Biolase Epic Hygiene User manual

5400112 Rev A Epic Hygiene User Manual
MADE IN THE USA
©2019 BIOLASE, Inc. All rights reserved.
Epic Pro, Epic X, Epic Hygiene, Epic, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece, ComfortPulse, WaterLase, and WaterLase iPlus are either trademarks or
registered trademarks of BIOLASE, Incorporated in the United States and/or other countries. All other trademarks are property of their registered owners. Subject to change
without notice.
MADE IN THE USA
biolase.com
BIOLASE, INC.
4 Cromwell
Irvine, CA 92618 USA
Telephone: [phone]
Telephone: [phone]
Fax: [phone]
Service: [phone]
EU REPRESENTATIVE
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert Germany
[phone]
www.mt-procons.com
19-1703 Epic H UserManual_Cover-r1.indd 1 11/18/2019 12:32:22 PM

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Epic Hygiene User Manual
1 INTRODUCTION ........................................................................................................... 6
4 SPECIFICATIONS ........................................................................................................ 10
4.1 General ....................................................................................................................................... 10
4.2 Electrical .....................................................................................................................................10
4.3 Laser. ......................................................................................................................................... 10
4.4 Other Light Sources ....................................................................................................................10
5 EQUIPMENT DESCRIPTION .......................................................................................11
5.1 System Components ..................................................................................................................11
5.2 General .......................................................................................................................................12
Base Console ..............................................................................................................................13
Fiber Delivery System .................................................................................................................13
Handpiece ...................................................................................................................................13
Wireless Footswitch .................................................................................................................... 14
6 SAFETY WITH THE EPIC HYGIENE ........................................................................... 15
6.1 Safety Instructions ..................................................................................................................... .15
6.3 Safety Features .......................................................................................................................... 17
3
Contents
6.2 Safety Classification....................................................................................................................16
Control Button..............................................................................................................................13
3 CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS .......................................7
3.1 Contraindications ....................................................................................................................... ...7
3.2 Warnings and Precautions ......................................................................................................... ..7
Prescription Statement ............................................................................................................... ...7
Training ........................................................................................................................................ ..7
Eyewear ...................................................................................................................................... ...8
Anesthesia ..................................................................................................................................... 8
Adjacent Structures .................................................................................................................... ...8
Suction ........................................................................................................................................... 8
Plume Removal .......................................................................................................................... ...8
Treatment, Technique and Settings ............................................................................................. ..9
Clinical Environment ...................................................................................................................... 9
2 INDICATIONS FOR USE ................................................................................................7

4Epic Hygiene User Manual
Energy Monitor ............................................................................................................................... 17
System Monitor ............................................................................................................................... 17
Power Switch .................................................................................................................................. 17
Control Button ................................................................................................................................. 17
Wireless Footswitch ........................................................................................................................ 18
Remote Interlock ............................................................................................................................ 18
Emergency Stop ............................................................................................................................. 18
Functional Display .......................................................................................................................... 18
7 INSTALLATION AND SETUP ..........................................................................................19
7.1 System Setup ................................................................................................................................ 19
7.2 Connecting the Fiber Optic Cable................................................................................................... 19
7.3 Handpiece Assembly .................................................................................................................... 20
7.4 Single - Use Tips ........................................................................................................................... 21
7.5 Operation -Turn on the Epic Hygiene ............................................................................................ 23
7.6 Settings Screen ............................................................................................................................. 24
7.7 Pairing the Footswitch to the Laser Console ................................................................................. 24
7.8 Control Button ................................................................................................................................ 25
7.9 Entering Ready or Standby Modes ............................................................................................... 26
7.10 Ready Mode ................................................................................................................................ 26
7.11 Wireless Footswitch .................................................................................................................... 26
7.12 Peak Power Display .................................................................................................................... 27
7.13 Pulse Mode Selection .................................................................................................................. 27
7.14 Using the Epic Hygiene Touch Screen Display ................................................................. .......... 28
7.15 Procedures Button ....................................................................................................................... 29
7.16 Turn the Laser Console Off ......................................................................................................... 29
8 CLINICAL APPLICATIONS ............................................................................................ 30
8.1 Overview.... ................................................................................................................................... 30
8.2 Table of Pre-Programmed Hygiene Settings ................................................................................ 30
Contents
Access Key Code............................................................................................................................. 17
Facility Requirements...................................................................................................................... 19

Epic Hygiene User Manual
9 MAINTENANCE ............................................................................................................. 31
9.1 Daily Maintenance ......................................................................................................................... 31
9.2 Cleaning and Sterilization Procedures .......................................................................................... 31
Step 1- Cleaning Process - Handpiece ......................................................................................... 32
Step 2- Sterilization Process - Handpiece ...................................................................................... 32
Step 3- Disinfecting the Fiber Optic Cable ..................................................................................... 33
9.3 Fiber Optic Lens Inspection and Cleaning ................................................................................... 34
9.4 Installing/Replacing the Console Battery Pack................................................................................ 35
9.5 Changing the Wireless Footswitch Batteries ............................................. .................................... 36
9.7 Storage .......................................................................................................................................... 37
10 CALIBRATION................................................................................................................ 38
11 SOFTWARE SPECIFICATION .......................................................................................38
12 TROUBLESHOOTING ................................................................................................... 39
APPENDIX A - TIP GUIDE .................................................................................................. 41
APPENDIX C - ACCESSORIES ......................................................................................... 43
APPENDIX D- LABELING ................................................................................................. 44
APPENDIX E - SAFETY - LITHIUM-ION BATTERY PACKS ............................................ 48
APPENDIX F - ELECTROMAGNETIC COMPATIBILITY ................................................... 50
APPENDIX G - WIRELESS EQUIPMENT COMPLIANCE STATEMENT ...........................54
5
Contents
9.6 Transportation ...............................................................................................................................37
Lens Inspection Procedure...................... ...................................................................................... .34
Cleaning the Lens.......................................................................................................................... .34
APPENDIX B - TIP INITIATION...........................................................................................42

6Epic Hygiene User Manual
1 Introduction
The Epic™ Hygiene is a dental laser intended for the treatment of specific soft-tissue conditions, in
particular for the ablation, vaporization and coagulation of oral soft-tissue, including marginal and
interdental gingival and the epithelial lining of free gingiva.
Epic Hygiene utilizes a solid state diode as a semiconductor source for invisible infrared radiation. The
energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and
the other end to the Handpiece. Various types of single use, disposable tips are designed and optimized
for different applications. The device is activated by means of a wireless footswitch.
This is a prescription device that is indicated for professional use only by dentists and other licensed
dental professionals, such as dental hygienists, where permitted by state or local practice regulations.
The use of this device requires proper clinical and technical training. This manual provides instructions
for those professionals that have completed the appropriate training.
When used and maintained properly, the Epic Hygiene 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.

Epic Hygiene User Manual
• Hemostasis and coagulation
•Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
•Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket
•Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft-tissue in the periodontal
pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth,
attachment loss and tooth mobility).
•Laser soft-tissue curettage
7
2 Indications for Use
3 Contraindications, Warnings, and Precautions
3.1CONTRAINDICATIONS
All clinical procedures performed with Epic Hygiene must be subjected to the same clinical judgment and
care used with traditional techniques. Patient risk must always be considered and fully understood before
clinical treatment. Practitioners must completely understand the patient’s medical history prior to treatment
and exercise caution for general medical conditions that might contraindicate a local procedure; such
conditions may include, but are not limited to, allergy to local or topical anesthetics, heart disease
(including pacemakers and implantable defibrillators), lung disease, bleeding disorders, sleep apnea, an
immune system deficiency, or any medical conditions or medications that may contraindicate the 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.
3.2 WARNINGS AND PRECAUTIONS
PRESCRIPTION STATEMENT
U.S. Federal Law restricts this device to sale by or on the order of a dentist or other licensed dental
practitioners.
TRAINING
Only licensed dental professionals who have reviewed and understood this User Manual and received
proper training should use this device within their scope of practice. Clinicians must use their own clinical
judgment and professional knowledge to determine all aspects of treatment, including technique, power
settings, pulse interval, duration, etc. BIOLASE assumes no responsibility for parameters, techniques,
methods, or results.

Epic Hygiene User Manual
EYEWEAR
Doctor, patient, assistant, and all others inside or entering the operatory must wear appropriate laser
protective eyewear suitable for the 980 nm ± 10 nm wavelength, OD4 or greater (DIR LB4),
whenever the laser is in use. Prior to use, inspect the eyewear for pitting and/or cracking. Replace
if damaged; do not use.
CAUTION: The specifications for the protective eyewear provided with the Epic Hygiene
laser system are marked on the side of the glasses. Always check the eyewear
specifications marked on the glasses to ensure they offer the required protection for
the specific laser wavelength.
For additional information, refer to the instructions for use provided with the glasses.
8
3 Contraindications, Warnings, and Precautions
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 noted, adjust settings, apply anesthesia, or cease
treatment if required.
ADJACENT STRUCTURES
Always be aware of adjacent structures and substructuresduringuse.Beextremelycarefulnotto
inadvertentlypenetrateorablateunderlyingoradjacent tissues. Do not direct energy toward hard-
tissue such as tooth or bone. Do not direct energy towards amalgam, gold or other metallic surfaces.
Do not direct energy towards cements or other fillingmaterials.Exerciseextremecautionwhenusing
thisdeviceinareassuchaspockets,cavitiesorchannels such as third molar sockets, where critical
structures (i.e. nerves, vessels) could be damaged. Do not proceed with using the laser if visibility is
limited in these areas.
SUCTION
Usehigh-speedsuctionasrequiredtomaintainaclearfieldofvisionduringtreatment.Donotfirethe
laser 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 filtered masks, and other protective equipment is
used at all times during the laser procedure.

9
Epic Hygiene User Manual
3 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 utilized (e.g. tip type) and other procedural requirements. Closely observe and
monitor clinical effects and use your judgment to determine the clinical parameters and approach for the
treatment. Make appropriate power, pulse length, and interval adjustments to compensate for varying
tissue compositions, density, and thickness. Always start treatment at the lowest power setting for the
specific indication and increase as required. BIOLASE assumes no responsibility for parameters,
techniques, methods or results.
CLINICAL ENVIRONMENT
Only use this device in clinical environments that observe proper standard aseptic techniques with all oral
procedures.

10 Epic Hygiene User Manual
4.1GENERAL
• Dimension (W x L x H)
• Weight
4.2 ELECTRICAL
• Operating voltage
• Frequency
• External Fuses
• Main control
• Remote Interruption
•Disable Control
•Battery
• DC Power Supply Module
4.3LASER
• Laser Classification
• Medium
• Wavelength
• Max Power Output
• Power Accuracy
•Operating Modes
• Fiber Tip Diameter
• Pulse Duration
• Pulse Interval
• Pulse Repetition Rate
• NOHD (Nominal Ocular Hazard Distance)
• MPE (Maximum Permissible Exposure)
• Beam Divergence
• Standard Fiber Cable Length
4.4OTHER LIGHT SOURCES
• Aiming Beam
4 Specifications
5.7 in x 6.5 in. x 4.4 in (14.5 cm x 11.2 cm x 16.5 cm)
2.5 lbs / 1kg
100V - 240V ~ at 1.5A
50 / 60 Hz
None
Main Power Switch (ON/OFF Control Button)
Remote interlock
Emergency Stop Button
Lithium Ion Rechargeable, 14.4V, 2.9Ah
12V DC, 5A
IV (4)
InGaAs Semi-conductor diode
980 ± 10nm
1.5W Max Average Power, 10W Max Peak Power
± 20%
Continuous, Pulse Modulation
400µm
0.01ms – 20ms
0.04ms – 20ms
Up to 20kHz (for reference)
2.71 meters
30W/m2
8 - 22° per side
5 feet (1.5 meters)
Laser diode, max 1 mW, 625 nm – 670 nm, Class 2

Epic Hygiene User Manual
5.1SYSTEM COMPONENTS
The Epic Hygiene laser system includes the following:
1. Laser Console
2. Peel-off Screen Protectors (qty. 25)
3. Fiber Optic Cable (Installed)
4. Assorted Tips
5. Handpiece (qty. 2)
6. Laser Protective Eyewear (qty. 3)
7. DC Power Supply Module
8. Power Cord (qty. 1)
9. Welcome Kit (Includes User Manual)
10. Laser Warning Sign
11. Tip Initiation Kit
12. Remote Interlock Cable
13. Wireless Footswitch
14. Philips-Head Screwdriver (for installing Footswitch batteries)
15. AAA Batteries (qty. 2)
WARNING: No modication of this equipment is allowed.
11
5 Equipment Description

12Epic Hygiene User Manual
5.2 GENERAL
The Epic Hygiene system consists of three components:
Figure 5.1
Wireless Footswitch
Fiber Optic Cable
Handpiece
Tip
5 Equipment Description
Base Console
Fiber Delivery System
LED Indicators
LED Indicators
Control Button
Fiber Storage Channel

BASE CONSOLE
The base console is portable, contains the diode laser and all the elements which power the laser, and
has a touchscreen which allows the user to navigate from screen to screen, select procedures, enter
and/or change settings, etc. (Figure 5.1).
CONTROL BUTTON:
Activates the controls and console display; places the laser into Standby, Ready, or Sleep mode.
LED Indicators:
Amber = Standby mode
Green = Ready mode
Blinking green = Laser is firing
Blinking blue = Pairing active
FIBER DELIVERY SYSTEM
The fiber delivery system (Figure 5.2) consists
of the Fiber Optic Cable, the reusable
Handpiece, and the fiber Tips, and transmits
laser radiation from the laser console through
the Handpiece and fiber Tips to the target
tissue. The laser ships from the factory with the
Fiber Optic Cable already attached to the base
console.
HANDPIECE
The Handpiece (Figure 5.3) is re-usable. It is
a conduit for delivering the optical energy
produced by the laser to the treatment site and
must be cleaned and sterilized between
patients to avoid cross-contamination
(See Section 9).
Figure 5.2
Figure 5.3
13
5 Equipment Description
Epic Hygiene User Manual

14Epic Hygiene User Manual
WIRELESS FOOTSWITCH
The Epic Hygiene laser will only emit laser energy
when the user presses down on the Footswitch
while the laser is in Ready mode. It is designed
to work using wireless technology and is powered
by two AAA batteries which are installed prior to
shipment from the factory; it ships already paired
to the base console.
The Footswitch is protected by a metal cover. To
access, first press down on the cover to unlatch
it, then press the Footswitch to fire the laser
(Figure 5.4).
Figure 5.4
Footswitch
Cover
5 Equipment Description

Epic Hygiene User Manual
Failure to comply with the precautions and warnings described in this User Manual may lead to
exposure to dangerous optical radiation sources. Please observe all safety instructions and warnings as
specified below.
6.1 SAFETY INSTRUCTIONS
Follow these safety instructions before and during treatments:
• When the laser is in use, all operatory entrances must be marked with the warning sign included in
the product packaging (see Appendix D).
•Do not operate in the presence of explosive or flammable materials. Flammable anesthetics
or oxidizing gases such as nitrous oxide (N2O) and oxygen (O2) should be avoided. Solvents
of adhesives and flammable 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.
•All persons present in the operatory must wear laser protective eyewear. Always
ensure that the laser protective eyewear is appropriate for the laser wavelength; refer to the
markings on the eyewear itself for the specifications of the protection provided.
• Prior to use inspect the eyewear for pitting and/or cracking; do not use if damaged; for replacement
or additional laser protective eyewear, please contact BIOLASE.
•Do not look directly into the beam or at specular reflections.
•Never direct or point the beam at a person’s eyes.
•Do not aim the laser at metallic or reflective surfaces, such as surgical instruments or dental
mirrors. If aimed directly at these surfaces the laser beam will reflect, creating a potential hazard.
• Always place the system into Standby mode (by pressing the control button while in Ready
mode) before exchanging Handpieces or disposable Tips.
• Always ensure that the proper laser parameters are set before the Epic Hygiene laser is used in a
procedure.
•Toggle the ON/OFF switch (located on the rear of the console) to the OFF (O) position before
leaving the unit unattended.
•Do not use the Epic Hygiene if the Fiber Optic Cable is damaged or broken.
•Do not use the laser if there's a suspicion it is not functioning properly or other than described in this
User Manual.
WARNING: Use of controls or adjustments or performance of procedures other than
those specified in this User Manual may result in hazardous radiation exposure.
15
6 Safety with the Epic Hygiene

16 Epic Hygiene User Manual
6.2 SAFETY CLASSIFICATION
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.
6 Safety with the Epic Hygiene
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
adhesives and flammable solutions used for cleaning and disinfecting should be allowed
to evaporate before the laser equipment is used.
The following safety classifications are applicable to the device:
•Laser radiation – Class 4
•Aiming Beam – Class 2
•Type of protections against electrical shock – Class 1
•Degree of protection against electrical shock – Type B applied part
•Not protected against water ingress – Ordinary equipment
•Not suitable for use in presence of flammable anesthetic mixture
•Operation mode – Continuous wave and pulse modulation
•Wireless Footswitch – IPX6
CAUTION: DO NOT position this equipment so that it is difficult to pull the plug from the
power source.
CAUTION: To avoid the risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.
LASER WARNING: DO NOT open the console housing at any time. Danger from
optical radiation may exist.
CAUTION: Be aware that the metal cannula on the Tips may become hot during use.
Avoid contact of the cannula with any tissue.

Figure 6.1: Power Switch, DC
Power Input, Remote Interlock
Figure 6.2: DC Power Supply Module
17
6 Safety with the Epic Hygiene
6.3 SAFETY FEATURES
ENERGY MONITOR
Theenergymonitormeasuresandverifiespoweroutput.
Power deviations of more than ± 20% from the selected
value will cause the display to show the error message:
“LASER CURRENT HIGH/LOW”.
Thelaserconsolewillnotoperateuntilthesystemfirstclears
the error and then goes into Ready mode. If the error
message persists, please contact BIOLASE Service at
1-800-321-6717 or your BIOLASE-authorized service
representative.
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 cannot resume until the
error is cleared.
POWER SWITCH
The laser console can be switched ON ( I ) or OFF (O) using
the power switch on the back of the console. Turn the power
switch OFF (O) only when the system will not be in use for a
long period of time.
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.
Placing the laser in Sleep mode by pressing and holding the
Control button on the front panel of the console does not re-set
the access key code.
CONTROL BUTTON
Once the power switch is set to the ON ( I ) position, enter the
access key code. After setting the desired parameters for a
procedure, press the CONTROL button on the control panel to
enter into Ready mode. The aiming beam will illuminate to
indicate that the system is ready for use.
Epic Hygiene User Manual

18 Epic Hygiene User Manual
Figure 6.3: Wireless Footswitch
WIRELESS FOOTSWITCH
The Epic Hygiene 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 and is paired to the laser console at
the factory.
REMOTE INTERLOCK
This feature allows the laser to be connected to a remote
sensor which prevents it from firing when the sensor is
triggered. To install the remote interlock, insert the plug
(a) at the end of the connector (Figure 6.4) into the rear of
the laser console and attach the two wires (b) at the other
end to a door switch; the laser will stop immediately when
the connection to the door switch is deactivated, i.e.,
when the door is opened.
EMERGENCY STOP
Press the red emergency laser stop button to instantly
turn off the laser console (Figure 6.5). The message
“Emergency Switch Error” will appear on the console
display and the amber LED will begin flashing. To clear
the error, press the emergency laser stop button again; in
2 to 5 seconds the amber LED will stop flashing and the
system will automatically go into Standby mode.
FUNCTIONAL DISPLAY
The system color display with touch screen and LED
indicators on the control panel shows the functional
conditions of the system.
Figure 6.4: Remote
Interlock Connector
Figure 6.5: Emergency
Laser Stop
CAUTION: Use only the DC Power Supply Module supplied with the Epic Hygiene laser
system. (BIOLASE P/N 2400075)
6 Safety with the Epic Hygiene
(a)
(b)

Epic Hygiene User Manual
7.1 SYSTEM SETUP
7.2 CONNECTING THE FIBER OPTIC CABLE
The Epic Hygiene ships with the Fiber Optic Cable already connected to the laser console.
To disconnect the Fiber Optic Cable from the laser console, make sure the laser console is
turned off and the cable is completely unwound from the console base, grab the Fiber
Optic Cable access plug and slowly pull it straight back from the optical access port (Figure 7.1).
To re-install the Fiber Optic Cable, make sure the laser console is turned off. The Fiber Optic
Cable is attached to the console by inserting the optical access plug (Figure 7.1) into the optical access
port (Figure 7.2).
CAUTION: Do not connect or disconnect the fiber cable while the laser console is turned
ON. Only connect or disconnect the fiber when the laser console is turned OFF.
19
7 Installation and Set-Up
• Place the unit in a clean, dry, and well-ventilated area; do not cover or block the ventilation
channels. These channels provide an air-flow path to cool the unit.
• Verify the power switch is in the OFF (O) position.
•Epic Hygiene will work using either DC power or its rechargeable battery pack:
o DC Power Supply Module: Connect the DC power supply module to the laser console, attach
one end of the power cord to the DC power supply module and plug the other end of the
power cord into a wall outlet.
o Rechargeable Battery: The Epic Hygiene is shipped with the battery pack already installed; to
charge the battery pack, connect the power cord of the DC power supply module to the laser
console and plug into a wall outlet. Before first use, fully charge the battery (at least 3 hours).
Once the battery is charged, unplug the power cord from the wall outlet and the laser
console. The laser console will run on battery power alone. To fully charge the battery, plug
the DC power supply module in and then turn the laser console ON ( I ) at the power switch.
The laser console will start to charge and the unit will go into Sleep mode (the screen is dark)
after 5 minutes; if the power supply is plugged in but the console is turned OFF (O) at the
power switch, the battery will still charge, but at a slower rate.
NOTE: The laser ships with the lithium ion battery pack already installed.
FACILITY REQUIREMENTS:
Electrical Supply: 100V - 240V ~ at 1.5A, 50/60Hz
Environmental: Temperature 15-35 ºC (59-95 ºF), Humidity 10-90%, non-condensing