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1. Once settings have been selected for enamel dentin or cementum cutting carefully position the fiberoptic tip approximately D 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 NOTE Always remember that laser power and therefore hydrokinetic energy are delivered from the very end of the tip Tissue cutting technique 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 cutting techniques it is very important to have the exact treatment location visually identified before and during treatment 5100105 Rev E 09 06 Maintain a fiber tip to treatment tissue dista
2. 2 8 um 2780 nm e Frequency 20 Hz e Average power 0 0 6 0 W e Power accuracy 20 e Pulse energy 0 300 mJ e Pulse duration 140 150 us e Delivery head angles 0 Straight and 90 Standard e Delivery tip diameter 200 1200 um e Divergence 8 e Mode Multimode e Aiming Beam Red 655 nm laser safety classification e Nominal Ocular Hazard Distance NOHD 5CM 5100105 Rev E 09 06 SECTION 6 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Contraindications All clinical procedures performed with the Waterlase 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 local 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 Medical clearance from patient s physician is advisable when 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 pat
3. SEUD E 20 Connect Unit to Operatory 20 Fill Self Contained Water System Bottle i 20 Secure Fiber Optic Assembly to Un 20 Connecting Handpiece to Fiber Optic Cable 22 Disconnecting the Handpiece esses 22 Installing FIp Into Manapiece alc 23 Changing popa editar irati aedi dec uinea ettet deseo cune nac de acia mats 24 Tip Cleaning and Inspection esses nme 24 A 24 GUI Me 24 Operational State Description a 25 Be Be gn AE EEN 25 Modify and Save Preferred Values as Presets 27 Activate the TEE 27 Torn the Waterlase Olarra ANA enone ed 27 Error Messages UTI TEM 27 SECTION 5 WATERLASE SPECIFICATIONS eee eee nne 28 E o poses GANA aep A Vu E RUE RUE Leon 28 Dimensions NW da 28 miei Em 28 NEE M EE 28 OPIC MC EMPTUM 28 SECTION 6 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 29 Biere We ee ninia 29 Indications Warnings and Precautions 29 A A TUTTI a 29 AGES ENE APA AA au e desti esie eia Ges 29 Treatment Technique and Settings 29 Hard Tissue Procedures aaa AA DAA ne 29 Gurettage Procedures aap iia 29 Fluid Entrapment and Air Emboltem a 29 Root G nal Procedures cross 30 e tege esmas coi 30 Clinica
4. 1 EnamelCutting 60 75 Dentin Cutting Soft Tissue Cutting 15 24 a 4 SoftTissue Coagulation 075 o n Table 4 Suggested Combination of Presets for Bone and Soft Tissue Surgical Procedures a mM uM E Bone Resection and Bone Resection and Cutting 2 Bone Shaving and Contouring i 3 Soft Tissue Cutting 4 SoftTissue Coagulation 075 o n NOTE Air and Water are always programmed in the Auto mode The Waterlase may be used for the applications listed in Section 7 Waterlase 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 5100105 Rev E 09 06 Waterlase User Manual seyan anss1 os JASE jueuiepuqap senang dejeu jeueo 1001 0 joun pe ue se Awojodjng uonedunxe ding Awojoding 3INSSIL LJOS sj ajep Auoq Woy anssi JONe nueJb jo JeAOWAY Bulueajo pue Juawapuqap IEUE ooy uaw a6Jejua Buipnjour uonejedaud eues 100 INSSIL OYYH AdeJay Pues joo 0 ppunfpe ue se Awojodjng uogedunxe ding Awojoding 3NSSIL LJOS Bulueap pue juauirepuqap pues 1003 usw abuejua Buipnjour uo
5. 49 Non Interlocked Protection Housing Warning 49 Laser etc c 49 Protective Te A e UC NANANA aaah 50 Laser Explanatory Label ntermatonalt 50 Danger Label US OMY m tm 50 eg WEE 50 o nua ail i 50 Electrical Fre WIIG NR TIT TT pere 51 Cooling System Fill Drain a 51 Air Label 51 PP e o A 51 Remote Label 51 Walter Spray ON OPF E 51 AM AAA 51 Footswitch Label 51 Emergency Stop Label u s aaa kaman 51 APPENDIX C SPARE PARTS AND ACCESSORIES ees 54 APPENDIX D CLINICAL PROCEDURE GUIDELINES 55 Root Canal Clinical Protocol mn 55 o Gia TERME 55 APPENDIX E WATERLASE WARRANTY eene nennen nnne nun hann nnn 60 INTRODUCTION The Waterlase 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 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 utilizes direct laser energy to perform tissue removal incision excision ablation and coagulation For hard tissue procedures the YSGG solid state laser provides optical energy to a user controlled distribution of a
6. Handpiece 2 Carefully remove the handpiece from the fiber optic cable 3 Attach the protective cover to protect the optical shaft 4 Insert rear plug in handpiece base part 5 Carefully remove tip from the handpiece using a tip remover See Section 4 6 Insert tip plug into tip orifice 7 Wipe entire handpiece outer surface with cotton gauze and chemical disinfectant 2003 BIOLASE Technology Inc All Rights Reserved Waterlase User Manual Section 7 Clinical 8 Soak gauze in chemical disinfectant then wrap handpiece and tip in gauze 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 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 Set au
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8. SECTION 1 INSTALLATION OF THE WATERLASE Installation Instructions Upon request your local authorized BIOLASE representative will unpack the Waterlase and your service representative will install the unit Facility Requirements Electrical Supply Domestic 115 VAC 16 0 A International 230 VAC O 8 0 A Compressed Air Supply Laser Internal Cooling System e 80 120 psi 5 5 8 2 bar e Moisture in the air supply line may cause damage Please provide proper filtration to eliminate all moisture from air source Connections for air supply must be available in each operatory 2003 BIOLASE Technology Inc All Rights Reserved Wateriase User Manual Section 2 Safety 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 for air not water supply Connection to water supply may cause damage to Waterlase If the unit was connected to the water supply DO NOT turn the system on Contact your Biolase service representative CAUTION Unit must not be operated without filling the internal cooling system reservoir w
9. 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 T 4 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 80 W 1W x 0 30 0 30 W Tip Specifications For information on tip specifications please review the following 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 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 1 Dry out the water line as described in Section 4 Disconnecting the
10. contracts and all liability to BioLase d Seller s sole and exclusive liability and the Buyer s sole and EXCLUSIVE REMEDY under this warranty shall be at Seller s election the repair or replacement of goods only if Seller is promptly notified 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 1 repaired worked on or altered to affect the stability reliability or proper operation of such goods 11 subject to misuse negligence or accident of 111 connected installed used or adjusted otherwise than in accordance with the instructions furnished by Seller e All goods which Buyer considers defective shall be returned to Seller s office transportation costs prepaid and borne by Buyer unless otherwise agreed to in writing The risk of loss of goods shipped or delivered to Seller s plant to repair or replacement will be borne by Buyer f If it is found that Seller s Product has been returned without cause and ss 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 5100105 Rev E 09 06 Wateriase User Manual g LIMITATIONS BIOLASE shall not be responsible for labor and materials necessary to effect repairs caused by weathe
11. 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 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 EndoLase endodontic kits Adjacent Structures Waterlase 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 e bone root apex etc adjacent to the following structures maxillary sinus mental foramen and mandibular canal or any other major anatomical structures e nerves Excersise extreme caution when using this device in areas such as pockets ca
12. seJos Jayueo jo juaueas Guuaygbua uwoJ2 enssi yos Audomied u je amp AiBuiB jo uonanpa saiuojoejided elo Awojapnajado ene doyna7 sassaosge jo eBeurgip pue uoisiou ua ooa1 juejdui sisejsoulep uoisioxe pue uoisiour pealbure AjsejdowiBure AwopanG6us BuruBnouy jp buo Awojoual4 pue lojoauaJy Je ouleJ euiocJgi yes peydnueun jo eunsodxa saisdoig EUCISIOUI pue Buorsiox3 INSSIL LJOS uro oeootdy sedoso loy9a3s0 AuojoejsQ euoq songen snoasso osz cuo onge uos 240 jo uogaasau pue Buunojuo Bui eus Buying mue OSE S L auog 100 e 0 58228 UIE QO oj uogejedaud Yoo Aysejdojaweuz OS 00 unuag IP ouJ8J sanen A suonejedeud Aye INSSIL OYYH 00 9 DEE jaweug OO M aen 104 suongea3ipu isBunjes suwas sBunjes sadAl ww Buiwoj oJ 34 404 ajqeyins ysow aq Aew JAMOd anss sy 6ua uoneJgije5 Je a weig suone9i4i9ads Eau dij pa3sabbns ajqey en DOZL X 00 EJ O D e LL gt CC LO O o e wc LO Fiber Tip Calibration Chart Refer to Table 5 to review the different characteristics and calibration factors for the Waterlase 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
13. use conventional spoon curettes to dislocate and remove c For granulation tissue removal select the following Waterlase parameters i P 0 75W ii Water 7 Yo ii Air 11 iv Tip type G6 600 um diameter d 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 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 2003 BIOLASE Technology Inc All Rights Reserved NS APPENDIX E WATERLASE WARRANTY U S
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15. 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 NOTE DO NOT USE TAP WATER 1 Set 2 Set FIG 5 5100105 Rev E 09 06 Watenlase User Manual Slowly add 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 SEE FIG 6 BIOLASE BIOLASE HIT ET a L 2 Set amp Fill Level Remove the Funnel Assembly Attach the White Cap to the System Vent Tube Turn the System on for several minutes Reconnect the Funnel Assembly 2 3 4 5 6 Refill the system with Distilled water as required n NOTE 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 m NOTE DO NOT OVER FILL DRAIN EXCESS WATER THROUGH THE FUNNEL FOR 6100200 SYSTEMS DRAIN THROUGH THE SYSTEM VEN
16. ECTION 3 EQUIPMENT DESCRIPTION 11ee KEREN REESEN 12 Generali eg 12 Optical Power Unit Elements 12 A tetti s patere ids etm mi bes is APA 12 Keyswitch Figures 2 amp Z A 12 Footswitch connector Figure Zi 13 Remote Interlock Figure Z A 13 Power Connection FIQUIC Vaina 13 Gireuit Breaker Figure Z vips Nkaka a 13 Ventilation Channels Figure Zi 13 LOCKING Wheels FIQUEG 6 cives ie ve eoo I ne rua pat veas a vov eo er ous vk ra beoe KANG 14 Front Hande Figure C 14 Back Panel PIguEe Y liada 14 Handpiece Holder Figure 8 a 14 AIG We CIE IG tee an 14 Self Contained Water System Figure7 i 14 Delivery System Support Arm with Hook Figure 6 14 Water Bottle Switch Figure 7 14 Fill Drain Connector Figure 21 14 Waterlase Delivery System i 18 mises E TEE 18 Optical gom 18 Fiber Opie Gable ar A eee 18 Delivery System Connections on the Um 18 Handpiece A tetera a ere ae eee 18 Quick Release MechansmTabe nennen 18 a SA a o El 18 HN FG TOM AA ana 18 Protective Rubber Cap for fiber optic connector 18 Laser Connector HOUSING s ecce hei die 19 Handpiece Holder 19 AGANG AA EE 19 Ab EE 19 Rei CIMOW EE 19 FEVOIVING Mp le e occasion 19 SECTION 4 OPERATING INSTRUCTIONS conccocccconccconccccnncccnnnccnnnnnnnancnnnnnenannenananas 20
17. N OFF button Turn key to OFF position Turn circuit breaker to OFF VR XN dem Error Messages The Waterlase 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 The system will be placed in Standby mode when an error occurs 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 2003 BIOLASE Technology Inc All Rights Reserved Warerlase User Manual Section 5 Specifications SECTION 5 WATERLASE SPECIFICATIONS General Dimensions W x L x H e Unit 12 5 x 26 x 32 in 32 x66 x 81cm e With Fiber 12 5 x 26 x 40 in 32 x 66 x 102 cm e Weight 88 lbs 40 kg Electrical e Operating Voltage 115 VAC 10 230 VAC 10 international e Frequency 50 60 Hz e Current rating 16 0 A 8 A international e External fuses None e Main control Circuit breaker e On Off control Keyswitch e Remote interruption Remote interlock connector Waterlase e Water type Distilled or Sterile e External air source 80 120 psi 5 5 8 2 bar e Droplet size 5 200 um e Max droplet velocity 100 m s e Interaction zone 0 5 3 0 um from handpiece tip Optical e Laser classification IV e Medium Er Cr YSGG Erbium Chromium Yttrium Scandium Gallium Garnet e Wavelength
18. Original Equipment Owner a Seller warrants the goods and parts which are of its manufacture and shipped hereunder to be free from defects in material and workmanship for twelve 12 months from shipment Exceptions to this warranty are as follows 1 Waterlase MD tips are not included in the warranty 11 LaserSmile and Diolase Plus fibers are not included in the warranty 111 Waterlase MD Handpieces included in the original shipment are only warrantied for 90 days from shipment b This warranty 1s the only warranty made by Seller with respect to the goods delivered hereunder and no representative or person 1s 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 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
19. SI or more 3 Electrical input should be 115 VAC maximum 16 amperes for U S 230VAC 8 Ampere for International 4 The Handpiece should be properly connected 5 Verify that the water bottle is filled more than 1 3 with distilled or deionized water and that the pressure switch is in the OFF position 02003 BIOLASE Technology Inc All Rights Reserved Waterniase User Manual Section 4 Operating WARNING Laser and collateral radiation are emitted through the fiber optic port Removal of the SMA connector from the fiber optic port may lead to hazardous exposure Radiation is also emitted from the fiber shaft when the handpiece is removed DO NOT attempt to operate the Waterlase with the delivery system or the handpiece removed 6 f 8 9 10 11 Emergency stop button must be in a release position Turn circuit breaker to ON position Insert key into the switch and rotate clockwise to the ON position Press the On Off button on the front panel to start the unit Self Test messages will appear along with a 3 second delay Attach handpiece to the fiber optic cable shaft Section 4 Connecting Handpiece to Fiber Optic Cable Press Ready button and attach tip using the tip remover Section 4 Installing Tip Into Handpiece Select parameters appropriate for the procedure The mode and value of each parameter may be adjusted by the keys below the associated display To select a Preset s
20. T TUBE FOR ALL OTHER SYSTEMS REMOVING THE FUNNEL ASSEMBLY FROM THE SYSTEM 1 Disconnect the Funnel tubing from 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 2003 BIOLASE Technology Inc All Rights Reserved Section 9 Calibration PRIMIMG THE SYSTEM 1 Comnect all ancillary equipment to the System Power Cord Footswitch Air Line Delivery System w 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 BIOLASE 4 The system is now ready to operate ET 5100105 Rev E 09 06 Wateriase User Manual APPENDIX B LABELS Laser Hazard Symbol Location Top cover of Laser head directly above the Fiber Optic Connector Only visible during service High Voltage Hazard Symbol Locations e Top cover of Laser head directly above the High Voltage input e High Voltage Shield e PFN Board Capacitor e Front Capacitor Bracket e Only visible during service Danger Location Back panel centered below ventilation channels THIS PRODUCT CONFORMS m TO THE PROVISIONS OF Certification 21 CFR CHAPTER 1 Loca
21. TS OR IS NOT CLEAN The cutting effectiveness will be lessened and damage on the handpiece may occur to minimize risks do the following 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 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 To Start the Waterlase 1 Verify that all connections have been properly secured 2 The Air supply must be connected and the external air pressure must be at 80 P
22. Vaterfase The Complete Laser for Every Dentist User Manual BIOLASE 2003 BIOLASE Technology Incorporated All Rights Reserved BIOLASE Waterlase YSGG User Manual BIOLASE the BIOLASE logo Waterlase and the Waterlase logo are either registered trademarks or trademarks of BIOLASE Technology Incorporated in the United States and or other countries BIOLASE Technology Inc 4 Cromwell Irvine CA 92618 USA biolase com NASDAQ BLTI BIOLASE Europe GmbH Paintweg 10 92685 Floss Germany BIOLASE Australia Pty Ltd CAN116912353 26 Wakeman St Adelaide South Australia 5000 BIOLASE NZ Ltd Company Number 1737441 P O Box 302628 North Harbor Auckland 1330 New Zealand 5100105 Rev E 09 06 Contents INTRODUCTION all ciccia 7 SECTION 1 INSTALLATION OF THE WATERLASE eee eee 7 Installation wd ler len EE 7 Seegen ita 7 Electrical UY e o 7 Compressed Air Supply Laser Internal Cooling System 7 SECTION 2 SAFETY WITH THE WATERLASE eere nennen 9 PIEGAUlIONS cli 9 Salely INSIMUCTION State elica 9 Sale FO al Seres traten carino AA 10 EMCI NANA 10 Ciicul Breaker iaia 10 OS Wilco 10 READY BUT OM EE 10 FOOISWIICN naasa a ainia ada 10 Remate Interlock PIUg ua did 11 Emergency Stop Figure 9 aa 11 Functional DIS Pla 11 Layout of Control Elements 1 nnne 11 S
23. air Always use high speed suction to remove any excess fluid and avoid directing the spray into deep pockets cavities or channels such as the crevice 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 if it is not possible to access the treatment site without directing air into an area that may collect or entrap air In general the same care and 02003 BIOLASE Technology Inc All Rights Reserved Wateriase User Manual Section 6 Contra indications precautions should be taken when using the Waterlase as are taken when using any air and water emitting cutting device including the high speed drill Root Canal Procedures Review the clinical procedure and all labeling instructions provided with the endodontic tips and EndoLase kits 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 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
24. e 3 Root Canal Presets and Table 4 Bone Surgery Presets 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 to adjust any of the individual 2003 BIOLASE Technology Inc All Rights Reserved Waterniase User Manual Section 7 Clinical 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 Table 2 Pre Programmed Presets for General Hard and Soft Tissue Procedures Preset Procedure Power Water Setting Air Setting Watts Enamel Cutting 60 75 90 Dentin Cutting 22 DeniCutng 40 5 65 3 SofTssuCuting o 15 7 n 4 SottTissue Coagulation 075 o n Table 3 Suggested Combination of Presets for Root Canal Enlargement Preset Procedure Power Water Setting Air Setting Watts
25. e 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 device Waterlase operates unlike traditional dental instruments or devices and technique must be practiced and perfected to ensure efficient operation Please be aware that the Waterlase system removes hard tissues through 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 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 is presented in the following subsections Please study this Section carefully practice on tissue models and attend a Waterlase 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
26. fiber which corresponds to a K 20 hand file 4 Laser root canal enlargement is performed circumferentially starting at the apical third To start the procedure select a Z2 diameter 200 um 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 1 5 W and the procedure should always be conducted using appropriate air and water spray 5 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 6 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 Z2 and proceed with a second stroke A total of six 6 strokes are suggested for the Z2 instrumentation Flush debris i
27. he Funnel connector snaps into position and is now locked in place SEE FIG 2 Funnel Connector Receptacle Hook Funnel Assembly Funnel Connector Luer Connector Funnel Tube Assembly Yellow PLEASE NOTE 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 5100105 Rev E 09 06 BIOLASE Ze For systems 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 FIG 1 Hook and Hang FIG 1 3 Remove the white cap from the System Vent Tube which is located at the bottom of the system in between the Rear and Bottom Panels inside the small compartment and connect SEE FIG 3 IH AHH i a e RETA TASTE SS WAVEVAWAv EYE A wracece a e a cu sca sTa s u White Cap r Funnel Tube Assembly System Vent Tube Blue FIG 3 2003 BIOLASE Technology Inc All Rights Reserved Waterlase User Manual Section 9 Calibration 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 FIG 4 Sei EB Wf Luers Connected FIG 4 CONNECTING THE FUNNEL ASSEMBLY TO THE SYSTEM NOTE Before filling the system with Distilled
28. i P 2 50W ii Water 35 iii Air 40 iv Tip type G6 600 um diameter b Place the 600 um tip at approximately 1 5 2 0 mm from tissue Following a circular motion pattern proceed with bone removal to 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 2003 BIOLASE Technology Inc All Rights Reserved prepare the window In most cases a 3 4 mm diameter is adequate Thicker bone may require a power setting as high as P 2 3 50 W with Air 65 and Water 60 5 Amputation of root apex a Select Waterlase parameters and tip i P 2 25W li Water 30 96 iii 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 Apical cut Apical cut sanas W Gutta Percha Gutta Percha Labial Facial Apical Cut Labial View Apical Cut Side View Fig la Fig 1b 6 R
29. i Da TE rai e pair gei pra parir Maga n USA 5100105 Rev E 09 06 ELECTRICAL RATINGS 115 V e 50 60 Hz e Electrical Ratings 15 0A RN Location Next to Power cord connection CE 0050 Cooling System Fill Drain FILL DRAIN ki ba LB00 03 0004 SEU Location Back panel Air Label Location Back panel Key Switch Location Back panel Remote Label REMOTE LB00 03 0005 REVC Location Back panel ON O GEE Water Spray ON OFF 5000430 REVB 5000431 REVS Location Top of back panel CONFORMS TO i ED UL STD 2601 1 CD ETL Listed 9800166 CERTIFIED TO Location Back panel su CANICSA C22 2 NO 601 1 FOOTSWITCH Footswitch Label LB05 01 0007 REV Location Back panel Emergency Stop Label Location Top Cover 2003 BIOLASE Technology Inc All Rights Reserved Waterlase User Manual Figure 19 Danger Key Switch Q m ificati ho 6 Identification Certification mn fe E Remote ETL Listed EE SS Electrical Ratings Footswitch 1 WA xk e GA Ek i oe Y IA Cooling System FilVDrain mo a Ground NN 5100105 Rev E 09 06 Waterlase User Manual Figure 20 Water Spray On Off Emergency Stop Switch i Danger Label Control Panel Handpiece Handpiece Holder Laser Aperture Label gt 9 02003 BIOLASE Technology Inc All Rights Reserved EN BIOLASE PART NUMBER DESCRIPTION WC17 40 1603 Power cord Prescript
30. icoectomy Clinical Protocol The same clinical standards as with conventional instrumentation are applied to Waterlase for Apicoectomy procedures Following are procedural steps including laser operating parameters and surgical techniques recommended for Waterlase 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 1 Preparation of the surgical site a Establish access to the site using cotton rolls cheek retractors etc b Apply local anesthesia c Determine location for incision 2 Incision of gingival tissue to prepare the flap a Select Waterlase parameters and tip 1 P 15W 2 Water 20 3 Air 20 4 Tiptype 14 400 um diameter b Apply fiber tip in slight contact with gingival tissue and proceed with the incision following the flap design of your choice te 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 parameters and tip
31. ients should be closely monitored for signs of pain or discomfort If such signs are present adjust settings apply anesthesia or cease treatment if required 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 Hard Tissue Procedures All hard tissue e enamel dentin cementum and bone procedures must be performed 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 3 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 or water For example when performing surgical procedures the clinician should be aware of adjacent soft tissue pockets cavities or channels that may collect or entrap
32. igure 7 To pressurize the water bottle that supplies water to the atomization spray Fill Drain Connector Figure 7 Used to fill drain the water cooling system 5100105 Rev E 09 06 Figure 6 Front View Delivery System Support Arm with Hook Fiber Exit Control Panel Handle Locking Wheels 2003 BIOLASE Technology Inc All Rights Reserved Watenlase User Manual Section 3 Equipment Figure 7 Rear View Water UN etes Switch mil Key Switch pe q mo ee gt ATT Deionized Distilled Water Only Do not Use Tap Water Remote Interlock Outlet Pg Back Panel gt gt sos doo TU Power P Q9 Connection Channels NG Circuit Breaker Footswitch Air Input B P GG Connector Fill Drain 5 oe ne Pin Connector e T d 5100105 Rev E 09 06 Figure 8 Top View Emergency Stop Switch Control Panel Delivery System ERP Handpiece Holder Handpiece 2003 BIOLASE Technology Inc All Rights Reserved Waterlase User Manual Section 3 Equipment Waterlase Delivery System Handpiece The handpiece rotates and is detachable from the optical shaft It delivers optical energy and atomized spray to the treatment area Optical Tip The tip is detachable from the handpiece and serves as the optical power conduit to the tissue target Fiber Optic Cable The fiber optic cable contains the optica
33. imply push the button next to the preset value Figure 5 Turn water bottle switch to ON position and proceed 5100105 Rev E 09 06 Modify and Save Preferred Values as Presets The Waterlase 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 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 values and modes are permanently stored under that preset number and may be recalled at any time by pushing the preset button Activate the Waterlase Push the Ready button to enable the Waterlase and depress the footswitch when ready NOTE The user may evaluate the effect of each parameter setting prior to the procedure by directing the handpiece into a paper cup or sink and adjusting the values as desired Turn the Waterlase Off 1 Turn water bottle switch to OFF position 2 Disconnect tip if required Install tip plug 3 Dry out water line and disconnect handpiece if required Sec 4 Disconnecting the Handpiece Press STANDBY button Push the O
34. ing Tip Holder The revolving tip holder holds up to 6 tips and functions as a tip remover follow instructions enclosed with tip holder 02003 BIOLASE Technology Inc All Rights Reserved Waterniase User Manual Section 4 Operating SECTION 4 OPERATING INSTRUCTIONS Figure 10 Rear Plug Release Rear Plug Part Line Ay Release Tab squeeze here Figure 11 Protective Cap Release Protective Cap L 1 Quick Release Tab Figure 12 Handpiece Connection Tip Orifice d Handpiece Fiber Ferrule c Fiberoptic Shaft b Quick Release Tab o TAH Figure 13 Unplugging the Handpiece ILA Tip Plug LA HA 5100105 Rev E 09 06 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 Figure7 4 Verify minimum air pressure of 80 psi 5 2 bar from 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 Figure7 Fill Self Contained Water System Bottle 7 Push switch on bottle mounting bracket to OFF position NOTE If bottle was pressu
35. ing 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 Figure 18 Changing Tip Tip Groove C0 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 WARNING Use of controls or adjustments and performance of procedures other than those specified herein may result in hazardous radiation exposure Overview Waterlase 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 Modes for the Power and Air 8 Water Spray Bey Free da 1 lul 5100105 Rev E 09 06 Tip Cleaning and Inspection BEFORE AND AFTER EACH USE the tip surfaces must be inspected for chips pits and cleanliness DO NOT USE A TIP THAT HAS CHIPS PI
36. ion eyewear may be available Please contact your local authorized BIOLASE representative for additional information 5100105 Rev E 09 06 Wateriase User Manual APPENDIX D CLINICAL PROCEDURE GUIDELINES Root Canal Clinical Protocol This modality of treatment uses the Waterlase 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 User Manual pertaining to Contraindications Warnings and Precautions labeling for different endodontic tips and recommended 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 1 Prepare access to the pulp chamber with the Waterlase using a 600 um fiber tip at the appropriate setting for cutting enamel and dentin 2 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 11 Water 7 11 Di 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
37. ith DI or Distilled water Improper filling may damage the unit Please read the instructions carefully 5100105 Rev E 09 06 SECTION 2 SAFETY WITH THE WATERLASE 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 DANGER DO NOT USE THIS UNIT IN ANY MANNER OTHER THAN WHICH IS 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 Remove or cover all highly reflective items in the treatment area if possible 2 Do not operate in the presence of explosive or flammable materials 3 All persons present in the operatory must wear protective eyewear suitable for blocking 2 78 um wave length spectrum CAUTION Periodically inspect eyewear for pitting and cracking NOTE For replacement additional or prescription protective eyewear please contact your Waterlase represen
38. kwise until loose and try again Tighten the SMA Housing Locking Nut by turning it clockwise until fully seated Place the Delivery Support Arm into the mounting hole on the Delivery System Mounting Plate 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 NOTE Refer to the Waterlase 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 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 Connect handpiece The handpiece should be pointed straight 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 subs
39. l COMGIIONS niesna Ai 30 SS Eva ION tad 30 Tissue Contact and Tip Breakage oooooonnnccccccnnnncccccnnnonononanannnncnnonononononoss 30 MENA Em 31 Waters ln e oo 31 HIM Fre NOW eA ltd ida 31 Dena Materia SI 31 KONG ana aaa AR AA 31 SECTION 7 CLINICAL APPLICATIONS cer cere eere ree 32 a AA 32 Hard Tissue Cutting a 32 Soft Tissue Incision Excision and Ablation 33 Procedure Ire EE 33 Presets for Soft and Hard Tissue Procedures 33 Fiber Tip Calibration Chart 37 HP Spectator 37 Handpiece Cleaning and Grerltzaton rreren e enn 37 Handpiece Uli e ne ME 37 Steam Sterilization for Handpiece and Tips 38 Waterlase Indications for Uee aa 38 ENO Ec EET 38 Osectomy resection of bone to restore bony architecture resection of bone Torg aino el6 unida nt i pido id 39 Osseous crown engbtenmg ii 39 Soft Tissue Indiecaions ii 39 SECTION 8 MAINTENANCE 1 una na n4 nG GRAN NGA NUNG AA NN NAA SKK nn KEEN KEE ADA ANAKAN 41 Annual Manten acusan ad 41 Delivery SYSTEM orli aaa aaa 41 Dally MAINTENANCE sisi 41 Transporte lO WE 41 Storage ilaele 41 SECTION 9 CALIBRATION ma ra AA NAA ANA 42 leet ee EE 42 Calibration Schedule ardid 43 APPENDIX A Instructions For Filling The Internal Cooling Reservoir 44 APPENDIX B LABELS 49 Laser Hazard Symbolic nonet od do 49 High Voltage Hazard Symbol a 49 A PN 49 A TEM
40. l 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 steam or debris that could enter through the handpiece fiber tip orifice when tip is not in use Protective Rubber Cap for fiber optic connector The protective rubber cap protects the input end of the fiber optic cable when not attached to unit 5100105 Rev E 09 06 Laser Connector Housing The laser connector housing secures the delivery system to the unit 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 tips Revolv
41. 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 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 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 Indications Incision excision vaporization ablation and coagulation of oral soft tissues including Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal 2003 BIOLASE Technology Inc All Rights Reserved Waterniase User Manual Section 7 Clinical Flap preparation incision of soft
42. must be taken to prevent infection from the laser plume generated by vaporization of virally infected tissue during procedures done with laser and minimal 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 Dental 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 tip and delivery system Training Only licensed professionals who have successfully completed Waterlase training have read and understood this manual and know how to correctly operate the system should use this device 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 2003 BIOLASE Technology Inc All Rights Reserved Wateriase User Manual Section 6 Contra indications SECTION 7 CLINICAL APPLICATIONS Introduction The Waterlase device is designed to cut and remove hard and soft tissues within the oral cavity For hard tissue applications the Waterlase achieves its uniquely diverse capabilities through the process of light absorption by water droplets The proprietary flexible fiber optic system and handpiec
43. n 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 hemostasis 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 please refer to Appendix C Presets for Soft and Hard Tissue Procedures As described before Waterlase 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 Tabl
44. n between strokes using any conventional irrigation solutions i e NaOCl 2003 BIOLASE Technology Inc All Rights Reserved EN 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 At the end irrigate thoroughly and check canal dimensions using any 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 Note 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 5100105 Rev E 09 06 Wateriase User Manual Ap
45. n place at all times when no tip is installed and the laser is not in use Figure 16 Tip Installation Figure 17 Correct Tip Connection Tip Plug e Tip Orifice N NOTE Use only for storage a autoclave or offer sterilization dy Tip Remover A Tip Orifice d E AC LA KA Hl Tip Remover a gl I Ma I Handpiece Tip Groove b Tip c Handpiece INCORRECT CORRECT Place the system on READY when removing replacing a tip Blowing air will prevent any moisture or dirt from going inside 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 for use CAUTION Do not operate the laser or air water spray without the tip inserted into the handpiece 2003 BIOLASE Technology Inc All Rights Reserved Waterlase User Manual Section 4 Operating Changing Tips CAUTION The laser unit must be in READY mode when remov
46. nce 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 to remove desired tissues or materials Unlike traditional dental instruments with the Waterlase 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 you 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 i
47. nejedeud ue 1003 INSSIL OYYH sasseosqe jeaideuad jo aBeuresp pue uoisi2u sanssi eoibojoyyed jo jeaoway uoneJedaud dey ssauyiy yds pue eed jn4 suorsal anssi yos Jo uoismx3 Auioj euaJ4 BuiuBnoa Jebu Auopajnzado Auopanibuo Asejdonibuo 3NSSIL LJOS sanes JUSICIOUI jo BAOUI8 sjuejeas jo jueuieae d JO sanss pue syd jo uogeAeox3 INSSIL OYYH sassaosqe je2ideued jo afeuresp pue uoisiou sanssy eoibojoyjed jo jeacway uonesedaid dey sseuxoiu yids pue jerued ny Aysejdojnqysa sajos Jaques jo uawa BuiuaujBua umaa onsen yos AydoniadAy eaibui jo uogonpes saiwopayided elo Awoypajnqadg enejdoyna7 sasseosqe jo abeureup pue uolsiou Manosas juejdui sisejsouer uorsioxe pue uoisi2ul ealbule pue uioj2euaJJ Je ouleJ euloJqiJ es pejydnueun jo aunsodx3 saisdoiq euorsioul pue eUOISI2X3 INSSIL LJOS esedaid pua jooy Awojoa021dy s 001 yoo ay jo savide xede ay oj ssa00e MOpUIM e ajedaud oj suog Buns Du jnojuo2aJ snoassQ pue Ajsejdoa so AWwojpa so Awojoa so auog sanssi snoasso jedo jo uonoesaJ pue buunojuo Bui eus Gunny Jeue joo e 0 558338 uiejqo 0 uon esedaid yool Asejdoppweuz uyana Jo Buluay6nos anssi pue Je ouuaJ sauen A suoneiedaud Ane 3NSSIL GHVH 00 09 001 19 OOL 09 DOL L9 S1 0 520 Oot SLO 6210 50 OSL SL0 610 6520 OSL 520 090 520 G2 1 520 052 051 057 520 OSE 5 1 OS 00 0
48. oot end preparation for retrofill a Select Waterlase parameters and tip i P22 0W ii Water 30 iii Air 35 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 5100105 Rev E 09 06 Wateriase User Manual 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 7 Pathology and Granulation tissue removal a Select Waterlase parameters and tip i P 2 25W li Water 30 iii 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 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
49. questions to your local BIOLASE representative 2003 BIOLASE Technology Inc All Rights Reserved Waterlase User Manual Section 3 Equipment SECTION 3 EQUIPMENT DESCRIPTION General The Waterlase dental laser system consists of two modules e Optical Power Unit the Unit e Waterlase 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 and POWER 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 Button for service use only LCD Liquid Crystal Display The LCD display shows settings error messages and system status LEDs Light Emitting diodes The LED lights indicate selection of the corresponding function setting Keyswitch Figures 2 amp 7 The key can be removed only when in OFF position 5100105 Rev E 09 06 Figure 5 Control Panel 3 Ready Button O Standby Ready On Off Button i Function Button Preset LEDs 4 Standby Bu
50. r 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 line voltages which are outside the Laser s specific ratings failures due to low input air 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 h 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 2003 BIOLASE Technology Inc All Rights Reserved e
51. rized 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 Secure Fiber Optic Assembly to Unit NOTE Refer to Delivery System User Manual for more complete connection details 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 Remove the protective cap red or black from the Fiber Optic Connector and Waterlase Laser Aperture CAUTION DO NOT POWER UP YOUR LASER UNTIL THE HANDPIECE AND TIP ARE PROPERLY INSTALLED FAILURE TO DO SO MAY DAMAGE THE SYSTEM 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 mounting plate Centershaft Slide the SMA Connection and alignment pin into the alignment pin hole e Once the connector reaches the Laser Aperture turn the SMA Housing Locking Nut Clockwise 2003 BIOLASE Technology Inc All Rights Reserved Waterniase User Manual Section 4 Operating CAUTION When first turning the SMA Housing onto the Laser Aperture if it seems tight turn counter cloc
52. switch or READY Button Once the circuit breaker and keyswitch are set to the ON position the READY button on the keypad must be pressed to enable the footswitch Three beeps will sound to indicate that the system is ready for use Footswitch The Waterlase will not activate until the user presses down on the footswitch A protective cover prevents unintentional pressing of the footswitch 5100105 Rev E 09 06 Figure 3 Footswitch Footswitch Cord Protective Cover Housed in Protective Cover o el Remote Interlock Plug Each laser has a remote plug and connector on its rear panel The purpose is to enable a user provided remote switch e g on the entrance door to turn OFF the laser To use it properly requires a normally closed pair of contacts connected to pins 1 and 5 of the connector These contacts should have no voltage associated with them and should open on activation Emergency Stop Figure 8 Push to activate emergency stop Rotate and release button to restart Do not use as a normal means to stop the laser Figure 4 Emergency Stop Functional Display The Liquid Crystal Display LCD and the Light Emitting Diode LED indicators on the control panel show the functional conditions of the system Layout of Control Elements All control functions are located at a safe distance from energy output Control panel layout is described in Section 3 Control Panel NOTE Please direct any safety
53. tative 4 Do not look directly into the beam or at specular reflections 5 Direct the cutting spray toward targeted tissues only 6 Press STANDBY Standby button on the control panel before turning off the unit 7 Press STANDBY on the control panel before exchanging handpieces or removing the fiber optic connector from the unit 8 Move the circuit breaker to OFF 0 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 2003 BIOLASE Technology Inc All Rights Reserved Waterniase User Manual Section 2 Safety All operatory entrances must be marked with an approved warning sign Safety Features Energy Monitor The energy monitor measures and verifies power output Power deviations of more than 20 from the selected value will cause the display to show an error message The unit will not operate until the system is reset by pressing any key on the keypad If error messages persist please contact your BIOLASE representative Circuit Breaker The circuit breaker serves as a line switch to separate the unit from the main power supply 0 OFF 1 ON ON O OFF Keyswitch Figure 1 Circuit Breaker To switch unit ON turn key to horizontal position Use the proper key only The key cannot be removed while in the ON position Always remove key when not in use Figure 2 Key
54. the power meter head 4 2 4 8 cm from end of test fiber tip Turn both the water and air modes to OFF Set unit to READY and enter SERVICE mode Press the POWER and PRESET buttons simultaneously one 1 time to check the Power K setting The Display should now read Laser Head Power Calibration FM1033 Measure and record the actual power measurements at the present PK setting Compare these values to the range values on form FM1033 Using the and buttons adjust the Power K value one increment as necessary Retest and compare power readings to FM1033 Readjust Power K as necessary until the power output values are within the acceptable power ranges on FM1033 10 Press STANDBY to exit the SERVICE mode 11 Record calibration date and sign calibration schedule Table 6 5100105 Rev E 09 06 Waterniase User Manual 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 Technician Calibration Date Technician 02003 BIOLASE Technology Inc All Rights Reserved WER Section 9 Calibration OLA CONNECTING THE FUNNEL ASSEMBLY TO THE SYSTEM 1 Locate the Fill Drain receptacle on the the lower left hand side of the Rear Panel Insert the Funnel connector into the receptacle Ensure that t
55. 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 machine 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 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 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 2003 BIOLASE Technology Inc All Rights Reserved Wateriase User Manual Section 9 Calibration SECTION 9 CALIBRATION Calibrating Power NOTE Calibration is to be performed only by trained personnel 1 oR oh gt Carefully insert the test fiber into the laser head SMA port and tighten Set up
56. tion Back Panel centered below ventilation SUBCHAPTER J channels and Danger label LBOD 01 0002 DA N G E H Non Interlocked Protection Housing Invisible laser radiation W e when open arning AVOID EYE OR SKIN EXPOSURE Location Laser head access plate Accessible only TO DIRECT OR during service proceedings SCATTERED RADIATION Laser Aperture Location On the top cover under Fiber Optic Connector 02003 BIOLASE Technology Inc All Rights Reserved EM Protective Ground Location Under Circuit Breaker inside of Back Panel Laser Explanatory Label International Location On top cover over fiber optic connector Danger Label U S only VISIBLE and or INVISIBLE LASER Bee i i DATON AVOID EYE OR SKIN Location On top cover over fiber optic EXPOSURE TO DIRECT OR connector SCATTERED RADIATION Ground Location Next to E1 ground terminal LA E BIOLASE Technologg Ine a Ch DATI A UTA A O3504A16100200 Tha SST p rare D Ta ir paar E Pane AS 3118 227 PANAO 5173046 LABAS 3 1 o 519 MM 9 245 WH E SE CA Eiolasa Technology Inc 581 Calle Amanecer y 1 San Clemente CA 92873 TI jj j I dE e H LULU 01 0 3 6 d Location Back Panel above e ventilation channels Identification 005 5212 M SIGI HANS 2 7WI SO amp 745 AT PALA NAA DAD S AT AA MT KID SAT Aii 567 0304 Ap 0 150 131 acc B Mj SERO Espasa Pakain 2313978 and EH Caradar Brian 2015114 amc 2055524 iussi Parin
57. 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 periapical 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 e cysts neoplasm or abscess and hyperplastic tissues e granulation tissue from around the apex NOTE Any tissue growth Le 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 patients 5100105 Rev E 09 06 SECTION 8 MAINTENANCE Annual Maintenance The Waterlase 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 elec
58. titute for a handpiece CAUTION Handpiece should always be connected when turning ON the laser CAUTION Make sure that water bottle toggle switch is in OFF position when turning ON the laser Disconnecting the Handpiece 1 2 Turn the water bottle Toggle Switch to OFF position 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 5100105 Rev E 09 06 WARNING Disconnecting the Handpiece without drying out the water line may cause damage to the Handpiece and Fiber 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 NOTE Before autoclaving if Handpiece has not been dried out always blow compressed air through the inside body and only then plug both ends of the Handpiece 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 i
59. toclave cycle to the following parameters e Temperature 250 F 121 C e Pressure 15 psi 1 bar e Time 20 minutes 7 Atthe time of completion of the autoclave cycle remove the tray and let items cool Remove handpiece from pouch 9 Remove rear plug from handpiece base and protective cover from shaft of the fiber optic cable Waterlase Indications for Use Use of Waterlase may be indicated for Hard Tissue General Indications e Class Il Ill IV and V cavity preparation e Caries removal e Hard tissue surface roughening or etching e Enameloplasty excavation of pits and fissures for placement of sealants For use on adult and pediatric patients Root Canal Hard Tissue Indications e Tooth preparation to obtain access to root canal e Root canal preparation including enlargement e Root canal debridement and cleaning 5100105 Rev E 09 06 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 Le cysts neoplasm or abscess and hyperplastic tissues e granulation tissue from around the apex Incision and drainage of periapical abscesses NOTE Any tissue growth i e cyst neoplasm or other
60. tomized 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 is programmed to perform tissue removal incision excision ablation and coagulation using direct laser energy either with or without water for cooling and hydration Use of this device requires proper clinical and technical training This manual provides instructions for use for trained professionals When used and maintained properly the Waterlase will prove a valuable addition to your practice Please contact your authorized local BIOLASE representative if you have any questions or require assistance
61. tronic 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 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 Transportation The Waterlase 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
62. tton 6 Preset Buttons 4 Power Display LCD Da 7 Air Display LCD Fower Up Down Buttons a Air Mode Button Water Display LCD 12 Air Up Down Buttons 10 Water Mode Water Up Down 11 Buttons OTTIENI Footswitch connector Figure 7 Connect and secure footswitch Figure 3 Remote Interlock Figure 7 Plug in the remote interlock connector Power Connection Figure 7 Attach power cord to unit at this location Circuit Breaker Figure 7 Serves as a line switch to separate the unit from the main power supply Ventilation Channels Figure 7 Do not cover or block these channels They provide airflow path to cool unit 2003 BIOLASE Technology Inc All Rights Reserved Watenlase User Manual Section 3 Equipment Locking Wheels Figure 6 Press down on front tabs to render unit unmovable Lift up the tabs to release locking mechanism Front Handle Figure 6 Do not use to lift the unit Back Panel Figure 7 Handpiece Holder Figure 8 Holds handpiece when not in use Air Input Figure 7 Connect with tubing included to compressed dry air outlet Self Contained Water System Figure7 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 Figure 6 Provides support for fiber optic cable to reduce stress at connection to the unit Water Bottle Switch F
63. vities 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 Tissue Evaluation Any tissue growth e cyst neoplasm and other lesions removed with Waterlase 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 bite block to prevent accidental biting and breakage of the tip if necessary 5100105 Rev E 09 06 Tip Changing Failure to correctly replace the tip could result in damage to the fiber tip or the handpiece Carefully review the instructions on how to replace the fiber tip from section 5 1 6 of the Waterlase User Manual Water Splashing Water from spray may splash during treatment Use 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 if you cannot clearly see the treatment site Plume Removal Special care

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