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User Manual

1. ADJACENT STRUCTURES WaterLase iPlus 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 whether removed with WaterLase IPlus or conventionally must be submitted to a qualified laboratory for histopathology assessment TISSUE CONTACT AND TIP BREAKAGE Do not contact hard tissues with the Fiber Tip Hard tissue cutting occurs in non contact mode with the Tip 0 5 mm to 3 mm off the surface 3 to 5 mm for Turbo Handpiece Tips are 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
2. 5200158 Rev F Maintenance and Troubleshooting continued TROUBLESHOOTING The WaterLase iPlus constantly monitors its own performance and calibration If any performance errors occur the system will automatically go into Standby mode and the screen will show a message indicating the cause of the error and the recommendation for clearing it If after following the directions on the screen the error does not clear please call your local service representative for assistance Error z Number Error Reason F Corrective Action ix Possible error in Check bottle sensor Check bottle straw All bottle sensors off light source light source clean sensors i fecti heck bottle st 7 Bottle sensor Possible defective Check Bottle sensor Check bottle straw 1 off 2 on sensor 1 clean sensors Error in bottle Check out bottle Check bottle straw All bottle sensors on sensor system sensor system clean sensors Foot Switch pressed in Standby Mode Check Remote Interlock 15 28 Interlock is open Interlock is open Check Interlock Ee connector at back panel Shut Down temperature condition Emergency switch Emergency switch Check Emergency Release the Emergency pressed pressed switch Stop Button at the front t bottl t water Bottl No bottle error Bottle not detected us duci patera dun repair sensor clean the sensors Ressrvol toll Cooling water level Add de ionized Add specified water is low distilled sterile water if trained on t
3. 58 5200158 Rev F Labels Continued OUTER PACKAGING w H FRAGILE SEE THIS END UP HANDLE KEEP DRY INSTRUCTIONS WITH CARE FOR USE 106kPa 50kPa 20 C jo o NON CONDENSING RELATIVE ATMOSPHERIC TEMPERATURE HUMIDITY PRESSURE TEMPERATURE HUMIDITY ATMOSPHERIC LIMITATIONS LIMITATIONS PRESSURE LIMITATIONS 5200158 Rev F 59 Labels Continued Remote Label Keyswitch Label ho VE Peter putuku LM a mun LIP 4 wu OC LM L t LAR Identification H Certification SR im ETL Listing Electrical Rating Label Footswitch Label Air Intake 60 5200158 Rev F Labels Continued Laser Explanatory Label Laser Aperture Label 5200158 Rev F 61 Accessories ACCESSORIES LIST BIOLASE P N DESCRIPTION 2200479 6200236 6200150 2200798 2200696 2000204 2200485 6001029 6201074 6200500 6201126 6200502 6200503 7000414 7200407 TIP STARTER KIT Qty DESCRIPTION MC3 9mm flat Tip MZ10 6mm ZIPTIP 1000 um MZ8 6mm ZIPTIP 800 um 62 5200158 Rev F Tips TIP SETTINGS WATERLASE IPLUS GOLD HANDPIECES Z GLASS TIPS Gold Handpieces Lengths um Calibration Maximum Tissue Types Factor Power W 21 25 Root Canal 9 14 18 20 22 25 28 Root Canal Soft Tissue Ferrule Color NEE Diameter um tet 21 RootCanal Canal 6 9 14 40 All Types 10 14 10 14 60
4. 10 Press the Ready key again and let the 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 FILLING THE SELF CONTAINED WATER SYSTEM BOTTLE CAUTION Use only distilled purified or sterile water with no less than 20u Siemens meter conductance 1 Make sure that the system is in Standby mode this allows the bottle to de pressurize 2 Push the bottle release button and pull the bottle straight back from the holder Fig 4 9 E i 3 PULL UP 3 Twist the bottle clockwise and pull up the lid to open Fig 4 10 f Pr l 4 Fill the bottle with distilled purified or sterile water only DO NOT use tap water W x ZS 5 Align the arrow on the lid to the dot on the bottle and insert the bottle into Wm cas d F the lid then twist the lid clockwise until the arrows on both parts are lined up Fig 4 11 4 12 18 5200158 Rev F Set Up Instructions continued 6 Attach the bottle back into its holder make sure the connector is fully engaged WARNING DO NOT use tap water or any non approved solution If anything other than distilled purified or sterile water is used the system warranty will be voided WARNING Be careful handling the water bottle assembly Do not drop the parts even a small crack may cause damage when the bottle is pressurized NOTE BIOLASE recommends replacing the self contained water system
5. The control panel Fig 5 1 has one function control button for turning the system ON and OFF and for switching between Standby and Ready modes Pressing and holding the button for more than 2 seconds will turn the system ON OFF When the system is ON pushing the button will switch the system between Standby and Ready modes 5200158 Rev F 25 Operating Instructions continued The control panel also has one LED indicator for system status and laser power actuation Fig 5 1 Amber indicates that the system is in Standby mode e Green indicates Ready mode Blinking green indicates the laser is firing There are also two status indicators for the iLase batteries Amber charging mode e Green fully charged APPLICATIONS MENU LEVEL 0 DESCRIPTION After the system is powered up it takes approximately 45 seconds for the software to load Touch the screen to access the Level 0 Home Menu Fig 5 2 and Flow Chart in Fig 5 14 This screen offers a choice of one of seven operational areas Restorative Soft Tissue e Periodontics Implantology e Endodontics Expanded REPaiR To select a procedure category press the name of the category on the touch Screen NOTE The system is in Standby mode and cannot be changed to Ready mode while the Home menu is displayed LEVEL 1 DESCRIPTION Once a procedure category is selected the system goes to Level 1 which offers the clinical applic
6. Use a bite block to prevent breakage or swallowing of the Tip from biting High speed suction is required to remove any excess fluid and materials resulting from accidental Tip breakage TIP CHANGING Failure to correctly replace the Tip could result in damage to the Fiber Tip Handpiece or affect the emission of laser energy around the Tip A careful review of the instructions on how to replace the Tip is recommended 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 needed to maintain a clear field of vision during treatment Do not use the WaterLase iPlus if you cannot clearly see the treatment site 5200158 Rev F Contraindications Warnings and Precautions continued PLUME REMOVAL 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 the laser and minimal or no water spray Ensure that all appropriate protective equipment including high speed suction to remove the plume appropriate masks and other protective equipment is used at all times during procedures with this laser device DENTAL MATERIALS Do not direct laser energy towards amalgam gold or other metallic surfaces Do not direct energy towards dental cements or other similar filling materials
7. Wavelength Frequency Average power Power accuracy Pulse energy Pulse duration for H mode Pulse duration S mode Handpiece head angles Gold HP Tip diameter range Turbo Tip focal diameter range Output divergence Mode Aiming Beam Water Level Sensor Beam Maximum Permissible Exposure MPE Nominal Ocular Hazard Distance NOHD 11 x 19 x 33 in 28 x 48 x 84cm 11 x 19 x 40 in 28 x 48 x 102 cm 75 Ibs 34 kg 100 VAC 10 230VAC 10 50 60 Hz 5 0A 8A Circuit breaker Keyswitch Remote interlock connector Distilled De ionized or Sterile 80 120 psi 5 5 8 2 bar 0 100 0 100 0 5 5 0 mm from Handpiece Tip to target 4 ErCrYSGG Erbium Chromium Yttrium Scandium Gallium Garnet 2 78 um 2780nm 5 100 Hz 0 1 10 0 W 2096 0 600 mJ 60 us 700 us 70 contra angle 200 1200 um 500 1100 um 2 8 per side Multimode 635nm red laser 1mW max safety classification 1 635nm laser 1mW max safety classification 1 5cm 3 5 x 105 W m2 See separate specifications for the iLase Diode Laser Handpiece in the iLase User Manual Biolase P N 5400230 5200158 Rev F 33 34 Indications for Use WATERLASE IPLUS IS INDICATED FOR HARD TISSUE GENERAL INDICATIONS Class I Il Ill IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty excavation of pits and fissures for placement of
8. adjustments can be made to the following parameters Handpiece type and Tip type only the Tips which are allowed for this procedure Laser Power Pulse Repetition Rate and Pulse Mode Water Spray and Air percentage setting Handpiece The Handpiece recommended for the current procedure step appears at the bottom of the screen However the Handpiece can be changed by taking the following steps 1 Press the image of the Handpiece that you want to install a progress timer will appear in the form of a segmented circle outside of the Handpiece icon and the system will automatically purge the water from the installed Handpiece Patient Air 10096 ON air pressure in the bottle OFF Patient Water 10096 ON This step will take 3 4 seconds 2 When the water is purged from the Handpiece a new message will appear on the screen Exchange Handpiece now and then select Tip Attach the new Handpiece to the Fiber delivery system 3 Press the image of the Tip chosen for the procedure patient air and internal cooling air will be activated through the Handpiece and a new Tip may now be inserted 5200158 Rev F 27 Operating Instructions continued 4 Oncea new Tip is attached to the Handpiece press the Handpiece image again a progress timer will again appear for 3 4 seconds and the Handpiece will be primed with water To return to the Procedure screen press either the back or Handpiece button located at the bottom
9. i icon found on every screen accesses an Information Recommendations Screen Error screen appears when a system error is detected It will give the Error name and recommendations for correcting the error Fig 5 12 Service provides a pass code to allow entry to authorized Service personnel only Fig 5 13 5200158 Rev F Fig 5 13 31 Operating Instructions continued SYSTEM FLOW CHART Restorative Class Ky Si p gt Classll Class Ill IV V Soft Tissue h JA Gingival Recontouring Gi PY N gt Frenectomy i Biopsy Home SELECT CATEGORY Endo een gt Root Canal Therapy T zu Er Pulpotomy Apicoectomy Perio Pocket Therapy Closed ba rer al gt Pocket Therapy Open ki s gt Osseous Crown Lengthening Closed Osseous Crown Lengthening Open Y Settings Implant G s Implant Recovery e Advanced Expanded Y Ly K gt Troughing Laser Bandage REPaiR e Steps 1 4 d Steps 5 8 Fig 5 14 32 5200158 Rev F Specifications DIMENSIONS W X L X H Unit With Fiber Weight ELECTRICAL Class Medical Electrical ME Equipment Operating Voltage Frequency Current rating Main control On Off control Remote interruption WATER SPRAY Water type External air source Water Air nteraction zone OPTICAL Laser classification Medium
10. 10 minutes 6 Unwrap the Handpiece and Tip and 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 5200158 Rev F 43 Cleaning and Sterilization Continueo 9 Visually inspect the Handpiece for any residual soil If any residual soil is still present repeat steps 5 through 8 until it is removed 10 Using the Tip Remover or Revolving Tip holder remove the Tip from the Handpiece per 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 Tip removal using the Tip Remover or Revolving Tip Holder Slide the Handpiece laterally toward the Tip Remover or Revolving Tip Holder Fig 10 1 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 Fig 10 1 Carefully lift the Handpiece to disengage the Tip ferrule from the Handpiece head Use tweezers to slide the Tip out from the Tip holder or Tip Remover Fig 10 2 12 If the Tip is a single use access
11. 132 C 270 F 15 30 minutes Dynamic Air Removal 132 C 270 F 20 30 minutes Pre Vacuum 134 C EU only 20 30 minutes 7 Upon completion of the cycle the Handpiece and Tips must remain in the sterilization pouches prior to use to ensure sterility 8 To 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 Follow the instructions outlined in Section 4 Installing and Changing the Tip in the Handpiece 5200158 Rev F 45 46 Maintenance and Troubleshooting continued WARNING Repeated processing of the Handpiece and reusable Tips 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 If damage or wear is observed discard the Handpiece as required by local Waste Electrical and Electronic Equipment WEEE laws Used or damaged Tips must be disposed of in a biohazard medical waste Sharps container Use of damaged or worn Tips may cause damage to the delivery system and will compromise the clinical performance of the WaterLase iPlus Laser System The Tips must be inspected prior to each use for damage or wear as described in Appendix D TIP INSPECTION DAILY MAINTENANCE Use the display covers supplied with the system to cover protect the screen console Use disinfectant
12. Only UNN UI amp g hzH HOU TA 042 Made in U S A l 5201270 Rev B 5001138 Rev A Q B HB E Wem E2T X Esa P 30 sec OFF lL M 55 56 Labels Continued LASER HAZARD SYMBOL Indicates the system contains a laser Location Top cover of Laser head directly above the Fiber Optic Connector Only visible during service HIGH VOLTAGE HAZARD SYMBOL Warning Dangerous voltage Only visible during service Locations Top cover of Laser head directly above the High Voltage input PFN Board Capacitor Front Capacitor Bracket CERTIFICATION This device complies with FDA laser standards Location Back Panel NON INTERLOCKED PROTECTION HOUSING WARNING Location Laser head access plate Accessible only during service proceedings LASER APERTURE Indicates the laser aperture is at the end of the Fiber Location On the top cover adjacent to Fiber Optic Connector 5200158 Rev F THIS PRODUCT COMPLIES WITH EDA PERFORMANCE STAG ARGS FOR LATER PRODUCTE EXCEPT FOR DEVIANONS PURSUANT TO LASER ONCE ND SD DATID 24 JUNE 2007 ai daret Lor DANGER Invisible class 4 laser radiation present when open AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION 5200101 REV B Labels Continued LASER EXPLANATORY LABEL Provides laser specifications Location On top cover adjacent to Fiber optic connector SYSTEM GROUND CONNE
13. sealants For use on adult and pediatric patients ROOT CANAL HARD TISSUE INDICATIONS Tooth preparation to obtain access to root canal Rootcanal preparation including enlargement Rootcanal debridement and cleaning ENDODONTIC SURGERY ROOT AMPUTATION INDICATIONS Flap preparation incision of soft tissue to prepare a flap and expose the bone Cutting bone to prepare a window access to the apex apices of the root s Apicoectomy amputation of the root end Root end preparation for retrofill amalgam or composite Removal of pathological tissues i e cysts neoplasm or abscess and hyperplastic tissues i e granulation tissue from around the apex BONE SURGICAL INDICATIONS Cutting shaving contouring and resection of oral osseous tissues bone Osteotomy LASER PERIODONTAL PROCEDURES Full thickness flap Partial thickness flap Split thickness flap Laser soft tissue curettage Laser removal of diseased infected inflamed and necrosed soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium Removal of granulation tissue from bony defects Sulcular debridement removal of diseased infected inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index gingival bleeding index probe depth attachment loss and tooth mobility
14. shaft for any moisture and wipe off any that is found with a dry tissue 5 Carefully insert the Fiber shaft into the Handpiece until it clicks Fig 4 23 4 24 4 25 CAUTION Check the output end of the Fiber shaft for any A contamination or damage see Section 11 Maintenance and Troubleshooting DO NOT touch the output end to prevent contamination and or potential further damage If touched clean with a dry tissue NOTE Connecting and disconnecting the Handpiece and removal of the protective cover should be done carefully without applying excessive force WARNING To prevent the internal Fiber from breaking do not bend the flexible part of the Fiber shaft Fig 4 23 Fig 4 24 Fig 4 25 5200158 Rev F 21 22 Set Up Instructions continued DISCONNECTING THE HANDPIECE 1 Purge the Handpiece by following the instructions described in Section 5 Level 2 Description 2 Pull and disconnect the Handpiece from the Fiber Shaft Fig 4 26 3 Wipe any moisture off the Fiber shaft with dry tissue 4 Check that the window at the end of the Fiber is clean and not damaged if it s not clean use a dry cotton swab or a tissue to clean it Fig 4 26 5 Carefully attach a new Handpiece or Fiber protective sheath until it clicks into position WARNING Do not press Done if the Fiber protective cover is attached as water will fill the cover and may cause damage to the Fiber shaft If this happens take
15. surface and within the surface tissue layer absorbs laser radiation resulting in explosive water expansion Strong mechanical forces from rapid water expansion induce separation of surface material quickly and cleanly removing hard tooth tissue A flexible Fiber optic cable with a Handpiece delivers the unique laser wavelength and atomized distribution of water particles to the target tissue A visible light emitted from the Handpiece distal end pinpoints the area of treatment The optical power output and atomized water spray may be adjusted to specific user requirements for both soft and hard tissue applications In soft tissue mode the WaterLase iPlus is pro grammed to perform tissue removal incision ex cision ablation and coagulation using direct laser energy either with or without water for cooling and hydration In addition with the WaterLase iPlus laser system there is the option to include the iLase diode la ser a hand held self contained surgical device designed for a wide variety of dental soft tissue procedures Detailed information on the iLase can be found in the iLase User Manual Biolase P N 5400230 WaterLase iPlus is indicated for professional use on adult and pediatric patients Procedures must be performed only by licensed dental and medical practitioners in a dental or medical facility Use of this device requires proper clinical and technical expertise and this Manual provides instructions for use for
16. the WaterLase iPlus laser including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP d 1 2 P 80 MHz to 800 MHz d 2 3VP 800MHz to 2 5GHZ Where P is the maxi mum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from 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 pol NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 5200158 Rev F 69 Electromagnetic Compatibility continued GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The WaterLase iPlus is intended for use in the electromagnetic environment specified below The customer or the user of the WaterLase iPlus should assure that it is used in such an environment Immunity test IEG 60601 Continuous level Electromagnetic environment guidance test level A Field strengths from fixed transmitters such as base stations for radio cellular cordless telephone and land mobile radios amateur radio AM and FM radio br
17. the cover off and dry out both the Fiber shaft and the protective cover failure to do so may result in damage to the Fiber shaft INSTALLING AND CHANGING THE TIP IN THE HANDPIECE inar am pi This procedure applies to the Gold and Turbo Handpieces 1 Place the system in the Standby mode PLASTIC FERRULE 2 Proceed to Advanced screen Fig 5 11 and press the Tip change button at the bottom of the screen NOTE Always change Tips after pressing the Tip change button to turn on patient air and cooling air This helps clean the input end of the Tip from any light dirt or moisture 3 Remove the Tip plug from the Handpiece head by pulling it out and place it in the Handpiece box 4 Remove the Tip from its package and insert it into the Tip Remover or revolving Tip holder 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 5200158 Rev F Set Up Instructions continued WARNING Never touch the input proximal end of the Tip If the input surface is contaminated it may damage the Tip Handpiece and Fiber Delivery System Hold the Tip only by the plastic ferrule and the output distal end 5 Align the Tip orifice in the Handpiece head over the input proximal end of the Tip in the Tip Remover or revolving Tip holder 6 Carefully lower the Handpiece and insert a clean inspected Tip all the way in
18. those professionals who have completed the appropriate training When used and maintained properly the WaterLase iPlus proves a valuable addition to your practice Please contact Biolase Customer Service at 1 800 321 6717 in the U S for any service needs if you are located outside the U S please contact your Biolase authorized representative 5200158 Rev F 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 or adjustments or performance of procedures other than those specified in this User Manual may result in hazardous radiation exposure DANGER Invisible and or visible laser radiation when the laser is fired Avoid eye or skin exposure to direct or scattered radiation Class IV CAUTION This laser system has been designed and tested to meet or exceed the requirements of severe electromagnetic electrostatic and radio frequency interference testing However the possibility of electromagnetic or other interference may still exist DANGER Do not use this laser system in any manner other than described in this User Manual Do not use the laser system if you suspect it is functioning improperly 8 5200158 Rev F Safety with the WaterLase continued SAFETY INSTRUCTIONS Follow these safety instructions before a
19. to wipe down the front of the laser and the Handpiece holder after each procedure Do not use bleach or abrasive cleaners CAUTION DO NOT allow water to enter the laser unit especially where the Fiber and Handpiece connect any water entering the portals of the exhaust ring may damage the Fiber optics inside the Handpiece Single use Tips must be discarded after one use in a medical waste Sharps container MIRROR CHECK AND CLEANING NOTE If the performance of the delivery system is questionable but the Tip is in good condition check the mirror for damage or contamination WARNING Use of a contaminated or damaged mirror will cause damage of the Fiber Delivery System Set the system in Standby mode navigate to the illumination screen Fig 5 10 and remove the Tip 5200158 Rev F Maintenance and Troubleshooting continued MIRROR INSPECTION AND CLEANING Point the Handpiece towards a white surface The visible spot of the aiming beam should be clear uniform and well confined If dark areas and irregularities are present inspect the mirror Applies to both Turbo and Gold Handpieces NOTE If the plastic Tip ferrule is continuously getting damaged at the input end the mirror should be checked and cleaned and mirror alignment should be checked REMOVING THE HANDPIECE MIRROR 1 Insert the 3 pin side of the tool into the 3 holes of the cap in the Handpiece head Make sure you see all the pins fit snug
20. ATION INSTRUCTIONS The WaterLase iPlus laser system must be installed by a qualified Biolase employee or representative who will unpack and install the laser Please leave all crates and shipping containers unopened until your trained representative arrives Complete installation testing and demonstration require approximately one full day Please refer to Section 4 Setup Instructions for further details Please contact your representative before transporting the laser system to a different location Misalignment of optical components may occur during transportation if the laser is not properly packaged FACILITY REQUIREMENTS ELECTRICAL SUPPLY 100 VAC 15 0 Amps to 230 VAC 8 0 Amps 50 60 Hz NOTE The main power supply of the iPlus laser system has an isolation transformer that complies with a Transient Voltage of 4kV 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 the air source ENVIRONMENTAL REQUIREMENTS TEMPERATURE 15 30 C HUMIDITY 20 80 non condensing AIR SUPPLY Connections for an air supply must be available in each operatory Attach an air hose with 1 4 inside diameter male quick connectors on each end between the air inlet connector and the operatory air source CAUTION Prior to connection verify that the outlet is for A the air NOT the water supply Connection
21. Bone Soft Tissue 3 6 9 14 No Limi Enamel Bone Dentin Soft Tissue 800 3 6 9 1 00 No Limit Enamel Bone Dentin Soft Tissue 1000 3 6 9 1 00 No Limit Enamel Eons Dentin Soft Tissue SAPPHIRE TIPS Gold Hand pieces Lengths um Calibration Maximum Tissue Types Factor Power W Tissue 4 6 9 1 00 No Limit Enamel Bone Dentin j Soft Tissue Ferrule Color Tip Type Diameter um 750 1 00 No Limit Enamel Bone Dentin Soft Tissue 300 x 1200 1 00 No Limit Enamel Bone Dentin Soft Tissue 4 6 9 1 00 No Limit Enamel Bone Dentin Soft Tissue Tissue 5200158 Rev F 63 Tips Continued EI RER SE NEIN RH CIS to Pn ln Gs uB IMPUT Da S an E Cr i 4 L B d OB d i D DI o 2 e CALCULATING EMITTED POWER WITH TIP ATTACHMENT EXAMPLE 1 EXAMPLE 2 Tip Type MZ5 Tip Type RFT2 Calibration Factor 0 95 Calibration Factor 0 55 Display Power 4W Display Power 1W Then the Power Emitted is 4W x 0 95 3 80W Then the Power Emitted is 1W x 0 55 0 55 W 64 5200158 Rev F Tip Inspection TIP INSPECTION INSTRUCTIONS 1 Remove the Tip from the Handpiece and insert it into the correct side of the Tip test holder as shown using Tip remover with Tip inside the Tip remover 2 Insert the Tip test holder into the test adapter with the distal or laser emitting end of the Tip toward the microscope l
22. CTION Location Inside unit left ELECTRICAL SHOCK RATINGS Type BF Applied Part Location Next to E1 ground terminal inside unit REMOTE INTERLOCK LABEL Input for Remote Interlock Connector which when applied to the access door of the operatory and activated wll shut off the laser Location Back Panel ETL LISTED UL CSA CONFORMANCE LABEL Location Back Panel FOOTSWITCH LABEL Connection to footswitch Location Back Panel 5200158 Rev F ELECTRICAL RATINGS 100 230 V 50 60 HZ 15A 8A 5200193 REV C ETL LISTED CONFORMS TO UL STD 20014 NI CERERI D n 3 gt FOOTSWITCH Euri REV 57 Labels Continued EMERGENCY STOP The button used in emergencies to stop laser output Location Front Cover PROTECTIVE EARTH GROUND Location Next to E1 ground terminal inside unit ATTENTION SMALL GENERAL WARNING Location Back Panel AIR LABEL 827 kPa MAX 120 psi Waterlase Indicates minimum and maximum air pressure Location Wall amp Back Panel 420 kPa MIN 50007 34 60 psi REV E KEY SWITCH LABEL Turns laser on and off when key inserted Location Back panel WEEE WASTE ELECTRICAL AND ELECTRONIC Do not throw in trashbin Dispose of as regulated Location Back Panel POTENTIAL EQUALIZATION TERMINAL PEQ Potential equilization conductor used to connect the GND terminal of the operatory Location Lower back panel
23. Doing so may damage the WaterLase iPlus Tip and delivery system TRAINING Only licensed professionals who have reviewed and understood this User Manual and have been trained on how to correctly operate the system should use this device Surgical procedures related to soft tissue osseous endodontic or periodontal surgery should only be performed by clinicians who have training and experience in Oral Maxillofacial Periodontal or Endodontic Surgery 5200158 Rev F 39 40 Clinical Applications INTRODUCTION The WaterLase iPlus device is designed to cut and remove hard and soft tissues within the oral cavity For hard tissue applications the WaterLase iPlus achieves its uniquely diverse capabilities through the process of light absorption by water The proprietary flexible Fiber optic system and Handpiece deliver 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 iPlus device WaterLase iPlus operates unlike traditional dental instruments or devices and technique must be practiced and perfected to ensure efficient operation Please be aware that the WaterLase iPlus system removes hard tissues with the Fiber Tip applied in a non contact mode 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
24. Infectioh ecce rper ere Eb EXE eddie ut REFER XB E Qe ORTA TREE E ENANAR Eai ee 35 8 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS eee 36 R cT afe forze ER egeg 36 Warni ngs and Precautions gerere redet see perenne errr arene eee teft und oe ere ee rr cree er 36 Prescription State me mt u uuu y uu KE a Eaa NA a an aaa ERRRRE REA RR deed dita 36 ENEE deeg ICI asa cin cs ant pan TT 36 PINS SUN SNS gy Sun E siren nn ot DT UTE 36 Treatment Technique and Settings eee eee ee eee ee eee eee eee 36 Hard NET e 36 Soft Tissue Procedures Lu uuu uuu tiii cr rb FERRE RI Ene sees o ER RPERKRRR EEES ss ond nagar EERRERR RE SE Duke raa 37 4 5200158 Rev F Contents Continued Curettage Procedures uuu u rer beoe nen teh sien Pe RR x aate cad NETANE Ea ea lene Eea ed 37 Fluid Entrapment and Air Embolism sss sees ee eee eee a a 37 Root Canal Procedures iioii tet tinet ca erkunden cbe t lli es e eventos 37 Root Canal Disinfecti n PEOCOGUres u IIIa Us dx e R ERR eaters 37 Le Eeler H 37 Clinical e ele de EE 38 Tissue Evaluatio m 38 Tissue Contact and Tip Breakage eee eee 38 TIP CHANGING TT 38 Water Splashing EE 38 Plume Removal uu u eonan u uuu AERE ESENE EE E AEE EEE so nage bes EEEE ee 38 RENE EE 39 belle Te TTT 39 9 CLINICAL APPLICATIONS ccssar ee 40 MEME CUCU OI DE 40 Hard Tissue Cutting EE 40 Soft Tissue Incision Exci
25. 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 5200158 Rev F Javaliezidelats jot Use ermine LASER PERIODONTAL PROCEDURES continue Osseous crown lengthening e WaterLase Er Cr YSGG assisted new attachment procedure cementum mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium 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 a flap and expose the bone Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth hard and soft tissue impactions Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscesses Laser soft tissue curettage of the post extraction tooth sockets and the periapical area during apical surgery 5200158 Rev F Leukoplakia Operculectomy Oral papillec
26. R Connects the laser to a compressed dry air outlet at 80 120 psi 5 5 8 2 bar using the tubing provided SELF CONTAINED WATER BOTTLE Located on the rear of the laser this detachable bottle provides the water supply for Handpiece atomiza tion spray Fill the bottle only with distilled purified or sterile water DO NOT use tap water WATER BOTTLE RELEASE A push button release on the top of the self contained water bottle that allows its removal from the console for refilling 5200158 Rev F 13 14 Equipment Description continued FOOTSWITCH SUPPORT BRACKET This bracket on the rear bottom of the unit is designed to hold the closed footswitch clamshell when storing or moving the laser system Wrap the footswitch cable around the wrap plate above the bracket TELESCOPIC FIBER SUPPORT ARM Located at the top of the laser console it supports the delivery system Fiber and extends to bear its weight when the Handpiece is pulled forward extension releases when the Handpiece is let go and the arm is in a vertical position NOTE Proper placement of the Delivery System Cable in the Support Arm and of the Handpiece in the Handpiece holder is important for the convenient and safe handling of the delivery system Fiber Delivery System Telescopic Fiber Support Arm Touch Screen Back H Control Panel ack Handle Self contained Water System Ventilation YSGG Handpiece Fro
27. WaterLase iPlus m ie BIOLASE WaterLase iPlus User Manual Copyright 2015 Biolase Inc All Rights Reserved iPlus software copyright 2015 Biolase Inc Biolase the Biolase logo iLase ezlase and ezTip Waterlase iPlus are either trademarks or registered trademarks of Biolase Inc Other trademarks are property of their registered owners BIOLASE INC www biolase com USA 4 Cromwell Irvine CA 92618 Telephone 888 424 6527 Telephone 949 361 1200 Fax 949 273 6687 Service 800 321 6717 EUROPE EUROPEAN REPRESENTATIVE MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 www mt procons com EUROPEAN DISTRIBUTOR BIOLASE Europe GmbH Paintweg 10 92685 Floss Germany Telephone 499603808252 Fax 499603808250 CS L Contents T SAFETY WITH THE WATEREASE E 8 Safety Iristructions eerie rt e ORE E RR SR Ree DRE eens RES EREX RR ed dS Rake LR ERR RERERRR EE ER RREREERRRRE NESE 9 Safety Classification nn 10 2 EQUIPMENT DESCRIPTION uuu uu uu l uu u u u T aan s su Siapa iaaii 11 Systemi Pants MI ETE 11 General uw sasay srar deh vanes ANAE E AE aa RENO aaa ERRE aaa a AERES 11 Main nit ue E 11 Control Panel su u cates cae deren a Eege dee Pen whe cet bea nics ea SESE ete dp a tee ES SEENE eben eee ee 11 Energy MOnNItOT usu assaaasaaashuohuyyaaai uypauyawasqaqakan
28. abuywkyntaysyuyqusqaqaqhaschuysiyaaypyuuaqaqasqaschywykuwayppayaqua 12 Fiontand Back Ela SS ages aces TT 12 Locking TE 12 Emergency Stop E 12 Wade Mec 12 Footswitch Footswitch Connector mm narketa a nnne nennen nnns 13 Remote Interlock Outlet noir ct ote Rire eter ua eat bres bete eer niae e repe ze ska ieee 13 Power Connection Circuit Breaker erii eene err pe nA edie RAPERE SENE Y ERES 13 Ventilation Channels RTT DIEM 13 Air Inlet 0o del o REM 13 Self Contained Water Boile 13 Water Bottle Release nein tereti easier Deren ead pd ia neben ree diac saeua deua puede 13 Footswitch Support ele 14 Telescopic Fiber Support tu EE 14 WaterLase iPlus Delivery System eee 15 Delivery System Connection on the Unit n 15 3 rR E Le T 16 Installation Instr ctiOns ertt reote tene rh nas rer E ERXX VEER NEES RENE dde be eure Rb Re EE RR ERES 16 Facility Fequirements irpo REENEN ENEE NEES enn a EAE deen EXER U Ne NE eun bebe a en 16 Environmental Requirements n n ns 16 A SE UP INSTRUC MONS u uuu uu u uuu sun DIM EMEN MAD UN M IM DM M DM 17 gp 17 Connecting the Unit to the Operatory s srrirsissiennnsnnnnsuir iiaiai aaa aAa aa EEEREN 17 Filling the internal Cooling Water Reservoir sssssssen eme 17 Filling the Self Contained Water Syst
29. ations within the selected category that have been tested and cleared for use with our WaterLase technology Fig 5 3 There are currently 18 procedures identified within the 7 procedure categories offered in Level 0 See the Flow Chart Fig 5 14 To select a procedure touch the corresponding name or image LEVEL 2 DESCRIPTION When selection is made from the Level 1 menu the system proceeds to a Level 2 See Fig 5 4 Here all laser operating parameters are identified as pre sets for the selected step within the procedure as well as several steps 26 5200158 Rev F Operating Instructions continued recommended for the procedure Each step has its own name and its own recommended settings Changing the Water in the bottle When the system detects that the water level in the self contained bottle is low a blinking button with a low water level symbol will appear next to the Settings button Place the system into Standby mode and follow the steps outlined in Section 4 Filling the Self Contained Water System Bottle To return to Ready mode press the main Function button below the touchscreen NOTE When the bottle is disconnected an Error screen will appear When the bottle is re attached the Error screen will clear automatically when the system checks the bottle status approximately 5 seconds Three setting categories are shown at the bottom of the screen i e Handpiece and Tip Laser and Spray From here
30. bottle once every five years Refer to the expiration date noted on the bottle label SECURING THE FIBER OPTIC ASSEMBLY TO THE UNIT 1 Looking down to the top of the console locate the small hole on the lower left side and install the telescopic Fiber support arm Fig 2 1 NOTE Take the new trunk Fiber from the accessories box and drape it around your neck for convenience 2 Remove the protective silver cap from the proximal end of the Fiber Fig 4 14 4 Remove the protective cover of the Fiber shaft distal end and hold it against any light source look into the proximal end of the Fiber it should glow yellow be flat and clean Replace the cover 5 Remove the black plastic outer cover and the internal red protective cap from the laser head and laser aperture save these for future use do not lose them 6 After removing the red protective cap carefully look inside the laser aperture and check that the surface of the protective window is clean free of water dirt or damage Flg 4 15 If water or dirt is visible try to remove it by blowing dry compressed air in the aperture If this does not help call for Service NOTE If the laser head is not positioned properly within the cover of the laser console it will not be possible to connect the Fiber to the unit call Biolase or your authorized Biolase representative for additional support 5200158 Rev F 19 Set Up Instructions continued 7 A
31. c purposes Voltage fluctuations flicker emissions Class A IEC 61000 3 3 5200158 Rev F 67 Electromagnetic Compatibility continued GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The WaterLase iPlus is intended for use in the electromagnetic environment specified below The customer or the user of the WaterLase iPlus should assure that it is used in such an environment Immunity test IFE oeo Continuous level Electromagnetic environment guidance test level Electrostatic X 6 kV contact 6 kV contact Floors should be wood concrete or discharge ESD ceramic tile If floors are covered with 8kV air 8kV air synthetic material relative humidity should IEC 61000 4 2 be at least 3096 Electrical fast 2 kV for power 2 kV for power Main power quality should be that transient burst supply lines supply lines of a typical commercial or hospital environment IEC61000 4 4 1 kV forinput N A output lines Input output that does not apply because the footswitch cable length is less than 3 meters Surge 1 kV differential 1 kV differential Mains power quality should be that mode mode of a typical commercial or hospital IEC 61000 4 5 environment 2kV common 2kV common mode mode Voltage dips short 596 Ur 29596 lt 5 Ur 29596 Mains power quality should be that interruptions and dip in UT for 0 5 dip in UT for 0 5 of a typical commercial or hospital voltage variations cycle cycle env
32. cording to the EMC information provided in 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 part number 2000204 Footswitch includes shielded coiled footswitch cable footswitch 5 conducting wires Biolase part number 6200150 except those supplied or sold by Biolase as replacement parts for internal or external components may result in increased EMISSIONS or decreased IMMUNIT Y of the model WaterLase iPlus Y WARNING The use of accessories other than those specified GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The WaterLase iPlus is intended for use in the electromagnetic environment specified below The customer or the user of the WaterLase iPlus should assure it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissi The WaterLase iPlus laser uses RF energy only for its ipiam internal function Therefore its RF emissions are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 GE EE The WaterLase iPlus laser is suitable for use in all Class A establishments other than domestic and those directly IEC 61000 3 2 connected to the public low voltage power supply network that supplies buildings used for domesti
33. d 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 manufactur er 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 70 5200158 Rev F WaterLase lt iPlus BIOLASE Inc 4 Cromwell Irvine CA 92618 USA 949 361 1200 888 424 6527 biolase com MT Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 49 6894 581020 mt procons com MADE IN THE USA Copyright 2015 BIOLASE Inc All rights reserved EPIC iLase ezLase ezTip LaserWhite Deep Tissue Handpiece ComfortPulse WaterLase and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE Incorporated in the United States and or other countries All other trademarks are property of their registered owners Subject to change without notice 0482 BIOLASE
34. e 55 APPENDIX B ACCESSORIES ede c u u u u uu 62 Accessories MI Mr 62 b leel 214 dd e 62 Pig bb qa tmc 63 Tip Settings WaterLase iPlus MD Gold Handoieces rra 63 Z G aSS TIPS t 63 Sapphire U e mc 63 Calculating Emmitted Power with Tip Attachment 64 Example EE 64 Exarnple2 una ka errr ee ee 64 APPENDIX D TIP INSPECTION TTT 65 MP lee gel E CHO l E 65 Turbo Wiele EE 66 Fiber MIP IMS PE CUO M ME 66 Tip Cleaning InSUUQGCtI6S u u EEA EEE SENE 66 APPENDIX E ELECTROMAGNETIC COMPATIBILITY 67 NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED 5200158 Rev F TR gene Taer The WaterLase iPlus tissue cutting system is a unique device with diverse hard and soft tissue dental applications It utilizes advanced laser and water atomization technologies to safely and effectively cut shave contour roughen etch and resect oral hard tissue and direct laser energy to perform oral soft tissue removal incision excision ablation and coagulation WaterLase iPlus may also be used for specific endodontic and periodon tal applications When used for hard tissue procedures the YSGG solid state laser provides optical energy to a user controlled distribution of atomized water droplets and hydrated surface layer of hard tissue Water in the spray on the tissue
35. em Bottle nnnneeeneennnenneeeenrrnesrerrntnrsrerrtnnserrrnnrnnrtnerrnee eene 18 Securing the Fiber Optic Assembly to the Unn esse eee eee eee 19 Connecting the YSGG Handpiece to the Fiber Optic Cable 21 Disconnecting the Handplece uuu tree rer ke FERRE an eee dun nD ies KEES EENEG sano aya RAE wena cere 22 5200158 Rev F 3 Contents Continued 5 OPERATINGINSTRUCTIONS UU a Ses EE 24 gei l EAEAN Na 24 eral u Ta M 24 Starting the Water ase Plus 24 Activating the Water aser Plus L ua u naker E E iE e Aaa EEEE Eien 24 Tu urning the WaterLase iPlus e u R lacie ecto eee 25 User Interface General Navigation 25 Applications Men 26 Changing and Saving the Pre Geisen 28 Settings Memory T 29 Functions tor the Setting BULLONS EE 30 CUSTOM SettlngS 9 30 Description of the Funtional B ttons c tette saan EX Y RET Feet steve he ERE SEENEN 31 Other Sree ASt ETE 31 System Flow Chart E 32 LE el Leg le 24 Dimensions WX L X e ME 33 Ieeh 33 Water els U 33 lee 33 7 INDICATIONS FOR TE 34 Hard EE 34 Endodontic Surgery Root Amputation Indications eee 34 Bone Surgical Biel Le E 34 Laser Periodontal ees T 34 Soft Tissue Indications Including Pulpal Tissues a a 35 Root Canal Disi
36. enu or it can be completely independent if selected by the user and stored from the Advanced Menu This Menu also provides access to supplementary functions that allow the user to perform the following activities Access the Custom operational menu Advanced Menu not associated with any clinical procedure Purge and prime the Fiber delivery system Adjust sound Restore factory pre sets Select language Adjust the Aiming beam and Illumination Access the Service Screen When switching to the Settings Memory Menu from the Procedure screen or the Advanced screen the latest settings and name of the procedure step are displayed at the top of the display To save the current settings into one of the Favorites press and hold one of the nine buttons for 2 seconds the name of 5200158 Rev F 29 Operating Instructions continued the procedure and step will appear inside the button in the Advanced screen the name for the button will be given as Custom 1 Custom 2 etc FUNCTIONS FOR THE SETTING BUTTONS ADVANCED switches the system to the Advanced screen DRAIN WATER used only when replacing the Fiber when pressed Purge and Prime buttons appear Purge the Fiber is purged of water Prime the Fiber is primed with water SOUND allows adjustment of sound setting within the range 0 to 15 RESTORE leads to a dialogue screen asking Do you want to restore all factory
37. f the error messages persist please contact Biolase Service or your authorized local Biolase representative FRONT AND BACK HANDLES Use the front and back handles to move and or lift the laser console when necessary Y CAUTION Prior to lifting make sure the handles are not damaged DO NOT use the Fiber to pull the unit this could damage the Fiber optic and render the laser inoperable LOCKING WHEELS Allow easy transport of the laser from operatory to operatory Press down on the front tabs on the wheels to lock the console Lift up the tabs to release the locking mechanism EMERGENCY STOP The red button located on the front panel of the laser console instantly turns off the laser when pressed Safety Features 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 The system will be in Standby mode when turned back on even if it was in Ready mode at the time the Emergency Stop was activated Push the Ready button before using the system KEY SWITCH Used to switch the laser system ON by turning the key to the horizontal position always use only the key provided The key cannot be removed while it is in the ON position Always remove the key when the laser is left unattended 5200158 Rev F Equipment Description continued FOOTSWITCH FOOTSWITCH CONNECTOR Activates the laser the WaterLase iPlus laser will n
38. g the Tip in the Handpiece ACTIVATING THE WATERLASE IPLUS Push the Ready button to enable the WaterLase iPlus and depress the footswitch when Ready 5200158 Rev F Operating Instructions continued NOTE It s possible to evaluate the effect of each parameter setting prior to a procedure by directing the Handpiece into a sink or paper cup and adjusting the values as desired NOTE To help prevent inadvertent laser activation there is a 0 5 second delay between the time the footswitch is depressed and the laser actually emits energy TURNING THE WATERLASE IPLUS OFF Disconnect the Tip if required Install the Tip plug into the Handpiece head Press and hold the function control button for 2 seconds to turn the system OFF Turn the key counterclockwise to the OFF position Turn the circuit breaker to the OFF position USER INTERFACE GENERAL NAVIGATION INTRODUCTION The Graphical User Interface GUI is the main part of the system control It communicates with the user through the interactive touch screen display and is designed to provide easy and intuitive interaction with the laser system while performing clinical procedures The system automatically selects the recommended pre programmed settings corresponding to a selected clinical application It minimizes any potential error in setting laser parameters and creates a more satisfactory experience for both the user and the patient CONTROLS AND INDICATORS
39. ged Fig 11 10 WHEN ILLUMINATION SCREEN IS DISPLAYED WARNING Use of a dirty or contaminated Protective Window will cause damage of the Fiber Delivery System 1 Disconnect the Handpiece following the proper procedure described in Section 4 Set Up Instructions 2 Verify the laser is in Standby mode 3 Check the polished reflective surface of the window at the distal end of the Fiber Shaft Fig 11 10 11 12 4 If the surface is contaminated clean the window with a cotton swab dipped in isopropyl alcohol if the window is damaged a crater is visible in the middle of the window replace it as follows Using a small pin push the tab of the window holder Fig 11 13 Pull out the window holder from the metal bearing Fig 11 14 Immediately insert the new window holder by aligning the tab to the rectangular hole the tab should snap into the hole Fig 11 15 5 Wear protective eyewear and navigate to the illumination screen Fig 5 10 6 The visible aiming beam and illumination Fibers should be lit adjust brightness if necessary if the aiming beam is not visible replace the Fig 11 14 Fiber Delivery System Rectangular opening DANGER Invisible and or visible laser radiation when the laser is LI firing avoid eye or skin exposure to direct or scattered radiation pona Protective Window with tab aligned to rectangular opening Fig 11 15 5200158 Rev F 49 50 Maintena
40. hat heck ai Ai ight be I Air pressure failure Air pressure failure Cheecall J E ee compressor or disconnected Check connector 26 PoR pai Foai yich Connect Foot Switch footswitch short not detected not connected during Standby Foot Switch pressed Release the Foot Check connector in Standby Mode Switch Switch to Ready mode System Temperature Allow system to cool Let system run in Ready is high down mode for 5 10 minutes P ly re t Fiber not detected Fiber not detected Check Fiber ae Sien the Trunk Fiber No water in bottle Add water to bottle Add water to bottle 5200158 Rev F 51 Maintenance and Troubleshooting continued TROUBLESHOOTING THE DELIVERY SYSTEM USING THE FLOWCHART Find the Symptom left Inspect the Areas to Check middle Perform the recommended Repair Action right Use the Repair Actions to direct you to the appropriate corrections in this reference guide Repair Actions Slow cutting Evaluate Tip Weak or no Clean Tip popping sound Replace Tip Weak or no red beam Tip Flashing Evaluate Tip Clean Tip Replace Tip Slow cutting Weak or no popping sound Evaluate mirror Clean mirror Replace mirror Weak or no red beam Smell burnt plastic Evaluate window Clean window Replace trunk Fiber Evaluate input end 5 Trunk Fiber Input End v 6 Laser Apert
41. he Handpiece STEP 1 CLEANING PROCESS The cleaning process is intended to remove blood protein and other potential contaminants and 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 to perform the procedure and handle the laser Handpiece and Tips while wearing goggles masks gloves and shields 1 Upon completion of the clinical procedure detach the Handpiece from the Fiber ensure that the laser Tip remains installed in the Handpiece Do not remove the Tip 2 Insertthe 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 the Handpiece with the Tip still installed under lukewarm water 22 43 C for 10 seconds to remove gross soil 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 a 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 it wrapped for a minimum of
42. ironment If the user of the WaterLase on power supply iPlus requires continued operation input lines 40 Ur 60 40 Ur 60 during power mains interruptions it is dip in UT for 5 dip in UT for 5 recommended that the WaterLase iPlus IEC 61000 4 11 cycles cycles be powered from an uninterrupted power supply 70 Ur 30 70 Ur 30 dip in Ur for 25 dip in Ur for 25 cycles cycles 596 Ur 29596 596 Ur 29596 dip in Ur for 5 dip in Ur for 5 seconds seconds Power frequency 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 Uris the A C mains voltage prior to applications of the test level 68 5200158 Rev F Electromagnetic Compatibility continued GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The WaterLase iPlus is intended for use in the electromagnetic environment specified below The customer or the user of the WaterLase iPlus should assure that it is used in such an environment Immunity test Conducted RF IEC 61000 4 6 Radiated RF IEC61000 4 3 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies IEC 60601 test level 3 Vrms 150 kHz to 80 GHz 3V m 80 MHz to 2 5 GHz Continuous level 3V 3Vm Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of
43. lign the blue guide of the Fiber connector proximal end to the blue dot on the laser head interface Position the middle of the connector to the laser aperture and vertically push down gently as far as the connector will go Fig 4 17 WARNING DO NOT APPLY FORCE Applying force may create metal shavings or shave off the o rings of the spray connector and cause damage of the laser head components 9 Secure the retainer ring by turning it clockwise until it is snug Fig 4 19 10 Align the middle length of the Fiber to the hook of the telescopic arm and push it in gently to secure it 11 Remove the protective cover from the distal end of the Fiber again and verify that it is clean and not damaged see Section 11 Maintenance and Troubleshooting Fig 4 20 12 Carefully place the Fiber with its protective cover or with the Handpiece connected in the Handpiece holder Fig 4 21 20 5200158 Rev F Set Up Instructions continued CONNECTING THE YSGG HANDPIECE TO THE FIBER OPTIC CABLE This procedure applies to the Gold and Turbo Handpieces REAR plug Exhaust Handpiece Handpiece Head Tip plug Fig 4 22 1 Remove the Handpiece from the Handpiece box 2 Remove the rear plug from the Handpiece by pulling place the plug in the Handpiece box to store 3 Remove the Fiber protective cover from the Fiber shaft of the trunk Fiber by pulling place it in the Handpiece box to store 4 Checkthe Fiber
44. ly Turn counter clockwise approximately 3 turns to unscrew the cap Remove the cap in a safe place Fig 11 2 2 Insert the other side of the tool perpendicular to the plane of the backside of the mirror inside the opening Screw the threaded side of the tool into the mirror by turning the tool 2 275 full turns Do not thread all the way into the mirror for easier release of the mirror later Fig 11 3 3 Pull the mirror straight out from the head opening Fig 11 4 Wear gloves or finger Tips Do not handle the mirror with bare hands Grab the mirror with fingers or tweezers and unscrew it from the tool If you touch the mirror surface gently clean it with a cotton swab moistened with alcohol IMPORTANT The mirror is oval symetrical make sure of proper orientation when inserting the mirror into the opening in the Handpiece head Fig 11 5 11 6 NOTE If the mirror has burn marks clean the internal surfaces of the Handpiece head with a long cotton swab moistened with alcohol 9996 pure isopropyl alcohol is required for the use of this product 5200158 Rev F 47 48 Maintenance and Troubleshooting continued CHANGING THE HANDPIECE MIRROR 1 To inspect the mirror remove it following the proper procedure as illustrated above 2 Mirror can be contaminated or damaged Fig 11 7 CONTAMINATED DAMAGED MIRROR MIRROR Fig 11 7 A contaminated mirror can be cleaned with a cotton swab moistened with op
45. mb screws counter clockwise and pull back gently Fig 4 1 WARNING Be careful when opening the door Make sure it opens easily and clears the lid and tubing of the bottle The bracket holding the door is mounted at the bottom hinge Do not apply excessive force Locate the internal water reservoir and verify that the white clip on the blue tube connected to the side of the water reservoir is closed Push the button on the top connector and disconnect the tubing from the lid Fig 4 2 5200158 Rev F 17 Set Up Instructions continued 4 Remove the lid and filter assembly Fig 4 3 4 4 WARNING Be careful when handling the water filter assembly Do not touch the white filter material to prevent contamination and potential damage 5 Use the funnel supplied to fill the bottle with distilled purified or sterile water up to full Fig 4 5 6 Replace the filter assembly and close the lid tight 7 Plug in the water connector firmly until it clicks in place 8 Power up the system Switch the Power Circuit Breaker on the back panel to the ON position Fig 4 6 Turn the Keyswitch to the ON position Fig 4 7 When the keyswitch is turned ON the system will begin its boot up process The system will load the software approximately 30 seconds 9 Press the Ready key Fig 4 8 If the Water level low error message appears turn the system off and refill the cooling water container 74 full
46. mode on the left side of the screen changes to an unlocked lock symbol indicating that the system pre set parameters have been modified but not saved To save modifications to any settings press and hold the specific procedure mode for 2 seconds The unlocked lock symbol will change to a locked lock symbol indicating that the settings have been saved Otherwise the 28 5200158 Rev F Operating Instructions continued modifications will be lost when proceeding to a different screen To restore the factory pre programmed settings for the customized procedure mode indicated by a locked lock symbol press and hold the corresponding name of the step for 2 seconds The star symbol will re appear in place of the locked lock symbol confirming that the settings have been changed back to factory pre set values Factory recommended settings and modified settings can be saved as one of the Favorites if desired The entire original factory pre sets can be restored as well when the Settings Menu RESTORE ALL icon is selected No parameters can be changed while the system is in Firing mode De fault settings for Illumination both Aiming Beam and Light are in the middle of the adjustment range The same is true for the Sound Tone SETTINGS MEMORY MENU The Settings Memory Menu stores up to 9 Favorites Fig 5 9 It can correspond to a particular step of the procedure described in the Main Application M
47. n using any air and water emitting cutting device including the high speed drill ROOT CANAL PROCEDURES The WaterLase IPlus is better suited for straight and slightly curved canals Great care should be taken during instrumentation of curved canals as the endodontic Fiber Tip may break or perforate through the wall of these types of canals If during insertion the Fiber Tip does not advance easily into the canal do not force the Tip inside If necessary pull the Fiber out and use an endodontic hand file or a broach to open the path Do not force the Tip and or activate the laser while moving the Tip inside a narrow or curved canal or through the apex Place the end of the Tip 2mm from the apex or 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 ROOT CANAL DISINFECTION PROCEDURES The same precautions and warnings stated above are applicable to root canal disinfection procedures The Fiber Tips designed for this indication are the radial emitting RFT2 and RFT3 which have a 200um and a 300um diameter respectively and come in various lengths to accommodate different root canal lengths Effective laser root canal disinfection is performed with air and no water spray Do not exceed the maximum air setting for this procedure 10 5200158 Rev F 37 38 Contraindications Warnings and Precautions continued
48. nce and Troubleshooting continued ANNUAL MAINTENANCE The WaterLase iPlus should be serviced annually by a qualified trained Biolase certified technician As part of the annual maintenance the following will take place The system flash lamp will be inspected 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 Please contact your local representative to discuss extended service contracts and annual maintenance options DELIVERY SYSTEM The Fiber and Handpiece represent a sophisticated technology of 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 prior to shipment as well as when a trained engineer services the unit Depending on usage some of these components may require periodic servicing and or replacement between annual maintenances The unit will usually deliver lower power than normal if this is the case Please contact your service representative for assistance
49. nd during treatments d 2 Remove or cover all highly reflective items in the treatment area if possible Do not operate in the presence of explosive or flammable materials All persons present in the operatory must wear protective eyewear suitable for blocking 940nm if using the iPlus in conjunction with the iLase and 2 780nm energy multi wavelength glasses supplied by BIOLASE Do not look directly into the beam or at specular reflections Direct the cutting spray toward targeted tissues only CAUTION Periodically inspect eyewear for pitting and cracking For replacement or additional protective eyewear please contact Biolase Customer Service or your authorized local Biolase representative Press the Standby button on the control panel before changing the water in the reservoir and before turning off the laser system Move the circuit breaker to the OFF 0 position located on the rear panel and remove the key before leaving the unit unattended All operatory entrances must be marked with an approved warning sign provided indicating a laser is in use Take special care to contain the laser plume particles produced by the vaporization of virally or bacterially infected tissue during procedures utilizing the laser and minimal or no water spray ensure that all appropriate protective equipment including high speed suction to remove the plume appropriate masks and other protective equipment is used at all times d
50. ns Warnings and Precautions continued SOFT TISSUE PROCEDURES Soft tissue procedures can be performed using two pulse duration settings H short pulse 60 us and S long pulse 700 us However the long pulse S 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 iPlus 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 iPlus as are taken whe
51. nt Back Panel Handle Remote ER Emergency Interlock Outlet E Key Switch Stop Switch Footswitch Cable Wrap Plate Power Cable Power Wrap Plate Connection amp Circuit Breaker Ground Pin Footswitch Footswitch Support Bracket Connector Locking Wheels Air Inlet front only ce Connector Fig 2 1 Fig 2 2 5200158 Rev F Equipment Description continued WATERLASE IPLUS DELIVERY SYSTEM See Section 4 for detailed description and instructions DELIVERY SYSTEM CONNECTION ON THE UNIT The delivery system attaches to the top of the console via a multi connector that incorporates air water cooling air illumination waveguides and the optical energy Fiber optic HANDPIECE HOLDER Cradles the YSGG Handpiece when it is not in use FIBER OPTIC CABLE A component of the delivery system contains the optical Fiber together with the illumination waveguides air tubing and water tubing Delivers laser radiation from the laser unit to the Handpiece HANDPIECE The YSGG Handpiece is rotatable and detachable from the optical shaft It delivers optical energy illumination and atomized water spray to the treatment area Fiber Delivery System Back Handle Water Bottle Cover Water Bottle Release Push Button ILASE Diode Laser and Spare Battary Charging Port Touch Screen Control panel YSGG Handpiece Front Handle Fig 2 3 5200158 Rev F 15 16 Installation INSTALL
52. oadcast 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 iPlus laser is used exceeds the applicable RF compliance level above the WaterLase iPlus laser should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the WaterLase iPlus laser B Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICA TIONS EQUIPMENT AND THE EPIC DIODE LASER The WaterLase iPlus is intended for use in an electromagnetic environment in which radiated RF distur bances are controlled The customer or the user of the WaterLase iPlus can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equip ment transmitters and the WaterLase iPlus as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter M Rated maximum output 150kHz to 80Mhz 80 MHz to 800 MHz ad S power of transmitter W Z d 1 2VP d 1 2VP d 2 3 P 700 For transmitters rated at a maximum output power not listed above the recommende
53. of the display Fig 5 6 Tips Tip selection will always correspond to the selected Handpiece The names of the respective Tips are shown below each image for reference When Tip Selection is active the recommended Tip is highlighted preferred Tips for the Handpiece are outlined and all the Tips allowed for the specific application are shown on the screen Fig 5 6 Fig 5 7 Press the image of the Tip which may or may not be the recommended Tip Both Cooling Air and Patient spray Air will turn ON Replace the Tip To return to the Procedure screen once the Tip is installed press either the back or Handpiece button located at the bottom of the display Laser Power Laser power settings as well as pulse repetition rate and laser pulse mode are always defined by the procedure type and the selected Tip Fig 5 7 The Pulse Mode button switches the system between S long pulse and H short pulse modes Laser parameters can be changed at any time in Ready or Standby modes After adjusting these settings press the back or Laser button at the bottom of the display to return to the Procedure screen Spray Spray settings for air and water percent can also be adjusted while in Ready or Standby Fig 5 8 Mode selection scrolls between ON OFF and AUTO for both parameters CHANGING AND SAVING THE PRE SETS When system parameters are changed from the factory pre sets the star symbol visible in the highlighted procedure
54. opyl alcohol drops 3 Push Tip into cotton swab 4 Twirl cotton swab while maintaining pressure on Tip TURBO TIP INSPECTION 1 Before using the Tip inspect Tip surfaces for any damage or debris using loupes or a magnifier Clean or replace as required 2 Prior to insertion of the Tip inspect the O rings for any damage or debris Replace damaged O rings if you suspect that part of the O ring still remains inside the Handpiece blow dry clean air through the Handpiece FIBER 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 damaged or contaminated Tip may cause damage to the Delivery System and will compromise clinical performance of the WaterLase iPlus Tips can be inspected using magnifying lenses a microscope laser aiming beam or the Biolase Tip Inspection Kit 1 Check that both ends of the Tip appear flat and present a mirror like reflection of any light source Look for chips or nicks along the edges Fig D 1 2 Check the plastic ferrule to ensure it is clean and has no burn marks at the input end Fig D 2 If burn marks are present check the Handpiece alignment see Section 11 66 5200158 Rev F Electromagnetic Compatibility CAUTION Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility EMC and needs to be installed and put into service ac
55. or other instruments For soft tissue applications cutting is achieved in both a contact or non contact mode by application of direct laser energy either with or without water cooling and hydration spray A detailed description of the techniques for cutting hard and soft tissues with WaterLase iPlus is presented in the following subsections Please study this Section carefully practice on tissue models and attend a WaterLase iPlus training seminar before using this device in a clinical situation HARD TISSUE CUTTING Hard tissue cutting is achieved through a unique process that utilizes laser energized water and results in quick and clean hard tissue removal Once settings have been selected for enamel dentin or cementum cutting carefully position the Fiberoptic Tip approximately 5 mm away from the targeted tissue site to test the laser system Step on the footswitch and water spray and power will be immediately delivered to the tissue site You will notice a distinct gentle popping noise as water expands from laser energy absorption From this position 5 mm away from targeted tissue or slightly more if using the Turbo Handpiece there will be minimal to no cutting effect If the water spray is not flowing or no distinct popping noise is present stop the system immediately Refer to the troubleshooting section of this Manual for instructions or call your local representative for assistance NOTE Always remember that laser powe
56. ory dispose of in a biohazard medical Fig 10 2 waste Sharps container If the Tip is reusable rinse it with distilled purified or sterile water for 10 seconds and then dry with a lint free cloth 13 Visually inspect the Tip for any residual soil If any is present repeat step 12 until all residual soil is removed STEP 2 HANDPIECE STERILIZATION PROCESS The Steam sterilization process is intended to destroy infectious microorganisms and pathogens The Handpiece can be sterilized with no loss of functionality up to 100 autoclave cycles NOTE Always perform the procedure immediately after cleaning and prior to use only use FDA cleared USA or CE marked Europe sterilization accessories i e sterilization pouch and autoclave tray 1 Prior to sterilization remove the Rear and Tip plugs if installed 2 Place the Handpiece inside a single wrap self sealed pouch 44 5200158 Rev F Cleaning and Sterilization continue 3 The Tips may be autoclaved in the Tip holder Place the individual Tips or the Tip holder loaded with Tips into a separate single wrap self sealed pouch 4 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 Place the tray into the autoclave chamber and set the autoclave to the appropriate cycle as recommended below Type of sterilizer Temperature Minimum Time Drying Time Gravity displacement
57. ot activate until the user presses down on the footswitch Connect and secure the footswitch to the footswitch connector located on the back panel of the console Safety Features 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 that enables the laser to be connected to the remote sensor Customers may request that the remote interlock be connected to a door switch Safety Features Turns the laser OFF when a user provided remote switch e g on the entrance door is triggered protecting anyone entering the operatory while the laser is in use from inadvertent exposure to laser radiation To use it properly requires a normally closed pair of contacts to be connected to pins 1 and 5 of the connector These contacts should have no voltage associated with them and should open on activation POWER CONNECTION CIRCUIT BREAKER Located on the back panel allows the power cord to be attached to the laser console The circuit breaker serves as a line switch to separate the unit from the main power supply 0 OFF 1 ON The power cable can be wrapped over the holding plate above the connector when the system is not in use or when it is being transported VENTILATION CHANNELS These provide an air flow path to cool the system do not cover or block AIR INLET CONNECTO
58. pre sets Offers options for YES and Exit f YES is selected all factory pre sets are restored LANGUAGE gives an option of selecting one of mulTiple languages ILLUMINATION allows the adjustments for the visible aiming beam and light illumination for the Handpiece within a range O to 9 SERVICE leads to the Service Menu CUSTOM SETTINGS Parameters may be adjusted without any limitations and without any relation to any procedure in the Advanced screen Fig 5 11 When selecting the Advanced screen the system proceeds to that screen with all parameters shown and without referencing any particular procedure or limiting any range of adjustments SYSTEM POWER LIMITS H mode S mode Pulse rate Hz Min power W Max Power W Min power W Max Power W These parameters are for all MX MC Tips and MZ10 MZ8 MZ6 and MS75 Tips 30 5200158 Rev F Operating Instructions continued SYSTEM POWER LIMITS H mode S mode Pulse rate Hz Min power W Max Power W Min power W Max Power W DESCRIPTION OF FUNCTIONAL BUTTONS Change Handpiece selection will automatically purge the water from the Handpiece with a progress timer displayed 3 4 second See Handpiece section above Change Tip selection turns both Internal Cooling air and Patient air ON Press again and the system returns to the Advanced screen Settings leads to the Settings screen OTHER SCREENS Help
59. r and therefore energy is delivered from the very end of the Tip Laser tissue cutting tech nique can be characterized as end cutting whereas the mechani cal drill is known as a side cutting instrument If the water flow and laser energy popping sound are satisfactory gently and slowly move the Handpiece Tip closer to the targeted tissue site A large accumulation of water may be noticeable when approaching the treatment area Use high speed suction as needed to keep the field clear Due to the 5200158 Rev F Clinical Applications continued great differences between traditional dental drill and WaterLase iPlus 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 5 mm for Turbo Handpiece while moving the Handpiece over the tissue surface as required Keep in mind that cutting speed is determined primarily by parameter settings and distance from tissue not by rapid hand movement as with the high speed drill Gently and slowly move the Handpiece in a circular brushing or in and out motion as required to remove the desired tissues or materials Unlike traditional dental instruments the WaterLase iPlus will remove tissue more effectively the slower the Handpiece Tip is moved over the treatment site Cutting efficiency will vary depending upon the power
60. s for Power Water Air Pulse Repetition Rate and Mode S H in order to compensate for variations in tissue composition density and or thickness When a particular combination of customized values is especially effective and useful you have the option to store them as a new Preset Section 5 Settings Memory Menu The WaterLase iPlus may be used for the applications listed in Section 7 Indications for Use If you are not sure which preset or settings are best for a chosen procedure please refer to the suggested settings on the device or use your clinical experience to make the appropriate adjustments Attend training courses and experiment on model tissues before using the WaterLase iPlus on patients Refer to the WaterLase Clinical Manual for a list of pre sets programmed into the WaterLase iPlus 5200158 Rev F Cleaning and Sterilization HANDPIECE AND TIP CLEANING AND STERILIZATION CAUTION Handpieces and laser Tips MUST be sterilized prior to initial use and cleaned and sterilized between patients Disposable single use Tips must be disposed of in a biohazard medical waste Sharps container To clean the Fiber wipe with alcohol CAUTION Cleaning must be performed within a maximum of 1 hour after the procedure and prior to sterilization CAUTION Use only the MANUAL CLEANING process described below Other cleaning methods should be avoided since water entering the portals of the exhaust ring may damage the Fiber optics inside t
61. setting Tip diameter and spray configuration If the system is working slowly for the selected application at the selected power level the air and water spray settings can be adjusted Clinical efficiency depends upon power as well as spray Increased experience with the WaterLase iPlus will make it easier 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 completing the treatment release the footswitch and carefully remove the Handpiece from the patient s mouth Do not hit the Handpiece Tip on teeth or other instruments while removing the Handpiece or the Tip may break To remove the Tip use the Tip remover tool Place a new Tip on the Tip plug to avoid contamination and damage to the Handpiece At the end of the treatment the Handpiece and Tip must be autoclaved Section 10 Cleaning and Sterilization except for single use Tips such as ZipTips RFPT RFT and some others which must be disposed of in a biohazard medical waste Sharps container after use Single use Tips should not be reused to prevent cross contamination SOFT TISSUE INCISION EXCISION AND ABLATION Soft tissue procedures are performed with direct laser energy either with or without water spray Water spray settings are generally lower for soft tissue than for hard tissue During soft tissue cutting the air and water spray hydrate and cool the targeted ti
62. sion and Ablation 41 Presets for Soft and Hard Tissue Procedures esse eee eee 42 10 CLEANING AND STERILIZATION 5 5 35 5552224222 9 925 REXuEUR L u u uu usus sassa 43 Handpiece and Tip Cleaning and Sterilization a 43 Step WE Eege e 43 Step 2 Handpiece Sterilization Process a 44 11 MAINTENANCE AND TROUBLESHOOTING Daily Ee 46 Mirror Check and CISa img u u pedadenuaniaveccesadides REENEN yaaa akei a EENE aaa akaa ERE 46 Mirror Inspection and Cleaning eee 47 Removing the Handpiece Mirr9 r u aaa aasssssstaswawasyayasayawaqaaqasyiwusaakayaycwayayanaqaqa avaran 47 Changing the Handpiece Mi o u sa usa uu etre eth aasan aa aa aE aa E aA 48 Mirror Alignment CICK er 48 Fiber CHECK EE 49 Annual Maintenarnce ir u rr ke ret eR XR ndn de tene Ce Re RR EEEXRR XX uS see e CE ER SERRE ERR ER ne dete rore Re ERR ENERO 50 Delivery SV SUC TR u su RT EE 50 Laser CONMSONS p RC 50 MOU DIES MO OU NG UTERE 51 Troubleshooting the Delivery System enne eene nnne nes 52 5200158 Rev F 2 Contents Continued 12 TRANSPORTATION AND STORAGE esse seene 53 licence EEUU 53 irme C 53 TO CALIBRATION eno 54 lere yojnesrear o lU 54 APPENDIX A LABELS 35b ere ee MEIN M mE PME PM MEM ee
63. ssue There are two pulse settings for soft tissue applications 1 a short pulse setting of 60 us and 2 a long 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 described in the GUI instructions Section 5 Operating Instructions Once settings or presets have been selected carefully place the Tip in contact with the tissue to be incised Step on the footswitch and start moving the Tip along the tissue surface by applying light pressure The incision will be noticed immediately after laser activation Bleeding is controlled through reduction of the water setting or changing to S mode For superficial lesions or hemostasis the Tip must be placed out of contact at approximately 1 3 mm off the surface The most effective hemostasis is achieved when the water spray is turned off 5200158 Rev F 41 42 Clinical Applications continued PRESETS FOR SOFT AND HARD TISSUE PROCEDURES As described before WaterLase iPlus has the option of nine user programmable presets stored in the system memory There are about 50 pre set settings to select from or adjust to appropriate values for the procedure Always start treatment at the lowest recommended power setting and increase as necessary using clinical judgment The values pre programmed with the system are suggested values only Use your clinical judgment to adjust individual value
64. t a 3 Slide the adapter over the microscope to move the Tip surface toward the focal point of the microscope The focal point lies in the plane at the end of the clear end tube of the microscope Focal Point 4 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 5 To examine the proximal or trunk Fiber end of the Tip remove the adapter from the microscope and gently fit the other side of the test holder into the clear end tube of the microscope Refocus the Microscope v Good Burnt Broken Contaminated 6 Remove the Tip from the test holder using the Tip l remover If the Tip is contaminated at either end try W cleaning it as shown below If the Tip is damaged w replace it from the Handpiece using the Tip remover Tip oer with Tip inside and dispose of it To replace the batteries for the built in microscope light gently pull apart the upper and lower tubes of the microscope Locate the battery cover marked with OPEN slide the cover in the direction of the arrow remove the old batteries and replace with two size AA 1 5 volt Europe size M batteries 5200158 Rev F 65 Tip Inspection continued TIP CLEANING INSTRUCTIONS 1 Hold Tip with tweezers 2 Moisten cotton swab with 100 isopr
65. tical grade acetone or alcohol as follows Fig 11 8 Place the wet swab over the mirror surface and wait for approximately 5 seconds for the solvent to soften the contaminating material Wipe off the contamination by a quick turn and removal of the swab Repeat several times until all contamination is removed If the mirror has remaining burn marks or scratches it should be replaced While the mirror is removed and if it has contamination or burn marks clean the internal reflector inside the Handpiece head with a long cotton L swab moistened with acetone or alcohol Install the new or cleaned mirror and check for proper alignment Fig 11 5 11 6 Fig 11 10 MIRROR ALIGNMENT CHECK d Point the Handpiece towards a white surface The visible spot of the aiming beam should be clear uniform and well confined Fig 11 9 If the spot is confined on one side and has a satellite type reflection smile on the opposite side the mirror alignment is questionable Fig 11 10 To improve alignment remove the mirror and turn it 180 degrees If this does not help replace the Handpiece If that does not help replace the trunk Fiber 5200158 Rev F Maintenance and Troubleshooting continued FIBER CHECK STANDBY MODE a NOTE Regularly inspect the end of the Fiber Shaft Always inspect and clean the Protective Window at the end of the Fiber Shaft after the input end of the Tip or Handpiece mirror were dama
66. to the water supply may cause damage to the WaterLase iPlus system If the unit is connected to the water supply DO NOT turn the system on contact your service representative CAUTION DO NOT position this equipment so that it is difficult to pull the plug from the power source WARNING To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth 5200158 Rev F Set Up Instructions SETUP CONNECTING THE UNIT TO THE OPERATORY 1 2 3 4 gi FILLING THE INTERNAL COOLING WATER RESERVOIR Your WaterLase iPlus may have been shipped with a full cooling water reservoir In the event you need to fill the reservoir please follow the instructions below T Verify the circuit breaker is in the OFF position Verify the keyswitch is in the OFF position Connect the power cord to the rear of the unit Fig 2 2 Verify a minimum air pressure of 80 psi 5 5 bar is emitted from the air supply Check the air supply for moisture Connect the air supply to the unit s air inlet connector at the rear of the console Fig 2 2 CAUTION Do not connect the operatory air supply to the unit if water or oil is present The air compressor may need to be drained or cleaned and air filters installed if moisture appears Wet air will damage the laser system Check the air supply weekly to verify the absence of water and oil Open the back panel door by turning two thu
67. tomies Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Reduction of gingival hypertrophy Removal of pathological tissues i e cysts neoplasm or abscess and hyperplastic tissues i e granulation tissue from around the apex Soft tissue crown lengthening Treatment of canker sores herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty For use on adult and pediatric patients ROOT CANAL DISINFECTION Laser root canal disinfection after endodontic instrumentation 35 36 Contraindications Warnings and Precautions CONTRAINDICATIONS All clinical procedures performed with the WaterLase iPlus must be subjected to the same clinical judg ment and care as with traditional techniques Patient risk must always be considered and fully under stood 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 e g pacemakers implantable defribulators lung disease bleeding disorders or an immune system defi ciency Medical clearance from the patient s physician is advisable when doubt exists regarding treatment WARNINGS AND PRECAUTIONS PRESCRIPTION STATEMENT Federal Law restricts this de
68. until the shoulder of the Tip ferrule sits against the Handpiece head WARNING Be careful not to hit the input proximal end of the Tip against the Handpiece head and not to break the retaining fingers of the plastic ferrule 7 Slide the Handpiece laterally away from Tip Remover or Tip holder 8 Press the Tip Change button again on the Advanced screen to stop patient air and cooling air NOTE To remove the Tip repeat the process described 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 NOTE If the laser cuts hard and soft tissue slower than expected after installing the Fiber please follow the flowchart in Section 11 Troubleshooting the Delivery System Caution Use the same techniques when operating the MD 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 3 the regular tool does NOT work with Turbo Tips Refer to the Turbo Handpiece Instructions for Use for more information p n 5200147 Fig 4 33 5200158 Rev F 23 24 Operating Instructions OPERATION CAUTION Use of controls or adjustments and performance of procedures other than those specified herein may result in hazardous radiation exposure OVERVIEW Before using the WaterLase iPl
69. ure Clean input end Replace trunk Fiber Evaluate aperture Clean aperture Call service 1 800 321 6717 52 5200158 Rev F Transportation and Storage TRANSPORTATION The WaterLase iPlus ships inside a custom shipping crate Please save and store the crate in a cool dry place for future use The unit must not be transported from facility to facility unless packaged inside the crate The WaterLase iPlus is susceptible to misalignment if not handled properly The unit should ALWAYS be packed inside of its shipping crate when transported from one facility to another While the laser is semi portable and may be rolled from one operatory to another inside the same facility care should be taken when pushing the unit over doorway thresholds and other bumps or objects on the ground Do not roll the unit outside of the office building across a road or over any other rough surface Do not place the unit into a pick up truck van or other means of transportation unless it is completely packaged inside of its shipping crate Once crated the unit should be transported by forklift or pallet jack and should never be laid on its side dropped or banged If you have any questions regarding transportation please call your local representative STORAGE The WaterLase iPlus should be stored in a cool dry place when not in use Storage temperature should be 15 to 30 C 59 F to 86 F relative humidity 20 to 80 Co
70. uring the procedure DANGER DO NOT open system side doors These are to be used by authorized service personnel only Danger from radiation exposure and high voltage may exist NOTE Please direct any safety questions to your local Biolase rep resentative or call Biolase at 888 424 6527 or Biolase Service at 800 321 6717 US only 5200158 Rev F Safety with the WaterLase continued SAFETY CLASSIFICATION The following safety classifications are applicable to this device Laser Radiation Class 4 Aiming Beam Class 1 Type of protection against electrical shock Type BF Applied Part Laser Handpiece Not protected against water ingress Ordinary Equipment Main Unit IPX0 Footswitch IPX8 Not suitable for use in the presence of flammable anesthetic Not suitable for use in oxygen rich environments Operation Mode Non continuous with duty cycle of max 2 minutes ON min 30 seconds OFF at maximum power output A CAUTION High temperatures produced in the normal use of this laser equipment may ignite some materials e g cotton wool when saturated with oxygen solvents of adhesive and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used 10 5200158 Rev F Equipment Description SYSTEM PARTS LIST The iPlus laser systems include the following Power cord 1 US 1 International iPlus laser Display covers qt
71. us be sure the system has been installed properly as described previously in this Manual STARTING THE WATERLASE IPLUS 1 Verify that all connections have been properly secured and the Fiber cable properly attached 2 The air supply must be connected and the external air pressure must be at 80 PSI 5 5 bar or more 3 Electrical input should be at least 100 VAC maximum 15 amperes to 230VAC 8 amperes 4 Verify that the water bottle is more than 1 3 filled with distilled purified 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 to hazardous exposure to laser radiation Radiation is also emitted from the Fiber shaft when the Handpiece is removed DO NOT attempt to operate the WaterLase iPlus with the delivery system or the Handpiece not attached 5 Switch the circuit breaker ON 6 Insert the key into the keyswitch and rotate it clockwise to the ON position 7T Merify the emergency stop button is not engaged the button is not glowing red and no error message is displayed on the screen 8 The system will begin its startup process as the software is loaded about 45 seconds 9 Attach the Handpiece to the Fiber optic cable shaft Section 4 Connecting the YSGG Handpiece to the Fiber Optic Cable 10 Place the system into Standby mode and attach a Tip using the Tip remover Section 4 Installing and Changin
72. ver 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 5200158 Rev F 53 Calibration Calibration requires specialized equipment and is to be performed only by a Biolase trained service engineer who is provided with the proper calibration procedure and necessary circuit diagrams component parts list and descriptions etc CALIBRATION SCHEDULE Power calibration is to be performed annually The Service Engineer will write the date of installation and subsequent power calibration dates in the table provided below INSTALLATION AND CALIBRATION DATES 54 5200158 Rev F abels PRODUCT IDENTIFICATION LABEL Identifies product part number serial number manufacturer manufacturing date Location Back Panel above ventilation channels MANUFACTURER CATALOG PART NUMBER PRODUCT SERIAL NUMBER DATE OF MANUFACTURE REFER TO INSTRUCTION MANUAL Location Back panel TYPE BF APPLIED PART Location Distal end of trunk Fiber one side DUTY CYCLE Location Distal end of trunk Fiber opposite side 5200158 Rev F CREP MT Promedt Consulting GmbH B 0 LAS E wal scroll Altenhofstrasse 80 Irvine CA 92618 D 66386 St Ingbert Germany 949 361 1200 49 6894 581020 biolase com ocons com Waterlase iPlus Dental Laser System REF 7200854 01 Part No HID Serial No XXXXXXX YYYY MM Mfg Dat e Rx
73. vice to sale by or on the order of a dentist or physician or other licensed medical practitioner EYEWEAR Doctor patient assistant and all others inside the operatory must wear appropriate laser protection eyewear for the 2780nm and 940nm wavelengths OD 4 or greater 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 reviewed and understood this User Manual 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 type and duration of operation and make appropriate power air and water adjustments to compensate for varying tissue composition density and thickness HARD TISSUE PROCEDURES All hard tissue 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 5200158 Rev F Contraindicatio
74. y 25 Trunk Fiber and Fiber support Footswitch i M Yellow air tube User Manua Laser Warning sign Protective laser eyewear 3 ZER Handpieces 1 Gold 1 Turbo Tip holder Product registration card Limited warranty iLase Laser Optional Tip cleaning kit Additional accessories including Handpieces and Tips ordered separately GENERAL The WaterLase iPlus dental laser system consists of three modules Main Unit the Unit shown in Figures 2 1 2 2 and 2 3 WaterLase iPlus Fiber Delivery System the Delivery System shown in Figures 2 1 2 2 and 2 3 consists of the Fiber Handpiece and Tips Optional iLase soft tissue diode laser MAIN UNIT ELEMENTS Figures 2 1 2 2 and 2 3 show the front rear and top views of the unit CONTROL PANEL The main unit is controlled through a touch screen control panel See section 5 Operating Instructions for details and instructions Safety Features All control functions accessed through the Control Panel are located at a safe distance from the energy output 5200158 Rev F 11 12 Equipment Description continued ENERGY MONITOR The energy monitor measures and verifies power output Safety Features 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 arrow at the top of the touch screen I

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