Biolase waterlase dentistry C100 User Manual

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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

+49 6894 581020

www.mt-procons.com

5100109 REV. D (12/10)

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Page 1 NASDAQ: BLTI 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 +49 6894 581020 www.mt-procons.com 5100109 REV. D (12/10) © 2008, Biolase®...
Page 2 USER MANUAL...
Page 3 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 BIOLASE ®...
Page 5 Delivery System Support Arm with Hook (Figure 6) ....14 Water Bottle Switch (Figure 7) ....... . .14 Fill/Drain Connector (Figure7) .
Page 7 Section 9 CALIBRATION ..........42 Calibrating Power .
Page 8: Introduction
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”.
Page 9 • 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.
Page 10: Safety With The Waterlase C100
Move the circuit breaker to OFF (O) position (located on rear panel) and remove the key before leaving unit unattended. DANGER: DO NOT remove system housing. Danger from radiation exposure and high voltage may exist. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 11: Safety Features
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...
Page 12: Ready Button
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. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 13: Equipment
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): •...
Page 14 5 Preset LEDs (4) 6 Preset Buttons (4) 7 Air Display LCD Power Display LCD 13 Buttons 8 Air Mode Button Water Display LCD 12 9 Air Up/Down Buttons Water Up/Down 11 10 Water Mode Buttons ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 15: Footswitch Connector (Figure 7)
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.
Page 17 Figure 7: Rear View Water Bottle Switch Key Switch On/Off Patient Water Bottle Deionized/Distilled Water Only Back Panel (Do not use tap water) Remote Interlock Outlet Ventilation Footswitch/Power Supply Rack Circuit Breaker Channels Power Connection Footswitch Connector Air Input Fill/Drain Connector Ground Pin 5100109 REV.
Page 19: Waterlase Md Delivery System
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.
Page 20: Handpiece Holder
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). ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 21: Operating Instructions
SECTION 4: OPERATING INSTRUCTIONS SETUP Connect Unit to Operatory 1. Verify circuit breaker is in OFF position. 2. Verify keyswitch is in OFF position. 3. Connect power cord to unit (see Figure 7). 4. Verify minimum air pressure of 80 psi (5.2 bar) and maximum of 120 psi (8.2 bar) from clean air supply.
Page 22: Secure Fiber Optic Assembly To Unit
Center shaft. Slide the Fiber Optic Connector and alignment pin into the alignment pin hole. • Once the connector reaches the Laser Aperture, turn the Locking Nut Clockwise. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 23: Connecting Handpiece To Fiber Optic Cable
Connecting Handpiece to Fiber Optic Cable NOTE: Refer to the Waterlase C100 Interactive CD supplied by BIOLASE. ® 1. Remove Handpiece and Tip Remover from package. Hold the Handpiece and squeeze on the two opposite release tabs to release the Rear Plug, then twist the rear plug out. (Figure 10).
Page 24: Installing Tip In The Handpiece
Slide the handpiece laterally off the tip remover or tip holder. Now the tip is installed and the handpiece is ready for use. CAUTION: Do not operate the laser, or air/water spray without the tip inserted into the handpiece. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 25: Changing Tips
Changing Tips CAUTION: The laser unit must be in “READY” mode when removing/replacing tips. Always wear laser protective glasses when replacing the tips and laser is in READY mode. Ensure that no water is present on the tip or around tip orifice during tip replacement. Slide Tip Remover laterally on the tip groove and CAREFULLY pull the tip straight out (Figure 18).
Page 26: Tip Cleaning And Inspection
2. The Air supply must be connected and the external air pressure must provide at least 80 PSI to 120 PSI. 3. Electrical input must be 115 VAC, maximum 16 amperes for U.S. (230VAC, 8 Ampere for International). 4. The Handpiece must be properly connected. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 27 5. Verify that the water bottle is clean and filled with at least 1/3 full with distilled or deionized water and that the pressure switch is in the “OFF” position. 6. Power and Frequency share the same display. Toggle the “f” key to set mode of frequency or power selection; press the “Treat Beam”...
Page 28: Modify And Save Preferred Values As Presets
Standby Mode. The error must be cleared to resume operation. The cleared error will be indicated when the top line of the text shows “BIOLASE TECHNOLOGY”...
Page 29: Waterlase ® C100 Specifications
SECTION 5: WATERLASE C100 SPECIFICATIONS ® GENERAL Dimensions • Unit 12.55 x 27.73 x 33.28 in (32 x70 x 84.5cm) • With Fiber 12.55 x 27.73 x 52.5 in (32 x 66 x 133.5 cm) • Weight 110 lbs (50 kg) Electrical •...
Page 30: Contraindications, Warnings And Precautions
Always use high-speed suction to remove any excess fluid and avoid directing the spray into deep pockets, cavities or channels such as the socket ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 31: Root Canal Procedures
resulting from the extraction of a molar. Also, for example, avoid working through soft tissues adjacent to the roots of molars, especially the third inferior molars, which communicate directly with the sublingual and submandibular spaces. Do not use the Waterlase C100 if access is limited and requires operation with spray within narrow or enclosed spaces that could collect or ®...
Page 32: Tissue Evaluation
Surgical procedures on soft tissue, bone or root apex should only be performed by clinicians who have training and experience in Oral, Maxillofacial, or Endodontic Surgery. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 33: Clinical Applications
At the current position (5 mm away from targeted tissue), there will be minimal to no cutting effect. If the water spray is not flowing or no distinct popping noise is present, stop the system immediately. Refer to the troubleshooting section of this manual for instructions or call your local BIOLASE representative for assistance. NOTE: Always remember that laser power and, therefore, hydrophotonic energy are delivered from the very end of the tip.
Page 34: Soft Tissue Incision, Excision And Ablation
Always start treatment at the lowest power setting recommended, and increase as required using your clinical judgment. The values preprogrammed with the system or recommended in this manual are suggested values only. Use your clinical judgment ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 35 to adjust any of the individual values for Power, Water and Air in order to compensate for varying tissue composition, density and thickness specific to individual patients. If a particular combination of customized values is especially effective and useful, you can then store these values in the system as a new Preset. Instructions for storing a new group of preset settings are provided in Section 4: Modify and Save Preferred Values as Presets.
Page 36 HARD TISSUE: Root canal preparation including enlargement, Root canal debridement & cleaning, Removal of granulation tissue from bony defects. SOFT TISSUE: Pulpotomy, Pulp extirpation, Pulpotomy as an adjunct to root canal therapy, Sulcular debridement, Laser soft tissue curettage. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 37 Diameter Calibration Lengths Power Water Air Settings Tip Type Tissue Types (mm) Factor (mm) Settings (W) Settings (%) 1.00 4, 6, 9 Enamel 4.50 - 6.00 64 - 80 61 - 100 Dentin 3.00 - 4.50 70 - 86 60 - 100 1.00 Bone 1.75 - 3.50...
Page 38: Fiber Tip Calibration Chart
9. Leave handpiece and tip wrapped in gauze for 10 minutes. 10. Remove disinfectant gauze and wipe handpiece dry with dry gauze. CAUTION: DO NOT PERFORM CLEANING WITHOUT REAR AND TIP PLUGS ATTACHED TO THE HANDPIECE. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 39: Steam Sterilization For Handpiece And Tips
Steam Sterilization for Handpiece and Tips The steam sterilization process is intended to destroy infectious microorganisms and pyrogens. Always perform this procedure after cleaning and before use. 1. Clean handpiece and tips as described above. 2. Verify that rear plug and tip plug are properly inserted in the handpiece. 3.
Page 40: Waterlase ® C100 Indications For Use
• Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 41: Soft Tissue
• Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) • Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) • Exposure of unerupted teeth Soft Tissue Soft Tissue Indications Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: •...
Page 42: Maintenance
The entire laser cavity and optical train will be cleaned. All relevant electronic circuits will be calibrated. Filters and cooling fluid will be changed as well. Please contact your local BIOLASE representative to discuss extended service contracts and annual maintenance options.
Page 43: Calibration
SECTION 9: CALIBRATION CALIBRATING POWER NOTE: Calibration is to be performed only by trained personnel. Carefully insert the test fiber into the laser head SMA port and tighten. Set up the power meter head 4.2 – 4.8 cm from end of test fiber tip. Turn both the water and air modes to OFF.
Page 44: Calibration Schedule
Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician Calibration Date: Technician ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 45: Appendix A: Instructions For Filling The Internal Cooling Reservoir
APPENDIX A: Instructions For Filling The Internal Cooling Reservoir CONNECTING THE FUNNEL ASSEMBLY TO THE SYSTEM Locate the Fill/Drain receptacle on the lower left hand side of the Rear Panel. Insert the Funnel connector into the receptacle. Ensure that the Funnel Connector snaps into position and is now locked in place (see Figure 1). Receptacle Funnel Connector Figure 1...
Page 46 Remove the white cap from the System Vent Tube which is located at the bottom of the system, inbetween the Rear and Bottom Panels, inside the small compartment and connet (see Figure 3). Figure 3 White Funnel Tube Assembly (Blue) System Vent Tube ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 47 4. Assemble the Luer attached to the System Vent Tube to the Luer on the funnel assembly. Ensure that the two are tightened together. Place the cap in a safe area as this will be reattached at the end of this process (see Figure 4). Figure 4 Figure 5 Luers Connected...
Page 48 1. Disconnect the Funnel tubing form the System Vent tubing. Immediately attach the white cap to the System Vent tubing. Insert the System Vent tubing back into the system compartment. 2. Remove the Funnel Assembly in the reverse order of installation. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 49 PRIMING THE SYSTEM 1. Connect all ancillary equipment to the System (Power Cord, Footswitch, Air Line, Delivery System with Handpiece). 2. Turn the system ‘ON’. A ‘SYSTEM ERROR/COOLING FLOW ERROR’ will be exhibited on the Display. Allow the system to run for approximately 2 minutes.
Page 50: Appendix B: Labels
Location: Back Panel, centered below ventilation channels and Danger label. Non-Interlocked Protection Housing Warning Location: Laser head, access plate. Accessible only during service proceedings. LASER APERTURE Laser Apeture AT FIBER END Location: On the top cover. 5200100 REV. B ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 51: Attention Label
Attention Label Location: Next to protective ground. Protective Ground Location: Next to E1 ground terminal. INVISIBLE AND VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED INVISIBLE RADIATION CLASS 4 LASER PRODUCT Laser Explanatory Label Er, Cr: YSGG Laser System Location: On top cover, over fiber optic connector.
Page 52: Electrical Ratings
Location: Back panel. ETL LISTED ETL Listed CONFORMS TO UL 60601-1 9800165 CAN/CSA C22.2 NO. 601.1 Location: Back panel. IEC 60601-2-22 REV. A 5200192 Footswitch Label Location: Back panel. Emergency Stop Label Location: Top Cover. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 53 Figure 19: Rear View Key Switch Identification Certification Remote Interlock Outlet ETL Listed Electrical Ratings Power Connection Footswitch Ground Cooling System Fill/Drain Attention Label 5100109 REV. D (12/10)
Page 55: Appendix C: Spare Parts And Accessories
APPENDIX C: Spare Parts & Accessories BIOLASE PART NUMBER DESCRIPTION WC17-40-1603 Power Cord Prescription eyewear may be available. Please contact your local authorized BIOLASE representative for additional information. 5100109 REV. D (12/10)
Page 56: Appendix D: Clinical Procedure Guidelines
The motion should feel like painting or sweeping the wall. After completion of the first stroke re-insert the Z2 and proceed with a second stroke. A total of six (6) strokes are suggested for the Z2 instrumentation. Flush debris in between strokes using any conventional irrigation solutions (i.e. NaOCl). ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 57 Replace the Z2 tip with a Z3 and continue with enlargement and shaping. Use the same protocol and settings to operate the Z3. After six (6) strokes, replace the Z3 with a Z4 tip. Proceed with the Z4 using same settings, techniques and protocol as for Z2 and Z3.
Page 58: Apicoectomy Clinical Protocol
(technique, proper power, air and water settings, tip type and duration of operation) and to make appropriate power, air and water adjustments to compensate for varying tissue composition, density and thickness. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 59 b. Place the 600 µm tip at approximately 1.5–2.0 mm from tissue. Following a circular motion pattern proceed with bone removal to prepare the window. In most cases a 3–4 mm diameter is adequate. Thicker bone may require a power setting as high as P = 3.50 W with Air = 65% and Water = 60%.
Page 60 9. Suturing of the flap: a. Use the preferred technique and materials to suture the flap. 10. Patient post-operative care instructions and follow-up evaluations: a. Provide the patient with take home instructions and the follow-up schedule. ©2008 BIOLASE Technology Inc. All Rights Reserved.
Page 61: Appendix E: Waterlase ® C100 Warranty
Warranty are warranted only for the remaining unexpired portion of the original warranty period applicable to the goods. 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.
Page 62 BIOLASE’s reasonable control. Service needed due to customer negligence, operator error, contamination, misuse, abuse, alterations, repairs, or services not authorized, scratches, dents and damage from liquid spills are not covered by the Warranty.
Page 63 NOTES: 5100109 REV. D (12/10)

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