User Manual - Biolase Romania

User Manual - Biolase Romania
BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA
949.361.1200
888.424.6527
biolase.com
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
mt-procons.com
About BIOLASE
Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine
and dentistry that feature proprietary and patented technologies for
minimally invasive surgeries, reducing pain and improving clinical
results.
Only BIOLASE combines the leading laser technology – continuously
improved through ongoing clinical R&D and engineering – with
unmatched training, practice integration support and service.
BIOLASE leads the global dental laser market with over 21,000 lasers in
use today and the most complete family of dental lasers – from diode
lasers to the most advanced all-tissue laser, the WaterLase iPlus™.
One Color
(silk screen, laser etch, etc.)
Full Color
(print, web, etc.)
User Manual
Made in the USA
©2014 BIOLASE, Inc. All rights reserved. EPIC, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece,
Full Color
(print, web, etc.)
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.
EPIC T User Manual P/N 5400478 Rev A
EPIC T User Manual P/N 5400478 Rev A
TABLE OF CONTENTS
TABLE OF CONTENTS.............................................................................................................. 1
Introduction................................................................................................................................. 4
1.Packaging................................................................................................................................ 5
1.1 System Parts List .............................................................................................................. 5
1.2 Facility Requirements ........................................................................................................ 5
2. Equipment Description............................................................................................................ 6
2.1 General ............................................................................................................................. 6
2.2 Laser console.................................................................................................................... 6
2.3 Control Panel .................................................................................................................... 6
2.4 Delivery System ................................................................................................................ 7
2.5 Fiber Optic Connection...................................................................................................... 7
2.6 Deep Tissue Handpiece .................................................................................................... 8
3. Safety ..................................................................................................................................... 9
3.1 Precautions ....................................................................................................................... 9
3.2 Safety Instructions............................................................................................................. 9
3.3 Safety Features ............................................................................................................... 10
Energy Monitor .................................................................................................................. 10
System Monitor ................................................................................................................. 10
Power Switch..................................................................................................................... 11
Access Key Code .............................................................................................................. 11
Control Button ................................................................................................................... 11
Wireless Footswitch........................................................................................................... 11
Remote Interlock ............................................................................................................... 12
Emergency Stop ................................................................................................................ 13
Functional Display ............................................................................................................. 13
3.4 Safety Classification ........................................................................................................ 13
4. Operation Instructions........................................................................................................... 14
4.1 System setup .................................................................................................................. 14
4.2 Operation - Turn on the EPIC T-Series Laser.................................................................. 15
4.3 Settings Screen ............................................................................................................... 16
4.4 Pairing the Footswitch to the Laser console .................................................................... 16
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4.5 Control Button ................................................................................................................. 18
4.6 Entering READY or STANDBY Modes ............................................................................ 18
4.7 READY Mode .................................................................................................................. 19
4.8 Wireless Footswitch ........................................................................................................ 19
4.11 Using the EPIC T-Series Touch Screen Display ............................................................ 20
4.14 Turn the Laser console Off ............................................................................................ 21
5. Specifications ....................................................................................................................... 22
5.1 General ........................................................................................................................... 22
5.2 Electrical ......................................................................................................................... 22
5.3 Laser ............................................................................................................................... 22
5.4 Other Light Sources ........................................................................................................ 23
6. Contraindications, Warnings & Precautions .......................................................................... 24
6.1 Contraindications ............................................................................................................ 24
6.2 Warnings and Precautions .............................................................................................. 24
Prescription Statement ...................................................................................................... 24
Eyewear ............................................................................................................................ 24
Training ............................................................................................................................. 24
7. Clinical Applications .............................................................................................................. 25
7.1 Introduction ..................................................................................................................... 25
7.2 Indications for Use .......................................................................................................... 25
7.3 Pain Therapy................................................................................................................... 25
Pre-programmed Pain Therapy Settings............................................................................ 26
7.7 Table of Pre-Programmed Pain Therapy settings ............................................................ 27
Pain Therapy – Adverse Effects ........................................................................................ 27
Pain Therapy – Warnings and Precautions ........................................................................ 27
Recommended Use ........................................................................................................... 28
Using the Deep Tissue Handpiece .................................................................................... 28
8. Maintenance ......................................................................................................................... 29
8.1 Daily Maintenance........................................................................................................... 29
8.2 Cleaning and disinfection Procedures ............................................................................. 29
8.3 Installing/Replacing the Console Battery Pack ................................................................ 29
8.4 Changing the Wireless Footswitch Batteries ................................................................... 30
8.5 Transportation ................................................................................................................. 31
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8.6 Storage ........................................................................................................................... 31
9. Calibration ............................................................................................................................ 32
9.1 Calibration Schedule ....................................................................................................... 32
10. Software Specification ........................................................................................................ 32
11. Troubleshooting .................................................................................................................. 32
APPENDIX A – Labeling........................................................................................................... 34
APPENDIX B – Safety Precautions for Lithium-Ion Battery Packs ............................................ 38
APPENDIX C – Accessories ..................................................................................................... 41
APPENDIX E – Electromagnetic Compatibility ......................................................................... 42
APPENDIX F – Wireless Equipment Compliance Statement .................................................... 46
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INTRODUCTION
The Epic™ T-Series diode laser is a therapeutic device at the cutting edge of technology for use
in providing temporary relief of minor pain.
The Epic T-Series utilizes a solid state diode as a semiconductor source for invisible infrared
radiation. The energy is delivered to the treatment site via flexible fiber connected at one end to
the laser source and the other end to the handpiece. The device is activated by means of a
wireless footswitch.
This is a prescription device that is indicated for professional use only by licensed medical
practitioners. The use of this device requires proper clinical and technical training. This manual
provides instructions for those professionals that have completed the appropriate training.
When used and maintained properly, the Epic T-Series will prove a valuable addition to your
practice. Please contact BIOLASE Customer Service at 1-800-321-6717 for any service needs.
If you are located outside the USA, please contact your BIOLASE-authorized distributor.
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1.PACKAGING
1.1 SYSTEM PARTS LIST
The Epic T-Series laser system includes the following:
1. Laser console (lithium ion battery pack already installed)
2. Screen Protectors (Peel-off clear screen cover - qty. 30)
3. Delivery System (installed)
4. Deep Tissue Handpiece (1) (shipped separately)
5. Three (3) pairs of protective laser eyewear (two (2) pairs of doctor safety glasses,
one (1) pair of darker patient safety glasses)
6. DC power supply and power cord (one (1) for North America and one (1) for
International)
7. Welcome Kit (Welcome Letter, Limited Warranty Information, User Manual)
8. Laser Warning Sign
9. Remote Interlock cable
10. Philips-head screwdriver (for installing Footswitch batteries)
11. Footswitch
12. AAA batteries (2)
NOTE:
The laser ships with the lithium ion battery pack already installed.
NOTE:
Use proper care when transporting the unit. Refer to Section 8 in this User
Manual for instructions.
WARNING:
No modification of this equipment is allowed.
1.2 FACILITY REQUIREMENTS
Electrical Supply (100-240V ~):
•
1.5A, 50/60Hz
Environmental Requirements:
•
Temperature: 20-25 ºC
•
Humidity: 15-95%, Non-condensing
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2. EQUIPMENT DESCRIPTION
2.1 GENERAL
The EPIC T-Series system consists of three components:
● Laser console
● Delivery System
● Wireless Footswitch
2.2 LASER CONSOLE
The Console has a Display Panel (Touch Screen and Control Button) in front. It can be powered
by an external mains power supply or an internal replaceable lithium ion battery pack, 14.4V,
2.9 Ah.
2.3 CONTROL PANEL
ITEM
CONTROL
Button
LED
Indicator
ITEM DESCRIPTION
Activates the controls and display;
places the unit into STANDBY or
READY mode.
•
Amber indicates unit is in
STANDBY mode.
•
Green indicates unit is in READY
mode.
•
Blinking green indicates the
emission of laser power.
•
LED Indicator
Fiber Storage Channel
LED Indicator
Control Button
Blinking blue indicates pairing
between the footswitch and laser
console is active
Figure 2.1: Control Panel (Front View)
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2.4 DELIVERY SYSTEM
The Epic T-Series Delivery System consists of:
•
Re-useable Fiber Optic Assembly
•
Re-useable Deep-Tissue Handpiece (Figure 2.4)
NOTE:
The fiber optic cable is detachable from the console. The handpiece is a re-usable
accessory and will require disinfection prior to each patient treatment.
2.5 FIBER OPTIC CONNECTION
CAUTION:
Do not connect or disconnect the fiber while the laser console is turned on.
Only connect or disconnect the fiber when the laser console is turned off.
The Epic T-Series ships with the fiber optic cable already attached.
To disconnect the fiber optic cable from the laser console, make sure the laser console is
turned off and the cable is completely unwound from the console base, grab the fiber optic
access plug and slowly pull it straight back from the optical access port (Figure 2.3).
To re-install the fiber optic cable, make sure the laser console is turned off. The fiber optic
cable is attached to the console by inserting the optical access plug (Figure 2.2) into the optical
access port (Figure 2.3).
NOTE:
You should hear the fiber optic “click” into place; if you do not hear it “click,” remove
the fiber optic and reinstall it.
For storage, wind the cable in the fiber storage channel around the base of the console in a
counterclockwise direction (Figure 2.1).
CAUTION:
Do not bend the fiber optic at a sharp angle, as it is can break. Make sure it is
not caught or pinched between the housing and the fiber optic access plug.
Figure 2.3: Optical Access Port
Figure 2.2: Fiber Optic Access Plug
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2.6 DEEP TISSUE HANDPIECE
NOTE:
The Deep Tissue Handpiece is reusable and equipped with a disposable single-use
protective shield. The handpiece requires disinfection before and after each patient
treatment. This handpiece cannot be sterilized in the autoclave. For instructions
on disinfecting the handpiece, refer to section 8.
It is recommended to wipe the disposable shield with alcohol prior to use. The
disposable shield is for single-use only to avoid cross-contamination. Dispose of
when treatment session is completed.
Spacer
Red Cap Dust
Cover
Handpiece
Disposable
Shield
Protective Plug
Figure 2.4: Deep Tissue Handpiece
•
Remove Red Cap Dust Cover and Protective Plug from the Deep Tissue Handpiece.
•
Slide the handpiece over the shaft until it clicks into place
(Figure 2.5).
Figure 2.5
•
Place the protective shield over the adjustable spacer
(Figure 2.6).
Figure 2.6
•
Loosen the Lock Ring and set the Spacer at the desired spot
size Detent Location (Figure 2.7). Tighten the Lock Ring.
Figure 2.7
The handpiece is now ready to use.
To remove the handpiece, press and hold the buttons on the side of the fiber shaft and pull the
handpiece away from the shaft.
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3. SAFETY
3.1 PRECAUTIONS
Failure to comply with precautions and warnings described in this User Manual may lead to
exposure to dangerous optical radiation sources. Please comply with all safety instructions and
warnings.
3.2 SAFETY INSTRUCTIONS
Follow these safety instructions before and during treatments:
•
When the laser is in use, all operatory entrances must be marked with an appropriate
warning sign (one (1) included).
•
Do not operate in the presence of explosive or flammable materials. Flammable
anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided.
Solvents of adhesives and flammable solutions used for cleaning and disinfecting should
be allowed to evaporate before laser is used. Attention should also be drawn to the danger
of ignition of endogenous gases.
•
All persons present in the operatory must wear protective laser eyewear.
NOTE:
For replacement or additional protective laser eyewear, please contact BIOLASE.
CAUTION:
Periodically inspect laser eyewear for pitting and cracking.
LASER
WARNING:
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
WARNING:
Do not use this unit if you suspect it of functioning improperly or other than
described herein.
CAUTION:
This unit has been designed and tested to meet the requirements of
electromagnetic, electrostatic, and radio frequency interference standards.
However, the possibility of electromagnetic or other interference may still exist.
Relocating the device may help to eliminate the interference.
CAUTION:
Always ensure that the proper laser parameters are set before the EPIC T-Series
laser is used in a clinical setting.
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LASER
WARNING:
Always ensure that the protective laser eyewear is appropriate for the
laser wavelength.
•
Do not look directly into the beam or at specular reflections.
•
Never direct or point the beam at a person’s eyes.
•
Always place the system into STANDBY mode (by pressing the Control Button while in
READY mode) before exchanging handpieces.
•
Toggle the ON/OFF switch (located on the rear of the console) to the OFF (O) position
before leaving unit unattended.
LASER
WARNING:
Do not open unit housing at any time. Danger from optical radiation may
exist.
LASER
WARNING:
Do not aim the laser at metallic or reflective surfaces, such as surgical
instruments or dental mirrors. If aimed directly at these surfaces the laser
beam will reflect and create a potential hazard.
3.3 SAFETY FEATURES
Energy Monitor
The energy monitor measures and verifies power output. Power deviations of more than ± 20%
from the selected value will cause the display to show the error message: “LASER CURRENT
HIGH/LOW”.
The laser console will not operate until the system first clears the error and then goes into
READY mode. If the error message persists, please contact BIOLASE Service at
1-800-321-6717.
System Monitor
The system monitors the emergency stop switch, remote key, wireless footswitch connection,
and output power. An error in any one of these will stop the system. The text display will indicate
the type of error. Operation will not resume until the error is cleared.
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Power Switch
The laser console can be switched ON (I) or OFF (O) using the Power Switch on the back of the
console.
Power Switch
DC Power
Remote Interlock
Figure 3.1: Power Switch, DC Power Input,
Remote Interlock
CAUTION:
Figure 3.2: Power Supply Module with cord
Use only the Power Supply Module supplied with the EPIC T-Series laser system
(BIOLASE Part Number 2400129).
Access Key Code
The Access Key Code prevents unauthorized use of the system. It is activated every time the
system is turned on with the Power Switch (refer to Section 4 for code).
NOTE:
Placing the laser in sleep mode by pressing and holding the Control button on the
front panel does not re-set the Access Key Code. Turn the Power Switch OFF (O)
only when the system will not be in use for a long period of time.
Control Button
Once the power switch is set to the ON (I) position, enter the access key code. After setting the
desired parameters for a procedure, press the CONTROL button on the control panel to enter
into READY mode. The aiming beam will illuminate to indicate that the system is ready for use.
Wireless Footswitch
The Epic T-Series will not emit laser energy until the user presses down on the footswitch while
the laser is in READY mode. The footswitch is designed to work using wireless technology.
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Two (2) AAA batteries are required to power the footswitch (included). For instructions on how
to replace the footswitch batteries, see Section 8.
The footswitch is protected by a metal cover. To access, first press down on the cover to
unlatch it. Now the footswitch can be pressed to fire the laser.
Cover
Footswitch
Figure 3.3: Footswitch Assembly
Remote Interlock
This feature allows the laser console to be connected to the remote sensor, preventing its
operation when triggered (e.g., by opening door). The electric cable from this connector should
be wired to the normally closed switch, sensing the opening of a door and turning the laser
console off when the switch is open.
To override this feature, don’t connect the plug.
Figure 3.4: Remote Interlock Connector
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Emergency Stop
Press the red Emergency Laser Stop button to instantly turn off the laser console. The error
screen will display an “Emergency Switch Error” message and the amber LED will begin
flashing. To clear the error, press the Emergency Laser Stop button again; in 2 to 5 seconds the
amber LED will stop flashing and the system will automatically go into STANDBY mode.
Figure 3.5: Emergency Laser Stop (Left Profile View)
Functional Display
The System Color Display with Touch Screen and LED indicators on the control panel show the
functional conditions of the system.
3.4 SAFETY CLASSIFICATION
The following safety classifications are applicable to the device:
•
Laser Radiation – Class 4
•
Aiming Beam – Class 1
•
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
•
Wireless Footswitch – IPX6
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4. OPERATION INSTRUCTIONS
4.1 SYSTEM SETUP
•
Place the unit in a clean, dry, and well-ventilated area.
•
Verify power switch is in the OFF (O) position.
•
Epic T-Series will work using either DC power or the rechargeable battery pack:
o
DC Power: Connect the power cord of the power supply to the laser console and plug
into a wall outlet
o
Rechargeable Battery: The EPIC T-Series is shipped with the battery pack already
installed; to charge the battery pack, connect the power cord of the DC power supply
to the laser console and plug into a wall outlet. Before first use, fully charge the
battery (at least 3 hours). Once the battery is charged, unplug the power cord from
the wall outlet and the laser console. The laser console will run on battery power
alone.
The system ships from the factory with the fiber already connected to the laser
console
NOTE:
To fully charge the battery, plug the power supply in and then turn the laser console
ON (I) at the Power Switch. The laser console will start to charge and the unit will go
into sleep mode (with the screen off) after 5 minutes; if the power supply is plugged
in but turned OFF (O) at the Power Switch, the battery will still charge, but at a
slower rate
CAUTION:
Do not connect or disconnect the fiber while the laser console is turned on.
Only connect or disconnect the fiber when the laser console is turned off.
CAUTION:
Do not cover or block ventilation channels. These channels provide an airflow path to cool the unit.
CAUTION:
Do not bend the fiber optic cable at a sharp angle, as it is can break. Make
sure it is not caught or pinched between the housing and the fiber optic
access plug.
•
Remove protective cap from the end of the fiber shaft.
•
Carefully connect the handpiece to the fiber optic assembly (Figure 2.5).
•
Wind any excess fiber optic cable onto the fiber spool counterclockwise in the fiber storage
channel around the base of the console (Figure 2.1).
•
The handpiece is now ready to use. To store the handpiece, place it in the handpiece
holder located at the top of the laser console.
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LASER
WARNING:
Never point the laser at a person’s eyes.
LASER
WARNING:
Never operate the laser without a handpiece attached.
LASER
WARNING:
All persons present in the operatory must wear protective eyewear when
the laser is in use.
4.2 OPERATION - TURN ON THE EPIC T-SERIES LASER
•
Ensure that the battery has enough charge for operation, or connect the power supply cord
to the power connector on the laser console and plug the cord into a wall outlet.
•
Turn the Power Switch at the rear of the console to the ON (I) position. The “BIOLASE”
logo screen will appear (Figure 4.1). After three (3) seconds the EPIC T-Series “Welcome”
screen will be displayed (Figure 4.2).
Figure 4.1
Figure 4.2
Figure 4.3
•
Enter the three digit access code using the touch screen. The Access Key Code is 888. (If
the incorrect code is entered, an ‘X’ appears briefly in the window (Figure 4.3); press the ‘X’
or wait 3 seconds to revert back to the Welcome screen; re-enter the correct code.
•
The system will go to the HOME screen.
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Wireless Signal
Strength Indicator
Laser Console Battery
Strength Indicator
Settings Button
Figure 4.4: Home Screen
4.3 SETTINGS SCREEN
Pressing the Settings button
on the HOME screen accesses the Settings screen; this
screen allows the user to make changes to several system settings:
Language Selection
Aiming Beam (5 levels of brightness adjustment)
Volume (5 levels of sound adjustment)
Service Mode (accessible only by authorized BIOLASE Service
Representatives)
Restore to Factory Default Settings
Wireless Menu - Access to Pairing Screens
Figure 4.5
4.4 PAIRING THE FOOTSWITCH TO THE LASER CONSOLE
Verify that the footswitch and laser console are paired; a blue LED indicator light on the laser
console will blink when pairing is established. The laser and footswitch are shipped already
paired. However, if pairing is not confirmed, an “ ” will appear in the pairing icon located in the
upper left hand corner of the touchscreen (Figure 4.6).
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Figure 4.6
To re-establish pairing, take the following steps:
1. Go to the Settings menu on the laser console display by pressing the Settings button
and select the “Wireless” icon
.
2. A screen will appear indicating that pairing of the footswitch
to the laser console has been lost (Figure 4.7); press the
green PAIR button.
Figure 4.7
3. The message that “PAIRING WILL NOW BEGIN” will
appear; press the green check mark to continue
(Figure 4.8).
Figure 4.8
4. To complete the pairing process, turn the footswitch over
and press the Pairing Button
for four (4) seconds
(Figure 4.9).
`
Figure 4.9
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5a. The Wireless screen will appear indicating that pairing
was successful and that the footswitch and laser
console are now paired (Figure 4.10).
Proceed to step 6.
Figure 4.10
5b. If pairing has not occurred, the Wireless screen will
appear again indicating that pairing was not successful
(Figure 4.11); press the green button to repeat
steps 3 – 5a.
Figure 4.11
6. Press the Settings button to return to the Settings menu;
press the arrow on the bottom left of the Settings screen to
return to the Home screen (Figure 4.12).
Figure 4.12
4.5 CONTROL BUTTON
The CONTROL button on the front of the laser console is a multi-functional button (Figure 2.1).
Pressing and holding the Control Button for approximately two (2) seconds will allow the
transition from STANDBY or READY mode to SLEEP mode. Note that you will not be allowed
to go into READY mode unless you have chosen a treatment module on the HOME screen first.
4.6 ENTERING READY OR STANDBY MODES
Press and release the Control Button to place the laser console into either READY or
STANDBY mode. The laser console will only emit laser energy when the footswitch is pressed
and the laser console is set to READY mode. While in READY or STANDBY mode, mode
setting and/or power setting values may be changed only when the laser is not firing. If the
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laser is firing (i.e., the footswitch is engaged), the ability to change the settings is blocked.
(“READY” or “STANDBY” is displayed in the lower right hand corner of the display screen).
4.7 READY MODE
When entering READY mode, the laser console fan will turn on and pressing the footswitch will
activate laser radiation. There is a delay of two (2) seconds between switching to READY mode
and the ability of the laser console to emit a laser beam.
NOTE:
The aiming beam is on only when the laser is in READY mode or when adjusting the
brightness of the beam while in Settings mode. If the aiming beam is not visible in
either instance, remove the handpiece and confirm the beam is actually on by
shining the end of the trunk fiber on a plain, non-reflective surface. DO NOT look
directly at the output end of the trunk fiber. If the aiming beam is not on, turn off the
laser console, then remove and re-install the trunk fiber (see Section 2.6). If the
aiming beam is still not on, turn off the laser console and call Biolase Service.
4.8 WIRELESS FOOTSWITCH
The wireless footswitch is powered by two (2) AAA batteries.
When the wireless footswitch is pressed in READY mode and the laser fires, a beeping sound
indicates that laser energy is present. A green LED will begin flashing and a blue LED will light
at the top corners of the laser console, confirming the footswitch and laser are paired.
In the top left corner of most screens is a Signal Strength Indicator
which displays the
signal strength between the laser console and the footswitch (strongest is five (5) bars).
Pressing and releasing the footswitch while in Standby mode will update this indicator.
Although the unit will work with a signal level as low as one (1) bar, a weaker signal level will
make the connection between the footswitch and laser console more vulnerable to wireless (RF)
interference from other sources, such as cell phones or microwaves. To improve the signal
strength, reposition either the footswitch or the laser console until the signal indicator achieves
the strongest possible level for optimal operation.
NOTE:
When the footswitch is not in use, it will go into SLEEP mode to conserve battery
power. It automatically reactivates when it is pressed.
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4.11 USING THE EPIC T-SERIES TOUCH SCREEN DISPLAY
Figure 4.13
EPIC™ T-Series User Manual
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5400478 Rev A (04/14)
4.14 TURN THE LASER CONSOLE OFF
•
Wind the fiber cable onto the fiber spool counterclockwise around the base of the console.
•
Place the handpiece onto the handpiece holder.
CAUTION:
Verify that the fiber optic tubing assembly is not twisted once the
handpiece is returned to the holder. The fiber may break if it is twisted.
•
Press the CONTROL button on the front of the console for more than 2 seconds to turn the
display off.
•
Press the Power Switch at the rear of the laser console to the OFF (O) position if the laser
system will not be used for a long period of time.
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5. SPECIFICATIONS
5.1 GENERAL
Dimensions
5.7 in (W) x 4.4 in (H) x 6.5 in (L)
(14.5 cm x 11.2 cm x 16.5 cm)
Weight
2.75 lbs / 1.25 kg
5.2 ELECTRICAL
Operating Voltage
100V - 240V ~ at 1.5A
Frequency
50/60Hz
External Fuses
None
Main Control
Power Switch
Remote Interruption
Remote Interlock
Disable Control
Emergency Stop Button
Battery
Lithium Ion Rechargeable, 14.4V, 2.9Ah
DC Power Supply Module
12V DC, 5A
5.3 LASER
Laser Classification
IV (4)
Medium
InGaAsP Semiconductor diode
Wavelength
940 ± 10nm
Max Power Output
10W
Power Accuracy
± 20%
Power Modes
Continuous
Spot size
Deep Tissue Handpiece
30 mm diameter = 7.1 cm2 area
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Nominal Ocular Hazard
Distance (NOHD)
4.77 meters
Beam Divergence
8 - 22° per side angle
Standard Fiber Cable Length
6.8 feet (2 meters)
5.4 OTHER LIGHT SOURCES
Aiming Beam
EPIC™ T-Series User Manual
Laser diode, max 1 mW, 625 nm – 670 nm, Class 1
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6. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS
6.1 CONTRAINDICATIONS
All clinical procedures performed with Epic T-Series must be subjected to the same clinical
judgment and care used with traditional techniques. Patient risk must always be considered and
fully understood before clinical treatment. The clinician must completely understand the patient’s
medical history prior to treatment. Exercise caution for general medical conditions that might
contraindicate a local procedure. Such conditions may include allergy to local or topical
anesthetics, heart disease (including pacemakers), lung disease, bleeding disorders, sleep
apnea or an immune system deficiency, or any medical conditions or medications that may
contraindicate use of certain light/laser type sources associated with this device. Medical
clearance from patient’s physician is advisable when doubt exists regarding treatment.
6.2 WARNINGS AND PRECAUTIONS
Prescription Statement
Federal Law restricts this device to sale by or on the order of a physician or other licensed
medical practitioner.
Eyewear
Doctor, patient, assistant and all others inside the operatory must wear appropriate laser
eyewear protection for the diode laser wavelength of 940 ± 10nm.
Training
Only licensed professionals who have reviewed and understood this User Manual should use
this device. BIOLASE assumes no responsibility for parameters, techniques, methods, or
results. Physicians must use their own clinical judgment and professionalism in determining all
aspects of treatment, technique, proper power settings, interval, duration, etc.
LASER
WARNING:
EPIC™ T-Series User Manual
Never point the laser at a person’s eyes. All persons present in the
operatory must wear protective eyewear when the laser is in operation.
pg. 24
5400478 Rev A (04/14)
7. CLINICAL APPLICATIONS
7.1 INTRODUCTION
Please review this section carefully before using this device in a clinical situation.
7.2 INDICATIONS FOR USE
The Epic T-Series is intended for topical heating for the purpose of elevating tissue temperature
for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle
spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in
local blood circulation; the temporary relaxation of muscle.
7.3 PAIN THERAPY
The Epic T-Series diode laser is designed to provide near-infrared laser energy to a tissue
surface for the purpose of temporary pain relief when applied with the Deep Tissue Handpiece.
The pain therapy procedure is the process by which tissue temperature is elevated for the
temporary relief of minor pain, the temporary increase in local blood circulation, and the
temporary relaxation of muscle, as stated in the Indications for Use.
Affected muscles and/or joints have to be exposed to an adequate level of therapeutic energy
over a short period of time to provide effective therapeutic effects. Some patients may require
more than one laser application or a series of treatments before significant improvement is
reported. Repeat the therapy as necessary and monitor the progress of the patient’s condition
throughout the treatment.
Refer to the Fitzpatrick Skin Type Scale (Figure 7.1) when performing pain therapy procedures.
The diode wavelength has increased absorption in melanin in the skin, causing greater heating
of the skin surface of patients with a higher melanin concentration (darker skin types).
Patients with higher melanin content in their skin may feel more discomfort during treatment,
which may be alleviated by moving the handpiece, defocusing the energy, or decreasing the
power setting.
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Fitzpatrick Skin Type Scale
TYPE I
Highly sensitive, always burns, never tans. Example: Red hair with
freckles
TYPE II
Very sun-sensitive, burns easily, tans minimally. Example: Fair-skinned,
fair-haired Caucasians
TYPE III
Sun-sensitive skin, sometimes burns, slowly tans to light brown.
Example: Darker Caucasians
TYPE IV
Minimally sun-sensitive, burns minimally, always tans to moderate
brown. Example: Mediterranean-type Caucasians
TYPE V
Sun-insensitive skin, rarely burns, tans well. Example: Some Hispanics,
some Blacks
TYPE VI
Sun-insensitive, never burns, deeply pigmented. Example: Darker
Blacks
Figure 7.1
Pre-programmed Pain Therapy Settings
To access the pre-programmed procedure values:
1. Go to the Procedures menu by pressing the Pain Therapy icon
screen.
on the Home
2. Press the button associated with the type of condition requiring treatment.
CAUTION:
Always use clinical judgment when selecting power to ensure optimal clinical
results. Observe the clinical effects on the treatment area at all times and adjust
settings parameters accordingly.
To store your personal preferred settings for any procedure:
A. Follow steps 1 and 2 above.
B. Enter the new values.
C. Touch and hold the condition name for more than 2 seconds; you will hear a beeping
sound confirming the settings are saved.
NOTE:
The pain therapy pre-sets installed at the factory are based on clinical
recommendations and feedback from experienced laser medical practitioners.
EPIC™ T-Series User Manual
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7.7 TABLE OF PRE-PROGRAMMED PAIN THERAPY SETTINGS
MODE
SETTING
TIME
(SECONDS)
ENERGY (J)
SPACER
JOINT PAIN
CW
(Continuous)
4W
600
2400
30 mm
MUSCLE PAIN
CW
(Continuous)
4W
300
1200
30 mm
MUSCLE SPASM
CW
(Continuous)
4W
300
1200
30 mm
CUSTOM
CW
(Continuous)
4W
60
240
30 mm
PROCEDURE NAME
Figure 7.10
Pain Therapy – Adverse Effects
Some reddening of the skin at the treatment site is normal due to increased circulation;
however, in very rare cases burning or blistering of the skin may occur. Immediately stop
treatment, rinse the area with cool water or place a cold pack to the affected area for at least 5
minutes, then apply a burn ointment or spray. DO NOT USE ICE.
Patients should be monitored for discomfort and visual skin changes. Redness has been
associated with increased temperature at the site of application and increased absorption
properties of the skin. If discomfort or redness of the skin occurs at any time during the
treatment, you have the following options:
o
Move the handpiece relative to the affected anatomy
o
Defocus the energy by moving the handpiece further away from the skin
o
Decrease the power setting
o
Stop treatment
Pain Therapy – Warnings and Precautions
•
Scar tissue has been associated with poor circulation and reduced cooling through heat
transport by blood; power settings may have to be reduced to avoid overheating.
•
Patients with tender or sensitive skin may be hypersensitive to heat; reduce power as
necessary to ensure comfort during treatment.
•
Patients with swelling and/or inflammation may be sensitive to heat; reduce power as
necessary to ensure comfort during treatment.
•
Do not treat open wounds.
EPIC™ T-Series User Manual
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5400478 Rev A (04/14)
•
Muscle tissue closer to the skin surface may experience a higher absorption of heat;
carefully monitor skin temperature and reduce power as necessary.
•
Excessive fatty tissue is known to transmit heat without much attenuation; reduce power.
•
Different implant materials will respond differently to laser energy and heat; be aware of
any implants and their location; avoid direct exposure to laser energy or heat at the site of
the implant.
•
Avoid treatment of sites that have tattoos.
•
Do not apply ointment, creams, lotions or heating lotion patches at, or in close proximity to,
the treatment area.
•
Do not apply therapies prior to treatment that could change body temperature, such as
ultrasound, ice/heat pack, electrical stimulation, or heating patches.
•
Do not apply treatment over articles of clothing.
Recommended Use
There are four main variables that impact the safety and effectiveness of pain therapy
procedures:
o
Power output
o
Distance from the skin surface
o
Range of movement of the handpiece
o
Patient skin type
Safety and effectiveness are described by elevating the skin temperature in the treatment area
utilizing the setting recommended below. Use personal clinical judgment with consideration of
the Fitzpatrick Skin Type Scale when selecting procedure parameters; monitor the patient and
adjust the setting as necessary for effectiveness and patient comfort.
NOTE:
To avoid potential patient discomfort and/or skin damage, it is advisable to use a test
spot prior to the initial treatment to assess the suitability of the selected settings for
the individual patient.
Using the Deep Tissue Handpiece
If holding the handpiece in a constant location, the recommended initial power setting for
therapeutic effect is 4.0W CW delivered over 10 minutes of continuous treatment, with the
spacer set at a 30mm spot size. Always monitor patient response; adjust power and/or distance
as needed for patient comfort.
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8. MAINTENANCE
WARNING:
No modification of this equipment is allowed.
8.1 DAILY MAINTENANCE
Use the peel-off clear covers for the laser console supplied with the system. Use disinfectant to
wipe down the front panel and handpiece holder of the EPIC T-Series system after each
procedure. Do not use bleach or abrasive cleansers.
8.2 CLEANING AND DISINFECTION PROCEDURES
•
•
•
•
•
The handpiece is sold with clear, disposable protective shields. It is reusable and must
be disinfected between patients to avoid cross-contamination.
The Deep Tissue Handpiece is not autoclavable.
The clear protective shields are intended for single use only to avoid cross-contamination
and should never be re-used.
To disinfect the Deep Tissue Handpiece, wipe the entire outer surface of the handpiece
with cotton gauze and isopropyl alcohol.
It is recommended to wipe the disposable shield with alcohol prior to use. Dispose of
after one-time use.
8.3 INSTALLING/REPLACING THE CONSOLE BATTERY PACK
1. To install or replace the battery pack, remove the battery cover on the underside of the
console using the Phillips screwdriver included with the laser system (Figure 8.1).
2. To remove the battery, grip the battery at the top and pull the cable away from the
connector (Figure 8.2). Do not tug or wrench the cable from the connector.
3. To install the battery, insert the connector wire from the battery to the unit, making sure
the red wire is on the left, and gently place the battery into the compartment (Figure 8.2).
4. Replace the battery cover on the bottom of the unit, using the Phillips screwdriver
provided.
5. Connect the power cord of the DC power supply to the unit and plug into a wall outlet.
Before first use, you should fully charge the battery (at least three (3) hours). Once the
battery is charged, unplug the power cord from the wall outlet and the console. The unit
will run on battery power alone. (see Section 4.1)
6. Recycle the used Lithium Ion battery as regulated. Do not throw it in a trash bin.
EPIC™ T-Series User Manual
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5400478 Rev A (04/14)
Screws to remove
Battery cover
Figure 8.1: Battery Cover/Bottom of Console
NOTE:
Figure 8.2: Battery Pack/Connector Wire
Only use the battery pack supplied by BIOLASE. The battery pack is a separate
accessory (BIOLASE p/n 6400457).
8.4 CHANGING THE WIRELESS FOOTSWITCH BATTERIES
The wireless footswitch is powered by two AAA batteries. When the batteries are low, a warning
message will appear on the touchscreen indicating that the batteries need to be replaced. To
replace the batteries, unscrew the battery cover on the underside of the footswitch (Section 3),
remove the old batteries, and install the new ones, replacing the cover when done. Dispose of
the used batteries as regulated; do not throw them in a trash bin.
Do not press/push/touch the Pairing Button (Figure 8.3) while changing the batteries, as this will
disrupt the pairing of the laser console and footswitch.
Pairing Button
(Internal View)
Figure 8.3
Replacing the batteries may disrupt the pairing of the laser console and footswitch. If you find
the wireless communication has been interrupted, reestablish pairing by following the
instructions provided in Section 4.
NOTE:
To ensure the longevity of the battery power, only BIOLASE-supplied batteries are
recommended as replacements (BIOLASE p/n 6400463); these are industrial-grade
batteries which under normal use have a longer life than conventional AAA batteries.
EPIC™ T-Series User Manual
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8.5 TRANSPORTATION
The Epic T-Series is susceptible to damage if not handled properly. The unit should ALWAYS
be handled carefully and never banged, jarred, jolted, dropped, or knocked.
Do not transport the unit unless it is completely packaged inside its shipping box. If you have
any questions regarding transportation please call BIOLASE Service at 1-800-321-6717.
8.6 STORAGE
The Epic T-Series should be stored in a cool, dry place when not in use. Storage temperature
15°C-35°C (59°F-95°F), relative humidity 10%-70%, non-condensing. Cover the unit when not
in use for extended periods of time. Store the system in a place where it will not be accidentally
bumped or banged.
CAUTION:
Make sure the distal end of the handpiece shaft is protected from dirt with
the protective tip plug and handpiece.
CAUTION:
Remove the batteries from the footswitch if the EPIC T-Series is not likely
to be used for some time.
The Epic T-Series is shipped inside a custom shipping box. Please save and store the box in a
cool, dry place for use when transporting the laser, or for long-term storage.
EPIC™ T-Series User Manual
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9. CALIBRATION
9.1 CALIBRATION SCHEDULE
Calibration procedure is recommended to be performed every twenty-four (24) months in order
to maintain the required accuracy of output power versus displayed power. Bi-annual
calibrations can be performed at a certified depot repair facility. Call BIOLASE Service at 1-800321-6717 or your Authorized Service Representative to schedule an appointment.
10. SOFTWARE SPECIFICATION
BIOLASE respects the intellectual property of others, and we ask our users to do the same.
Epic T-Series software is protected by copyright and other intellectual property laws.
This product contains proprietary, copyrighted software developed by BIOLASE, Inc. All rights
reserved in the USA and other countries.
11. TROUBLESHOOTING
Should any of the on-screen messages listed in Figure 11.1 appear, follow the troubleshooting
instructions for the specific message as noted below.
NOTE:
For any on-screen message not listed in Figure 11.1, re-power the laser console; if
the message does not clear, call BIOLASE Service at 1-800-321-6717 or your
authorized Service Representative
EPIC™ T-Series User Manual
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Title
Error 1
Reason
Message
Thermistor Open
Fix
Thermistor Open
Call BIOLASE Service
Error 2
Thermistor Shorted
Thermistor Shorted
Error 3
Shutdown Temperature
System too hot
Allow 5-10 mins for laser to cool
down
Error 4
Laser Current High/ Low
Output is out of specs
Call BIOLASE Service
Error 5
FS shorted in Standby
FS is partially pressed or
is damaged
Press/Release FS or call Biolase
Service
Error 6
ON/OFF button Stuck
Key stuck
Press Front key
Error 7
Flash Corrupted
Memory Corrupted
Call BIOLASE Service
Error 8
No Fiber
Fiber not inserted
Plug in Trunk Fiber
Error 9
Lost Footswitch Communication
Wireless Interference
Reposition console or FS to
improve communication
Error 10
Emergency Switch
E-Switch Pressed
Press E-Switch Again
Error 11
Remote Interlock
Remote interlock open
Check Remote Interlock closed
Error 12
Battery Critically Low
Battery Critically Low
Plug in DC supply
Warning 1
Temp High
System is hot
Allow 5-10 mins for laser to cool
down
Warning 2
Battery Low
Battery is low
Plug in DC supply
Warning 3
Battery Not Connected
Battery not connected
Plug in Battery
Warning 4
FS Battery Low
Battery on FS low
Replace FS battery
Alert 1
Wireless Not Paired
No wireless connect
Re-establish pairing (see Sec 4)
Alert 2
System must be in READY
mode to lase
System is not in READY
mode
Press the Control Button in any
procedure screen
Figure 11.1
EPIC™ T-Series User Manual
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APPENDIX A – LABELING
Symbols
Description
Product ID Label
Location: Bottom of laser console
Manufacturer
Date of Manufacture
Catalog/Part Number
Product Serial Number
Refer to User Manual
Type B Applied Part:
The applied part is not conductive to the
patient.
FDA Compliance Label:
Indicates the device complies with FDA laser
standards.
EPIC™ T-Series User Manual
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Warning Label:
Indicates there is the risk of possible
exposure to both infrared and visible laser
radiation.
Location: Back of laser console
FCC Label:
Lists Federal Communication Commission
registration number.
Location: Bottom of Console
FCC Label:
Lists Federal Communication Commission
registration number.
Location: Bottom of Footswitch
FCC Compliance Notice:
The footswitch and laser console comply with
Part 15 of FCC Rules regarding unlicensed
transmissions.
Location: Bottom of Footswitch
IPX6
Ingress Protection Code:
The footswitch is water-resistant, protected
against splashes of water.
Laser Warning:
Indicates the system contains a laser.
Location: Back of Laser console
Fiber Warning:
Indicates the laser aperture is at the end of
the fiber.
Location: Back of Laser console
EPIC™ T-Series User Manual
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Emergency Laser Stop Switch:
The switch used in emergencies to stop laser
output.
Location: Right side of Laser console
WEEE (Waste Electrical and Electronic)
Recycle Lithium Ion battery as regulated. Do
not throw in trash bin.
DC Power, USB, Remote Interlock Label:
Identifies input ports
Power Input Rating:
12 Volts Direct Current, 5 amps
Mini USB Input:
For external programming
Remote Interlock:
Input for Remote Interlock Connector which,
when applied to the access door of the
operatory and activated, will shut off the
laser.
Prescription Statement:
Federal Law restricts this device to sale
by or on the order of a physician or other
licensed medical practitioner.
EPIC™ T-Series User Manual
pg. 36
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Atmospheric Pressure Limitations
Fragile:
Handle with care
Keep Dry
Humidity Limitations
Temperature Limitations
This End UP
EPIC™ T-Series User Manual
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APPENDIX B – SAFETY PRECAUTIONS FOR LITHIUMION BATTERY PACKS
When USING the BATTERY
WARNING
1. Misusing the battery may cause the battery to get hot, rupture, or ignite and cause serious
injury. Be sure to follow the safety rules listed below:
•
Do not place the battery in fire or heat the battery.
•
Do not install the battery backwards so that the polarity is reversed.
•
Do not connect the positive terminal and the negative terminal of the battery to each
other with any metal object (such as a wire).
•
Do not carry or store the batteries together with necklaces, hairpins, or other metal
objects.
•
Do not pierce the battery with nails, strike the battery with a hammer, step on the
battery, or otherwise subject it to strong impacts or shocks.
•
Do not solder directly onto the battery.
•
Do not expose the battery to water or salt water, or allow the battery to get wet.
2. Do not disassemble or modify the battery. The battery contains safety and protection
devices which, if damaged, may cause the battery to generate heat, rupture, or ignite.
3. Do not place the battery on or near fires, stoves, or other high-temperature locations. Do
not place the battery in direct sunshine or use or store the battery inside cars in hot
weather. Doing so may cause the battery to generate heat, rupture, or ignite. Using the
battery in this manner may also result in a loss of performance and a shortened life
expectancy.
CAUTION
1. If the device is to be used by small children, the caregiver should explain the contents of
the user’s manual to the children. The caregiver should provide adequate supervision to
ensure that the device is being used as explained in the user’s manual.
2. When the battery is worn out, insulate the terminals with adhesive tape or similar materials
before disposal.
3. Immediately discontinue use of the battery if, while using, charging, or storing the battery,
the battery emits an unusual smell, feels hot, changes color, changes shape, or appears
EPIC™ T-Series User Manual
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5400478 Rev A (04/14)
abnormal in any other way. Contact your sales location or BIOLASE if any of these
problems are observed.
4. Do not place the batteries in microwave ovens, high-pressure containers, or on induction
cookware.
5. In the event that the battery leaks and the fluid gets into one’s eye(s), do not rub the eye(s).
Rinse well with water and immediately seek medical care. If left untreated, the battery fluid
could cause damage to the eye.
When CHARGING the Battery
WARNING
1. Be sure to follow the rules listed below while charging the battery. Failure to do so may
cause the battery to become hot, rupture, or ignite and cause serious injury.
•
When charging the battery, either use a specified battery charger or otherwise
ensure that the battery charging conditions specified are met.
•
Do not attach the batteries to a power supply plug or directly to a car’s cigarette
lighter.
•
Do not place the batteries in or near fire, or into direct sunlight. When the battery
becomes hot, the built-in safety equipment is activated, preventing the battery from
charging further, and heating the battery can destroy the safety equipment and can
cause additional heating, breaking, or ignition of the battery.
2. Do not continue charging the battery if it does not recharge within the specified charging
time. Doing so may cause the battery to become hot, rupture, or ignite.
CAUTION
The temperature range over which the battery can be charged is 0°C to 45°C. Charging the
battery at temperatures outside of this range may cause the battery to become hot or to break.
Charging the battery outside of this temperature range may also harm the performance of the
battery or reduce the battery’s life expectancy.
EPIC™ T-Series User Manual
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When DISCHARGING the Battery
WARNING
Do not discharge the battery using any device except for the specified device. When the
battery is used in devices aside from the specified device it may damage the performance of
the battery or reduce its life expectancy, and if the device causes an abnormal current to flow, it
may cause the battery to become hot, rupture, or ignite and cause serious injury.
CAUTION
The temperature range over which the battery can be discharged is -20°C to 60°C. Use of the
battery outside of this temperature range may damage the performance of the battery or may
reduce its life expectancy.
EPIC™ T-Series User Manual
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APPENDIX C - ACCESSORIES
BIOLASE p/n
Description
2400040
Laser Safety Glasses (Clinician)
2400078
Laser Safety Glasses (Patient)
6400058
Remote Interlock Plug
2400129
Power Cord with Power Supply
6400522
Wireless Footswitch
6400311
Deep-Tissue Handpiece
6400310
Deep-Tissue Handpiece protective shields (qty. 20)
6400485
Peel-off clear screen covers (qty. 30)
6400457
Lithium ion battery pack for console
6400463
Battery Pack, (2 x AAA)
6400437
Trunk Fiber Assembly
EPIC™ T-Series User Manual
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APPENDIX E – 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.
Footswitch: Wireless, Biolase p/n 6400522
WARNING:
The use of accessories, other than those specified, except those supplied
or sold by Biolase, Inc. as replacement parts for internal or external
components, may result in increased EMMISSIONS or decreased
IMMUNITY of the EPIC diode laser system.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The Epic diode laser is intended for use in the electromagnetic environment specified below.
The customer or the user of the Epic diode laser should assure it is used in such an
environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
Group 1
The Epic diode laser uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
Class A
The Epic diode laser is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Class A
IEC 61000-3-3
EPIC™ T-Series User Manual
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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Epic diode laser is intended for use in the electromagnetic environment specified below. The customer
or the user of the model Epic diode laser should assure that it is used in such an environment.
IEC 60601
test level
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
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
Power frequency
(50-60 Hz)
magnetic field
Continuous
level
Electromagnetic environment guidance
± 6 kV contact
± 6 kV contact
± 8kV air
± 8kV air
± 2 kV for power
supply lines
± 2 kV for power
supply lines
Main power quality should be that of a
typical commercial or hospital
environment.
± 1 kV for
input/output lines
N/A
Input/output that does not apply
because the footswitch cable length is
less than 3 meters.
± 1 kV differential
mode
± 1 kV differential
mode
± 2 kV common
mode
± 2 kV common
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
<5% Ur
(>95% dip in UT)
for 0.5 cycle
<5% Ur
(>95% dip in UT)
for 0.5 cycle
40% Ur
(60% dip in UT) for
5 cycles
40% Ur
(60% dip in UT) for
5 cycles
70% Ur
70% Ur
(30% dip in Ur) for
25 cycles
(30% dip in Ur) for
25 cycles
<5% Ur
(>95% dip in Ur) for
5 seconds
<5% Ur
(>95% dip in Ur) for
5 seconds
3 A/m
3 A/m
IEC 61000-4-8
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, relative humidity
should be at least 50%.
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the model
Epic diode laser requires continued
operation during power mains
interruptions, it is recommended that
the model Epic diode laser be
powered from an uninterrupted
power supply.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: Ur is the A.C. mains voltage prior to applications of the test level.
EPIC™ T-Series User Manual
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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
(Continued)
The model Epic laser is intended for use in the electromagnetic environment specified below. The
customer or the user of the model Epic laser should assure that it is used in such an environment.
IEC 60601
test level
Immunity test
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 GHz
Radiated RF
3V/m
IEC61000-4-3
80 MHz to 2.5 GHz
Continuous
level
3V
3Vm
Electromagnetic environment guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the
model Epic diode laser, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800MHz to 2.5GHZ
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d 8s the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1 - At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Epic diode laser is used exceeds the applicable RF compliance level above, the Epic diode
laser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Epic diode laser.
B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
EPIC™ T-Series User Manual
pg. 44
5400478 Rev A (04/14)
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS
EQUIPMENT AND THE EPIC DIODE LASER
The Epic diode laser is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Epic diode laser can help prevent
electromagnetic interferences by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Epic diode laser as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter M
Rated maximum
output power of
transmitter W
150kHz to 80Mhz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 – At 80 MHz and 800 MHZ, the separation distance for the higher frequency range applies.
NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
EPIC™ T-Series User Manual
pg. 45
5400478 Rev A (04/14)
APPENDIX F - 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.
EPIC™ T-Series User Manual
pg. 46
5400478 Rev A (04/14)
BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA
949.361.1200
888.424.6527
biolase.com
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
mt-procons.com
About BIOLASE
Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine
and dentistry that feature proprietary and patented technologies for
minimally invasive surgeries, reducing pain and improving clinical
results.
Only BIOLASE combines the leading laser technology – continuously
improved through ongoing clinical R&D and engineering – with
unmatched training, practice integration support and service.
BIOLASE leads the global dental laser market with over 21,000 lasers in
use today and the most complete family of dental lasers – from diode
lasers to the most advanced all-tissue laser, the WaterLase iPlus™.
One Color
(silk screen, laser etch, etc.)
Full Color
(print, web, etc.)
User Manual
Made in the USA
©2014 BIOLASE, Inc. All rights reserved. EPIC, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece,
Full Color
(print, web, etc.)
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.
EPIC T User Manual P/N 5400478 Rev A
EPIC T User Manual P/N 5400478 Rev A
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