Biolase Waterlase Iplus User Manual

User Manual

PAGE INTENTIONALLY LEFT BLANK

	Contents
1 OVERVIEW.......................................................................................................................		7
2	INDICATIONS FOR USE...................................................................................................	8
	Hard-Tissue...........................................................................................................................................	8
	Endodontic Surgery (Root Amputation) Indications...............................................................................	8
	Bone Surgical Indications......................................................................................................................	8
	Laser Periodontal Procedures...............................................................................................................	8
	Soft-Tissue Indications Including Pulpal Tissues...................................................................................	9
	Root Canal Disinfection.........................................................................................................................	9
3	EQUIPMENT DESCRIPTION..........................................................................................	10
	System Parts List.................................................................................................................................	10
	General................................................................................................................................................	10
	Main Laser Console Elements.............................................................................................................	10
	Control Panel..................................................................................................................................	10
	Energy Monitor................................................................................................................................	11
	Front and Back Handles..................................................................................................................	11
	Locking Wheels...............................................................................................................................	11
	Emergency Stop..............................................................................................................................	11
	Keyswitch........................................................................................................................................	11
	Footswitch, Footswitch Connector..................................................................................................	12
	Remote Interlock Outlet..................................................................................................................	12
	Power Connection / Circuit Breaker................................................................................................	12
	Ventilation Channels.......................................................................................................................	12
	Air Inlet Connector..........................................................................................................................	12
	Self-Contained Water Bottle...........................................................................................................	12
	Water Bottle Release......................................................................................................................	13
	Footswitch Support Bracket............................................................................................................	13
	Telescopic Fiber Cable Support Arm..............................................................................................	14
	WaterLase iPlus Delivery System...................................................................................................	14
	Delivery System Connection on the Laser Console.......................................................................	15
4	SPECIFICATIONS...........................................................................................................	16
	Dimensions..........................................................................................................................................	16
	Electrical..............................................................................................................................................	16
	Air and Water Output...........................................................................................................................	16
	Optical..................................................................................................................................................	16

WaterLase iPlus User Manual

3

Contents
5 CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS	.........................................17
Contraindications.................................................................................................................................	17
Warnings and Precautions...................................................................................................................	17
Prescription Statement....................................................................................................................	17
Eyewear..........................................................................................................................................	17
Training............................................................................................................................................	17
Anesthesia......................................................................................................................................	17
Treatment, Technique and Settings.................................................................................................	17
Hard-Tissue Procedures.................................................................................................................	18
Soft-Tissue Procedures...................................................................................................................	18
Curettage Procedures.....................................................................................................................	18
Fluid Entrapment and Air Embolism................................................................................................	18
Root Canal Procedures...................................................................................................................	18
Root Canal Disinfection Procedures...............................................................................................	19
Adjacent Structures.........................................................................................................................	19
Clinical Conditions..........................................................................................................................	19
Tissue Evaluation............................................................................................................................	19
Tissue Contact and Tip Breakage...................................................................................................	19
Tip Changing...................................................................................................................................	19
Water Splashing..............................................................................................................................	20
Plume Removal...............................................................................................................................	20
Dental Materials..............................................................................................................................	20
6 SAFETY WITH THE WATERLASE.................................................................................	21
Precautions..........................................................................................................................................	21
Safety Instructions...............................................................................................................................	21
Safety Classification............................................................................................................................	22
7 INSTALLATION...............................................................................................................	23
Installation Instructions........................................................................................................................	23
Facility Requirements..........................................................................................................................	23
Environmental Requirements...............................................................................................................	23
Set-up Requirements...........................................................................................................................	24
Connecting the Unit to the Operatory.............................................................................................	24
Filling the Internal Cooling Water Reservoir....................................................................................	24
Filling the Self-Contained Water System Bottle..............................................................................	25
Installing the SureFire Delivery System..........................................................................................	26
Connecting the Handpiece to the Fiber Cable................................................................................	28

4	WaterLase iPlus User Manual

	Contents
	Disconnecting the Handpiece.........................................................................................................	29
	Installing and Changing the Tip in the Handpiece..........................................................................	29
8	OPERATING INSTRUCTIONS........................................................................................	31
	Operation.............................................................................................................................................	31
	Overview.........................................................................................................................................	31
	Starting the WaterLase iPlus..........................................................................................................	31
	Activating the WaterLase iPlus.......................................................................................................	32
	Turning the WaterLase iPlus Off.....................................................................................................	32
	User Interface / General Navigation................................................................................................	32
	Applications Menu...........................................................................................................................	33
	Changing and Saving the Pre-Sets.................................................................................................	35
	Settings/Memory Menu...................................................................................................................	36
	Functions for the Setting Buttons....................................................................................................	37
	Custom Settings..............................................................................................................................	37
	Description of the Functional Buttons.............................................................................................	38
	Other Screens.................................................................................................................................	38
	System Flow Chart..........................................................................................................................	39
9	CUTTING TISSUE...........................................................................................................	40
	Introduction..........................................................................................................................................	40
	Hard-Tissue Cutting.............................................................................................................................	40
	Soft-Tissue Cutting..............................................................................................................................	41
	Presets for Softand Hard-Tissue Procedures....................................................................................	42
10 CLEANING AND STERILIZATION.................................................................................		43
	Handpiece and Tip Cleaning and Sterilization.....................................................................................	43
	Step 1—Cleaning Process..............................................................................................................	43
	Step 2—Handpiece Sterilization Process.......................................................................................	44
	Step 3—Disinfecting the Fiber Cable..............................................................................................	45
11 MAINTENANCE AND TROUBLESHOOTING................................................................		46
	Daily Maintenance...............................................................................................................................	46
	Mirror Check and Cleaning.............................................................................................................	46
	Mirror Inspection and Cleaning.......................................................................................................	46
	Removing the Handpiece Mirror.....................................................................................................	47
	Changing the Handpiece Mirror......................................................................................................	47
	Mirror Alignment Check..................................................................................................................	48
	Fiber Check.....................................................................................................................................	48

WaterLase iPlus User Manual

5

Contents
Annual Maintenance............................................................................................................................	50
Delivery System..............................................................................................................................	50
Laser Console.................................................................................................................................	50
Calibration Schedule............................................................................................................................	51
Installation and Calibration Dates...................................................................................................	51
Troubleshooting....................................................................................................................................	52
Transportation......................................................................................................................................	53
Storage................................................................................................................................................	53
APPENDIX A: LABELS.......................................................................................................	54
APPENDIX B: ACCESSORIES...........................................................................................	61
Accessories List...................................................................................................................................	61
APPENDIX C: TIPS.............................................................................................................	62
Tip Types.............................................................................................................................................	62
Tip Ferrule Colors...........................................................................................................................	62
Tip Settings: WaterLase iPlus / Gold Handpieces...............................................................................	62
Z - Glass Tips..................................................................................................................................	62
Sapphire Tips..................................................................................................................................	63
APPENDIX D: TIP INSPECTION.........................................................................................	64
Tip Inspection Instructions...................................................................................................................	64
Tip Cleaning Instructions.....................................................................................................................	65
Turbo Tip Inspection............................................................................................................................	65
Fiber Tip Inspection.............................................................................................................................	65
APPENDIX E: SETTINGS...................................................................................................	66
APPENDIX F: ELECTROMAGNETIC COMPATIBILITY.....................................................	75

NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.

6	WaterLase iPlus User Manual

1 Overview

The WaterLase iPlus tissue cutting system is a unique device with diverse, hardand soft-tissue dental applications. It utilizes advanced laser and water atomization technologies to safely and effectively cut, shave, contour, roughen, etch, and resect oral hard-tissue, and direct laser energy to perform oral soft-tissue removal, incision, excision, ablation and coagulation. WaterLase iPlus may also be used for specific endodontic and periodontal applications.

When used for oral hard-tissue procedures, this YSGG solid-state laser provides optical energy to a user-controlled distribution of atomized water droplets and hydrated surface layer of hard-tissue. 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 iPlus laser applies optical energy to the soft-tissue for tissue removal, incision, excision, ablation, and coagulation using direct laser energy, either with water for cooling and hydration, or without water for coagulation.

A flexible Fiber 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 Fiber Tip. A visible light emitted from the Handpiece head illuminates the area of treatment. The optical power output and atomized water spray may be adjusted to specific user requirements for both softand hard-tissue applications.

WaterLase iPlus is indicated for professional use on adult and pediatric dental patients. Procedures must be performed only by licensed dental practitioners in a dental facility. Use of this device requires proper clinical and technical proficiency, and this User Manual provides instructions for use for those professionals who have completed the appropriate training.

When used and maintained properly, the WaterLase iPlus proves a valuable addition to a practice. Please contact BIOLASE Customer Service at 1-800-321- 6717 in the U.S and Canada for any service needs; if the user is located outside the U.S., please contact the BIOLASE-authorized representative.

WaterLase iPlus User Manual

7

2 Indications for Use

IMPORTANT: Review all Contraindications, Warnings and Precautions presented in Section 5 before proceeding with using this device on patients.

WATERLASE IPLUS IS INDICATED FOR:

HARD-TISSUE

GENERAL INDICATIONS*

•Class I, II, III, IV and V cavity preparation

•Caries removal

•Hard-tissue surface roughening or etching

•Enameloplasty, excavation of pits and fissures 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

ENDODONTIC SURGERY (ROOT AMPUTATION) INDICATIONS

•Flap preparation – incision of soft-tissue to prepare a flap 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 retrofill amalgam or composite

•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

LASER PERIODONTAL PROCEDURES

•Full thickness flap

•Partial thickness flap

•Split thickness flap

•Laser soft-tissue curettage

•Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket

•Removal of highly inflamed 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, inflamed 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.)

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

8	WaterLase iPlus User Manual

2 Indications for Use

LASER PERIODONTAL

PROCEDURES (CONTINUED)

•Osseous crown lengthening

•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).

•Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.

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

•Fibroma removal

•Flap preparation – incision of soft-tissue to prepare a flap and expose the bone.

•Flap preparation – incision of hardand softtissue to prepare a flap and expose unerupted teeth (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 postextraction 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

•Soft-tissue crown lengthening

•Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa

•Vestibuloplasty

*For use on adult and pediatric patients

ROOT CANAL DISINFECTION

•Laser root canal disinfection after endodontic instrumentation.

WaterLase iPlus User Manual

9

3 Equipment Description

SYSTEM PARTS LIST

The WaterLase iPlus laser systems include the following*:

• WaterLase iPlus Laser	• Tip Cleaning Kit
• Display Covers (qty. 25)	• Power cord, (1) US,
• Trunk Fiber and Fiber support	(1) International
• Yellow Air Tube	• Footswitch
• Protective Laser Eyewear (3)	• User Manual
• (2) Handpieces	• Laser Warning sign
• Tip Starter Kit	• Product Registration Card
• Tip Holder	• Limited Warranty

*Additional accessories, including Handpieces and Tips, ordered separately.

GENERAL

The WaterLase iPlus dental laser system consists of two modules:

•Main Laser Console (shown in Figures 3.1, 3.2, and 3.3)

•WaterLase iPlus Fiber Delivery System (the Delivery System, shown in Figures 3.1, 3.2, and 3.3, consists of the Fiber Cable, Handpiece, and Tips)

MAIN LASER CONSOLE ELEMENTS

Figures 3.1, 3.2, and 3.3 show the front, rear and top views of the laser console.

CONTROL PANEL

The main laser console is controlled through a touch screen control panel. See section 8, Operating Instructions, for details and instructions.

Safety Features

All control functions accessed through the Control Panel are located at a safe distance from the energy output.

10	WaterLase iPlus User Manual

3 Equipment Description

ENERGY MONITOR

The energy monitor measures and verifies power output.

Safety Features

Power deviations of more than 20% from the selected value will cause the display to show an error message; thelaser console will not operate until the system is reset by pressing the “Next” arrow

at the top of the touch screen. If the error message persists, please contact BIOLASE Service or the authorized BIOLASE representative.

FRONT AND BACK HANDLES

Use the front and back handles to move and/or lift the laser console when necessary.

CAUTION: Prior to lifting, make sure the handles are not damaged. DO NOT use the Fiber Cable to pull the laser console; this could damage the Fiber Cable and render the laser inoperable.

LOCKING WHEELS

Allow easy transport of the laser from operatory to operatory. Press down on the front tabs on the wheels to lock the console. Lift up the tabs to release the locking mechanism.

EMERGENCY STOP

The red button located on the front panel of the laser console, instantly turns off the laser when pressed.

Safety Features

The button will glow red to indicate an emergency stop, and the control panel will display an error message; press the button again to restart the system. The system will be in Standby mode when turned back on, even if it was in Ready mode at the time the Emergency Stop was activated. Push the Ready button before using the system.

KEYSWITCH

Use to switch the laser system ON by turning the key to the 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.

WaterLase iPlus User Manual

11

3 Equipment Description

FOOTSWITCH, FOOTSWITCH CONNECTOR

The Footswitch activates the laser; the WaterLase iPlus laser will not activate until the user presses down on the Footswitch. Connect and secure the Footswitch to the Footswitch connector located on the back panel of the console.

Safety Features

A protective cover prevents unintentional pressing of the Footswitch. The protective cover can be opened or closed by pressing it from the top.

REMOTE INTERLOCK OUTLET

Each laser has a remote plug and connector on its rear panel that enables the laser to be connected to the remote sensor. Customers may request that the remote interlock be connected to a door switch.

Safety Features

The Safety Features turn the laser OFF when a user-provided remote switch (e.g., on the entrance door) is triggered, protecting anyone entering the operatory while the laser is in use from inadvertent exposure to laser radiation. To use it properly requires a normally closed pair of contacts to be connected to pins 1 and 5 of the connector. These contacts should have no voltage associated with them and should open on activation.

POWER CONNECTION / CIRCUIT BREAKER

Located on the back panel, allows the power cord to be attached to the laser console. The circuit breaker serves as a line switch to separate the laser console from the main power supply (0 = OFF, 1 = ON). The power cable can be wrapped over the holding plate above the connector when the system is not in use or when it is being transported.

VENTILATION CHANNELS

These provide an air flow path to cool the system; do not cover or block.

AIR INLET CONNECTOR

Connects the laser to a compressed dry air outlet at 80-120 psi (5.5 - 8.2 bar) using the tubing provided.

SELF-CONTAINED WATER BOTTLE

Located on the rear of the laser, this detachable bottle provides the water supply for Handpiece atomization spray. Fill the self-contained water bottle with only distilled or de-ionized water. DO NOT USE TAP OR FILTERED WATER, which can leave deposits that may damage the fiber cable or Handpiece.

12	WaterLase iPlus User Manual

3 Equipment Description

WATER BOTTLE RELEASE

A push button release on the top of the self-contained water bottle that allows its removal from the console for refilling.

FOOTSWITCH SUPPORT BRACKET

This bracket on the rear bottom of the laser console is designed to hold the closed Footswitch clamshell when storing or moving the laser system. Wrap the Footswitch cable around the wrap plate above the bracket.

Fiber Delivery

System

Telescopic Fiber

Support Arm

Touch Screen

Back Handle

Control Panel

Self-contained

Water System

Ventilation

Handpiece

Front

Back Panel

Handle

Remote

Keyswitch

Emergency

Interlock Outlet

Stop Switch

Footswitch Cable

Wrap Plate

Power Cable

Power

Wrap Plate

Connection &

Circuit Breaker

Ground Pin

Footswitch

Footswitch

Support Bracket

Locking Wheels

Connector

Air Inlet

(front only)

Connector

Fig 3.1

Fig 3.2

WaterLase iPlus User Manual

13

3 Equipment Description

TELESCOPIC FIBER CABLE SUPPORT ARM

Located at the top of the laser console, it supports the Delivery System (Fiber Cable), and extends to bear its weight when the Handpiece is pulled forward; extension releases when the Handpiece is let go and the arm is in a vertical position.

NOTE: Proper placement of the Delivery System Cable in the Support Arm and of the Handpiece in the Handpiece holder is important for the convenient and safe handling of the delivery system.

WATERLASE IPLUS DELIVERY SYSTEM

(See Section 4 for detailed description and instructions)

Fiber Delivery System

Back Handle

Water Bottle Cover

Water Bottle Release Push Button

iLase Spare Battery Charging Port

Touch Screen Control panel

Handpiece

Front Handle

Fig 3.3

14	WaterLase iPlus User Manual

3 Equipment Description

DELIVERY SYSTEM CONNECTION ON THE LASER CONSOLE

The delivery system attaches to the top of the console via a multi-connector that incorporates air, water, cooling air, illumination waveguides, and the optical energy Fiber Cable.

HANDPIECE HOLDER

Cradles the Handpiece when it is not in use.

FIBER CABLE

A component of the delivery system: contains the optical Fiber Cable, together with the illumination waveguides, air tubing, and water tubing. Delivers laser radiation from the laser console to the Handpiece.

HANDPIECE

The Handpiece is rotatable and detachable from the optical shaft. It delivers optical energy, illumination, and atomized water spray to the treatment area.

WaterLase iPlus User Manual

15

4 Specifications

DIMENSIONS (W X L X H)

• Laser Console		11 x 19 x 33 in (28 x 48 x 84cm)
•	Laser Console with Fiber Cable	11 x 19 x 40 in (28 x 48 x 102 cm)
•	Weight	75 lbs. (34 kg)

ELECTRICAL

• Class I Medical Electrical (ME) Equipment
• Operating Voltage:		100 VAC ± 10% / 230VAC ± 10%
• Frequency:		50 / 60 Hz
•	Current rating:	5A / 8A
•	Main control:	Circuit breaker
• On / Off control:		Keyswitch
• Remote interruption:		Remote interlock connector

AIR AND WATER OUTPUT

•Water type:

•External air source:

•Water:

•Air:

•Interaction zone:

OPTICAL

•Laser classification:

•Medium:

•Wavelength:

•Frequency:

•Average power:

•Power accuracy:

•Pulse energy:

•Pulse duration for “H” mode:

•Pulse duration “S” mode:

•Handpiece head angles:

•Gold HP Tip diameter range:

•Turbo Tip focal diameter range:

•Output divergence:

•Mode:

•Aiming Beam:

•Water Level Sensor Beam:

•Nominal Ocular Hazard Distance (NOHD):

•Maximum Permissible Exposure (MPE):

Distilled or De-Ionized only 80 - 120 psi. (5.5 - 8.2 bar 0 - 100% 0 - 100%

0.5 - 5.0 mm from Handpiece Tip to target

4

Er,Cr:YSGG

(Erbium, Chromium:Yttrium, Scandium,Gallium, Garnet)

2.78 µm (2780nm)

5 – 100 Hz

0.1– 10.0 W

±20%

0 – 600 mJ

60 µs

700 µs

70° contra-angle 200 – 1200 µm 500-1100 µm

≥ 8° per side

Multimode

635nm (red) laser, 1mW max (safety classification 1)* 635nm laser, 1mW max (safety classification 1)

5cm

3.5 x 105 W/m2

16	WaterLase iPlus User Manual

5 Contraindications, Warnings, and Precautions

CONTRAINDICATIONS

All clinical procedures performed with the WaterLase iPlus must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully under stood before clinical treatment. The clinician must completely understand the patient’s medical history prior to treatment. 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 defribulators), lung disease, bleeding disorders, or an immune system deficiency. Medical clearance from the patient’s physician is advisable when doubt exists regarding treatment.

WARNINGS AND PRECAUTIONS

PRESCRIPTION STATEMENT

Federal Law restricts this device to sale by or on the order of a dentist or physician or other licensed medical practitioner.

EYEWEAR

When using the WaterLase all-tissue laser system, doctor, patient, assistant, and all others insie or entering the operatory must always wear appropriate laser protection eyewear for the 2780nm wavelength, OD3 or greater (OD 3+). Refer to the OD specification imprinted on the glasses.

TRAINING

Only licensed professionals who have reviewed and understood this user manual, and have been trained on how to correctly operate the system should use this device. Surgical 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.

ANESTHESIA

Although in most 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

Only licensed professionals who have reviewed and understood this user manual should use this device.

Always start treatment at the lowest power setting for the specific tissue and increase as required.

Observe clinical effects and use judgment to determine the aspects of the treatment (technique, proper power, pulse mode, air and water settings, tip type and duration of operation) and make appropriate power, air and water adjustments to compensate for varying tissue composition, density and thickness.

WaterLase iPlus User Manual

17

5 Contraindications, Warnings, and Precautions

HARD-TISSUE PROCEDURES

All hard-tissue (i.e. 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. The long pulse settings (700 µs) are indicated only for soft-tissue applications. Do not use long pulse settings to perform hard-tissue procedures.

SOFT-TISSUE PROCEDURES

Soft-tissue procedures can be performed using two pulse duration settings: (H) short pulse (60 µs) and

(S) long pulse (700 µs). However, the long pulse (S) range is indicated ONLY for soft-tissue applications.

CURETTAGE PROCEDURES

Exercise extreme caution when using this device in areas where critical structures (i.e., nerves and vessels) could be damaged, such as in the apical third of the 3rd molar socket. Do not proceed with using the laser if visibility is limited in these areas.

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 fluid and avoid directing the spray into deep pockets, cavities or channels such as the crevice resulting from the extraction of a molar. Also, for example, avoid working through soft-tissues adjacent to the roots

of molars, especially the third inferior molars, which communicate directly with the sublingual and submandibular spaces. Do not use the WaterLase iPlus 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 iPlus as are taken when using any air and water emitting cutting device, including the high speed drill.

ROOT CANAL PROCEDURES

The WaterLase iPlus 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 the Fiber Tip inside. If necessary, pull the Fiber Tip out and use an endodontic hand file or a broach to open the path. Do not force the Fiber Tip and/or activate the laser while moving the Fiber Tip inside a narrow or curved canal, or through the apex. Place the end of the Fiber 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.

18	WaterLase iPlus User Manual

5 Contraindications, Warnings, and Precautions

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 200µm and a 300µm 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 for this procedure (10%).

ADJACENT STRUCTURES

WaterLase iPlus can remove both hardand soft-tissues. Therefore, always be aware of adjacent structures and substructures during treatments. Be extremely careful not to inadvertently penetrate or ablate through the apex, the root canal wall, or underlying/adjacent tissues. Also, be aware and use extreme caution working on tissue (i.e., bone, root apex, etc.) adjacent to the following structures: maxillary sinus, mental foramen and mandibular canal, or any other major anatomical structures (i.e., nerves). Exercise extreme caution when using this device in areas such as pockets, cavities, or

channels, where critical structures (i.e. nerves, vessels) could be damaged. Do not proceed with using the laser if visibility is limited in these areas.

CLINICAL CONDITIONS

Use a sterile field and aseptic technique with all procedures, especially for surgical interventions.

TISSUE EVALUATION

Any tissue growth (i.e. cyst, neoplasm and other lesions), whether removed with WaterLase iPlus or conventionally, must be submitted to a qualified laboratory for histopathology assessment.

TISSUE CONTACT AND TIP BREAKAGE

Do not contact hard-tissues with the Fiber Tip. Hard-tissue cutting occurs in non-contact mode with the Tip ~0.5 mm to 3 mm off the surface (3 to 5 mm for Turbo Handpiece). Tips are very brittle and fragile, and could break if pressed against tooth or bone tissues or if forced through a narrow or curved path or root canal. Use a bite block to prevent breakage or swallowing of the Tip from biting. High-speed suction is required to remove any excess fluid and materials resulting from accidental Tip breakage.

TIP CHANGING

Failure to correctly replace the Tip could result in damage to the Fiber Tip, Handpiece, or affect the emission of laser energy around the Tip. A careful review of the instructions on how to replace the Tip is recommended.

WaterLase iPlus User Manual

19

5 Contraindications, Warnings, and Precautions

WATER SPLASHING

Water from spray may splash during treatment. Use protective eyewear and/or a face shield to protect from splashing. Use high-speed suction, as needed, to maintain a clear field of vision during treatment.

Do not use the WaterLase iPlus if the user cannot clearly see the treatment site.

PLUME REMOVAL

Laser plume may contain viable tissue particulates. Special care must be taken to prevent infection from the laser plume generated by vaporization of virally or bacterially infected tissue during procedures done with the laser and 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 with 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 filling materials. Doing so may damage the WaterLase iPlus Tip and delivery system.

20	WaterLase iPlus User Manual

6 Safety with the WaterLase

PRECAUTIONS

Failure to comply with these 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 performance of procedures other than those specified in this user manual may result in hazardous radiation exposure.

DANGER: Invisible and/or visible laser radiation when the laser is fired. Avoid eye or skin exposure to direct or scattered radiation.

Class IV.

CAUTION: This laser system has been designed and tested to meet or exceed the requirements of severe electromagnetic, electrostatic and radio frequency interference testing. However, the possibility of electromagnetic or other interference may still exist.

DANGER: Do not use this laser system in any manner other than described in this user manual. Do not use the laser system if it is suspected as functioning improperly.

SAFETY INSTRUCTIONS

Follow these safety instructions before and during treatments:

1.Remove or cover all highly reflective items in the treatment area, if possible.

2.Do not operate in the presence of explosive or flammable materials.

3.All persons present in the operatory must wear protective eyewear suitable for blocking 940nm (if using the iPlus in conjunction with 2,780nm energy (multi-wavelength glasses supplied by BIOLASE, Inc.).

4.Do not look directly into the beam or at specular reflections.

5.Direct the cutting spray toward targeted tissues only.

CAUTION: Periodically inspect eyewear for pitting and cracking. For replacement or additional protective eyewear, please contact BIOLASE Customer Service or the authorized BIOLASE representative.

6.Press the Standby button on the control panel before changing the water in the reservoir and before turning off the laser system.

WaterLase iPlus User Manual

21

6 Safety with the WaterLase

7.Move the circuit breaker to the OFF (0) position (located on the rear panel) and remove the key before leaving the laser console unattended.

8.All operatory entrances must be marked with an approved warning sign (provided) indicating a laser is in use.

9.Take special care to contain the laser plume (particles produced by the vaporization of virally or bacterially infected tissue during procedures utilizing the laser and 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 the procedure.

DANGER: DO NOT open system side doors. These are to be used by authorized service personnel only. Danger from radiation exposure and high voltage may exist.

NOTE: Please direct any safety questions to the local BIOLASE representative, or call BIOLASE at [phone], or BIOLASE Service at [phone] (US only).

SAFETY CLASSIFICATION

The following safety classifications are applicable to this device:

•Laser Radiation - Class 4

•Aiming Beam - Class 1

•Type of protection against electrical shock - Type BF Applied Part: Laser Handpiece

•Not protected against water ingress - Ordinary Equipment

•Main Laser Console - IPX0

•Footswitch - IPX8

•Not suitable for use in the presence of flammable anesthetic

•Not suitable for use in oxygen-rich environments

•Operation Mode - Non-continuous with duty cycle of max 2 minutes ON, min 30 seconds OFF at maximum power output

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 flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used.

22	WaterLase iPlus User Manual

7 Installation

INSTALLATION INSTRUCTIONS

The WaterLase iPlus laser system must be installed by a qualified BIOLASE employee or representative who will unpack and install the laser. Please leave all crates and shipping containers unopened until the trained representative arrives. Complete installation, testing, and demonstration require approximately one full day.

Please contact the representative before transporting the laser system to a different location. Misalignment of optical components may occur during transportation if the laser is not properly packaged.

FACILITY REQUIREMENTS

ELECTRICAL SUPPLY: 100 VAC @ 15.0 Amps to 230 VAC @ 8.0 Amps, 50/60 Hz

NOTE: The main power supply of the iPlus laser system has an isolation transformer that complies with a Transient Voltage of 4kV.

COMPRESSED AIR SUPPLY: 80 - 120 psi (5.5 - 8.2 bar)

CAUTION: Moisture in the air supply line may damage the laser system. Please provide proper filtration to eliminate all moisture from the air source.

ENVIRONMENTAL REQUIREMENTS

TEMPERATURE: 15 - 30 °C HUMIDITY: 20% - 80%, non-condensing

AIR SUPPLY: Connections for an air supply must be available in each operatory. Attach an air hose with 1/4” inside diameter male quick connectors on each end between the air inlet connector and the operatory air source.

CAUTION: Prior to connection, verify that the outlet is for the air, NOT the water supply. Connection to the water supply may cause damage to the WaterLase iPlus system. If the laser console is connected to the water supply, DO NOT turn the system on; contact the service representative.

CAUTION: DO NOT position this equipment so that it is difficult 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.

WaterLase iPlus User Manual

23

7 Installation

SET-UP REQUIREMENTS

CONNECTING THE LASER CONSOLE TO THE OPERATORY

1.Verify the circuit breaker is in the OFF position.

2.Verify the keyswitch is in the OFF position.

3.Connect the power cord to the rear of the laser console (Fig 3.2).

4.Verify a minimum air pressure of 80 psi (5.5 bar) is emitted from the air supply.

5.Check the air supply for moisture.

6.Connect the air supply to the laser console’s air inlet connector at the rear of the console (Fig 3.2).

CAUTION: Do not connect the operatory air supply to the laser console if water or oil is present. The air compressor may need to be drained or cleaned and air filters installed if moisture appears.

Wet air will damage the laser system. Check the air supply weekly to verify the absence of water and oil.

FILLING THE INTERNAL COOLING WATER RESERVOIR

The WaterLase iPlus may have been shipped with a full cooling water reservoir. In the event the user needs to fill the reservoir, please follow the instructions below.

1.Open the back panel door by turning two thumb screws counter clockwise and pull back gently (Fig 7.1).

WARNING: Be careful when opening the door. Make sure it opens easily and clears the lid and tubing of the bottle. The bracket holding the door is mounted at the bottom hinge. Do not apply excessive force!

2.Locate the internal water reservoir and verify that the white clip on the blue tube connected to the side of the water reservoir is closed.

3.Push the button on the top connector and disconnect the tubing from the lid (Fig 7.2).

4.Remove the lid and filter assembly (Fig 7.3, 7.4).

Fig 7.1

Fig 7.2

Fig 7.3

Fig 7.4

24	WaterLase iPlus User Manual