Ultradent Products GEMINIEVO 810 DIODE LASE User manual

USER MANUAL

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

4
WARNINGS & CAUTIONS
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.
Safety is paramount when using any energy-based surgical instrument and your oce should implement a safety program
for the Gemini EVO 810+980 soft tissue diode laser. If your oce does not already have a safety ocer, one should be
appointed to be responsible for understanding proper use, safe operation, and maintenance of the Gemini EVO laser system.
Their duties should include training oce personnel in all aspects of system safety and management of the Gemini EVO laser
and all accessories. / ADDITIONAL TROUBLESHOOTING: For additional troubleshooting questions and tips call 1.801.553.4574.
To check for the latest software updates, download the Gemini EVO App in the iOS or Android web store.
CAUTION: Read these instructions carefully prior to using your Gemini EVO 810+980 soft tissue diode laser.
CAUTION: Ensure that all users are properly trained prior to use. Consult 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 ber optic cable in a clockwise manner around the ber wrap to avoid ber
breakage. (See Page 33).
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: 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
60-64 of this manual.
CAUTION: Periodically inspect laser eyewear for pitting and cracking.
CAUTION: In the event abnormal performance is observed, discontinue use and follow instructions in the
service and troubleshooting section of this manual.

5
WARNINGS & CAUTIONS
WARNING: Visible and Invisible Laser Radiation – Avoid eye or skin exposure to direct or scattered
radiation. Class IV Laser Product
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 Specication DIN EN207 Annex II of the
Directive 89/686/EEC with wavelength protection of 810nm- 980nm, and ±10nm of OD 5+.
WARNING: Never direct or point the beam at a person’s eyes.
WARNING: Do not look directly into the beam or at specular reections.
WARNING: Do not aim the laser at metallic or reective surfaces, such as surgical instruments or dental
mirrors. If aimed directly at these surfaces the laser beam will reect and create a potential hazard.
WARNING: Never operate the laser without a ber tip attached.
WARNING: Laser aperture at the end of the handpiece.
WARNING: Laser aperture warning label axed 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 adjustments or performance of procedures other than those specied 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 specied, except those supplied or sold by Ultradent
Products, Inc., as replacement parts for internal or external components, may result in increased EMISSIONS
or decreased IMMUNITY of the Gemini EVO 810+980 soft tissue laser. Refer to pages
60-64 for additional information.

LASER
ACTIVE
BATTERY
LEVEL
6
The Gemini EVO 810+980 soft tissue laser includes the following.
Laser Unit
Pre-Initiated Disposable Tips (10)
Bending tool included in the tip box
3 mm, 7 mm, and 25 mm PBM adapters
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 (x3)


NOTE: Use proper care when transporting the unit
ALSO INCLUDED: Laser Warning Sign, Laser Training 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 rst. If you are unsure about any aspect of the assembly, call your customer service representative or dealer
for assistance.
SHIPPING CONTAINER INFORMATION
The shipping container you received with your Gemini EVO 810+980 soft tissue 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.
WHAT IS IN THE BOX

7
TABLE OF CONTENTS
Overview
Display ........................................................................................................................................ 08
Guided Touch Interface “GTI”.......................................................................................................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 ................................................................................................ 16
04 - Manual Power Adjustment ...................................................................................................17
05 - Laser STBY and Active Modes .............................................................................................. 18
06 - Preset Procedure Settings and Customization ................................................................ 19-21
07 - Tip Illumination ................................................................................................................... 22
08 - Haptic Sense “HS” - Activation Pedal and PBM adjustments ................................................22
09 - Sound ................................................................................................................................... 23
10 - Aiming 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 Sterilization Procedures ................................................................................... 46-48
Procedural Recommendations.................................................................................................... 49
Facility & Environmental Considerations..................................................................................... 50
General Safety Considerations ............................................................................................... 51-53
.................................................................................................................. 54
Service and Troubleshooting.................................................................................................. 55-58
Cybersecurity................................................................................................................................59
Electromagnetic Environment Guidance................................................................................ 60-64
Labeling.................................................................................................................................. 65-68
Warranty.......................................................................................................................................69

8
OVERVIEW - DISPLAY




















03
04
05
06
07
02
01
08 10 12 14
15
16
17
18
19
20
131109

9
OVERVIEW - GUIDED TOUCH INTERFACE “GTI”


















PRESET
TIP LIGHT
SOUND
VOICE
MENU
WI-FI
ACTIVE
STBY
AIMING
UPDATE
HOME
810 980
DUAL
HAPTIC
09
08
07
06
101112131415
18
17
16
01 02 03 04 05

10
OVERVIEW - LASER UNIT
Transparent Display
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

11
OVERVIEW - ACTIVATION PEDAL
LASER
ACTIVE
BATTERY
LEVEL
BLUETOOTH
CONNECTION
HAPTIC
FEEDBACK
60 to 100%
Icon turns
blue when
connected
Activation Pedal will
not connect if battery
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
LASER
ACTIVE
BATTERY
LEVEL
BLUETOOTH
CONNECTION
HAPTIC
FEEDBACK

12
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 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 procedures

QUICK START
Plug In Power Supply
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.
2.
Insert AA Batteries into Activation Pedal
Install the (2) provided AA batteries into the wireless activation pedal.
When replacing the AA batteries, we recommend an ALKALINE type battery.
3.
Turn Laser Unit ON
The Universal ON/OFF button is a membrane 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:
810 nm, Dual or 980 nm Wavelength.
6.
Select Your Desired Power Setting
Select your desired power setting, then activate the laser. (Pages 17-21)
7.
Download the mobile App
1.
PRESET
TIP LIGHT
SOUND
VOICE
MENU
WI-FI
ACTIVE
STBY
AIMING
UPDATE
HOME
810 980
DUAL
HAPTIC
“Please select wavelength”

14
CONTROLS, OPERATION & USE
01 - ELECTRONIC KEY PASSCODE
The Gemini EVO 810+980 soft tissue 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 Guided Touch 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 EXTREMELY LIGHT TOUCH TO WORK EFFECTIVELY.
THE LIGHTER THE FINGER PRESSURE,
THE MORE LIKELY IT WILL SENSE THE TOUCH

810 980
DUAL
15
CONTROLS, OPERATION & USE
When selecting a wavelength, the 3 wavelength options 810 / DUAL / 980 will be shown as they are the only necessary
icons to be touched while selecting a wavelength.
02 - SELECTING A WAVELENGTH
When the system is turned on, and the electronic passcode is properly input (Page 14), you will be prompted with
voice conrmation “Please select wavelength” and two ashing 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 selecting the desired
wavelength, voice

will sound as follows:
“810 STBY”
“980 STBY”

STBY”

16
PAIRING A NEW ACTIVATION PEDAL
Follow the instructions on Page 36 to add a new activation pedal to an existing Gemini EVO device.
CONTROLS, OPERATION & USE
PRESET
TIP LIGHT
SOUND
VOICE
MENU
WI-FI
ACTIVE
STBY
AIMING
UPDATE
HOME
810 980
DUAL
HAPTIC
PRESET
TIP LIGHT
SOUND
VOICE
MENU
WI-FI
ACTIVE
STBY
AIMING
UPDATE
HOME
810 980
DUAL
HAPTIC
Install the provided 2 AA batteries
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.
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 and pedal
Enter the Passcode
Depress and release the Activation Pedal
once. Connection is done automatically.
03 - ACTIVATION PEDAL CONNECTION
Connecting the Activation Pedal with your Laser Unit via Bluetooth for the rst time is simple.

17
PRESET
MENU
WI-FI
ACTIVE
STBY
HOME
810 980
DUAL
CLINICAL TIP
Optimal results will be achieved by regulating the power and the speed that the operator moves the ber optic tip.
Tissue charring is an undesirable after-eect of too much power or of the ber tip moving too slowly. Always use the
least amount of power that is required to complete your procedure. The ideal tissue response will show little or no
discoloration after treatment and will result in 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 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, touch the LEFT and RIGHT arrows on the Guided Touch Interface. 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
initiate the laser.

18
PRESET
MENU
WI-FI
ACTIVE
STBY
HOME
810 980
DUAL
ACTIVE
STBY
ACTIVE
STBY


“DUAL


“810 STBY”
“980 STBY”
“DUAL

STBY”
CONTROLS, OPERATION & USE
05 - LASER STBY AND ACTIVE MODES
The Active/STBY Guided Touch Interface selection serves a dual purpose. It activates (ACTIVE) and deactivates
the laser (STBY). By default, the system powers up in STBY mode. The laser cannot be activated prior to selecting
a wavelength. Each time the ACTIVE/STBY selection is touched, the system toggles between Active and STBY modes.
There is an audio conrmation (unless voice conrmation 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 depressed in the Active mode, the outer indicator lines around each
wavelength icon on the display ashes to provide a visual indication that the laser is ring. There is also an audio beep
when laser is being red. For safety purposes, a laser ring delay of 0.25 seconds was implemented in order
to prevent accidental activation.

19
A Simulated Screen
showing the Gingivectomy
Preset Procedure and dual
wavelength mode selected.
CONTROLS, OPERATION & USE
06 - PRESET PROCEDURE SETTINGS
AND CUSTOMIZATION
Touch the PRESET selection to bring up all the preset procedures 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 procedure is highlighted.

20
Decontamination Yes 0.6w 0.5w 0.6w
Aphthous Ulcer No 0.7w 0.6w 0.8w
Hemostatis Yes 0.9w 0.8w 1.0w
Debridement Yes 0.4w 0.3w 0.5w
SURGICAL Tissue Contact
Incision / Excision Yes 1.1w 1.0w 1.2w
Implant Recovery Yes 1.3w 1.1w 1.5w
Tooth Exposure Yes 0.8w 0.7w 0.9w
Operculectomy Yes 1.2w 1.1w 1.4w
Gingivoplasty Yes 0.8w 0.7w 0.9w
Gingivectomy Yes 1.0w 0.9w 1.1w
Frenectomy Yes 1.2w 1.1w 1.4w
Pulpotomy Yes 0.8w 0.7w 1.0w
Troughing Yes 0.9w 0.8w 1.0w
810 DUAL 980
PAIN RELIEF Tissue Contact
7mm Tip User choice 0.3w 0.3w 0.3w
3mm Tip User choice 0.3w 0.3w 0.3w
25mm Tip Spacer 1.0w 1.0w 1.0w
810 DUAL 980
NON SURGICAL Tissue Contact 810 DUAL 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 dier slightly from the settings indicated on this page. All power settings are shown in average
power.
CONTROLS, OPERATION & USE
PRESET PROCEDURE SETTINGS AND CUSTOMIZATION
The Gemini EVO 810+980 soft tissue laser is pre-programmed with 16 procedures listed under three categories: NON
SURGICAL, SURGICAL, and PAIN RELIEF. Within each category are the most commonly used procedures with suggested power
settings. Always use the minimum amount of power necessary to perform a particular procedure. Manual power adjustment
may be necessary depending on patient and procedural needs.