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LABELING

UNIT LABEL

PEDAL LABEL

SYMBOLS

DESCRIPTION

TYPE B APPLIED PART

THE APPLIED PART IS NOT CONDUCTIVE TO THE

PATIENT

LASER STOP

EMERGENCY SWITCH TO STOP LASER OUTPUT POWER

NON-IONIZING RADIATION

REFER TO USER’S MANUAL

BARCODE LABEL

Power Input: 13V - 3.5A

Model: GEMINI 810+980 DIODE LASER

Connect only to provided power supply.

ID:

IC:

Refer to

User’s Manual

The applied part is not

conductive to the patient

DANGER. Visible and/or

invisible laser radiation

Non-ionozing

Radiation

COMPLIES WITH: IEC 60601-2-22:2007 / IEC 60825-1:2007

AS WELL AS TO US FEDERAL REGULATIONS FOR LASER PERFORMANCE

STANDARDS SET OUT IN 21CFR 1040.10 AND 1040.11

EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATED JUNE 24, 2007

EC REP

Distributed by

European Rep

ULTRADENT PRODUCTS, INC

505 West 10200 South

South Jordan, UT
84095 - USA

1 (888) 230-1420

EMERGO EUROPE

Molenstraat 15

2513 BH, The Hague

The Netherlands

AZENA MEDICAL, LLC

21 Massolo Dr. - Unit C

Pleasant Hill, CA
94523 - USA

1 (800)466-5273

Manufactured by

Manufacture Date

Part Number

Serial Number

REF

THIS PRODUCT COMPLIES WITH FDA

PERFORMANCE STANDARDS FOR LASER

PRODUCTS EXCEPT FOR DEVIATIONS

PURSUANT TO LASER NOTICE 50 DATE

JUNE 24, 2007

0086

Non-ionozing

Radiation

Refer to

User’s Manual

Distributed by

ULTRADENT PRODUCTS, INC

505 West 10200 South

South Jordan, UT

84095 - USA

1 (888) 230-1420

THIS DEVICE COMPLIES WITH PART 15 OF FCC RULES.

OPERATION IS SUBJECT TO THE FOLLOWING TWO

CONDITIONS:

1) THIS DEVICE MAY NOT CAUSE HARMFUL INTERFERENCE

2) THIS DEVICE MUST ACCEPT ANY INTERFERENCE RECEIVED

INCLUDING INTERFERENCE THAT MAY CAUSE UNDESIRABLE

INTERFERENCE

COMPLIES WITH: IEC 60601-2-22:2007 / IEC 60825-1:2007

AS WELL AS TO US FEDERAL REGULATIONS FOR LASER

PERFORMANCE STANDARDS SET OUT IN 21CFR 1040.10

AND 1040.11 EXCEPT FOR DEVIATIONS PURSUANT

TO LASER NOTICE 50 DATED JUNE 24, 2007

AZENA MEDICAL, LLC

21 Massolo Dr. - Unit C

Pleasant Hill, CA
94523 - USA

1 (800)466-5273

Manufactured by

Power Input: AA Batteries

Model: GEMINI 810+980 DIODE LASER

Manufacture Date

Part Number

Serial Number

REF

EC REP

European Rep

EMERGO EUROPE

Molenstraat 15

2513 BH, The Hague
The Netherlands

0086

WESTERN EUROPE ELECTRONIC AND ELECTRICAL

DISPOSAL STANDARD (WEEE)

Содержание 810

Страница 1: ...USER MANUAL ...

Страница 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 ...

Страница 3: ...ent needs based on tissue type and optimal wavelength absorption characteristics You will discover that the Gemini 810 980 diode laser cuts faster reduc es tissue tagging and generates less collateral thermal heat than other di ode 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 pat...

Страница 4: ...ibility 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 Se...

Страница 5: ...it 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 lase...

Страница 6: ...per 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 ...

Страница 7: ...ound 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 Sp...

Страница 8: ...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 ...

Страница 9: ...T 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 ...

Страница 10: ...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 ...

Страница 11: ...5 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 ...

Страница 12: ...ng 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 ...

Страница 13: ...all 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...

Страница 14: ...y 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 ...

Страница 15: ... 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 Ring Flashing Wavelength Ring CONTROLS OPERATION USE 810 STANDBY 980 STANDBY DUAL WAVELENGTH STANDBY When you select the desired wavelength voice confirmati...

Страница 16: ... 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 Blu...

Страница 17: ...ser 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 c...

Страница 18: ...laser is in Active mode When the system is in Active mode touching any selection other than UP and DOWN or LEFT and RIGHT will return the system to the Standby mode When the activation pedal is depressed in the Active mode the outer indicator ring around each wavelength icon on the display flashes to provide a visual indication that the laser is firing There is also an audio beep when laser is bei...

Страница 19: ...RAL 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 A Simulated Screen showing the preset Gingivectomy procedure and dual wavelength mode selected CONTROLS OPERATION USE 19 ...

Страница 20: ...osure Yes 1 0 W 1 3 W 1 2 W Initiated Tip Aphthous Ulcer No 0 6 W 0 8 W 0 7 W Uninitiated Tip Operculectomy Yes 1 4 W 1 8 W 1 6 W Initiated Tip Frenectomy Yes 1 0 W 1 3 W 1 2 W Initiated Tip Implant Recovery Yes 1 3 W 1 7 W 1 5 W Initiated Tip Implant Recovery Yes 1 1 W 1 4 W 1 3 W Initiated Tip Hemostasis Yes 0 8 W 1 0 W 0 9 W Initiated Tip Frenectomy Yes 1 1 W 1 4 W 1 3 W Initiated Tip 810 810 8...

Страница 21: ...d Power Dial will start flashing on the display Use UP DOWN or LEFT RIGHT to adjust the new average power to the desired setting To save the setting press and hold the PROCEDURES key for 3 seconds You will hear two audible beeps when the setting has been saved To reset all preset procedure settingstothefactorydefault press PROCEDURES once to bring up preset procedures on the display then press and...

Страница 22: ...al tissue accumulates on the fiber tip during surgery and the extreme heat that develops will deteriorate the optical efficiency Fibers can fracture if a blackened area greater than 3 4 mm develops Replace the disposable single use fiber optic tip as necessary and for each new patient The tips are provided in a sealed package Each tip contains a pre cleaved pre stripped piece of fiber They are des...

Страница 23: ...ation or the treatment of aphthous ulcers do not require the laser tip to be initiated One way to initiate the tip is to rub the tip on articulating film while firing the laser on a low power setting IMPORTANT NOTE Not all soft tissue procedures require an initiated or darkened tip and contact with tissue Those procedures that do not require tissue contact will use a fiber tip that is NOT initiate...

Страница 24: ...ound setting when it is powered on Voice Confirmation can be turned ON and OFF by touching the voice confirmation selection on the keypad The system s default aiming light level is Medium Touch the AIMING LIGHT selection on the keypay to bring up the aiming light levels Adjust the aiming light level by touching the UP and DOWN arrow on the keypad To exit touch any key on the keypad This will confi...

Страница 25: ...nterruption 100 Standby Time Standby Time Standby Time Standby Time Usage Time Usage Time Usage Time Usage Time 75 50 25 1 Day Minimum of 60 minutes of charging is required before first use Please connect power supply reminder 3 Days 5 Days 7 Days 1 5Hours 1 0Hours 30 min 15 min 0 15 POWER SUPPLY Use only the provided 13V 4A AC DC power supply for charging the system battery and as an alternate la...

Страница 26: ...er diodes to the target tissues These fibers are made of a thin glass silica Note that there are potential hazards when inserting steeply bending or improperly securing the fiber optic tips to the handpiece Failure to follow these recommendations may lead to damage of the fiber or delivery system and or harm to the patient staff or laser operator CAUTION AVOID DAMAGING THE FIBER Do not wrap the fi...

Страница 27: ...r unit and the magnet will hold the handpiece in place Neck Magnet 18 OPERATING MODE The Gemini 810 980 diode laser will only deliver energy in pulsed temporal emission mode and is optimized to efficiently deliver energy and provide the operator with ideal control of target tissue temperatures The pulse width is fixed and not user adjustable The operator will only need to adjust the laser waveleng...

Страница 28: ...tablish a dedicated laser treatment room with a remote interlock connector A switch on the entrance door is attached and is electronically wired into the laser unit via 2 3 mm plug jack When the door to the room is opened the connector switch provides an electrically open circuit that deactivates laser emissions To use the remote interlock feature an interlock connector switch and cable must be pu...

Страница 29: ...0 transparency and an arch of 32 degress for optimal viewing angle from any direction The light is generated by a thin film less than a micron thick of specially designed electroluminescent phosphor Display type Electroluminescent Transparency 92 Brightness 300 cd m 2 Color Broadband Yellow Peak Wavelength 582 nm Voltage 180V AC Response time 1 8 ms Glass type Float Glass Glass thickness 1 1 mm fu...

Страница 30: ...ce and dispose of in an infectious waste container SHARPS 2 Clean the handpiece and attached fiber cable by using one CaviWipes towelette or equivalent product to completely pre clean exposed areas of all gross debris Be sure to wipe the threaded area where the disposable tip attaches 3 Remove the handpiece shell following the instructions on the next page Use a fresh towelette to pre clean the ne...

Страница 31: ...edures The keypad and electroluminescent display should be covered with a protective clear adhesive barrier film replaceable after each patient If the exterior of the laser unit becomes contaminated it should be wiped down with CaviWipes or equivalent product then re covered with a new protective plastic cover DO NOT spray any disinfectant directly on the laser unit because it could damage the tra...

Страница 32: ... with traditional techniques and instruments Patient risk must always be considered and fully understood before clinical treatment The clinician must completely understand the patient s medical history prior to treatment 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...

Страница 33: ...0 104 F and 95 relative humidity or less Transportation and storage environmental conditions to be within 20 to 50 C 4 to 122 F and relative humidity of 10 to 95 or less Atmospheric pressure to be within 50kPa 106kPa in operating transportation and storage conditions All gases that are combustible or support combustion and are used in the operatory area where the Gemini 810 980 diode laser is bein...

Страница 34: ...eted Class II devices Usually states or provinces do not have a specific licensure requirement for use of surgical laser devices by dentists Many states do however require hygienists who will be using lasers to attend licensure training that includes both a lecture and hands on experience The license applicants are then required to pass a proficiency test for certification prior to using lasers Th...

Страница 35: ...ease bleeding disorders and immune system deficiency or any medical conditions or medications that may contra indicate use of certain light laser type sources associated with this device Medical clearance from patient s physician is advisable when doubt exists regarding treatment The Gemini 810 980 diode laser is not indicated for hard tissue procedures The Laser is attracted to melanin hemoglobin...

Страница 36: ...its Maximum Permissible Exposure MPE highest level of laser radiation to which a person may be exposed without hazardous effects or adverse biological changes in the eyes or skin The Nominal Hazard Zone NHZ is the space within which the level of direct reflected or scattered radiation during normal operation exceeds the appropriate MPEs The outer limit of the NHZ is equal to the NOHD The NOHD for ...

Страница 37: ...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 37 ...

Страница 38: ...ming beam wavelength 650 10 nm Aiming beam power 5mW max Beam divergence 617 mrad Power range 0 1 Watt to 2 0 Watts Average Pulse frequency 50 Hz Pulse width Variable Duty cycle Variable Voice confirmation YES Power requirements 100 240 VAC 50 to 60 Hz 13V Current 4 0 Amps Battery 11 1V Rechargeable Lithium Ion Wireless frequency Bluetooth at 2 4 GHz Maximum Operating Altitude 5 000 meters or 16 4...

Страница 39: ...be checked at 0 5 1 0 1 5 and 2 0 watts The power meter display should be within 20 of the meter reading If not replace the fiber tip If the output is still outside the 20 tolerance the system must be returned to the manufacturer for re calibration The laser unit cannot be re calibrated by the user or service contractor and this must not be attempted This equipment has been tested and found to com...

Страница 40: ...w to operate the laser SOLUTION 1 Allow 10 15 minutes for laser to cool down 2 Turn off the laser unit and wait 5 minutes then turn the unit back on If the laser performs when re tried the microprocessor has been able to make adjustments and the unit will function properly If the unit fails to fire when re tried the device will need to be sent for re calibration by the manufacturer 3 Plug in the p...

Страница 41: ...er a wavelength mode is selected to re sync 2 Replace the two AA batteries in the activation pedal 3 Touch the ACTIVE STANDBY selection to activate the laser SERVICE AND TROUBLESHOOTING I CAN HEAR THE LASER FIRING BUT IT IS CUTTING SLOWLY OR NOT CUTTING AT ALL CAUSE 1 Fiber tip is not initiated 2 Fiber tip is not in contact with tissue 3 Power setting is too low SOLUTION 1 The fiber tip should be ...

Страница 42: ... few minutes for the temperature to descrease before resuming normal operations 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 Press the activation pedal once to reactivate the connection with the laser unit The Bluetooth icon on the activation pedal will turn blue and the Bluetooth symbol ...

Страница 43: ...duire de brouillage et 2 I utilisateur de I appareil doit accepter tout brouillage radioélectrique subi meme si le brouillage est susceptible d en compromettre le fonctionnement This device complies with Health Canada s Safety Code The installer of this device should ensure that RF radiation is not emitted in excess of Health Canada s requirement Information can be obtained at http www hc sc gc ca...

Страница 44: ...ting section of this manual should you encounter any connectivity issues between the laser unit and the activation pedal This device has passed wireless coexistence testing with common devices found in dental practices at a minimum separation distance of 30 cm Accessories Medical grade power supply Maximum length 6ft 1 8 meters Ultradent P N 8981 Activation Pedal Wireless Bluetooth at 2 4GHz Ultra...

Страница 45: ...laser should make sure that it is used in such an environment DEFINITIONS ELECTROMAGNETIC EMISSION EMISSION TEST RF emissions according to CISPR 11 RF emissions according to CISPR 11 Harmonic emissions ac cording to IEC 61000 3 2 Voltage fluctuations flick er emissions according to IEC 61000 3 3 GROUP 1 CLASS B CLASS A COMPLIES The Gemini laser uses RF energy only for its internal function Therefo...

Страница 46: ...r a bat tery Electrostatic discharge ESD according to IEC 61000 4 2 Electrical fast transient burst according to IEC 61000 4 4 Magnetic field of power frequen cies 50 60 Hz according to IEC 61000 4 8 Surge voltages according to IEC 61000 4 5 Voltage dips short inter ruptions and variations of the power supply according to IEC 61000 4 11 6 kV contact discharge 8 kV air discharge 1kV for input and o...

Страница 47: ...w ing graphic symbol Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m NOTES 1 The higher frequency range applies at 80 MHz and 800 MHz 2 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predic...

Страница 48: ... the relevant communication device as specified below For transmitters whose maximum nominal output is not specified in the above table the recommended working clearance d in meters m can be determined using the equation in the corresponding column where P is the maximum nominal output of the transmitter in watts W specified by the transmitter manufacturer Remark 1 The higher frequency range appli...

Страница 49: ...RODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATE JUNE 24 2007 0086 ID IC Non ionozing Radiation Refer to User s Manual Distributed by ULTRADENT PRODUCTS INC 505 West 10200 South South Jordan UT 84095 USA 1 888 230 1420 THIS DEVICE COMPLIES WITH PART 15 OF FCC RULES OPERATION IS SUBJECT TO THE FOLLOWING TWO CONDITIONS 1 THIS DE...

Страница 50: ...th 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 ON OFF STOP LABELING Laser Aperture Mini USB DC Power 13V 3 5A Remote Interlock Service Only 50 LASER APERTURE ...

Страница 51: ... WHICH COMPANY MANUFACTURES DATE OF MANUFACTURE INDICATES THE DATE AND YEAR OF MANUFACTURE CATALOG PART NUMBER INDICATES THE MANUFACTURER PART NUMBER SERIAL NUMBER INDICATES SERIAL NUMBER FOR THE PRODUCT PART LASER APERTURE INDICATES WHERE LASER ENERGY COMES OUT 51 PN REF SN 70kPa 106kPa 10 95 0 C 32 F 40 C 104 F SHIP VERTICAL WITH ARROWS POINTED UPWARD FRAGILE HANDLE WITH CARE DO NOT USE IF PACKA...

Страница 52: ...y Manufacture Date Part Number Serial Number SN PN REF THIS PRODUCT COMPLIES WITH FDA PERFORMANCE STANDARDS FOR LASER PRODUCTS EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATE JUNE 24 2007 0086 ID IC Non ionozing Radiation Refer to User s Manual Distributed by ULTRADENT PRODUCTS INC 505 West 10200 South South Jordan UT 84095 USA 1 888 230 1420 THIS DEVICE COMPLIES WITH PART 15 OF FCC RULES O...

Страница 53: ...2 two years from 8989 2 112216 ...

Страница 54: ......

Страница 55: ......

Страница 56: ...12 Manufactured by Azena Medical 21 Massolo Dr Pleasant Hill CA 94523 Made in USA Distributed by Ultradent Products Inc 505 West Ultradent Drive South Jordan Utah 84095 8989 3 080917 3021 Citrus Circle Suite 180 Walnut Creek CA 94598 USA Made in USA ...

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