Biolase waterlase dentistry C100 User manual

© 2008, Biolase® 5100109 REV. D (12/10)
biolase.com
NASDAQ: BLTI
USA
BIOLASE®Technology, Inc.
4 Cromwell
Irvine, CA 92618
949.361.1200
Europe
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert
Germany
[phone]
www.mt-procons.com
EC REP

USER MANUAL

5100109 REV. D (12/10)
© 2008 BIOLASE Technology, Incorporated. All Rights Reserved.
BIOLASE Waterlase®C100 YSGG User Manual.
BIOLASE, the BIOLASE logo, Waterlase, and the Waterlase®C100 logo
are either registered trademarks or trademarks of BIOLASE Technology
Incorporated in the United States and/or other countries.
biolase.com
NASDAQ: BLTI
USA
BIOLASE®Technology, Inc.
4 Cromwell
Irvine, CA 92618
949.361.1200
Europe
EC REP MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert
Germany
[phone]
www.mt-procons.com
USER MANUAL

©2008 BIOLASE Technology Inc. All Rights Reserved.
CONTENTS
INTRODUCTION ..............................................7
Section 1 INSTALLATION OF THE WATERLASE C100 .........................7
Installation Instructions..........................................7
Facility Requirements ...........................................7
Electrical Supply............................................7
Compressed Air Supply/Laser Internal Co .........................7
Section 2 SAFETY WITH THE WATERLASE C100. . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Precautions ..................................................9
Safety Instructions .............................................9
Safety Features...............................................10
Energy Monitor ............................................10
Circuit Breaker ............................................10
Keyswitch................................................10
READY Button ............................................11
Footswitch ...............................................11
Remote Interlock Outlet .....................................11
Emergency Stop (Figure 8) ...................................11
Functional Panel ..........................................11
Layout of Control Elements ...................................11
Section 3 EQUIPMENT ................................................12
General ....................................................12
Optical Power Unit Elements.....................................12
Control Panel .............................................12
Keyswitch (Figures 2 & 7)....................................12
Footswitch Connector (Figure 7) ...............................14
Remote Interlock (Figure 7) ..................................14
Power Connection (Figure 7) .................................14
Circuit Breaker (Figure 7) ....................................14
Ventilation Channels (Figure 7) ................................14
Locking Wheels (Figure 6) ...................................14
Front Handle (Figure 6) .....................................14
Back Panel (Figure 7).......................................14
Handpiece Holder (Figure 8) .................................14
Air Input (Figure 7).........................................14
Self Contained Water System (Figure 7) .........................14

5100109 REV. D (12/10)
Delivery System Support Arm with Hook (Figure 6) .................14
Water Bottle Switch (Figure 7).................................14
Fill/Drain Connector (Figure7).................................14
Waterlase MD Delivery System ...................................18
Handpiece ...............................................18
Laser Tip ................................................18
Trunk Fiber...............................................18
Delivery System Connections on the Unit ........................18
Handpiece Collar ...........................................18
Quick Release Mechanism/Tabs ...............................18
Optical Shaft..............................................18
Tip Plug (for tip) ...........................................18
Protective Rubber Cap (for fiber optic connector) ..................18
Laser Connector Housing ....................................18
Handpiece Holder .........................................19
Protective Cover ...........................................19
Rear Plug ................................................19
Tip Remover ..............................................19
Revolving Tip Holder........................................19
Section 4 OPERATING INSTRUCTIONS .................................. 20
Setup ................................................... 20
Connect Unit to Operatory .................................. 20
Fill Self Contained Water System Bottle ......................... 20
Secure Fiber Optic Assembly to Unit.............................. 21
Connecting Handpiece to Fiber Optic Cable. ..................... 22
Disconnecting the Handpiece ................................ 22
Installing Tip in the Handpiece ............................... 23
Changing Tips............................................ 24
Operation .................................................. 24
Overview ............................................... 24
Tip Cleaning and Inspection ................................. 25
Operational State Description ................................ 25
To Start the Waterlase®C100 ................................ 25
Modify and Save Preferred Values as Presets .................... 27
Activate the Waterlase®C100 ................................ 27
Turn the Waterlase®C100 Off ................................ 27
Error Messages........................................... 27
Section 5 WATERLASE®C100 SPECIFICATIONS ........................... 28
General ................................................... 28
Dimensions (W x L x H) .................................... 28
Electrical ............................................... 28

©2008 BIOLASE Technology Inc. All Rights Reserved.
Waterlase®C100 ......................................... 28
Optical ................................................ 28
Section 6 CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS ............ 29
Contraindications ............................................ 29
Indications, Warnings and Precautions ............................ 29
Eyewear ................................................ 29
Anesthesia .............................................. 29
Treatment, Technique and Settings ............................ 29
Curettage Procedures ...................................... 29
Fluid Entrapment and Air Embolism ........................... 29
Root Canal Procedures ..................................... 30
Adjacent Structures ....................................... 30
Clinical Conditions ........................................ 30
Tissue Evaluation ......................................... 31
Tissue Contact and Tip Breakage ............................. 31
Tip Changing ............................................ 31
Water Splashing .......................................... 31
Plume Removal .......................................... 31
Dental Materials .......................................... 31
Training ................................................ 31
Section 7 CLINICAL APPLICATIONS..................................... 32
Introduction ................................................ 32
Hard Tissue Cutting ....................................... 32
Soft Tissue Incision, Excision and Ablation ...................... 33
Procedure Guidelines ...................................... 33
Presets for Soft and Hard Tissue Procedures..................... 33
Fiber Tip Calibration Chart .................................. 37
Tip Specifications ......................................... 37
Handpiece Cleaning and Sterilization ......................... 37
Handpiece Cleaning ....................................... 37
Steam Sterilization for Handpiece and Tips ...................... 38
Waterlase®C100 Indications for Use.............................. 39
Hard Tissue ............................................. 39
Soft Tissue .............................................. 40
Section 8 MAINTENANCE ............................................. 41
Annual Maintenance ......................................... 41
Delivery Maintenance ......................................... 41
Daily Maintenance ........................................... 41
Transportation .............................................. 41
Storage ................................................... 41

5100109 REV. D (12/10)
Section 9 CALIBRATION .............................................. 42
Calibrating Power ............................................ 42
Calibration Schedule.......................................... 43
Appendix A: INSTRUCTIONS FOR FILLING THE INTERNAL COOLING RESERVOIR .... 44
Appendix B: LABELS .................................................. 49
Laser Hazard Symbol ......................................... 49
High Voltage Hazard Symbol.................................... 49
Certification ................................................ 49
Non-Interlocked Protection Housing Warning ....................... 49
Laser Aperture .............................................. 49
Attention Label.............................................. 50
Protective Ground............................................ 50
Laser Explanatory Label ....................................... 50
Ground ................................................... 50
Indentification .............................................. 50
Electrical Ratings ............................................ 51
Cooling System Fill/Drain ...................................... 51
Air Label................................................... 51
Key Switch ................................................. 51
Water Spray ON/OFF ......................................... 51
Remote Label ............................................... 51
ETL Listed ................................................. 51
Footswitch Label............................................. 51
Emergency Stop Label ........................................ 51
Appendix C: SPARE PARTS AND ACCESSORIES ............................. 54
Appendix D: CLINICAL PROCEDURE GUIDELINES ........................... 55
Root Canal Clinical Protocol .................................... 55
Procedure .............................................. 55
Apicoectomy Clinical Protocol ................................... 57
Procedure .............................................. 57
Appendix E: WATERLASE®C100 WARRANTY................................ 60
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©2008 BIOLASE Technology Inc. All Rights Reserved.
INTRODUCTION
The Waterlase®C100 Er,Cr:YSGG (Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet) tissue cutting system is a unique device
with diverse hard and soft tissue dental applications. For hard tissue procedures, the Waterlase®C100 utilizes advanced laser
and water atomization technologies to safely and effectively perform tissue cutting, shaving, contouring, roughening, etching and
resection. For soft tissue procedures, the Waterlase®C100 utilizes direct laser energy to perform tissue removal, incision, excision,
ablation and coagulation.
For hard tissue procedures, the YSGG solid-state laser provides optical energy to a user controlled distribution of atomized water
droplets. As the water droplets absorb the optical energy, hydrokinetic cutting effects results. The hydrokinetic process refers to the
removal of tissues with highly energized water particles. Strong absorption of laser energy by atomized water droplets results in an
intense yet controlled water particle excitation and micro-expansion. The resulting forces induce mechanical separation of surface
material, yielding quick and clean mechanical hard tissue removal. A flexible fiber optic cable with a handpiece delivers the unique
laser wavelength and atomized distribution of water particles to the tissue target. A red light emitted from the handpiece distal end
pinpoints the area of treatment. The optical power output and atomized water spray may be adjusted to specific user requirements
for both soft and hard tissue applications.
For soft tissue applications a different mode of operation is utilized. In soft tissue mode, the Waterlase®C100 is programmed to
perform tissue removal, incision, excision, ablation and coagulation using direct laser energy either with or without water for cooling
and hydration.
Use of this device requires proper clinical and technical training. This manual provides instructions for use for trained professionals.
When used and maintained properly, the Waterlase®C100 will prove a valuable addition to your practice. Please contact your
authorized local BIOLASE representative if you have any questions or require assistance.
CANADA: This device must be installed and operated according to the guidelines of CAN/CSA-Z3 86-92, “Laser
Safety in a Health Care Facility”.
SECTION 1: INSTALLATION OF THE WATERLASE®C100
INSTALLATION INSTRUCTIONS
Upon request, your local authorized BIOLASE representative will unpack the Waterlase®C100 and your service representative will
install the unit.
FACILITY REQUIREMENTS
Electrical Supply
USA (UL) 115 VAC @ 16.0 A
International: 230 VAC @ 8.0 A
Compressed Air Supply
 • 80-120psi(5.5-8.2bar) 7

5100109 REV. D (12/10)
CAUTION: Prior to connection, verify that outlet is for air, not water supply. Connection to water supply may cause damage to
the Waterlase®C100 system. If the unit was connected to the water supply, do NOT turn the system on. Contact
your service representative.
CAUTION: Unit must not be operated without filling the internal cooling system reservoir with DI or Distilled water. Improper
filling may damage the unit. Please read the instructions carefully.
 • Moisture in the air supply line may damage the laser system. Please provide proper filtration to eliminate all moisture from air
source.
Connections for air supply must be available in each operatory.
Attach air hose with 1/4” inside diameter male quick connectors on each end between air inlet connector (Figure 7) and operatory
air source.
To fill cooling system, please refer to the instruction sheets P/N 5000875 that are included in the package containing the funnel
assembly.
For reference, the Instructions For: Filling the Internal Cooling Reservoir P/N 5000875 are included in this manual, see Appendix A.
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©2008 BIOLASE Technology Inc. All Rights Reserved.
SECTION 2: SAFETY WITH THE WATERLASE®C100
PRECAUTIONS
Failure to comply with precautions and warnings described herein may lead to exposure to dangerous voltage levels or optical
radiation sources. Please comply with all safety instructions and warnings.
SAFETY INSTRUCTIONS
Follow these safety instructions before and during treatments:
1. Remove or cover all highly reflective items in the treatment area, if possible.
2. Do not operate in the presence of explosive or flammable materials.
3. All persons present in the operatory must wear protective eyewear suitable for blocking 2.78 µm wavelength spectrums. Ensure
Waterlase®C100 Handpiece Mirror is clean and there is no evidence of moisture or water present (refer to mirror inspection
and remove inspection kit).
4. Do not look directly into the beam or at specular reflections.
5. Direct the cutting spray toward targeted tissues only.
6. Press STANDBY (Standby button) on the control panel before turning off the unit.
7. Press STANDBY on the control panel before exchanging handpieces or removing the fiber optic connector from the unit.
8. Move the circuit breaker to OFF (O) position (located on rear panel) and remove the key before leaving unit unattended.
CAUTION: Use of controls or adjustments or performance of procedures other than those specified herein may result in
hazardous radiation exposure.
CAUTION: This unit has been designed and tested to meet or exceed the requirements of severe electromagnetic,
electrostatic and radio frequency interference testing. However, the possibility of electromagnetic or other
interference may still exist.
CAUTION: DO NOT USE THIS UNIT IN ANY MANNER OTHER WHICH IS NOT DESCRIBED HEREIN. DO NOT USE THE UNIT
IF YOU SUSPECT IT IS FUNCTIONING IMPROPERLY.
CAUTION: Periodically inspect eyewear for pitting and cracking.
NOTE: For replacement, additional, or prescription protective eyewear, please contact your Waterlase®C100
representative.
DANGER: DO NOT remove system housing. Danger from radiation exposure and high voltage may exist.
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5100109 REV. D (12/10)
All operatory entrances must be marked with an approved laser warning sign.
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 an error message. The unit will not operate until the system is reset by pressing any key on the keypad. If
error messages persist please contact your BIOLASE representative.
Circuit Breaker
The circuit breaker serves as a line switch to separate the unit
from the main power supply (0 = OFF, 1 = ON).
Keyswitch
To switch unit ON, turn the key to the horizontal position.
Use the proper key only. The key cannot be removed while
in the ON position. Always remove key when not in use.
Figure 2: Keyswitch
Figure 1: Circuit Breaker
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©2008 BIOLASE Technology Inc. All Rights Reserved.
READY Button
Once the circuit breaker and key switch are set to the ON position, the READY button on the keypad must be pressed to enable the
footswitch. Three beeps will sound to indicate that the system is ready for use.
Footswitch
The Waterlase®C100 will not activate until the user presses down on the footswitch. A
protective cover prevents unintentional pressing of the footswitch.
Remote Interlock Plug
Each laser has a remote plug and connector on its rear panel. The purpose is to enable a user
provided remote switch (e.g., on the entrance door) to turn OFF the laser. To use it properly
requires a normally closed pair of contacts connected to pins 1 and 5 of the connector. These
contacts should have no voltage associated with them and should open on activation.
Emergency Stop (Figure 8)
Push to activate emergency stop. Rotate and release button to restart. Do not use as a
normal means to stop the laser.
Functional Display
The Liquid Crystal Display (LCD) and the Light Emitting Diode (LED) indicators on the control
panel show the functional conditions of the system.
Layout of Control Elements
All control functions are located at a safe distance from energy output. Control panel layout is described in Section 3, Control Panel.
NOTE: Please direct any safety questions to your local BIOLASE representative.
Figure 3: Footswitch
Figure 4: Emergency Stop
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5100109 REV. D (12/10)
SECTION 3: EQUIPMENT
GENERAL
The Waterlase®C100 dental laser system consists of two modules:
• OpticalPowerUnit(theUnit)
• Waterlase®C100 Atomizing Delivery System (the Delivery System)
OPTICAL POWER UNIT ELEMENTS
Control Panel
The control panel consists of three components (see Figure 5):
 •Buttons
 •LiquidCrystalDisplay(LCD)
 •LightEmittingDiodes(LEDs)
Buttons
The buttons allow for selection and control of all system variables.
 •ON/OFF  TurnsSystemON and OFF.
 •STANDBY  Disablestheunit.
 •READY  Enablestheunit.
 •+/-   AdjustsAIR, WATER, POWER and FREQUENCY values.
 •MODE   Selectsairandwateroperationalstates(ON, OFF, AUTO).
 •PRESETS  Systemisprogrammedwith4PRESETS, or values can be 1, 2, 3, 4 customized
(Section 4: Modify and Save Preferred Values and Presets).
 •f FUNCTION Selects frequency or power mode, and service.
LCD (Liquid Crystal Display)
The LCD display shows settings, error messages and system status.
LEDs (Light Emitting Diodes)
The LED lights indicate selection of the corresponding function (setting).
Keyswitch (Figures 2 & 7)
The key can be removed only when in OFF position.
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©2008 BIOLASE Technology Inc. All Rights Reserved.
6 Preset Buttons (4)
5 Preset LEDs (4)
4 Function Button
3 Ready Button
2 Standby Button
On/Off Button 1
Power Display LCD 14
Power Display LCD 13
Buttons
Water Display LCD 12
Water Up/Down 11
Buttons
7 Air Display LCD
8 Air Mode Button
9 Air Up/Down
Buttons
10 Water Mode
Figure 5: Control Panel
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5100109 REV. D (12/10)
Footswitch Connector (Figures 7)
Connect and secure footswitch (Figure 3).
Remote Interlock (Figures 7)
Plug in the remote interlock connector.
Power Connection (Figures 7)
Attach power cord to unit at this location.
Circuit Breaker (Figures 7)
Serves as a line switch to separate the unit from the main power supply.
Ventilation Channels (Figures 7)
Do not cover or block these channels. They provide airflow path to cool unit.
Locking Wheels (Figures 6)
Press down on front tabs to render unit unmovable. Lift up the tabs to release locking mechanism.
Front Handle (Figures 7)
Do not use to lift the unit.
Back Panel (Figures 7)
Handpiece Holder (Figures 8)
Holds handpiece when not in use.
Air Input (Figures 7)
Connect with tubing (included) to compressed dry air outlet. (80-120 PSI or 5.5-8.2 bar).
Self Contained Water System (Figures 7)
Provides water supply for handpiece atomization spray. Fill bottle only with deionized/distilled water. Do not use tap water.
Delivery System Support Arm with Hook (Figures 6)
Provides support for fiber optic cable to reduce stress at connection to the unit.
Water Bottle Switch (Figures 7)
To pressurize the water bottle that supplies water to the atomization spray.
Fill/Drain Connector (Figures 7)
Used to fill/drain the water-cooling system.
14

©2008 BIOLASE Technology Inc. All Rights Reserved.
Delivery System
Support Arm
with Hook
Fiber Exit
Locking Wheels
Handle
Emergency Stop Switch
Control Panel
Figure 6: Front View
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5100109 REV. D (12/10)
Key Switch
On/Off
Power Connection
Footswitch/Power Supply Rack
Patient Water Bottle
Deionized/Distilled Water Only
(Do not use tap water)
Water Bottle Switch
Air Input
Fill/Drain Connector
Circuit Breaker
Remote Interlock Outlet
Ventilation
Channels
Footswitch Connector
Ground Pin
Back Panel
Figure 7: Rear View
16

©2008 BIOLASE Technology Inc. All Rights Reserved.
Figure 8: Top View
Control Panel
Handpiece Holder
Handpiece
Emergency Stop Switch
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5100109 REV. D (12/10)
WATERLASE®C100 DELIVERY SYSTEM
Handpiece
The handpiece rotates and is detachable from the optical shaft. It delivers optical energy and atomized cooling spray to the
treatment area.
Laser Tip
The tip is detachable from the handpiece and serves as the optical power conduit to the tissue target.
Trunk Fiber
The fiber optic cable contains the optical fiber together with the air and water tubing. Laser radiation is delivered from laser unit
to the handpiece through the optical fiber.
Delivery System Connections on the Unit
Please refer to Delivery System User Manual for specific connections instructions.
Handpiece Collar
The handpiece collar secures the handpiece to the fiberoptic cable.
Quick Release Mechanism/Tabs
To disconnect the handpiece or protective cover, squeeze on the two opposite dots with one hand, and with the other, twist the
handpiece or protective cover off the shaft.
Optical Shaft
The optical shaft contains the fiberoptic cable and tip coupling mechanism.
Tip Plug (for tip)
The tip plug protects the handpiece optical components from damage due to water, contaminants or debris that could enter
through the handpiece fiber tip orifice when tip is not in use.
Protective Rubber Cap (for fiber optic connector)
The protective rubber cap protects the input end of the fiber optic cable when not attached to unit.
Laser Connector Housing
The laser connector housing secures the delivery system to the unit.
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©2008 BIOLASE Technology Inc. All Rights Reserved.
Handpiece Holder
The handpiece holder supports the handpiece when not in use.
Protective Cover
The protective cover protects the optical shaft when handpiece is disconnected.
Rear Plug
The rear plug protects the handpiece when disconnected from optical shaft.
Tip Remover
The tip remover tool helps to remove and insert laser tips.
Revolving Tip Holder
The revolving tip holder holds up to 6 tips and functions as a tip remover (follow instructions enclosed with tip holder).
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