Diolase 10 - Biolase

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BIOLASE Diolase10 Pain Therapy Laser User Instructions.
BIOLASE, the BIOLASE logo, Diolase 10, the Diolase 10 logo, Deep Tissue and Body
Contour are either registered trademarks or trademarks of BIOLASE Incorporated in the
United States and/or other countries.
Biolase Technology, Inc.
4 Cromwell
Irvine, CA 92618
949.361.1200
Europe
M T Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
www.mt-procons.com
0482
P/N 5400153 Rev. F (05/10)

Pain Therapy Laser
User Instructions
U S E R I N S T R U C T I O N S

Contents
1 5400153 REV. F (05/2010)
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Section 1 INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Installation Instructions . . . . . . . . . . . . . . . . . . . . . . 5
Facility Requirements . . . . . . . . . . . . . . . . . . . . . . . 5
Electrical Supply . . . . . . . . . . . . . . . . . . . . . . . . . 5
Environmental Requirements . . . . . . . . . . . . . . 5
Section 2 SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Energy Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . 7
System Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . 8
Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Key Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
READY Button . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . 10
Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . 10
Functional Display . . . . . . . . . . . . . . . . . . . . . . . 10
Safety Classification . . . . . . . . . . . . . . . . . . . . . . . 10
Section 3 EQUIPMENT DESCRIPTION . . . . . . . . . . . . . . . . 11
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Laser Delivery System . . . . . . . . . . . . . . . . . . . . . 11
Front Panel and Main Screen . . . . . . . . . . . . . . 12
Side View of Diolase10 Laser . . . . . . . . . . . . 13
Rear View of Diolase10 Laser . . . . . . . . . . . . 15
Front View of Diolase10 Laser . . . . . . . . . . . . 16
Diolase10 Deep Tissue Handpiece . . . . . . 17
Diolase10 Body Contour Handpiece . . . . 18

Section 4 OPERATING INSTRUCTIONS . . . . . . . . . . . . . . . 19
System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Starting up the Diolase10 Laser . . . . . . . . . . 20
ON/OFF Button . . . . . . . . . . . . . . . . . . . . . . . . 21
READY/STANDBY Buttons . . . . . . . . . . . . . . . . 21
Navigation Wheel . . . . . . . . . . . . . . . . . . . . . . . 21
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
POWER Buttons . . . . . . . . . . . . . . . . . . . . . . . . 22
Peak Power Display . . . . . . . . . . . . . . . . . . . . . 22
TIMER Button . . . . . . . . . . . . . . . . . . . . . . . . . . 22
LASER MODE Button . . . . . . . . . . . . . . . . . . . . 23
TOTAL ENERGY Button . . . . . . . . . . . . . . . . . . . 23
PULSE LENGTH Button . . . . . . . . . . . . . . . . . . 23
PULSE INTERVAL Button . . . . . . . . . . . . . . . . . 24
PROCEDURES Button . . . . . . . . . . . . . . . . . . . 24
SETTINGS Menu . . . . . . . . . . . . . . . . . . . . . . . . 25
Shutting Down the Diolase10 Laser . . . . . . . 25
Using the Diolase 10
Deep Tissue Handpiece . . . . . . . . . . . . . . 26
Section 5 SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . 27
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Other Light Sources . . . . . . . . . . . . . . . . . . . . . . 27
2

Contents (continued)
3 5400153 REV. F (05/2010)
Section 6 CONTRAINDICATIONS, WARNINGS
AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . 28
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . 28
Warnings and Precautions . . . . . . . . . . . . . . . . . . 28
Prescription Statement . . . . . . . . . . . . . . . . . . . 28
Eyewear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Clinical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Section 7 CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . 31
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . 31
Clinical Instructions . . . . . . . . . . . . . . . . . . . . . . . . 31
Fitzpatrick Skin Type Scale . . . . . . . . . . . . . . . . . . 31
Recommended Clinical Settings . . . . . . . . . . . . . 32
Section 8 MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Annual Maintenance . . . . . . . . . . . . . . . . . . . . . . 33
Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 33
Contamination Control Procedures . . . . . . . . . . . . . . 33
Cleaning Instructions for Handpiece
and Fiber Optic Cable. . . . . . . . . . . . . . . . . . . . 34
Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Section 9 CALIBRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Calibration Schedule. . . . . . . . . . . . . . . . . . . . . . . 35
Section 10 SOFTWARE SPECIFICATION . . . . . . . . . . . . . . . . 35
Section 11 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . 36
Appendix A LABELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
B SPARE PARTS AND ACCESSORIES . . . . . . . . . . 39
C Diolase10 System LIMITED WARRANTY . . . 40

INTRODUCTION
The Diolase10 pain therapy laser is a therapeutic device indicated for temporary
relief of minor pain. This is at the cutting edge of technology, designed for a wide
variety of procedures for painful conditions, including muscle and joint pain and
stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and back
pain. The Diolase10 laser utilizes a solid state diode as a semiconductor source of
infrared laser radiation that is not visible to the eye. 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 countour handpiece. The device is activated by means of a footswitch.
The Diolase10 laser is a prescription device that is indicated for use by a licensed
medical professional. The use of this device requires proper clinical and technical
training. The manual provides labeling instructions for the user and all other office
personnel to review and apply during use of this device. Training by an authorized
Biolase Laser Specialist is strongly recommended.
CANADA: This device must be installed and operated according to the guidelines of
CAN/CSA-Z386-92 “Laser safety in a health care facility.”
When used and maintained properly, the Diolase10 laser will prove a valuable
addition to your practice. Please contact Biolase Service at (877) 670-4767 for any
service needs.
4

SECTION 1: INSTALLATION
Installation Instructions
Upon request, your local authorized representative will unpack and install the
Diolase10 pain therapy laser.
The Diolase10 pain therapy laser includes the following:
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Console
Delivery System (One Deep Tissue Handpiece, one Fiber Assembly attached to
the console)
User Instructions
3 pairs of laser safety glasses
Footswitch with cord
Power supply with cord
Disposable handpiece covers
Remote interlock assembly
Peel-off display covers
Laser Safety Sign
Use proper care to unpack and set up the system. Refer to section 8 of this manual
for instructions on transporting the device.
FACILITY REQUIREMENTS
Electrical Supply (100-240V)
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1.5 - 3A, 50/60Hz
Environmental Requirements
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Temperature: 20-25 ºC
Humidity: 15-95%
5 5400153 REV. F (05/2010)

SECTION 2: SAFETY
The Diolase10 laser is comprised of the electrical, the optical, the software, and the
mechanical sub-systems. It is designed with safety and effectiveness in mind. User
knowledge of the potential optical and electrical hazards is important for the safe
operation of this device.
Precautions
Failure to comply with precautions and warnings described herein may lead to injury
due to exposure to dangerous optical laser radiation sources. Please review carefully
and comply with all safety instructions provided for this device.
Safety Instructions
Follow these safety instructions before and during treatments:
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All operatory entrances must be marked with an appropriate laser warning sign
included with shipment.
Do not operate in the presence of explosive or flammable materials. Flammable
anesthetics or oxidizing gases such as nitrous oxide (N 2 O) 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.
Periodically inspect laser eye wear for pitting and cracking.
!
Do not look directly into the beam or at specular reflections.
Never direct or point the beam at anyone’s eyes or at reflective surfaces.
!
NOTE: For replacement or additional protective laser eyewear, please contact
your authorized dealer.
WARNING: Do not aim the laser at metallic or reflective surfaces, such as
surgical instruments. If aimed directly at these surfaces, the laser beam will
reflect and create a potential hazard.
Press STANDBY (Standby button) on the control panel before turning off unit.
6

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Always press STANDBY on the control panel before exchanging handpieces or
treatment probes.
Turn Power Switch to OFF position before leaving the unit unattended(see rear
panel).
!
!
!
!
CAUTION: Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous radiation
exposure.
CAUTION: 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.
DANGER: Do not open the unit housing at anytime. Danger from optical
radiation may exist.
Safety Features
Energy Monitor
The current 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: “DIODE CALIBRATION”.
The unit will not operate until the system is reset by pressing the “Enter” button
or touching the Check Mark. If the error messages persist, please contact Biolase
Service at 1-877-670-4767.
7 5400153 REV. F (05/2010)

System Monitor
The system monitors the following items: emergency stop switch, remote interlock,
footswitch connection or attachment, and output power. Any error in one of these
settings will stop the system. The error message will indicate the type of error.
Operation will not resume until the error is cleared.
Power Switch
The unit can be switched ON or OFF using the toggle switch at the back panel. [ Figure
1 ].
!
Key Access
An electronic keypad prevents unauthorized use of the system. It is activated every
time the system Power Switch is turned ON.
!
READY Button
Once the power switch is set ON, the key access passcode is entered, and the unit
is in the Standby mode, the READY button on the keypad must be pressed to enable
the footswitch. The aiming beam will be lit to indicate that the system is ready for
use.
CAUTION: Use only the Power Module supplied with the Diolase10 laser.
(Labeled Diolase10)
[ Figure 1 ] Power Switch
ON
OFF
[ Figure 2 ] Power Supply with cord
NOTE: Turning the laser off by pressing the ON/OFF button on the front
panel does not re-set the key access. Always turn Power Switch OFF only
when system is not in use.
8

Footswitch
The Diolase10 laser will not emit laser energy until the user presses down on
the footswitch. The footswitch is designed to work using the footswitch cable
or wirelessly using wireless technology. One full charge of the battery will allow
approximately one week of regular operation [ Figure 3 ].
When the battery is low, a permanent cable [ Figure 4 ] should be connected to
resume operation. The unit must be turned ON to charge the footswitch. It takes 4
hours of charging time for full battery capacity.
[ Figure 3 ] Wireless Footswitch [ Figure 4 ] Footswitch Cable
!
!
NOTE: Charge the battery for 4 hours prior to initial usage. This allows the
battery to be conditioned and provide the highest level of performance.
9 5400153 REV. F (05/2010)
NOTE: It is recommended to recharge the battery overnight every week.

[ Figure 5 ] Remote Interlock Connector [ Figure 6 ] Emergency Laser Stop
Remote Interlock
This feature allows the device to be connected to a remote sensor [ Figure 5 ] which will
prevent its operation when triggered (i.e., by opening a door). The electric cable from this
connector should be wired to a normally closed switch which will turn the laser OFF when
the switch is open. This feature is overridden when the plug is not connected.
Emergency Stop
Press the red Emergency Laser Stop button [ Figure 6 ] to instantly shut down the
unit. Press the Enter or Check Mark to reset the error message.
Functional Display
The Color TFT Display with Touch Screen and LED indicators on the control panel
show the functional conditions of the system.
Safety Classification
The following safety classifications are applicable to the device:
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Laser Radiation – Class IV
Type of protections against electrical shock – Class 1
Degree of protection against electrical shock – Type B Applied Part
Not protected against water ingress – Ordinary Equipment
Not suitable for use in presence of flammable anesthetic mixture
Operation Mode – Continuous Operation
Emergency
Laser Stop
10

SECTION 3: EQUIPMENT DESCRIPTION
General
The Diolase10 laser consists of two permanently connected components:
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Console
Delivery System
CONSOLE [ Figures 7-11 ]
The Console has a Control Panel (Touch Screen and Keypad) in front and a
detachable Base attached at the bottom rear of the Console.
LASER DELIVERY SYSTEM
The Diolase10 Laser Delivery System consists of the following:
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Fiber Optic Assembly
Deep Tissue Handpiece [ Figures 12,13 ]
!
11 5400153 REV. F (05/2010)
NOTE: All fiber optic cables and handpieces are shipped non-sterile.
NOTE: The fiber optic cable is permanently attached to the Diolase10 Console.
The Handpiece is reusable and equipped with a disposable non-sterile protective
cover for single patient use. The handpiece requires cleaning before and after
each patient treatment. For instructions on cleaning the handpiece, refer to
section 8.

FRONT PANEL [ Figure A ]
# Item Item Description
1 ON/OFF Turns the controls and display on and off.
2 READY Allows energy delivery when footswitch is pressed.
3 READY LED Indicates unit is in READY mode.
4 STANDBY Does not allow energy delivery.
5 STANDBY LED Indicates unit is in STANDBY mode.
6 EMISSION LED Indicates emitting of the laser power.
7 WIRELESS LED Indicates communication with footswitch.
8 NAVIGATION WHEEL Allows to select functions and adjust parameters.
MAIN SCREEN [ Figure B ]
# Item Item Description
7
5
3
8
1 PEAK POWER DISPLAY Indicates peak power delivered in pulse mode.
2 AVERAGE POWER DISPLAY Indicates average power delivered.
3 TIMER (up/down) Displays time count down or cumlative time
depending on timer mode.
4 SETTING MENU Selects user adjustable settings menu.
5 PROCEDURES Selects pre-set procedure parameters.
6 PULSE LENGTH (up/down) Allows adjustment of laser ON time.
7 PULSE INTERVAL (up/down) Allows adjustment of laser OFF time.
6
1
4
2
[ Figure A ] [ Figure B ]
8 LASER MODE Allows switching and indicates laser operation
mode (continuous or pulsed).
[ Figure 7 ]
9 ENERGY DISPLAY Displays cumulative laser energy delivered.
1
2
3
4
5
9
6
8
7
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[ Figure 8 ]
Power Switch
Power Connector
Stand
13 5400153 REV. F (05/2010)
Emergency Stop
Service Connector
Remote
Interlock
Connector
Footswitch
Connector

Fiber
[ Figure 9 ]
14

[ Figure 10 ]
Fiber Outlet
15 5400153 REV. F (05/2010)
Cooling ventilation
channels
Regulatory
Compliance &
Description Labels
(See Appendix A)
Power Switch
Compliance Label
(located on bottom)

Touch Screen
[ Figure 11 ]
Control Panel
Deep Tissue
Handpiece
Handpiece
Holder
16

Diolase10 Deep Tissue Handpiece
1) Remove Red Dust Cover from Deep Tissue Handpiece.
2) Slide handpiece over monocoil shaft until it clicks into place.
3) Place protective cover over the adjustable
spacer.
4) Loosen the Lock Ring and set the spacer
at the 30 mm spot size detent location.
Tighten the Lock Ring.
5) Place handpiece into the Diolase 10
handpiece holder.
To remove handpiece, press and hold the buttons on the side of the shaft and pull handpiece
away from shaft.
17 5400153 REV. F (05/2010)
[ Figure 12 ] Diolase10 Deep Tissue Handpiece
[ Figure 13 ] Installation of Deep Tissue Handpiece

Diolase10 Body Contour Handpiece (Optional Accessory)
The Body Contour Handpiece is an optional accessory designed to provide a unique
form fitting shape around the body as well as a rectangular energy distribution. It is
available for purchase separately from Biolase. The total area of Laser Energy Output
is 35mm x 8mm = 2.8 cm 2 Spot Size.
[ Figure 14 ] Diolase10 Body Contour Handpiece and Diolase10 Disposable Shield
To disconnect the handpiece from the fiber optic assembly:
1. Take the handpiece body in one hand & the shaft in another [ Figure 15 ].
2. Push two buttons on the handpiece shaft.
3. Pull handpiece with the ring to separate.
To connect the Handpiece to the Fiber optic cable, push the handpiece
on the fiber shaft until it clicks on and is secured.
Fiber Shaft
Handpiece
Protective Window
[ Figure 15 ] Disconnecting the Handpiece (push both buttons)
18

SECTION 4: OPERATING INSTRUCTIONS
System Setup
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Place unit in a clean, dry and well ventilated area.
Verify power switch is in OFF position.
Verify visually that the protective window is clean. Blow off any residue or dirt
with compressed air. For best results use a micro cotton swab moistened with
isopropyl alcohol.
Carefully connect the Deep Tissue Handpiece.
Place handpiece in handpiece holder.
!
!
19 5400153 REV. F (05/2010)
NOTE: For procedures requiring average power of 5W or greater, limit
continuous firing of the Diolase10 system to 20 minutes.
CAUTION: Do not cover or block ventilation channels. These channels
provide air-flow path to cool unit. [see Figure 10]
WARNING: Never point the fiber optic at the eyes.
CAUTION: Do not bend or pull fiber optic cable sharply or the fiber will
break.
WARNING: All persons present in the operatory MUST wear protective laser
eyewear when laser is in operation.

Operation
Starting up the Diolase10 Laser
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Connect power cord to power connector on the unit and plug into wall outlet.
Connect footswitch cable to the unit and to the footswitch.
Turn the power switch to the ON position. The Diolase10 Welcome Screen will
be displayed.
Enter the three digit key access code using the touch screen or system “navigation
wheel”. Access Key Code is 123.
You can also use the Arrow and “Enter” buttons on the Navigation Wheel to select
the numbers.
The system will go to the Main Screen and will default to the STANDBY mode.
OPTIONAL: To use the footswitch wirelessly, disconnect and press the footswitch.
Blue LEDs will confirm wireless communication.
You are now ready to use the Diolase10 Laser.
BIOLASE
Welcome to
Diolase 10
1 2 3 4
5 6 7 8
[ Figure 16 ] Welcome Screen [ Figure 17 ] Main Screen
20

ON/OFF Button
Press the ON/OFF button. At this time the unit will go to “sleep” mode.
READY/STANDBY Buttons
Unit will only emit laser energy when the footswitch is pressed and the unit is in
READY mode. Settings may be adjusted in both modes. In READY mode, values may
be changed only when the footswitch is released.
Press the READY button. At this time the system fan will turn ON and pressing the
footswitch will activate laser radiation. There is a 2 second delay between switching
to READY mode and the ability of the system to emit a laser beam. This is evidenced
by the delay in the appearance of the red aiming beam.
Navigation Wheel
The Navigation Wheel can be used to modify settings or make selections:
• “Up“ and “Down” arrows are used to scroll between functions.
• “Left” and “Right” arrows are used to increase / decrease values.
• “Enter” button is used to select function or enter the value.
Footswitch
When the footswitch is pressed and the laser fires, a beeper will sound, indicating
that laser energy is present. An amber LED will also light up on the top of the front
panel. When the footswitch is not pressed, the beeper and LED will terminate,
indicating that laser energy is not present.
!
21 5400153 REV. F (05/2010)
NOTE: Charge footswitch battery for 4 hours when first connected. Power
switch should be ON. Before disconnecting the footswitch cord after each
charge, re-cycle the power by turning the power switch OFF and ON to reset
wireless communication. Then unplug footswitch cord from the unit
and from the footswitch. Press the footswitch – blinking blue LEDs confirm
presence of wireless communication. Footswitch will operate for about 1
week without recharging, so long as the power switch is maintained in the
“ON” position.

If you have more than one Diolase10 laser unit in your facility, you must observe
the following precautions:
!
WARNING: DO NOT establish wireless communication with more than one
Diolase10/footswitch combination simultaneously. Instead, establish
wireless communication sequentially, one pair at a time. See note above
for instructions on establishing wireless communication.
WARNING: DO NOT disconnect the footswitch cable at either end when
! the laser is firing.
WARNING: Before turning off the power switch at the rear of the
Diolase10 device, disconnect the footswitch cable at either end. (Note
! that the power switch must be turned ON when charging the footswitch.)
!
WARNING: When an aiming beam is not present, inspect and clean the
protective window (see Section 8).
POWER Buttons
The Average Power is displayed in the center of the main screen.
This is a calculated value depending on the Peak Power, Pulse
mode, Pulse Interval and Pulse Length settings. To change the
average power, press the AVERAGE POWER area and then select the arrows to adjust
power level. Press either the right arrow to increase power level or the left arrow to
decrease power level.
Peak Power Display
TIMER Buttons
This area is shown only when the system is in the pulsed mode and
presents the peak power based on the Average Power, Pulse Length
and Pulse Interval settings.
The TIMER has both countdown and count-up features. When
the timer is set greater than 00:00 , the system is in countdown
mode. The arrow will point down and will count down only during
firing. The unit stops firing when the timer reaches 00:00. A brief pause and beep
will indicate the end of the timer cycle. At that point the timer will reset to the initial
22

countdown time setting. The system will count up when the timer is set to 00:00.
In count-up mode, the unit will measure the treatment time while the footpedal is
activated. To reset the treatment time to 00:00, press and hold the timer button for
3 seconds.
LASER MODE button
The Laser MODE button graphically indicates whether the system is in Continuous
Mode or in Pulsed Mode. When the system is in Pulsed Mode, both Pulse Length
and Pulse Interval active displays are present as well as the Peak Power window.
These windows are inactive in Continuous Mode. The Laser MODE button toggles
between Pulsed and Continuous Modes.
23 5400153 REV. F (05/2010)
In Continuous Mode, laser power is constantly delivered when the unit is
fired. There are no Pulse Length or Interval adjustments in this mode.
In Pulsed Mode, laser radiation is delivered in repetitive pulses, controlled by
Pulse Length and Pulse Interval settings. The Pulse Length, Pulse Interval,
and Peak Power windows are activated.
TOTAL ENERGY button
The TOTAL ENERGY button displays the total energy delivered. The
total can be reset to 0 Joules by pressing and holding the button for
approximately 3 seconds.
PULSE LENGTH Button [ Figure 18 ]
In Pulse Mode, press the PULSE
LENGTH button to adjust laser
ON time. Press HOME icon at any
time to return to the Main Screen.
Press the arrows to increase or
decrease pulse length. Press the DISK icon to save
pulse settings. To cancel any changes, press the
HOME icon prior to saving any new parameters.
Laser ON time is when the laser energy is applied.
A longer time leads to generally more thermal
effect. [ Figure 19 ]
[ Figure 18 ] Pulse Mode Screen

PULSE INTERVAL Button [ Figure 18 ]
In Pulse Mode, press the PULSE INTERVAL button to adjust laser OFF
time. Press HOME icon at any time to return to the Main Screen.
Press the arrows to increase or decrease pulse interval. Press the
DISK icon to save pulse settings. To cancel any changes, press the
HOME icon prior to saving any new parameters.
Increased laser OFF time allows generally greater tissue cooling with less thermal
effect. [ Figure 19 ]
PROCEDURES Button [ Figure 20 ]
The system has seventeen pre-sets to be programmed by the user.
All of them can be customized to your preference. Fifteen of the
seventeen pre-sets have been labeled for specific clinical indications. Please refer to
the Indications For Use section to review the clinical indications.
In order to customize parameters for a particular clinical procedure:
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Adjust parameters on the Main Screen
Select PROCEDURES Button
Scroll to the desired procedure name.
Press and hold the selected Procedure for
2 seconds. An audible tone indicates that
the Parameters have been saved for that
Procedure.
[ Figure 19 ] Relationship between Pulse Length
and Pulse Interval in the Pulse Mode
[ Figure 20 ] Procedures Screen
24

SETTINGS Menu [ Figure 21 ]
s
s
s
25 5400153 REV. F (05/2010)
By pressing the SETTINGS
button, you can get access to
several system settings:
Aiming Beam (5 levels of brightness
adjustment)
Beep Sound (3 levels of sound
adjustment)
Screen Calibration – used to recalibrate
the touchscreen alignment. Follow the
on screen instructions.
Shutting Down the Diolase10 Laser
s
s
s
Place the handpiece back on the
handpiece holder.
Press the ON/OFF button to turn the display OFF.
If laser system will not be used for a long period of time, Turn the Power Switch to
the OFF position.
!
[ Figure 21 ] Menu Screen
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,
bent sharply or tugged.

Using the Diolase10 Deep Tissue Handpiece
The Deep Tissue Handpiece is indicated for use at the 30 mm spot size.
1) Set the spot size to 30 mm:
Loosen the lock ring and slide spacer to the 30 mm spot size detent location.
Tighten the lock ring to prevent spacer from moving during treatment.
2) Select appropriate laser parameters:
To select power and exposure time, refer to Clinical Settings. Adjust power as
necessary to maintain patient comfort during treatment.
3) Perform treatment:
A) Set the system into Ready mode, by pressing the READY button.
B) Place handpiece with protective cover in contact to the treatment area.
C) Use the red laser beam as reference for center of the treatment location to
position the handpiece.
D) Press the footpedal to activate the infrared laser. A beeping sound is produced
to alert the user that the laser is firing.
E) Treat the area for the duration needed.
G) Check with the patient periodically to ensure comfort during use. Reduce power
when patient is reporting discomfort.
Using the Optional Diolase10 Body Contour Handpiece
Please refer to the Clinical Settings found on page 32 for detailed instructions on how to
use the Diolase10 Body Contour Handpiece.
26

SECTION 5: Diolase10 Laser
SPECIFICATIONS
General
s
s
Dimensions W x H x D (3.5” x 7.0” x 2.5”) (8.5 x 18 x 6cm)
Weight 2 lbs. (1.0 kg)
Electrical
Operating Voltage 100 to 240 ~ at 2A
Frequency 50 / 60 Hz
External Fuses None
Main Control Power Switch
On / Off Controls Keypad Button, Emergency Stop
s
s
s
s
s
s
Remote Interruption Remote Interlock Connector
Laser
Laser Classification IV (4)
Medium GaAlAs
Wavelength 940 ± 15 nm
Max Output Power 10 Watts @ 940nm
Power Accuracy ± 20%
Power Modes Continuous, Pulse Modulation
Pulse Length* 0.06 ms - 1 sec
Pulse Interval* 0.06 ms - 1 sec
Pulse Repetition Rate
Spot Size
up to 10 KHz (for reference)
Deep Tissue HP 30 mm diameter = 7.1 cm2 area
Body Contour HP Rectangular 35mm x 8mm = 2.8 cm2 area
s
s
s
s
s
s
s
s
s
s
s
s
NOHD** 11.8 meters
Fiber Cable Length 6 feet (1.829 meters)
Other Light sources
s
Aiming Beam Laser Diode, max 3 mW, 630-670nm, class 3B
* The following Pulse length and
interval settings will result in the
ranges specified:
** Without handpiece
27 5400153 REV. F (05/2010)
Display Range
0.05 ms
0.10 ms
0.20 ms
0.05 ms – 0.07 ms
0.10 ms – 0.14 ms
0.20 ms – 0.28 ms

SECTION 6: CONTRAINDICATIONS,
WARNINGS AND PRECAUTIONS
Contraindications
All clinical procedures performed with the Diolase10 laser must be subjected to
the same clinical judgment and care as with traditional techniques. Patient risk must
always be considered and fully understood before clinical treatment. The clinician
must completely understand the patient’s medical history prior to treatment. 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, lung disease, malignancies, bleeding disorders, sleep
apnea or an immune system deficiency. Medical clearance from patient’s physician is
advisable when doubt exists regarding treatment.
Warnings and Precautions
Prescription Statement
Federal law restricts this device to sale by or on the order of a 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±15 nm.
Clinical Use
Use your clinical judgment to determine all aspects of treatment including, but not
limited to, the laser treatment protocol, technique, power settings, pulse duration and
interval settings, mode of operation as well as the accessories (e.g. handpiece type)
and other procedural requirements. Always start treatment at the lowest power
setting for the procedure and increase as required. Make appropriate adjustments to
compensate for varying skin tissue types, density and thickness.
!
WARNING: Stop the treatment if the patient experiences any pain or
discomfort or if the handpiece is too hot to touch.
28

All patients must receive a Fitzpatrick Skin Type (see Section 7: Clinical Applications)
evaluation prior to treatment. According to Dr. Thomas B Fitzpatrick, most people
when exposed to sun will fall into 1 of 6 different types of skin. The therapeutic
power level for this device and the Deep Therapy Handpiece is determined
based on the patient skin type and tolerance to heat at the location of treatment.
Treatment site assessment is also required to determine treatment conditions and
laser power settings and dose applicable to the patient. Here are the most important
things to look for:
A) 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
heating.
B) Tender or sensitive skin – patient may be hypersensitive to heat. Reduce power
as necessary to ensure comfort during treatment.
C) Swelling/inflammation – patient may be sensitive to heat. Reduce power as
necessary to ensure comfort during use.
D) Redness – has been associated with increased temperature at the site and an
increase in absorption properties of the skin. Reduce power as low as necessary to
maintain comfort during use.
E) Open wounds – do not treat.
F) Muscle tissue closer to skin surface – may have higher absorption, carefully
monitor skin temperature and reduce power as necessary.
G) Excessive fatty tissue – is known to transmit heat without much attenuation.
Reduce power as necessary.
H) Implants – different materials will respond differently to the laser energy and
heat. Be aware of any implants and location. Avoid direct exposure of the implant
site to laser or heat.
I) Tattoos – Avoid treatment of sites that have tattoos.
J) No ointments, creams, lotions or heating lotion patches at the site or on close
proximity.
29 5400153 REV. F (05/2010)

K) No therapies that could change body temperature e.g. ultrasound, ice/heat pack,
electrical stimulation, heating patches, etc., prior to laser use.
L) No treatment over articles of clothing.
Patients must be monitored for pain or discomfort throughout the entire procedure.
In any case if the patient does not tolerate the therapy discontinue treatment
immediately.
Training
Training by a Biolase Laser Specialist or Authorized Representative is strongly
recommended. Only licensed professionals who have read 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.
!
FOR HEALTH CANADA ONLY: The device is intended as an adjunct to the
treatment of pain in the context of a comprehensive treatment plan by a
qualified health care provider.
30

SECTION 7: CLINICAL APPLICATIONS
Indications for Use
Use of the Diolase10 laser may be appropriate for the following indication for use:
The Diolase10 laser emits energy in the near-infrared spectrum to provide 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.
Clinical Instructions
The Diolase10 laser is a 940nm diode laser system designed to provide near-
infrared laser energy to tissue for the purpose of elevating the temperature and
providing temporary relief of minor pain.
Pain affected sites, muscles and/or joints, have to be exposed to an adequate level
of therapeutic energy over a short period of time for effective therapeutic effects.
Follow the Fitzpatick Skin Type Scale below, select the appropriate clinical parameter
and reduce power as necesary for patient comfort.
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: Mediterranian 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
31 5400153 REV. F (05/2010)

Recommended Clinical Settings:
Some patients may require more than one laser application or a series of treatments
before significant improvement is reported. Repeat this therapy as necessary and
monitor progress of the patient’s condition throughout the treatment.
Deep Tissue Handpiece at 30 mm spot size:
TYPE II: Set Power to 4.0W CW for 2 minutes, followed by Power at 3.25W for 3
minutes and then set Power to 2.75W CW for the remaining 5 minutes
TYPE III: Set Power to 4.5W CW for 2 minutes, reduce Power to 4.0W for the
remaining 8 minutes.
TYPE IV: Set Power to 4.0W CW for 2 minutes, reduce Power to 3.5W for the
remaining 8 minutes.
TYPE V: Set Power to 3.5W CW for 2 minutes, reduce Power to 3.0W for the
remaining 8 minutes.
Type I and VI are less common, settings are not available at this time.
Body Contour Handpiece:
Two main therapeutic power settings P1 = 2.75W and P2 = 5.5W are recommended
for this handpiece. For patients treated at P1 = 2.75W the Body Contour handpiece
has to be placed in contact with the skin and laser energy has to be delivered for 10
minutes continuously. At the higher setting of P2 = 5.5W the handpiece has to be
in non-contact at ~2-3mm away from the skin surface. The exposure time stays the
same. Patients should be monitored for discomfort. If discomfort is reported at any
time during the treatment there are several options: a) decrease the power setting;
b) defocus the energy by moving the handpiece further away from the skin; or c)
stop treatment.
32

SECTION 8: MAINTENANCE
Annual Maintenance
The Diolase10 laser should be serviced annually by a qualified, trained, and
certified technician. Annual calibrations can be performed at a certified depot
repair facility. Call Biolase Service at 1-877-670-4767 or your Authorized Service
Representative to schedule an appointment.
Please contact Biolase Service at 1-877-670-4767 or your Authorized Representative
to discuss Extended Service Contracts and Annual maintenance options.
Daily Maintenance
Use a disinfectant to wipe down
the front panel of the Diolase10
system after each procedure. Use
peel-off clear covers supplied with the
system. Do not use bleach or abrasive
cleansers.
Check and clean the protective
window of the fiber optic shaft with a
cotton swab moistened
with ispropyl alcohol.
!
Contamination Control Procedures
The Diolase10 laser is a device that uses a handpiece in contact with the skin of the
patient. Non-sterile disposable protective covers are provided for the doctor to use
with every patient.
NOTE: The protective disposable covers are intended for one time use only and
therefore cannot be cleaned and reused.
33 5400153 REV. F (05/2010)
[ Figure 22 ] Check and clean the protective
window of the fiber optic shaft.
WARNING: Failure to check and clean the window will lead to reduced
optical power efficiency and permanent damage to the system.

Cleaning and Disinfection for the Handpiece and Fiber Optic Cable
The cleaning process is intended to remove potential contaminants from the surfaces
of reusable accessories. This process may also reduce the quantity of particles,
and other contaminants present. Cleaning must be conducted only by qualified
office personnel trained to perform the procedure and handle the Diolase10 fiber
optic Delivery System. Wear protective latex gloves when handling a contaminated
delivery system. To clean the fiber cable, gently wipe the entire cable including
shaft with cotton gauze and chemical disinfectant. Keep the window intact. If the
window is dirty, clean with a cotton swab moistened with isopropyl alcohol.
To clean the handpiece:
s
s
s
Remove the disposable cover from the handpiece.
Carefully remove the handpiece from the fiber optic cable (see Section 3).
Wipe the entire outer surface of the handpiece with cotton gauze and
isopropyl alcohol or a mild chemical disinfectant.
Transportation
The Diolase10 laser is a precision laser treatment device and 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 of its shipping
box. If you have any questions regarding transportation please call your local
Representative.
Storage
The Diolase10 laser should be stored in a cool dry place when not in use. Store the
unit in a temperature range from 15°C - 35°C (59°F - 95°F) with a relative humidity
of 10%-70%. 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.
The Diolase10 laser was shipped inside a custom shipping box. Please save and
store the box in a cool dry place.
!
CAUTION: Make sure the distal end of the Handpiece shaft is protected
from dirt with the protective tip plug and Handpiece.
34

SECTION 9: CALIBRATION
Calibration Schedule
Calibration procedure is recommended to be performed every 12 months in order
to maintain the required accuracy of output power versus displayed power. Annual
calibrations can be performed at a certified depot repair facility. Call Biolase Service
at 1-877-670-4767 or your Authorized Service Representative to schedule an
appointment.
SECTION 10: SOFTWARE SPECIFICATION
Biolase respects the intellectual property of others, and we ask our users to do the
same. Diolase10 software is protected by copyright and other intellectual property
laws. This product includes software developed by Biolase Technology Copyright
©2009 Biolase Technology.
35 5400153 REV. F (05/2010)

SECTION 11: TROUBLESHOOTING
The table below shows the list of error messages which can be fixed by the user in
most cases. If Corrective Action does not help, re-power the laser. If the Error is still
not cleared after re-powering, please call Service at (877) 670-4767 or your Biolase
Authorized Representative.
!
NOTE: For all Error Messages not listed in the table, re-power the system
and if the Error is not cleared, call Biolase Service at (877) 670-4767 or your
Biolase Authorized Representative.
ERROR REASON
Footswitch not
available
Remote Interlock
Open
Emergency
Pressed
Diode Current
Error
Thermistor Error
Overtemperature
Footswitch
shorted
Remote
Interlock
Open
Emergency
Pressed
Output is out
of specs
Thermistor
Error
System
too hot
FIX
Footswitch not
in Ready mode
Check Remote
Interlock
Press E-Switch
again
Calibration
Error
Call service
Wait to cool
down.
bad
bad
bad
bad
bad
bad
CORRECTIVE ACTION
1. Press READY button;
2. Connect Footswitch cable;
3. Charge Footswitch battery.
1. Disconnect Interlock;
2. Close Interlock switch.
Call Service for
laser calibration.
Call Service for
laser calibration.
Call Service for
laser calibration.
Wait 5-10 mins for
laser to cool down
36

APPENDIX A: LABELS
A.1 Identification
Location: Back Panel
[ Figure 11 ]
A.3 Laser Aperture
Location: Back Panel, Right Side
37 5400153 REV. F (05/2010)
A.2 Footswitch
Location: Back Panel, Left Side
[ Engraved ]
A.4 Remote Interlock
Location: Left Side
[ Engraved ] [ Figure 9 ]

A.5 Emergency Laser Stop Switch
Location: Left Side
A.7 Compliance Label
Location: Bottom Side
[ Figure 11 ]
A.6 Warning Label
Location: Back Panel
38

APPENDIX B: SPARE PARTS AND
ACCESSORIES
DESCRIPTION
2400040 Laser Safety Glasses
6400058 Remote Interlock Plug
6400142 Power Supply, Diolase10
6400177 Footswitch, Diolase10
6400053 Footswitch charging cable
6400091 Touchscreen Peel-off covers (qty. 30)
6400180 Body Contour Disposable clear handpiece covers (30 pack)
7400029 Body Contour Handpiece
7400023 Wall Mount
7400036 Battery Pack, Diolase10
6400133 Replacement Battery for Battery Pack
6400206 Travel Case, Diolase10
5400144 Laser Safety Sign
6400310 Diolase10 Deep Tissue Handpiece Protective Covers (qty 20)
6400311 Diolase10 Deep Tissue Handpiece
39 5400153 REV. F (05/2010)

APPENDIX C: Diolase10 Laser LIMITED
WARRANTY
(a) Seller warrants the goods and parts which are of its manufacture and shipped hereunder
to be free from defects in material and workmanship for twenty four (24) months from
shipment.
(b) This warranty is the only warranty made by seller with respect to the goods delivered
hereunder and no representative or person is authorized to assume on Seller’s behalf,
any obligations or liabilities beyond this warranty in connection with the sale of Seller’s
goods. This warranty is made to the original purchaser only at the original location and is
non-transferable, and may only be modified or amended by a written instrument signed by
a duly authorized office of the seller. Major sub-systems manufactured by other firms, but
integrated into Seller’s system are covered by the original manufacturer’s warranty. Goods
or parts which are replaced or repaired under this Warranty are warranted for 90 days after
replacement/repair.
(c) All accessories used with Biolase lasers must be manufactured by or certified in writing by
Biolase. Use of non-authorized accessories will void the warranty, all service contracts and
all liability to Biolase.
(d) Seller’s sole and exclusive liability and the Buyer’s sole and EXCLUSIVE REMEDY under this
warranty shall be, at Seller’s election, the repair or replacement of goods, only if Seller is
promptly notified by Buyer upon discovery of the defects and the Seller’s examination of
such goods discloses to Seller’s satisfaction that such defects actually exist and the goods
have not been (i) repaired, worked on, or altered to affect the stability, reliability, or proper
operation of such goods; (ii) subject to misuse, negligence or accident; or (iii) connected,
installed, used or adjusted otherwise than in accordance with the instructions furnished by
Seller. Replacement parts may be new or equivalent to new. Seller, at its sole discretion,
may repair or replace any component or hardware product that manifests a defect in
materials or workmanship during the Limited Warranty Period.
(e) All goods which Buyer considers defective shall be returned to Seller’s office, transportation
costs prepaid and borne by Buyer (unless otherwise agreed to in writing). The risk of loss
of goods shipped or delivered to Seller’s plant to repair or replacement will be borne by
Buyer.
(f) If it is found that Seller’s Product has been returned without cause and is still serviceable,
Buyer will be notified and the product returned at Buyer’s expense; in addition, a charge for
testing and examination may, in Seller’s sole discretion, be made on Products so returned.
(g) SELLER MAKES NO EXPRESS OR IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED
TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE EXCEPT AS EXPRESSLY SET FORTH IN THE ABOVE WARRANTY. IN NO EVENT
SHALL SELLER BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL INDIRECT OR
SPECIAL DAMAGES OF ANY KINDS, INCLUDING BUT NOT LIMITED TO, DAMAGES
FOR LOSS OF REVENUE, LOSS OF BUSINESS OR BUSINESS OPPORTUNITIY, OR
OTHER SIMILAR FINANCIAL LOSS ARISING OUT OF OR IN CONJUNCTION WITH THE
PERFORMANCE, USE OF OR INTERRUPTED USE OF SELLER’S PRODUCTS, SYSTEM(S) OR
MATERIALS.
40