Home

5100109 REV. D (12/10)

1. 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 MMOS ETC 24 ecto ta Ama A 24 OVEIVIEW arpas Kag kya e a eed v ei duque ved 24 Tip Cleaning and Inspection 25 Operational State Description 25 To Start the Waterlase C lOO oe cake ss ad kee ee s a de 25 Modify and Save Preferred Values as Presets 27 Activate the Waterlase C100 444 de sees Ras 27 Turn the Waterlase C100 Off 27 Error Messages xx ees nuda dae beu e DIT ed dt d Ea fo hee 27 WATERLASE C100 SPECIFICATIONS 28 eric P 28 Dimensions Wx Lx H 28 Aba AA 28 5100109 REV D 12 10 Section 6 Section 7 Section 8 Walerlase GC LOO 242503344 bA kA AA eed eR Rs Ra ae eas 28 DUCA a maana ea kath aot maa nan eed deeds ahah LEE 28 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 29 Contraindications 29 Indications Warnings and Precautions 29 Eyewear bee dere wand be ek dee
2. 38 Waterlase C100 Indications for Use 39 Hard TISSUE de Seta ada ee D ot 39 DOM TISSU wars se nt din eat Pea ct mi AE 40 MAINTENANCE Al Annual Maintenance 41 Delivery Maintenance 41 Daily Maintenance 41 TKANSPOKALION x s ewe RAR eee hae RR ee wha ds Seed eed wee 41 O deen Sh Brat ASA ANG me amp fist MAGA ate ELA 41 2008 BIOLASE Technology Inc All Rights Reserved Section 9 Appendix A Appendix B Appendix C Appendix D Appendix E CALIBRATION 42 Galibrating POWer csse br we mesdames E RET be se 42 Calibration Schedule s howe nha RS RE BEES a bee eb ee E 43 LABELS AAP 49 Laser Hazard Symbol 49 High Voltage Hazard Symbol 49 incu acrescer dubasuoader hala ed da haah hm os 49 Non Interlocked Protection Housing Warning 49 Laser Aperture 2 a 49 Attention Label aa ier rem UNG a Re due qu m wee ue Wed RA ER E Ye wee 50 Protective Ground 5a nme a s Rose a eer es 50 Laser Explanatory Labels edes pum es wae Pov ui Ee3 tele es ee 50 GROWING RET 50 IndentfiCation s cures ac Gabe we ge bee KG de ON av UR ek E 50 Electrical Rates 4 ose cc na
3. 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 5100109 REV D 12 10 Fiber Exit Emergency Stop Switch Figure 6 Front View Delivery System Support Arm with Hook Control Panel Handle Locking Wheels 2008 BIOLASE Technology Inc All Rights Reserved 15 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 Bree Remote Interlock Outlet Ventilation Footswitch Power Supply Rack Circuit Breaker r Channels Power Connection Footswitch Connector Air Input Fill Drain Connector Ground Pin 16 5100109 REV D 12 1
4. Figure 8 14 Air Input Figure 7 14 Self Contained Water System Figure 7 14 2008 BIOLASE Technology Inc All Rights Reserved Section 4 Section 5 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 nci id sia os oh MOG a Se hae ea hh Sharon 0 18 ES DECIDE TE 18 TRUNK FIDE s d usse eh ehe rh Fea as lp hun bas 18 Delivery System Connections on the Unit 18 Handpiece Coll r 245 48 tue ER eum upd Dh de x Doe d 18 Quick Release Mechanism Tabs 18 ODUCal Saltos mtas ten koe he Pu E 18 We Plug s A 18 Protective Rubber Cap for fiber optic connector 18 Laser Connector Housing 18 Handpiece Holder sun aime Re E oe RR ee RP SG oS des 19 Protective Cover 19 acrinal paaa Saale Ue acres one ares oust ee D NG es 19 Mens aad she hak eae ad att aie 19 Revolving Tip Holder 19 OPERATING INSTRUCTIONS 20 Ju Pst pathos Gace senso a eee BANAT IASA hae Bee ae ee 20 Connect Unit to Operatory
5. or value of Air and Water function may be adjusted by keys below the associated display The following are examples of the Water and Air displays showing a 70 value setting for Water a 90 value setting for Air and an AUTO mode setting for both Water Display Air Display 70 90 AUTO AUTO To Start the Waterlase C100 1 Verify that all connections have been properly secured 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 25 al 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 up down buttons to increase decrease frequency or power 7 The Emergency Stop button must be in a release position 8 Turn the circuit breaker to ON position KO Insert the key into the switch and rotate clockwise to the ON position 10 Press the On Off button on the front panel to start the unit 1 Self Test messages will appear after a 3 second delay 2 Attach handpiece to the fiber optic cable shaft Section 4 Connecting
6. 1 5 W and the procedure should always be conducted using appropriate air and water spray To measure the working length insert the Z2 fiber into the canal and mark the length less 2 mm using a waterproof black marker Use the mark as reference point to insert Z2 approximately 2 mm short of the working length Activate the system and start moving the fiber upwards coronally to initiate enlargement While moving the fiber apply slight pressure on the side wall of the canal Take about eight 8 seconds to move the fiber from its apical location to the coronal end of the canal The motion should feel like painting or sweeping the wall After completion of the first stroke re insert the 72 and proceed with a second stroke A total of six 6 strokes are suggested for the 72 instrumentation Flush debris in between strokes using any conventional irrigation solutions i e NaOCI 2008 BIOLASE Technology Inc All Rights Reserved 55 7 Replace the Z2 tip with a Z3 and continue with enlargement and shaping Use the same protocol and settings to operate the Z3 8 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 A total of eighteen 18 strokes six 6 with each of the fiber types are suggested for cleaning and enlargement of most canals Depending on the case additional strokes may be necessary 9 Atthe end irrigate thoroughly and check canal dimensions using a
7. C3 300x1200 1 00 Hane 175 350 Soft Tissue 0 75 2 50 HARD TISSUE Cavity preparations I V Caries removal Enameloplasty Tooth preparation to obtain access to a root canal Cutting Shaving Contouring amp resection of oral osseous tissues bone Osteotomy Ostectomy Osteoplasty Apicoectomy SOFT TISSUE Excisional amp incisional biopsies exposure of unerupted teeth Fibroma removal Frenectomy amp Frenotomy Gingival troughing Gingivectomy Gingivoplasty Gingival incision amp excision Hemostasis Implant recovery Incision amp drainage of abscesses Leukoplakia Operculectomy Oral papillectomies Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores Vestibuloplasty Removal of pathological tissues Incision amp drainage of periapical abscesses Enamel 4 50 6 00 Dentin 3 00 4 50 Bone 1 75 3 50 Soft Tissue 0 75 2 50 HARD TISSUE Cavity preparations I V Caries removal Hard Tissue roughening or etching Enameloplasty Tooth preparation to obtain access to a root canal Cutting Shaving Contouring amp resection of oral osseous tissues bone Osteotomy Ostectomy Osteoplasty amp Osseous recontouring Culling bone to prepare a window access to the apex apices of the root roots SOFT TISSUE Excisional amp incisional biopsies exposure of unerupted teeth Fibroma removal Frenectomy amp Gingival troughing Gingivectomy Gingivoplasty Gingival incision amp ex
8. Handpiece to Fiber Optic Cable 13 Press the Ready button and attach the tip using the tip remover tool Section 4 Installing Tip Into Handpiece 14 Select the appropriate parameters for the procedure The mode and value of each parameter may be adjusted by the keys below the associated display To select a Preset simply push the button next to the preset value Figure 5 15 Turn water bottle switch to ON position and proceed 26 5100109 REV D 12 10 Modify and Save Preferred Values as Presets Selecting pulse frequency Press f button to switch from power adjustment mode amp pulse frequency adjustment Press up or down buttons of treatment Beam to select frequency Press f again to go back to power adjustment mode Beware of power range limitations depending on frequency table 1a The Waterlase C100 has four pre programmed presets stored on the system The values of the presets as well as additional combinations of presets are presented in Section 7 Fiber Tip Calibration Chart To select and store a new set of values for Power Frequency Water and Air first select the preset number 1 2 3 or 4 that you wish to change Then select the desired values and mode for Power Water and Air After all variables have been set push the selected preset button and hold in place for 2 3 seconds until you hear a beep The beeper demonstrates that the new values and modes are now stored These new va
9. Procedures Review the clinical procedure and all labeling instructions provided with the endodontic tips and EndoLase root canal kit before proceeding with any treatment Always use air and water spray at the recommended settings to enlarge and remove debris from inside the root canal Do not exceed the power setting of P 1 5 W for root canal enlargement with any of the endodontic tips Z2 Z3 or Z4 The Waterlase C100 is better suited for straight and slightly curved canals Great care should be taken during instrumentation of curved canals as the endodontic fiber tip may break or perforate through the wall of the curved canal If during insertion the fiber tip does not advance easily into the canal do not force the tip inside A possibility is to pull the fiber out and use an endodontic hand file or a broach to open the path The Waterlase C100 is an end cutting device so to avoid penetration of a canal wall or the apical foramen do not force the tip and or activate the laser while moving the tip inside a narrow or curved canal or through the apex Place the end of the tip 2mm from the apex or away from being in contact with the wall of a curved canal Activate the laser and spray only during the outward stroke when the fiber tip is pulled towards the coronal portion of the canal For additional information on laser root canal enlargement review the recommended clinical procedure presented in Appendix C or the instructions provided with the End
10. ae Soe ea gw a al ween es 29 Anesthesia jo sus ere Gag KAN AG la Eus Go aaa a woe 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 Evall ON is de NA dee e a Rd ey n e 31 Tissue Contact and Tip Breakage 31 WC Mane M ate rn pe TLB ANAND so ea ae ete LA ha 31 Water Splashing 31 Plume Removal es 31 Dental Materials 31 TANE tet ot tear ee a Pe nc a en ae eh es 31 CLINICAL APPLICATIONS 32 WNC GUI AAP 32 Hard Tissue Cutting 32 Soft Tissue Incision Excision and Ablation 33 Procedure Guidelines 33 Presets for Soft and Hard Tissue Procedures 33 Fiber Mp Calibration Chart osese hae aah wom de Rr OR Rl KANA GA KG 37 Tip Specifications 37 Handpiece Cleaning and Sterilization 37 Handpiece Cleaning 37 Steam Sterilization for Handpiece and Tips
11. 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 5100109 REV D 12 10 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 2008 BIOLASE Technology Inc All Rights Reserved 19 SECTION 4 OPERATING INSTRUCTIONS SETUP 20 Connect Unit to Operatory Verify circuit breaker is in OFF position Verify keyswitch is in OFF position Connect power cord to unit see Figure 7 POON k Verify minimum air pressure of 80 psi 5 2 bar and maximum of 120 psi 8 2 bar from clean air supply 5 Check air supply for moisture WARNING Do not connect the operatory air supply to the unit if water or oil is present Air compressor may need to be drained or cleaned and air filters installed if moisture appears Wet air will damage the unit Check air supply weekly to verify absence of water and oil 6 Connect to the unit air supply see Figure 7 Fill Self Contained
12. contact with tissue and proceed with the removal Use any necessary instruments such as forceps etc to secure this tissue and with the tip in contact carefully detach the lesion The tissue must be removed as one piece for histopathological evaluation purposes In case the lesion is not easily accessible or it is too soft to be removed with the laser use conventional spoon curettes to dislocate and remove c For granulation tissue removal select the following Waterlase C100 parameters i P 0 75 W ii Water 7 11 Air 2 1196 iv Tip type G6 600 um diameter e With the tip in contact mode slowly remove any granulation tissue from the periapical area Use the 600 um tip in a defocused mode 2 mm from surface at settings for bone debridement P 2 0 W W 30 and A 35 to clean bone and remove debris Surgical curettes can also be use to scrape the bone and remove granulation tissue To irrigate and rinse the site use sterile saline 8 Irrigation of site a Use sterile saline to irrigate and rinse the site before suturing 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 59 APPENDIX E Waterlase C100 Warranty U S ORIGINAL EQUIPMENT OWNER 60 Seller warrants the
13. not been dried out always blow compressed air through the inside body and only then plug both ends of the Handpiece See sterilization instructions and draft Installing Tip Into Handpiece CAUTION Always use the Tip Remover Figure18 a or Revolving Tip Holder during tip installation and changing tip DO NOT use your fingers To prevent contamination and damage to Handpiece Tip Plug Figure 18 e must be in place at all times when no tip is installed and the laser is not in use Tip Plug e a NOTE Use only for storage autoclave or other sterilization Tip Remover a Tip Orifice d Tip Groove b Tip c Handpiece INCORRECT CORRECT Figure 16 Tip Installation Figure 17 Correct Tip Connection Place the system on READY when removing replacing a tip Blowing air prevents moisture or dirt from entering the handpiece NOTE Always use the Tip Remover to replace or remove tips from the Handpiece Remove the tip from the package and slide into the Tip Remover or Tip Holder over the first groove on the Tip Ferrule Figure 16 b This allows easy insertion and removal of the tip into and from the Tip Orifice Figure 17 Insert the tip keeping it perpendicular to the handpiece The tip is fully seated when the tip remover arrives at a point flush against the tip orifice Figure 17 Slide the handpiece laterally off the tip remover or tip holder Now the tip is installed and the handpiece is ready fo
14. retractors etc b Apply local anesthesia c Determine location for incision 2 Incision of gingival tissue to prepare the flap a Select Waterlase C100 parameters and tip 1 P 15W 2 Water 20 3 Air 20 4 Tip type T4 400 um diameter b Apply fiber tip in slight contact with gingival tissue and proceed with the incision following the flap design of your choice i e semilunar scalloped triangular rectangular etc WARNING Reduce air and water to a minimum when working on unattached gingiva to avoid any fluid entrapment Keep a flow of water spray when the cut is approaching the underlying bone 3 Flap reflection a Reflect flap apically to expose the bone 4 Bone removal to prepare window access to root apex a Select Waterlase C100 parameters and tip i P22 50W ii Water 35 ili Air 40 iv Tip type G6 600 um diameter Always start treatment at the lowest power setting for the specific tissue and increase as required Closely observe the clinical effects and use your judgment to determine the aspects of the treatment 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 57 b Place the 600 um tip at approximately 1 5 2 0 mm from tissue Following a circular motion patter
15. the Z2 Z3 or 74 tips above P 2 5 W Do NOT operate T4 tips above P 2 5 W With Straight Handpiece Do NOT operate any tips above P 4 W CAUTIONS If a reduction in cutting efficiency is observed replace the tip Failure to replace the tip correctly could result in damage to the tip or the mirror The tips have limited lifetimes therefore damage attributed to overuse of the disposable tip may not be covered by warranty 36 5100109 REV D 12 10 Fiber Tip Calibration Chart Refer to Table 5 to review the different characteristics and calibration factors for the Waterlase C100 tips To calculate the expected power output from different families of tips follow the instructions below e Select the tip for the procedure e Review Table 5 Tips Suggested Clinical Specifications to select appropriate calibration factors for the selected tip e Calculate the power emitted at the tip by multiplying the display power by the calibration factor of the tip type Remember that for a calibration factor of 1 the emitted power is the same as the display Also actual emitted power could vary as much as 20 Following are examples on how to calculate emitted power for T4 and Z2 tips Example 1 Example 2 Tip Type T4 Tip Type Z2 Calibration Factor 0 90 Calibration Factor 0 30 Display Power 2W Display Power 1W Then the Power Emitted is Then the Power Emitted is 2W x 0 90 1 80W 1W x 0 30 0 30 W Tip Specifications For informatio
16. 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 37 38 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 Place handpiece and tip s inside separate single wrap self seal autoclave pouches 4 Gently place the autoclave pouches on the autoclave tray Be careful when handling the handpiece and tip s Do not stack other instruments on top of the handpiece or tip pouches 5 Place autoclave tray inside of autoclave chamber 6 Set autoclave cycle to the following parameters Short Time Vacuum Cycle e Temperature 132 degrees Celsius 270 degrees Farenheit e Time 6 minutes e Dry Time 20 minutes minimum e Pressure 15PSI e Standard Gravity Displacement Cycle e Temperature 121 degrees Celsius 250 degrees Farenheit e Time 60 minutes e Dry Time 20 minutes minimum e Pressure 15PSI 7 At the time of completion of the autoclave cycle remove the tray and let items cool 8 Remove handpiece from pouch 9 Remove rear plug from handpiece base and protective cover from shaft of the fiber optic cable 5100109 REV D 12 10 Wat
17. 0 Figure 8 Top View Control Panel Handpiece Holder Handpiece Emergency Stop Switch 2008 BIOLASE Technology Inc All Rights Reserved 17 WATERLASE C100 DELIVERY SYSTEM 18 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
18. DY under this warranty shall be at Seller s election the repair or replacement of goods only if Seller is promptly notified in writing 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 of iii connected installed used or adjusted otherwise than in accordance with the instructions furnished by Seller 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 lf itis 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 LIMITATIONS BIOLASE shall not be responsible for labor and materials necessary to effect repairs caused by weather acts of governments strikes or labor disputes failure of transportation fire flood or other catastrophic occurrences suppliers failures caused by over voltage due to high input AC l
19. EE FIG 7 2 Remove the Funnel Assembly Figure 4 DT mmm dh RDNS cesescecscessec Vacca LU o655Ge69e 054 AS 7 7 7 LL LR IUT TUE SS UVA AAA Luers Connected Figure 5 Before filling the system with Distilled Deionized Water determine whether you need to use 1 Min Max Limits or 2 Min Max Limits that are located on the Funnel Fill Tube To determine read the last seven digits in the serial number located on the UPC label on the Rear Panel If the digits are 6000848 6000848C 6000906 Use the 1 Set of Min Max limits located on top 6100200 Use the 2 Set of Min Max limits located on the bottom This will ensure that the Cooling System is filled to the proper level DO NOT USE TAP WATER 3 Attach the White Cap to the System Vent Tube 46 5100109 REV D 12 10 1 Set 2 Set AW Wn p 4 Turn the System on for several minutes 5 Reconnect the Funnel Assembly 6 Refill the system with Distilled water as required Figure 6 Figure 7 2 Set Fill Level Dd THESE STEPS MAY HAVE TO BE REPEATED SEVERAL TIMES IN ORDER TO PURGE ALL AIR FROM THE SYSTEM THIS WILL ENSURE THE ENTIRE SYSTEM IS FILLED TO THE PROPER LEVEL DO NOT OVER FILL DRAIN EXCESS WATER THROUGH THE FUNNEL FOR 6100200 SYSTEMS DRAIN THROUGH THE SYSTEM VENT TUBE FOR ALL OTHER SYSTEMS REMOVING THE FUNNEL ASSEMBLY FROM THE SYSTEM 1 Disconnect the Funnel tub
20. Figure 1 Receptacle Funnel Connector Hook Funnel Assembly Figure 1 Funnel Connector Luer Connector d Funnel Tube Assembly Yellow Some Funnel Assemblies may have yellow or blue funnel tube assemblies International Units will have yellow tubing on their Funnel Tube Assembly required by regulations 44 5100109 REV D 12 10 2 For system with the suffix 6100200 attach the hook located at the top of the Funnel to the metal hook attached on the back panel of the system see Figure 2 Hook and Hang 3 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 Funnel Tube Assembly Blue Figure 3 zw e owen White Cap System Vent Tube 2008 BIOLASE Technology Inc All Rights Reserved 45 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 _FILLIDRAIN ay D B e FILLING THE SYSTEM WITH DISTILLED DEIONIZED WATER NOTE 1 Slowly ass Distilled Deionized water into the funnel until the water level can be observed through the tubing window located between the Min Max labels The level will change constantly as air migrates from the system up through the funnel S
21. GG BIOLASE biolase com NASDAQ BLTI USA BIOLASE Technology Inc 4 Cromwell Irvine CA 92618 949 361 1200 Europe ECIREPI MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 www mt procons com 6 0482 2008 Biolase 5100109 REV D 12 10 Waterlase e100 BIOLRSE USER MANUAL USER MANUAL 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 ECIREP MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 www mt procons com 5100109 REV D 12 10 CONTENTS Section 1 Section 2 Section 3 INTRODUCTION 7 INSTALLATION OF THE WATERLASE C100 7 Installation Instructions 7 Facility Requirements i nh Re ma me d talk S dues 7 Electrical SEDEM e laud Reed AA 7 Compressed Air Supply Laser Internal Co 7 SAFETY WITH THE WATERLASE C100 9 PrRECALMONS PTT NEED 9
22. Listed Location Back panel Footswitch Label Location Back panel Emergency Stop Label Location Top Cover 2008 BIOLASE Technology Inc All Rights Reserved 51 Figure 19 Rear View Key Switch Identification Certification Remote Interlock Outlet ETL Listed r Electrical Ratings Power Connection r Footswitch Ground Air Cooling System Fill Drain Attention Label 52 5100109 REV D 12 10 Figure 20 Top View Laser Explanatory Label Control Panel Handpiece Holder Handpiece Laser Apeture Emergency Stop Switch Locking Wheels 2008 BIOLASE Technology Inc All Rights Reserved 53 APPENDIX C Spare Parts amp 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 54 5100109 REV D 12 10 APPENDIX D Clinical Procedure Guidelines ROOT CANAL CLINICAL PROTOCOL This modality of treatment uses the Waterlase C100 to effectively remove necrotic and infected tissue from root canals and to enlarge and taper the canal in preparation for obturation Before proceeding with any endodontic treatment carefully review the sections of the Waterlase C100 User Manual pertaining to Contraindications Warnings and Precautions labeling for different endodontic tips and rec
23. Safety INSIFUCHONS 2 ka dues m nasse ka a x RR RE RR CRURA CRETA deu 9 Salety Features uius KNA ia dd alada we 10 Energy MOnitor 251444 eel Rue EC ETIAM oe OE ae UG 10 Circuit 81688 2 s uos ek des reor nip s imparte dis 10 Keys Witch aaa o e dodenus ben eel Gah ih eA AP 10 READY BUON eei pedi tb adr des Pete Rotor ada s 11 Ross TM 11 Remote Interlock Outlet 11 Emergency Stop Figure 8 11 Functional Panel 24 7 acentos lo AA Rd A As aca t fee eth a 11 Layout of Control Elements 11 EQUIPMENT 12 General wc es bae LAB ewan yee he Pa NERD NG eda nG 12 Optical Power Unit Elements 12 Control Panel s eere a TA Dh ted pba Bene tase age dt re 12 Keyswitch Figures 2 amp 7 12 Footswitch Connector Figure 7 1 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
24. Water System Bottle 7 Push switch on bottle mounting bracket to OFF position If bottle was pressurized you will hear a hissing sound while bottle depressurizes 8 After bottle is depressurized unscrew from mounting bracket Fill bottle with distilled or sterile water only CAUTION Do not use tap water 9 Attach bottle back to mounting bracket Remove the Handpiece Package and the Tip Package and set aside on flat surface Remove the Delivery System and place on a flat surface CAUTION Do not excessively or forcibly bend the Delivery System The minimum bending diameter is 6 7 5100109 REV D 12 10 Rear Plug Part Line a ang Release Tab squeeze here Figure 10 Rear Plug Release Protective Cap Quick Release Tab Figure 11 Protective Cap Release p Orifice d Handpiece i Fiberoptic Shaft b Quick Release Tab E Ferrule c Figure 12 Handpiece Connection Secure Fiber Optic Assembly to Unit Remove the protective cap red or black from the Fiber Optic Connector Tip Plug and Waterlase C100 Laser Aperture CAUTION DO NOT POWER UP YOUR LASER UNTIL THE HAND PIECE AND TIP ARE PROPERLY INSTALLED FAILURE TO DO SO MAY DAMAGE THE SYSTEM Figure 13 Unplugging the Handpiece e Place the Delivery Support Arm into the mounting hole on the Delivery System Mounting Plate e For SMA insertion align the blue dot of the SMA Housing with the blue dot on the mou
25. ages and system status LEDs Light Emitting Diodes The LED lights indicate selection of the corresponding function setting Keyswitch Figures 2 amp 7 The key can be removed only when in OFF position 12 5100109 REV D 12 10 Figure 5 Control Panel On Off Button 1 Q Standby Button 3 Ready Button 4 Function Button On Off Standby Ready Power Display LCD 4 5 Preset LEDs 4 6 Preset Buttons 4 STANDBY READY FIRING Treat Beam I e O a e Presets 7 Air Display LCD Power Display LCD 3 Buttons 00 sul Air 8 Air Mode Button YSGG oe inp WE or AUTO Water Display LCD 12 9 Air Up Down Buttons Water BIOLASE Water Up Down O Buttons 10 Water Mode 2008 BIOLASE Technology Inc All Rights Reserved 13 14 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
26. asis the tip must be placed out of contact at approximately 1 3 mm off the surface Effective hemostasis is achieved when the water spray is turned off Procedure Guidelines For guidelines on specific dental and surgical procedures with the Waterlase C100 please refer to Appendix D Presets for Soft and Hard Tissue Procedures As described before Waterlase C100 has the option of four user programmable presets stored in the system memory Examples of pre programmed values for general hard and soft tissue procedures are presented in the following Table 2 Pre Programmed Presets for General Hard and Soft Tissue Procedures Table 3 Root Canal Presets and Table 4 Bone Surgery Presets All pre sets utilize a 20Hz pulse repetition rate After deciding on the treatment protocol select preset settings or adjust the parameters to appropriate values for the procedure 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 33 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
27. ate doth AGA ee BELA baa See eee NAG 51 Cooling System Fill Drain ee eee 51 Al eal lise papa acs DN hii fn a pe Nga ad Dh dg eke Reet ae ye 51 KEY SWIC Ica SAR asp eni nre aai eae AA 51 Water Spray ON OFF 2206 16242 h e pana woh ak ak REED ERES RR 51 Remote Label 51 BS Mates eo ary Bet eo heed dae on et oped 51 Footswitch Label ss su Jas Lie de En oie Sek Se RRA n e eel es 51 Emergency Stop Label 51 SPARE PARTS AND ACCESSORIES 54 CLINICAL PROCEDURE GUIDELINES 55 Root Canal Clinical Protocol 55 PEOCEQUIE ee dir n mada se ANG DATS LA BDAY qe BALANG ati eee E a 55 Apicoectomy Clinical Protocol 57 Procedure imine tren Wh bee EE fe be eas OR GRR a ae 57 WATERLASE C100 WARRANTY 60 5100109 REV D 12 10 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 ener
28. cision Hemostasis Implant recovery Incision amp drainage of abscesses Leukoplakia Operculectomy Oral papillectomies Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores Vestibuloplasty Removal of pathological tissues Incision amp drainage of periapical abscesses Diameter Calibration Lengths Power Water Air Settings Tip Type N Tissue Types mm Factor mm Settings W Settings T4 400 Enamel 1 50 2 50 Dentin 0 75 1 25 Soft Tissue 0 25 0 50 HARD TISSUE Excavation of pits amp fissures for placement of sealants Removal of incipient caries SOFT TISSUE Gingivoplasty Gingivectomy Operculectomy Gingival troughing Frenectomy Excision of soft tissue lesions Full partial amp split thickness flap preparation Removal of pathological tissues Incision amp drainage of periapical abscesses 14 18 20 Dentin 0 75 1 50 22 25 28 Root Canal 0 25 0 75 33 Soft Tissue HARD TISSUE Root canal preparation including enlargement Root canal debridement amp cleaning SOFT TISSUE Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy 73 320 9 14 18 20 22 25 28 Dentin 0 75 1 50 Root Canal 0 25 0 75 24 400 0 75 9 14 18 20 Soft Tissue 25 0 22 25 28 HARD TISSUE Root canal preparation including enlargement Root canal debridement amp cleaning Removal of granulation tissue from bony defects SOFT TISSUE Pulp
29. d 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 0A International 230 VAC 8 0A Compressed Air Supply e 80 120 psi 5 5 8 2 bar 2008 BIOLASE Technology Inc All Rights Reserved 7 e 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 CAUTION Prior to connection verify that outlet is
30. e block to prevent accidental biting and breakage of the tip if necessary Tip Changing Failure to correctly replace the tip could result in damage to the fiber tip or the handpiece Water Splashing Water from spray may splash out of the patient s mouth during treatment It is recommended that the user utilize protective eyewear and or a face shield to protect from splashing Use high speed suction as required to maintain a clear field of vision during treatment Do not use the Waterlase C100 if you cannot clearly see the treatment site Plume Removal Special care must be taken to prevent infection from the laser plume generated by vaporization of virally infected tissue during procedures done with laser and water spray or no water spray Ensure that all appropriate protective equipment including high speed suction to remove the plume appropriately filtered masks and other protective equipment is used at all times during procedures with this laser device Dated Materials Do not direct energy towards amalgam gold or other metallic surfaces Do not direct energy towards cementum or other similar filling materials Doing so may damage the Waterlase C100 tip and delivery system and may unnecessarily reflect laser energy Training Only licensed professionals who have successfully completed Waterlase C100 training have read and understood this manual and know how to correctly operate the system should use this device Surgica
31. e for transportation unless it is completely packaged inside of its shipping crate Once crated the unit should be transported by forklift or pallet jack and should never be laid on its side dropped or banged If you have any questions regarding transportation please call your local representative STORAGE The Waterlase C100 should be stored in a cool dry place when not in use Storage temperature should be in the range of 15 C to 30 C 59 F to 86 F and the relative humidity should be in the range of 20 to 80 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 Waterlase C100 was shipped inside a custom shipping crate Please save and store the crate in a cool dry place The unit must not be transported unless packaged inside the crate 2008 BIOLASE Technology Inc All Rights Reserved 41 SECTION 9 CALIBRATION CALIBRATING POWER Calibration is to be performed only by trained personnel 1 Carefully insert the test fiber into the laser head SMA port and tighten 2 Set up the power meter head 4 2 4 8 cm from end of test fiber tip 3 Turn both the water and air modes to OFF 4 Set unit to READY and enter SERVICE mode 5 Press the POWER and PRESET buttons simultaneously one 1 time to check the DAC setting 6 The Display should now read Laser Head Power Calibration FM1409 7 Measure and record the actual power measu
32. e presence of explosive or flammable materials All persons present in the operatory must wear protective eyewear suitable for blocking 2 78 um 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 CAUTION Periodically inspect eyewear for pitting and cracking NOTE For replacement additional or prescription protective eyewear please contact your Waterlase C100 representative Do not look directly into the beam or at specular reflections Direct the cutting spray toward targeted tissues only Press STANDBY Standby button on the control panel before turning off the unit Press STANDBY on the control panel before exchanging handpieces or removing the fiber optic connector from the unit 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 9 All operatory entrances must be marked with an approved laser warning sign SAFETY FEATURES 10 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
33. echnique can be characterized as end cutting whereas the mechanical drill is known as a side cutting instrument Gently and slowly move the handpiece tip closer to the targeted tissue site As you approach the treatment area you may notice a large accumulation of water Use high speed suction as necessary to keep the field clear Because of the great differences between traditional dental and Waterlase C100 cutting techniques it is very important to have the exact treatment location visually identified before and during treatment 32 5100109 REV D 12 10 Maintain a fiber tip to treatment tissue distance of 1 0 mm while moving the handpiece over the tissue surface as required Keep in mind that cutting speed is determined primarily by parameter settings and distance from tissue not by rapid hand movement as with the high speed drill Gently and slowly move the handpiece in a circular brushing or in and out motion as required remove desired tissues or materials Unlike traditional dental instruments with the Waterlase C100 the slower you move the handpiece tip the quicker you will remove tissue Cutting efficiency will vary depending upon power setting and spray configuration If you feel that the system is working slowly at the selected power setting you can adjust the air and water spray settings You will notice that clinical efficiency depends upon power as well as spray As you gain experience with the Waterlase C100 y
34. erlase C100 Indications for Use Use of Waterlase C100 may be indicated for Hard Tissue General Indications Class Il Ill IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty excavation of pits and fissures for placement of sealants For use on adult and pediatric patients Root Canal Hard Tissue Indications Tooth preparation to obtain access to root canal Root canal preparation including enlargement Root canal debridement and cleaning Endodontic Surgery Root Amputation Indications Soft and Hard Tissue Flap preparation incision of soft tissue to prepare a flap and expose the bone Cutting bone to prepare a window access to the apex apices of the root s Apicoectomy amputation of the root end Root end preparation for retrofill amalgam or composite Removal of pathological tissues i e cysts neoplasm or abscess and hyperplastic tissues i e granulation tissue from around the apex Incision and drainage of periapical abscesses Any tissue growth i e cyst er lesions must be submitted to a qualified laboratory for histopathological evaluation Bone Surgical Indications Cutting shaving contouring and resection of oral osseous tissues bone Ostectomy Laser Periodontal Procedures Full thickness flap Partial thickness flap Split thickness flap Laser soft tissue curettage Laser removal of diseased infected inflamed and necrosed
35. 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 8 5100109 REV D 12 10 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 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 SAFETY INSTRUCTIONS Follow these safety instructions before and during treatments 1 2 3 D 0 Or d Remove or cover all highly reflective items in the treatment area if possible Do not operate in th
36. goods and parts which are of its manufacture and shipped hereunder to be free from defects in material and workmanship for twelve 12 months from shipment Exceptions to this warranty are as follows i Waterlase C100 tips are not included in the warranty ii Waterlase C100 Handpieces included in the original shipment are only warrantied for 90 days from shipment 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 only for the remaining unexpired portion of the original warranty period applicable to the goods 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 Seller s sole and exclusive liability and the Buyer s sole and EXCLUSIVE REME
37. gy 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 use
38. ine voltages which are outside the Laser s specific ratings failures due to low input air 5100109 REV D 12 10 pressure which fall below the unit s specified ratings or any other causes which are beyond 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 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 LIABILE 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 OPPORTUNITY 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 2008 BIOLASE Technology Inc All Rights Reserved 61 NOTES 62 5100109 REV D 12 10 NOTES 2008 BIOLASE Technology Inc All Rights Reserved 63
39. ing 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 47 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 3 When the priming is complete the SYSTEM ERROR verbiage will disappear and be replaced by PRESS ANY KEY 4 The system is now ready to operate 48 5100109 REV D 12 10 APPENDIX B Labels LBOO 00 0001 REYE 7 17 92 THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO 50 DATED 26 JULY 2001 5200191 REV B DANGER Invisible laser radiation when open AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION LB00 01 0008 REV B Laser Hazard Symbol Location e Top cover of Laser head directly above the Fiber Optic Connector e Only visible during service High Voltage Hazard Symbol Location e Top cover of Laser head directly above the High Voltage input High Voltage Shield PFN Board Capacitor Front Capacitor Bracket Only visible duri
40. l area during apical surgery Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Reduction of gingival hypertrophy Removal of pathological tissues i e cysts neoplasm or abscess and hyperplastic tissues i e granulation tissue from around the apex Any tissue growth i e cyst neoplasm or other lesions must be submitted to a qualified laboratory for histopathological evaluation Soft tissue crown lengthening Treatment of canker sores herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty For use on adult and pediatric patient 5100109 REV D 12 10 SECTION 8 MAINTENANCE ANNUAL MAINTENANCE The Waterlase C100 should be serviced annually by a qualified trained and certified technician During the annual visit the system flash lamp will be inspected and the system will be calibrated 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 Six months preventive maintenance service might be offered DELIVERY SYSTEM The fiber delivery system and handpiece represent high technology laser transmitting components Due to the precision involved in the manufacture and alignment
41. l procedure Such conditions may include but are not limited to allergy to local or topical anesthetics heart disease lung disease bleeding disorders sleep apnea or an immune system deficiency It is advised that medical clearance be obtained from the patient s physician when any doubt exists regarding treatment Indications Warnings and Precautions Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser protection eyewear for the 2 78 um wavelength OD 4 Anesthesia Although in most cases anesthesia may not be required patients should be closely monitored for signs of pain or discomfort If such signs are present adjust settings apply anesthesia or cease treatment if required All precautions must be followed if flammable anesthesia is used in conjunction with any laser surgical system Treatment Technique and Settings Only licensed professionals who have successfully completed training should use this device Always start treatment at the lowest power setting for the specific tissue and increase as required Closely observe clinical effects and use your judgment to determine the aspects of the treatment technique proper power air and water settings tip type and duration of operation and make appropriate power air and water adjustments to compensate for varying tissue composition density and thickness All hard tissue i e enamel dentin cementum and bone procedures must be pe
42. l 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 31 SECTION 7 CLINICAL APPLICATIONS INTRODUCTION The Waterlase C100 device is designed to cut and remove hard and soft tissues within the oral cavity For hard tissue applications the Waterlase C100 achieves its uniquely diverse capabilities through the process of light absorption by water droplets The proprietary flexible fiber optic system and handpiece delivers both optical energy and atomized water to the treatment site for precise hard tissue removal To efficiently remove hard and soft tissues it helps to understand the unique nature of the Waterlase C100 device Waterlase C100 operates unlike traditional dental instruments or devices and technique must be practiced and perfected to ensure efficient operation Please be aware that the Waterlase C100 system removes hard tissues by utilizing a hydrokinetic process with the fiber tip applied in a non contact mode The fiber tip has to be positioned at approximately 1 mm from the surface and great care must be taken not to brush or push the tip into tissue during treatments The tip is fragile and may break if knocked or pressed into the tooth or other instruments For soft tissue applications cutting is achieved in a contact or non contact mode by application of direct
43. laser energy either with or without water cooling and hydration spray A detailed description of the techniques for cutting hard and soft tissues with Waterlase C100 is presented in the following subsections Please study this Section carefully practice on tissue models and attend a Waterlase C100 training seminar before using this device in a clinical situation Hard Tissue Cutting Hard tissue cutting is achieved through a unique process described as hydrokinetic cutting This process refers to the removal of tissue with laser energized water particles and results in quick and clean hard tissue removal Once settings have been selected for enamel dentin or cementum cutting carefully position the fiberoptic tip approximately 5 mm away from the targeted tissue site Step on the footswitch and water atomization spray and power will be immediately delivered to the tissue site You will notice a distinct gentle popping noise as water droplets expand from laser energy absorption 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 Always remember that laser power and therefore hydrophotonic energy are delivered from the very end of the tip Tissue cutting t
44. lues and modes are permanently stored under that preset number and may be recalled at any time by pushing the preset button Activate the Waterlase C100 Push the Ready button to enable the Waterlase C100 and depress the footswitch when ready The user may evaluate the effect of each parameter setting prior to the procedure by directing the hand piece into a paper cup or sink and adjusting the values as desired Turn the Waterlase C100 Off 1 Turn the water bottle switch to OFF position 2 Set Air Water to 100 ON mode Wait until hearing the water bubling sound 3 Remove the tip then remove the handpiece 4 Press STANDBY button 5 Push the ON OFF button 6 Turn key to OFF position Error Messages The Waterlase C100 constantly monitors its own performance and calibration If any performance errors occur the text at the top of the power display will indicate the cause of the error and when required for safety the device will go to the 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 in place of SYSTEM ERROR 2008 BIOLASE Technology Inc All Rights Reserved 27 SECTION 5 WATERLASE C100 SPECIFICATIONS GENERAL Dimensions Unit With Fiber Weight Electrical Operating Voltage Frequency Current rating External fuses Main control On Off control Remote interruption Wate
45. mal means to stop the laser AN 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 Please direct any safety questions to your local BIOLASE representative 2008 BIOLASE Technology Inc All Rights Reserved 11 SECTION 3 EQUIPMENT GENERAL The Waterlase C100 dental laser system consists of two modules e Optical Power Unit the Unit e Waterlase C100 Atomizing Delivery System the Delivery System OPTICAL POWER UNIT ELEMENTS Control Panel The control panel consists of three components see Figure 5 e Buttons e Liquid Crystal Display LCD e Light Emitting Diodes LEDs Buttons The buttons allow for selection and control of all system variables e ON OFF Turns System ON and OFF e STANDBY Disables the unit e READY Enables the unit e Adjusts AIR WATER POWER and FREQUENCY values e MODE Selects air and water operational states ON OFF AUTO e 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 e fFUNCTION Selects frequency or power mode and service LCD Liquid Crystal Display The LCD display shows settings error mess
46. n on tip specifications please review the previous table Similar specifications are also provided with each individual package of tips Please carefully read all warnings and cautions for each tip type before using them in a clinical setting Handpiece Cleaning and Sterilization To assure proper sterilization the Waterlase C100 Dental Handpiece must be cleaned and then steam autoclaved per the following instructions before each use Contamination control requires both cleaning and steam sterilization and should be performed by trained personnel while wearing protective gear gloves masks shields etc Handpiece Cleaning The cleaning process is intended to remove blood protein and other potential contaminants from the handpiece surface and crevices Always perform this procedure prior to steam sterilization Dry out the water line as described in Section 4 Disconnecting the Handpiece Carefully remove the handpiece from the fiber optic cable Attach the protective cover to protect the optical shaft Insert rear plug in handpiece base part Carefully remove tip from the handpiece using a tip remover see Section 4 Insert tip plug into tip orifice Wipe entire handpiece outer surface with cotton gauze and chemical disinfectant Soak gauze in chemical disinfectant then wrap handpiece and tip in gauze O ON DO BW N Leave handpiece and tip wrapped in gauze for 10 minutes 10 Remove disinfectant gauze and
47. n 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 5 Amputation of root apex a Select Waterlase C100 parameters and tip i P2225W ii Water 30 ili Air 35 iv Tip type G6 600 um diameter b Bring tip approximately 1 mm from the root surface Direct the tip at slight angle so as to give a bevel effect and proceed with cutting An example of bevel cut is presented in Figures 1a and 1b The angled cut provides better access to the apical Gutta Percha for retrofilling N ___ Apical cut Apical cut At eos Gutta Percha Gutta Percha Labial Facial Apical Cut Labial View Apical Cut Side View Fig 1a Fig 1b 6 Root end preparation for retrofill a Select Waterlase C100 parameters and tip i P220W 1 Water 30 ii Air 35 iv Tip type G6 600 um diameter b Position the tip at approximately 1 mm from the sectioned root Direct the tip at the sectioned surface and prepare a small pit for placing the sealant c Use any of your preferred materials to seal the end of the root 58 5100109 REV D 12 10 7 Pathology and Granulation tissue removal a Select Waterlase C100 parameters and tip i P2225W ii Water 30 ili Air 30 iv Tip type G6 600 um diameter b Locate any pathology that has to be removed for lab evaluation Apply the tip in slight
48. ng service Certification 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 Apeture Location On the top cover 2008 BIOLASE Technology Inc All Rights Reserved 49 50 A ES ES Biolase Technology Inc 4 Cromwell Irvine CA 92618 5100109 REV D 12 10 Attention Label Location Next to protective ground Protective Ground Location Next to El ground terminal Laser Explanatory Label Location On top cover over fiber optic connector Ground Location Under Circuit Breaker inside of Back Panel Identification Location Back panel above Ventilation Channels ELECTRICAL RATINGS 100 230 V 50 60 HZ 15A 8A e 5200193 REV B FILL DRAIN LB00 03 0004 REV D 5000734 5000417 RNE ON OOFF 5000430 REVB 5000431 REVB REMOTE LB00 03 0005 REVC AN ETLLISTED fi CONFORMS TO E mig UL60601 1 5 CANICSA C22 2 NO 601 1 EC60601 222 2 FOOTSWITCH 5200102 REV A Electrical Ratings Location Next to Power cord connection Cooling System Fill Drain Location Back panel Air Label Location Back panel Key Switch Location Back panel Water Spray ON OFF Location Top of back panel Remote Label Location Back panel ETL
49. nting plate Center shaft Slide the Fiber Optic Connector and alignment pin into the alignment pin hole e Once the connector reaches the Laser Aperture turn the Locking Nut Clockwise 2008 BIOLASE Technology Inc All Rights Reserved 21 22 CAUTION When first turning the Locking Nut onto the Laser Aperture if it seems tight turn counter clockwise until loose and try again e Tighten the Locking Nut by turning it clockwise until fully seated e Place the Delivery Support Arm into the mounting hole on the Delivery System Mounting Plate e Snap the Delivery System into the hook on the end of the Delivery System Support Arm figure 6 and place the Fiber Optic Shaft into the Handpiece Holder figure 8 Connecting Handpiece to Fiber Optic Cable 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 2 CAREFULLY remove protective cap by squeezing on the two opposite tabs and twist cover off the Delivery System Figure 11 CAUTION Do not bump protective cover into fiber ferrule 3 Prior to assembling the handpiece check for water contamination Verify that NO water is present along the fiberoptic shaft and on fiber ferrule For cleaning and drying use lint free tissue 4 Connect handpiece The handpiece should be pointed st
50. ny graduated endo files Use any of your preferred techniques and materials to fill the canal and restore the tooth It is important to note that sound principles of endodontic treatment have not been affected by using this device and technique Protocols that constitute correct endodontic treatment such as irrigation drying obturation etc remain within the scope of the operator s clinical judgment and experience Clinicians who are conservative of tooth structure and wish to keep the tapered shape of the canal to a minimum may find this laser procedure sufficient for such goals However if the goal is to achieve a more tapered shape to accommodate the wide Gutta Percha points additional instrumentation may be necessary 56 5100109 REV D 12 10 APICOECTOMY CLINICAL PROTOCOL The same clinical standards as with conventional instrumentation are applied to Waterlase C100 for Apicoectomy procedures The following are procedural steps including laser operating parameters and surgical techniques recommended for Waterlase C100 Apicoectomy Before starting any procedure carefully review the Contraindications Warnings and Precaution section of the User Manual Surgical procedures on soft tissue bone and root apex should only be performed by clinicians who have training and knowledge in Oral Maxillofacial and Endodontic Surgery Procedure 1 Preparation of the surgical site a Establish access to the site using cotton rolls cheek
51. oLase root canal kit Adjacent Structures Waterlase C100 can remove both hard and soft tissues Therefore always be aware of adjacent structures and substructures during treatments Be extremely careful not to inadvertently penetrate or ablate through the apex the root canal wall or underlying adjacent tissues Also be aware and use extreme caution working on tissue i e bone root apex etc adjacent to the following structures maxillary sinus mental foramen and mandibular canal or any other major anatomical structures i e nerves Exercise extreme caution when using this device in areas such as pockets cavities or channels where critical structures i e nerves vessels could be damaged Do not proceed with using the laser if visibility is limited in these areas Clinical Conditions Use a sterile field and aseptic technique with all procedures especially for surgical interventions 5100109 REV D 12 10 Tissue Evaluation Any tissue growth i e cyst neoplasm and other lesions removed with Waterlase C100 or conventionally must be submitted to a qualified laboratory for histopathology assessment Tissue Contact and Tip Breakage Do not contact hard tissues with fiber tip Hard tissue cutting occurs in non contact mode with the tip 1mm off the surface Also the tip is very brittle and fragile and could break if pressed against tooth or bone tissues or if forced through a narrow or curved path or root canal Use a bit
52. odes for the Power and Air amp Water Spray EE and Air Parameter Range of Values el ON Mode Au Mode Cl Mode Power 00 50 Wats 0 100 Sanay LL 25 5100109 REV D 12 10 Table la Range of Power Versus Frequency Tip Cleaning and Inspection BEFORE AND AFTER EACH USE the tip surfaces must be inspected for chips pits and cleanliness Refer to tip inspection and cleaning kit DO NOT USE A TIP THAT HAS CHIPS PITS OR IS NOT CLEAN The cutting effectiveness will be lessened and damage on the handpiece may occur to minimize risks do the following e New tips or tips in use must be cleaned wearing gloves or finger cots Clean the tip surfaces with PURE ACETONE OR 100 ALCOHOL ONLY IF ACETONE IS NOT AVAILABLE Pay particular attention to the distal end of the tip as IT MAY REQUIRE SOME SCRUBBING 30 sec to 1 minute TO REMOVE ANY DEBRIS e One of the easiest ways to clean the tips is to leave the tip in the tip remover and cover the open slot with your finger This will hold the tip in place while you scrub with lint free Q tips or wipes e After installation of the tip WIPE THE END ONE MORE TIME TO ENSURE CLEANLINESS Operational State Description Each function Power Water and Air has a separate display indicating the value of the parameter and its mode For example when the mode is in AUTO Water and or Air will flow only when the footswitch is pressed and power is emitted The mode and
53. of the laser beam and internal optics and depending on use the components may need to be periodically replaced in order to maintain tissue cutting efficiency Properly following the operating and maintenance instructions of this manual will increase the delivery system s lifetime Please contact your authorized local BIOLASE representative if replacement of the fiber delivery system or handpiece is needed DAILY MAINTENANCE Use standard dental disinfectant to wipe down the handpiece after each procedure Do not use bleach or abrasive cleansers Be careful to prevent water from entering the unit especially around the fiber optic handpiece connectors It is recommended that the water bottle be emptied and dried at the end of each day and filled with fresh deionized or sterile water each morning TRANSPORTATION The Waterlase C100 is highly susceptible to misalignment if not handled properly The unit should ALWAYS be packed inside of its shipping crate when transported from one location to another While the unit is semi portable and may be rolled from one operatory to another inside of the same office care should be taken when pushing the unit over doorway thresholds and other bumps or objects on the ground The unit should never be banged jarred jolted dropped or knocked Do not roll the unit outside of the office building across a road or over any other rough surface Do not place the unit into a pick up truck van or other moving machin
54. ommended settings for power and air and water spray Initial training on extracted teeth is strongly recommended Start working on patients only after practice of the technique on extracted teeth and training is completed Select simple cases such as straight canals on anterior teeth first Procedure l Prepare access to the pulp chamber with the Waterlase C100 using a 600 um fiber tip at the appropriate setting for cutting enamel and dentin Use the same G6 tip to remove the coronal portion of the infected necrotic pulp The recommended range of settings for this procedure is Power 0 75 1 00 W Air 2 1126 Water 7 11 The initial instrumentation is performed using the small size K files to allow a K 20 or 25 to reach the working length A Z2 diameter 200 um fiber tip is the thinnest endodontic fiber which corresponds to a K 20 hand file Laser root canal enlargement is performed circumferentially starting at the apical third To start the procedure select a Z2 diameter 200 uim endodontic fiber tip with a length comparable to the established working length Place fiber tip into the handpiece and select treatment settings Use the control panel to enter appropriate settings for Power Water and Air The parameters suggested for this procedure are P 1 50 W Water 24 Auto mode and Air 34 Auto mode These settings can be finely adjusted to better optimize for each patient s care Power settings should not exceed P
55. on the keypad If error messages persist please contact your BIOLASE representative Circuit Breaker ge ON The circuit breaker serves as a line switch to separate the unit Figure 1 Circuit Breaker OFF from the main power supply 0 OFF 1 ON OT Keyswitch To switch unit ON turn the key to the horizontal position e Use the proper key only The key cannot be removed while C OF in the ON position Always remove key when not in use F Figure 2 Keyswitch 5100109 REV D 12 10 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 Figure 3 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 Figure 4 Emergency Stop Push to activate emergency stop Rotate and release button to restart Do not use as a nor
56. otomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Sulcular debridement Laser soft tissue curettage 2008 BIOLASE Technology Inc All Rights Reserved 35 Enamel 4 50 6 00 Dentin 3 00 4 50 Bone 1 75 3 50 Soft Tissue 0 75 2 50 HARD TISSUE Cavity preparations I V Caries removal Hard Tissue roughening or etching Enameloplasty Tooth preparation to obtain access to a root canal Cutting Shaving Contouring amp resection of oral osseous tissues bone Osteotomy Ostectomy Osteoplasty amp Osseous recontouring Cutting bone to prepare a window access to the apex apices of the root roots Apicoectomy Root end preparation for retrofill SOFT TISSUE Excisional amp incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy amp Frenotomy Gingival troughing Gingivectomy Gingivoplasty Gingival incision amp excision Hemostasis Implant recovery Incision amp drainage of abscesses Leukoplakia Operculectomy Oral papillectomies Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores Vestibuloplasty Full partial amp split thickness flap preparation Removal of pathological tissues Incision amp drainage of periapical abscesses EYEWEAR Doctor patient assistant and all others inside the operatory must wear appropriate laser protective eyewear for the 2 78 um wavelength WARNINGS Do NOT operate Z tips without air and water spray or
57. ou will be able to determine spray and power efficiency from the sound of the popping water droplets A sharper more distinct popping sound represents a higher cutting rate After you have completed treatment release the footswitch and carefully remove the handpiece from the patient s mouth Do not hit the handpiece tip into teeth or other instruments while removing the handpiece or the tip may break To remove the tip use the tip remover tool Place a new tip on the tip plug to avoid contamination and damage to the handpiece At the end of the treatment the handpiece and tip must be autoclaved see sterilization instructions in Section 8 Daily Maintenance Soft Tissue Incision Excision and Ablation Soft tissue procedures are performed with direct laser energy either with or without the water spray The water spray settings are generally lower for soft tissue than for hard tissue During soft tissue cutting the air and water spray hydrates and cools the target For soft tissue procedures select appropriate settings or presets as shown in Section 7 Fiber Tip Calibration Chart Once settings or presets have been selected carefully place the tip in contact with the tissue to be incised Step on the footswitch and start moving the tip along the tissue surface by applying light pressure The incision will be noticed immediately after laser activation Bleeding is controlled through reduction of the water setting For superficial lesions or hemost
58. r 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 23 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 The same motion is used with Tip Remover CAUTION DO NOT pull tip with Tip Remover tilted E E Tip Groove Figure 17 Changing Tlps Remove tip from Tip Remover and slide in the new tip Insert the new tip by following the instructions presented in Section 4 Disconnecting the Handpiece OPERATION Overview WARNING Use of controls or adjustments and performance of procedures other than those specified herein may result in hazardous radiation exposure Waterlase C100 provides user control for Power Water and Air parameters The user may select a Preset a set of stored values and modes of operation for Power Water and Air or vary the individual values to adjust Power Water and Air as appropriate for the procedure The following table shows the range of values for Power Water and Air and their operational states Table 1 Range of Values and Operational States and M
59. raight up when the handpiece is connected or disconnected see Figure 12 Taking care not to scrape the handpiece against the fiber ferrule Figure 12 c slide the handpiece down the shaft until it clicks into place at the quick release tabs The handpiece MUST be properly secured to the fiberoptic shaft Figure 12 b The protective cap is NOT a substitute for a handpiece Disconnecting the Handpiece CAUTION The Handpiece should always be connected when turning ON the laser CAUTION Make sure that the water bottle toggle switch is in OFF position when turning ON the laser 1 Turn the water bottle Toggle Switch to OFF position 2 While laser is in the Ready mode with Tip attached dry out the water line a switch laser to ENAMEL mode pre set 1 b turn Air and Water to ON mode c wait for 15 seconds and watch clear tubing to dry water out d switch Air and Water back into AUTO mode WARNING Disconnecting the Handpiece without drying out the water line may cause severe damage to the Hand piece and Trunk Fiber 5100109 REV D 12 10 3 While laser is in the Ready mode carefully disconnect Fiber Tip using Revolving Tip Holder or Tip Remover and replace it with Tip Plug Press Standby button 4 Disconnect the Handpiece Place the Protective Cap on the Fiber Optic Shaft 5 Connect the Rear Plug to the Handpiece Turn System OFF Before autoclaving if Handpiece has
60. rements at the present DAC setting Compare these values to the range values on form FM1409 8 Using the and buttons of AIR adjust the DAC value as necessary 9 Retest and compare power readings to FM1409 Readjust DAC value as necessary until the power output values are within the acceptable power ranges on FM1409 10 Press STANDBY to exit the SERVICE mode 11 Record calibration date and sign calibration schedule Table 6 42 5100109 REV D 12 10 CALIBRATION SCHEDULE Power calibration is to be performed annually The Service Technician shall write the date of installation and subsequent power calibration dates in the table provided below Table 6 Installation and Calibration Dates Installation Date ibration Date nician nician ibration Date ician ibration Date ibration ician ibration ibration ibration Date nician ibration Date nician ibration Date nician ibration Date nician ibration Date nician 2008 BIOLASE Technology Inc All Rights Reserved 43 APPENDIX A Instructions For Filling The Internal Cooling Reservoir CONNECTING THE FUNNEL ASSEMBLY TO THE SYSTEM 1 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
61. rformed using air and water spray at appropriate settings Failure to use the spray will result in tissue thermal damage Curettage Procedures Exercise extreme caution when using this device in areas where critical structures i e nerves and vessels could be damaged such as in the apical third of the 3rd molar socket Do not proceed with using the laser if visibility is limited in these areas Fluid Entrapment and Air Embolism Do not direct air or spray toward tissues that may trap air fluid For example when performing surgical procedures the clinician should be aware of adjacent soft tissue pockets cavities or channels that may collect or entrap air fluid 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 29 30 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 entrap air In general the same care and precautions should be taken when using the Waterlase C100 as are taken when using any air and water emitting cutting device including the high speed drill Root Canal
62. rlase C100 Water type External air source Interaction zone Optical Laser classification Medium Wavelength Frequency Average power Power accuracy Pulse energy Pulse duration Delivery head angles Delivery tip diameter Divergence Mode Aiming Beam Nominal Ocular Hazard Distance 28 5100109 REV D 12 10 12 55 x 27 73 x 33 28 in 32 x70 x 84 5cm 12 55 x 27 73 x 52 5 in 32 x 66 x 133 5 cm 110 Ibs 50 kg 115 VAC 10 230 VAC 10 international 50 60 Hz 16 0 A 8 A international None Circuit breaker Key switch Remote interlock connector Distilled or DI 80 120 psi 5 5 8 2 bar 0 5 3 0 mm from handpiece tip IV Er Cr YSGG Erbium Chromium Yttrium Scandium Gallium Garnet 2 78 um 2780 nm 10 30Hz 5Hz incremental step 0 0 6 0W 20 0 300 mJ 140 150 us 0 Straight and 90 Standard 200 1200 um ge Multimode Red 655 nm laser safety classification 1 NOHD 5cm SECTION 6 CONTRAINDICATIONS WARNINGS amp PRECAUTIONS CONTRAINDICATIONS All clinical procedures performed with the Waterlase C100 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 which might contraindicate a loca
63. soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocketing lining and junctional epithelium Removal of granulation tissue from bony defects 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 39 40 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 Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Flap preparation incision of soft tissue to prepare a flap and expose the bone Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth hard and soft tissue impactions Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscesses Laser soft tissue curettage of the post extraction tooth sockets and the periapica
64. 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 Table 2 Pre Programmed Presets for General Hard and Soft Tissue Procedures Power Watts a Water Setting Air Setting Table 3 Suggested Combination of Presets for Root Canal Enlargement Power Watts Ha Water Setting 96 Air Setting 96 31 fancam 60 a pra 1 ET rss Coaguatn 075 2 9 Table 4 Suggested Combination of Presets for Bone and Soft Tissue Surgical Procedures Power Watts ipd Water Setting 96 Air Setting 96 Contouring Air and Water are always programmed in the Auto mode The Waterlase C100 may be used for the applications listed in Section 7 Waterlase C100 Indications for Use Table of Indications for Use If you are not sure which preset or settings to use for a particular application please refer to the suggested settings presented in Tables 2 3 and 4 from section 7 Presets for Soft and Hard Tissue Procedures and use your clinical judgment to make appropriate adjustments Attend training courses and experiment on model tissues before starting a new procedure in your practice 34 5100109 REV D 12 10 SUGGEST TIP CLINICAL SPECIFICATIONS Diameter Calibration Power Water Air Settings Tip Type Factor Lengths mm Tissue Types Settings W Settings Le Enamel 4 50 6 00 Dentin 3 00 4 50

5100109 REV. D (12/10)

Contents

Download Pdf Manuals

Related Search

Related Contents