PARTNERING O D Y S S IN E ESTHETIC Y Navigator 3 W AT T D I O D E L A S E R Owners Manual ® TM DIGITAL DENTISTRY SM
TABLE OF CONTENTS Section 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Section 2 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.0 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.1 Delivery System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TABLE OF CONTENTS Section 4 Safety Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 4.1 Laser Safety Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 4.2 Continuing Education. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 4.3 In-Office Safety Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TABLE OF CONTENTS Section 6 System Components: Preparations, Care and Maintenance . . . . . 28 6.0 Unit Dose Fiber Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 6.0.1 General......................................................................................................................................28 6.0.2 Replacing a Unit Dose Fiber Tip ...............................................................................................
Section 1 INTRODUCTION As dentists strive to create the perfect smile, they are often compromised by the technology they use in their practice. Respected leaders from the dental profession and dental equipment manufacturers have sought to identify the most practical and least invasive technology available to deliver restorative and preventive care.
Section 2 SPECIFICATIONS 2.0 SPECIFICATIONS Weight: Dimension in inches (H X W X L): Laser Classification (Per 60825): Wavelength: Beam Divergence: Power Range: Hertz Rate in Pulsed Mode: Pulse Duration: Duty Cycle: Aiming Beam (3 mW ): Audible Notification: Visual Notification: Power Requirements: Amperage: Battery: Wireless Foot Pedal: Power source: 2.
Section 2 SPECIFICATIONS 2.2 WARRANTY (ALSO SEE SECTION 8) Laser: Rechargeable lithium polymer battery: Handpiece assembly: 2 years Parts and Labor 1 year 6 months 2.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.0 REMOVING THE LASER FROM THE PACKAGING 3.0.1 Unpacking the Laser & Dealer Assistance Your local authorized Ivoclar Vivadent dealer can provide a representative to assist you when you are ready to remove the laser from its shipping container. Do not attempt to unpack the laser and install the various components without reading this section first. If you are unsure about any aspect of the assembly, call your authorized dealer representative for assistance. 3.0.
Section 3 LASER ASSEMBLY INSTRUCTIONS Each of the following items should be inspected, inserted into the appropriate receptacle, and when applicable, locked or snapped into place. 3.1.1 Wireless Foot Pedal Installation Procedure 1. Make sure the laser is completely turned off before replacing the battery in the foot pedal. 8. Remove the battery from its packaging and attach the battery to the terminal, Fig. 3.1.1f. 2. Place the pedal face down on a hard, clean surface, Fig. 3.1.1a. 9.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.2 Power Cord Installation Remove the power cord from the Odyssey Navigator package and plug the power cord into the appropriate receptacle on the back of the laser cradle. See Fig 3.1.2 Plug the power cord into a 110 Volt AC outlet rated at 60Hz. Use only the power supply that comes with the device. Use of other power supplies may damage the device or cause electrical shock. Fig 3.1.2 3.1.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.4 Connection of Handpiece Assembly to the Laser 1. The handpiece assembly is already installed when you receive your new Odyssey Navigator Diode Laser. Please leave the handpiece assembly connected to the laser unit unless you have to switch handpiece assemblies or if you have to ship the laser for technical reasons. Disconnecting the handpiece for even short periods can lead to contamination of the precision polished end of the fiber connector.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.5 Inserting the unit dose fiber tip into the handpiece Remove a unit dose fiber tip from its package, remove the plastic protective cap, and snap it into the handpiece. Figs 3.1.5a, 3.1.5b and 3.1.5c. Avoid placing your finger on either end of the handpiece tips as the tips are gamma irradiated and have to be clean for optimal performance and safety.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.6 Placing the laser unit in the docking cradle Place the laser unit in the cradle by tipping the laser unit slightly forward and inserting it into the cradle. Fig 3.1.6. Do not force the unit into the cradle and be sure to place the fiber cord through the cradle opening. The Odyssey Navigator diode laser is supplied with a rechargeable lithium polymer battery which provides up to 45 minutes continuous lasing or 8 hours stand-by time, i.e.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.8 Emergency Shutdown Switch Before you activate the laser, make sure the red Laser Stop button is in the depressed position. The laser will activate only with the button in the depressed position. If the laser needs to be stopped quickly, pushing and releasing the red Laser Stop button will immediately shut the laser off. The Safety Alert Window will appear on the screen if the button is released. Fig 3.1.8a Button depressed— laser will activate Fig 3.1.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.11 Installation Test 1. 2. 3. 4. After login, from the Main Menu, touch the “Quick Set Up” Button The Odyssey Navigator is pre-set to “Continuous Wave” (CW) Power setting is pre-set to 1.0W Hold the fiber approximately 2-4 mm away from a piece of articulating paper. 5. Touch “Ready” button – laser is in “Ready” mode. A green checkmark will be displayed, Fig. 3.1.11, you will be able to see the aiming beam on the articulating paper at the end of the fiber tip. 6.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.13 Touch Screen Menu The Main Menu screen gives you the choice to use a ”Quick Set Up” (Fig 3.1.13a) - with settings you designate for each procedure–or you may select a pre-set program sorted in alphabetical order under the “Procedures”, or under the “Specialty” categories, Fig. 3.1.13b. The settings are portrayed with four adjustable settings: Mode, Power, Time and Aiming Beam.
Section 3 LASER ASSEMBLY INSTRUCTIONS Aiming Beam The Odyssey Navigator diode laser is actually two lasers in one, the infrared 810 nm wavelength laser which performs the actual treatment of the soft tissue, the “working beam” and the 650 nm “laser pointer” which illuminates the focal point of the “working beam” allowing the operator to aim prior to and during laser activation. In addition, the aiming beam control allows for five levels of illumination ranging from off to maximum intensity.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.1.14 Preset Programs The Odyssey Navigator comes with procedure specific settings installed. The Procedures are accessed from the Main Menu by depressing “Procedures.” Procedures may also be accessed through the “Specialty” category. By accessing in this way, the procedures are sorted according to speciality, Fig. 3.1.14. After selecting a procedure, the settings may be manually adjusted to suit your needs during a clinical procedure.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.2 EVALUATING THE FACILITY AND ENVIRONMENTAL CONSIDERATIONS In order to insure the safe use of the laser in your facility, please check to make sure that the proposed location has the following: 3.2.1 Power Requirements 110 - 240 V AC ±10 % at 50 - 60 Hz 3 Amps 9 volt Lithium battery for the foot pedal 3.2.2 Heating and Ventilation The laser should be operated in areas with the optimum temperature range of 20º - 30ºC (68º - 86º F). 3.2.
Section 3 LASER ASSEMBLY INSTRUCTIONS 3.2.8 Odyssey Navigator Diode Laser Frequency The Odyssey Navigator diode laser wireless technology is electronically coded. Each pedal and Odyssey Navigator diode laser share a UNIQUE SERIAL NUMBER INTERLOCK protocol for reliable operation: • • • 20 An Odyssey Navigator pedal communicates with only one Odyssey Navigator diode laser; there is 2-way electronic code which must be verified for every transmission and acknowledgement.
Section 4 SAFETY CONSIDERATIONS The safe use of the Odyssey Navigator is the responsibility of the entire dental team, the laser safety officer appointed, and the dental office team. Protocols for the safe use of lasers have been developed by a combination of medical and dental professionals working in concert with educators at the university level, scientists and laser manufacturers. Dental professionals have had to develop protocols and guidelines for using the laser on oral soft tissues.
Section 4 SAFETY CONSIDERATIONS 4.3 IN-OFFICE SAFETY ISSUES 4.3.1 Lighting Always use the Odyssey Navigator in a well lighted and ventilated area. 4.3.2 Combustible chemicals or gases Make certain that chemicals or gases capable of supporting or causing combustion are not present when using the laser (e.g. alcohol gauze, liquid topical anesthetics). 4.3.
Section 4 SAFETY CONSIDERATIONS 4.3.10 Emergency Shutdown Options Any of 1. 2. 3. 4. these mechanisms can be used to shut down the emission of laser energy in a real or perceived emergency: Depress and release the emergency shutdown button Foot Pedal – remove your foot to stop lasing Switch the Power/Fan to the off position (O) Power Cord – unplug from the wall outlet 4.3.11 Hard Tissue Procedures The Odyssey Navigator diode is not an appropriate laser for hard tissue procedures.
Section 5 OPERATING THE LASER 5.0 INTENDED USES The Odyssey Navigator is intended to be used for oral soft tissue surgery including: sulcular debridement of diseased or fibrous tissue, i.e. excision and biopsy, gingivectomy and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy and photocoagulation.
Section 5 OPERATING THE LASER 5.3 TISSUE RESPONSES TO LASER ENERGY Maximum results will be achieved by regulating the power and the speed that the operator moves the fiber tip. Tissue Charring is an undesirable after effect of too much power or the tip moving too slowly. Always use the least amount of power necessary to complete your procedure. The ideal tissue response will show little or no discoloration after lasing and there will be less residual damage and faster healing.
Section 5 OPERATING THE LASER 5.4.8 Select Your Power Press the arrows until you have reached the desired Wattage. Beginning with a low of 0.1 Watts, the power increases in increments of 100 mW up to a maximum of 3.0 Watts (CW). By holding the arrow keys to increase or decrease the power, you can have an un-interrupted increase until you reach your desired power. 5.4.
Section 5 OPERATING THE LASER 5. Remove your foot from the foot pedal and touch the Ready button to place the Laser in Standby Mode until you are ready to start another procedure. 6. Remove the unit dose fiber tip and dispose in a suitable biowaste Sharps disposal. 7. Remove the handpiece sleeve only and follow the autoclave instructions. 8. If you are not going to be starting another procedure, return back to the Main Menu and press Logout. It is now safe to turn the power button to the OFF position. 9.
Section 6 SYSTEM COMPONENTS: PREPARATIONS, CARE AND MAINTENANCE 6.0 UNIT-DOSE FIBER TIPS The fiber optic element of a laser is responsible for carrying the light from the diode array to the tissue being treated. The dental laser fibers are usually made of quartz, sapphire, silica or a combination of those elements. Quartz/silica is the most popular product used in diode lasers. Be advised about the potential hazards when inserting, steeply bending or improperly securing the fiberoptics to the handpiece.
Section 6 SYSTEM COMPONENTS: PREPARATIONS, CARE AND MAINTENANCE 6.1.2 Cleaving the Fiber The tips are designed for single use application.However, if the need arises to cleave the tip the operator should place their index finger at the spot of the proposed cleave (Fig. 6.1.2a) so as to stabilize the fiber. Using the pen style cleaver, draw the cleave blade across the top of the fiber with enough pressure to ”score” the fiber (Fig. 6.1.2b). The fiber should break at the score mark.
Section 6 SYSTEM COMPONENTS: PREPARATIONS, CARE AND MAINTENANCE 6.2.3 Calibration The Odyssey Navigator Laser uses solid-state circuitry to continuously monitor the power output, and adjusts the power supplied to the laser module to keep the output consistent with the user defined setting. If output levels are more than ± 20% of the set value, the unit is designed to shut down power to the laser, and an audible alarm will sound.
Section 6 SYSTEM COMPONENTS: PREPARATIONS, CARE AND MAINTENANCE 6.3.2 Recommended Autoclave Procedure 1. Autoclave the handpiece sleeve only. First remove the unit-dose tip after the procedure. Unscrew the metal handpiece sleeve counterclockwise and separate from the handpiece. The recommended autoclave cycle is 132°C at 27 psi for 15 minutes. Fig 6.3.2a and b. 2.
Section 6 SYSTEM COMPONENTS: PREPARATIONS, CARE AND MAINTENANCE 6.3.3 Prepare Fiber The unit dose fiber tips are individually wrapped and gamma irradiated. Fiber tips cannot be autoclaved. They should be wiped down with cold disinfectant prior to use. If the packaging is visibly damaged or holes are visible, do not use the fiber tip. The unit dose fiber tips are pre-stripped and pre-cleaved and once inserted on the handpiece are ready for use.
Section 7 LABELS, SIGNS, WARNINGS AND MANUFACTURER’S INFORMATION 7.1 REGULATORY COMPLIANCE The Odyssey Navigator Diode Laser has been tested to the latest safety standards applicable to medical lasers in the US and Canada including IEC 60825, IEC 60601-2-22, IEC 60601-1, CSA/CAN C22.2 No. 601.1 and the Food and Drug Administration’s Laser Performance Standard (21 CFR 1040.10 and 1040.11).
Section 7 LABELS, SIGNS, WARNINGS AND MANUFACTURER’S INFORMATION 7.3.4 CAUTION US Federal law restricts this device to sale by or on the order of a licensed dentist. 7.3.5 CAUTION Eyewear that protects your eyes from wavelengths other than 810 nm do not provide proper protection for use with this laser. Damage to the retina or cornea may be irreparable if exposed to direct, reflected or scattered radiation. Always wear protective eyewear when operating the laser. 7.3.
Section 8 SERVICING 8.1 WARRANTY POLICY The Odyssey Navigator Diode Laser is warranted against defective materials and workmanship for a period of: » 2 years for laser » 1 year for battery » 6 months for handpiece and fiber assembly from the date of purchase, and will be repaired or replaced, at our discretion, if returned prepaid to our factory. This warranty does not cover damage to the Odyssey Navigator Diode Laser unit or components caused by accident, misuse, or being tampered with.
Section 9 SELECTED REFERENCES ON LASER DENTISTRY Coluzzi, Donald J. and Convissar, Robert A., “Atlas of laser applications in dentistry”. 2007 Quintessence Publishing Co., Inc. Vassallo, John, Dental Clinics of North America, vol. 48(4), W.B Saunders Company, 2004. Academy of Laser Dentistry, www.laserdentistry.org. The World Federation of Laser Dentistry, www.wfld-org.info. The Journal of Oral Laser Applications, official publication of the European Society for Laser Applications.
Section 10 TROUBLESHOOTING PROBLEM: Laser has no response. Corrective Action: Check that the power cord is securely plugged into back of the laser unit. Corrective Action: Check that the power switch on the side panel is turned to the on ( | ) position. Corrective Action: Check that the Laser Stop button is depressed. If not, depress the button. Corrective Action: Check the fiber/handpiece attachment and verify that it is properly engaged. Corrective Action: The laser battery is not charged.
INVISIBLE AND VISIBLE LASER RADIATION. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION. WAVELENGTH: 810nm OUTPUT: 3 WATTS WAVELENGTH: 650nm OUTPUT: 3 mW CLASS 4 LASER PRODUCT This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
