initiated
Tip
Type
PI PRO 4
Pre-initiated
E4
Non-initiated
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Epic Pro User Manual
9 Presets
9.5 SURGICAL
Thermal
Level
(Range)
Procedure
Treatment
Mode
(Range)
Biopsy STP 8
Frenectomy STP 8
Operculectomy STP 8
Exposure of
Unerupted Tooth
STP 8
Hemostatis CW N/A N/A
9.6 ENDO
Power
Limit
(Range)
5.6W
(3.2-6.4W)
5.6W
(3.2-6.4W)
5.6W
(3.2-6.4W)
5.6W
(3.2-6.4W)
Average
Power
(Range)
Pulse
Width
(Range)
Pulse
Energy
(Range)
N/A 1 ms N/A N/A
N/A 1 ms N/A N/A
N/A 1 ms N/A N/A
N/A 1 ms N/A N/A
1.5W
(1- 5W)
1ms N/A 10s
Timer
(Preset
Val ue)
Tip
Type
PI PRO 4
Pre-initiated
PI PRO 4
Pre-initiated
PI PRO 4
Pre-initiated
PI PRO 4
Pre-initiated
E4
Non-initiated
Procedure
Treatment
Mode
(Range)
Thermal
Level
(Range)
Power
Limit
(Range)
Pulpotomy CW N/A N/A
9.7 ORAL LESIONS
Treatment
Procedure
Mode
(Range)
Aphthous Ulcers Pulse N/A N/A
Herpetic lesion Pulse N/A N/A
Thermal
Level
(Range)
Power
Limit
(Range)
Average
Power
(Range)
0.1W
(0.1-0.5W)
Average
Power
(Range)
1.6W
(1-3W )
1.6W
(1-3W )
Pulse
Width
(Range)
Pulse
Energy
(Range)
Timer
(Preset
Val ue)
N/A N/A 60s
Pulse
Width
(Range)
Pulse
Energy
(Range)
Timer
(Preset
1 ms N/A 30s
1 ms N/A 30s
Val ue)
Tip
Type
E4
Non-initiated
Tip
Type
E4
Non-initiated
E4
Non-initiated
Epic Pro User Manual
53
10 Cleaning, Disinfection, and Sterilization
10.1 CLEANING THE CONSOLE
Use the screen protectors provided to keep water and debris from contaminating the touchscreen, and
use a disinfectant to wipe down the console and Handpiece Holder after each procedure. Do not use
bleach or abrasive cleansers.
10.2 CLEANING AND STERILIZATION PROCEDURES,
HANDPIECE AND TIPS
CAUTION: Handpiece and Tips must be cleaned and sterilized prior to rst-time use.
Handpieces are reusable and must be cleaned and sterilized between patients to
avoid cross-contamination.
Tips are single-use only to avoid cross-contamination and are designed to
withstand only a single sterilization cycle; discard in a biohazard medical waste
sharps container after use.
The contamination control suggested for the Epic Pro Surgical Handpiece and Tips is steam sterilization.
However, before sterilization, the Epic Pro reusable Handpiece should be MANUALLY cleaned per the
following procedure.
CLEANING MUST BE PERFORMED WITHIN A MAXIMUM OF 1 HOUR AFTER THE
PROCEDURE AND A LWAYS PRIOR TO STERILIZATION.
STEP 1 - CLEANING PROCESS (HANDPIECE)
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 by qualied ofce personnel trained to perform the procedure.
Wear protective latex gloves when handling the contaminated delivery system.
1. After each use, carefully remove the tip from the Handpiece and discard in a biohazard medical
waste sharps container.
2. Carefully disconnect the Handpiece from the Fiber Optic Cable by taking the Handpiece body in
one hand and the shaft in the other, then pressing both buttons at the base of the ber shaft and
gently pulling the Handpiece by the collar to separate it from the shaft without twisting.
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.
54
Epic Pro User Manual
10 Cleaning, Disinfection, and Sterilization
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.
STEP 2 - STEAM STERILIZATION FOR SURGICAL HANDPIECE, SINGLE USE TIPS
The steam sterilization process is intended to destroy infectious microorganisms and pathogens.
CAUTION: Always perform the procedure immediately after cleaning and prior to use
and only use FDA-cleared (USA) or CE-marked (Europe) sterilization accessories,
i.e., sterilization pouch and autoclave tray. The product packaging is not suitable for
steam sterization.
• Place the Handpiece and ber 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 10.1
• Once the cycle is completed, remove the tray and let each sterilized item cool and dry. The
H a n d p i e c e a n d T i p s m u s t r e m a i n i n t h e s t e r i l i z a t i o n p o u c h e s u n t i l u s e d i n
order to maintain sterility
• Reassemble the Handpiece by pushing the Handpiece onto the ber shaft until it clicks into place
and is secured (See Section 7)
Type of Sterilizer Temperature Minimum Time Drying Time
121°C ( 250°F) 30 minutes
Gravity Displacement
Dynamic-Air-Removal
(Pre-Vacuum)
132°C (270°F) 15 minutes
132°C (270°F)
4 minutes 20 – 30 minutes
134°C (EU only)
15 – 30 minutes
Epic Pro User Manual
Figure 10.1
55
10 Cleaning, Disinfection, and Sterilization
10.3 DISINFECTING THE FIBER OPTIC CABLE
Wear protective latex gloves when handling the contaminated delivery system.
Always disinfect the ber between patients by wiping it completely 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. DO NOT AUTOCLAVE.
10.4 DISINFECTING THE WHITENING HANDPIECE
The Whitening Handpiece is sold with disposable non-sterile protective shields. Neither the
Handpiece nor the shields can be sterilized in the autoclave.
To disinfect the Whitening Handpiece, wipe it down with gauze and isopropyl alcohol.
Always wipe the disposable shield with alcohol prior to use. Discard after single use; these are intended
for one-time use only and should never be reused to prevent cross-contamination.
56
Epic Pro User Manual
11 Maintenance and Calibration
11.1 ANNUAL CALIBRATION
Epic Pro should be calibrated every 2 years in order to maintain the required accuracy of output power
versus displayed power. Calibration can be performed at a certied depot repair facility. Call BIOLASE
Service at 1-800-321-6717 or your Authorized Service representative for instructions on how to return
the laser for service.
11.2 CHANGING THE WIRELESS
FOOTSWITCH BATTERIES
The wireless Footswitch is powered by two AAA batteries. When the
batteries are low, the green LED on the Footswitch cover will blink
and a warning message will appear on the screen indicating that the
batteries need to be replaced.
To replace the batteries:
1. Close the Footswitch cover (Figure 11.1).
2. Use a coin to remove the battery compartment cover on the side
of the Footswitch by turning it counter-clockwise (Figure 11.2).
3. Remove the depleted batteries from the compartment and insert
two new batteries (Figure 11.3).
4. Replace the battery compartment cover; turn clockwise to
secure.
In the unlikely event that pairing of the laser console and Footswitch
is disrupted when the batteries are replaced, the message
‟FOOTSWITCH NOT DETECTED“ will appear on the touchscreen;
re-establish pairing by following the instructions outlined in Section 7.7.
Replace both batteries at the same time; do not mix old and new
batteries. Old batteries must be discarded as regulated;
do not throw them in a trash bin.
To ensure the longevity of the Footswitch’s battery power, only use
BIOLASE-supplied batteries as replacements (P/N 6400463); these
are industrial-grade and under normal use have a longer life than
conventional AAA batteries.
Figure 11.1
Figure 11.2
Figure 11.3
Epic Pro User Manual
57
11 Maintenance and Calibration
11.3 FIBER CABLE LENS INSPECTION AND CLEANING
11.3.1 LENS INSPECTION PROCEDURE
The lens is at the distal end of the Fiber Optic Cable (Figure 11.4); this is where debris may accumulate
with use. To inspect the lens, take the following steps:
CAUTION: DO NOT inspect the lens while the laser system is powered on; the aiming
beam or laser beam can permanently impair vision if aimed at the eye.
CAUTION: Never reuse single-use Tips as this will damage the Fiber Optic Cable lens.
1. Remove the Handpiece from the ber shaft.
2. Inspect the distal end of the ber using a magnier or loupes with at least
10X magnication (Figure 11.5).
3. Inspect the lens.
11.3.2 CLEANING THE LENS:
If debris or dark spots are observed on the lens, clean the window using the
procedure outlined below.
1. Always use a new, unused Microbrush to clean the
lens provided (Figure 11.6).
2. Dip the Microbrush in isopropyl alcohol.
3. Gently rub the lens surface to remove debris or dark spots (Figure
11.7 ) .
4. Repeat as nee ded using a new M icr obr ush each time
until no residue appears on the swab.
Figure 11.4
Figure 11.5
Figure 11.6
58
CAUTION: If blemishes appear below or inside the lens,
contact BIOLASE or your authorized service representative
to order a replacement lens.
Figure 11.7
Epic Pro User Manual
12 Troubleshooting
If the system detects a system fault while on the main treatment screen, an Error button appears in the
bottom left hand corner of the screen. Pressing the button will display information related to the error
(Figure 12.1). It will not be possible to enter Ready or Standby modes until the fault is resolved.
If after following the directions on the screen the error does not clear, please call your local BIOLASE
Service Representative for assistance.
Error Message Reason(s) Fix
1 Door interlock
disconnected
2 Laser overheating Error Code: 2
3 Laser temperature
too low
Error Code: 1
Insert door interlock
Laser overheating.
Wait until cools
down. Reduce
room temperature
if possible
Error Code: 3
Laser temperature
sensor malfunction.
Please contact the
manufacturer
Remote interlock
connector not
inserted on left side
panel of system
Laser temperature
detected greater
than 50°C
Laser temperature
detected less than
10°C
Insert remote interlock
Allow system to cool for
5-10 minutes. If problems
persist, contact the
manufacture for evaluation
Allow system to reach
ambient room temperature.
If problems persist,
contact the manufacturer
for evaluation
Figure 12.1
4 Power transistor
overheating
Epic Pro User Manual
Error Code: 4
Device overheating.
Please contact the
manufacturer
Power transistor
temperature detected
greater than 75°C
Allow system to cool
for 5-10 minutes. If
problems persist,
contact the manufacturer
for evaluation
59
12 Troubleshooting
Error Message Reaso n(s) Fix
5 Power transistor
temp too low
6 Optical Feedback
Out of Range
7 Voltage Reference Error Code 7:
8 Footswitch pressed
while not in ready
state
9 Fiber Not Detected Error Code 9:
Error Code 5:
Internal temperature
sensor malfunction.
Please contact
the manufacturer
Error Code 6:
Power Calibration
Failed. Please
contact manufacturer
Voltage reference
failure
Error Code 8:
Release footswitch.
If it is not pressed,
replace the Footswitch
Fiber not detected.
Insert treatment ber
to resume
Power transistor
temperature
detected less
than 10°C
Optical feedback
detected a
value out of the
calibrated range
Voltage feedback
out of range
Footswitch pressed
down while entering
Ready Mode from
Standby Mode
Fiber not inserted
into system
Allow system to reach
ambient room temperature.
If problems persist,
contact the manufacturer
for evaluation
Contact the manufacturer
Contact the manufacturer
Release the Footswitch
and attempt to re-enter
Ready Mode
Fully insert ber SMA
connector into the optical
port a s described in
Section 7.3. If problem
persist contact the
manufacturer for evaluation
10 Laser current
exceeds set value
11 APC Temperature
Feedback
60
Error Code 10:
Internal error with
current setting
Error Code 11:
Cannot achieve
set temperature
Current feedback
detected current out
of acceptable range
Temperature
feedback setting
was not able to be
veried by software
within 5 seconds
of emission
Contact the manufacturer
Conrm a pre-initiated tip
is installed to the end of
ber. Conrm pre-initiated
tip did not lose its initiated
state. If problems persist,
contact the manufactuer
for evaluation
Epic Pro User Manual
12 Troubleshooting
Error Message Reason(s) Fix
12 Calibration
Data Corrupted
13 Optical
module overheating
14 Optical module
temperature too low
16 Factory Procedure
Data Corrupted
Error Code 12:
System calibration
data stored in internal
memory has been
compromised
Error 13:
Optical module
overheating
Error 14:
Optical module
temperature too low
Error 16:
Factory procedure
data corrupted.
Please contact the
manufacturer
System calibration
data could not be
veried for integrity
Optical temperature
detected greater
than 50°C
Optical temperature
detected less
than 10°C
System
memory corrupted
Contact the manufacturer
Allow system to cool for
5-10 minutes. If problems
persist, contact the
manufactuer for evaluation
Allow system to reach
ambient room temperature.
If problems persist,
contact the manufacturer
for evaluation
Copy valid procedures le
onto SD card and attempt to
Update Procedures through
System Information screen
17 System
Clock Failure
18 Cap Voltage Error Error 18:
Er r o r 17:
System Clock Failure
Main controller board
capacitor voltage out
of range
Main controller board
system clock not
operating correctly
Main controller
board capacitor's
voltage is out of
acceptable range
Contact the manufacturer
Contact the manufacturer
Figure 11.2
Epic Pro User Manual
61
Appendix A Labels
PRODUCT
IDENTIFICATION LABEL:
LOCATION:
Bottom of laser console
LASER APERTURE WARNING:
LOCATION:
Back of console
FCC AND IC ID LABEL:
LOCATION:
Bottom of wireless Footswitch
Epic Pro
Diode Laser System
7410004
XXXXXXX
YYYY-MM
Input: 100-240V~, 50/60Hz, 1.2A/0.5A
Output: +18VDC, 5.55A
Contains: FCC ID: OA3MRF24J40MA
Contains: IC ID: 7693A-24J40MA
Rx Only
Made in USA
62
Epic Pro User Manual
Appendix A Labels
5400635 Rev. A
MANUFACTURER
CATALOG/PART NUMBER
PRODUCT SERIAL NUMBER
DATE OF MANUFACTURE
LASER WARNING SYMBOL:
Indicates the system contains a laser
LOCATION:
Back of laser console
FCC DECLARATION OF CONFORMITY:
Electromagnetic interference is under limits
approved by the Federal Communications Commission
R X ON LY
(US) Federal Law restricts this device to sale by or
on the order of a denist or other licenced dental practitioner
LASER EXPLANATORY AND CERTIFICATION LABEL:
LOCATION:
Back of console
ELECTRICAL SHOCK HAZARD
RX Only
CAUTION: Invisible and visible laser radiation. Avoid eye or skin contact
exposure to direct or scattered invisible radiation. Class 4 laser product.
• Pulse Width: 10µs - 100ms
Rayonnement laser visibles et invisibles. Éviter l’exposition des yeux ou de
la peau pour diriger ou la radio thérapie épars produit laser de classe 4.
IEC 60825-1: 2014 • IEC 60601-2-22: 2007+A1: 2012
This product complies with FDA performance standards for laser products except for
deviations pursuant to Laser Notice No. 50, dated 24 June, 2007.
• Max. C.W.: 25W
• Aiming: 5mW Max. C.W. @ 450 - 680nm
• Pulse Rate: up to 20kHz• Wavelength: 940 ± 20nm
• Pulse Energy: 3.0J Max
Epic Pro User Manual
63
Appendix A Labels
ETL LABEL:
Meets Product Safety Standards
LOCATION:
Back of console
NON-IONIZING RADIATION:
Device includes an international radiator (Bluetooth)
REFER TO USER MANUAL
TYPE BF APPLIED PART:
The applied part is not conductive to the patient
FCC COMPLIANCE NOTICE:
LOCATION:
Bottom of wireless Footswitch
FOOTSWITCH PRODUCT ID LABEL:
LOCATION:
Bottom of Footswitch
INGRESS PROTECTION CODE:
The Footswitch is water-resistant, protected
splashes of water
LASER WARNING SIGN
Included in the welcome kit; must be placed outside
of the operatory whenever the laser system is in use.
Wireless Footswitch
MC
IPX6
64
Epic Pro User Manual
Appendix A Labels
INVISIBLE AND VISIBLE LASER RADIATION
SINGLE USE ONLY – DO NOT REUSE
(SINGLE-USE ACCESSORIES)
WEEE (WASTE ELECTRICAL AND ELECTRONIC:
Recycle lithium ion battery as regulated. Do not throw in trash bin.
THIS END UP
LOCATION:
Outer carton (shipping box)
FRAGILE: HANDLE WITH CARE
LOCATION:
Outer carton (shipping box)
KEEP DRY
LOCATION:
Outer carton (shipping box)
TEMPE R ATURE LIM ITATI ONS
LOCATION:
Outer carton (shipping box)
HUMIDITY LIMITATIONS
LOCATION:
Outer carton (shipping box)
ATMOSPHERIC PRESSURE LIMITATIONS
LOCATION:
Epic Pro User Manual
Outer carton (shipping box)
65
Appendix B: Tip Guide
NON-INITIATED
Tip Name Diameter Length (mm) Application Part Number
4
mm
7
mm
9
mm
4
mm
7
mm
9
mm
E4-4 400µm 4 Surgical 7400016
E4-7 400µm 7 Perio
7410003/
7400019
E4-9 400µm 9 Perio 7410019
E3-4 300 µm 4 Surgical 7400017
E3-7 300µm 7 Perio
7410002/
7400020
E3-9 300µm 9 Perio 7400020
PRE- IN ITI ATED
Name Diameter Length Application Part Number
PI PRO 3-3 300µm 4mm Surgical 7430001
PI PRO 4-4 400µm 4mm Surgical 7430002
NOTE: All BIOLASE Tips for diode lasers are sold non-sterile and are for single-use only.
See Section 10 in this User Manual for cleaning and sterilization instructions.
66
Epic Pro User Manual
Appendix C Accessories/Spare Parts
PART NO. DESCRIPTION
6400105 Surgical Handpiece
2400276/2400278 Laser Safety Glasses
6400629 Fiber Optic Cable
6400622 Disposable Screen Protector (20/Pack)
6400616 Remote Interlock Plug
2400043 Power Cord (US)
2400055 Power Cord (Int'l)
6201667 Wireless Footswitch
7400022 Whitening Handpiece
6400463 Battery Pack, Footswitch (2 x AAA)
6400180 Disposable Shields for Whitening Handpiece (30/Pack)
7400030 Laserwhite20 Whitening Gel Kit (5/Pack)
7400063 Laserwhite 20 whitening Gel Kit (Canada only)
7400017 Surgical EZ Tip, E3-4mm (non-initiated), 30-Pack
7400016 Surgical EZ Tip, E4-4mm (non-initiated) 30-pack
7400020 Perio EZ Tip Combo Pack, E3-7mm, E3-9mm (non-initiated) 30-pack
7400019 Perio EZ Tip Combo Pack, E4-7mm, E4-9mm (non-initiated) 30-pack
7410002 Perio EZ Tip, E3-7mm (non-initiated) 30-pack
7410003 Perio EZ Tip, E4-7mm (non-initiated) 30-pack
7430001 Pi Pro Tip, Surgical, A3-4mm (pre-initiated) 20-pack
7430002 Pi Pro Tip, Surgical, A4-4mm (pre-initiated) 20-pack
5400637 Danger Warning Sign
Epic Pro User Manual
67
Appendix D Electromagnetic Compatibility
APPENDIX D: ELECTROMAGNETIC COMPATIBILITY
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 (US), 2400055 (Int’l).
Footswitch: Wireless, BIOLASE p/n 6201667.
WARNING: The use of accessories, other than those specied, 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 Pro diode laser system.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The Epic Pro diode is intended for use in the electromagnetic environment specied below.
The customer or the user of the Epic Pro diode should assure it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
The Epic Pro diode laser uses RF energy only for its
RF emissions
CIS PR 11
RF emissions
CIS PR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
Group 1
Class A
Class A
Class A
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
The Epic Pro 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.
IEC 61000-3-3
68
Epic Pro User Manual
Appendix D Electromagnetic Compatibility
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Epic Pro diode laser is intended for use in the electromagnetic environment specied below. The
customer or the user of the Epic Pro diode should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
IEC 60601
test level
± 6 kV contact
± 8kV air
Continuous level Electromagnetic environment - guidance
± 6 kV contact
± 8kV air
Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material, relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
IEC 61000-4-11
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV differential
mode
± 2kV common
mode
<5% Ur (>95%
dip in UT) for 0.5
cycle
40% Ur (60%
dip in UT) for 5
cycles
70% Ur (30%
dip in Ur) for 25
cycles
± 2 kV for power
supply lines
N/A
± 1 kV differential
mode
± 2kV common
mode
<5% Ur (>95%
dip in UT) for 0.5
cycle
40% Ur (60%
dip in UT) for 5
cycles
70% Ur (30%
dip in Ur) for 25
cycles
Main power quality should be
that of a typical commercial or
hospital environment.
Input/output that does not apply because
the Footswitch cable length is less than
3 meters.
Main power quality should be
that of a typical commercial or
hospital environment.
Main power quality should be that
of a typical commercial or hospital
environment. If the user of the Epic
Pro diode requires continued operation
during power main interruptions, it is
recommended that the Epic Pro diode
be powered from an uninterrupted
power supply.
<5% Ur (>95%
dip in Ur) for 5
seconds
Power frequency
(50-60 Hz)
magnetic eld
IEC 61000-4-8
NOTE: Ur is the A.C. mains voltage prior to applications of the test level.
Epic Pro User Manual
3 A/m 3 A/m Power frequency magnetic elds should
<5% Ur (>95%
dip in Ur) for 5
seconds
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
69
Appendix D Electromagnetic Compatibility
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Epic Pro is intended for use in the electromagnetic environment specied below. The customer or
the user of the Epic Pro should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC61000-4-3
IEC 60601
test level
3 Vrms
150 kHz to
80 GHz
3V/m
80 MHz to
2.5 GHz
Continuous level Electromagnetic environment - guidance
3 V
3Vm
Portable and mobile RF communications
equipment should be used no closer
to any part of the Epic Pro 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 maxi mum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d
is the recommended separation
distance in meters (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic
site survey,
compliance level in each frequency
range.
Interference may occur in the vicinity
of equipment marked with the following
symbol:
a
should be less than the
b
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 af fected by
absorption and reection from structures, objects, and people.
70
Epic Pro User Manual
Appendix D Electromagnetic Compatibility
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Epic Pro diode laser is intended for use in the electromagnetic environment specied below. The
customer or the user of the Epic Pro diode should assure that it is used in such an environment.
Immunity test
A. Field strengths from xed 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 xed RF
transmitters, an electromagnetic site survey should be considered. If the measured eld strength
in the location in which the Epic Pro diode laser is used exceeds the applicable RF compliance
level above, the Epic Pro 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 Pro diode laser.
B. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V1] V/m.
IEC 60601
test level
Continuous level Electromagnetic environment - guidance
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE EPIC DIODE LASER
The Epic Pro 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 Pro diode can help prevent
electromagnetic interferences by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Epic Pro diode as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter M
Rated maximum output
power of transmitter W
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.
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
NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects, and people.
Epic Pro User Manual
71
Appendix E Wireless Equipment Statement
APPENDIX E: WIRELESS EQUIPMENT COMPLIANCE STATEMENT
This statement applies only to the wireless portion of the device:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. 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
FCC ID OA3MRF24J40MA
IC ID 7693A-24-24J40MA
Type of Radio Equipment Low Power Device (2400-2483.5 MHz)
Equipment Type Radio Equipment (RE)
Min Power 475 uW
Max Power 475 uW
Field Strength 92dBuV
72
Epic Pro User Manual
biolase.com
BIOLASE, INC.
4 Cromwell
Irvine, CA 92618 USA
Telephone: (888) 424-6527
Telephone: (949) 361-1200
Fax: (949) 273-6687
Service: (800) 321-6717
EU REPRESENTATIVE
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert Germany
+49 6894 581020
www.mt-procons.com
MADE IN THE USA
MADE IN THE USA
©2017 BIOL ASE, Inc. All r ights re served.
Epic Pro, Epic X, Epic , iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpi ece, Co mfor tPulse, WaterLase, and WaterLase i Plus are either trademarks or
registe red trademarks of BIOL ASE, Incorporated in the United States and/or other co untries. All ot her trademarks are propert y of their registered owners.
Subject to chang e without notic e.
5400638 Rev. A
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