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Biolase Water Express User Manual

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Contents
INTRODUCTION ................................................................................................................... 7
1 OVERVIEW ....................................................................................................................... 8
2 INDICATIONS FOR USE .................................................................................................. 9
3 SPECIFICATIONS ............................................................................................................ 12
3.1 Dimensions .................................................................................................................................... 12
3.2 Electrical ........................................................................................................................................ 12
3.3 Air and Water Spray ...................................................................................................................... 12
3.4 Optical ........................................................................................................................................... 12
4 EQUIPMENT DESCRIPTION ......................................................................................... 13
4.1 System Components ..................................................................................................................... 13
4.2 General .......................................................................................................................................... 13
4.2.3 Fiber Delivery System ........................................................................................................... 17
4.2.4 Wireless Footswitch ............................................................................................................... 18
5. CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS ....................................... 19
5.1 Contraindications ........................................................................................................................... 19
5.2 Warnings and Precautions ............................................................................................................19
6. SAFETY WITH THE WATERLASE EXPRESS ............................................................... 22
6.1 Safety Measures ........................................................................................................................... 22
6.2 Safety Classication ...................................................................................................................... 22
6.3 Safety Instructions ......................................................................................................................... 23
6.4 Safety Features ............................................................................................................................. 24
7. INSTALLATION AND SETUP ......................................................................................... 25
7.1 Facility Requirements .................................................................................................................... 25
7.2 Environmental Requirements ........................................................................................................ 25
7.3 Setup Requirements ...................................................................................................................... 26
7.3.2 Using the Remote Interlock ................................................................................................... 27
7.3.4 Installing the Tablet ................................................................................................................ 28
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Contents
7.3.7 Connecting the Fiber Optic Cable ......................................................................................... 31
7.3.8 Installing the Fiber Optic Cable Retainer ............................................................................... 32
7.3.9 Connecting/Disconnecting the Handpiece to the Fiber Optic Cable ...................................... 33
7.3.12 Enabling BIOLASE CONNECT ...........................................................................................37
8. OPERATING INSTRUCTIONS ....................................................................................... 38
8.1 Overview ....................................................................................................................................... 38
8.2 Tablet Holder - Function Control Button and LED Indicators ......................................................... 38
8.3 Daily Start-up ................................................................................................................................. 39
8.3.2 Waking the system from SLEEP mode ..................................................................................40
8.4 Activating the Waterlase Express .................................................................................................. 40
8.5 Turning the Waterlase Express Off ................................................................................................ 41
9. USER INTERFACE ......................................................................................................... 42
9.1 Icons - Denition ............................................................................................................................ 42
9.2 Main Menu ..................................................................................................................................... 44
9.2.2 Settings .................................................................................................................................. 45
9.2.3 System Information ................................................................................................................ 45
9.2.6 Web Portal ............................................................................................................................. 47
9.3 Home (Procedures Main) Screen .................................................................................................. 48
9.4 Favorites ........................................................................................................................................ 50
9.4.1 Create a Favorite ................................................................................................................... 50
9.4.3 Adjusting the Handpiece, Aiming Beam, and Illumination ..................................................... 51
9.5 Presets .......................................................................................................................................... 52
9.6 Basic Mode .................................................................................................................................... 52
9.7 Advanced Mode ............................................................................................................................. 52
9.7.1 Accessing Advanced Mode .................................................................................................... 53
9.8 System Flow Chart ........................................................................................................................ 55
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Waterlase Express User Manual
Contents
10 CUTTING TISSUE .......................................................................................................... 56
10.1 Hard-tissue Cutting ...................................................................................................................... 56
10.2 Soft-tissue Cutting ....................................................................................................................... 57
11 CLEANING, DISINFECTION, AND STERILIZATION .................................................... 58
12 MAINTENANCE ............................................................................................................ 61
12.1 Daily Care of the Tablet and Console .......................................................................................... 61
12.2 Annual Maintenance .................................................................................................................... 61
12.3 Service and Calibration ............................................................................................................... 61
12.4 Tip Inspection .............................................................................................................................. 61
12.4.1 Tip Inspection Instructions (Using the Tip Cleaning and Inspection Kit) ..............................62
12.5 Tip Cleaning ................................................................................................................................63
12.6 Handpiece Mirror Inspection ....................................................................................................... 64
12.6.2 Changing the Handpiece Mirror ........................................................................................... 65
12.7 Fiber Optic Cable Check ............................................................................................................. 66
12.7.1 Replacing the Protective Window ........................................................................................ 67
12.8 Installing/Replacing the Wireless Footswitch Batteries ............................................................... 68
12.9 Pairing the Footswitch and Laser ................................................................................................ 68
12.9.1 Pairing the Footswitch and Laser ........................................................................................ 69
12.9.2 Selecting the Footswitch Channel ....................................................................................... 70
12.10 Internal Cooling Water Reservoir ..............................................................................................71
12.10.1 Filling the Internal Cooling Water Reservoir ...................................................................... 71
12.10.2 Draining the Internal Cooling Water Reservoir .................................................................. 72
12.11 Transportation ............................................................................................................................73
12.12 Storage ...................................................................................................................................... 73
13. TROUBLESHOOTING .................................................................................................. 74
13.1 Troubleshooting ........................................................................................................................... 74
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Contents
APPENDIX A – LABELS .................................................................................................... 78
APPENDIX B – ACCESSORIES/SPARE PARTS .............................................................. 84
APPENDIX C – TIPS........................................................................................................... 85
APPENDIX D – ELECTROMAGNETIC COMPATIBILITY .................................................. 87
APPENDIX E – WIRELESS EQUIPMENT COMPLIANCE STATEMENT .......................... 91
INDEX.................................................................................................................................. 92
Waterlase Express is indicated for professional use on dental patients. Procedures must be performed only by licensed dental practitioners in a dental facility. Use of this device requires clinical and technical training, and this manual provides instructions for use.
The Waterlase Express tablet contains video animations which demonstrate specic clinical
applications available with the device. All statements of individual claims presented are based on references which can be viewed within the White Paper section of the Learning Center on the Waterlase Express tablet.
CAUTION: From time to time you may see software related updates from Samsung, please do not accept or execute software related updates without further instruction from BIOLASE
to ensure that updates will not adversely impact the use of your Waterlase Express.
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Waterlase Express User Manual
Overview Introduction
Congratulations on the addition of the Waterlase Express™ all-tissue laser to your practice! Waterlase patented technology provides a minimally invasive, highly precise, and exceptionally gentle dental experience for your patients, as well as unmatched results in treatment outcomes.
This User Manual is designed to help you become familiar with the operation and functions of the laser system. Read it carefully before using the laser clinically, follow all safety instructions and cautions, and always have it accessible as a reference.
We appreciate your commitment to better care and know your investment in this technology is a sound foundation for the successful growth of your practice.
BIOLASE Team
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1 Overview1 Overview
The Waterlase Express all-tissue laser is a unique Er,Cr:YSGG* solid state tissue-cutting system manufactured by BIOLASE for use in oral hard- and soft-tissue dental applications. It sets a new standard of affordability, accessibility, and ease of use for all-tissue lasers.
Waterlase Express utilizes advanced laser and water atomization technologies to safely and effectively cut, shave, contour, roughen, etch, and resect oral hard-tissues, and direct laser energy to perform oral soft-tissue removal, incision, excision, ablation and coagulation. Waterlase Express may also be used
for specic endodontic and periodontal applications.
When used for oral hard tissue procedures, the Waterlase Express laser provides optical energy to a user-controlled distribution of atomized water droplets and hydrated surface layer of hard-tissue. The water present in the target tissue absorbs laser radiation, resulting in explosive molecular expansion and ablation of hard-tissue. The water in the spray provides cooling and hydration for the target tissue.
For oral soft-tissue procedures, the Waterlase Express laser applies optical energy to the soft-tissue for tissue removal, incision, excision, ablation and coagulation, using direct laser energy. These procedures can be done in conjunction with water, for cooling and hydration, or without water, for coagulation.
A exible Fiber Optic Cable connects at one end to the laser and at the other to a Handpiece that delivers laser energy to the target tissue through a ber Tip. A visible light emitted from the Handpiece
head illuminates the area of treatment. Certain laser parameters may be adjusted by the user for both soft- and hard-tissue applications. The laser is activated using a Wireless Footswitch.
A removable Tablet serves as the user interface. Through the Tablet, the user may select laser procedures, access information on the system’s clinical performance, and view educational and reference materials. The user may also utilize the Tablet to communicate directly with BIOLASE customer care, educators, and peer professionals. Additional service needs are also provided through the Tablet, but no patient data of any kind is stored on the Tablet itself or the laser system.
Waterlase Express is indicated for professional use on dental patients. Procedures must be performed only by licensed dental practitioners in a dental facility. Use of this device requires clinical and technical training, and this manual provides instructions for use.
If used and maintained properly, Waterlase Express will prove a valuable addition to your practice. Please contact BIOLASE customer service at 1-800 -321-6717 in the U.S. and Canada for any service needs; if you are located outside North America, please contact your BIOLASE- authorized representative.
In Canada, this device must be installed, operated, and maintained according to the current revision
of the guidelines specied in the Canadian standard CAN/CSA-Z386:2014 safe use of lasers in
health care.
*Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet
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Waterlase Express User Manual
2 Indications for Use2 Indications for Use
The Waterlase Express may be used for the following indications:
GENERAL HARD-TISSUE INDICATIONS*
• Class I, II, III, IV and V cavity preparation
• Caries removal
• Hard-tissue surface roughening or etching
• Enameloplasty, excavation of pits and ssures for placement of sealants
*For use on adult and pediatric patients
ROOT CANAL HARD-TISSUE INDICATIONS
• Tooth preparation to obtain access to root canal
• Root canal preparation including enlargement
• Root canal debridement and cleaning
ROOT CANAL DISINFECTION
• Laser root canal disinfection after endodontic treatment
ENDODONTIC SURGERY (ROOT AMPUTATION) INDICATIONS
• Flap preparation – incision of soft-tissue to prepare a ap and expose the bone
• Cutting bone to prepare a window access to the apex (apices) of the root(s)
• Apicoectomy – amputation of the root end
• Root end preparation for retroll amalgam or composite
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a
qualied laboratory for histopathological evaluation.
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
BONE SURGICAL INDICATIONS
• Cutting, shaving, contouring and resection of oral osseous tissues (bone)
• Osteotomy
SOFT-TISSUE INDICATIONS INCLUDING PULPAL TISSUES*
Incision, excision, vaporization, ablation and coagulation of oral soft-tissues, including:
• Excisional and incisional biopsies
• Exposure of unerupted teeth
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2 Indications for Use2 Indications for Use
SOFT-TISSUE INDICATIONS INCLUDING PULPAL TISSUES* (CONTINUED)
• Fibroma removal
• Flap preparation – incision of soft-tissue to prepare a ap and expose the bone
• Flap preparation – incision of soft-tissue to prepare a ap and expose unerupted teeth
(hard and soft-tissue impactions)
• Frenectomy and frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscesses
• Laser soft-tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Reduction of gingival hypertrophy
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a
qualied laboratory for histopathological evaluation.
• Soft-tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Vestibuloplasty
*For use on adult and pediatric patients
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Waterlase Express User Manual
2 Indications for Use2 Indications for Use
LASER PERIODONTAL PROCEDURES
• Full thickness ap
• Partial thickness ap
• Split thickness ap
• Laser soft-tissue curettage
• Laser removal of diseased, infected, inamed and necrosed soft-tissue within the
periodontal pocket
• Removal of highly inamed edematous tissue affected by bacteria penetration of the pocket
lining junctional epithelium
• Removal of granulation tissue from bony defects
• Sulcular debridement (removal of diseased, infected, inamed or necrosed soft-tissue in the
periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
• Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
• Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
• Osseous crown lengthening
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
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3 Specications3 Specications
3.1 DIMENSIONS
• Laser console (W x L x H) 9 x 18 x 12 in (23 x 46 x 30.5 cm)
• Tablet (W x H x D) 6.7 in x 9.3 in x 0.2 in (16.9 cm x 23.8 cm x 0.6 cm)
• Screen size 9.7 in (24.6 cm)
• Weight laser console (with water) 27.2 lbs (12.3 kg)
• Weight Tablet 0.9 lbs (390 g)
3.2 ELECTRICAL
Class I Medical Electrical (ME) Equipment
• Operating voltage 100 - 240 VAC
• Frequency 50 / 60 Hz
• Current rating 6A / 3A
• Main control Main Power Switch
• On / Off control Keyswitch
• Remote interruption Remote interlock connector
3.3 AIR AND WATER SPRAY
• Water type Distilled or De-Ionized only
• External air source 60-120 psi. (4.1 – 8.2 bar)
• Water 0 - 100%
• Air 0 - 100%
3.4 OPTICAL
• Laser classication IV (4)
• Medium Er,Cr:YSGG
• Wavelength 2.78 µm (2780nm)
• Mode Free-running Pulsed
• Frequency (Pulse Rate) 5 – 50 Hz
• Average power 0.1-4.0 W
• Power accuracy ± 20%
• Pulse energy 10– 250 mJ
• Pulse duration for “H” mode (Short pulse) 60 µs
• Pulse duration “S” mode (Long pulse) 700 µs
• Handpiece head angles 70° contra-angle
• Fiber Tip diameter range (Spot size) 200 – 1200 µm
• Output divergence ≥ 8° per side
• Aiming beam 625-670 nm (red) laser, 1mW max (Laser Class 1)
• Nominal ocular hazard distance (NOHD) 5cm
• Maximum permissible exposure (MPE) 3.46 X 10⁵W/m²
(Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet)
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Waterlase Express User Manual
4 Equipment Description4 Equipment Description
4.1 SYSTEM COMPONENTS
The Waterlase Express laser system includes the following*:
• Laser Console
• Tablet and International AC Adapter (packed separately)
• Tablet Protective Covers
• Fiber Optic Cable
• Fiber Optic Cable Support Arm
• Fiber Optic Cable Retainer
• Yellow Air Tube
• Laser Protective Eyewear (3)
• Handpieces (2)
• Handpiece Holder
• Fiber Tip Starter Kit (Assorted Tips)
• Fiber Tip Holder
*Additional accessories, including extra Handpieces, Tips, and screen protectors may be ordered separately from BIOLASEstore.com.
• Internal Reservoir Fill Kit
• Tip Cleaning and Inspection Kit
• Power Cord (1-US, 1-Int’l, 1-UK)
• Remote Interlock Plug
• Wireless Footswitch
• Footswitch Batteries
• Welcome Kit – Includes:
• Welcome Letter
• Waterlase Express User Manual
• Waterlase Express Quick Start Guide
• Laser Warning Sign
• Product Registration Flyer
• Limited Warranty
4.2 GENERAL
The Waterlase Express laser system consists of four primary components:
1. Laser Console
2. Tablet
3. Fiber Delivery System
4. Wireless Footswitch
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4 Equipment Description4 Equipment Description
4.2.1 LASER CONSOLE
POWER CONNECTION/MAIN POWER SWITCH
The power cord attaches to the back panel of the laser console. The other end must be plugged into an electrical power source in order for the laser system to work. The main power switch serves as a line switch to separate the console from the main power supply (O = OFF, I = ON)
Internal Reservoir Connector
Remote Interlock Outlet
Air Inlet Connector
Power Connection | Main Power Switch
Figure 4.1
KEYSWITCH
Located on the right front panel of the laser console, the Keyswitch is used to turn the laser ON by turning the key clockwise to a horizontal position; always use only the key provided. The key cannot be removed while it is in the ON position. Always remove the key when the laser is left unattended.
EMERGENCY STOP
The emergency stop (red) button is located on the left front panel of the laser console. Pressing this button instantly stops the emission of laser energy; the button will glow red to indicate the emergency stop has been engaged and the screen will display the message “Emergency Stop Pressed.”
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Waterlase Express User Manual
4 Equipment Description
4 Equipment Description
TABLET HOLDER
The Tablet Holder is the hinged panel located at the front of the console and includes the control panel and Tablet Latch. The Tablet is inserted into the control panel, once in place and connected to the
micro USB inside the panel, it is locked into position by ipping the Latch over the top of the Tablet (a
thumbscrew at the rear of the latch prevents removal of the tablet).
CONTROL PANEL
The Function Control button is located in the center of the control panel; it activates the controls and display, and is used to place the system into Ready (green), Standby (amber), or Sleep mode. There are also two LED indicators on either side of the function control button; one indicates the
Tablet is properly installed, and the other conrms the wireless connection with the Footswitch is active.
HANDPIECE HOLDER
The Handpiece Holder cradles the Handpiece when it is not in use. It can be attached to the Tablet Holder on the right or the left, based on user preference.
Function Control Button
Tablet Connectivity Indicator
Tablet Latch
Table t
Tablet Holder/ Control Panel
Emergency Stop
Wireless Footswitch
Connectivity Indicator
Handpiece Holder
Keyswitch
Waterlase Express User Manual
Figure 4.2
15
4 Equipment Description4 Equipment Description
PATIENT WATER BOTTLE
This is a detachable water bottle located on the back of the console that is the water supply for the Handpiece atomization spray. A push-button release is located on the top of the self-contained patient
water bottle that releases the bottle from the console for lling/relling with distilled or de-ionized water.
VENTILATION CHANNELS
The slots on the sides and rear of the console provide an air ow path to cool the laser system. Do
not cover or block these during use; leave a minimum of 4 inches between the laser console and any wall or partition.
AIR INLET CONNECTOR
This adaptor on the back of the console provides the connection to a compressed dry air outlet at 60 – 120 psi (4.1 – 8.2 bar) using the yellow tubing provided.
Fiber Optic Cable
Handle
Handpiece
Ventilation Channels
CAUTION: Moisture or oil in the air supply line will damage the laser system. Always provide
an air dryer, mist separator, and proper ltration at the compressor output to eliminate all
moisture or oil from the air source. Any damage from moisture or oil in the air line is not covered by the system warranty.
Fiber Support Arm
Patient Water Bottle Release
Ventilation Channels
Patient Water Bottle
Figure 4.3
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Waterlase Express User Manual
4 Equipment Description4 Equipment Description
REMOTE INTERLOCK PLUG
This plug connects the laser to a door switch (not included). It will stop the laser immediately if the operatory door is opened while the laser is in use. Although use of this feature is optional, the plug itself must be inserted in the Remote Interlock Outlet at the rear of the console for the laser system to operate.
NOTE: To enable the interlock feature, call BIOLASE for instructions if necessary.
INTERNAL COOLING WATER RESERVOIR FILL CONNECTOR
The Waterlase Express laser system contains an internal cooling water reservoir which must be
lled prior to initial use of the laser. A reservoir ll kit is included with the system and attaches to the
connector on the rear of the console.
FIBER OPTIC CABLE SUPPORT ARM
This removable accessory supports the weight of the Fiber Optic Cable, keeping it from looping to the ground; its use is optional, based on user preference.
HANDLE
Use the handle at the top of the console to lift, carry, or reposition the laser on a stable, at surface.
4.2.2 TABLET
The system is operated through a Tablet terminal display that has wireless remote access capability; when Wi-Fi connectivity is activated, the Tablet allows remote access by BIOLASE for diagnostics,
software/rmware updates, and other system data requirements. No patient data is accessed. When
installed in the Tablet Holder, the Tablet will charge only if the power to the laser system is ON.
4.2.3 FIBER DELIVERY SYSTEM
FIBER OPTIC CABLE
The Fiber Optic Cable contains the optical ber together with the illumination waveguide, air tubing and water tubing. Laser radiation is delivered from the laser to the Handpiece through the optical ber.
FIBER OPTIC CABLE RETAINER
Please note that a Fiber Optic Retainer, as described in Section 7.3.8, is included with your Waterlase Express. This optional accessory is initially installed by your authorized Waterlase Field Service Technician. The Fiber Optic Retainer is only installed if the Handpiece Holder is installed on the right side of the Tablet holder. Its use is not recommended if the Handpiece Holder is installed on the left side of the Tablet holder.
Waterlase Express User Manual
17
4 Equipment Description
4 Equipment Description
HANDPIECE
The Handpiece is re-usable, rotatable, and detachable from the Fiber Optic Cable and must be cleaned and sterilized between patients (see section 11). It delivers optical energy, illumination, air, and atomized water spray to the treatment area and utilizes a variety of Tips to focus the optical energy on the selected treatment site.
A visible light emitted from the Handpiece head illuminates the area of treatment. The visible spot of
the aiming beam should be clear, uniform, and well-dened. If the aiming beam is not present while in
Ready mode or when the laser is ring, replace the Fiber Delivery System.
Cover
4.2.4 WIRELESS FOOTSWITCH
The Waterlase Express laser will only emit laser energy when the user presses down on the Footswitch while the laser is in Ready mode. It is designed to pair with the laser console using wireless technology and is powered by two (2) AAA batteries. (Refer to Section 12 for instructions on how to replace the Footswitch batteries included with the system).
Pairing Button/
Battery
Compartment
Cover
The Footswitch is protected by the Footswitch Cover. To access, press down on the Footswitch Cover.
Three separate LED indicator lights are displayed on the top of the battery housing of the Footswitch.
LED Indicator Status
Blue Solid
Green Solid
Green Blinking The Footswitch batteries are low; replace the batteries.
Amber Blinking or Solid
The Footswitch is connecting to the laser, or has successfully paired with the laser.
ON: The Footswitch is pressed while paired to the laser. OFF: The Footswitch is not pressed, or the system is in Sleep
mode, or the batteries are dead.
A critical error or short has occurred; the relevant error message will appear on the Tablet screen.
Footswitch
Figure 4.4
18
CAUTION: Repeated rapid tapping of the Footswitch may cause a system error; release the
Footswitch, wait 2 seconds, then press rmly down on the Footswitch to clear it. A system
restart is not required.
Waterlase Express User Manual
5 Contraindications, Warnings, and Precautions5 Contraindications, Warnings, and Precautions
5.1 CONTRAINDICATIONS
All clinical procedures performed with the Waterlase Express must be subjected to the same clinical judgment and care as with standard techniques. 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 and exercise caution for general medical conditions which might contraindicate a local procedure. Such conditions may include, but are not limited to, allergy to local or topical
anesthetics, heart disease (e.g., pacemakers, implantable debrillators), lung disease, bleeding disorders, or an immune system deciency. Medical clearance from the patient’s physician is advisable
when doubt exists regarding treatment.
5.2 WARNINGS AND PRECAUTIONS
PRESCRIPTION STATEMENT
U.S. Federal Law restricts this device to sale by or on the order of a dentist or other licensed dental practitioner.
TRAINING
Only licensed professionals who have reviewed and understood this user manual and have received proper training on how to correctly operate the system should use this device. Procedures related to soft-Tissue, osseous, endodontic, or periodontal surgery should only be performed by clinicians who have training and experience in Oral Maxillofacial, Periodontal, or Endodontic surgery.
EYEWEAR
Doctor, patient, assistant, and all others inside or entering the operatory must wear appropriate laser protection eyewear for the 2780 nm wavelength (OD 3 or greater) whenever the laser is in use. Prior to use, inspect eyewear for pitting and cracking; do not use if damaged.
CAUTION: Always check the eyewear specications as etched on the glasses to ensure they
offer the protection required for the laser wavelength.
ANESTHESIA
Although in many cases anesthesia may not be required, patients should be closely monitored for signs of pain or discomfort. If such signs are present, adjust settings, apply anesthesia, or cease treatment if required.
TREATMENT, TECHNIQUE, AND SETTINGS
Always start treatment at the factory-installed default settings for the chosen application and adjust as required. Closely observe clinical effects and use your judgment to determine the aspects of the treatment (e.g., technique, proper power, pulse mode, air and water settings, tip type, and duration of operation) and make appropriate adjustments to compensate for varying tissue composition, density, and thickness.
Waterlase Express User Manual
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5 Contraindications, Warnings, and Precautions5 Contraindications, Warnings, and Precautions
CLINICAL ENVIRONMENT
Only use this device in clinical environments that observe proper standard aseptic techniques with all oral procedures.
HARD-TISSUE PROCEDURES
All hard-tissue (enamel, dentin, cementum and bone) procedures must be performed using air and water spray at appropriate settings. Failure to use the spray will result in tissue thermal damage.
SOFT-TISSUE PROCEDURES
Soft-tissue procedures can be performed using two pulse duration settings H-Mode and S-Mode, either with water for cooling and hydration, or without water for coagulation.
The S-Mode (long pulse) settings are indicated for soft-tissue applications only. Do not use S-Mode
to perform hard tissue procedures.
FLUID ENTRAPMENT AND AIR EMBOLISM
Do not direct air or spray toward tissues that may trap air or water. For example, when performing surgical procedures the clinician should be aware of adjacent soft-tissue pockets, cavities, or channels
that may collect or entrap air. Always use high-speed suction to remove any excess uid and avoid
directing the spray into deep pockets. Do not use the Waterlase Express if it is not possible to access the treatment site without directing air into an area that may collect or entrap air. In general, the same care and precautions should be taken when using the Waterlase Express as are taken when using any air and water emitting cutting device.
ROOT CANAL PROCEDURES
The Waterlase Express is better suited for straight and slightly curved canals. Great care should be taken during instrumentation of curved canals as the endodontic Fiber Tip may break or perforate through the wall of these types of canals. If during insertion the Fiber Tip does not advance easily into
the canal, do not force it. If necessary, pull the Fiber Tip out and use an endodontic hand le or a broach
to open the path. Do not force the Tip and/or activate the laser while moving the Tip inside a narrow or curved canal, or through the apex. Place the end of the Tip ~2mm from the apex or from being in contact with the wall of a curved canal. Activate the laser and spray only during the outward stroke when the Fiber Tip is pulled towards the coronal portion of the canal.
ROOT CANAL DISINFECTION PROCEDURES
The same precautions and warnings stated above are applicable to root canal disinfection procedures. The Fiber Tips designed for this indication are the radial emitting RFT2 and RFT3, which have a 200 µm and a 300 µm diameter, respectively, and come in various lengths to accommodate different root canal lengths. Effective laser root canal disinfection is performed with air and no water spray. Do not exceed the maximum air setting (10%) for this procedure.
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Waterlase Express User Manual
5 Contraindications, Warnings, and Precautions5 Contraindications, Warnings, and Precautions
ADJACENT STRUCTURES
Always be aware of adjacent structures and substructures during treatment. Be extremely careful not to inadvertently penetrate or ablate through underlying/adjacent tissues and be aware and use extreme caution when working on tissue adjacent to major anatomical structures, such as nerves or vessels. Exercise extreme care when using this device in areas such as pockets, where critical structures such as nerves or vessels could be damaged. Do not proceed with using the laser if visibility in these areas is limited.
TISSUE EVALUATION
Any tissue growth (i.e., cyst, neoplasm and other lesions), either removed with Waterlase Express or
conventionally, must be submitted to a qualied laboratory for histopathological assessment.
TISSUE CONTACT AND TIP BREAKAGE
Do not contact any hard surface with the Fiber Tip as it is very brittle and fragile and could break. If the Fiber Tip should break during a procedure, immediately and carefully suction the debris from the treatment site, rinse, and repeat.
FIBER TIP CHANGING
Failure to correctly replace the Fiber Tip could result in damage to the Fiber Tip and/or Handpiece, or affect the emission of laser energy around the Tip. A careful review of the instructions on how to replace the Fiber Tip is recommended (refer to Section 7.3.10).
WATER SPLASHING
Water from spray may splash during laser use. The use of a face shield as protection from spattering is
recommended. Use high-speed suction as required to maintain a clear eld of vision during a procedure.
Do not use the Waterlase Express if you cannot clearly see the treatment site.
PLUME REMOVAL
CAUTION: Laser plume may contain viable tissue particulates.
Special care must be taken to prevent infection from the laser plume generated by the vaporization of virally or bacterially infected tissue during procedures utilizing the laser with minimal or no water spray. Ensure that all appropriate protective equipment (including high-speed suction to remove the plume, appropriate masks, and other protective equipment) is used at all times during procedures utilizing this laser device.
DENTAL MATERIALS
Do not direct laser energy towards amalgam, gold, or other metallic surfaces. Do not direct energy
towards dental cements or other similar lling materials. Doing so, may damage the Waterlase Express
Fiber Tip and Fiber Optic Cable.
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6 Safety with The Waterlase Express6 Safety with The Waterlase Express
6.1 SAFETY MEASURES
WARNING: No modication of this equipment is allowed.
Failure to comply with the following precautions and warnings may lead to exposure to dangerous voltage levels or optical radiation sources. Please comply with all safety instructions and warnings.
CAUTION: Use of controls or adjustments, or carrying out procedures other than those
specied in this User Manual, may result in hazardous radiation exposure.
CAUTION: This Laser System has been designed and tested to meet the requirements of severe electromagnetic, electrostatic, and radio frequency interference testing. However, the possibility of electromagnetic or other interference may still exist.
DANGER: Invisible and/or visible laser radiation – avoid eye or skin exposure to direct or scattered radiation. Do not use this Laser System in any manner other than as described in this User Manual. Do not use the Laser System if you suspect it is not functioning properly; contact BIOLASE for assistance.
NOTE: For Canada, this device must be installed, operated, and maintained according to the
current revision of the guidelines specied in the Canadian standard CAN/CSA-Z386:2014
Safe use of lasers in health care.
6.2 SAFETY CLASSIFICATION
The following safety classications are applicable to the device:
• Laser Radiation - Class 4
• Aiming Beam - Class 1
• Type of protection against electrical shock - Class 1
• Applied part, laser Handpiece – Type BF
• Not protected against water ingress - Ordinary Equipment
• Console - IPX0
• Footswitch – IPX6
• Not suitable for use in the presence of ammable anesthetic
• Not suitable for use in oxygen-rich environments
• Operation Mode – Free-running pulsed
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6 Safety with The Waterlase Express6 Safety with The Waterlase Express
CAUTION: High temperatures produced in the normal use of this laser equipment may ignite some materials (e.g., cotton wool when saturated with oxygen); solvents of adhesive and
ammable solutions used for cleaning and disinfecting should be allowed to evaporate before
the laser equipment is used.
6.3 SAFETY INSTRUCTIONS
Follow these safety instructions before and during treatments:
1. Remove or cover all highly reective items in the treatment area, if possible.
2. Do not operate in the presence of explosive or ammable materials.
3. All persons present in the operatory, including patients, must wear protective eyewear suitable for
blocking 2.78 µm (2780 nm) laser energy (OD 3 or greater, supplied by BIOLASE).
CAUTION: Prior to use, inspect eyewear for pitting and cracking; do not use if damaged. For replacements or additional protective eyewear, please contact BIOLASE Customer Service or your authorized local BIOLASE representative.
4. Do not look directly into the beam or at specular reections.
5. Direct the cutting spray toward targeted tissues only.
6. Place the laser system in Standby mode by pressing the Function Control button on the Tablet
Holder before changing the water in the patient water bottle, installing the Fiber Optic Cable, attaching the Handpiece, changing a Fiber Tip, and turning off the laser system.
CAUTION: Only remove the Patient Water Bottle when the system is in Standby mode; the Patient Water Bottle is pressurized while the system is in Ready mode.
7. Switch the circuit breaker to the OFF (O) position and remove the key before leaving the laser
unattended for long periods of time.
8. All operatory entrances must be marked with an approved warning sign (included with the laser
system) indicating a laser is in use.
DANGER: DO NOT open the side doors of the console as danger from radiation exposure
and high voltage may exist. These are to be opened only by authorized BIOLASE service personnel.
9. Take special care to contain the laser plume, i.e., particles produced by the vaporization of
virally or bacterially infected tissue, during procedures utilizing the laser with minimal or no water spray. Ensure that all appropriate protective equipment (including high-speed suction to remove the plume, appropriate masks, and other protective equipment) is used at all times during procedures.
NOTE: Please direct any safety questions to your authorized BIOLASE representative; US and Canada, call BIOLASE at (888) 424 -6527, or BIOLASE Service at (800) 321-6717.
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6 Safety with The Waterlase Express6 Safety with The Waterlase Express
6.4 SAFETY FEATURES
ENERGY MONITOR
The energy monitor checks power output. Power deviations of more than ± 20% and ± 50% for power levels below 1 Watt from the selected value will cause the display to show the error message "Internal HV System Error", the laser will not operate until the error is resolved, at which time the laser will be in Standby mode; if the error message persists, please contact BIOLASE Service or your authorized BIOLASE representative.
SYSTEM MONITOR
Waterlase Express continually monitors all system functions, including the Fiber Optic Cable, water bottle status, air status, voltage, Tablet connection, and Wireless Footswitch connectivity. An error in any one of these areas will stop the system and the Tablet will display an error message. Operation cannot resume until the error is cleared. If the Tablet is not properly connected to the laser, the system will stay in Standby mode until the Tablet is installed and the error is cleared.
EMERGENCY STOP
The emergency stop (red) button is located on the front panel of the laser console. Pressing this button instantly stops the emission of laser energy; the button will glow red to indicate an emergency stop has taken place and the screen will display the message “Emergency Stop Pressed.” To restart the laser system, press the button a second time (the system will be activated in Standby mode).
REMOTE INTERLOCK
When used, this feature enables a cable to connect the laser to a remote switch/sensor attached to a door. When the remote switch is activated, for example when the entrance door to the operatory is
opened while the laser is ring, it will immediately turn the laser off, protecting anyone entering from
inadvertent exposure to laser radiation.
NOTE: The remote interlock plug must be installed in the console in order for the system to operate, even if the remote interlock function is not used.
WIRELESS FOOTSWITCH
Waterlase Express will only emit laser energy when the user presses down on the Footswitch while the laser is in Ready mode. The Footswitch Cover shields the Footswitch to prevent it from being pressed unintentionally. The protective cover can be opened or closed only by pressing down on it.
CIRCUIT BREAKER
The circuit breaker serves as a line switch to separate the console from the main power supply (O = OFF, I = ON).
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Waterlase Express User Manual
7 Installation and Set-Up7 Installation and Set-Up
The Waterlase Express laser system must be unpacked and installed by a qualied BIOLASE employee
or agent. Please leave the shipping container unopened until your trained representative arrives.
7.1 FACILITY REQUIREMENTS
NOTE: The main power supply of the Waterlase Express laser system has an isolation transformer that complies with a Transient Voltage of 4kV.
ELECTRICAL SUPPLY: 100VAC @ 6.0 Amps max to 240VAC @ 3.0 Amps, 50/60 Hz
COMPRESSED AIR SUPPLY: 60 -120 psi (4.1 – 8.2 bar)
CAUTION: Moisture in the air supply line may damage the laser system. Always provide
an air dryer, mist separator, and proper ltration at the compressor output to eliminate all
moisture from the air source. If water is introduced into the air supply line call your authorized BIOLASE service representative for assistance.
7.2 ENVIRONMENTAL REQUIREMENTS
TEMPERATURE: 15 – 30 °C
HUMIDITY: 20% - 80%, non-condensing
ATMOSPHERIC PRESSURE (altitude):
Functional: 80KPa (2000 meters) to 102kPa (-56meters) Storage: 50KPa (4944 meters) to 102KPa (-56 meters)
AIR SUPPLY: Connections for an air supply must be available in each operatory. Attach an air hose with a ¼ inch outside diameter male quick connector on each end between the air inlet connector and the operatory air source.
CAUTION: Prior to connecting the yellow air hose, verify that the outlet is for the air, NOT the water supply. Connection to the water supply may cause damage to the Waterlase Express system. If the laser system is connected to the water supply, DO NOT turn the system on; contact your service representative. Any damage resulting from connecting the air line to the water supply is not covered by the system warranty.
CAUTION: DO NOT position this equipment so that it is difcult to pull the plug from the power source.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
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7 Installation and Set-Up7 Installation and Set-Up
7.3 SETUP REQUIREMENTS
The Waterlase Express is designed to be transportable between operatories either manually, using the console handle, or by wheeling it on the custom cart offered as a system option. In either case, prior
to use the laser must be properly set up, as described in this user manual, to ensure safe and efcient
functionality.
7.3.1 CONNECTING THE LASER SYSTEM
To ensure proper operation, always place the laser console upright on a at, clean, dry surface a minimum of four (4) inches from any wall.
CAUTION: Waterlase Express ships from the factory with the internal cooling water reservoir
empty. Before rst-time use, the reservoir must be lled with distilled or de-ionized water using the reservoir ll kit included with the laser system. For instructions on how to ll the
reservoir, refer to section 12.10. DO NOT USE TAP WATER.
1. Verify the main power switch is in the OFF position.
2. Verify the Keyswitch is in the OFF position.
3. Connect the power cord to the rear of the console.
4. Verify the minimum air pressure of 60 psi (4.1 bar) is emitted from the air supply (max 120 psi,
8.2 bar). Using air pressure greater than 120 psi may damage the internal components of the laser system.
5. Check the air supply for moisture.
6. Connect the air supply to the console’s air inlet connector at the rear of the console with the yellow tubing provided.
CAUTION: DO NOT connect the operatory air supply to the console if water or oil is present. The air compressor may need to be drained or cleaned. Install an air dryer, mist
separator, and proper ltration. Wet air will damage the laser system. Check the air supply
weekly to verify the absence of water and oil.
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Waterlase Express User Manual
7 Installation and Set-Up7 Installation and Set-Up
7.3.2 USING THE REMOTE INTERLOCK
The remote interlock is a safeguard designed to protect anyone who might
enter the operatory while the laser is ring without wearing appropriate laser
protection eyewear. To utilize this safety feature, the remote interlock plug (a) must be wired to a multi-conductor wire and inserted into the rear of the laser console. The other end of the wire (b) is attached to a door switch/ sensor; if the door is opened, the connection to the switch is deactivated,
immediately stopping the laser from ring. Contact BIOLASE or your
authorized BIOLASE representative with any questions on how to install this feature.
NOTE: The plug must be installed into the console in order for the laser to work, whether or not the remote interlock function is used (Figure 7.1). Cable is not included.
7.3.3 INSTALLING THE HANDPIECE HOLDER
The Handpiece Holder is packaged as a separate item in the system packaging. Attach it to the Tablet Holder utilizing the smaller of the two screws and Allen wrenches provided (Figure 7.2):
1. Grip the Handpiece Holder with the cradle facing the same direction as
the Tablet Holder (Figure 7.3).
(a)
(a)
(b)
Figure 7.1
2. Slide the Handpiece Holder into the slot at the back of the Tablet
Holder (Figure 7.4) until the holes in both pieces are aligned.
3. Insert the smaller of the two screws provided into the hole and tighten
with the smaller Allen wrench.
NOTE: The Handpiece Holder can be installed on the left side of the Tablet Holder, if preferred. To do so, the cradle must be rotated; remove the two screws holding the cradle to
the at surface of the Handpiece Holder, rotate it 180 degrees, then reattach it, again using
Cradle
the two screws.
Figure 7.2
Waterlase Express User Manual
Figure 7.3 Figure 7.4
27
7 Installation and Set-Up7 Installation and Set-Up
7.3.4 INSTALLING THE TABLET
The Tablet is attached to the console by a USB connector incorporated inside the bottom of the control panel. Holding it parallel to the Tablet Holder, slide the Tablet downward into the Holder/control panel so
that it makes contact with the USB connector, and lock into place by ipping the upper Latch over the
Tablet; tighten the thumbscrew on the back of the Tablet Latch to prevent the Tablet's removal. Once the Tablet is properly connected and active, the LED indicator on the front of the Tablet Holder/Control Panel will light up.
The Tablet battery is fully charged prior to shipment. However, if it does not turn on when the power button on the side of the Tablet is pressed, take the following steps:
1. Remove the Tablet from the Tablet Holder by either pulling up on the upper two corners or pushing up from the bottom two corners.
2. After connecting the USB cable to the charging adapter, insert it into the Tablet’s USB/accessory port at the bottom of the Tablet and plug the charging adapter into a standard AC power outlet. It should take at least 15 minutes to charge the tablet for use on the console. The Tablet will continue to charge when the console is on. International power adapters are provided for the charging adapter
3. Remove the USB cable from the Tablet and replace the Tablet in the Tablet Holder.
Tablet Latch
Tablet Holder/ Control Panel
USB Connector (Inside Holder)
USB/Accessory Port
Power Button
Volume
Figure 7.5
28
NOTE: When installed, the Tablet will charge only when the system is plugged in and ON. If the system is OFF, the Tablet will not charge.
Waterlase Express User Manual
7 Installation and Set-Up7 Installation and Set-Up
7.3.5 FILLING THE PATIENT WATER BOTTLE
The patient water bottle provides the water supply for the Handpiece spray. An error message will appear on the screen if the built-in sensor detects the
water level is low, or the bottle empty; ll or replace the water in the patient
water bottle following the steps outlined below:
1. Make sure the system is in Standby mode for at least ve seconds;
this allows the bottle to depressurize.
2. Push the bottle release button on top of the bottle holder and pull the bottle straight back.
3. Twist the bottle assembly so that the arrow on the cap aligns with the circle on the base (Figure 7.6); lift the cap off the base.
4. Fill the bottle only with distilled or de-ionized water. DO NOT USE
TAP OR FILTERED WATER.
5. Replace the cap by matching the arrow on the cap to the circle on the base (Figure 7.6). Twist the cap clockwise until the arrow on
the cap and the arrow on the base are aligned (Figure 7.7).
Figure 7.6
6. Attach the bottle back into its Holder; make sure the connector is fully engaged.
WARNING: Be careful when handling the patient water bottle; do not drop or knock it against a hard surface. Even a small crack may cause damage when the bottle is pressurized.
DO NOT USE IF DAMAGED.
NOTE: BIOLASE recommends replacing the patient water bottle every ve years. Refer to
the expiration date noted on the bottle label.
Figure 7.7
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