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USER MANUAL

1. Modify and Save Preferred Values as Presets Activate the Waterlase MDX Turn the Waterlase MDX OFF lt ETE E a aa a User Interface General Navigation Waterlase MDX Specifications A E AE DIMENSIONS aaae NREN RA Waterlase MDX Co ere ee Contraindications Warnings and Precautions NE Ya E DS ies pda Warnings and Precautions mI quM EN SINC Sl Av aa Treatment Technique and Settings 5200999 Rev D Waterlase MDX 01 14 Contents continued Section 7 Hard Tissue Procedures reat Cet Soft Tissue Procedures ansa esuriens imr Sat ant auri Curettage Procedures Fluid Entrapment and Air Embolism ROO Calial coi gg iawn cn xis cras Adjacent Stl clllles aaa aaa era a LONGAN ON Sn Tissue evaluation
2. Mirror Alignment Check Changing the Waterlase MDX Handpiece Mirror Troubleshooting the Delivery System gie geglesqu agan baki a a Waterlase MDX Indications for Use MM General INGIGAUONS eaaa a nta a rete qas Root Canal Hard Tissue Indications Endodontic Surgery Root Amputation Indications Bone Sutdical Res Laser Periodontal Procedures Contents continued Section 8 Section 9 Appendix A Appendix B Appendix C Appendix D Appendix E Soft Tissue Indications including Pulpal Tissues 56 Root Canal DISINFECTION 56 faces asuka aaa ka aaa a aaa E a ana aa a a 57 Annal IMAaINTEMANCE ot abus 57 Dally x ag dea x px osx 57 TRAN tm 57 rH 58 Calibra OM sucio e EP 59 Calibration Schedule 59 C 60 ACCOSSOTGS 65 Clinica
3. Tissue Contact Tip Breakage TO CAN lare pet Walter oplashilig PIUME FCI OV Al eo etra eade datei duda MuR tat ated eerte dam Clinical Applications 2 ANO GN GN ON Hard CUMING x i nitent Soft Incision Excision and Ablation Presets for Soft and Hard Tissue Procedures Fiber Tip Calibration Chart Calculating Emitted Power with Tip Attachment Pre programmed Pre sets for General Hard and Soft Tissue FOG UNG ios aduentu di Operating Guidelines BN joies teen NEN mmm ViSU al INSPECCION T SCOT AIMN Bed aol a Basic Maintenance aaa aana iagad eee aaa cece Handpiece and Tip Cleaning and Sterilization Step 1 Cleaning Process Step 2 Sterilization Process Mirror Check and Cleaning Mirror Inspection and Cleaning
4. E og 2 F de ee na uu up Y Ace uus Ea FIGURE 4 8 FIGURE 4 9 3 Twist the bottle clockwise and pull up the lid to open fig 4 9 4 Fill bottle with distilled or sterile water only 5 Align arrow on the lid and dot on the bottle and insert bottle into the lid fig 4 10 6 Twist the lid clockwise all the way until the arrows on both parts match fig 4 11 FIGURE 4 10 FIGURE 4 11 7 Attach bottle back to its holder make sure connector is fully engaged WARNIN Be ndling the water bott Do not dro An m amat ER OPTIC ASSEMBLY 1 Verify the Laser Head is centered to the top cover If misaligned call Biolase headquarters for additional support 19 E on off BIOLRSE AUTO standby 60 FIGURE 4 12 FIGURE 4 13 2 Locate the hole on the left side of top view of laser unit and install telescopic fiber support arm fig 4 13 3 Take the new trunk fiber fig 4 14 from the accessories it around your neck fig 4 15 FIGURE 4 14 FIGURE 4 15 4 Remove protective black rubber cap at the proximal end of fiber fig 4 16 5 Remove Protective Cover off the Fiber Shaft and place it against any light source Check proximal end of the fiber it should glow yellow be flat and clean fig 4 17 5200999 Rev D Waterlase MDX 01 14 FIGURE 4 1
5. Ferrule Color Diameter pm Lengths Tip Type Tissue Types 7 Glass Tips Root Canal Root Canal Soft Tissue Root Canal All Types All Types Bone Soft Tissue Enamel Bone Dentin Soft Tissue No Limit Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Sapphire Tips M Enamel Dentin Soft Tissue No Limit No Limit Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue No Limit 9 1100 NoLimit 5200999 Rev D Waterlase MDX 01 14 Enamel Bone Dentin Soft Tissue Bone Dentin Soft Tissue INDICATIONS FOR USE Z Glass Tips RFT Root canal debridement cleaning and disinfection M Sulcular debridement Laser soft tissue currettage Removal of granulation tissue RFT Root canal debridement cleaning and disinfection M Same as MT4 Sulcular debridement Laser soft tissue Same as MT4 currettage Combines applications of MZ4 and MZ6 tips Combines applications of MZ4 and MZ6 tips Decontamination and ablation of soft tissue in We periodontal pockets Cleaning the root surface similar to MZ5 M Same as MGG6 Same as MGG6 M Same as MGG6 Same as MGG6 Same as MGG6 Same as MGG6 Sapphire Tips Frenectomy and frenetomy Gingival troughing Excavation of pits and fissures for placement of Gingivectomy Gingivoplasty Gingival incision and sealants Pits and fissures caries removal excision Removal of path
6. Installation Instructions Facility Requirements i ne tr dta RB t e brine Electrical Supply aa pan aaa A ence a a Compressed Air Supply Equipment Description esee eese ea MR Optical Power Unit Elements MONET Front and Back Handles LOCKING Emergency SIOD Footswitch Connector Remote Interlock Outlet Power Connection Circuit Breaker Ventilation 5 1 PANG TONGGO Self Contained Water Bottle Water Bottle Release Footswitch Support Bracket FIDE SUD DOM ae Handpiece Holder a adage Waterlase MDX Delivery System Delivery System Connection on the Unit FDE OPIO ee Protective Black Rubber for fiber optic connector cO cO CO COON NN
7. Air Inlet Connector Connect with tubing included to compressed dry air outlet at 80 120 psi 5 5 8 2 bar Self Contained Water Bottle Provides water supply for the handpiece atomization spray Fill bottle only with distilled or sterile water Do not use tap waier e Water Bottle Release When the system is in standby mode after bottle is depressurized push the release button and pull back to remove the water bottle After refilling the bottle replace the bottle into its holder and secure the bottle in place TIENI e Footswitch Support Bracket For storage or moving the unit the bracket is designed to hold the closed footswitch clamshell Wrap the footswitch cable around the wrap plate above FIGURE 3 3 Handpiece in Handpiece Holder e Fiber Support Arm Supports delivery system on the unit It extends to support weight of the delivery system when handpiece is pulled forward Extension comes back when handpiece is released and arm is in vertical position Handpiece Holder Supports handpiece when not in NOTE Proper placement of the Delivery System Cable in the Support Arm and of the Handpiece in the Handpiece holder is important for convenient and safe handling of the delivery system See illustrations pages 12 14 11 Figure 3 1 Front View Fiber Delivery System Telescopic Fiber Support Arm Touch Screen Control Panel Locking Wheels
8. For use on adult and pediatric patients ROOT CANAL DISINFECTION Laser root canal disinfection after endodontic instrumentation 5200999 Rev D Waterlase MDX 01 14 SECTION 8 MAINTENANCE ANNUAL MAINTENANCE The Waterlase MDX should be serviced annually by a qualified trained and authorized Biolase 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 Authorized local Biolase representative to discuss extended service contracts and annual maintenance options Delivery System The fiber delivery system and handpiece represent high technology laser transmitting components Depending on use and due to the precision involved in the manufacture and alignment of the laser beam and internal optics the components may need to be periodically replaced to maintain tissue cutting efficiency Properly following the operating and maintenance instructions of this Manual will increase the delivery system s lifetime Laser Console The laser console contains electronic and mechanical components that are thoroughly checked when the unit is first shipped as well as when an authorized Biolase engineer services the unit Depending on the use of the unit some of these components may require periodic servici
9. STANDBY READY MODE MODE lf damage found crater in the middle of the window replace Fiber Delivery System no damage found switch laser to the Ready mode Red aiming beam and illumination fibers should light adjust brightness if necessary If aiming beam 15 not visible replace Fiber Delivery System see Sec 7 Troubleshooting WINDOW DAMAGE pe GONE WINDOW 53 WATERLASE MDX INDICATIONS FOR USE IMPORTANT Review all Contraindications Warnings and Precautions presented in Section 6 before proceeding with using this device on patients Use of Waterlase MDX may be indicated for HARD TISSUE GENERAL INDICATIONS Class 111 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 Flap preparation incision of soft tissue to prepare a flap and expose the bone e 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 cysts neop
10. The Waterlase MDX 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 MDX 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 MDX utilizes direct laser energy to perform tissue removal incision excision ablation and coagulation Use of this device requires proper clinical and technical training This manual provides instructions for use for trained dental surgeons and practitioners When used and maintained properly the Waterlase MDX will prove a valuable addition to your practice Please contact your authorized local Biolase representative if you have any questions or require assistance SECTION 1 SAFETY WITH THE WATERLASE PRECAUTIONS Failure to comply with these precautions and warnings may lead to exposure to dangerous voltage levels or optical radiation sources Please comply with all safety instructions and warnings CAUTION Use of controls adjustments performance of procedures other those specified herein may result in hazardous radiation exposure DANGER Invisible and or visible laser radiation Avoid eye or skin exposure to direct or scattered radiation Class IV CAUTION This unit has b
11. ALL TISSUE LASER FOR DENTISTRY B USER MANUAL Biolase YSGG Waterlase MDX Laser User Manual Biolase the Biolase logo Waterlase the Waterlase MDX logo are either registered trademarks or trademarks of Biolase Incorporated in the United States and or other countries biolase com NASDAQ BIOL BIOLASE Inc 4 Cromwell Irvine CA 92618 USA 949 361 1200 or 888 424 6527 Service 800 321 6717 Europe MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 www mt procons com 5200999 Rev D Waterlase MDX 01 14 CONTENTS Section 1 Section 2 Section 3 Safety with the Waterlase PALEGIN RTT Plume Safety agan aaa ka keran Ka A Ka a aaa ja ka Ka aa KN aaa ENG WIOMILOM asana Circuit Breaker Ba a AK ma TAA gebag A Biang a KN Mu m A SMA NG ERROR TT ET Remote Interlock Outlet IM CTOCN CV S 9 aa ar sa aaa ara E science Control Panel Layout of Control Panel Installation of the Waterlase MDX
12. 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 15 to achieve a more tapered shape to accommodate the wide Gutta Percha points additional instrumentation may be necessary 5200999 Rev D Waterlase MDX 01 14 APPENDIX D TIPS SUGGESTED CLINICAL SPECIFICATIONS EEA LEA EIER 0 750 0 750 0 750 120 amp 1 20 f wal 6 6 6 9 9 9 i _ 0 400 0 750 0600 TL 120 B t 1 T m D D B C IP SETTINGS WATERLASE MDX 300 MD GOLD HANDPIECES Calibration Maximum Factor Power W Ferrule Color Diameter pm Tip Type Tissue Types Z Glass Tips RFT Root Canal Root Canal Soft Tissue Root Canal All Types All Types Bone Soft Tissue Enamel Bone Dentin Soft Tissue C hoo notimit noumi __ No Limit ss 1e SETTINGS WATERLASE 450 MD GOLD HANDPIECES Calibration Maximum Factor Power W Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Sapphire Tips M Enamel Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Enamel Bone Dentin Soft Tissue Bone Dentin Soft Tissue
13. Gallium Garnet 2 78um 2780nm 1096 10 50 Hz 0 1 8 0 W MDX300 0 1 9 OW MDX450 20 2 300 mJ MDX300 2 450mJ MDX450 Pulse duration for soft and hard tissue procedures 60us Pulse duration range for soft tissue procedures only 700 5 Handpiece head angles Tip diameter range Output divergence Mode Aiming Beam Water level sensor 70 contra angle 200 1200um gt 8 per side Multimode 635nm laser 1mW max safety classification 1 635nm laser 1mW max safety classification 1 Nominal Ocular Hazard Distance NOHD 5 35 SECTION 6 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS CONTRAINDICATIONS All clinical procedures performed with the Waterlase MDX 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 including pacemakers lung disease bleeding disorders sleep apnea or an immune system deficiency Medical clearance from patient s physician is advisable when doubt exists regarding treatment WARNINGS AND PRECAUTIONS Federal law restricts this device to sale by or o
14. Hold the tip only over the plastic ferrule and the output end Repeated processing of the handpiece and reusable may reduce the useful life of these devices Check the handpiece for damage or wear prior to each use The handpiece should be free of nicks distortion corrosion or other signs of mechanical degradation damage wear is observed discard the handpiece Use of damaged or worn tips may cause damage to the delivery system and will compromise the clinical performance of the Waterlase MDX Laser System The tips must be inspected prior to each use for damage or wear as described under Section 7 Tip Inspection 5200999 Rev D Waterlase MDX 01 14 MIRROR CHECK AND CLEANING NOTE If performance of the delivery system is questioned and the Tip is in good condition check the Handpiece for damage contamination WARNING Use of contaminated or damaged Mirror will cause damage of the Fiber Delivery System set system in the Ready mode and remove the Tip Mirror Inspection and Cleaning 1 Point the Handpiece towards a white surface The red spot of the aiming beam should be clear uniform and well confined If dark areas and irregularities are present inspect the mirror E 4 GOOD MIRROR ALIGNMENT BAD MIRROR NOTE If the plastic tip ferrule is continuously getting damaged at the input end mirror should be checked and cleaned Mirror alignment should be checked 2
15. To inspect the mirror remove it following proper procedure see Changing the Waterlase MDX Handpiece Mirror 3 Mirror can be contaminated or damaged 49 T GOOD MIRROR CONTAMINATED DAMAGED MIRROR MIRROR Contaminated mirror can be cleaned and with cotton swab moistened with optical grade acetone or alcohol e Place wet swab over the mirror surface and wait for 5sec for solvent to soften the contaminating material e Wipe off the contamination by quick turn and removal of the swab e Repeat several times until all contamination is removed If mirror has remaining burn marks or scratches it should be replaced While mirror is removed and it has contamination or burn marks clean the internal reflector inside handpiece head with long cotton swab moistened with acetone or alcohol Install the new or cleaned mirror and check proper alignment Mirror Alignment Check 1 Point the Handpiece towards a white surface The red spot of the aiming beam should be clear uniform and well confined If spot is confined on one side and has satellite type reflection smile on the opposite side mirror alignment is questioned BAD ALIGNMENT 5200999 Rev D Waterlase MDX 01 14 3 To improve alignment remove the mirror and turn it 180 degrees see Sec 7 Changing the Waterlase MDX Handpiece Mirror If this does not help replace the handpiece If that does not help replace the trunk fiber NOTE Ifthe
16. part number 2000204 Footswitch includes shielded coiled footswitch cable footswitch 5 conducting wires Biolase part number 6200150 WARNING The use of accessories other than those specified except those supplied or sold by Biolase as replacement parts for internal or external components may result in increased EMISSIONS or decreased IMMUNITY of the model Waterlase MDX GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Waterlase MDX is intended for use in the electromagnetic environment specified below The customer or the user of the Waterlase MDX should assure it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The model Waterlase MDX uses RF energy only RF emissions for its internal function Therefore its RF emissions are very low and are not likely CISPR 11 to cause any interference in nearby electronic equipment RF emissions The model Waterlase 15 suitable for use Class A in all establishments other than domestic and CISPR 11 those directly connected to the public low voltage power supply network that supplies Harmonic emissions buildings used for domestic purposes Class A IEC 61000 3 2 Voltage fluctuations flicker emissions Class A IEC 61000 3 3 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The model Waterlase is intended for use in the electromagnetic environment specified below The
17. 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 Waterlase MDX may be used for the applications listed in Section 7 Waterlase MDX 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 Table 2 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 FIBER TIP CALIBRATION CHART Refer to Appendix D Tips Suggested Clinical Specifications to review the different characteristics and calibration factors for the Waterlase MDX tips To calculate the expected power output from different families of tips follow the instructions below Select the tip for the procedure e Review Appendix D Tips Suggested Clinical Specifications to select appropriate calibration factors for the selected tip Use Calibration Menu to read the actual power coming out of the tip or 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 15 the same as the display Also actual emitted power could vary as much as 20
18. 4 inside diameter male quick connectors on each end between air inlet connector fig 3 2 and operatory air source CAUTION Prior to connection verify that outlet is for air not water supply Connection to water supply may cause damage to the Waterlase MDX system If the unit was connected to the water supply do NOT turn the system on Contact your authorized local Biolase service representative SECTION 3 EQUIPMENT DESCRIPTION GENERAL The Waterlase MDX dental laser system consists of two modules Optical Power Unit the Unit shown in Figures 3 1 3 2 and 3 4 Waterlase MDX Atomizing Delivery System the Delivery System shown shown in Figures 3 3 and 3 4 OPTICAL POWER UNIT ELEMENTS Figures 3 1 3 2 and 3 4 show the front rear and top views of the unit Control Panel The optical power unit is controlled through a touch panel control screen Please see section 4 Operating Instructions for detailed instructions on using the control panel e Front and Back Handles Use the front and back handles to move the unit and lift when necessary CAUTION Prior to lifting make sure handles are not damaged Do not use the delivery system to the unit this could damage fiber optic render the unit inoperable e Locking Wheels Press down on front tabs to lock the unit Lift up the tabs to release locking mechanism e Emergency Stop Press the red emergency stop button to instan
19. 5200999 Rev D Waterlase MDX 01 14 CALCULATING EMITTED POWER WITH ATTACHMENT Example 1 Example 2 Tip Type MZ4 Tip Type RFT2 Calibration Factor 0 90 Calibration Factor 0 55 Display Power 2W Display Power 1W Then the Power Emitted 15 Then the Power Emitted 15 2W x 0 90 1 80 1W x 0 55 0 55 W PRE PROGRAMMED PRE SETS FOR GENERAL HARD AND SOFT TISSUE PROCEDURES Sub Water preset Example of Procedure Aus Ai letter ETA ee BABA I Eee 2 eee Iw em EI um DER eer Eee J emere Sill lll Soft Tissue Cutting big incision 10 w anes thetic Control Laser bandage Troughing cereo ond LR D m m m OPERATING GUIDELINES Preset 1 Always wear magnifying loupes for better viewing of the operation area 2 Always first fire the laser outside the mouth for patient comfort and to verify water spray 3 Always start 10mm away from the target tissue de focused at lower power settings and work your way towards the tissue 43 TIP INSPECTION NOTE Prior to each use always check the distal end of the tip for damage or contamination Check both ends of the tip when replacing WARNING Use of the damaged or contaminated may cause damage of the Delivery System and will compromise clinical performance of the Wat
20. Place the pouches on an autoclave tray Take care when handling the handpiece and tip s 5 Do not stack other instruments on top of the pouches 6 Placethe tray into the autoclave chamber and set the appropriate cycle as recommended below 47 Type of Sterilizer Temperature Min Time Drying Time Gravity Displacement 132 C 270 F 15 30 minutes 132 C 270 F Dynamic Air Removal 20 30 minutes Pre Vacuum 134 C EU only 7 Upon completion of the cycle the handpiece and tips must remain in the sterilization pouches until needed to maintain sterility 8 reassemble remove the tip from the sterilization pouch with tweezers and insert it into the Tip Remover or Tip Holder if not already in the Tip Holder e Insert by aligning the first groove of the tip ferrule against the receiving edges of the holder then slide the tip in e Align the tip orifice of the handpiece over the input end of the tip that is placed in the Tip Remover or Tip Holder and carefully lower the handpiece and insert the tip all the way until the shoulder of the tip ferrule sits against the handpiece head e Slide the handpiece laterally away from the Tip Remover or Tip Holder Refer to Section 4 INSTALLING AND CHANGING THE TIP IN THE HANDPIECE for additional information WARNING Never touch the input end of the tip If the input surface becomes contaminated it may damage the tip handpiece and the Fiber Delivery System
21. 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 RF T2 RFT3 The Waterlase 15 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 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 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 37 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 Waterla
22. 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 tip in this 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 MDX if you cannot clearly see the treatment site 5200999 Rev D Waterlase MDX 01 14 Plume Removal CAUTION Laser plume may contain viable tissue particulates Special care must be taken to prevent infection from the laser plume generated by vaporization of virally or bacterially 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 dental cements or other similar filling materials Doing so may damage the Waterlase MDX 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 th
23. axis of the tooth Activate laser and start moving along the gingival margin to prepare a trough all the way to the crest of the bone This trough will allow for increased visibility and access and to initiate removal of diseased epithelium lining The radial and forward cutting action of this tip allows for effective separation and removal at the same time of the inflamed and diseased epithelium lining The narrow tip glides easily to allow minimally invasive treatment of the entire epithelium lining all the way to the bottom of the pocket m B 4 T n C pan an gt ai E Do X o m gt 5200999 Rev D Waterlase MDX 01 14 Alternatively a bottom up technique can be used in which the laser is fired only when moving the tip coronally The protocol is optimized for safety and efficacy using either one of the techniques STEP 3 CALCULUS REMOVAL Step 3 Tip Power Water Mode Rate Smoothening Proceed with the mechanical removal of calculus using preferred hand and or ultrasonic scalers After gross calculus removal remove calculus using the laser using the same settings provided in the previous step To remove calculus from the root surface aim the laser tip 5 to 15 degrees from the root surface Move the tip in the same pattern as used to remove epithelium lining Make enough passes to cov
24. front only N FERN 5200999 Rev D Waterlas MDX 01 14 Front Handle lees 5 9 00 A LM 4 Figure 3 2 Rear View Self contained Back Handle Water System Ventilation Back Panel Remote _ Key Switch Interlock Outlet oV Footswitch Cable a Wrap Plate E Power Cable B Power Connection 8 Wrap Plate HN Circuit Breaker Ground Pin Footswitch Connector Bracket Air Inlet Connector m n m a b ic m E a om z ee gt eli Le e iam e d e l Figure 3 4 Top View Trunk Fiber Water Bottle Cover Tray for Revolving Tip Holder 6 EN Water Bottle Q Release Push Button Da 4 Touch Panel LN Control System CSS P Front Handle Handpiece in Handpiece Holder WATERLASE MDX DELIVERY SYSTEM see Section 4 for detailed description and instructions Delivery System Connection on the Unit The delivery system attaches to the unit via a multi connector incorporating air water cooling air illumination waveguides and the optical energy fiber optic 5200999 Rev D Waterlase MDX 01 14 Fiber Optic Cable Fiber optic cable contains the optical fiber together with the illumination waveguides air tubing and water tubing Laser radiation is delivered from laser unit to the handpiece through the optical fibe
25. in case Handpiece or Fiber Delivery System needs to be disconnected Allows re filling priming of the spray delivery system when components are connected back Settings Menu System settings like brightness of the Aiming Beam Illumination and Language Sound associated with the touch buttons can be adjusted Tip Type Selection menu Allows selection of tip and handpiece appropriate to the chosen procedure Service Menu Provides access to the system calibration and memory Accessible only for authorized Biolase Field Service Engineers 29 TO START THE WATERLASE MDX 1 Verify that all connections have been properly secured The Air supply must be connected and the external air pressure must be at 80 PSI 5 5 bar or more 2 3 Electrical input should be at least 100 VAC maximum 15 amperes to 230VAC 8 amperes 4 The Handpiece should be properly connected 5 Verify that the water bottle is filled more than 1 3 with distilled or sterile water DANGER Laser and collateral radiation are emitted through the fiber optic port Removal of the multi connector from the fiber optic port may lead hazardous exposure Radiation is also emitted from the fiber shaft when the handpiece is removed DO NOT attempt to operate the Waterlase MDX with the delivery system or the handpiece removed 6 Switch the circuit breaker ON 7 Insert the key into the keyswitch and rotate clockwise to the ON position NOTE The emergency s
26. local Biolase representative STORAGE The Waterlase MDX should be stored in a cool dry place when not in use Storage temperature should be 15 to 309 59 to 86 F relative humidity 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 MDX was shipped inside of a custom shipping crate Please save and store the crate in a cool dry place The unit must not be transported unless packaged inside of the crate 5200999 Rev D Waterlase MDX 01 14 SECTION 9 CALIBRATION Calibration requires specialized equipment and is to be performed only by an authorized Biolase service engineer The service engineer will follow this procedure Connect an output power meter to the laser using a test fiber The power meter head should be 1 to 2 inches from the fiber tip Using the software provided by Biolase verify the test setup is complete Begin the calibration routine The software will vary the unit s output power settings and use the power readings from the meter to calibrate the power output monitoring settings If required the software will revise the unit s internal calibration settings to ensure power remains within 20 Calibration Schedule Power calibration is to be performed annually The Service Engineer shall write the date of installation and subsequent power calibration dates in the table provided bel
27. removed while in the ON position Always remove key when unit left unattended for long time Footswitch The Waterlase MDX will not activate until the user presses down on the footswitch A protective cover prevents unintentional pressing of the footswitch The protective cover can be opened or closed by pressing it from the top Remote Interlock Outlet 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 Your authorized local Biolase service engineer can assist you in connecting the remote interlock to a door switch Emergency stop Press the red emergency stop button to instantly turn off the unit The button will glow red to indicate an emergency stop and the control panel will display an error message Press the button again to restart the system If the system was on when the emergency stop was activated the system will be in standby mode when turned back on You must push the ready button before using the system again Control Panel The touch screen control panel shows the functional conditions of the system Layout of Control Elements All control functions are located at a safe distance from energy output Control pa
28. switch Emergency switch Check Emergency Release the Emer pressed pressed switch gency Stop Button at the front Add de ionized distilled water Reservoir fail Add specified water if trained on that Cooling water level is low Air pressure failure Air pressure failure Check air Air pressure compressor might be low or disconnected Foot Switch Connect Foot disconnected Switch Fiber not detected Check Fiber Check footswitch connector Foot Switch not detected Fiber not detected Properly re connect the Trunk Fiber 5200999 Rev D Waterlase MDX 01 14 SECTION 5 WATERLASE MDX SPECIFICATIONS GENERAL Dimensions W x L x Unit With Fiber Weight Electrical Operating Voltage Frequency Current rating Main control On Off control Remote interruption Waterlase MDX Water type External air source Droplet size Max droplet velocity 11 x19 x 32 in 28 x 48 x 81cm 11 x19 x 40 in 28 x 48 x 102 cm 75 los 34 kg 100 VAC 10 230VAC 1096 50 60 Hz 15 0 A 8A Circuit breaker Keyswitch Hemote interlock connector Distilled or Sterile 80 120 psi 5 5 8 2 bar 5 200 um 100 m s Interaction zone 0 5 3 0 mm from handpiece tip to target Optical Laser classification Medium Wavelength Frequency Average power Power accuracy Pulse energy 4 Er Gr YSGG Erbium Chromium Yttrium Scandium
29. 6 FIGURE 4 17 Remove black and red protective cups from laser head and aperture fig 4 12 and 4 18 store all the cups for further use do not lose them Carefully look inside the laser aperture fig 4 18 and check that surface of the protective window is clean free of water dirt or damage e f water or dirt found try to clean by blowing the dry compressed air in the aperture e If this does not help call for system Service FIGUBE 4 18 FIGURE 4 19 8 Align the blue guide of fiber connector to blue dot of laser head interface Position the middle of the connector to the laser aperture and vertically push down gently all the way NG FIGURE 4 20 FIGURE 4 21 21 NOTE You may need to move connector slightly to the sides to ensure proper engagement of interfaces APPLY FORCE 9 Secure retainer ring by turning clockwise until it is snug fig 4 21 10 Align middle of the fiber to the hook of telescopic arm and push gently to engage fig 4 22 NOTE Make sure the black retaining O ring is in the front side of the hook 11 Disconnect Protective Cover from the distal end of the Fiber Delivery Cable and verify that it is clean and not damaged fig 4 23 also see Sec Fiber Check 12 Properly align fiber and the Protective Cover or the handpiece in the handpiece holder fig 2 3 FIGURE 4 22 FIGURE 4 23 CONNECTING HANDPIECE TO FIBE
30. CREEN Pressing the settings button in the lower right of the main screen will bring up the Settings screen Through this screen you can adjust the volume of the system speaker the strength of the illumination and the intensity of the aiming beam Use the up and down arrows to make these adjustments 31 Press Back icon to return to the Home screen Press the tip icon on the Home screen to access the Select Tip screen below BIOLASE BIOLASE SELECT TIP SETTINGS MI TIE On the Select Tip screen all available tips for the Gold handpiece are displayed When you select a tip the calibration factor and expected power output appear on the Gold Handpiece button at the bottom right of the screen Actual power can vary from the expected power by as much as 20 press that button and the screen will display power air and water settings To return to the Select Tip screen press the tip icon at the bottom of the screen When using a Turbo handpiece simply press the silver button on the bottom left of the select Tip Screen 5200999 Rev D Waterlase MDX 01 14 USER INTERFACE GENERAL NAVIGATION USERINTERFACE Waterlase MDX E 307 30 ee eade gana lt Waterand spray Arusing SERVICE PLEASE THITH COUR F w HATES LOW Pes to naed Tee BIOLRSE PURGE PRIME
31. IODONTAL THERAPY CLINICAL PROTOCOL WARNINGS amp PRECAUTIONS Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser protective eyewear for the 2 78 um wavelength OD 4 Use caution when using the tip inside the periodontal pocket Excessive force could break the tip and inconvenience your patient Laser protective magnification loupes are recommended for this procedure Do not direct air or spray toward tissue that may entrap air or water Exercise caution when working inside the pocket without continuous water flow Hard tissue structures that come in immediate contact with the laser energy in the absence of water could be damaged Make sure to maintain a consistent water flow during the entire treatment especially in the deeper areas of the pocket PROCEDURE After routine periodontal evaluation through radiographic and clinical examination and assessment of probing depth gingival recession clinical attachment level hyperplasia bleeding on probing plaque suppuration bone loss furcation and mobility proceed with the following steps STEP 1 ANESTHESIA Apply anesthetic to the treatment site as needed Topical anesthetic is usually adequate STEP 2 TROUGHING AND INNER EPITHELIUM LINING Step 2 Power Air Water Mode Epithelium Removal SELECT SETTINGS AS PROVIDED IN THE TABLE ABOVE USING A GOLD HANDPIECE Place tip in contact with the gingival crest parallel to the long
32. Location On top cover adjacent to fiber optic connector Ground Location Next to E1 ground terminal inside unit Identification Location Back Panel above ventilation channels Electrical Ratings Location Next to Power cord connection Air Label Location Base rear of unit Key Switch Location Back panel Remote Interlock Label Location Back Panel ETL Listed 0 rocas ro 0 CANI CSA C22 2 NO 601 1 Location Back Panel IEC 60601 2 22 gt FOOTSWITCH Footswitch Label 5200102 Location Back Panel Emergency Stop Label Location Front Covert Protective Earth Ground Location Back Panel Attention Small Location Back Panel WEEE Label Location Back Panel 5200999 Rev D Waterlase MDX 01 14 48086 4 E amp 0992 OE er INE RAE AN Remote Label le 4 Keyswitch Label identification Go N 240555290060 Certification ETL Listing Electrical 5 27 28 Rating Label Footswitch Label Air Intake waterlase MDX Q Laser Aperature Label Laser Explanatory Label 5200999 Rev D Waterlase MDX 01 14 APPENDIX ACCESSORIES REMOTE INTERLOCK POWER CORD USA POWER CORD EUROPE AIR HOSE 65 APPENDIX C CLINICAL PROCEDURE GUIDELINES PER
33. N Contents continued Section 4 Section 5 Section 6 6 el Protective Cover for fiber optic Shaft 200 Rear a a be E OL REB MU ori tme La wae aa I ak odo dm TT e Operating Instr cllons aaa Waa aa a aa A aa Aa a a a Connect Unit to Operatory Filling the Internal Cooling Water Reservoir Fill Self Contained Water System Bottle secure Fiber Optic Assembly to Unit Connecting Handpiece to Fiber Optic Cable Disconnecting the Handpiece Installing and Changing the Tip in the Gold Handpiece Tip Inspection Instructions Tip Cleaning Instructions cina oun vendue OW CIV IOW Rm Operational State Description KOV BUTOMS T AR Touch creen sasanga ck To Start the Waterlase MDX
34. R OPTIC CABLE 1 Remove the Handpiece from the Handpiece Box 2 Remove the Rear Plug from the handpiece by pulling the plug out fig 4 24 and place it in the Handpiece Box to store HANDPIECE HEAD REAR PLUG EXHAUST HANDPIECE iO TIP PLUG FIGURE 4 24 FIGURE 4 25 3 Remove the fiber Protective Cover from the Fiber Shaft of the Trunk Fiber by pulling the cover off fig 4 25 and place it in the Handpiece Box 5200999 Rev D Waterlase MDX 01 14 4 Check the Fiber Shaft for any moisture and wipe off any that 15 found NOTE Check output end of the Fiber Shaft for any contamination of damage see Sec 7 Fiber Check WARNING not touch output end of the Fiber Shaft to prevent any contamination and age If touched clean with dry tissue 5 Carefully insert the Handpiece onto the Fiber Shaft until it clicks fig 4 26 and 4 27 FIGURE 4 26 FIGURE 4 27 NOTE Connection and disconnection of the Handpiece and the Protective Cover should be done carefully without application of excessive force WARNING To prevent the internal fiber from breaking do not bend the flexible part of Fiber Shaft CAUTION Handpiece should always be connected before turning ON the laser 23 DISCONNECTING THE HANDPIECE 1 Press Change Handpiece icon on the Touch Screen SELECT HANDPIECE OR REFILL THE WATER BOTTLE 2 Press Start icon and wait until Deliver
35. Rate Water and Air as appropriate for the procedure OPERATIONAL STATE DESCRIPTION System Control Panel consists of the permanently displayed Key Buttons and the Touch Screen Display 1 Key Buttons e ON OFF Key Turns the Touch Screen Display OFF Sleep mode System controls are still powered up Press it when system is not in use overnight System will automatically switch into the Sleep mode when not in use for 10 minutes e Standby Key Turns Touch Screen ON Main laser controls and cooling system are OFF Use itall the time when not performing the treatment System will automatically switch into the Standby mode when not in use for 10 minutes e Ready lt all system controls ON Laser is ready to emit Use when ready to perform clinical treatment procedure 2 Touch Screen Controls Each laser control function Power Water and Air has a separate control display indicating the value of the parameter and its mode Each mode indicator acts as a control button and when pressed scrolls through available options See Sec 4 User Interface for navigation algorithm through the Menus e Power level control Shows and controls average power of the laser Maximum power is limited depending on the Pulse Repetition Rate and Pulse Mode Power adjustment steps are 0 25 Watts 5200999 Rev D Waterlase MDX 01 14 Minimum Max Power Max Power Max Power Max Power Pulse Per Sec Powe
36. W mirror into the handpiece repeat whole procedure in reverse order Ped Attention Mirror is oval symmetrical make sure of proper orientation when inserting the mirror into the handpiece head 91 TROUBLESHOOTING THE DELIVERY SYSTEM When any of the listed Delivery System Checking Areas Repair Actions Symptoms are found inspect the Checking Areas following this chart step by step and Slow cutting 4 Tha Dieta End perform recommended Repair Action 7 popping sound ip Tip flashing Smell burnt plastic Replace Tip and check Steps 3 4 WARNING Early discovery and repair of problems will improve the dependability of the laser system and prevent further problems Clean first then replace Mirror Clean first then replace Fiber Replace Fiber and check Step 6 Blow clean air Call Service 5200999 Rev D Waterlase MDX 01 14 FIBER CHECK NOTE Regularly inspect the end of the Fiber Shaft Always inspect and clean the Protective Window at the end of the Fiber Shaft after input end of the Tip or damaged 1 Disconnect the Handpiece following proper procedure pe Verify laser is in the Standby mode Check polished reflective surface of the window in the middle of the Fiber Shaft Clean with a non linting cotton swab and isopropyl alcohol if surface is contaminated
37. a LECT Of REFILL THE WATER BOTTLE uoc a the bottle Press Done to prime the spay waterline and pressurize water botte ERROR MESSAGES The Waterlase MDX constantly monitors its own performance and calibration If any perfor mance errors occur the system will be placed in Standby mode and the screen will indicate the cause of the error and provide recommendations on clearing the error If you cannot clear an error after following the directions on the error screen please call your authorized local Biolase service representative for assistance Error Corrective Number Error Reason Fix Action All bottle sensors Errorin bottle Check out bottle Check bottle straw off sensor system sensor system clean sensors Check bottle straw clean sensors Bottle sensor 1 off Check Bottle Check ambient 2 on sensor light source Possible defective sensor 1 Check bottle sensor light source Possible error in light source All bottle sensors on Foot Switch Foot Switch Press the Foot owitch to Ready pressed in standby pressed owitch in Ready mode mode mode Interlock is open Interlock is open Check Interlock Check Remote Interlock connector at back panel Shut Down temp oystem temp is Allow system to Let system run in condition high cool down Ready mode for 5 10 minutes Emergency
38. ate Pulse Step 1 Tip Power Air Water Mode Rate Pulp Removal MZ25 75 1 0W 2 1196 7 11 STEP 2 CONVENTIONAL INSTRUMENTATION 1 Estimate the working length following standard protocol 2 Start instrumentation using K files or a combination of K files and rotary files to enlarge and shape the canal 3 Apical instrumentation is performed to at least a size 30 K file to allow the RFT2 to reach the apex Always start treatment at the lowest power setting for the specific tissue and increase as required Closely observe the clinical effects and use 69 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 STEP 3 CLEANING amp ENLARGEMENT RFT2 1 Use the RFT2to perform apical and partial coronal 2 3 cleaning 2 Place tip into handpiece and select settings from the table below 3 Fill canal with sterile solution 4 Insert RFT2 1 mm short of the apex Use the rubber slider on the tip as a depth indicator 5 Activate laser and start moving the tip coronally at approximately 1 mm s Maintain tip in contact with the side surface of the canal wall during the entire apical to coronal pass 6 Repeat steps 4 and 5 oneor two more times to ensure that the entire inner canal has been cl
39. ce in the absence of long junctional epithelium e Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage SOFT TISSUE INDICATIONS INCLUDING PULPAL TISSUES 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 flap and expose the bone Flap preparation incision of soft tissue to prepare flap and expose unerupted teeth hard and soft tissue impactions Frenectomy and frenotomy e Gingival troughing for crown impressions Gingivectomy e Gingivoplasty Gingival incision and excision 95 Hemostasis Implant recovery Incision and drainage of abscesses e 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 e Removal of pathological tissues cysts neoplasm or abscess and hyperplastic tissues 1 granulation tissue from around the apex Soft tissue crown lengthening e Treatment of canker sores herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty
40. ct Seal the clot within the sulcus by applying a barrier such as surgical glue cyanoacrylate along the gingival margin using a pipette This seal is necessary to provide a barrier from external debris that might interfere with proper initiation of healing of the treated pocket The first probing should be performed 3 months after the treatment POST OPERATIVE PATIENT INSTRUCTIONS Do not to use a toothbrush for the first 24 hours after the procedure Rinse with Peridex or other chlorhexidine solution two times per day for 2 weeks post treatment After 24 hours start brushing again using a soft bristle toothbrush and toothpaste floss daily and use an over the counter mouthwash rinse after the 2 week Peridex regimen Schedule follow up visits including the first probing at 3 months Some offices bring the patient back on a routine basis for coronal polishing and post operative evaluation prior to the 3 month follow up SINGLE USE NON STERILE TIPS INCLUDED 1 Useonly as specified in this guide 2 Tip may break if excessive force is applied 3 Dispose of tip in sharps container after single use Specifications RFPT5 14 Operation Calibration Factor 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 t
41. customer or the user of the model Waterlase MDX should assure that it is used in such environment lt lEC 60601 Compliance Electromagnetic environment Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete discharge ESD ceramic tile If floors are covered with 8 kV air 8 kV air synthetic material relative humidity IEC 61000 4 2 should be at least 30 Electrical fast 2 kVfor power 2 kVfor power Mains power quality should be that of a transient burst supply lines supply lines typical commercial or hospital 61000 4 4 1 kVforinput N A sub pU output lines Input output that does not apply because the footswitch cable length is less than 3 meters Surge 1 kV differen 41 kVailferen Mains power quality should be that of 61000 4 5 tial mode tial mode a typical commercial or hospital environment 2 kV common 2 kV common mode mode Voltage dips lt 5 Ur lt 5 Ur Mains power quality should be that of a short interrup gt 95 dip in gt 95 dip in typical commercial or hospital tions and voltage UT for 0 5 UT for 0 5 cycle environment If the user of the model variations on cycle Water lase MDX requires continued power supply 40 Ur operation during power mains input lines 40 Up 60 dip in Ur interruptions it is recommended that the 60 dip in UT for 5 cycles model Water lase MDX be powered from 61000 4 11 for 5 cycles 70 U an uninterruptible po
42. d of the handpiece after each procedure HANDPIECE AND TIP CLEANING AND STERILIZATION CAUTION 5 and laser tips must be sterilized prior to initial use and cleaned and sterilized between patients Disposable single use tips i e quartz glass must be disposed of in a biohazard medical waste Sharps container Cleaning must be performed within a maximum of one 1 hour after the procedure prior to sterilization CAUTION Use only MANUAL CLEANING described below Other cleaning methods should be avoided since water entering the portals of the exhaust ring may damage the fiber optics inside the handpiece Step 1 Cleaning Process The cleaning process is intended to remove blood protein and other potential contaminants as well as to reduce the quantity of particles microorganisms and pathogens present from the handpiece laser tip surfaces and crevices Cleaning should be performed prior to sterilization and must be conducted only by qualified office personnel trained in the process who know how to handle the laser handpiece and tips and wearing goggles masks gloves and shields 1 Upon completion of the clinical procedure ensure that the laser tip remains installed in the handpiece Do not remove the tip 2 Insert the Rear Plug into the handpiece during the cleaning procedure care must be taken to prevent the cleaning solution and rinse water from entering the portals of the exhaust ring 3 Rinse t
43. eaned RFT3 7 Usethe RFT3to perform final cleaning of the coronal 2 3 8 Placetip into the handpiece and select settings from the table below 9 Fill canal with sterile solution 10 Insert RFT3 at the junction between apical and middle third 11 Activate laser and start moving the tip coronally at approximately 1 mm s Use the same technique as step 5 12 Re inserttip and perform an additional pass over the same area 13 Repeat Steps 10 through 12 three more times to ensure cleaning of the remaining coronal 2 3 Step 3 Power Air Water Mode Enlargement Step 3 Tip Power Water Mode Rate Deane 1 25 W 5OHz 34 24 H Enlargement Hydrophotonic effect Tip postion during different passses 5200999 Rev D Waterlase MDX 01 14 STEP 4 DISINFECTION RFT2 1 Use the RFT2 to perform disinfection of the apical and partial coronal 2 3 2 Place tip into handpiece and select settings from the table below This procedure is performed with 10 air flow and no water 3 Insert RFT2 1 mm short of the apex 4 Activate laser and start moving the tip coronally at approximately 1 mm s Maintain tip in contact with the side surface of the canal wall during the entire pass Use a brushing technique to deliver YSGG laser energy to the surface 5 Re insert tip immediately and perform an additional pass over the same area 6 Repeat steps 3 thr
44. een 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 DESCRIBED HEREIN DO NOT USE THE UNIT IF YOU SUSPECT IT IS FUNCTIONING IMPROPERLY WARNING No modification of this equipment is allowed 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 Donot operate in the presence of explosive or flammable materials 3 All persons present in the operatory must wear protective eyewear suitable for blocking 2 78um energy CAUTION Periodically inspect eyewear for pitting and cracking NOTE Forreplacement or additional protective eyewear please contact your authorized local Biolase representative 4 Do not look directly into the beam or at specular reflections 5 Direct the cutting spray toward targeted tissues only 5200999 Rev D Waterlase MDX 01 14 6 Press STANDBY Standby button the control panel before changing water and before turning off the unit 7 Press Change HP button on the control panel twice before exchanging handpieces changing water or removing the fiber optic connector from the unit 8 Move the circuit breaker to OFF 0 position located on rear panel and
45. er the entire root surface Use a to insert into the pocket and push the gingiva away and with loupes visualize the root surface The surface has to look clean and free of any calculus deposits Use the Root Surface Smoothening setting to refine the root surface to promote new attachment Use the same pattern as used for calculus removal Make enough passes to cover the entire root surface STEP 4 OUTER EPITHELIUM LINING REMOVAL Step 4 Power Air Water Mode Removal Remove the outer epithelium using the same tip and laser settings provided in the Step 3 Position the tip parallel to and approximately 1 mm away from the outer gingiva Angle the end of the tip slightly toward the surface Activate the laser and move the tip over a 5 mm area from the gingival margin apically The tissue surface is altered only enough to disrupt the epithelium layer without significant tissue removal After removing the soft tissue proceed with root surface preparation Use your preferred conventional instrumentation and technique to perform this next step 67 STEP 5 PRESSURE CLOT Insert a curette into the pocket to push the gingiva away and visualize the root surface The surface should be clean and free of any calculus deposits Applying external pressure should produce a thin layer blood clot inside the pocket Hold and press a wet gauze in place over the outer area of the pocket for approximately 3 minutes to achieve this effe
46. erlase MDX Tips can be inspected using magnifying lenses microscope laser aiming beam or Biolase Tip Inspection Kit NOTE Use ofthe Inspection Kit is recommended learn differentiate good damaged and contaminated Tips See page 27 for Cleaning Instructions Visual Inspection 1 Check that both ends of the tip appear flat and have mirror like reflection of any light source Look for chips or nicks along the edges 2 Check the plastic ferrule to ensure it is clean and has no burn marks at the input end If burn marks are present check handpiece alignment see Sec 7 Mirror Alignment Check Use of the Aiming Beam 1 Set system to Ready mode and point handpiece towards a white surface The red spot from the aiming beam should be well confined or have several concentric circles 5200999 Rev D Waterlase MDX 01 14 2 While still in the Ready mode check that the end of the tip does not glow The red beam should not be visible when observed from the side end of the tip must be dry BASIC MAINTENANCE NOTE This will not completely clean or sterilize the handpiece and tip e Use standard dental disinfectant to wipe down the handpiece after each procedure handpiece does not need to be disconnected from the unit Do not use bleach or abrasive cleaners e With the tip still attached use Non linting cotton swab and isopropyl alcohol to wipe the tip and the hea
47. he handpiece with the tip under lukewarm water 22 43 C for 10 seconds to remove gross soll 4 Prepare a cleaning solution per the manufacturer s instructions Use a commercially available surgical instrument detergent enzymatic cleaning solution with a pH of 7 0 such as Enzol or similar enzymatic presoak and cleaner Follow instructions for disposal of used solution 5 Soak a piece of gauze large enough to wrap the handpiece in the cleaning solution Squeeze out the excess liquid and wrap the handpiece with the tip still installed and leave wrapped for a minimum of 10 minutes 6 Unwrap the handpiece and tip Using a soft bristled brush dipped in the cleaning solution gently brush around the tip ferrule crevices and other hard to clean areas for 15 seconds The brush should be wet but not dripping Avoid contact with the exhaust ring and portals 7 Rinse the handpiece under lukewarm running tap water 22 43 C for 10 seconds 8 Dry the handpiece with a lint free cloth 9 Visually inspect the handpiece for any residual soil If present repeat steps 5 through 8 until any residual soil is removed 10 Using the Tip Remover or Revolving Tip Holder remove the tip from the handpiece following the steps outlined below 11 Gently wipe the orifice of the handpiece head with a dry lint free cloth making sure to remove any soil debris that may have accumulated in the crevice between the laser tip and the handpiece 5200999 Re
48. he 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 MDX cutting techniques it is very important to have the exact treatment location visually identified before and during treatment Maintain a distance of 0 5 to 3 mm between the fiber tip and the treatment tissue 3 to omm for turbo handpiece while moving the handpiece over the tissue surface as required Keepin mind that cutting speed is determined primarily by parameter settings and distance from tissue not by rapid hand movement as with the highspeed 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 MDX 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
49. ip type and duration of operation and to make appropriate power air and water adjustments to compensate for varying tissue composition density and thickness 5200999 Rev D Waterlase MDX 01 14 ENDODONTIC THERAPY CLINICAL PROTOCOL WARNINGS amp PRECAUTIONS Eyewear Doctor patient assistant and all others inside the opera tory must wear appropriate laser protective eyewear for the 2 78um wavelength OD 4 Clinical Use The Endolase HFT M system is suited for straight and slightly curved canals Before proceeding with any endodontic treatment a careful review of Contraindications Precautions and Warnings proper clinical training and practice on extracted teeth is recommended Use caution when using tips through narrow and curved passages at all times Forcing a tip through a narrow curved or obstructed canal could results in tip breakage and or perforation Activate the laser only when moving the tip upward coronally STEP 1 ACCESS PREPARATION All settings provided are for use with the Gold Handpiece 1 Access is prepared using the MZ5 ZipTip M 6mm 2 Select settings listed in the table below Angle the tip 30 45 to the long axis of the tooth to cut enamel effectively 3 Lower power setting or defocus the beam to cut through dentin 4 Use the MZ5 for removal of pulp Select pulp removal settings see table below to remove vital non vital pulpal tissue Step 1 Tip Power Pulse Air Water Mode R
50. is 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 Periodontal and Endodontic Surgery 39 SECTION 7 CLINICAL APPLICATIONS INTRODUCTION The Waterlase MDX device is designed to cut and remove hard and soft tissues within the oral cavity For hard tissue applications the Waterlase MDX 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 MDX device Waterlase MDX operates unlike traditional dental instruments or devices and technique must be practiced and perfected to ensure efficient operation Please be aware that the Waterlase MDX system removes hard tissues through a hydrophotonic process with the fiber tio applied in a non contact mode The fiber tip has to be positioned at approximately 0 5 to 3 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
51. l Procedure Guidelines 66 Periodontal Therapy Clinical Protocol 66 Endodontic Therapy Clinical Protocol 69 Tips Suggested Clinical Specifications 73 Electromagnetic Compatibility 76 5200999 Rev D Waterlase MDX 01 14 o 9 TE 4 N L wi qnt T In ped elt A T gt gt a m 4 A t 794 Em Fr 7 a K Manesh s 7 L f r tak FR nemen en Que IM LI eu a Me die dM mea md we BEP em A a Sz 1 1 4 11 j i kah 3 s amp L M b bas d mr AU SEI a4 4 gt LI a 5 o 1 n seip 4 Jem gt oe 1 M m F Tm x M 4 e E a gt m rs Mi ni el qe A Tag Ac r ne em 2 Ur TTN wan ws MR ae gt INTRODUCTION
52. l Rights Reserved
53. lasm or abscess and hyperplastic tissues 1 granulation tissue from around the apex NOTE tissue growth i e cyst neoplasm or other lesions must be submitted to a qualified laboratory for histopathological evaluation BONE SURGICAL INDICATIONS e Cutting shaving contouring and resection of oral osseous tissues bone e Osteotomy 5200999 Rev D Waterlase MDX 01 14 LASER PERIODONTAL PROCEDURES Full thickness flap Partial thickness flap Split thickness flap e 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 pocket lining and junctional epithelium e 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 Osseous crown lengthening Waterlase Er Cr YSGG assisted new attachment procedure cementum mediated periodontal ligament new attachment to the root surfa
54. m the microscope and gently fit the other side of the test holder into the clear end tube of the microscope Refocus ial the Microscope 06 Remove the tip from the test holder using the tip remover If the tip is contaminated at either end try cleaning it as shown below If the tip is damaged replace it from the handpiece using the tip remover and dispose of it Tip remover with tip inside TIP CLEANING INSTRUCTIONS gt 1 Hold tip with tweezers 2 Moisten cotton swab with 100 isopropyl alcohol drops 3 Push tip into cotton swab 4 Twirl cotton swab while maintaining pressure on tip m sd 2 m lt gt uw me es Lon A t oe S NENG gt 27 CAUTION Use of controls adjustments and performance of procedures other than those specified herein may result in hazardous radiation exposure Overview Before using the Waterlase MDX be sure the system has been started appropriately as described earlier in this manual After the system has completed its startup process turn the unit on by pressing the On Off button The Waterlase MDX provides user control for Power Water and Air parameters The user may select one of 16 Presets stored values and modes of operation for Power Water and Air or vary the individual values to adjust Power Pulse Mode Pulse
55. mbinations of presets are presented in Section 7 Pre programmed Pre sets for General Hard and Soft Tissue Procedures To select and store a new set of values and or modes for Power PPS Water and first select the values you wish to store from the system main menu Then select the preset group 1 2 3 or 4 in which you wish to save the new values Push the selected preset button a b c or d and hold in place for 2 3 seconds until you hear a beep 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 MDX Push the Ready button to enable the Waterlase and depress the footswitch when ready NOTE Theuser may evaluate the effect of each parameter setting prior to the procedure by directing the handpiece into a sink or paper cup and agjusting the values as desired When switching from Standby to Ready or cycling between to S modes the operator must wait two 2 seconds before pressing the footswitch If the operator presses the footswitch within that two second period a Footswitch pressed in by error message will appear After this period the laser will fire TURN THE WATERLASE MDX OFF e Disconnect tip if required Install tip plug e Press STANDBY button e Pushthe ON OFF button e Turn key to OFF position e Turn circuit breaker to OFF SETTINGS S
56. n the order of a licensed medical or dental practitioner Eyewear Doctor patient assistant and all others inside the operatory must wear appropriate laser protection eyewear for the 2 78um 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 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 pulse mode air and water settings tip and duration of operation and make appropriate power air and water adjustments to compensate for varying tissue composition density and thickness 5200999 Rev D Waterlase MDX 01 14 Hard Tissue Procedures All hard tissue i 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 The long pulse settings 700 us are indicated only for soft tissue applications Do not use long pulse settings to perform hard tissue procedures Soft Tissue Procedures Soft tissue procedures can be perf
57. n which radiated RF disturbances are controlled The customer or the user of the Waterlase MDX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Waterlase MDX as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of M on u 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W d 1 2NP d 1 2NP d 2 34 0 12 0 12 0 1 0 38 0 38 1 1 2 1 2 2 3 10 3 8 3 8 1 3 100 12 12 23 For transmitters rated at maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people BIOLASE biolase com NASDAQ BIOL USA Biolase Inc 4 Cromwell Irvine CA 92618 USA 949 361 1200 Europe MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 www mt procons com 2014 Biolase Inc Al
58. nel layout and instructions are described in Section 4 Operating Instructions NOTE Please direct any safety questions to your authorized local Biolase representative or call Biolase at 888 4 BIOLASE 888 424 6527 5200999 Rev D Waterlase MDX 01 14 SECTION 2 INSTALLATION OF THE WATERLASE MDX INSTALLATION INSTRUCTIONS Your local authorized Biolase representative will the Waterlase MDX and your authorized Biolase service representative will install the unit Please leave all crates and shipping containers unopened until your authorized trained service representative arrives Complete installation testing and demonstration requires approximately one full day The Waterlase MDX must be installed with an authorized Biolase representative please refer to Section 4 Operating Instructions for setup instructions Please contact your authorized local Biolase representative before transporting unit to a different location Misalignment of optical components may occur during transportation if the unit is not properly packaged FACILITY REQUIREMENTS e Electrical Supply 100 VAC 15 0 Amps to 230 VAC 8 0 Amps 50 60 Hz e Compressed Air Supply 80 120 psi 5 5 8 2 bar CAUTION 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
59. ng and or replacement between annual maintenances The unit will usually deliver lower power than normal if this is the case Please contact your authorized local Biolase service representative for assistance 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 Clean the tips before and after every use to maximize their useful life See Tip Cleaning Instructions for details TRANSPORTATION The Waterlase MDX is 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 57 Do not the unit outside of the office building across road 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 fork lift or pallet jack and should never be laid on its side dropped or banged If you have any questions regarding transportation please call your authorized
60. ological tissues Incision and drainage of periapical abscessess Full partial and split thickness flap preparation Most applications are the same as for MT4 and MGG6 Cutting contouring shaving and resection of oral tips taking into consideration flat shape of the tip osseous tissue bone Same as MT4 Excisional and incisional biopsies Cavity preparation l V Caries removal Hard tissue Exposure of unerupted teeth Fibroma removal roughening or etching enameloplasty Tooth Hemostasis Implant recovery Incision and drainage preparation to access to a root canal Cutting of abscesses Leukoplakia Operculectomy Oral contouring shaving and resection of oral osseous papillectomy Reduction of gingival hypertrophy tissue bone Osteotomy ostectomy osteoplasty Soft tissue crown lengthening Treatment of canker and osseous recontouring Cutting bone to prepare sores Vestibuloplasty a window access to the apex of the root Apicoectomv Root end for retrofi Same as MGG6 Same as MGG6 considering more shallow Same as MGG6 considering more shallow cutting cutting profile of tip profile of tip Same as MGG6 and MG6 considering bigger surface Same as MGG6 considering bigger surface area and area and significantly shallower cutting profile of tip significantly shallower cutting profile of tip Calibration Factor Actual power emitted from the tip displayed power multiplied by the Calibrati
61. om fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Waterlase MDX is used exceeds the applicable RF compliance level above the Water lase MDX should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Waterlase MDK Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m 5200999 Rev D Waterlase MDX 01 14 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE WATERLASE MDX The Waterlase is intended for use in an electromagnetic environment i
62. on Factor Applicable to entire range of power settings for the tip type Cautions If a reduction in cutting efficiency is observed replace the tip Failure to replace the tip correctly could result in damage of the tip or the handpiece mirror The tips have limited lifetime therefore damage of the delivery system attributed to overuse of the disposable tip may not be covered by warranty IMPORTANT Federal law restricts this device to sale by or on the order of a dentist or a physician Only licensed professionals who have successfully completed training should use the laser and accessories Always start treatment at the lowest power setting and increase as required power settings air and water settings tip type and duration of the operation and to 1 make appropriate adjustments to compensde for varying tissue composition density and thickness Closely observe the clinical effects and use your professional judgment to determine the aspects of the treatment technique proper 75 APPENDIX E ELECTROMAGNETIC COMPATIBILITY CAUTION Medical Electrical Equipment needs special precautions regarding Electro magnetic Compatibility EMC and needs to be installed and put into service according the information provided the following tables Portable and mobile Radio Frequency RF communications equipment can affect Medical Electrical Equipment Accessories Medical grade power cord maximum length 10ft 2 44 meters Biolase
63. ormed using two pulse duration settings H short pulse 50 us and S long pulse a range of 700 us The long pulse range is indicated ONLY for soft tissue applications 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 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 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 precautions should be taken when using the Waterlase MDX as are taken when using any air and water emitting cutting device including the high speed drill Root Canal Procedures
64. ough 5 two to three more times to ensure disinfection of apical and partial coronal 2 3 RFT3 7 Use the to perform final disinfection of the coronal 2 3 8 Place tip into handpiece and select settings from the table below Use 10 air flow as before see step 2 9 Insert RFT3 at the junction between apical and middle third 10 Activate laser and start moving the tip coronally at approximately 1mm s Use the same techniques as step 4 disinfection 11 Re insert tip immediately and perform an additional pass over the same area 12 Repeat steps 9 through 11 three to four more times to ensure disinfection of the remaining coronal 2 3 71 RESTORATION PLACEMENT Use any of your preferred techniques and materials to fill the canal and restore the tooth Single Use Non Sterile Tips Included Pul Step 4 Tip Power oe Air Water Mode Rate 1 Useonly as specified in this guide 2 lip may break when excessive force is applied 3 Dispose in sharps container after single use CALIBRATION FACTOR Tip Diameter um 275 415 Tip Length mm 25 21 21 17 Max Power of Operation Watt 29 Calibration Factor 0 55 0 85 Laser Power recommended with procedural steps are values on the display The actual power output can be calculated by multiplying that value by the Calibration Factor for each tip NOTE
65. ow Table 6 Installation and Calibration Dates Installation Date Calibration Date Calibration Date Calibration Date Calibration Date Calibration Date Calibration Date Calibration Date Calibration Date 59 APPENDIX A THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATED 24 JUNE 2007 DANGER Invisible laser radiatior when open AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION PENA ANA 5200999 Rev Waterlase MDX 01 14 Laser Hazard Symbol Location Top cover of Laser head directly above the Fiber Optic Connector Only visible during service High Voltage Hazard Symbol Only visible during service Locations Topcover or Laser head directly above the High Voltage input e Board Capacitor e Front Capacitor Bracket Certification Location Back Panel Non Interlocked Protection Housing Warning Location Laser head access plate Accessible only during service proceedings Laser Aperture Location On the top cover adjacent to Fiber Optic Connector BIOLASE BR l 0 56286 St Ingbert Germa biolase com waum ny procons com Waterlase MDX 450 Laser System 7200860 06 mp pasi YYYY MM gt 5 0482 MadeinU S A ELECTRICAL RATINGS 100 230 V S060 HZ Laser Explanatory Label
66. plastic tip ferrule is continuously getting damaged at the input mirror alignment should questioned CHANGING THE WATERLASE MDX HANDPIECE MIRROR pen and examine 01 E 03 ka a 01 Insert the 3 pin side of the tool onto 3 holes of 02 Insert the other side of the tool perpendicular to the 03 Pull mirror straight out from the head opening the cap in a handpiece head Make sure all pins plane of the backside of the mirror inside the opening Grab the mirror with fingers or tweezers and fit snugly Turn counter clockwise approximately Screw unscrew from the tool wear gloves or finger 3 turns to unscrew the cap Remove the cap the threaded side of the tool into the mirror by turning tool tips do not handle mirror from the tool and place in a clockwise 2 2 5 full turns Do not thread all the way into with bare hands If you touch the mirror safe place the mirror for easier release of the mirror later surface gently clean it with alcohol Thread new Do not turn handpiece with the opening mirror onto the mirror replacement tool down otherwise the mirror may fall out If mirror has burn marks clean the internal surfaces of the handpiece head with a long cotton swab to close and secure mirror 05 moistened with alcohol 99 9 pure isopropyl alcohol is required for the use of this product Please order from your authorized distributor Biolase P N 3000251 To insert and secure the NE
67. r Protective Black Rubber Cap for fiber optic connector Protects input end of the fiber optic cable when not attached to unit Optical Shaft Contains fiberoptic cable illumination waveguides and protective window Protective Cover for fiber optic shaft Protects optical shaft when handpiece is disconnected To disconnect the handpiece or protective cover pull the handpiece or protective cover off the shaft Handpiece The handpiece is rotatable and detachable from the optical shaft It delivers optical energy illumination and atomized water spray to the treatment area Rear Plug Protects handpiece when disconnected from optical shaft Tip Plug Protects 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 Tip The tip is detachable from the handpiece and serves as the optical power conduit to the target tissue Because the laser energy passes through this tip your laser unit s proper function depends on the tip s condition A damaged tip may reflect laser energy back into the handpiece potentially damaging the handpiece and or fiber optic Clean and inspect the tips before and after every use to maximize their useful life See Tip Inspection Instruction amp Tip Cleaning Instructions in Section 4 for details Tip Remover Tool to remove and insert tips Revolving Tip Holder May hold up to 6 tips operates as Tip Remo
68. r for H mode 5 H mode 5 Hz H amp S Modes MDX 450 MDX 450 300 300 W W W Laser radiation symbol is flashing together with beep sound when footswitch is pressed and system emitting laser beam Pulse Mode control The laser pulse has two modes short pulse mode and 5 long pulse mode These modes control the pulse duration at about 60 us for H mode and about 700 us for S mode Pulse Frequency control Laser pulses can be delivered at different rates or number of pulses per second or PPS also called Hertz Hz Press Pulse Frequency Control to change laser pulse repetition rate Can be selected in the range of 10 50 Hz with 5 10 Hz step Water and Air Level controls Shows and controls relative percentage of water and air in the spray Controls independently from 196 to 10096 with 196 step Water and Air Mode controls When pressed the Water and Air mode indicators cycle through the OFF AUTO and ON modes displaying their current setting When set ON and system is in Ready mode water or air will start flowing immediately When set in AUTO mode water or air will flow after footswitch is pressed Pre set Selection Menu Allows access to 4 groups of 4 pre set system operating parameters total 16 pre sets Any change to any pre set can be memorized Change Handpiece Menu Provides access to the automatic purging drying of the delivery system
69. remove the key before leaving unit unattended DANGER DO NOT open system side doors These are to be used by authorized Biolase service personnel only Danger from radiation exposure and high voltage may exist All operatory entrances must be marked with an approved warning sign indicating a laser is in the operatory 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 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 CAUTION Laser plume may contain viable tissue particulates 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 the Next button on the touch screen If error messages persist please contact your authorized local Biolase representative Circuit Breaker The circuit breaker on the back panel serves as a line switch to separate the unit from the main power supply 0 OFF 1 ON Keyswitch To switch unit ON turn key to horizontal position Use the proper key only The key cannot be
70. s connected to the side of the water reservoir is closed fig 4 3 Push button on the top connector and disconnect tubing from the lid fig 4 4 FIGURE 4 3 FIGURE 4 4 Remove lid and filter assembly see fig 4 5 and 4 6 FIGURE 4 5 FIGURE 4 6 17 5 Use funnel to fill with distilled or deionized water to 94 s full FIGURE 4 7 6 Replace filter assembly and close lid tight 7 Plug in water connector firmly until it clicks in place 8 Power up the system e Switch the Power Circuit Breaker on the back panel ON e Turn the Keyswitch to the ON position e When keyswitch is turned ON the system will begin its boot up process Once the system emits second beep and the display screen turns dark about 45 seconds push the ON OFF key on the front panel 9 Press Ready key If Water level low error message is shown turn the system OFF and then refill the cooling water to 34 full level 10 Press Ready key again and let system run for 1 2 minutes to clear the air bubbles from all components of the cooling system 11 Close the back door and tighten the two captive screws FILL SELF CONTAINED WATER SYSTEM BOTTLE 1 Make sure that the system is in the Standby mode bottle is de pressurized 2 Push the bottle release button and pull the bottle out from the holder towards the back handle see fig 4 8 5200999 Rev D Waterlase MDX 01 14 a ahi t i ES jr
71. se MDX 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 Tissue Evaluation Any tissue growth I e cyst neoplasm and other lesions removed with Waterlase MDX 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 0 5 to 3 mm 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
72. sue to be incised Step on the footswitch and start moving the tip along the tissue surface by applying light pressure The incision will be 41 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 MDX please refer to Appendix C PRESETS FOR SOFT AND HARD TISSUE PROCEDURES As described before Waterlase MDX has the option of 16 user programmable presets stored in the system memory Examples of pre programmed values for general hard and soft tissue procedures are presented in Table 2 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 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
73. t in Sec 7 Troubleshooting the Delivery System Use same techniques when operating Turbo handpiece and MX Tips Also note that 1 the Turbo tip holder remover tool is different than the regular tip holder remover 2 the Turbo tool works ONLY with Turbo tips and 3 the regular tool does NOT work with Turbo tips Also refer to the Turbo Handpiece instructions for use for more information P N 6201126 5200999 Rev D Waterlase MDX 01 14 TIP INSPECTION INSTRUCTIONS 01 Remove the tip from the handpiece and insert it into the correct side of the tip test holder as shown using the tip remover Tip remover with tip inside 02 Insert the tip test holder into the test adapter with the distal or laser emitting end of the tip toward the microscope 03 Slide the adapter over the microscope to move the tip Surface toward the focal point of the microscope The FOCAL POINT i focal point lies in the plane at the end of the clear end tube of the microscope 04 Turn on the microscope s built in light by gently pulling apart the upper and lower tubes or hold it up to another light source and bring the surface of the tip into focus using the thumb wheel Examine the tip surface carefully for damage or contamination BURNT BROKEN CONTAMINATED 05 To examine the proximal or trunk fiber end of the tip remove the adapter fro
74. tly turn off the unit The button will glow red to indicate an emergency stop and the control panel will display an error message Press the button again to restart the system If the system was on when the emergency stop was activated the system will be in standby mode when turned back on You must push the Ready key before using the system again e Keyswitch To switch unit ON turn key to horizontal position Use the proper key only The key cannot be removed while in the ON position e Footswitch Connector Connect and secure footswitch here e Remote Interlock Outlet 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 Customers may request that the remote interlock be connected to a door switch Power Connection Circuit Breaker Attach power cord to unit at this location The circuit breaker serves as a line switch to separate the unit from the main power supply 0 OFF 1 ON Power cable can be wrapped over the holding plate above the connector when system is not in use or during transportation e Ventilation Channels Do not cover or block these channels They provide an air flow path to cool the system
75. top button must not be engaged verify by making sure the button is not glowing red and no error message is displayed 8 The system will begin its startup process Once the display screen is dark about 20 30 seconds a chime will sound and the Home screen will appear 9 Attach handpiece to the fiber optic cable shaft Sec 4 Connecting the Handpiece to Fiber Optic Cable 10 Press Ready button and attach tip using the tip remover Sec 4 Installing and Changing Tip Into Handpiece 1 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 simply push one of the four preset buttons labeled 1 through 4 A second screen showing the four presets within the selected set will then allow you to select preset a b c or d After a chime indicating that your selection was accepted the main screen will display your new preset values BIOLRSE PRESETS CURRENT SETTINGS lt 6 00 45 50s 80 2a 3 00 30 AUTO 30 AUTO POWER MODE H20 AIR 2b 4 00 40 60 POWER H20 AIR 2c 3 00 i 30 AUTO 30 AUTO POWER MODE H20 AIR 2d 3 00 15 302 302 POWER IODE H20 AIR 5200999 Rev D Waterlase MDX 01 14 MODIFY AND SAVE PREFERRED VALUES AS PRESETS The Waterlase MDX has sixteen pre programmed presets stored on the system The values of the presets as well as additional co
76. v D Waterlase MDX 01 14 Tip removal using the Tip Remover or the Revolving Tip Holder e Slide the handpiece laterally toward the Tip Remover or Revolving Tip Holder e Place your thumb against the selected tip slot to prevent the laser tip from falling out of the Tip Holder when disconnecting it from the handpiece e Carefully lift the handpiece to disengage the tip ferrule from the handpiece head e Use tweezers to slide the tip out from the Tip Holder or Tip Remover 12 If the tip is a single use accessory dispose of in a biohazard medical waste Sharps container If the tip is reusable rinse it with distilled water for 10 seconds Dry with a lint free cloth 13 Visually inspect the tip for any residual soil If present repeat Step 12 until residual soil is removed Step 2 Sterilization Process The Steam sterilization process is intended to destroy infectious microorganisms and pathogens NOTE Always perform this procedure immediately after cleaning and prior to use only use FDA cleared USA or CE marked Europe sterilization accessories i e Sterilization pouches and autoclave trays 1 Prior to sterilization remove the Rear Plug and Tip Plug if installed N Place thehandpiece inside a single wrap self seal autoclave pouch Tips may be autoclaved in the Holder place the individual or the Tip Holder loaded with tips inside a separate single wrap self seal autoclave pouch 4
77. ver follow instructions enclosed with tip holder NOTE Notfor use with Turbo tips 15 SECTION 4 OPERATING INSTRUCTIONS SETUP Connect Unit to Operatory 1 2 3 4 5 Verify circuit breaker is in OFF position Verify keyswitch is in OFF position Connect power cord to unit fig 3 2 Verify minimum air pressure of 80 psi 5 5 bar from air supply Check air supply for moisture CAUTION 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 6 moisture appears Wet air will damage the unit Check air supply weekly to verify absence of water and oil Connect to the unit s air inlet connector fig 3 2 Filling the Internal Cooling Water Reservoir Your Waterlase MDX may have been shipped with a full cooling water reservoir In the event you need to fill the reservoir please follow the instructions below 1 Open the back panel door turning two thumb screws counter clockwise and back gently fig 4 1 and 4 2 WARNING careful opening the door Make sure door opens easily and clears the bottle lid and tubing Door holding bracket is mounted the bottom hinge Do not apply excessive force 5200999 Rev D Waterlase MDX 01 14 0000000 F aa FIGURE 4 1 FIGURE 4 2 Locate internal water reservoir Verify that white clip on the blue tube that i
78. ver or revolving Tip Holder Insert by aligning the first groove of the Tip Ferrule against the receiving edges of the Holder then sliding the Tip in the use of tweezers is highly recommended fig 4 29 and 4 30 WARNING Never touch the input end of the Tip If the input surface is contaminated damage the Tip Handpiece and the Fiber Delivery System Hold the tip only over the plastic ferrule and the output end NOTE Always inspect the Tip prior to use see Sec Tip Inspection FIGURE 4 30 FIGURE 4 31 4 Align the tip orifice of the handpiece over the input end of the Tip placed in the Tip Remover or revolving Tip Holder fig 4 31 5 Carefully lower the handpiece and insert a clean inspected Tip see Tip Inspection all the way until the shoulder of the tip ferrule sits against the handpiece head fig 4 32 and 4 33 25 FIGURE 4 32 FIGURE 4 33 WARNING careful not to hit the proximal end of the against the handpiece head and not to break retaining fingers of the plastic ferrule 6 Slide the Handpiece laterally away from Tip Remover or Tip Holder fig 4 34 FIGURE 4 34 To remove the Tip repeat the whole process in reverse order Put your thumb against the selected tip slot to prevent Tips from falling out of the Tip Holder when connecting and disconnecting Tips from the Handpiece lf the laser cuts hard and soft tissue after fiber installation slower than expected please follow the flowchar
79. wer supply 10 Ur 30 dip in Ur 30 dip in Up for 25 cycles for 2 or 25 cycles lt 5 U lt 5 U gt 95 5 gt 95 dip in Up for 5 in Ur for 5 Seconds seconds Power frequency 3 A m 3 A m Power frequency magnetic fields should 50 60 Hz be at levels characteristic of a typical magnetic field location in a typical commercial or hospital environment IEC 61000 4 8 NOTE Up is the A C mains voltage prior to application of the test level GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The model Waterlase MDX 15 intended for use in the electromagnetic environment specified below The customer or the user of the model Waterlase MDX should assure that it is used in such environment IEC 60601 comp lance environment Conducted RF 3 Vrms Portable mobile communica tions equipment should be used closer to any part of the model Water lase including cables than the recommended separation distance Radiated RF calculated from the eguation applicable 3 to the frequency of the transmitter IEC 61000 4 6 150 kHzto 80 GHz 61000 4 3 80 MHz to 2 5 Recommended separation distance GHz 1 2 P d 1 2VP 80MHz to 800 MHz 2 3 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is the recommended separation distance in meters m Field strengths fr
80. with or without water cooling and hydration spray A detailed description of the techniques for cutting hard and soft tissues with Waterlase MDX is presented in the following subsections Please study this Section carefully practice on tissue models and attend a Waterlase MDX training seminar before using this device in a clinical situation HARD TISSUE CUTTING Hard tissue cutting is achieved through a unique process described as hydrophotonic 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 cuiting carefully position the fiberoptic tip approximately 5 mm away from the targeted tissue site Step on the foot switch 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 authorized local Biolase representative for assistance 5200999 Rev D Waterlase MDX 01 14 Always remember that laser power and therefore hydrophotonic energy are delivered from the very end of t
81. y System is purged watching the progress bar on the screen WARNING Failure purge the handpiece prior disconnecting cause damage of the 3 Remove Tip using Tip Remover or revolving Tip Holder and replace it with the Tip Plug fig 4 24 P Pull and disconnect the Handpiece from the Fiber Shaft E Wipe any moisture off the Fiber Shaft with dry tissue Check that window at the end of the fiber is clean use dry non linting cotton swab or tissue to clean and not damaged see also Sec Fiber Check N Carefully attach new Handpiece or fiber Protective Sheath until it clicks on the Fiber Shaft f new Handpiece is connected press Done f Protective Cover is connected or work complete turn system OFF WARNING Do not press Done button if fiber Protective Cover is attached water will fi 1 Set the system in the Ready mode Do not step on the footswitch NOTE Always change Tips in Ready mode when cooling air is blowing out from the tip orifice of the handpiece head This helps clean the input end of the tip from any light dirt or moisture 5200999 Rev D Waterlase MDX 01 14 PROXIMAL END DISTAL END INPUT END OUTPUT END PLASTIC FERRULE SHAFT FIGURE 4 28 FIGURE 4 29 2 Remove the Tip Plug by pulling it out and place it in the Handpiece Box 3 Remove Tip from the package for new Tips only and insert it into the Tip Remo
82. you gain experience with the Waterlase MDX 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 hand piece from the patients mouth Do not hit the handpiecetip into teeth or other instruments while removing the handpiece or the tip may break To remove the tip use the tip remover tool Placea newtip 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 Handpiece and Tip Cleaning and Sterilization later in this section SOFT TISSUE INCISION EXCISION AND ABLATION ooft 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 There are two pulse settings for soft tissue applications 1 a short pulse setting of 60 us and 2 along pulse setting range of 700 us The second range of pulses is indicated only for soft tissue applications For these procedures select appropriate settings or presets as shown in Section 7 Presets for Soft and Hard Tissue Procedures Once settings or presets have been selected carefully place the tip in contact with the tis

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