Ultradent Products GEMINIEVO 810 DIODE LASE Скачать руководство пользователя страница 62

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ELECTROMAGNETIC ENVIRONMENT GUIDANCE

INTERFERENCE

IMMUNITY TEST

IEC 60601-1-2

TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC

ENVIRONMENT GUIDANCE

Electrostatic discharge

(ESD) according to IEC

61000-4-2

+/- 2, +/-4, +/- 6, +/-8 kV

contact discharge

+/- 2, +/-4, +/-8 kV, +/-15 kV

air discharge

+/- 2, +/-4, +/- 6, +/-8 kV

contact discharge

+/- 2, +/-4, +/-8 kV, +/-15 kV

air discharge

Floors should be wood, concrete, or ceramic tile.

If floors are covered with synthetic material, the

relative humidity should be at least 50%.

Electrical fast transient/

burst according to IEC

61000-4-4

100kHz repe/- 2kV for

power supply lines

100kHz repe/- 2kV for

power input/output lines

100kHz repe/- 2kV for

power supply lines

Not applicable

The quality of the line power supply should be that

of a typical commercial or hospital environment.

Surge voltages according

to IEC 61000-4-5

± 1 kV differential mode

± 2 kV common mode

voltage

± 1 kV differential mode

± 2 kV common mode

voltage

The quality of the line power supply should be that

of a typical commercial or hospital environment.

Voltage dips, short

interruptions and

variations of the power

supply according to IEC

61000-4-11

Voltage (VAC) 100, 240 over

0% residual with ½ cycles on

a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

0% residual with 1

cycles on a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

70% residual with 25

cycles on a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

0% residual with 250

cycles on a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

0% residual with ½ cycles on

a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

0% residual with 1

cycles on a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

70% residual with 25

cycles on a phase angle of

0 ° / 90 ° / 180° / 270 °

Voltage (VAC) 100, 240 over

0% residual with 250

cycles on a phase angle of

0 ° / 90 ° / 180° / 270 °

The quality of the line power supply should be that

of a typical commercial or hospital environment.

If the user of the Gemini EVO laser requires it to

continue functioning following interruptions of the

power supply, it is recommended to have the Gemini

EVO laser powered by an uninterruptible power

supply or a battery.

Magnetic field of power

frequencies (50/60 Hz)

according to IEC 61000-4-8

3 A/m

Power frequency magnetic fields should be at

levels characteristic of a typical location in a typical

commercial or hospital environment

Interference Immunity

The Gemini EVO laser is intended for operation in the electromagnetic environment specified below. The customer or user

of the Gemini EVO laser should make sure that it is used in such an environment.

Содержание GEMINIEVO 810 DIODE LASE

Страница 1: ...U S E R M A N U A L ...

Страница 2: ......

Страница 3: ...FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A DENTIST OR PHYSICIAN OR OTHER LICENSED MEDICAL PRACTITIONER ...

Страница 4: ...sult your distributor for training recommendations Mandatory training on the Gemini EVO laser is done via this manual CAUTION Do not modify this equipment without authorization of the manufacturer CAUTION Laser fume and or plume may contain viable tissue particles CAUTION Always wind the fiber optic cable in a clockwise manner around the fiber wrap to avoid fiber breakage See Page 33 CAUTION Do no...

Страница 5: ...m will reflect and create a potential hazard WARNING Never operate the laser without a fiber tip attached WARNING Laser aperture at the end of the handpiece WARNING Laser aperture warning label affixed to system handpiece WARNING Always place the system into STBY mode when leaving the Gemini EVO 810 980 soft tissue laser unattended for a few minutes or between patients WARNING Use of controls or a...

Страница 6: ...ining Card Information and User s Manual Please note Warranty Information is included in back of the User s Manual UNPACKING INSTRUCTIONS 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 the Gemini EVO 810 980 soft tissue laser or install the system without reading this manual first If ...

Страница 7: ...ng Light 23 11 Photobiomodulation PBM 24 29 12 Disposable Tip Operation 30 31 13 Battery and Battery Level Indications 32 14 Power Supply 32 15 Fiber Wrapping 33 16 Handpiece Magnet 34 17 Operating Mode 34 18 Emergency Stop 35 19 Remote Interlock 35 20 Adding New Activation Pedal and Pairing 36 21 Transparent Electroluminescent Display 37 22 Wi Fi Connectivity and Dashboard 38 45 Cleaning and Ster...

Страница 8: ... SOUND LEVEL 07 POWER BAR 08 VOLUME INDICATION 09 REMOTE INTERLOCK 10 SOFTWARE UPDATE 11 WI FI STRENGTH 12 BLUETOOTH 13 BATTERY 14 POWER SUPPLY 15 POWER INDICATOR 16 SOFTWARE VERSION 17 AIMING LIGHT LEVEL 18 980 WAVELENGTH 19 980 ACTIVE STBY 20 VALUE TYPE INDICATOR 03 04 05 06 07 02 01 08 10 12 14 15 16 17 18 19 20 13 11 09 ...

Страница 9: ...ENU SELECTION 08 VOICE CONFIRMATION 09 TIP ILLUMINATION 10 SOUND 11 ACTIVE STBY 12 UP DOWN ARROWS 13 LEFT RIGHT ARROWS 14 AIMING LIGHT 15 HAPTIC SENSE 16 AVAILABLE UPDATES 17 PRESET PROCEDURES 18 HOME PRESET TIP LIGHT SOUND VOICE MENU WI FI ACTIVE STBY AIMING UPDATE HOME 810 980 DUAL HAPTIC 09 08 07 06 10 11 12 13 14 15 18 17 16 01 02 03 04 05 ...

Страница 10: ...y Strain Relief Base ON OFF Emergency Stop Optical Fiber LED Tip Magnetic Handpiece Holder Mini USB factory use only External Power Supply Plug Remote Interlock Port Surgical Handpiece Optical Fiber with Protection Tube Guided Touch Interface ...

Страница 11: ...y indication shows red 25 to 59 0 to 24 Laser Active turns green when pedal is pressed Haptic Sense HS indicator Battery Indicator Bluetooth Overstep Shroud Protection Activation Area Pedal Status Indicators Battery Compartment Lid AA Batteries x2 Label Anti Skid Areas L A S E R A C T IV E B A T T E R Y L E V E L B L U E T O O T H C O N N E C T IO N H A P T IC F E E D B A C K ...

Страница 12: ...h patient treatment Disposable tips are intended for single use only and must be disposed of after each patient use Refer to pages 46 48 for cleaning and sterilization procedures Anodized Aluminum Handpiece Optical Ferrule Do Not Touch Bendable Stainless Steel Tube Optical Fiber Fiber Strain Relief Illumination Tip Turn counter clockwise Remove to Sterilize Haptic Sense HS Enabled only with PBM pr...

Страница 13: ...brane switch which requires pressure click in order to be activated 4 Enter Electronic Key Passcode Enter the electronic key passcode on the Guided Touch Interface using the Up and Down arrow keys The security code sequence is UP DOWN UP DOWN A checkmark icon will appear when the correct key is input 5 Select Your Desired Wavelength Select the desired laser wavelength on the Guided Touch Interface...

Страница 14: ...h Interface The Gemini EVO 810 980 soft tissue laser is equipped with Guided Touch Interface GTI which means only the icons that are relevant for a given procedure will be shown When entering the electronic key passcode only the UP and DOWN arrows will be shown as they are the only necessary icons to be touched while entering the passcode UP DOWN UP DOWN THE GUIDED TOUCH INTERFACE AREA REQUIRES AN...

Страница 15: ... prompted with voice confirmation Please select wavelength and two flashing wavelength graphics to select the desired wavelength of choice The Gemini EVO 810 980 soft tissue 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 Flashing Wavelength By se...

Страница 16: ...appear on the display and Activation Pedal when it is properly connected and the Laser is in Active mode 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 Press Active to initiate the Bluetooth connection between the laser unit ...

Страница 17: ...ng 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 darker pigmented soft tissue CONTROLS OPERATION USE 04 MANUAL POWER ADJUSTMENT The Gemini EVO 810 980 soft tissue laser can output up to a maximum of 2 0 watts of average power To adjust the power setting manually t...

Страница 18: ...nd STBY modes There is an audio confirmation unless voice confirmation is muted and an icon for either ACTIVE or STANDBY near each wavelength indicator The red aiming beam and tip illumination are visible only when the laser is in Active mode When the system is in Active mode touching any selection other than LEFT and RIGHT will return the system to the STBY mode When the Activation Pedal is depre...

Страница 19: ...rocedures and categories on the display A collection of pre programmed procedures will be revealed on the display Selecting the LEFT and RIGHT arrows will toggle between NON SURGICAL SURGICAL and PAIN RELIEF 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 ...

Страница 20: ... 980 Note Preset procedure settings are only a general recommendation from the manufacturer They are not meant to replace the need for proper training or clinical judgment of the operator The presettings are subject to changes through software updates and may therefore differ slightly from the settings indicated on this page All power settings are shown in average power CONTROLS OPERATION USE PRES...

Страница 21: ...ry default press and hold the PRESET ICON for 5 seconds You will hear three audible beeps when the settings are reset Another way to customize the preset procedures is through the DASHBOARD See page 45 for additional instructions Hold 3 seconds Customize Save Hold 5 seconds Factory Reset Power bar Indicator and power value will start flashing on the display CONTROLS OPERATION USE PRESET PROCEDURE ...

Страница 22: ...Activation Pedal Amber Handpiece and Activation Pedal for PBM procedures CONTROLS OPERATION USE 07 TIP ILLUMINATION The Gemini EVO 810 980 soft tissue laser handpiece is equipped with a tip illumination light to provide better visibility of the surgical site during treatment To toggle the light intensities between LOW MEDIUM HIGH and OFF touch the MENU icon and select TIP LIGHT on the Guided Touch...

Страница 23: ...con shows Red when OFF PRESET TIP LIGHT SOUND VOICE MENU WI FI ACTIVE STBY AIMING UPDATE HOME 810 980 DUAL HAPTIC CONTROLS OPERATION USE 09 SOUND To change the sound level touch the MENU and then the SOUND icon on the Guided Touch Interface Adjust the sound level by touching the Up Down arrows To exit touch the MENU icon to save your selection The system remembers the last used sound setting when ...

Страница 24: ...oing so will damage the components CAUTION The spacers are single use only to avoid possible cross contamination They must be disposed of after use in a bio hazard medical waste Sharps container CAUTION Wavelength appropriate eye protection must be worn at all times while using and in proximity of a PBM adapter while it is in use WARNING The PBM adapters must only be used with a Gemini EVO laser D...

Страница 25: ...he 25 mm PBM adapter The PBM adapter is now ready to use To remove the PBM adapter unscrew it from the Gemini EVO laser handpiece and re install dust covers when not in use 25 mm Adapter 7 mm Adapter 25 mm Spacer 3 mm Adapter Dust cover Front Dust cover Back Thread 3 mm and 7 mm PBM adapters can be used intraorally PBM dust covers for the 25 mm adapter should be wiped down with Caviwipes or equiva...

Страница 26: ...r treatment time is completed If the activation pedal is released mid treatment the timer will pause and will resume when the pedal is depressed again Click ACTIVE to select treatment time in seconds Display will flash 0 0 seconds Using the right arrow select the time in seconds followed by ACTIVE to enable timer Press and hold right arrow advances timer faster in 10 seconds increments Use the UP ...

Страница 27: ...recommendation in any way When you are ready to begin treatment hold the PBM adapter in contact with the target treatment area The PBM adapter is designed to be held in a constant location for the duration of the treatment If the desired treatment area is larger than the PBM adapter s spot size move the adapter to a new location and start a new treatment only after the initial treatment time has e...

Страница 28: ...ary to avoid overheating Do not treat directly over the site of any known primary malignant carcinoma or secondary metastasis except for palliative care with informed consent and oncologist permission Do not treat pregnant women as the effects of photobiomodulation therapy on the fetus are unknown PBM ADAPTER MAINTENANCE The disposable spacers are supplied non sterile by the manufacturer and shoul...

Страница 29: ...mw cm 4244 mw cm Weight Spot Size Power under preset Power Density 03 0 6 2 3 12 7 27 5 5 21 1 114 6 15 3 1 11 7 63 7 39 8 0 30 4 165 5 54 11 0 42 1 229 2 09 1 8 7 0 38 2 33 6 7 25 7 140 1 21 4 3 16 4 89 1 45 9 2 35 1 191 0 60 12 2 46 8 254 6 06 1 2 4 7 25 5 30 6 1 23 4 127 3 18 3 7 14 0 76 4 42 8 6 32 8 178 2 57 11 6 44 5 241 9 12 2 4 9 4 50 9 36 7 3 28 1 152 8 51 10 4 39 8 216 4 24 4 9 18 7 101 ...

Страница 30: ...mulates on the fiber tip during surgery and the 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 designed for single use o...

Страница 31: ...ore a procedure activate and fire the laser at 1 watt of average power for 1 2 seconds prior to wiping the tip This action will ensure that the pre initiation does not wipe off during the cleaning process Should you start treating a patient with an un initiated tip and then need to initiate the tip to continue treatment rub the tip on articulating film while firing the laser on a low power setting...

Страница 32: ...ng connector on the rear of the Laser Unit Only use the power supply provided with the system WARNING To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth 100 Usage Time 2 0 Hours of consecutive max power of 2 0W Usage Time 1 5 Hours of consecutive max power of 2 0W Usage Time 1 0 Hour of consecutive max power of 2 0W Usage Time 30 min o...

Страница 33: ...e laser 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 t...

Страница 34: ...it and the magnet will hold the handpiece in place 17 OPERATING MODE The Gemini EVO 810 980 soft tissue laser will only deliver energy in Pulsed temporal emission mode and is optimized to provide the operator ideal control of target tissue temperatures and efficiency of energy delivered The pulse width is fixed and not user adjustable The operator will only need to adjust the laser wavelength and ...

Страница 35: ...inician to establish 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 3 5 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 cab...

Страница 36: ...NN EC T IO N HA PT IC FE ED BA CK Bluetooth Pairing Successful Bluetooth Pairing Enabled Keep pedal depressed until STEP 3 LASER ACTIVE BATTERY LEVEL BLUETOOTH CONNECTION HAPTIC FEEDBACK 2 4 1 3 5 CONTROLS OPERATION USE If batteries are installed remove both of them Keep the pedal depressed until the completion of STEP 3 Activation Pedal icons will flash simultaneously along with the haptic feedba...

Страница 37: ... an arch of 15 degrees for optimal viewing angle from any direction The light is generated by a thin film less than 2 microns thick of specially designed electroluminescent phosphor DISPLAY SPECIFICATIONS Display type Electroluminescent Transparency 80 Brightness 300 cd m 2 Color Broadband Yellow Peak Wavelength 582 nm Voltage 195V AC Response time 1 8ms Glass type Soda lime Glass thickness 4 1mm ...

Страница 38: ...ernet connection You will receive an authentication code via email 2 Scan your laser Your Gemini EVO unit contains an unique QR code located on the bottom of your unit or activation pedal Point your phone camera to the QR code and the app will scan the laser unit You can nickname your Gemini EVO laser any name you like and click SAVE 3 Enabling Wi Fi After saving your device name above follow the ...

Страница 39: ...ecting the appropriate Wi Fi network and entering the password the Gemini EVO unit will establish a secure connection with your local Wi Fi The Wi Fi connection between your local Wi Fi network to the Gemini EVO unit can take up to 2 minutes to complete The Gemini EVO unit displays a progress bar on the electroluminescent display Upon connection the App displays the main page shown below 6 Office ...

Страница 40: ...l show several important status conditions such as the health of your battery the strength of your Wi Fi connection and the ability to add and remove another Gemini EVO laser from your account The Status page is the overall health of your Gemini EVO device This page will enable you to add or remove a Gemini EVO device from your registered account You can have multiple Gemini EVO devices registered...

Страница 41: ...me The user s manual will always contain the latest update enabling you to always have access to the latest documentation With the Gemini EVO app you can track how many procedures have been performed by category see which wavelength mode is used the most as well as the overall laser usage time of this Gemini EVO device The account page allows you to change your registered name phone number and pro...

Страница 42: ... best to analyze and implement it into our next update cycle The main menu features several well organized links to help the user manage their Gemini EVO device Some of the available features are Get overall visual of everything happening with your Gemini EVO Procedure Reports displays all procedures performed time power settings great for patient notes Vitals showing the overall health of your Ge...

Страница 43: ... will display graphically the most commonly used average power in manual mode 05 Lifetime Laser Usage This feature will display the total amount of time the laser has been used This is similar to a car odometer It stays with the device 06 Top 10 Preset Procedures This feature shows the top procedures performed by name and by category This is a good way to visualize which procedure is most performe...

Страница 44: ...e slightly delayed 03 Bluetooth Signal When your Gemini EVO connects with your activation pedal under ACTIVE mode the network strength bar will be displayed If connection shows weak or poor move your activation pedal closer to the Gemini EVO device 04 Visual and Audible Status Visual and Audible settings are the most common settings used with Gemini EVO Being able to quickly visualize those settin...

Страница 45: ... track your objectives under the main dashboard If your device is outside the United States you can change currency by selecting the top right menu 05 Custom Presets Your Gemini EVO comes with preset procedures settings where the power is already set for optimal performance At times it may be necessary to change these settings In order to do that simply select the icon to adjust to the new preset ...

Страница 46: ...our after the procedure and always prior to sterilization 1 After use carefully remove the disposable fiber tip from the handpiece 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...

Страница 47: ...icators and sterilization containers that have been cleared by the US FDA for the selected sterilization cycle specifications It is recommended to use a sterilizer and any accessories that are capable of reaching 135 degrees C 275 degrees F and capable of reaching a 10 minute cycle with a 30 minutes dry time such as the Getinge Sterilizer 533LC FDA 510k K070657 along with an FDA cleared sterilizat...

Страница 48: ...hesive barrier film replaceable after each patient If the exterior of the laser unit should become contaminated it should be wiped down with CaviWipes or equivalent product then re covered with a new protective plastic cover We recommend wringing out any cleaning wipes before use to avoid dripping liquid on the laser unit To reassemble slide the handpiece shell onto the handpiece body and turn clo...

Страница 49: ...ot canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores herpetic and aphthous ulcers of the oral mucosa Treatment of aphthous ulcers Vestibuloplasty Tissue retraction for impression Lesion tumor removal Laser Periodontal Procedures Laser soft tissue curettage Laser removal of diseased Infected Inflamed and necrosed soft tissue within the periodont...

Страница 50: ... 32 104 F and relative humidity of 95 or less Atmospheric pressure to be within 70kPa 106kPa in operating transportation and storage conditions COMBUSTIBLE CHEMICALS AND GASES All gases that are combustible or support combustion and are used in the operatory area where the Gemini EVO 810 980 soft tissue laser is being operated must be turned off during the procedure Cleaning supplies or other flam...

Страница 51: ...er C Electronic Product Radiation Control are required to certify compliance with the regulations and furnish various reports to the Center for Devices and Radiological Health CDRH For manufacturers of medical lasers such as the Gemini EVO 810 980 soft tissue laser system additional review by the FDA of the safety and effectiveness of the device is required Companies who intend to market a medical...

Страница 52: ...ent discomfort and even lead to possible pulpal necrosis EYE AND SKIN PROTECTION While the Gemini EVO 810 980 soft tissue 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 800 plus nm wavelengths associated with lasers Eye protection must conform to Specification DIN EN207 A...

Страница 53: ...ace selection Remote Interlock open circuit deactivates the Laser Remote Interlock switch provided by request Release your foot from the Activation Pedal GENERAL SAFETY CONSIDERATIONS EMERGENCY SHUTDOWN OPTIONS Perform any of these actions to terminate laser emissions in the event of a real or perceived emergency ...

Страница 54: ...am wavelength 650 10nm Aiming beam power 2mW max Beam divergence 254 mrad Power range 0 1 Watt to 2 0 Watts Average Pulse frequency 20 800Hz Pulse width 0 05ms Duty cycle 0 1 4 Voice confirmation YES Power requirements Input 100 240 VAC 50 to 60 Hz 1 5A Output 18V DC 3 6A 65W Battery 14 4V Rechargeable Lithium Ion Wireless frequency Bluetooth at 2 4 GHz Wi Fi 2 4 GHz WPA2 WPA Enterprise Maximum Op...

Страница 55: ... treatment or to assess the unfavorable conditions which would render a treatment unacceptable or hazardous Maximum LASER OUTPUT of laser radiation with the magnitudes of cumulative measurement uncertainty and any expected increase in the measured quantities after manufacture is stated as the standard uncertainty of measurement WIRELESS INTERFERENCE This equipment has been tested and found to comp...

Страница 56: ...onnection between your local network and your Gemini EVO device 2 Under the Gemini EVO App select Add a Device and follow the instructions This will enable you to connect with your current network again with a new password 3 Contact your network administrator to make sure your local network is broadcasting the Wi Fi name Sometimes for security purposes this feature is enabled preventing outside us...

Страница 57: ...is not activating the start of the procedure 3 The unit sounds strange when using the 3 mm and 7 mm tips SOLUTION 1 Once treatment time in seconds is selected you need to select ACTIVE once more to enable the procedure 2 If your Activation Pedal is not awake tap once to turn it on Then it will activate the procedure and enable multiple procedures consecutively 3 Due to the low pulse modulation of ...

Страница 58: ...A 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 will appear on the display when the laser is in Active mode and the Activation Pedal is successfully connected Display Communication Error There will be audible sound Display Com...

Страница 59: ...boot and code signing using industry standard algorithms The Gemini EVO 810 980 soft tissue laser supports the ability to provide Cybersecurity Routine Updates and Patches remotely The device provides notification on the Guided Touch Interface mobile app and web interface Dashboard when a new update is available The user then has the ability to install the update directly into the device with any ...

Страница 60: ...he Activation Pedal and the Laser Unit during use will result in the immediate termination of any laser emission Reference the Service and Troubleshooting 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 distanc...

Страница 61: ...below The customer or user of the Gemini EVO laser should make sure that it is used in such an environment EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions according to CISPR 11 GROUP 1 The Gemini EVO laser uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF em...

Страница 62: ...le of 0 90 180 270 Voltage VAC 100 240 over 0 residual with 1 cycles on a phase angle of 0 90 180 270 Voltage VAC 100 240 over 70 residual with 25 cycles on a phase angle of 0 90 180 270 Voltage VAC 100 240 over 0 residual with 250 cycles on a phase angle of 0 90 180 270 Voltage VAC 100 240 over 0 residual with cycles on a phase angle of 0 90 180 270 Voltage VAC 100 240 over 0 residual with 1 cycl...

Страница 63: ...ge 150kHz to 80MHz field strengths should be less than 3V m ELECTROMAGNETIC ENVIRONMENT GUIDANCE IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE 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 Portable and mobile radio equipment must not be used within the recommended working clearance from ...

Страница 64: ...is not specified in the above table the recommended working clearance 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 applies at 80 MHz and 800 MHz Remark 2 These guidelines may not be applicable in all cases The propagation ...

Страница 65: ...NS PURSUANT TO LASER NOTICE 50 DATED JUNE 24 2007 01 008614070000303 11 200713 21 G2 5 001 00001 10 MERCURY SCAN BARCODE BARCODE 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 2 THIS DEVICE MUST ACCEPT ANY INTERFERENCE RECEIVED INCLUDING INTERFERENCE THAT MAY CAYSE UNDESIRABLE INTERFERANCE 279...

Страница 66: ...VO 810 980 soft tissue 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 ON OFF STOP OPTICAL FIBER 18V 3 6A ...

Страница 67: ...SN SERIAL NUMBER INDICATES SERIAL NUMBER FOR THE PRODUCT PART 0 C 32 F 40 C 104 F RECOMMENDED STORAGE TEMPERATURE OPTICAL FIBER APPLICATOR 70kPa 106kPa ATMOSPHERIC PRESSURE LIMITATION LASER APERTURE INDICATES WHERE LASER ENERGY COMES OUT 10 95 RELATIVE HUMIDITY RANGE WARNING INDICATES POSSIBLE EXPOSURE TO BOTH RED AND INFRARED LASER RADIATION KEEP AWAY FROM HEAT SUNLIGHT PRESCRIPTION STATEMENT FED...

Страница 68: ...AN BARCODE BARCODE 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 2 THIS DEVICE MUST ACCEPT ANY INTERFERENCE RECEIVED INCLUDING INTERFERENCE THAT MAY CAYSE UNDESIRABLE INTERFERANCE 2797 Model Gemini EVO 810 980 Diode Laser Power Input AA Batteries ID QOQBGM13P IC 5123A BGM13P AZENA MEDICAL LLC...

Страница 69: ...cover Product issues caused by any other reason including but not limited to acts of God modifications of or to any part of the Product improper testing assembly mishandling misuse neglect adjustments alterations to the products improper operation contrary to current instructions relating to installation maintenance or operation or contrary to industry standards relating to acceptable input power ...

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Страница 72: ... 3021 Citrus Circle Suite 180 Walnut Creek CA 94598 USA Made in the USA of U S and imported components Distributed by Ultradent Products Inc 505 West Ultradent Drive South Jordan Utah 84095 1010000AR02 022322 800 552 5512 ULTRADENT COM ...

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