Contents 1. OVERVIEW ............................7 2. INDICATIONS FOR USE ........................8 Hard-Tissue ............................8 Endodontic Surgery (Root Amputation) Indications ................8 Bone Surgical Indications ........................8 Laser Periodontal Procedures ......................8 Soft-Tissue Indications Including Pulpal Tissues ................. 9 Root Canal Disinfection ........................9 Crown and Veneer Removal ........................
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Contents Electrical ............................. 14 Air and Water Output .......................... 14 Optical ..............................14 5. EQUIPMENT DESCRIPTION ......................15 System Parts List ..........................15 General............................... 15 Main Laser Console Elements ......................15 Control Panel ..........................15 Energy Monitor ..........................16 Emergency Stop ..........................16 Front and Back Handles ........................
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User Interface Navigation ......................35 Introduction ..........................35 Procedure Menu Navigation ..................... 35 System Menu ..........................40 Changing the Tip or Handpiece ....................45 Biolase Connect ........................47 9. CLINICAL APPLICATION........................48 Overview ............................48 Hard-Tissue Cutting ........................... 48 Soft-Tissue Cutting ..........................49 10.
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Contents Replacing the Protective Window ....................57 Replacing the O-Rings ........................58 Re-Attach the Handpiece ......................58 Annual Maintenance........................... 59 Delivery System ..........................59 Laser Console ..........................59 Calibration Schedule .......................... 60 Installation and Calibration Dates ....................60 Troubleshooting ..........................61 Transportation ............................
When used and maintained properly, the Waterlase iPlus proves a valuable addition to a practice. cut, shave, contour, roughen, etch, and resect oral Please contact BIOLASE Customer Service at hard-tissue. In addition, this direct laser energy 1-800-321-6717 in the U.S for any service needs;...
Indications for Use IMPORTANT: Review all Contraindications, Warnings and Precautions presented in Section 3 before proceeding with using this device on patients. WATERLASE IPLUS IS INDICATED FOR: HARD-TISSUE BONE SURGICAL INDICATIONS • Cutting, shaving, contouring and resection GENERAL INDICATIONS* of oral osseous tissues (bone) •...
Indications for Use LASER PERIODONTAL • Leukoplakia PROCEDURES (CONTINUED) • Operculectomy • Osseous crown lengthening • Oral papillectomies • Waterlase Er,Cr:YSGG assisted new • Pulpotomy attachment procedure (cementum-mediated • Pulp extirpation periodontal ligament new-attachment to • Pulpotomy as an adjunct to root canal the root surface in the absence of long junctional epithelium).
Contraindications, Warnings, and Precautions CONTRAINDICATIONS All clinical procedures performed with the Waterlase iPlus must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient’s medical history prior to treatment.
Contraindications, Warnings, and Precautions 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. Observe clinical effects and use 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.
Contraindications, Warnings, and Precautions 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 Tip may break or perforate through the wall of these types of canals.
Contraindications, Warnings, and Precautions TISSUE CONTACT AND TIP BREAKAGE Do not contact hard-tissues with the 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.
Specifications DIMENSIONS (W X L X H) • Laser Console 11 x 19 x 34 in (28 x 48 x 86cm) • Laser System, Fully Assembled 11 x 19 x 40 in (28 x 48 x 102 cm) • Weight 75 lbs.
Equipment Description SYSTEM PARTS LIST The Waterlase iPlus laser systems include the following*: *Additional accessories, including Handpieces and Tips, ordered separately. • Waterlase iPlus Laser • Tip Cleaning Kit • Fiber Optic Cable and Fiber support • Power cord, (1) US, (1) International •...
"Next" arrow at the top of the touch screen. If the error message persists, please contact BIOLASE Service or the authorized BIOLASE representative for your area.
Equipment Description FOOTSWITCH, FOOTSWITCH CONNECTOR The Footswitch activates the laser; the Waterlase iPlus laser will not 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.
Front Handle Fig 5.3 NOTE: Only official Biolase SD Cards may be used. Any other SD card will cause an "Invalid SD Card" error, which will prevent system operation until the invalid SD card is removed. An SD card may be used during during a service update, for instance.
Equipment Description TELESCOPING FIBER OPTIC CABLE SUPPORT ARM Located at the top of the laser console, it supports the Delivery System (Fiber Optic Cable), and extends to bear its weight when the Handpiece is pulled forward. The support arm locks at incremental angles from vertical to horizontal.
2. Do not operate in the presence of explosive or flammable materials. 3. All persons present in the operatory must wear protective eyewear for the 2780nm wavelength, OD4 (DI LB4) or greater (safety glasses supplied by BIOLASE, Inc.). CAUTION: Periodically inspect eyewear for pitting and cracking. For replacement or additional protective eyewear, please contact BIOLASE Customer Service or the authorized BIOLASE representative.
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 the local BIOLASE representative, or call BIOLASE at (888) 424-6527, or BIOLASE Service at (800) 321-6717 (US only).
Installation INSTALLATION 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 the trained representative arrives. Complete installation, testing, and demonstration require approximately one full day.
Installation SET-UP REQUIREMENTS CONNECTING THE LASER CONSOLE TO THE OPERATORY 1. Verify the circuit breaker is in the OFF position. 2. Verify the keyswitch is in the OFF position. 3. Connect the power cord to the rear of the laser console (Fig 5.2). Fig 7.1 4.
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Installation 5. Fill the bottle with distilled or de-ionized water up to ¾ full (Fig 7.5). DO NOT USE TAP OR FILTERED WATER. 6. Replace the filter assembly and close the lid tightly. 7. Plug in the water connector firmly, until it “clicks” in place. 8.
Installation INSTALLING THE HANDPIECE HOLDER The Handpiece Holder is packaged as a separate item in the system packaging. Attach it to the back of the Display using the screw and hex key Allen wrench provided (Figure 7.9): 1. Hold the Handpiece Holder with the wider portion Fig 7.9 of the cradle facing upwards (Figure 7.9).
NOTE: If the laser head is not aligned properly within the cover of the laser console, it will not be possible to connect the Fiber Optic Cable to the laser console; call BIOLASE, Inc. or the authorized BIOLASE representative for additional support.
Installation 6. Align the blue guide of the Fiber Optic Cable 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 7.18, 7.19).
Installation CONNECTING THE HANDPIECE TO THE FIBER OPTIC CABLE CAUTION: Handpieces are not sterile when sold and MUST be sterilized prior to initial use, and cleaned and sterilized between patients. Refer to Section 10 for complete instructions on cleaning and sterilization. Always hold and move the Handpiece or Protective Cover along the same axis as the Fiber Shaft.
Installation DISCONNECTING THE HANDPIECE 1. If the handpiece and fiber cable were previously primed with water, ALWAYS purge the handpiece before disconnecting it. Make sure you have a handpiece connected and a tip inserted before purging. 2. To disconnect the Handpiece, hold the Fiber Optic Cable by the metal collar and pull on the Handpiece until it comes completely off the fiber shaft.
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Installation NOTE: The Tip must be sterilized before initial use and between pa- tients, if it is a reusable sapphire tip. Remove the Tip from its sterilization pouch and insert it into the Tip Remover or the Revolving Tip Holder by aligning the first groove of the Tip ferrule against the receiving edges of the holder, then sliding the Tip in;...
Operating Instructions OPERATION OVERVIEW CAUTION: Use of controls or adjustments and performance of procedures other than those specified herein may result in hazardous radiation exposure. CAUTION: Post the laser warning sign provided with the Waterlase outside the operatory when the laser is in use. Everyone entering or present in the room must wear appropriate laser eyewear for the 2780 nm wavelength.
Operating Instructions CONTROLS AND INDICATORS The control panel has one Function Control Button, Figure 8.3. When in a procedure settings screen with laser parameters selected, pressing the Function Control Button will switch the system between Standby and Ready modes. The control panel also has two LED indicators on either side of the Function Control Button.
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Operating Instructions If anticipating a pause between scheduled patients: 1. From the Procedure Settings screen, Select Change Handpiece, Figure 8.4. 2. Select Purge (Figure 8.5) and point the Handpiece away from the laser console. 3. Remove the Handpiece, dry the Fiber shaft with a lint free gauze, and place the Protective Cover on the Fiber Cable.
Operating Instructions CHANGING THE WATER IN THE PATIENT WATER BOTTLE When the system detects that the water level in the Patient Water Bottle is low, a yellow warning icon with will appear. Place the system into Standby mode, wait about 10 seconds for the Bottle to de- pressurize, and follow the steps outlined in Section 7: Filling the Patient Water Bottle.
To play a second video, press the Video Mode icon again. NOTE: Performing Skin Resurfacing requires an additional accessory, sold separately. Fractional Handpiece PN 7220002. Do not perform Skin Resurfacing without a Fractional Handpiece and training. Contact your local Biolase representative. Waterlase iPlus User Manual...
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Operating Instructions Video Mode Active Fig 8.8 PROCEDURE SCREEN Once a procedure category is selected, the next screen displays the list of procedures available for that category, Figure 8.9. To select a procedure, press the radial menu segment first, and then press the illustration in the center of the screen, Figure 8.10.
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Operating Instructions The Waterlase iPlus contains detailed animations of each procedure to help illustrate the tip positioning and best practices throughout each protocol. To view the videos, press the Video Mode icon. Then, select the procedure the user would like to view. When active, the Video Mode icon will appear blue.
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Operating Instructions PROCEDURE SETTINGS SCREEN Once a step is selected, the next screen displays the factory preset parameters, Figure 8.13. These parameters are chosen based on testing, published research, or expert clinician experience. Settings can be adjusted by pressing the pull-down menu at the top of the screen, which displays the Custom Settings screen.
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Operating Instructions Icons Power (W) Energy (mJ) Air & Water Modes: Repetition Rate (Hz) Auto: Footswitch Air Setting (%) Control Water Setting (%) On: Always On in WiFi Status Ready Mode Factory Setting Temporary Custom Setting Off: Always Off Saved Custom Setting Laser Pulse Duration: H Mode: 60µs S Mode: 700µs...
Operating Instructions The Waterlase iPlus can store up to 12 favorite procedure or step settings. Saved Favorites (Fig. 8.17) can be accessed by pressing the heart icon on the left side of the Main or Procedure screens. To rename or delete a Favorite, press and hold the chosen favorite for about 2 seconds –...
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Operating Instructions Icons Power (W) Energy (mJ) Air & Water Modes: Repetition Rate (Hz) Auto: Footswitch Air Setting (%) Control Water Setting (%) On: Always On in Ready Mode Tip Change Off: Always Off Handpiece Change Laser Pulse Duration: Save to Favorite H Mode: 60µs S Mode: 700µs Fig 8.19...
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Operating Instructions SETTINGS This category allows the user to personalize the laser system in the following areas: • Initial Setup • Repeat initial setup • Perform Factory Reset • Enable / Disable Mandatory Checklist, Figure 8.21 • User • Add, change, or delete a user •...
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Operating Instructions SYSTEM INFORMATION System Information provides the user with the following data (Figure 8.23): • Laser serial number • Memory • Software Versions • Background Color (The user interface can be displayed in Dark mode or Light mode. Dark mode is default.) •...
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• Stores how-to videos for daily maintenance Fig 8.26 activities, Figure 8.27 • User Manual • Contact Customer Support • If Wi-Fi is enabled, the user can send an automated email requesting support to BIOLASE Fig 8.27 Waterlase iPlus User Manual...
Operating Instructions CAUTION: Connection to IT-networks including other equipment could result in previously unidentified risks to patients, operators or third parties. The responsible organization should identify, analyze, evaluate and control these risks. Changes to the IT-network could introduce new risks that require additional analysis. Changes to the IT-network include: - Changes in network configuration - Connection of additional items...
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Operating Instructions When changing the Handpiece (Figure 8.29): 1. Press the Change Handpiece icon, and then select the next Handpiece on the screen. 2. The system will purge the Handpiece and Fiber. CAUTION: Do not remove the Handpiece before purging is complete. Water on the Fiber Optic Cable will damage it.
ENABLING BIOLASE CONNECT BIOLASE Connect may be enabled during first-time set-up, or at any later time by going to the main Menu and selecting the Wi-Fi option. An active wireless connection is necessary to implement this feature on the Waterlase iPlus.
BIOLASE recommends anyone using Waterlase iPlus to study this section carefully, practice on tissue models, and attend a company-sponsored training seminar before using this laser in a clinical situation.
Clinical Application 10. To remove the Tip from the Handpiece, select the Change Tip icon on the Display, and use the Tip Remover tool. Make sure air is on while replacing the tip to keep the tip and handpiece dry, internally.
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Attend training courses and experiment on model tissues before using the Waterlase iPlus on patients. For more information on clinical procedures, please visit https://www.biolase.com/procedures/dentists/ or https://www.biolase.com/education/waterlase-academy/ Waterlase iPlus...
Cleaning and Sterilization HANDPIECE AND TIP CLEANING AND STERILIZATION STEP 1—HANDPIECE AND TIP CLEANING CAUTION: Handpieces and laser Tips are not sterile when sold and must be sterilized prior to initial use (Step 2); Handpieces, and re-usable Sapphire Tips must be cleaned and sterilized between patients.
Cleaning and Sterilization 6. Unwrap the Handpiece and Tip. Using a soft-bristled brush dipped in the cleaning solution, gently brush around the Tip ferrule, crevices, and other hard-to-clean areas for 15 seconds. The brush should be wet, but not dripping. (Figure 10.4) 7.
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Cleaning and Sterilization STEP 2—HANDPIECE AND REUSEABLE TIP STERILIZATION PROCESS The steam sterilization process is intended to destroy infectious microorganisms and pathogens. NOTE: Always perform the procedure immediately after cleaning and prior to use; only use FDA-cleared or CE-marked (Europe) sterilization accessories, i.e., sterilization pouch and autoclave tray.
Cleaning and Sterilization STEP 3—DISINFECTING THE FIBER OPTIC CABLE Always disinfect the Fiber Cable between patients. Use an appropriate disinfecting solution such as CaviCide or a similar quaternary ammonium compound product (containing 20% alcohol or less) and follow the manufacturer’s instructions. Wipe the full length of the Fiber Cable. Fig.
Maintenance and Troubleshooting DAILY MAINTENANCE Use disinfectant 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 liquid to enter the Laser System, especially where the Fiber Optic Cable connects to the Console and where it connects to the Handpiece.
Maintenance and Troubleshooting IMPORTANT: The mirror is oval symmetrical, 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 Fig. 11.4 of the Handpiece head with a long cotton swab moistened with alcohol.
Maintenance and Troubleshooting 2. 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). 3. To improve alignment, remove the mirror and turn it 180 degrees. If this does not help, replace the Handpiece.
Maintenance and Troubleshooting NOTE: The protective window will continue to rotate after fully installed. There should be minimal to no gap between the end of the Fiber Optic Cable and protective window. The protective window kit is available for re-order (p/n 7240002).
Maintenance and Troubleshooting 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 •...
Maintenance and Troubleshooting CALIBRATION SCHEDULE: 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. Power calibration is to be performed annually. The Service Engineer will write the date of installation and...
Maintenance and Troubleshooting 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 the local service representative for assistance.
Fiber not detected Fiber not detected seated properly and that the metal retaining ring is fully tightened. Add distilled or de-ionized water to Patient Water Patient Water Bottle is empty or Patient Water Bottle is empty or missing Bottle and install it. Contact Customer Service if error missing persists.
Appendix A Labels PRODUCT IDENTIFICATION LABEL Waterlase iPlus All-Tissue Laser Dental Laser System BIOLASE, Inc. 27042 Towne Centre Drive Identifies product part number, serial number, Suite 270 7200854-XX Foothill Ranch, CA 92610-2811 USA manufacturer, manufacturing date. +1 949.361.1200 biolase.com MT Promedt Consulting GmbH Altenhofstrasse 80 D-66386 St.
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Appendix A Labels LASER HAZARD SYMBOL Indicates the system contains a laser. Location: Top cover of laser head, directly above the Fiber Optic Cable connector. (Only visible during service) HIGH VOLTAGE HAZARD SYMBOL Warning - Dangerous voltage (Only visible during service). Locations: •...
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Appendix A Labels LASER WARNING SIGN Included in the Welcome Kit; must be placed outside of the operatory whenever the laser system is in use. VISIBLE AND/OR INVISIBLE LASER RADIATION. AVOID EYE OR SKIN EXPOSURE TO DIRECT AND/OR SCATTERED RADIATION. Approved: ____________________ Date: ____________________ Er, Cr: YSGG, 2.78µm, 10W max...
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Appendix A Labels WEIGHT LABEL LOCATION: BACK PANEL EMERGENCY STOP The button used in emergencies to stop laser output. Location: Front Cover PROTECTIVE EARTH GROUND Location: Next to E1 ground terminal, inside laser console. ATTENTION (SMALL)/GENERAL WARNING Location: Back Panel LB00-40-0002 REV A AIR LABEL 827 kPa MAX.
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Appendix A Labels OUTER PACKAGING THIS END UP HANDLE KEEP DRY WITH CARE 106kPa +60 C 50kPa -20 C NON-CONDENSING ATMOSPHERIC RELATIVE TEMPERATURE HUMIDITY PRESSURE TEMPERATURE HUMIDITY ATMOSPHERIC LIMITATIONS LIMITATIONS PRESSURE LIMITATIONS Waterlase iPlus User Manual...
Appendix C Tips TIP TYPES TIP FERRULE COLORS Tip types following Dental Standard ISO Series Diameter/Color Codes RFT2 LF12 RCT2 RFT3 RFPT5 RFPT8 MZ10 GLASS 1200µm* 600µm* 1000µm* 200µm* 500µm* 800µm* RCT3 320µm* MGG6 SFT8 MC12 SAPPHIRE 300µm x 1200µm* 400µm* 600µm* 600µm*...
Appendix D Tip Inspection TIP INSPECTION INSTRUCTIONS 1. Remove the Tip from the Handpiece and insert it into Tip Remover with Tip inside the correct side of the Tip test holder as shown using 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.
Waterlase iPlus. Tips can be inspected using magnifying lenses, a microscope, laser aiming beam, or the BIOLASE Tip Inspection Kit. Check that both ends of the Tip appear flat and present a mirror-like reflection of any light source.
6200150) WARNING: The use of accessories, other than those specified, except those supplied or sold by BIOLASE as replacement parts for internal or external components, may result in increased EMISSIONS or decreased IMMUNITY of the model Waterlase iPlus. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Waterlase iPlus is intended for use in the electromagnetic environment specified below.
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Appendix E Electromagnetic Compatibility 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. IEC 60601 Immunity Test Continuous Level Electromagnetic Environment - Guidance...
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Appendix E Electromagnetic Compatibility 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. IEC 60601 Immunity Test Continuous Level Electromagnetic Environment - Guidance...
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Appendix E Electromagnetic Compatibility 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. IEC 60601 Immunity Test Continuous Level Electromagnetic Environment - Guidance...
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