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I Lase F Ant


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I Lase F Ant

  1. 1. iLase™ Frequently Asked Questions What is the iLase? The iLase from BIOLASE is the world’s first personal laser for dentists or hygienists* to perform a full range of minimally invasive soft-tissue and hygiene procedures. A single, independent handpiece with no external connections provides intuitive finger-control of up to 5 Watts of peak laser power, and up to 3 Watts of continuous wave laser power. No extra foot pedal, and no extra cords are added to the operatory! The exclusive ComfortPulse™ reduces both patient discomfort and the need for anesthetic. Customizable pre-sets for the most common procedures save time and improve efficiency. It is also ideal for orthodontic and periodontal practices. * Where local law allows. What is a “personal” laser? Isn’t that the same thing as a portable laser? The “personal” laser advances portability to a whole new level. You can carry all the components of a personal laser in one hand – or on a tray, right next to the other dental instruments – and you don’t have to plug it in to a power outlet. Only the iLase lets you do this! Other portable lasers either require you to carry and place a foot pedal, or plug the device in to a power outlet, or carry the component(s) with two hands, or any combination of these. Every clinician in the dental office can have their own, personal iLase handpiece to take with them to use throughout the day. And when leaving the office, up to 4 integrated handpieces can be stored in a single iLase charging station, while the batteries recharge. What procedures can the iLase perform? The iLase can perform the same, comprehensive set of 25 FDA cleared soft-tissue and hygiene procedures as the popular ezlase™. For the most common, everyday soft-tissue and hygiene procedures – such as gingivectomy, troughing for crown preparations, and sulcular debridement – the iLase is the perfect tool for every clinician. How is the iLase different from other dental diode lasers? The iLase is the only “personal” dental laser available: laser, user interface, battery power, and all the controls in a single, integrated handpiece. This provides maximum freedom of movement when operating the laser and also transporting it, and it does not add any extra foot pedals or cords to your operatory. Other distinguishing product features include: ComfortPulse™ and 940 nm wavelength for efficient cutting with less discomfort Page 1 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  2. 2. iLase™ Frequently Asked Questions Bendable tips provide better access to all areas of the mouth for optimal clinician convenience and clinical results Tips available in a variety of diameters and lengths provide greater precision for different procedures and tissue types Maximum of 5 W peak and 3 W continuous wave laser power Intuitive user interface display and navigation 10 factory-loaded presets of the most common procedures, and 2 extra pre-sets, all user- customizable What components make up the iLase system? An iLase system is made up of an integrated handpiece, and a charging station which can charge up to 4 iLase batteries simultaneously. The iLase integrated handpiece has 4 different parts: 1) The Main Body, which includes the user interface display, navigation button, and laser. 2) Rechargeable battery for electric power. 3) Protective cover and finger switch for laser activation 4) Disposable fiber optic ezTip™ (8 different types to choose from) Page 2 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  3. 3. iLase™ Frequently Asked Questions Cover Display Navigation button Fiber Battery optic Finger Switch ezTip™ Main Body The iLase charging station serves two purposes. Firstly, it recharges up to 4 iLase batteries simultaneously. Additionally, it is a convenient location to store the iLase integrated handpieces when not in use. The batteries can be recharged whether or not they are connected to an integrated handpiece. What is the size and weight of an iLase handpiece? The iLase handpiece, with battery and shroud attached, weighs approximately 3.5 oz, or less than 100 g. The length from the end of the battery to the end of the shroud, without a tip attached, is approximately 7.2” (183 mm), and tip length varies between 4 to 14 mm. The diameter of the widest portion of the handpiece is approximately 3/4 ” (18.7 mm). An important ergonomic advantage of the iLase handpiece is that the center of gravity rests where the base of a user’s thumb and index finger meet. This will help minimize the arm, wrist, and hand force needed by a user to operate the device throughout the day. Page 3 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  4. 4. iLase™ Frequently Asked Questions What is the size and weight of an iLase charging station? The iLase charging station is approximately 2.5” (70 mm) tall and covers a footprint of approximately 4.72” x 3.95” (120 mm x 100 mm). It weighs approximately 412 g (0.90 lbs, or 14.5 oz). Is the finger switch difficult to use? Will it make my finger tired? The ergonomically-designed finger switch surrounds the entire handpiece and works with only slight pressure anywhere on its surface. So the clinician can activate the laser comfortably using the finger and hand position most convenient for the type and location of the procedure being performed. Page 4 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  5. 5. iLase™ Frequently Asked Questions What if I accidentally press the finger switch? As long as the iLase is not in “ready” mode, it will not deliver any laser energy, even if the finger switch is pressed. But when the iLase is in “ready” mode and the finger switch is pressed, the following sequence occurs: The iLase will immediately generate an audible “beep” tone, but no laser energy will be delivered. After about 1/3 of a second, the iLase will then begin to deliver laser energy. So in the case of an accidental press of the finger switch while the iLase is in “ready” mode, the user will have about 1/3 of a second to release the finger switch before the iLase begins to deliver laser energy. LEDs on the user interface clearly indicate whether or not the iLase is in “ready” mode, and the visible red aiming beam will turn on only when the iLase is in “ready” mode. What safety features does the iLase have? With proper training, the iLase is a very safe product to use. Its safety features include: Electronic pass-key must be entered upon power-up in order to enable any functionality. Laser energy can only be emitted (fired) when the system is placed in “ready” mode by the user and the finger switch is pressed. Pressing the finger switch when the system is not in “ready” mode will not result in emission of laser energy. The red, visible aiming beam will turn on only when the system is in “ready” mode. This is another visual clue that the system will emit laser energy upon pressing the finger switch. When the finger switch is pressed (in “ready” mode), an audible “beep” tone is immediately generated, but there is a 1/3 second delay of actual emission of laser energy. This enables a user to stop pressing the finger switch if necessary before the laser energy emits. After 1 minute of continuous pressing of the finger switch in “ready” mode, the system will stop emitting laser energy and produce a “beep” tone. This is a useful feature in case some object accidentally presses the finger switch. In order to continue firing the laser, simply press the finger switch again. Time-out features. After 3 minutes of no activity in “ready” mode, the system will automatically enter “standby” mode. After 3 minutes of no activity in “standby” mode, the system will automatically enter “sleep” mode. The battery can easily be removed by a simple pull, without the use of tools, at any time to remove power from the system. If the internal system begins to overheat, a warning message will first be displayed to the user, but the system will remain active; if the internal system overheats too much, it will stop Page 5 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  6. 6. iLase™ Frequently Asked Questions or prevent further emission of laser energy until it cools down. At no time will the external temperature of the device become too hot for human contact. Several methods of communicating system status to the user through the display screen, LED, and audible tone. Other internal system checks, including delivery of the proper amount of laser energy How long does the battery last? For longer procedures, such as sulcular debridement, a fully charged battery will last for one patient. But for shorter procedures, such as single-tooth troughing for crown preparation, a fully charged battery can last for several patients or procedures. It is advisable to have a fully charged, spare battery readily available at all times when using the iLase. The iLase battery can be recharged up to 500 times before a replacement is necessary. (Note: A fully charged battery is capable of providing power for over 30 minutes when continuously firing at 1 Watt in continuous wave mode. Firing at 2 Watts in continuous wave mode continuously for about 15 minutes will cause the system to overheat and shut down, although a fully charged battery would not yet be fully depleted in this scenario.) How long does it take to recharge a battery? A depleted battery will fully recharge in less than 1 hour. How do I know if a battery is charged? When a battery is connected to the iLase handpiece, there is a battery level indicator on the display. When a battery is connected to the iLase charging station, an LED will display charge status (green = fully charged, amber = not yet fully charged). I don’t see an “emergency stop” button. What happens if I need to shut down immediately? Removing battery power serves as the emergency stop. The battery is easily removed by pulling it out of the handpiece, without the use of tools. I don’t see an ON/OFF switch. How do I turn the device on and off? Attaching a battery will immediately power-up the system, but a few other steps are necessary before the device can emit laser energy. Upon power-up, the user must enter an electronic Page 6 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  7. 7. iLase™ Frequently Asked Questions pass-key, select a procedure, and then place the system into “ready” mode in order to enable laser firing. The iLase also features “time-out” functions. If there is no activity in “ready” mode for 3 minutes, the system will automatically enter “standby” mode. If there is no activity in “standby” mode for 3 minutes, the system will automatically enter “sleep” mode. To “wake up” the iLase from “sleep” mode, simply press the navigation button. To turn off (remover power from) the iLase, simply remove the battery. Does the iLase have pre-set values for the most popular procedures? Yes! Recommended values for power and pulse mode are factory installed for 10 procedures: gingivectomy, troughing, infected pockets, excision, frenectomy, implant recovery, crown lengthening, exposure of unerupted teeth, aphthous ulcers, and hemostasis. In addition, there are 2 extra custom pre-sets that the clinician may set by himself or herself. How were the factory-installed pre-set values determined? Through feedback from experienced clinicians in the field, and through laboratory evaluation on tissue models. For more information, please contact your Biolase representative. Can I change the factory-installed pre-set values? Yes, and any changes can also be saved for future use. There is also an easy way to restore the original factory-installed pre-set values. Is the iLase patented? The finger switch is patent pending – Biolase has filed a patent application with the USPTO. In addition, Biolase has several patents for the ezlase and tips that also protect the iLase. Can the iLase be sterilized? None of the parts are shipped sterile, but the cover and tips must be sterilized (autoclaved) before use. However, the main body portion of the handpiece and the battery cannot be sterilized – they should be cleaned with a recommended chemical disinfectant before use. Also, the tips are intended for single use only and should be properly disposed in a biohazard sharps container after each procedure. Page 7 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  8. 8. iLase™ Frequently Asked Questions How do I connect tips? Tips are very easy to connect, without the use of tools. Simply insert a tip into the end of the handpiece cover, and turn (twist) to tighten. The tip should be finger tight, and the red aiming beam should make a pattern of a small circle (“doughnut” shape). To remove the tip, simply turn (twist) it in the opposite direction. What kind of maintenance is required for the iLase? The main body and batteries should be regularly wiped and cleaned with a disinfectant (such as CaviCide®). The window at the output end of the main body should also be cleaned every week with a cotton swab and alcohol. The cover and tips should be cleaned (with disinfectant) and sterilized (autoclave) before each use. Note that the tips are intended for single-use only and should be disposed of properly. Does the iLase offer tooth whitening? Not at this time. BIOLASE might provide single-tooth whitening capability at a later date. For the fastest in-office full-mouth whitening solution, please ask about our Total Diode Solution™, the ezlase. Does the iLase offer temporary pain relief? Not at this time. BIOLASE might provide this capability at a later date. For a proven method to help temporarily relieve pain caused by TMD conditions, please ask about our Total Diode Solution, the ezlase. How much output power does the iLase provide? 5 Watts of peak power, and 3 Watts of continuous wave power. How many pulse modes does the iLase provide? Continuous wave 50% duty cycle (1 msec ON / 1 msec OFF) 33% duty cycle (0.1 msec ON / 0.2 msec OFF) Can I customize the pulse modes? No, the pulse modes are fixed. If interested in customizing pulse modes, please ask about the ezlase. Page 8 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.
  9. 9. iLase™ Frequently Asked Questions What is ComfortPulse™? ComfortPulse™ – available only on BIOLASE iLase and ezlase diode lasers – delivers laser energy in very short pulses, which minimizes thermal damage to the tissue. The result is reduced patient discomfort and a reduced need for anesthetic. Should I buy the iLase or ezlase? Both! The iLase is the ideal minimally invasive solution for common, everyday soft-tissue procedures such as gingivectomies, troughing for crown impressions, and hygiene. The ezlase is the Total Diode Solution for both common and advanced soft-tissue procedures, full-mouth in- office teeth whitening, and temporary minor pain relief. What comes with my iLase purchase? The iLase can be purchased as a complete system, or as individual components. 1-Handpiece System includes: 1x handpiece; 2x covers; 2x batteries; 1x charging station; 1x box of tips; 3x safety glasses; 1x tip initiation block; 1x danger posted sign; 1x handpiece carrying case 2-Handpiece System includes: 2x handpieces; 4x covers; 4x batteries; 1x charging station; 1x box of tips; 6x safety glasses; 2x tip initiation blocks; 2x danger posted signs, 2x handpiece carrying cases Has the iLase been reviewed by the FDA? The iLase has received 510(k) clearance from the FDA, and it is also available for sale in other countries outside the US. For more information, please contact your Biolase representative or distributor. What is the warranty? 2 years Page 9 Extracted from P/N 5200129, Rev B Aug 2010 © 2010 Biolase Technology, Inc.