Gemini 810 User Manual
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Gemini 810 User Manual

Gemini 810 User Manual

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  • Page 1 USER MANUAL...
  • Page 2 Meticulous Structured CREATIVE INCREDIBLY Innovative TECHNOLOGY FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A DENTIST OR PHYSICIAN OR OTHER LICENSED MEDICAL PRACTITIONER...
  • Page 3 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 se- lect laser settings that best suit specific procedures and patient needs based on tissue type and optimal wavelength absorption characteristics.
  • Page 4 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.
  • Page 5 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 Company filter model CYN.
  • Page 6 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.

  • Page 7: Table Of Contents

    TABLE OF CONTENTS Overview Display ..................................08 Keypad ..................................09 Laser Unit ..................................10 Activation Pedal ................................11 Fiber Delivery System ..............................12 Quick Start ................................... 13 Controls - Operation & Use 01 - Electronic Key Passcode ........................ 14 02 - Selecting a Wavelength ........................15 03 - Activation Pedal Connection ......................

  • Page 8: Display

    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...
  • Page 9 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...

  • Page 10: Keypad

    OVERVIEW - LASER UNIT Transparent Display Base LED Tip Optical Fiber Strain Relief Keypad Emergency Surgical Handpiece Stop ON/OFF Micro USB (factory use only) Power Plug Optical Fiber with Protection Tube Remote Interlock Port...

  • Page 11: Activation Pedal

    OVERVIEW - ACTIVATION PEDAL Indicators Overstep/Shroud Protection Battery Compartment Lid Label / Anti Skid Areas AA Batteries (x2) Activation Area Bluetooth Battery Indicator Active Connection 60 to 100% 25 to 59% Laser Active turns green when pedal is 0 to 24% pressed.

  • Page 12: Fiber Delivery System

    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.

  • Page 13: Quick Start

    Select Your Desired Wavelength Select the desired laser wavelength on the keypad: 810 nm, 980 nm, or Dual Wavelength. “Please select wavelength” Select Your Desired Power Setting Select your desired power setting, then activate the laser. (Pages 17-21)

  • Page 14: Controls, Operation & Use

    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...

  • Page 15: Selecting A 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.

  • Page 16: Activation Pedal Connection

    CONTROLS, OPERATION & USE 03 - ACTIVATION PEDAL CONNECTION Connecting the activation pedal to your laser unit via Bluetooth for the first time is simple. Enter the passcode. Install the provided 2 AA batteries Turn the laser unit ON. into the Activation Pedal. Select the wavelength of choice.

  • Page 17: Manual Power Adjustment

    04 - MANUAL POWER ADJUSTMENT 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.

  • Page 18: Laser Standby And Active Modes

    There is also an audio beep when laser is being fired. For safety purposes, a laser firing delay of 0.25 seconds was implemented in order to prevent accidental activation. SYSTEM IN STANDBY MODE SYSTEM IN ACTIVE MODE “810 ACTIVE” “810 STANDBY” “980 ACTIVE” “980 STANDBY” WAVELENGTH - ACTIVE MODE WAVELENGTH - STANDBY MODE “DUAL...

  • Page 19: Preset Procedures Settings

    CONTROLS, OPERATION & USE 06 - PRESET PROCEDURE SETTINGS Touch the PROCEDURES selection to bring up all the preset procedures on the display. Selecting the LEFT and RIGHT arrows will toggle between GENERAL DENTISTRY, ORTHODONTICS or HYGIENE categories. Selecting the UP and DOWN arrows will toggle between procedures within each category. The corresponding power setting for each procedure is displayed on the Power Indicator when the procedure is highlighted.
  • Page 20 CONTROLS, OPERATION & USE 07 - PRESET PROCEDURE SETTINGS The Gemini 810 + 980 diode laser has 20 preset procedures listed under three categories: General Dentistry, Orthodontics, and Hygiene. Within each category are the most commonly used procedures with suggested power settings. Aways use the minimum amount of power necessary to perform a particular procedure.
  • Page 21 CONTROLS, OPERATION & USE 08 - CUSTOMIZING PRESET PROCEDURE SETTINGS The Gemini laser’s preset procedure settings can be customized. To save your own procedure setting, press PROCEDURES once to bring up preset procedures on the display and navigate to the procedure you would like to customize.

  • Page 22: Disposable Tip Operation

    CONTROLS, OPERATION & USE 09 - DISPOSABLE TIP OPERATION The disposable fiber tip is relatively flexible, but can be broken if bent at an angle that is too sharp. Use the provided Bending Tool to bend the tip to the desired angle. Do not bend the tip any more than the Bending Tool allows.

  • Page 23: Initiation Of Fiber Tips

    Follow the procedure above to uninitiate a fiber tip. 11 - TIP ILLUMINATION The Gemini 810 + 980 diode laser’s handpiece is equipped with a tip illumination light to provide better visibility of the surgical site during treatment. To toggle the light intensity between LOW, HIGH, and DISABLED, touch the TIP ILLUMINATION selection on the keypad.

  • Page 24: Sound

    CONTROLS, OPERATION & USE 12- SOUND The system’s default sound volume level is Medium. Touch the SOUND selection on the keypad to bring up the sound levels. Adjust the sound level by touching the UP and DOWN arrow on the keypad. To exit, touch any key on the keypad. This will confirm and save your selection. The system remembers the last used sound setting when it is powered on.

  • Page 25: Battery And Battery Level Indications

    14 - BATTERY and BATTERY LEVEL INDICATIONS The Gemini 810 + 980 diode laser is equipped with a powerful nano-core lithium polymer battery capable of delivering a full day of laser usage and lasting several days in Standby mode. Simply connect the provided power supply to the rear of the unit and charging will start immediately.

  • Page 26: Fiber Wraping

    CONTROLS, OPERATION & USE 16 - FIBER WRAPPING A fiber wrapping system was built within the laser unit in order to provide a safe and convenient way to manage and store the optical fiber system. To store the fiber properly, always wrap in a clockwise direction to protect and store the fiber optic cable when not in use.

  • Page 27: Handpiece Magnet

    CONTROLS, OPERATION & USE 17 - HANDPIECE MAGNET The Gemini 810 + 980 diode laser is designed with a strong magnet that will secure the surgical handpiece in place when the laser is not in use. Gently place the handpiece behind the transparent display over the neck of the laser unit and the magnet will hold the handpiece in place.

  • Page 28: Emergency Stop

    19 - EMERGENCY STOP The Gemini 810 + 980 diode laser can be immediately deactivated in any mode, at any time, and at any power setting by pressing the red STOP button located in the front left of the system.

  • Page 29: Transparent Electroluminescent Display

    CONTROLS, OPERATION & USE 21 - TRANSPARENT ELECTROLUMINESCENT DISPLAY The Gemini 810 + 980 diode laser is designed with a unique transparent electroluminescent display, which produces high-resolution images that can be viewed from a field of vision up to 170 degrees.

  • Page 30: Cleaning And Sterilization Procedures

    CLEANING AND STERILIZATION PROCEDURES GUIDELINES The Gemini 810 + 980 diode laser is not supplied in sterile condition, nor must it be sterilized before use with the exception of the handpiece. The following cleaning and sterilization procedures are recommended before the initial use and after each subsequent use: 1.
  • Page 31 CLEANING AND STERILIZATION PROCEDURES 1. Place the handpiece shell in a separate single-wrap, self-seal autoclave pouch. 2. Place on an autoclave tray with paper side up; do not stack other instruments on top of the pouch. 3. Place the tray inside the autoclave chamber and set the cycle to 135° C (275° F) for a minimum of 15 minutes, with a dry time of 30 minutes.

  • Page 32: Procedural Recomendations

    The clinician must completely understand the patient’s medical history prior to treatment. INDICATIONS FOR USE The particular and specific intended use of the Gemini 810+980 Diode Laser is to remove, ablate and coagulate tissue, mainly used for dental surgical procedures and is marketed as a dental soft tissue surgical product.

  • Page 33: Facility & Environmental Considerations

    Gemini laser unit. In order to ensure the safe use of the Gemini 810 + 980 diode laser in your facility, please check to make sure that the proposed location is compatible with the specifications listed below.

  • Page 34: General Safety Considerations

    GENERAL SAFETY CONSIDERATIONS GUIDELINES Safe use of the Gemini 810 + 980 diode laser is the responsibility of the entire dental team including the doctor, any system operators, and the dental office safety officer. MARKETING REQUIREMENTS REGARDING MEDICAL DEVICE SAFETY (USA) The United States Food and Drug Administration (FDA) has control over the sale and use of all medical devices including the Gemini 810 + 980 diode laser.
  • Page 35 Extended exposure to such energy could cause patient discomfort and even lead to possible pulpal necrosis. ADVERSE EFFECTS If used properly, there are no known adverse effects of using the Gemini 810 + 980 diode laser. Please thoroughly read and understand all warning, precautions, and contra-indications in this manual prior to use.
  • Page 36 GENERAL SAFETY CONSIDERATIONS EYE AND SKIN PROTECTION While the Gemini 810 + 980 diode laser is in use, doctors, system operators, auxiliary staff, patients, and anyone in the operatory must wear the appropriate safety eyewear that has been designed for use with the wavelengths of 800 nm and higher that are associated with lasers. Eye protection must conform to Specification DIN EN207 Annex II of the Directive 89/686/EEC with optical density of OD+5 for the wavelength range of 800 nm–1000 nm such as NoIR Laser Company filter model CYN.
  • Page 37 GENERAL SAFETY CONSIDERATIONS EMERGENCY SHUTDOWN OPTIONS: Perform any of these actions to terminate laser emissions in the event of a real or perceived emergency: Press the emergency “STOP” button. Press the “ON/OFF” button. Touch the ACTIVE/STANDBY keypad selection Remote Interlock open circuit deactivates the Laser Release your foot from the Activation Pedal...

  • Page 38: System Specifications

    Battery: 11.1V Rechargeable Lithium Ion Wireless frequency: Bluetooth at 2.4 GHz Maximum Operating Altitude: 5,000 meters or 16,404 feet THE GEMINI 810 + 980 DIODE LASER COMPLIES WITH THE FOLLOWING • 21 CFR 1040.10 and 1040.11 • IEC 60825-1 •...

  • Page 39: Service And Troubleshooting

    ALL OTHER CONDITIONS In the event that the Gemini 810 + 980 diode laser fails to operate correctly and your distributor representative is unable to help, the system will need to be returned to the manufacturer for repair.
  • Page 40 SERVICE AND TROUBLESHOOTING TROUBLESHOOTING GUIDE WHY IS THE AIMING LIGHT OFF OR BARELY VISIBLE? CAUSE: 1 - The laser is in STANDBY mode. 2 - The disposable tip is defective. 3 - The fiber optic cable is damaged or broken. SOLUTION: 1 - Touch the ACTIVE/STANDBY selection on the keypad to put the system in Active mode.
  • Page 41 SERVICE AND TROUBLESHOOTING WHY DOES THE LASER NOT FIRE WHEN I PRESS THE ACTIVATION PEDAL? CAUSE: 1 - Activation pedal not connected. 2 - Activation pedal AA Batteries are too low to operate. 3 - Laser is in Standby mode. SOLUTION: 1 - Check to see if the Bluetooth indicator on the activation pedal is on, and if there is a Bluetooth indicator on the top right of the display.
  • Page 42 Please wait a few minutes for the temperature to descrease before resuming normal operations. ACTIVATION PEDAL DISCONNECTED The Gemini 810 + 980 diode laser is equipped with a long range Bluetooth chip. Please check the two AA batteries in the activation pedal and replace if needed.

  • Page 43: Regulatory Compliance

    REGULATORY COMPLIANCE FCC/INDUSTRY CANADA TWO PART STATEMENT This device complies with FCC Part 15 and Industry Canada license exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

  • Page 44: Electromagnetic Environment Guidance

    2402 to 2480 MHz with TX power of +0dBm and RX sensitivity of -93dBm and uses GFSK modulation. The pedal is pre-configured by the manufacturer to only sync with the Gemini laser unit that has a matching unique identifier. This prevents interference with other RF wireless technologies that may be present.
  • Page 45 ELECTROMAGNETIC EMISSION The Gemini 810 + 980 diode laser is intended for operation in the electromagnetic environment specified below. The customer or user of the Gemini laser should make sure that it is used in such an environment. GUIDANCE ELECTROMAGNETIC ENVIRONMENT –...
  • Page 46 ELECTROMAGNETIC ENVIRONMENT GUIDANCE INTERFERENCE IMMUNITY The Gemini 810 + 980 diode laser is intended for operation in the electromagnetic environment specified below. The customer or user of the Gemini laser should make sure that it is used in such an environment. INTERFERENCE...
  • Page 47 HF transmitters. If the measured field strength in the location in which the Gemini 810 + 980 diode laser is used exceeds the applicable RF compliance level above, the Gemini laser unit should be observed to verify normal operation.
  • Page 48 The Gemini 810 + 980 diode laser is intended for operation in an electromagnetic environment where radiated HF interference is checked. The customer or the user of the Gemini laser can help prevent electromagnetic interference by duly observing the minimum distances between portable and/or mobile RF communication devices (transmitters) and the Gemini laser unit.

  • Page 49: Labeling

    EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATED JUNE 24, 2007 THIS PRODUCT COMPLIES WITH FDA Power Input: 13V - 3.5A PERFORMANCE STANDARDS FOR LASER Model: GEMINI 810+980 DIODE LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATE Connect only to provided power supply.
  • Page 50 13V / 3.5A Service Only EMERGENCY TERMINATION OF LASER EMISSIONS The Gemini 810 + 980 diode laser has been designed with several methods to terminate emission of laser energy in emergency situations. These methods include a power button (ON/OFF) and the emergency (STOP) button located at the front of the laser unit.
  • Page 51 LABELING DESCRIPTION SYMBOLS SYMBOLS MANUFACTURER SHIP VERTICAL, WITH INDICATES WHICH COMPANY ARROWS POINTED UPWARD MANUFACTURES DATE OF MANUFACTURE FRAGILE - HANDLE WITH INDICATES THE DATE AND YEAR OF CARE MANUFACTURE CATALOG PART NUMBER DO NOT USE IF PACKAGE IS INDICATES THE MANUFACTURER DAMAGED PART NUMBER.
  • Page 52 Serial Number COMPLIES WITH: IEC 60601-2-22:2007 / IEC 60825-1:2007 Power Input: AA Batteries Model: GEMINI 810+980 DIODE LASER AS WELL AS TO US FEDERAL REGULATIONS FOR LASER PERFORMANCE STANDARDS SET OUT IN 21CFR 1040.10 AND 1040.11 COMPLIES WITH: IEC 60601-2-22:2007 / IEC 60825-1:2007...
  • Page 56 800.552.5512 U L T R A D E N T . C O M Manufactured by Azena Medical. 21 Massolo Dr, Pleasant Hill, CA 94523. Made in USA. 3021 Citrus Circle, Suite 180, Walnut Creek, CA 94598 USA. Made in USA. 8989.1 8989.3 102015...

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