Ivoclar Vivadent Marine GPS System manual

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Table of contents for the manual

  • Page 1

    O w n er s M a n ua l N a v i g a t o r 3 W A T T D I O D E L A S E R ODYSSEY TM ® P ARTNERING IN ESTHETIC DIGIT AL DENTISTRY S M[...]

  • Page 2

    Section 1 I n t r o d u c t i o n .............................................5 Section 2 S p e c i f i c a t i o n s ............................................6 2 . 0 S p e c i f i c a t i o n s ...........................................................6 2 . 1 D e l i v e r y S y s t e m S p e c i f i c a t i o n s ............................[...]

  • Page 3

    Section 4 S a f e t y C o n s i d e r a t i o n s ....................................2 1 4 . 1 L a s e r S a f e t y P r o g r a m ....................................................2 1 4 . 2 C o n t i n u i n g E d u c a t i o n ....................................................2 1 4 . 3 I n - O f f i c e S a f e t y I s s u e s...............[...]

  • Page 4

    Section 6 System Components: Preparations, Car e and Maintenance . . . . . 28 6 . 0 U n i t D o s e F i b e rT i p s .....................................................2 8 6.0.1 General ......................................................................................................................................28 6.0.2 Replacing a Unit Do[...]

  • Page 5

    A s dentists strive to create the perfect smile, they ar e often compromised by the technology they use in their practice. Respected leaders from the dental pr ofession and dental equipment manufacturers have sought to identify the most practical and least invasive technology available to deliver restorative and pr eventive care. T oday , thanks to[...]

  • Page 6

    2.0 SPECIFICA TIONS Weight: 2.5 lbs Dimension in inches (H X W X L): While in cradle - 9 1/2” X 4” X 6” Out of cradle – 7” x 4” x 3” Laser Classification (Per 60825): Laser Diode Class 4 Laser Device W avelength: Laser 810 nm ±10 nm Aiming Beam 650 nm ±10 nm Beam Divergence: 9 degrees ± 1 degree Power Range: 100 mw to 3 Watts Hertz[...]

  • Page 7

    2.2 W ARRANTY (ALSO SEE SECTION 8) Laser: 2 years Parts and Labor Rechargeable lithium polymer battery: 1 year Handpiece assembly: 6 months 2.3 P AR TS LIST (1) Laser Unit (1) Fiber Cleaver (3) Protective Glasses (1) Package of (50) Unit dose fiber Handpiece Tips – Standard length, (6 mm) 60 degree angle (1) Handpiece assembly and (2) autoclavabl[...]

  • Page 8

    3.0 REMOVING THE LASER FROM THE P ACKAGING 3.0.1 Unpac king the Laser & Dealer Assistance Y our local authorized Ivoclar Vivadent dealer can provide a repr esentative to assist you when you are ready to remove the laser fr om its shipping container . Do not attempt to unpack the laser and install the various components without reading this sect[...]

  • Page 9

    1. Make sure the laser is completely turned off befor e replacing the battery in the foot pedal. 2. Place the pedal face down on a hard, clean surface, Fig. 3.1.1a. 3. Remove the hexdriver from its holder on the underside of the pedal. Lift up on the long end, and working the long end up and down, pull the hexdriver from its holder , Fig. 3.1.1b. 4[...]

  • Page 10

    3.1.2 Power Cor d Installation Remove the power cord fr om the Odyssey Navigator package and plug the power cord into the appr opriate receptacle on the back of the laser cradle. See Fig 3.1.2 Plug the power cord into a 110 V olt AC outlet rated at 60Hz. Use only the power supply that comes with the device. Use of other power supplies may damage th[...]

  • Page 11

    3.1.4 Connecti on of Handpiece Assembly to the Laser 1. The handpiece assembly is already installed when you r eceive 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 handpi[...]

  • Page 12

    3.1.5 Inserti ng the unit dose fiber tip into the handpiece R emove 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[...]

  • Page 13

    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 for ce the unit into the cradle and be sure to place the fiber cor d through the cradle opening. The Odyssey Navigator diode laser is supplied with a rechargeable lithiu[...]

  • Page 14

    3.1.8 Emergenc y Shutdown Switch Before you activate the laser , make sure the r ed 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 r ed Laser Stop button will immediately shut the laser off. The Safety Alert [...]

  • Page 15

    3.1.11 Installation T est 1. After login, from the Main Menu, touch the “Quick Set Up” Button 2. The Odyssey Navigator is pre-set to “Continuous W ave” (CW) 3. Power setting is pre-set to 1.0W 4. Hold the fiber approximately 2-4 mm away fr om a piece of articulating paper . 5. T ouch “Ready” button – laser is in “Ready” mode. A gr[...]

  • Page 16

    3.1.13 T ouch 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 procedur e–or you may select a pre-set pr ogram sorted in alphabeti- cal order under the “ Pr ocedures ”, or under the “ Specialty ” categories, Fig. 3.1.13b. The settings are portrayed with [...]

  • Page 17

    A iming 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 a ctiv[...]

  • Page 18

    3.1.14 Preset Programs The Odyssey Navigator comes with procedur e specific settings installed. The Procedur es are accessed from the Main Menu by depr essing “Procedur es.” Procedures may also be accessed thr ough the “Specialty” category . By accessing in this way , the procedur es are sorted according to speciality , Fig. 3.1.14. After s[...]

  • Page 19

    3.2 EV ALUA TING THE F ACILITY AND ENVIRONMENT AL CONSIDERA TIONS In o rd er to i nsu r e the s afe u se of t he l ase r in yo ur fa ci lit y , ple as e che ck to m ak e sur e th at th e pr op ose d loc at ion h as th e fol lo win g: 3.2.1 Power Requir ements 110 - 240 V AC ±10 % at 50 - 60 Hz 3 Amps 9 volt Lithium battery for the foot pedal 3.2.2[...]

  • Page 20

    3.2.8 Odyssey Navigator Dio de Laser Frequency The Odyssey Navigator diode laser wireless technology is electr onically coded. Each pedal and Odyssey Navigator diode laser share a UNIQUE SERIAL NUMBER INTERLOCK pr otocol for reliable operation: • An Odyssey Navigator pedal communicates with only one Odyssey Navigator diode laser; there is 2-way e[...]

  • Page 21

    T he safe use of the Odyssey Navigator is the responsibility of the entir e dental team, the laser safety officer appointed, and the dental office team. Pr otocols for the safe use of lasers have been developed by a combination of medical and dental pro- fessionals working in concert with educators at the university level, scientists and laser manu[...]

  • Page 22

    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 Combust ible chemicals or gases Make certain that chemicals or gases capable of supporting or causing combustion are not pr esent when using the laser (e.g. a lcoho l gauz e, li quid to pical a nest het ics) . 4.3.3 Safety Eyewea[...]

  • Page 23

    4.3.10 Emergency Shutdown Options Any of these mechanisms can be used to shut down the emission of laser energy in a real or per ceived emergency: 1. Depress and r elease the emergency shutdown button 2. Foot Pedal – remove your foot to stop lasing 3. Switch the Power/Fan to the off position (O) 4. Power Cord – unplug fr om the wall outlet 4.3.[...]

  • Page 24

    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 r emoval, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and r econtour[...]

  • Page 25

    5.3 TISSUE RESPONSES TO LASER ENERGY Maximum results will be achieved by r egulating 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 procedur e. The ideal tissue response will[...]

  • Page 26

    5.4.8 Select Y our Power Press the arr ows until you have reached the desired W attage. Beginning with a low of 0.1 Watts, the power incr eas- es in increments of 100 mW up to a maximum of 3.0 W atts (CW). By holding the arrow keys to increase or decr ease the power , you can have an un-interrupted increase until you reach your desir ed power . 5.4[...]

  • Page 27

    5 . Remove your foot from the foot pedal and touch the Ready button to place the Laser in Standby Mode until you are r eady 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 startin[...]

  • Page 28

    6.0 UNIT -DOSE FIBER TIPS The fiber optic element of a laser is responsible for carrying the light fr om the diode array to the tissue being treated. The dental laser fibers are usually made of quartz, sapphir e, silica or a combination of those elements. Quartz/silica is the most popular product used in diode lasers. Be advised about the potential[...]

  • Page 29

    6.1.2 Cleavi ng 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 pres- sure [...]

  • Page 30

    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 ar e more than ± 20% of the set value, the unit is designed to shut down power to the laser , and an audi[...]

  • Page 31

    6.3.2 Recomm ended Autoclave Procedur e 1. Autoclave the handpiece sleeve only . First remove the unit-dose tip after the pr ocedure. Unscrew the metal handpiece sleeve counterclockwise and separate fr om the handpiece. The recommended autoclave cycle is 132°C at 27 psi for 15 minutes. Fig 6.3.2a and b. 2. Do not place the laser unit or the fiber [...]

  • Page 32

    6.3.3 Pr epare 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 pr e-stripped and pre-cleaved and once inserted [...]

  • Page 33

    7.1 REGULA TOR Y 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). The laser has also[...]

  • Page 34

    7.3.4 CAUTION US Federal law restricts this device to sale by or on the or der of a licensed dentist. 7.3.5 CAUTION Eyewear that protects your eyes fr om wavelengths other than 810 nm do not provide proper pr otection for use with this laser . Damage to the retina or cornea may be irreparable if exposed to direct, r eflected or scattered radiation.[...]

  • Page 35

    8.1 W ARRANTY 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 pur chase, and will be repaired or r eplaced, at our discretion, if returned prepaid to our factory . This warranty [...]

  • Page 36

    C oluzzi, Donald J. and Convissar , Robert A., “Atlas of laser applications in dentistr y” . 2007 Quintessence Publishing Co., Inc. V assallo, John, Dental Clinics of North America , vol. 48(4), W .B Saunders Company , 2004. A cademy of Laser Dentistry , www .laserdentistry .org. The World Federation of Laser Dentistry , www .wfld-org.info. The[...]

  • Page 37

    PROBLEM: Laser has no response. C orrective Action: Check that the power cord is secur ely 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, depr ess the button. Corrective Action: Check t[...]

  • Page 38

    T his device complies with part 15 of the FCC Rules . Operation is subject to the following two conditions: (1) T his device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. UNITED ST A TES Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 1[...]