Ivoclar Vivadent Odyssey Navigator User manual

Owners Manual
Navigator
3 W AT T D I O D E L A S E R
ODYSSEY
TM
®
PARTNERING IN ESTHETIC DIGITAL DENTISTRYSM
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Section 1
Introduction.............................................5
Section 2
Sp cifications............................................6
2.0 Specifications...........................................................6
2.1 DeliverySystemSpecifications .............................................6
2.2 Warranty(alsoseesection8)...............................................7
2.3 PartsList...............................................................7
Section 3
Las rAss mblyInstructions................................8
3.0 Removing the Laser from the Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.0.1 Instructions on Unpacking & Dealer Assistance ............................................................................8
3.0.2 Shipping Container Information ..................................................................................................8
3.0.3 Contents of Shipping Container...................................................................................................8
3.1 ProcedureforProperLaserAssembly........................................8
3.1.1 Wireless Foot Pedal Installation Procedure....................................................................................9
3.1.2 Power Cord Installation .............................................................................................................10
3.1.3 Direct Power Supply ..................................................................................................................10
3.1.4 Installing the handpiece cable to the laser .................................................................................11
3.1.5 Inserting the unit-dose laser tip into the handpiece....................................................................12
3.1.6 Placing the laser unit in the docking cradle ................................................................................13
3.1.7 Odyssey Navigator Remote Interlock ..........................................................................................13
3.1.8 Emergency Shutdown Switch ....................................................................................................14
3.1.9 Powering up the Laser ...............................................................................................................14
3.1.10 Enter the digital key...................................................................................................................14
3.1.11 Installation Test ..........................................................................................................................15
3.1.12 Check of the Emergency Shutdown System ...............................................................................15
3.1.13 Touch Screen Menu ..................................................................................................................16
3.1.14 Preset Programs .........................................................................................................................18
3.2 Evaluating the Facility and Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . 19
3.2.1 Power Requirements ..................................................................................................................19
3.2.2 Heating and Ventilation .............................................................................................................19
3.2.3 Transport and Storage................................................................................................................19
3.2.4 Lighting .....................................................................................................................................19
3.2.5 Combustible Chemicals and Gases.............................................................................................19
3.2.6 High Speed Vacuum Systems .....................................................................................................19
3.2.7 Access and Visual ......................................................................................................................19
3.2.8 Odyssey Navigator Diode Laser Frequency .................................................................................20
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TABLE OF CONTENTS
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Section 4
Saf tyConsid rations....................................21
4.1 LaserSafetyProgram....................................................21
4.2 ContinuingEducation....................................................21
4.3 In-OfficeSafetyIssues...................................................22
4.3.1 Lighting ....................................................................................................................................22
4.3.2 Combustible chemicals or gases ...............................................................................................22
4.3.3 Safety Eyewear ........................................................................................................................22
4.3.4 Test Firing the Laser ..................................................................................................................22
4.3.5 Power Changes With Fiber Changes .........................................................................................22
4.3.6 Danger - Laser In Use Signage ..................................................................................................22
4.3.7 Sharps Disposal and Sponge Removal .......................................................................................22
4.3.8 Plume Evacuation .....................................................................................................................22
4.3.9 Laser Security ............................................................................................................................22
4.3.10 Emergency Shutdown Options ..................................................................................................23
4.3.11 Hard Tissue Procedures .............................................................................................................23
Section 5
Op ratingth Las r .....................................24
5.0 IntendedUses..........................................................24
5.1 StandbyandReadyStatus................................................24
5.2 ContinuousorPulseMode................................................24
5.2.1 Continuous Wave (CW) Mode ...................................................................................................24
5.2.2 Pulsed Energy Mode ..................................................................................................................24
5.3 issueResponsestoLaserEnergy..........................................25
5.4 SystemsProcedures.....................................................25
5.4.1 Treatment Area Requirements ....................................................................................................25
5.4.2 Foot Pedal..................................................................................................................................25
5.4.3 Unit-dose Fiber Tip ..................................................................................................................25
5.4.4 Fiber Preparation........................................................................................................................25
5.4.5 Emergency Shut Off Button .....................................................................................................25
5.4.6 Digital Key ................................................................................................................................25
5.4.7 Setting Parameters for the Quick Set Mode ..............................................................................25
5.4.8 Select Your Power .....................................................................................................................26
5.4.9 Selecting Programs ....................................................................................................................26
5.4.10 Aiming Beam ............................................................................................................................26
5.4.11 Tips............................................................................................................................................26
5.4.12 Procedure ..................................................................................................................................26
5.4.13 Odyssey Navigator Self Diagnostic and Monitoring.....................................................................27
3
Navigator
3 W AT T D I O D E L A S E R
O D Y S S E Y
TM
®
TABLE OF CONTENTS
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Section 6
Syst m Compon nts: Pr parations, Car and Maint nanc . . . . . 28
6.0 UnitDoseFiber ips.....................................................28
6.0.1 General......................................................................................................................................28
6.0.2 Replacing a Unit Dose Fiber Tip .................................................................................................28
6.1 FiberPreparation.......................................................28
6.1.1 Quartz/Silica Fiber .....................................................................................................................28
6.1.2 Cleaving the Fiber .....................................................................................................................29
6.1.3 Initiating the Fiber .....................................................................................................................29
6.2 LaserMaintenance......................................................29
6.2.1 Laser Chassis Disinfection ..........................................................................................................29
6.2.2 LCD Display ..............................................................................................................................29
6.2.3 Calibration.................................................................................................................................30
6.2.4 Battery Useful life ......................................................................................................................30
6.3 HandpieceSterilization..................................................30
6.3.1 Handpiece Components.............................................................................................................30
6.3.2 Recommended Autoclave Procedure ..........................................................................................31
6.3.3 Prepare Fiber .............................................................................................................................32
6.3.4 Mounting the Tip .....................................................................................................................32
Section 7
Lab ls, Signs, Warnings and Manufactur r’s Information. . . . . . . 33
7.1 RegulatoryCompliance ..................................................33
7.2 Labels................................................................33
7.2.1 Danger Laser in Use ...................................................................................................................33
7.2.2 Class 4 Laser Product ................................................................................................................33
7.2.3 Aiming Beam laser.....................................................................................................................33
7.2.4 Interference with wireless signal.................................................................................................33
7.3 DeviceCautions........................................................33
7.4 Nominal Ocular Hazard Distance (NOHD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Section 8
S rvicing ..............................................35
8.1 WarrantyPolicy ........................................................35
8.2 Repairs & Returns to Ivoclar Vivadent, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Section 9
S l ct d R f r nc s on Las r D ntistry . . . . . . . . . . . . . . . . . . . . . 36
Section 10
Troubl shooting ........................................37
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TABLE OF CONTENTS
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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. Today, thanks to continuing efforts by these
industry leaders, we have seen the introduction of many new devices that have advanced the dental professional’s ability to
perform at the highest standards.
The ODYSSEY®NAVIGATOR™DIODE LASER from Ivoclar Vivadent, Inc. represents the latest solid state diode laser technology
available for soft tissue modification and preventative care; now featuring wireless power control. Unlike solid state lasers
that utilize a man-made rod of elements such as yttrium, aluminum, and garnet, doped with a rare earth compound like
Erbium, the diode has components that have become known for their durability, dependability and longevity. We are, of
course, referring to semi-conductor crystal technology like that found in televisions, DVD players, telephones and many more
household products that we have learned to rely on each day. The major components of the ODYSSEY NAVIGATOR are semi-
conductor “chips” made from Aluminum, Gallium and Arsenide, together commonly referred to as AlGaAs. They are activat-
ed or “pumped” by passing an electrical current through the diode to produce an elliptical shaped display of monochromatic
light that can be focused into a very small point and placed into the delivery fiber.
The wavelength produced by the diode is approximately 810 nanometers (nm) and produces invisible non-ionizing thermal
radiation that does not create changes in cellular DNA. The diode is air cooled and highly efficient when used correctly. For
safety, the diode features several ways to stop energy flow if the operator wishes to deactivate the laser. The safety system
includes a choice of an emergency shutoff switch, a power switch, a power cord or an electrical plug. Any of these items
can be used to shut down the laser. The design and technology used in the ODYSSEY NAVIGATOR allows the dentist or
hygienist* to transport the laser between different operatories. It has a lightweight and durable chassis that is designed to
use 110 – 120 V electricity found in most dental offices.
Training is recommended and opportunities for such are available through such outlets as Ivoclar Vivadent, Inc. Please visit
our web site for training dates and locations at www.g todyss ylas r.com.In addition, The Academy of Laser Dentistry,
dental schools and many dental continuums offer suitable courses. You may also ask your authorized dealer representative
for the names of dental professionals in your area who have a laser and who could help you in a mentoring capacity. Laser
safety is paramount in importance and each office should quickly develop and implement a laser safety program and appoint
a “laser safety officer” to be responsible for the laser. Their duties include management of the laser and all accessories as
well as training office personnel in all aspects of laser safety. There are many applications for using this laser system and you
will be amazed at the results and wonder how you ever practiced dentistry without the ODYSSEY NAVIGATOR.
* In States / Provinces where the Dental Practice Act does not prevent hygientists to utilize a laser.
5
Navigator
3 W AT T D I O D E L A S E R
O D Y S S E Y
TM
®
INTRODUCTION
Section 1
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2.0 SPECIFICATIONS
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
Wavelength: 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 Rate in Pulsed Mode: fixed 10 Hz
Pulse Duration: fixed 0.05 seconds
Duty Cycle: pulsed mode 50%
continuous wave 100%
Aiming Beam (3 mW ): Yes
Audible Notification: Yes
Visual Notification: Yes
Power Requirements: 110 - 120 VAC @ 60 Hertz
220 - 240 VAC @ 50 Hertz
Amperage: 1.5 Amps @ 110-115 V AC
0.75 Amps @ 210-230 V AC
Battery: Rechargeable lithium polymer
45 minutes continuing lasing time
8 hours stand by time – laser on, not being charged by cradle or AC power
Wireless Foot Pedal: Frequency: 2.4 GHz
Power source: Battery 9 volt Lithium
2.1 DELIVERY SYSTEM SPECIFICATIONS
»Handpiece assembly with autoclavable sleeves
»Disposable, unit-dose fiber silica tips for the handpiece
50 per box – Standard length tips (6 mm)
50 per box – Perio length tips (9 mm)
25 per box – Non-contact tips (3.5 mm)
»Laser Aperture – Custom ST adaptor
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SPECIFICATIONS
Section 2
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2.2 WARRANTY (ALSO SEE SECTION 8)
Laser: 2 years Parts and Labor
Rechargeable lithium polymer battery: 1 year
Handpiece assembly: 6 months
2.3 PARTS 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) autoclavable sleeves
(1) Wireless Foot Pedal
(1) 9 Volt Battery
(1) Power Cord
(1) Hexdriver
(1) Owner’s Manual
(1) Training DVD
(1) Clinical Guide
(1) Laser Safety Sign
Complies with:
IEC 60601-2-22
IEC 60825-1
21 CFR 1040.10 and 1040.11
UL 2601-1
CSA/CAN C22.2 No. 601.1
FCC Parts 15 & 18 (47 CFR)
1C-RSS 210
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.
CAUTION: US Federal Law restricts this device to sale by or on the order of a licensed dentist.
7
Navigator
3 W AT T D I O D E L A S E R
O D Y S S E Y
TM
®
SPECIFICATIONS
Section 2
INVISIBLE AND VISIBLE LASER RADIATION.
AVOID E E OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.
WAVELENGTH: 810nm OUTPUT: 3 WATTS
WAVELENGTH: 650nm OUTPUT: 3 mW
CLASS 4 LASER PRODUCT
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3.0 REMOVING THE LASER FROM THE PACKAGING
3.0.1 Unpacking th Las r & D al r Assistanc
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.
3.0.2 Shipping Contain r Information
We recommend that you retain your original container in which you received your laser should you need to return
the laser for service or repair. The shipping container you received with your laser has been specially designed to
safely transport the laser.
3.0.3 Cont nts of Shipping Contain r
The contents of the shipping container should include the following:
(1) Laser Unit
(1) Fiber Cleaver
(3) Protective Glasses
(1) Package of (50) Unit dose fiber Handpiece Tips - (6 mm) 60 degree angle
(1) Handpiece assembly and two autoclavable sleeves
(1) Wireless Foot Pedal
(1) 9 Volt Battery
(1) Power Cord
(1) Hexdriver
(1) Owner’s Manual
(1) Training DVD
(1) Clinical Guide
(1) Laser Safety Sign
(1) Warranty Information
Pl as ch ck all it ms s nt with your las r to insur that all compon nts ar account d for.
3.1 PROCEDURE FOR PROPER LASER ASSEMBLY
1. Assemble wireless foot pedal
2. Install power cord
3. Assemble handpiece and tip
4. Install remote interlock - optional
5. Check Laser “Shut Off” button
6. Turning on power
7. Entering the digital key
8. Test fire the laser
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LASER ASSEMBLY INSTRUCTIONS
Section 3
R m mb r: Always t st fir th las r outsid th
mouth b for using it on a pati nt. Th doctor or
hygi nist, th pati nt and any staff m mb r pr s nt
in th op ratory should b w aring th appropriat
saf ty y w ar wh n v r th las r is b ing op rat d.
Strict adh r nc to protocols for saf las r us is
ss ntial.
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1. Make sure the laser is
completely turned
off before 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. Insert the hexdriver into
the screw holding down
the battery cover. Rotate
the hexdriver counter-
clockwise until the screw
comes out completely,
Fig. 3.1.1c.
5. Repeat for the other
screw holding down the
battery cover.
6. Push down on one
end of the battery cover
while simultaneously
lifting up on the other
end to remove the
battery cover, Fig. 3.1.1d.
7. Locate the battery
terminal inside the
well and pull the
terminal out. Do not
pull excessively on the
wires, Fig. 3.1.1e.
8. Remove the battery from
its packaging and attach
the battery to the
terminal, Fig. 3.1.1f.
9. Place the battery in the
well, with the connector
to the same side as
where the wire leads
emerge from the
housing, Fig. 3.1.1g.
10. Replace the battery
cover, and replace the
two screws. Turn the
hexdriver clockwise to
tighten the screws. The
screws are sufficiently
secure once they
no longer turn with
gentle finger-applied
force. Do not over-
tighten, Fig. 3.1.1h.
11. Replace the hexdriver
back in its holder,
Fig. 3.1.1i.
12. Place the pedal face up.
Allow at least 1 minute
after completing this
procedure before
turning on the laser.
Navigator
3 W AT T D I O D E L A S E R
O D Y S S E Y
TM
®
LASER ASSEMBLY INSTRUCTIONS
Section 3
Each of the following items should be inspected, inserted into the appropriate receptacle, and when applicable,
locked or snapped into place.
3.1.1 Wir l ss Foot P dal Installation Proc dur
Fi . 3.1.1a
Fi . 3.1.1b
Fi . 3.1.1f
Fi . 3.1.1
Fi . 3.1.1h
Fi . 3.1.1i
Fi . 3.1.1c
Fi . 3.1.1d
Fi . 3.1.1e
NOTE: An xtra 9 volt Lithium batt ry
should b k pt in your offic inv ntory as
th batt ry should b r plac d v ry 100
hours of continu d op ration.
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3.1.2 Pow r 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.
3.1.3 Dir ct Pow r Supply
If immediate power is needed and the battery is not charged, unplug the power cord from the cradle, Fig. 3.1.3a,
and plug it directly into the laser, Fig. 3.1.3b and 3.1.1c.
10
The Leader in Diode Lasers.
LASER ASSEMBLY INSTRUCTIONS
Section 3
Fi 3.1.2
Fi 3.1.3a Fi 3.1.3b Fi 3.1.3c
NOTE: To pr v nt pow r surg s du to l ctrical storms or spik s in lin voltag ,
you should us a pow r strip with a circuit br ak r or unplug th las r wh n you
ar not pr s nt.
NOTE: Th batt ry will b charg d if th cabl is plugg d dir ctly into th las r.
Th las r can b switch d on or off for th batt ry to b charg d.
NOTE: DO NOT l av th AC cord attach d to th las r or cradl wh n th pow r
supply is unplugg d from th wall as this might inadv rt ntly drain th batt ry.
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