Gemini 810, 980 User Manual

USER MANUAL
Meticulous Structured
CREATIVE
INCREDIBLY
Innovative
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A DENTIST OR PHYSICIAN OR OTHER LICENSED MEDICAL PRACTITIONER
Inspiration
The true sign of intelligence is not knowledge but imagination.
Albert Einstein
Laser technology enables clinicians to provide less invasive treatment for many preventative, restorative, cosmetic, and surgical soft tissue procedures. The Gemini 810 + 980 diode laser represents a new advancement in dental laser technology. With its unique eye-catching design, simple user interface, and multiple wavelength modes, you can perform a range of soft-tissue pro­cedures with ease.
The Gemini 810 + 980 diode laser is the first soft tissue dental laser to provide a choice of two laser wavelengths in one system. You have the ability to se­lect laser settings that best suit specific procedures and patient needs based on tissue type and optimal wavelength absorption characteristics.
You will discover that the Gemini 810 + 980 diode laser cuts faster, reduc­es tissue tagging and generates less collateral thermal heat than other di­ode lasers you may have used, allowing you to provide a higher standard of care. The laser also features an incredible, innovative transparent display designed to wow your patients.
Choosing to integrate laser technology into your practice yields many bene­fits, including increased patient comfort and satisfaction and more efficient treatment. To get the maximum benefits of laser technology, consider joining a study group so that you can exchange tips and ideas with fellow clinicians. A study group is also an excellent way to keep abreast of the latest procedures and technological advances. A great place to start is the Academy of Laser Dentistry, www.laserdentistry.org.
Failure to comply with precautions and warnings described in this User Manual may lead to exposure to dangerous optical radiation sources. Please comply with all safety instructions and warnings.
CAUTION: Do not use in the presence of combustible or combustion-supporting gases. CAUTION: Always test activate the device outside the mouth before using on a patient.
CAUTION: This unit has been designed and tested to meet the requirements of electromagnetic, electrostatic, and radio frequency interference standards. However, the possibility of electromagnetic or other interference may still exist. Relocating the device may help to eliminate the interference.
CAUTION: Do not modify this equipment without authorization of the manufacturer.
CAUTION: Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in pages 44-48 of this manual.
CAUTION: Periodically inspect laser eyewear for pitting and cracking.
CAUTION: Read these instructions carefully prior to using your Gemini 810 + 980 diode laser.
CAUTION: Always wind the fiber optic cable in a clockwise manner around the fiber wrap to avoid fiber breakage (See Page 26).
Safety is paramount when using any energy-based surgical instrument, and your office should implement a safety program for the Gemini 810 + 980 diode laser. If your office does not already have a safety officer, one should be appointed to be responsible for understanding proper use, safe operation, and maintenance of the Gemini laser system. Their duties should include training office personnel in all aspects of system safety and management of the Gemini laser and all accessories.
CAUTION: Ensure that all users are properly trained prior to use. Consult your distributor for training recommendations.
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WARNINGS & CAUTIONS
WARNING: Laser aperture at the end of the handpiece. WARNING: Laser aperture warning label affixed to system handpiece.
WARNING: Laser Safety Eye Protection MUST BE WORN by the Operator, Patient, Assistant, and anyone present when the laser is activated. Eye Protection must conform to Specification DIN EN207 Annex II of the Directive 89/686/EEC with wavelength protection
of 810 nm-980 nm, and ±10 nm of OD 5+ such as NoIR Laser
WARNING: Visible and Invisible Laser Radiation – Avoid eye or skin exposure to direct or scattered radiation.
Class IV Laser Product
WARNINGS & CAUTIONS
WARNING: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
WARNING: Do not open unit housing at any time. Danger from optical radiation may exist.
WARNING: The use of accessories, other than those specified, except those supplied or sold by Ultradent Products, Inc., as replacement parts for internal or external components, may result in increased EMMISSIONS or decreased IMMUNITY of the Gemini 810 + 980 diode laser. Refer to pages 44-48 for additional information.
WARNING: Do not aim the laser at metallic or reflective surfaces, such as surgical instruments or dental mirrors. If aimed directly at these surfaces the laser beam will reflect and create a potential hazard.
WARNING: Never direct or point the beam at a person’s eyes.
WARNING: Always place the system into STANDBY mode when leaving the Gemini 810 + 980 diode laser unattented for few minutes or between patients.
WARNING: Never operate the laser without a fiber tip attached.
WARNING: Do not look directly into the beam or at specular reflections.
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Company filter model CYN.
WHAT IS IN THE BOX
Purchase of the Gemini 810 + 980 diode laser includes the following.
Laser Unit
Disposable Tips (10)
Laser Warning Sign
Warranty Information
USB Cable
User Manual
Activation Pedal with 2 AA Batteries
*DC Power Supply
*Actual Power supply may vary from image
*Actual eyewear may vary from image
Fiber Delivery System
*Protective Eyewear (3)
NOTE: The laser ships with the lithium ion battery and fiber delivery
system already installed
WARNING: No modification of this equipment is allowed
NOTE: Use proper care when transporting the unit
UNPACKING INSTRUCTIONS
SHIPPING CONTAINER INFORMATION
A manufacturer or dealer representative can provide assistance when you are ready to remove the Laser from its shipping container. Please do not attempt to unpack theGemini 810 + 980 diode laser and install the system without reading this manual first. If you are unsure about any aspect of the assembly, call your customer service representative or dealer for assistance.
The shipping container you received with your Gemini 810 + 980 diode laser was specially designed to safely transport the device. In the unlikely event that you need to return the laser for service or repair, please retain the original shipping container.
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Display ........................................................................................................................................................................ 08
Keypad ..........................................................................................................................................................................09
Laser Unit .................................................................................................................................................................... 10
Activation Pedal ..........................................................................................................................................................11
Fiber Delivery System ................................................................................................................................................12
Quick Start ................................................................................................................................................................... 13
01 - Electronic Key Passcode ................................................................................................................ 14
02 - Selecting a Wavelength .................................................................................................................. 15
03 - Activation Pedal Connection ........................................................................................................ 16
04 - Manual Power Adjustment ............................................................................................................17
05 - Laser Standby and Active Modes ................................................................................................ 18
06 - 08 - Preset Procedures Settings ............................................................................................. 19-21
09 - Disposable Tip Operation ............................................................................................................. 22
10 - Initiation of Fiber Tips ................................................................................................................... 23
11 - Tip Illumination ................................................................................................................................ 23
12 - Sound .................................................................................................................................................. 24
13 - Aiming Light ...................................................................................................................................... 24
14 - Battery and Battery Level Indications ...................................................................................... 25
15 - Power Supply .................................................................................................................................... 25
16 - Fiber Wraping ................................................................................................................................... 26
17 - Hand Piece Magnet ........................................................................................................................... 27
18 - Operating Mode ............................................................................................................................... 27
19 - Emergency Stop ............................................................................................................................... 28
20 - Remote Interlock .............................................................................................................................28
21 - Transparent Electroluminescent Display ................................................................................... 29
Cleaning and Sterilization Procedures .................................................................... 30
Procedural Recomendations ...................................................................................... 32
Facility & Environmental Considerations ................................................................ 33
General Safety Considerations ...............................................................................34-37
System Specifications................................................................................................... 38
Service and Troubleshooting ................................................................................. 39-42
Regulatory Compliance ................................................................................................ 43
Electromagnetic Environment Guidance ............................................................ 44-48
Labeling ...................................................................................................................... 49-52
Overview
Controls - Operation & Use
TABLE OF CONTENTS
7
Whitening
8
OVERVIEW  DISPLAY
01
02
03
04
05
06
07 08 09 10 11 12
13
14
15
16
17
01  ELECTRONIC PASSCODE 07  VOLUME INDICATION 13  980 STANDBY MODE 02  PRESET PROCEDURES 08  REMOTE INTERLOCK 14  980 WAVELENGTH 03  SOUND LEVEL 09  POWER DIAL 15  980 ACTIVE MODE 04  810 ACTIVE MODE 10  BLUETOOTH 16  POWER INDICATION 05  810 WAVELENGTH 11  BATTERY LEVEL 17  AIMING LIGHT 06  810 STANDBY MODE 12  POWER ADAPTER
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OVERVIEW  KEYPAD
14 15
01  PRESET PROCEDURES 07  RIGHT ARROW 13  DOWN ARROW 02  TIP ILLUMINATION 08  980 WAVELENGTH 14  EMERGENCY STOP 03  DUAL WAVELENGTH 09  SOUND 15  ON/OFF 04  810 WAVELENGTH 10  AIMING LIGHT 05  LEFT ARROW 11  VOICE CONFIRMATION 06  UP ARROW 12 ACTIVE/STANDBY
01 02 03 04 05 06 07 08 09 10 11
12 13
Transparent Display
Strain Relief
Base
ON/OFF
Emergency
Stop
Optical Fiber
LED Tip
Micro USB
(factory use only)
Power Plug
Remote Interlock Port
Surgical Handpiece
Optical Fiber with Protection Tube
Keypad
OVERVIEW  LASER UNIT
10
60 to 100%
Active Connection
25 to 59%
0 to 24%
Laser Active turns green when pedal is pressed.
Battery Indicator
Bluetooth
Overstep/Shroud
Protection
Activation Area
Indicators
Battery Compartment Lid
AA Batteries (x2)
Label / Anti Skid Areas
OVERVIEW  ACTIVATION PEDAL
11
OVERVIEW  FIBER DELIVERY SYSTEM
The fiber delivery system is a unique and ergonomic optical cable that is non-detachable from the laser unit. The handpiece will require cleaning and sterilization after each patient treatment. Disposable tips are intended for single-use only and must be disposed of after each patient use.
Refer to page 30 for cleaning and sterilization procedures.
Anodized Aluminum Handpiece
Optical Ferrule
Bendable Stainless Steel Tube
Optical Fiber
Fiber Strain Relief
Illumination Tip
12
Turn counter-clockwise (Remove to Sterilize)
QUICK START
Plug In Power Supply
Insert AA Batteries into Activation Pedal
Turn Laser Unit ON
Enter Electronic Key Passcode
Select Your Desired Wavelength
Select Your Desired Power Setting
During initial setup use the AC/DC power supply for at least one hour to fully charge the battery. Plug the power supply into an AC outlet and connect to the corresponding connector on the rear of the system.
Install the (2) provided AA batteries into the wireless activation pedal. When replacing the AA betteries, we recomend an ALKALINE type battery.
The universal ON/OFF button is a membrane switch that requires pressure in order to be activated.
Enter the electronic key passcode on the keypad using the UP and DOWN arrow keys. The security code is UP, DOWN, UP, DOWN. A checkmark icon will appear when the correct key is input.
Select the desired laser wavelength on the keypad: 810 nm, 980 nm, or Dual Wavelength.
Select your desired power setting, then activate the laser. (Pages 17-21)
1.
2.
3.
4.
5.
6.
“Please select wavelength”
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01 - ELECTRONIC KEY PASSCODE
The Gemini 810 + 980 diode laser is equipped with an electronic key passcode. When you turn the laser unit on, the passcode key screen will be displayed at the bottom center of the screen. The correct passcode sequence should be entered on the Keypad:
UP, DOWN, UP, DOWN
CONTROLS, OPERATION & USE
Access to Laser will not be granted
until correct passcode is entered.
14
02 - SELECTING A WAVELENGTH
When the system is turned on, and the electronic passcode is properly input (Page 14), you will be prompted to select the desired wavelength. A voice confirmation will say, “Please select wavelength,” and two wavelength rings will flash. The Gemini 810 + 980 diode laser can operate in three wavelength modes: 810 nm alone, 980 nm alone, or Dual Wavelength. A wavelength mode must be selected before proceeding further, but may be changed at any time.
Flashing Wavelength RingFlashing Wavelength Ring
CONTROLS, OPERATION & USE
“810 STANDBY”
“980 STANDBY”
“DUAL WAVELENGTH STANDBY”
When you select the desired wavelength,
voice confirmation (if
enabled) will sound as
follows:
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03 - ACTIVATION PEDAL CONNECTION
Install the provided 2 AA batteries into the Activation Pedal.
Enter the passcode.
Depress the activation pedal. Connection between the activation pedal and laser unit is done automatically.
The activation pedal comes with a protective shroud to prevent accidental laser activation. Please do not step on the protective shroud as it could result in accidental damage to the activation pedal.
Turn the laser unit ON.
Select the wavelength of choice. A Bluetooth indicator will appear
on the display and activation pedal when it is properly connected and the laser is in Active mode.
Connecting the activation pedal to your laser unit via Bluetooth for the first time is simple.
CONTROLS, OPERATION & USE
16
X
04 - MANUAL POWER ADJUSTMENT
CLINICAL TIP
The Gemini 810 + 980 diode laser can output up to a maximum of 2.0 watts of average power. To adjust the power setting manually, touch the UP and DOWN or the LEFT and RIGHT arrows on the keypad. Each touch of an arrow raises or lowers the power by 0.1 watts. Touching and holding an arrow will increase the speed in which the power setting is raised or lowered. Touch the ACTIVE button to put the laser in active mode. Depress the activation pedal to activate the laser.
Maximum results will be achieved by regulating the power output of the laser and the speed at which the operator moves the fiber optic tip. Tissue charring is an undesirable aftereffect of using too much power or of the fiber tip moving too slowly.. Always use the least amount of power that is required to complete your procedure. The ideal treatment will result in little or no discoloration, less collateral damage, and faster healing.
Avoid penetrating or damaging the periosteum, and do not attempt to use the laser on alveolar bone. Because the laser energy is attracted to melanin and hemoglobin, power must be reduced when treating patients with dark-pigmented soft tissue.
CONTROLS, OPERATION & USE
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