User Manual 5200158 Rev. E (12/13)
User Manual
5200158 Rev. E (12/13)
Copyright ©2011
Biolase Technology, Inc.
All Rights Reserved.
iPlus™ software copyright ©2010
Biolase Technology, Inc.
Biolase, the Biolase logo, iLase™, ezlase
and ezTip®, Waterlase®, iPlus™ are either
trademarks or registered trademarks
of Biolase Technology, Inc.
Other trademarks are property
of their registered owners.
Biolase Technology, Inc.
www.biolase.com
USA
4 Cromwell
Irvine, CA 92618
Telephone: (888) 424-6527
Telephone: (949) 361-1200
Fax: (949) 273-6687
Service: (800) 321-6717
Europe
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
www.mt-procons.com
BIOLASE Europe GmbH
Paintweg 10
92685 Floss
Germany
Telephone: +499603808252
Fax: +499603808250
Contents
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Section 1
SAFETY WITH THE WATERLASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Plume Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Energy Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Circuit Breaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Keyswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Footswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Remote Interlock Outlet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Emergency Stop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Layout of Control Elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Section 2
INSTALLATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Installation Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Facility Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Electrical Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Compressed Air Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Section 3
EQUIPMENT DESCRIPTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Main Unit Elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Front and Back Handles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Locking Wheels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Emergency Stop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Keyswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Footswitch Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Remote Interlock Outlet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Power Connection / Circuit Breaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Ventilation Channels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Air Inlet Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Self Contained Water Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Water Bottle Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1
Contents
(continued)
Footswitch Support Bracket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Fiber Support Arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Handpiece Holder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
iLase Diode Laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Waterlase iPlus Delivery System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Delivery System Connection on the Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Fiber Optic Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
iLase Charging Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Section 4
SETUP INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Connect Unit to Operatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Filling the Internal Cooling Water Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Fill Self-Contained Water System Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Secure Fiber Optic Assembly to Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Connecting YSGG Handpiece to Fiber Optic Cable. . . . . . . . . . . . . . . . . . . . . . 25
Disconnecting the Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Installing and Changing Tip in the Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Tip Inspection Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Tip Cleaning Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Section 5
OPERATING INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
To Start the Waterlase iPlus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Activate the Waterlase iPlus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Turn the Waterlase iPlus Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
User Interface / General Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Controls and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Applications Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Level 0 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2
Contents
(continued)
Level 1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Level 2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Changing Water in the Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Spray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Changing and Saving the Pre-Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Settings / Memory Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Functions for the Setting Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Advanced . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Drain Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Sound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Restore. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Illumination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Custom Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Power Limits for the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Description of Function Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Change Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Change Tip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Other Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Help “I” icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Error Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Service Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
System Flow Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Section 6
SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Dimensions (WxLxH). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Electrical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Water Spray. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3
Contents
(continued)
Section 7
INDICATIONS FOR USE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Hard Tissue. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
General Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Root Canal Hard Tissue Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Endodontic Surgery (Root Amputation) Indications. . . . . . . . . . . . . . . . . . . 42
Bone Surgical Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Laser Periodontal Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Soft Tissue Indications including Pulpal Tissues . . . . . . . . . . . . . . . . . . . . . . . . 43
Root Canal Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Section 8
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS. . . . . . . . . . . 44
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Eyewear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Anesthesia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Treatment, Technique and Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Hard Tissue Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Soft Tissue Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Curettage Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Fluid Entrapment and Air Embolism. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Root Canal Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Root Canal Disinfection Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Adjacent Structures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Clinical Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Tissue Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Tissue Contact and Tip Breakage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Tip Changing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Water Splashing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Plume Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Dental Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Section 9
CLINICAL APPLICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Hard Tissue Cutting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Soft Tissue Incision, Excision and Ablation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4
Contents
(continued)
Procedures Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Presets for Soft and Hard Tissue Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Fiber Tip Calibration Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Calculating Emitted Power With Tip Attachment. . . . . . . . . . . . . . . . . . . . . . . . . . 51
Use of the Aiming Beam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Presets Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Section 10
CLEANING AND STERILIZATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Handpiece and Tip Cleaning and Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Section 11
MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Basic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Mirror Check and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Mirror Inspection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Mirror Alignment Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Changing the Handpiece Mirror. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Troubleshooting the Delivery System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Fiber Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Annual Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Delivery System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Laser Console. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Daily Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Transportation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Section 12
CALIBRATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Calibration Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Appendix A
LABELS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Appendix B
ACCESSORIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Appendix C
CLINICAL PROCEDURE GUIDELINES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Periodontal Therapy Clinical Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Warnings & Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5
Contents
(continued)
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Step 1: Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Step 2: Troughing and Inner Epithelium Lining . . . . . . . . . . . . . . . . . . . . . . 76
Step 3: Calculus Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Step 4: Outer Epithelium Lining Removal . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Step 5: Pressure Clot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Post Operative Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Single-Use Non-Sterile Tips Included. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Endodontic Therapy Clinical Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Warnings & Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Step 1: Access Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Step 2: Conventional Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Step 3: Cleaning & Enlargement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
RFT2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
RFT3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Step 4: Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
RFT2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
RFT3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Obturation & Restoration Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Calibration Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Appendix D
TIPS: SUGGESTED CLINICAL SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . 82
Tip Settings: Waterlase iPLUS/MD Gold Handpieces . . . . . . . . . . . . . . . . . . . . . . 83
Indications For Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Appendix E
ELECTROMAGNETIC COMPATIBILITY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
6
Introduction
The Waterlase iPlus tissue cutting system is a unique device with diverse hard and soft tissue
dental applications. For hard tissue procedures, the Waterlase iPlus utilizes advanced laser and
water atomization technologies to safely and effectively perform tissue cutting, shaving, contouring,
roughening, etching and resection. For soft tissue procedures, the Waterlase iPlus utilizes direct laser
energy to perform tissue removal, incision, excision, ablation and coagulation. The Waterlase iPlus can
also be used for endodontic and periodontal applications.
For hard tissue procedures, the YSGG solid-state laser provides optical energy to a user-controlled
distribution of atomized water droplets and hydrated surface layer of hard tissue. Water in the spray,
on tissue surface and within the surface tissue layer absorb laser radiation, resulting in explosive water
expansion. Strong mechanical force from rapid water expansion induce separation of surface material,
quickly and cleanly removing hard tooth tissue. A flexible fiber optic cable with handpiece delivers the
unique laser wavelength and atomized distribution of water particles to the target tissue. A visible
light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output
and atomized water spray may be adjusted to specific user requirements for both soft and hard tissue
applications.
In soft tissue mode, the Waterlase iPlus is programmed to perform tissue removal, incision, excision,
ablation and coagulation using direct laser energy either with or without water for cooling and hydration.
The Waterlase iPlus system may also include the iLase diode laser, a surgical device designed for a
wide variety of dental soft tissue procedures. For more information about the iLase, please refer to the
iLase user manual (Biolase P/N 5400230).
Use of this device requires proper clinical and technical training. This manual provides instructions for
use for trained dental surgeons and practitioners.
When used and maintained properly, the Waterlase iPlus will prove a valuable addition to your practice.
Please contact your authorized local Biolase representative if you have any questions or require
assistance.
7
1 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 herein
may result in hazardous radiation exposure.
DANGER: Invisible and/or visible laser radiation­– Avoid eye or skin exposure to direct or scattered radiation.
Class IV.
CAUTION: This unit 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 unit in any manner other than described herein. Do not use the unit if you suspect
it is 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 and
2,780nm energy, supplied by BIOLASE.
CAUTION: Periodically inspect eyewear for pitting and cracking.
NOTE: For replacement or additional protective eyewear, please contact your Waterlase iPlus representative.
4. Do not look directly into the beam or at specular reflections.
5. Direct the cutting spray toward targeted tissues only.
6. Press STANDBY (Standby button) on the control panel before changing water and before turning off
the unit.
7. Move the circuit breaker to OFF (0) position (located on rear panel) and remove the key before leaving
unit unattended.
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.
All operatory entrances must be marked with an approved warning sign indicating a laser is in the
operatory.
8
1 Safety with the Waterlase
(continued)
8. PLUME REMOVAL
CAUTION: 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 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.
SAFETY FEATURES
ENERGY MONITOR
The energy monitor measures and verifies power output. Power deviations of more than 20% from the
selected value will cause the display to show an error message.
The unit will not operate until the system is reset by pressing the “Next” button on the touch screen. If
error messages persist please contact your Representative.
CIRCUIT BREAKER
The circuit breaker on the back panel serves as a line switch to separate the unit from the main power
supply (0 = OFF, 1 = ON).
KEYSWITCH
To switch unit ON, turn key to horizontal position. Use the proper key only. The key cannot be removed
while in the ON position.
Always remove the key when the unit is left unattended for a long time.
FOOTSWITCH
The Waterlase iPlus will not activate until the user presses down on the footswitch. 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. The purpose is to enable a user-provided
remote switch (e.g., on the entrance door) to turn OFF the laser. To use it properly requires a normallyclosed pair of contacts connected to pins 1 and 5 of the connector. These contacts should have no
voltage associated with them and should open on activation.
Your Biolase service engineer can assist you in connecting the remote interlock to a door switch.
9
1 Safety with the Waterlase
(continued)
EMERGENCY STOP
Press the red emergency stop button to instantly turn off the unit. 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. If the system was on when the emergency stop was
activated, the system will be in standby mode when turned back on. You must push the “ready” button
before using the system again.
CONTROL PANEL
The touch screen control panel shows the functional conditions of the system.
LAYOUT OF CONTROL ELEMENTS
All control functions are located at a safe distance from energy output. Control panel layout and instructions are described in Section 5, Operating Instructions.
Please refer to iLase User Manual for safety features associated with the iLase.
Please refer to iLase User Manual for safety features, associated with the iLase.
NOTE:Please direct any safety questions to your local Biolase representative, or call Biolase at (888)
4-BIOLASE [(888) 424-6527], or Biolase Service at (800) 321-6717
10
2 Installation
INSTALLATION INSTRUCTIONS
Your local authorized representative will unpack the Waterlase iPlus and your service representative will install
the unit. Please leave all crates and shipping containers unopened until your trained service representative
arrives. Complete installation, testing and demonstration requires approximately one full day.
The Waterlase iPlus must be installed with a qualified Biolase employee or representative; please refer
to Section 4, Setup Instructions, for setup instructions.
Please contact your representative before transporting unit to a different location. Misalignment of
optical components may occur during transportation if the unit is not properly packaged.
FACILITY REQUIREMENTS
ELECTRICAL SUPPLY: 100 VAC @ 15.0 Amps to 230 VAC @ 8.0 Amps, 50/60 Hz
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 air source.
Connections for air supply must be available in each operatory.
Attach air hose with 1/4” inside diameter male quick connectors on each end between air inlet
connector and operatory air source.
CAUTION: Prior to connection, verify that outlet is for air, not water supply. Connection to water supply may
cause damage to the Waterlase iPlus system. If the unit was connected to the water supply, do NOT turn the
system on. Contact your service representative.
11
3 Equipment Description
(continued)
GENERAL
The Waterlase iPlus dental laser system consists of three modules:
• Main Unit (the Unit – shown in Figures 2.1, 2.2, and 2.3)
• Waterlase iPlus Fiber Delivery System (the Delivery System – shown in Figures 2.1, 2.2, and 2.3)
• iLase Diode Laser Handpiece (optional).
MAIN UNIT ELEMENTS
Figures 2.1, 2.2, and 2.3 show the front, rear and top views of the unit.
CONTROL PANEL
The main unit is controlled through a touch screen control panel. Please see section 5, Operating Instructions, for detailed
instructions on using the control panel.
FRONT AND BACK HANDLES
Use the front and back handles to move the unit and lift when necessary.
CAUTION: Prior to lifting, make sure handles are not damaged. Do not use the delivery system to pull the
unit; this could damage the fiber optic and render the unit inoperable.
LOCKING WHEELS
Press down on front tabs to lock the unit. Lift up the tabs to release locking mechanism.
EMERGENCY STOP
Press the red emergency stop button to instantly turn off the unit. 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. If the system was on when the
emergency stop was activated, the system will be in standby mode when turned back on. You must push the “Ready” key before
using the system again.
KEY SWITCH
To switch unit ON, turn key to horizontal position. Use the proper key only. The key cannot be removed while in the ON position.
FOOTSWITCH CONNECTOR
Connect and secure footswitch here.
REMOTE INTERLOCK OUTLET
Each laser has a remote plug and connector on its rear panel. The purpose is to enable a user-provided remote switch (e.g., on the
entrance door) to turn OFF the laser. To use it properly requires a normally-closed pair of contacts connected to pins 1 and 5 of the
connector. These contacts should have no voltage associated with them and should open on activation.
Customers may request that the remote interlock be connected to a door switch.
12
3 Equipment Description
Header
(continued)
FIBER DELIVERY
SYSTEM
TELESCOPIC FIBER
SUPPORT ARM
TOUCH SCREEN
CONTROL PANEL
YSGG HANDPIECE
FRONT
HANDLE
EMERGENCY
STOP SWITCH
LOCKING WHEELS
(FRONT ONLY)
FIG 2.1
13
3 Equipment Description
(continued)
BACK HANDLE
SELF-CONTAINED
WATER SYSTEM
VENTILATION
BACK PANEL
REMOTE
INTERLOCK OUTLET
KEY SWITCH
FOOTSWITCH CABLE
WRAP PLATE
POWER CABLE
WRAP PLATE
POWER CONNECTION &
CIRCUIT BREAKER
GROUND PIN
FOOTSWITCH SUPPORT
FOOTSWITCH CONNECTOR
BRACKET
AIR INLET CONNECTOR
FIG 2.2
14
3 Equipment Description
(continued)
POWER CONNECTION / CIRCUIT BREAKER
Attach power cord to unit at this location. The circuit breaker serves as a line switch to separate the
unit from the main power supply (0 = OFF, 1 = ON). Power cable can be wrapped over the holding plate
above the connector when system is not in use or during transportation.
VENTILATION CHANNELS
Do not cover or block these channels. They provide an air flow path to cool the system.
AIR INLET CONNECTOR
Connect with tubing (included) to compressed dry air outlet at 80-120 psi (5.5 - 8.2 bar)
SELF CONTAINED WATER BOTTLE
Provides water supply for handpiece atomization spray. Fill bottle only with distilled or sterile water.
Do not use tap water.
WATER BOTTLE RELEASE­
When system is in “standby” mode, after bottle is depressurized, push the release button and pull back
to remove the water bottle. After refilling the bottle, replace the bottle into its holder and secure the
bottle in place.
FOOTSWITCH SUPPORT BRACKET
For storage or moving the unit, the bracket is designed to hold the closed footswitch clamshell. Wrap
the footswitch cable around the wrap plate above.
FIBER SUPPORT ARM
Supports delivery system on the unit. It extends to support weight of the delivery system when
handpiece is pulled forward. Extension comes back when handpiece is released and arm is in vertical
position.
HANDPIECE HOLDER
Supports YSGG handpiece when not in use.
ILASE DIODE LASER
Sits in the charging cradle with additional charging port for spare battery.
NOTE: Proper placement of the Delivery System Cable in the Support Arm and of the Handpiece in the
Handpiece holder is important for convenient and safe handling of the delivery system.
15
3 Equipment Description
(continued)
FIBER DELIVERY SYSTEM
BACK HANDLE
WATER BOTTLE COVER
WATER BOTTLE RELEASE PUSH BUTTON
ILASE DIODE LASER AND SPARE
BATTERY IN CHARGING PORT
TOUCH SCREEN
CONTROL PANEL
YSGG HANDPIECE
FRONT HANDLE
FIG 2.3
WATERLASE IPLUS DELIVERY SYSTEM
(see Section 4 for detailed description and instructions)
DELIVERY SYSTEM CONNECTION ON THE UNIT
The delivery system attaches to the unit via a multi-connector incorporating air, water, cooling air,
illumination waveguides and the optical energy fiber optic.
16
3 Equipment Description
(continued)
FIBER OPTIC CABLE
Fiber optic cable contains the optical fiber together with the illumination waveguides, air tubing and
water tubing. Laser radiation is delivered from laser unit to the handpiece through the optical fiber.
HANDPIECE
The YSGG handpiece is rotatable and detachable from the optical shaft. It delivers optical energy,
illumination and atomized water spray to the treatment area.
ILASE CHARGING PORT
May hold one iLase laser handpiece and one extra iLase battery.
17
4 Setup Instructions
SETUP
CONNECT UNIT TO OPERATORY
1. Verify circuit breaker is in OFF position.
2. Verify keyswitch is in OFF position.
3. Connect power cord to unit (see fig.2.2).
4. Verify minimum air pressure of 80 psi (5.5 bar) from air supply.
5. Check air supply for moisture.
CAUTION: Do not connect the operatory air supply to the unit if water or oil is present. Air compressor
may need to be drained or cleaned and air filters installed if moisture appears. Wet air will damage the unit.
Check air supply weekly to verify absence of water and oil.
6. Connect to the unit’s air inlet connector (see fig. 2.2).
FILLING THE INTERNAL COOLING WATER RESERVOIR
Your Waterlase iPlus may have been shipped with a full cooling water reservoir. In the event you need 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;
WARNING: Be careful opening the door. Make sure door opens easily and clears the bottle lid and tubing.
Door holding bracket is mounted at the bottom hinge. Do not apply excessive force!
FIG 4.1
18
FIG 4.2
4 Setup Instructions
(continued)
2. Locate internal water reservoir. Verify that white clip on the blue tube that is connected to the side of
the water reservoir is closed;
3. Push button on the top connector and disconnect tubing from the lid;
4. Remove lid and filter assembly.
WARNING: Be careful handling the water filter assembly. Do not touch white filter material to prevent
contamination and potential damage
FIG 4.3
FIG 4.4
5. Use the funnel (supplied) to fill with distilled or deionized water to ¾’s full;
FIG 4.5
6. Replace filter assembly and close lid tight;
19
4 Setup Instructions
(continued)
7. Plug in water connector firmly, until it “clicks” in place;
8. Power up the system:
• Switch the Power Circuit Breaker on the back panel ON;
• Turn the Keyswitch to the ON position;
• When keyswitch is turned ON, the system will begin its boot-up process. The system will load the
software and the rotating tooth image appears on the display screen (about 30 seconds).
9. Press “Ready“ key. If “Water level low” error message is shown, turn the system OFF refill the
cooling water to ¾ full level.
10. Press “Ready” key again and let system run for 1-2 minutes to clear the air bubbles from all components of the cooling system.
11. Close the back door and tighten the two captive screws.
FILL SELF-CONTAINED WATER SYSTEM BOTTLE
1. Make sure that system is in the Standby mode (bottle is de-pressurized);
2. Push the bottle release button and pull the bottle out from the holder towards the back handle;
FIG 4.6
FIG 4.7
3. Twist the bottle clockwise and pull up the lid to open;
4. Fill bottle with distilled or sterile water only;
5. Align arrow on the lid and dot on the bottle and insert bottle into the lid;
WARNING: DO NOT use the tap water or non-authorized solution. If tap water or other
non-approved solution is used, system warranty will be voided.
20
4 Setup Instructions
(continued)
6. Twist the lid clockwise all the way until the arrows on both parts match;
FIG 4.8
FIG 4.9
7. Attach bottle back to its holder; make sure connector is fully engaged.
WARNING: Be careful handling the water bottle assembly. Do not drop the parts. Any crack may cause
damage when bottle is pressurized.
NOTE: BIOLASE recommends replacing the self-contained water system bottle once every five years.
SECURE FIBER OPTIC ASSEMBLY TO UNIT
1. Verify the Laser Head is centered to the top cover. If misaligned call Biolase headquarters for additional support;
2. Locate the hole on the left side of top view of laser unit and install telescopic fiber support arm;
21
4 Setup Instructions
(continued)
3. Take the new trunk fiber from the accessories box and drape it around your neck;
FIG 4.10
FIG 4.11
4. Remove protective black rubber cap at the proximal end of fiber;
5. Remove Protective Cover off the Fiber Shaft and place it against any light source. Check proximal end
of the fiber – it should glow yellow, be flat and clean.
6. Remove black and red protective cups from laser head and aperture (store all the cups for further use,
FIG 4.12
22
FIG 4.13
4 Setup Instructions
(continued)
do not lose them);
7. Carefully look inside the laser aperture and check that surface of the protective window is clean, free
of water, dirt or damage.
• If water or dirt found, try to clean by blowing the dry compressed air in the aperture;
• If this does not help – call for system Service.
FIG 4.14
FIG 4.15
8. Align the blue guide of fiber connector to blue dot of laser head interface. Position the middle of the
connector to the laser aperture and vertically push down gently all the way;
FIG 4.16
FIG 4.17
NOTE: You may need to move connector slightly to the sides to ensure proper engagement of all interfaces.
DO NOT APPLY FORCE!
WARNING: Applying force may create metal shavings or shave off the o-rings of the spray connector and
cause damage of the laser head components. .
23
4 Setup Instructions
(continued)
9. Secure retainer ring by turning clockwise until it is snug;
10. Align middle of the fiber to the hook of telescopic arm and push gently to engage;
NOTE: Make sure the black retaining O-ring is in the front side of the hook.
11. Disconnect Protective Cover from the distal end of the Fiber Delivery Cable and verify that it is clean
and not damaged (see also Maintenance Section);
FIG 4.18
FIG 4.19
12. Properly align fiber and the Protective Cover (or the handpiece) in the handpiece holder.
24
4 Setup Instructions
(continued)
CONNECTING YSGG HANDPIECE TO FIBER OPTIC CABLE
This procedure applies to the Gold and Turbo Handpieces.
1. Remove the Handpiece from the Handpiece Box;
2. Remove the Rear Plug from the handpiece by pulling the plug out and place it in the Handpiece Box to store;
REAR PLUG
TIP PLUG
FIG 4.20
FIG 4.21
3. Remove the fiber Protective Cover from the Fiber Shaft of the Trunk Fiber by pulling the cover off and place it
in the Handpiece Box;
4. Check the Fiber Shaft for any moisture and wipe off any that is found;
NOTE: Check output end of the Fiber Shaft for any contamination of damage (see Maintenance Section)
WARNING: Do not touch output end of the Fiber Shaft to prevent any contamination and potential further
damage. If touched, clean with dry tissue.
5. Carefully insert the Fiber Shaft into the Handpiece until it “clicks”.
correct
FIG 4.22
FIG 4.23
NOTE: Connection and disconnection of the Handpiece and the Protective Cover should be done carefully,
without application of excessive force.
WARNING: To prevent the internal fiber from braking, do not bend the flexible part of the Fiber Shaft.
25
4 Setup Instructions
(continued)
DISCONNECTING THE HANDPIECE
1. Purge the handpiece by following the instructions described in how to change a handpiece in the
Graphical User Interface (GUI), Section 5;
2. Pull and disconnect the Handpiece from the Fiber Shaft;
WARNING: Failure to purge the handpiece prior to disconnecting may cause damage of the Fiber Delivery
system.
3. Wipe any moisture off the Fiber Shaft with dry tissue;
4. Check that window at the end of the fiber is clean (use dry cotton swab or tissue to clean) and not
damaged (see also Maintenance Section);
5. Carefully attach new Handpiece or fiber Protective Sheath until it “clicks” on the Fiber Shaft;
FIG 4.24
WARNING: Do not press ”Done” button if fiber Protective Cover is attached – water will fill the Cover and
may cause damage of the Fiber Shaft. If this happens, take the Cover off and dry out both Fiber Shaft and
Protective Cover. Failure to do so may result in damage to the Fiber Shaft.
26
4 Setup Instructions
(continued)
INSTALLING AND CHANGING TIP IN THE HANDPIECE
This procedure applies to the Gold and Turbo Handpieces.
1. Set the system in the “Standby” mode;
2. Set the system in Advanced mode (Fig 5.11). Press tip change button at bottom.
NOTE: Always change Tips after pressing the tip change button to turn on patient air and cooling air. This
helps clean the input end of the tip from any light dirt or moisture.
PROXIMAL END
PLASTIC FERRULE
DISTAL END
SHAFT
FIG 4.25
FIG 4.26
3. Remove the Tip Plug by pulling it out and place it in the Handpiece Box;
4. Remove Tip from the package (for new Tips only) and insert it into the Tip Remover or revolving Tip Holder. Insert
by aligning the first groove of the Tip Ferrule against the receiving edges of the Holder, then sliding the Tip in (the
use of tweezers is highly recommended);
WARNING: Never touch the input end of the Tip. If the input surface is contaminated, it may damage the
Tip, Handpiece and the Fiber Delivery System. Hold the tip only over the plastic ferrule and the output end.
NOTE: Always inspect the Tip prior to use (See Sec. Tip Inspection).
FIG 4.28
5. Align the tip orifice of the handpiece over the input end of the Tip, placed in the Tip Remover or revolving Tip Holder;
27
4 Setup Instructions
(continued)
6. Carefully lower the handpiece and insert a clean/inspected Tip (see: Tip Inspection) all the way until
the shoulder of the tip ferrule sits against the handpiece head;
FIG 4.29
WARNING: Be careful not to hit the proximal end of the Tip against the handpiece head and not to break
retaining fingers of the plastic ferrule.
7. Slide the Handpiece laterally away from Tip Remover or Tip Holder.
8. Press the tip change button again on the advanced screen to stop patient air and cooling air.
FIG 4.30
FIG 4.31
NOTE: To remove the Tip, repeat the whole process in reverse order. Put your thumb against the selected tip
slot to prevent Tips from falling out of the Tip Holder when connecting and disconnecting Tips from
the Handpiece.
NOTE: If the laser cuts hard and soft tissue after fiber installation slower than expected, please follow the
flowchart in Sec. Troubleshooting the Delivery System.
NOTE: Use same techniques when operating MD Turbo handpiece and MX Tips. Also note that (1) the
Turbo tip holder/remover tool is different than the regular tip holder/remover; (2) the Turbo tool works ONLY
with Turbo tips; and (3) the regular tool does NOT work with Turbo tips. Also refer to the Turbo Handpiece
instructions for use for more information, P/N 5200147.
28
4 Setup Instructions
(continued)
TIP INSPECTION INSTRUCTIONS
[01] Remove the tip from the handpiece and insert
it into the correct side of the tip test holder
as shown using the tip remover.
Tip remover with tip inside
[02] Insert the tip test holder into the test
adapter with the distal (or laser-emitting)
end of the tip toward the microscope.
[03] Slide the adapter over the microscope to move
the tip surface toward the focal point of the
FOCAL POINT
microscope. The focal point lies in the plane at
THUMB WHEEL
the end of the clear end tube of the microscope.
[04] Turn on the microscope’s built-in light by gently pulling apart the upper and lower tubes,
or hold it up to another light source, and bring the surface of the tip into focus using the
thumb wheel. Examine the tip surface carefully for damage or contamination.
GOOD
BURNT
BROKEN
CONTAMINATED
[05] To examine the proximal (or trunk fiber) end of the tip,
remove the adapter from the microscope, and gently
fit the other side of the test holder into the clear end
tube of the microscope. Refocus the Microscope.
[06] Remove the tip from the test holder using the tip remover.
If the tip is contaminated at either end, try cleaning it as
shown below. If the tip is damaged, replace it from the
Tip remover with tip inside
handpiece using the tip remover and dispose of it.
TO REPLACE THE BATTERIES FOR THE BUILT-IN MICROSCOPE LIGHT, gently pull apart the upper and lower
tubes of the microscope. Locate the battery cover marked with “OPEN”, slide the cover in the direction of the
arrow, remove the old batteries and replace with two size AA 1.5 volt (Europe size M) batteries.
TIP CLEANING INSTRUCTIONS
1. Hold tip with tweezers.
2. Moisten cotton swab with 100% isopropyl alcohol drops
3. Push tip into cotton swab
4. Twirl cotton swab while maintaining pressure on tip
29
5 Operating Instructions
OPERATION
CAUTION: Use of controls or adjustments and performance of procedures other than those specified herein
may result in hazardous radiation exposure.
OVERVIEW
Before using the Waterlase iPlus, be sure the system has been started appropriately, as described
earlier in this manual.
30
5 Operating Instructions
(continued)
TO START THE WATERLASE IPLUS
1. Verify that all connections have been properly secured and fiber cable properly attached
2. The Air supply must be connected and the external air pressure must be at 80 PSI (5.5 bar) or more.
3. Electrical input should be at least 100 VAC, maximum 15 amperes to 230VAC, 8 amperes.
4. Verify that the water bottle is more than 1/3 filled with distilled or sterile water.
DANGER: Laser and collateral radiation are emitted through the fiber optic port. Removal of the
multiconnector from the fiber optic port may lead to hazardous exposure. Radiation is also emitted from the
fiber shaft when the handpiece is removed. DO NOT attempt to operate the Waterlase iPlus with the delivery
system or the handpiece not attached.
5. Switch the circuit breaker ON.
6. Insert the key into the keyswitch and rotate clockwise to the ON position.
7. The emergency stop button must be released (verify by making sure the button is not glowing red, and no error message is displayed).
8. The system will begin its startup process. The system will load the software and the tooth image appears on the display screen
(about 30 seconds).
9. Attach handpiece to the fiber optic cable shaft (Sec. 4: Connecting the Handpiece to Fiber Optic Cable).
10. Place system into Standby mode and attach tip using the tip remover (Sec. 4: Installing and Changing Tip Into Handpiece)
ACTIVATE THE WATERLASE IPLUS
Push the Ready button to enable the Waterlase iPlus, and depress the footswitch when ready.
NOTE: The user may evaluate the effect of each parameter setting prior to the procedure directing the
handpiece into a sink or paper cup and adjusting the values as desired
NOTE: To help prevent inadvertent laser activation, there is a 0.5-second delay between footswitch depress
and actual laser emission.
TURN THE WATERLASE IPLUS OFF
• Disconnect tip, if required. Install tip plug.
• Press and hold the function control button for 2 seconds to turn the system OFF.
• Turn key to OFF position
• Turn circuit breaker to OFF.
31
5 Operating Instructions
(continued)
USER INTERFACE / GENERAL NAVIGATION
INTRODUCTION
The Graphical User Interface (GUI) is the main part of the system control, communicating to the user
through the interactive touch screen display. It is designed to provide easy and intuitive interaction with
the laser system during performance of clinical procedures.
The system automatically selects recommended pre-programmed settings correspondent to the
selected clinical application. It minimizes potential error of setting laser parameters and creates a more
satisfactory experience for both user and patient.
CONTROLS AND INDICATORS.
The control panel (Fig. 5.1) has one functions control button for turning the system ON and OFF, and
for switching between Standby and Ready Modes. Pressing and holding the button for more than 2
seconds will turn the system ON / OFF. When ON, pushing the button will switch the system between
Standby and Ready Modes.
The control panel also has one LED indicator for system status and laser power actuation. An amber
light indicates that the system is in Standby Mode. A green light indicates Ready Mode, and a blinking
green indicates that the laser is firing.
There are also two status indicators for the iLase batteries: Amber light for charging mode, Green light
for fully charged state.
FIG 5.1
32
5 Operating Instructions
(continued)
APPLICATIONS MENU
LEVEL 0 DESCRIPTION
After the system is powered up, there is approximately 45 second delay for loading the software. After the
system is loaded, a tooth is displayed on the screen like a screen saver. A touch of the screen will bring the
system to Level 0 Home Menu (See Fig. 5.2 and Flow Chart in Fig. 5.15) and one can see the tooth tissues with
option to select the operational areas.
FIG 5.2
FIG 5.3
There are 6 main categories of procedures to be selected at this level:
• Restorative
• Soft Tissue
• Periodontics
• Implantology
• Endodontics
• Expanded
To select the procedure category press the name on the touch screen.
The system is in Standby Mode and cannot be turned to Ready Mode while the Home Menu is displayed.
LEVEL 1 DESCRIPTION
When a procedure category is selected, the system goes to Level 1 with a number of clinical applications within
the selected category, which have been tested to be efficient for use with Waterlase technology
(See Fig. 5.3 as example).
Currently there are 16 procedures completely identified within 6 Procedure Categories (See the Flow Chart, Fig. 5.15).
33
5 Operating Instructions
(continued)
FIG 5.4
FIG 5.5
To select a procedure – touch the correspondent name or image.
The system is in Standby Mode and cannot be turned to Ready Mode.
LEVEL 2 DESCRIPTION
When a particular procedure is selected, the system goes to Level 2 (See Fig. 5.4 for an example). At this level, all laser operating parameters are identified as pre-sets for the selected step within the procedure. Several steps to follow during the procedure are recommended.
Each step has its own name (which may be also a trademark name). Each step has its own recommended settings.
Changing Water in the bottle. When water in the bottle is detected LOW, a blinking button with a low water level symbol will appear
next to the Settings button. The user may then place the system into Standby Mode to allow the user to change the water in the bottle. When the
bottle is disconnected, an Error screen will appear. When the bottle is re-attached, the Error screen shall be cleared either automatically, when the
bottle status is checked by the system, or manually. Pressing the main Function button (below the touchscreen) will return the system to Ready
Mode. The same algorithm is true for all procedure screens.
Three setting categories are shown at the bottom: Handpiece and Tip, Laser, and Spray. Adjustments can be made to:
• Handpiece type and Tip type: all tips which are allowed for this procedure
• Laser: Power, Pulse Repetition Rate and Pulse Mode
• Spray: Water and Air percentage
Handpiece type is selected as preferred for the current procedure step and is named at the bottom.
Handpiece can be changed to the same type or a different type. To do so
1. First, press the handpiece image button; the system shall automatically purge the water from the handpiece (Patient Air 100% ON,
air pressure in the bottle OFF, Patient Water 100% ON); a progress timer will be shown (3-4 second) in a form of a segmented circle
outside of the handpiece icon in the button, and water will be purged from the handpiece;
2. When done, a new message: “Excnge Handpiece now and then select Tip” shall
appear. At that time a new handpiece can be re-attached.
34
5 Operating Instructions
(continued)
3. Then press the desired tip image (which might be the same tip or a new tip); patient air (and internal cooling air)
will be activated through the handpiece, and a new tip may be inserted.
4. After a new tip is attached to the new Handpiece, press the handpiece image again; a progress timer is shown
again for 3-4 second, and the handpiece shall be primed with water.
To come back to the Procedure screen, the back or handpiece button at the bottom row should be pressed again.
TIPS selection always corresponds with the selected handpiece type. Their names are shown at the bottom of each
tip image for reference. When the Tip Selection is active, one main recommended tip is highlighted, preferred tips are
outlined, and all allowed-for-use tips are shown (Fig. 5.6).
• Press the tip image (which might be the same tip or a new tip);
• Both Cooling Air and Patient (spray) Air will turn ON;
• Replace the tip.
To come back to the Procedure screen when the tip is installed, the back or handpiece button at the bottom row should
be pressed again.
FIG 5.6
FIG 5.7
FIG 5.8
LASER power setting as well as pulse prepetition rate and laser pulse mode are always defined by the type of
procedure and the selected tip type (Fig 5.7). The Pulse Mode button switches the system between S (long pulse) and
H (short pulse) modes. Laser parameters can be changed at any time in Ready or Standby Modes. After adjustment,
pressing the back or Laser button will bring the system back to the Procedure screen.
SPRAY settings for air and water % can also be adjusted in Ready or Standby Modes (Fig 5.8).
Mode selection scrolls between ON, OFF and AUTO for both parameters.
35
5 Operating Instructions
(continued)
CHANGING AND SAVING THE PRE-SETS
When system parameters are changed from factory pre-sets, the “star” symbol changes to an “unlocked lock”
symbol. That indicates that the system pre-set parameters have been modified but not saved.
To save modified parameters, press and hold the step name’s button for 2 seconds. The “unlocked lock” symbol
shall change to a “locked lock” symbol, indicating that the modified settings have been saved. Otherwise, the
modifications will be lost when going to a different screen.
To restore factory pre-programmed settings for the customized procedure step (indicated by a “locked lock” symbol),
the correspondent step name’s button shall be pressed and held for 2 seconds. The “star” symbol shall re-appear in
place of the “locked lock” symbol, indicating that settings have been changed back to factory pre-set values.
Factory recommended or modified settings can be saved as one of the “Favorites”, if required.
The entire original factory pre-sets can be restored as well, when in the Settings Menu “RESTORE ALL” icon is
selected.
None of the parameters can be changed when system is in FIRING mode.
De-fault settings for Illumination (both Aiming Beam and Light) are in the middle of the adjustment range. The same
is true for the Sound Tone.
SETTINGS / MEMORY MENU
The Settings / Memory Menu stores up to 9 “Favorites” (Fig. 5.9). It can correspond to a particular step of the
procedure described in the Main Application Menu or can be completely independent, if selected by the user and
stored from the Advanced Menu.
This Menu also provides access to the following supplementary functions:
• Access to the Custom operational menu, Advanced Menu, not associated with any clinical procedure;
• Purging and priming of the fiber delivery system;
• Adjustment of the loudness of the touch-tone;
• Restoration of all factory pre-sets;
• Selection of the Language;
• Adjustment of the Aiming beam and Illumination;
• Access to the Service Screen.
36
5 Operating Instructions
(continued)
When switched to this screen from the Procedure screen or from the Advanced screen, the latest settings and name of the
procedure step are displayed in the top row. To save the current settings into one of the “Favorites”, press and hold one of
the nine buttons for 2 seconds. The name of the procedure and step will appear within the button. When working from the
Advanced screen, the name for the button will be given as “Custom 1”, etc.
FUNCTIONS FOR THE SETTING BUTTONS
FIG 5.9
FIG 5.10
FIG 5.11
• ADVANCED button switches the system to the Advanced mode;
• DRAIN WATER button shall be used only when replacing the fiber. When pressed, “Purge” and “Prime” buttons appear.
When “Purge” is activated – the fiber shall be purged of water.
When “Prime” is activated – the fiber shall be primed with water.
• SOUND will lead to adjustment of sounds within the range 0 to 15.
• RESTORE function will lead to dialogue screen “Do you want to restore all factory pre-sets?” with YES and Exit options.
If YES is selected, all factory pre-sets will be restored.
• LANGUAGE button gives an option of selecting one of multiple languages.
• ILLUMINATION screen will have adjustments for visible aiming beam and light illumination for Handpiece from 0 to 9.
• SERVICE button will lead to Service Menu.
CUSTOM SETTINGS
The user has the capability to adjust parameters without any limitation and without relation to any procedure in the Advanced
screen (Fig. 5.11).
When selecting the “Advanced” button, the system goes to the screen with all parameters shown, without referencing any
particular procedure or limiting any range of adjustments.
37
5 Operating Instructions
(continued)
POWER LIMITS FOR THE SYSTEM ARE SHOWN IN THIS TABLE:
Pulse rate, Hz
H - mode
S - mode
Min power, W
Max Power, W
Min power, W
Max Power, W
5
0.10 2.50 0.102.50
8
0.10 4.75 0.104.75
10
0.10 6.00 0.106.00
12
0.10 7.25 0.107.25
15
0.10 9.00 0.109.00
20
0.10 10.000.1010.00
25
0.25 10.000.2510.00
30
0.25 10.000.259.00
40
0.25 9.00 0.258.00
50
0.25 8.00 0.256.00
75
0.50 6.00 0.000.00
100
0.50 4.00 0.000.00
*These parameters are for all
MX, MC tips and
MZ10, MZ8, MZ6
and MS75 tips.
DESCRIPTION OF FUNCTIONAL BUTTONS:
• Change Handpiece selection will automatically purge the water from the handpiece, with a progress timer
displayed (3-4 second). Then a message to change the handpiece will appear. When the handpiece is changed, the
same button should be pressed and the priming cycle starts with progress segmented circle shown.
• Change Tip selection turns both Internal Cooling air and Patient air ON. When pressed again, the system will return
to the Advanced screen.
SETTINGS button leads to the Settings screen.
FIG 5.12
FIG 5.13
OTHER SCREENS
Help “i” icon on icon on every screen can be selected to go to an Information / Recommendations Screen.
Error screen screen will appear when a system error is detected. It will give the Error name and
recommendations for how to correct it (Fig 5.12).
Service screen screen will have a pass code to provide access to authorized personnel (Fig. 5.13).
38
5 Operating Instructions
(continued)
SYSTEM FLOW CHART:
FIG 5.15
39
5 Operating Instructions
(continued)
ERROR MESSAGES
The Waterlase iPlus constantly monitors its own performance and calibration. If any performance errors occur, the system will be placed in Standby
mode and the screen will indicate the cause of the error and provide recommendations on clearing the error.
If you cannot clear an error after following the directions on the error screen, please call your local service representative for assistance.
Error
Number
Reason
Fix
Corrective Action
6
All bottle sensors off
Possible error in light
source
Check bottle sensor
light source
Check bottle straw,
clean sensors
7
Bottle sensor 1 off,
2 on
Possible defective
sensor 1
Check Bottle sensor
Check bottle straw,
clean sensors
8
All bottle
sensors on
Error in bottle sensor
system
Check out bottle sensor Check bottle straw,
clean sensors
system
13
Foot Switch pressed in
Standby Mode
Foot Switch pressed in
Standby Mode
Release the Foot Switch Check connector, Switch
to “Ready” mode
Interlock is open
Interlock is open
Check Interlock
Check Remote Interlock
connector at back panel
17
Shut Down temperature
condition
System Temperature is
high
Allow system to cool
down
Let system run in
“Ready” mode for
5-10 minutes
18
Emergency switch
pressed
Emergency switch
pressed
Check Emergency
switch
Release the Emergency
Stop Button at the front
19
No bottle error
Bottle not detected
Insert bottle or repair
sensor
Insert water Bottle and
clean the sensors
23
Reservoir fail
Cooling water level
is low
Add de-ionized/distilled Add specified water, if
trained on that
water
24
Air pressure failure
Air pressure failure
Check air compressor
Air pressure might be
low or disconnected
26
Foot Switch not
detected
Foot Switch not
connected
Connect Foot Switch
Check connector,
footswitch short during
standby
29
Fiber not detected
Fiber not detected
Check Fiber
Properly re-connect
the Trunk Fiber
31
No water
No water in bottle
Add water to bottle
Add water to bottle
15, 28
40
Error
6 Specifications
GENERAL
DIMENSIONS (W X L X H)
• Unit • With Fiber
• Weight
11 x 19 x 33 in (28 x 48 x 84cm)
11 x 19 x 40 in (28 x 48 x 102 cm)
75 lbs (34 kg)
ELECTRICAL
• Operating Voltage:
• Frequency:
• Current rating:
• Main control:
• On / Off control:
• Remote interruption:
100 VAC ± 10% / 230VAC ± 10%
50 / 60 Hz
15.0 A / 8A
Circuit breaker
Keyswitch
Remote interlock connector
WATER SPRAY
• Water type:
Distilled or Sterile
• External air source:
80 - 120 psi. (5.5 - 8.2 bar)
• Water:
0 - 100%
•
Air:0 - 100%
• Interaction zone:
0.5 - 5.0 mm from handpiece tip to target
OPTICAL
• Laser classification:
4
•
Medium:Er, Cr:YSGG
Erbium, Chromium, Yttrium, Scandium, Gallium Garnet
• Wavelength:
2.78 µm (2780nm)
• Frequency:
5 – 100 Hz
• Average power:
0.1 – 10.0 W
• Power accuracy:
± 20%
• Pulse energy:
0 – 600 mJ
• Pulse duration for “H” mode: 60 µs
• Pulse duration “S” mode: 700 µs
• Handpiece head angles:
70° contra-angle
• Gold HP tip diameter range: 200 – 1200 µm
• Turbo tip focal diameter range: 500-1100 µm
• Output divergence:
≥ 8° per side
•
Mode:Multimode
• Aiming Beam:
635nm (red) laser, 1mW max (safety classification 1)*
• Water Level Sensor Beam:
635nm laser, 1mW max (safety classification 1)
• Nominal Ocular Hazard
Distance (NOHD): 5cm
See separate specifications for iLase Diode Laser Handpiece in the iLase User Manual - Biolase P/N 5400230
*Some Waterlase iPlus units assembled prior to March 2012 might contain a 530nm (green) aiming beam laser.
41
7 Indications For Use
IMPORTANT: Review all Contraindications, Warnings and Precautions presented in Section 7 before
proceeding with using this device on patients.
USE OF WATERLASE IPLUS MAY BE 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.
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory
for histopathological evaluation.
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 and 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
42
7 Indications For Use
(continued)
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
• 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 soft tissue to prepare a flap 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
• 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.
43
8 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 understood 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, lung disease, bleeding disorders, or an immune system deficiency. Medical clearance
from patient’s physician is advisable when doubt exists regarding treatment.
WARNINGS AND PRECAUTIONS
Federal law restricts this device to sale by or on the order of a licensed medical or dental practitioner.
EYEWEAR
Doctor, patient, assistant, and all others inside the operatory must wear appropriate laser protection
eyewear for the 2.78 µm, 940nm wavelengths (OD 4 or greater).
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.
Closely observe clinical effects and use your 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.
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). The long pulse range is indicated ONLY for soft tissue applications.
44
8 Contraindications, Warnings, and Precautions
(continued)
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
Instructions andlabeling for root canal therapy procedures are provided with the EndoLase™ RFT Root
Canal Therapy Kit.
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 the curved canal. If during insertion the fiber tip does not advance easily into the canal, do not
force the tip inside. A possibility is to pull the fiber out and use an endodontic hand file 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 away 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. For additional information on laser
root canal enlargement, review the recommended clinical procedure presented in Appendix C, or the
instructions provided with the EndoLase™ RFT Root Canal Therapy Kit.
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 canal
length sizes. Effective laser root canal disinfection is performed with air and no water spray. Do not
exceed the maximum air setting for this procedure, with is 10%.
45
8 Contraindications, Warnings, and Precautions
(continued)
ADJACENT STRUCTURES
Waterlase iPlus can remove both hard and 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) 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 fiber tip. Hard tissue cutting occurs in non-contact mode with the
tip ~0.5 to 3 mm off the surface (3 to 5 mm for Turbo handpiece). The tip is 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 of the tip from swallowing or 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.
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 required to maintain a clear field of vision during treatment.
Do not use the Waterlase iPlus if you cannot clearly see the treatment site.
46
8 Contraindications, Warnings, and Precautions
(continued)
PLUME REMOVAL
CAUTION: 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 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 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.
TRAINING
Only licensed professionals who have reviewed and understood this User Manual, and know how to
correctly operate the system should use this device. Surgical procedures related to soft tissue, osseous,
endodontic, or periodontic surgery should only be performed by clincians who have training and experience in Oral, Maxillofacial, Periodontal, or Endodontic Surgery.
47
9 Clinical Applications
INTRODUCTION
The Waterlase iPlus device is designed to cut and remove hard and soft tissues within the oral cavity.
For hard tissue applications, the Waterlase iPlus achieves its uniquely diverse capabilities through the
process of light absorption by water. The proprietary flexible fiber optic system and handpiece delivers
both optical energy and atomized water to the treatment site for precise hard tissue removal.
To efficiently remove hard and soft tissues it helps to understand the unique nature of the Waterlase
iPlus device. Waterlase iPlus operates unlike traditional dental instruments or devices and technique
must be practiced and perfected to ensure efficient operation.
Please be aware that the Waterlase iPlus system removes hard tissues through a hydrophotonic
process with the fiber tip applied in a non-contact mode. The fiber tip has to be positioned at approximately 0.5 to 3 mm from the surface (3 to 5 mm for Turbo handpiece) and great care must be taken
not to brush or push the tip into tissue during treatments. The tip is fragile and may break if knocked or
pressed into the tooth or other instruments.
For soft tissue applications, cutting is achieved in a contact or non-contact mode by application of direct
laser energy either with or without water cooling and hydration spray. A detailed description of the techniques for cutting hard and soft tissues with Waterlase iPlus is presented in the following subsections.
Please study this Section carefully, practice on tissue models and attend a Waterlase iPlus training
seminar before using this device in a clinical situation.
HARD TISSUE CUTTING
Hard tissue cutting is achieved through a unique process described as hydrophotonic cutting. This
process refers to the removal of tissue with laser energized water and results in quick and clean hard
tissue removal.
Once settings have been selected for enamel, dentin or cementum cutting, carefully position the
fiberoptic tip approximately 5 mm away from the targeted tissue site to test the laser system. Step on
the footswitch, and water spray and power will be immediately delivered to the tissue site. You will
notice a distinct, gentle “popping” noise as water expand from laser energy absorption. At this position
(5 mm away from targeted tissue , or slightly more for Turbo handpiece), there will be minimal to no
cutting effect. If the water spray is not flowing or no distinct popping noise is present, stop the system
immediately. Refer to the troubleshooting section of this Manual for instructions or call your local
representative for assistance.
48
9 Clinical Applications
(continued)
NOTE: Always remember that laser power and, therefore, hydrophotonic energy are delivered from the very
end of the tip. Tissue cutting technique can be characterized as “end cutting,” whereas the mechanical drill is
known as a “side cutting” instrument.
If the water flow and “popping” noise are OK, gently and slowly move the handpiece tip closer to the
targeted tissue site. As you approach the treatment area you may notice a large accumulation of water.
Use high speed suction as necessary to keep the field clear. Because of the great differences between
traditional dental drill and Waterlase iPlus cutting techniques, it is very important to have the exact
treatment location visually identified before and during treatment.
Maintain a distance of 0.5 to 3 mm between the fiber tip and the treatment tissue (3 to 5 mm for Turbo
handpiece) while moving the handpiece over the tissue surface as required. Keep in mind that cutting
speed is determined primarily by parameter settings and distance from tissue, not by rapid hand
movement as with the high-speed drill. Gently and slowly move the handpiece in a circular, brushing or
in-and-out motion as required to remove desired tissues or materials. Unlike traditional dental instruments, with the Waterlase iPlus, the slower you move the handpiece tip the quicker you will remove
tissue.
Cutting efficiency will vary depending upon the power setting, tip diameter, and spray configuration. If
you feel that the system is working slowly at the selected power setting, you can adjust the air and
water spray settings. You will notice that clinical efficiency depends upon power as well as spray. As
you gain experience with the Waterlase iPlus you will be able to determine spray and power efficiency
from the sound of the popping water droplets. A sharper, more distinct popping sound represents a
higher cutting rate.
After you have completed treatment, release the footswitch and carefully remove the handpiece from
the patient’s mouth. Do not hit the handpiece tip into teeth or other instruments while removing the
handpiece or the tip may break. To remove the tip use the tip remover tool. Place a new tip on the tip
plug to avoid contamination and damage to the handpiece. At the end of the treatment the handpiece
and tip must be autoclaved (see Handpiece and Tip Cleaning and Sterilization later in this section) ,
except for single-use tips (such as ZipTips, RFPT, RFT, and some others) which should be disposed of in a
biohazard medical waste sharps container. Single-use tips should not be reused.
SOFT TISSUE INCISION, EXCISION AND ABLATION
Soft tissue procedures are performed with direct laser energy, either with or without the water spray.
The water spray settings are generally lower for soft tissue than for hard tissue. During soft tissue
cutting, the air and water spray hydrates and cools the target. There are two pulse settings for soft
tissue applications: (1) a short pulse setting of 60 µs, and (2) a long pulse setting range of 700 µs. The
second range of pulses is indicated only for soft tissue applications.
49
9 Clinical Applications
(continued)
For these procedures, select appropriate settings or presets as described in the GUI instructions,
Section 5. Once settings or presets have been selected, carefully place the tip in contact with the tissue
to be incised. Step on the footswitch and start moving the tip along the tissue surface by applying
light pressure. The incision will be noticed immediately after laser activation. Bleeding is controlled
through reduction of the water setting. For superficial lesions or hemostasis, the tip must be placed out
of contact at approximately 1-3 mm off the surface. Effective hemostasis is achieved when the water
spray is turned off.
PROCEDURE GUIDELINES
For guidelines on specific dental and surgical procedures with the Waterlase iPlus, please refer to
Appendix C.
PRESETS FOR SOFT AND HARD TISSUE PROCEDURES
As described before, Waterlase iPlus has the option of nine user programmable presets stored in the
system memory. There are about 50 pre-set settings to select from or adjust to appropriate values for
the procedure. Always start treatment at the lowest recommended power setting, and increase as required using clinical judgment. The values pre-programmed with the system are suggested values only.
Use your clinical judgment to adjust the individual values for Power, Water, Air, pulse repetition rate and
mode S/H in order to compensate for variations in tissue composition, density and, or thickness. When
a particular combination of customized values is especially effective and useful, you have the option
to then store the values in the system as a new Preset. Instructions for storing a new group of preset
settings are provided in Section 5: Settings/Memory Menu.
The Waterlase iPlus may be used for the applications listed in Section 7: Waterlase iPlus Indications
for Use, Table of Indications for Use. If you are not sure which preset or settings to use, please refer to
the suggested settings on the device or use your clinical experience to make appropriate adjustments.
Attend training courses and experiment on model tissues before using the Waterlase iPlus on patients.
FIBER TIP CALIBRATION CHART
Refer to Appendix D Tips: Suggested Clinical Specifications to review the different characteristics and
calibration factors for the Waterlase iPlus tips. To calculate the expected power output from different
families of tips, follow the instructions below.
• Select the tip for the procedure.
• Review Appendix D Tips: Suggested Clinical Specifications to select appropriate calibration factors
for the selected tip.
• Use Calibration Menu to read the actual power coming out of the tip or calculate the power emitted
at the tip by multiplying the display power by the calibration factor of the tip type. Remember that for a
calibration factor of 1, the emitted power is the same as the display. Also, actual emitted power could
vary as much as ±20%.
50
9 Clinical Applications
(continued)
CALCULATING EMITTED POWER WITH TIP ATTACHMENT:
Example 1: Example 2:
Tip Type: MZ4
Tip Type: RFT2
Calibration Factor: 0.90 Calibration Factor: 0.55
Display Power: 2W Display Power: 1W
Then the Power Emitted is:
Then the Power Emitted is:
2W x 0.90 = 1.80 W
1W x 0.55 = 0.55 W
51
9 Clinical Applications
(continued)
FIG 9.1
FIG 9.2
USE OF THE AIMING BEAM.
1.
Set system to “Ready” mode and point handpiece towards a white surface. The visible spot from
the aiming beam should be well confined or have several concentric circles;
FIG 9.3
FIG 9.4
2. While still in the “Ready” mode, check that the end of the tip does not “glow.” The visible beam
should not be visible when observed from the side (end of the tip must be dry);
52
FIG 9.5
Header
9
Clinical Applications
(continued)
PRESETS TABLE
* indicates the factory-programmed tip selection.
PRESETS TABLE
Restorative
Procedure
*indicates the factory-programmed tip selection
Procedure Step
Handpiece
Tip Types
Power
Hz
PREF
PREF
NOM
NOM
Gold
ComfortPrep
Turbo
Gold
Class I
RapidPrep
Turbo
Gold
BondPrep
Turbo
Mode
H
S
Spray, %
Water
Air
MZ10
9.00
15
H
70
90
MZ8*
6.00
15
H
50
80
MZ6
3.75
15
H
30
60
MZ5
3.00
15
H
30
60
MZ4
2.00
15
H
30
60
MT4
2.00
15
H
30
60
MGG6
3.75
15
H
30
60
MC6
3.75
15
H
30
60
MS75
5.50
15
H
50
80
MX11
9.00
15
H
70
90
MX9*
6.00
15
H
50
80
MX7
3.75
15
H
30
60
MX5
2.00
15
H
30
60
MZ10
10.00
20
H
70
90
MZ8*
8.00
20
H
70
90
MZ6
5.00
20
H
50
80
MZ5
4.00
20
H
30
60
MZ4
2.75
20
H
30
60
MT4
2.50
20
H
30
60
MGG6
5.00
20
H
50
80
MC6
5.00
20
H
50
80
MS75
7.25
20
H
50
80
MX11
10.00
20
H
70
90
MX9*
8.00
20
H
70
90
MX7
5.00
20
H
50
80
MX5
2.50
20
H
30
60
MZ10
7.00
50
H
50
80
MZ8*
4.50
50
H
30
60
MZ6
2.50
50
H
30
60
MZ5
2.00
50
H
30
60
MZ4
1.50
50
H
30
60
MT4
1.25
50
H
30
60
MGG6
2.25
50
H
30
60
MC6
2.50
50
H
30
60
MS75
3.75
50
H
30
60
MX11
6.25
50
H
50
80
MX9*
4.50
50
H
30
60
MX7
2.50
50
H
30
60
MX5
1.25
50
H
30
60
MZ10
9.00
15
H
70
90
MZ8*
6.00
15
H
50
80
MZ6
3.75
15
H
30
60
53
MX5
2.50
20
H
30
60
MZ10
7.00
50
H
50
80
MZ8*
4.50
50
H
30
60
MZ6
2.50
50
H
30
60
MZ5
2.00
50
H
30
60
MZ4
1.50
50
H
30
60
Header
9
Clinical Applications
Gold
(continued)
PRESETS TABLE
BondPrep
MT4
1.25
50
H
30
60
MGG6
2.25
50
H
30
60
MC6
2.50
50
H
30
60
MS75
3.75
50
H
30
60
50
H
50
80
H
Mode
H
30
* indicates the factory-programmed tip selection.
MX11
6.25
Restorative (continued) *indicates the factory-programmed tip selection
Procedure
Procedure Step
Turbo
Handpiece
MX9*
Tip Types
MX7
4.50
Power
2.50
50
Hz
50
PREF
PREF
MX5
NOM
1.25
NOM
50
H
MZ10
9.00
15
MZ8*
6.00
15
MZ6
3.75
15
Gold
ComfortPrep
Turbo
Gold
Class III
Class
RapidPrep
Turbo
Gold
BondPrep
Turbo
54
S
30
60
Spray, %
60
Water
30
Air
60
H
70
90
H
50
80
H
30
60
MZ5
3.00
15
H
30
60
MZ4
2.00
15
H
30
60
MT4
2.00
15
H
30
60
MGG6
3.75
15
H
30
60
MC6
3.75
15
H
30
60
MS75
5.50
15
H
50
80
MX11
9.00
15
H
70
90
MX9*
6.00
15
H
50
80
MX7
3.75
15
H
30
60
MX5
2.00
15
H
30
60
MZ10
10.00
20
H
70
90
MZ8*
8.00
20
H
70
90
MZ6
5.00
20
H
50
80
MZ5
4.00
20
H
30
60
MZ4
2.75
20
H
30
60
MT4
2.50
20
H
30
60
MGG6
5.00
20
H
50
80
MC6
5.00
20
H
50
80
MS75
7.25
20
H
50
80
MX11
10.00
20
H
70
90
MX9*
8.00
20
H
70
90
MX7
5.00
20
H
50
80
MX5
2.50
20
H
30
60
MZ10
7.00
50
H
50
80
MZ8*
4.50
50
H
30
60
MZ6
2.50
50
H
30
60
MZ5
2.00
50
H
30
60
MZ4
1.50
50
H
30
60
MT4
1.25
50
H
30
60
MGG6
2.25
50
H
30
60
MC6
2.50
50
H
30
60
MS75
3.75
50
H
30
60
MX11
6.25
50
H
50
80
MX9*
4.50
50
H
30
60
MX7
2.50
50
H
30
60
MX5
1.25
50
H
30
60
MZ10
9.00
6.00
15
H
70
50
90
80
MZ8*
6.00
4.00
15
H
50
30
80
60
MZ6
3.75
2.50
15
H
30
60
Header
9
Clinical Applications
Gold
(continued)
PRESETS TABLE
BondPrep
MGG6
2.25
50
H
30
60
MC6
2.50
50
H
30
60
MS75
3.75
50
H
30
60
MX11
6.25
50
H
50
80
Turbo
Handpiece
MX9*
Tip Types
MX7
4.50
Power
2.50
50
Hz
50
H
Mode
H
30
PREF
PREF
MX5
NOM
1.25
NOM
50
H
MZ10
9.00
6.00
15
MZ8*
6.00
4.00
15
MZ6
3.75
2.50
15
* indicates the factory-programmed tip selection.
Restorative (continued) *indicates the factory-programmed tip selection
Procedure
Procedure Step
Gold
ComfortPrep
Turbo
Gold
Class
I V
Class
III, IV,
RapidPrep
Turbo
Gold
BondPrep
Turbo
Soft Tissue
S
30
60
Spray, %
60
Water
30
Air
60
H
70
50
90
80
H
50
30
80
60
H
30
60
MZ5
3.00
2.00
15
H
30
60
MZ4
2.00
1.50
15
H
30
60
MT4
2.00
1.25
15
H
30
60
MGG6
3.75
2.50
15
H
30
60
MC6
3.75
2.50
15
H
30
60
MS75
5.50
3.50
15
H
50
30
80
60
MX11
9.00
6.00
15
H
70
50
90
80
MX9*
6.00
4.00
15
H
50
30
80
60
MX7
3.75
2.50
15
H
30
60
MX5
2.00
1.25
15
H
30
60
MZ10
10.00
8.00
20
H
70
90
MZ8*
8.00
5.25
20
H
70
50
90
80
MZ6
5.00
3.25
20
H
50
30
80
60
MZ5
4.00
2.50
20
H
30
60
MZ4
2.75
2.00
20
H
30
60
MT4
2.50
1.75
20
H
30
60
MGG6
5.00
3.25
20
H
50
30
80
60
MC6
5.00
3.25
20
H
50
30
80
60
MS75
7.25
4.75
20
H
50
30
80
60
MX11
10.00
8.00
20
H
70
90
MX9*
8.00
5.25
20
H
70
50
90
80
MX7
5.00
3.25
20
H
50
30
80
60
MX5
2.50
1.75
20
H
30
60
MZ10
7.00
50
H
50
80
MZ8*
4.50
50
H
30
60
MZ6
2.50
50
H
30
60
MZ5
2.00
50
H
30
60
MZ4
1.50
50
H
30
60
MT4
1.25
50
H
30
60
MGG6
2.25
50
H
30
60
MC6
2.50
50
H
30
60
MS75
3.75
50
H
30
60
MX11
6.25
50
H
50
80
MX9*
4.50
50
H
30
60
MX7
2.50
50
H
30
60
MX5
1.25
50
H
30
60
MZ10
9.00
15
H
70
90
MZ8*
6.00
15
H
50
80
MZ6
3.75
15
H
30
60
55
BondPrep
MT4
1.25
50
H
30
60
MGG6
2.25
50
H
30
60
Header
9
Clinical Applications
(continued)
Turbo
MC6
2.50
50
H
30
60
MS75
3.75
50
H
30
60
MX11
6.25
50
H
50
80
MX9*
4.50
50
H
30
60
MX7
2.50
50
H
30
60
MX5
1.25
50
H
30
60
Soft Tissue *indicates the factory-programmed tip selection
Procedure
Procedure Step
Rapid Cut
Gingival Recontour
Smooth Cut
Tissue Plasty
Rapid Cut
Frenectomy
Biopsy
Smooth Cut
Tip Types
Power
Hz
PREF
PREF
NOM
NOM
H
MT4*
2.50
75
H
Gold
Gold
Gold
Gold
Gold
40
20
3.25
75
H
40
20
75
H
40
20
H
MZ5
2.75
75
MT4*
2.50
50
S
40
20
20
20
MZ6
4.00
50
S
20
20
MGG6
4.00
50
S
20
20
MZ5
3.50
50
S
20
20
MZ6*
2.25
50
S
10
10
MZ5
2.00
50
S
10
10
MGG6
2.25
50
S
10
10
MC3
2.00
50
10
10
MZ5*
2.75
50
H
40
20
MT4
2.50
50
H
40
20
H
MC3
2.75
50
MZ5*
3.50
50
S
S
40
20
20
20
MT4
2.50
50
S
20
20
MC3
3.50
50
S
20
20
S
10
10
OFF
20
2.00
50
Laser Bandage Dry
Gold
MZ5*
0.50
30
Rapid Cut
Gold
Laser Bandage Dry
Air
3.25
MZ5*
Tissue Plasty
Spray, %
Water
MZ6
Gold
Gold
S
MGG6
Tissue Plasty
Smooth Cut
Mode
Handpiece
H
MZ5*
2.75
50
H
40
20
MT4
2.50
50
H
40
20
H
MC3
2.75
50
MZ5*
3.50
50
S
40
20
20
20
MT4
2.50
50
S
20
20
MC3
3.50
50
S
20
20
MZ5*
2.00
50
S
10
10
MC3
2.00
50
S
10
10
Gold
MZ5*
0.50
30
OFF
20
Handpiece
Tip Types
Power
Hz
PREF
PREF
NOM
NOM
H
MZ10
10.00
20
MZ8*
8.00
20
MZ6
5.00
MZ5
4.00
MZ4
MT4
Gold
H
Endo
Procedure
Procedure Step
Gold
56
Access
Mode
S
Spray, %
Water
Air
H
70
90
H
70
90
20
H
50
80
20
H
30
60
2.75
20
H
30
60
2.50
20
H
30
60
MGG6
5.00
20
H
50
80
MC6
5.00
20
H
50
80
Header
9
Clinical Applications
Biopsy
(continued)
Endo
Tissue Plasty
Gold
Laser Bandage Dry
Gold
MC3
2.00
50
MZ5*
0.50
30
S
H
10
10
OFF
20
*indicates the factory-programmed tip selection
Procedure
Procedure Step
Mode
Spray, %
Handpiece
Tip Types
Power
Hz
PREF
PREF
NOM
NOM
MZ10
10.00
20
H
70
90
MZ8*
8.00
20
H
70
90
MZ6
5.00
20
H
50
80
Gold
Access
Root Canal Therapy
Turbo
H
S
Water
Air
MZ5
4.00
20
H
30
60
MZ4
2.75
20
H
30
60
MT4
2.50
20
H
30
60
MGG6
5.00
20
H
50
80
MC6
5.00
20
H
50
80
MS75
7.25
20
H
50
80
MX11
10.00
20
H
70
90
MX9*
8.00
20
H
70
90
MX7
5.00
20
H
50
80
MX5
2.50
20
H
30
60
RFT2*
1.25
50
H
24
34
Conventional Filing
Clean & Shape
Disinfection
Gold
Gold
Gold
Access
Pulpotomy
Turbo
Coagulation
Flap
Osseous Access
Gold
Gold
Gold
RFT3
2.25
50
H
24
34
RFT2*
0.75
20
H
OFF
10
RFT3
1.50
20
H
OFF
10
MZ10
10.00
20
H
70
90
MZ8*
8.00
20
H
70
90
MZ6
5.00
20
H
50
80
MZ5
4.00
20
H
30
60
MZ4
2.75
20
H
30
60
MT4
2.50
20
H
30
60
MGG6
5.00
20
H
50
80
MC6
5.00
20
H
50
80
MS75
7.25
20
H
50
80
MX11
10.00
20
H
70
90
MX9*
8.00
20
H
70
90
MX7
5.00
20
H
50
80
H
MX5
2.50
20
30
60
MZ8*
2.00
50
S
OFF
20
MZ5
1.00
50
S
OFF
20
MS75
1.75
50
S
OFF
20
MGG6
1.50
50
S
OFF
20
S
MZ6
1.50
50
OFF
20
MT4*
2.50
20
H
20
40
MZ5
3.00
20
H
20
40
MZ8*
4.50
25
H
20
40
MZ5
3.00
25
H
20
40
MGG6
2.50
25
H
20
40
MZ6
2.50
25
H
20
40
57
Gold
MZ4
2.75
20
H
30
60
MT4
2.50
20
H
30
60
MGG6
5.00
20
H
50
80
MC6
5.00
20
H
50
80
MS75
7.25
20
H
50
80
MX11
10.00
20
H
70
90
MX9*
MC3
MX7
MZ5*
MX5
8.00
2.00
5.00
0.50
2.50
20
50
20
30
20
H
70
10
50
OFF
30
90
10
80
20
60
MZ8*
2.00
50
S
OFF
20
20
Header
9
Clinical Applications
Access
Biopsy
Pulpotomy
(continued)
Tissue Plasty
Laser Bandage Dry
Gold
Turbo
Gold
Procedure
Procedure Step
Flap
Osseous Access
MZ5
1.00
50
S
OFF
MS75
Tip
Types
MGG6
1.75
Power
1.50
50
Hz
50
S
Mode
S
OFF
PREF
MZ6
PREF
1.50
NOM
50
NOM
H
MT4*
MZ10
2.50
10.00
20
H
Gold
Gold
Gold
Access
Apicoectomy
Root Amputation
Gold
Root Canal Therapy
Turbo
Turbo
Perio
Perio
Procedure
Procedure
Pocket Therapy
Closed
Pocket Therapy
Closed
Pulpotomy
Bone Debride
Conventional Filing
Gold
Clean & Shape
Gold
Pocket Therapy
Open
58
S
OFF
20
Spray, %
20
OFF
Water
20
Air
20
70
40
90
MZ5
MZ8*
3.00
8.00
20
H
20
70
40
90
MZ8*
MZ6
4.50
5.00
25
20
H
20
50
40
80
MZ5
3.00
4.00
25
20
H
20
30
40
60
MGG6
MZ4
2.50
2.75
25
20
H
20
30
40
60
MZ6
MT4
2.50
25
20
H
20
30
40
60
MZ8*
MGG6
8.50
5.00
25
20
H
70
50
90
80
MZ5
MC6
6.00
5.00
25
20
H
50
80
MGG6
MS75
5.00
7.25
25
20
H
50
80
MZ6
MX11
5.00
10.00
25
20
H
50
70
80
90
MX7
MX9*
7.00
8.00
25
20
H
70
90
MZ8*
MX7
3.75
5.00
100
20
H
OFF
50
10
80
MZ5
MX5
2.00
2.50
100
20
H
OFF
30
10
60
MGG6
2.00
100
H
OFF
10
MZ6
RFT2*
2.00
1.25
100
50
H
H
OFF
24
10
34
2.25
50
H
24
34
OFF Spray, % 10
*indicates the factory-programmed tip
selection
RFT3
TipRFT2*
Types
Power
0.75
Hz
20
HMode
PREF
RFT3
Tip Types
MZ10
RFPT5*
NOM
1.50
Power
10.00
1.5
NOM
20
Hz
20
30
H
S
H
Mode
H
H
Water
Air
OFF
10
Spray, %
70
90
15
15
Inner
Epi Removal
Procedure
Step
Handpiece
Gold
PREF
Handpiece
Gold
Calculus Removal
PREF
Gold
PREF
MZ8*
RFPT5*
NOM
8.00
3.5
NOM
20
75
H
H
Water
70
40
Air
90
20
Inner Epi Removal
Gold
Calculus Removal
Outer Epi Removal
Gold
Gold
Gold
RFPT5*
RFPT5*
MZ6
MZ6
RFPT5*
MZ5
MC3
MZ6*
MZ4
MGG6
30
30
20
30
75
20
30
25
20
30
H
H
H
H
H
H
H
20
20
50
20
20
30
20
20
30
20
11
11
80
11
11
60
11
40
60
11
Osseous Recontour
Access
Gold
Flap
Gold
Calculus Removal
Outer Epi Removal
Gold
Gold
1.5
1.50
5.00
1.5
3.50
4.00
1.5
2.50
2.75
1.5
2.25
2.50
2.5
2.50
5.00
2
4.00
5.00
2.5
3.00
7.25
3.5
3.00
10.00
30
25
20
30
25
20
50
25
20
50
75
20
75
75
20
H
H
H
H
H
H
H
H
H
H
20
20
30
20
20
50
40
20
50
40
20
50
40
20
70
11
40
60
11
40
80
20
40
80
20
11
80
20
11
90
2.5
3.00
8.00
2.5
3.50
5.00
30
75
20
H
H
55
20
70
30
11
90
2.5
2.50
30
75
20
30
20
H
H
H
H
55
20
50
55
20
30
30
11
80
30
40
60
65
20
OFF
65
OFF
20
20
OFF
40
40
20
40
20
11
11
20
20
OFF
20
OFF
11
20
11
20
Procedure
Step
Disinfection
Turbo
Pocket Therapy
Open
S
Gold
Handpiece
Endo (continued) *indicates the factory-programmed tip selection
Coagulation
H
H
H
MS75
MGG6
MT4
MZ8
MC3
MGG6
MT4*
MZ8
MC6
MZ5
MZ6*
MS75
MC3*
MGG6
MX11
MC3*
MC3
MX9*
S
Gold
Gold
MZ6
MZ8
MX7
MGG6
MT4*
MX5
MS75
MZ5
MZ8*
Calculus Removal
Gold
Coagulation
Gold
MZ8
MZ5
MC3*
MC3*
MS75
3.5
3.00
2.00
4
1.00
3.50
1.5
1.75
30
20
50
30
50
75
30
50
Gold
MZ6
MGG6
MGG6
MZ6
1.5
1.50
1.5
1.50
30
50
30
50
MS75
MT4*
2.25
2.50
30
20
H
H
20
20
11
40
MZ8
MZ5
2.5
3.00
30
20
H
H
20
20
11
40
MT4*
MZ8*
2.5
4.50
75
25
H
H
40
20
20
40
MZ5
MZ5
2.75
3.00
75
25
H
H
40
20
20
40
MC3*
MGG6
2.5
2.50
30
25
H
H
55
20
30
40
MZ6
2.5
30
H
55
30
Osseous Recontour
Flap
Outer Epi
Removal
Flap
Gold
Gingival
Recontour
Gold
Osseous Access
Gold
H
H
S
H
H
H
S
H
S
H
S
S
Flap
Gold
MT4*
2
50
H
40
20
MZ5
2.5
50
H
40
20
MC3*
3.5
75
H
40
20
MC3*
2.5
30
H
55
30
Header
9
Clinical Applications
Calculus Removal
(continued)
Pocket Therapy
Osseous Recontour
Gold
Gold
Open
Perio (continued)
Procedure
Gold
Gold
Gold
Pocket Therapy
Closed
Pocket Therapy
Open
2.5
30
H
55
30
2.5
30
H
55
30
MS75
3.5
30
H
65
40
MZ8
4
30
H
65
40
MC3*
1.5
30
H
20
11
MZ6
1.5
30
H
20
11
30
H
20
11
30
Hz
HMode
Outer Epi
Gold
MGG6
*indicates
the factory-programmed
tip selection 1.5
Removal
2.25
Handpiece
TipMS75
Types
Power
Procedure Step
MZ8
2.5
PREF
PREF
NOM
InnerGingival
Epi Removal
Recontour
Calculus Removal
Osseous CL Closed
MZ6
MGG6
Outer EpiRecontour
Removal
Osseous
Gold
Gold
Flap
Gold
Bone Plasty
Calculus
Removal
Gold
Gold
Osseous Recontour
Tissue Plasty
Gingival
Recontour
Outer Epi
Removal
Flap
Gingival
Recontour
Recontour
Osseous CL Open Osseous
Gold
Gold
Gold
Gold
Gold
Gold
Gold
Osseous Recontour
Gold
Tissue Plasty
Gold
Osseous CL Closed
Bone Plasty
Tissue Plasty
Gold
Gold
Gingival
Recontour
Gold
Flap
Gold
Osseous CL Open Osseous Recontour
Gold
30
NOM
H
H
S
20 Spray, % 11
20
Water
11
Air
MT4*
RFPT5*
2.5
1.5
75
30
H
40
15
20
15
MZ5
RFPT5*
2.75
3.5
75
75
H
H
40
40
20
20
RFPT5*
MC3*
MZ6
MZ6
MC3
MGG6
MGG6
MS75
MZ8
MZ8
MT4*
MZ6*
MZ5
MGG6
MC3*
MC3
1.5
2.5
1.5
2.5
1.5
2.5
1.5
2.25
3.5
2.5
4
2
2.5
2.5
2.5
3.5
2.5
30
30
30
30
30
30
30
30
30
50
50
50
50
75
50
H
H
H
H
H
H
H
H
H
H
H
H
H
H
H
20
55
20
55
20
55
20
20
65
20
65
40
40
40
40
40
40
11
30
11
30
11
30
11
11
40
11
40
20
20
20
20
20
20
MC3*
MZ8
2.5
4
30
50
H
H
55
40
30
20
MZ6
MZ6*
2.5
2.25
30
50
H
S
55
10
30
10
MGG6
MGG6
2.5
2.25
30
50
H
S
55
10
30
10
MS75
MZ8
3.5
3.5
30
50
H
S
65
20
40
20
S
MZ8
MC3
4
2.25
30
50
H
65
10
40
10
MC3*
MT4*
1.5
2.5
30
75
H
H
20
40
11
20
MZ6
MZ5
1.5
2.75
30
75
H
H
20
40
11
20
MGG6
MT4*
1.5
2
30
50
H
H
20
40
11
20
MS75
MZ5
2.25
2.5
30
50
H
H
20
40
11
20
MZ8
MC3*
2.5
30
H
20
55
11
30
MT4*
MZ6
2.5
75
30
H
40
55
20
30
MZ5
MGG6
2.75
2.5
75
30
H
40
55
20
30
MC3*
MS75
2.5
3.5
30
H
55
65
30
40
MZ6
MZ8
2.5
4
30
H
55
65
30
40
MGG6
MZ6*
2.5
2.25
30
50
H
S
55
10
30
10
MS75
MGG6
3.5
2.25
30
50
H
S
65
10
40
10
MZ8
4
3.5
30
50
H
S
65
20
40
20
MZ6*
MC3
2.5
2.25
50
H
S
40
10
20
10
MGG6
2.5
50
H
40
20
MC3
2.5
50
H
40
20
H
MZ8
4
50
40
20
MZ6*
2.25
50
S
10
10
MGG6
2.25
50
S
10
10
MZ8
3.5
50
S
20
20
S
MC3
2.25
50
10
10
MT4*
2.5
75
H
40
20
MZ5
2.75
75
H
40
20
MT4*
2
50
H
40
20
MZ5
2.5
50
H
40
20
MC3*
2.5
30
H
55
30
MZ6
2.5
30
H
55
30
MGG6
2.5
30
H
55
30
MS75
3.5
30
H
65
40
59
Osseous CL Open Osseous Recontour
Gold
MGG6
2.50
25
H
20
40
MC3
2.50
25
H
20
40
H
9 Clinical Applications
Tissue Plasty
Gold
(continued)
Implants
Procedure
4.00
25
30
50
2.25
50
S
10
10
MGG6
2.25
50
S
10
10
MZ8
3.50
50
S
20
20
MC3
2.25
50
S
10
10
*indicates the factory-programmed tip selection
Procedure Step
Rapid Cut
Implant Recovery
MZ8
MZ6*
Osseous Access
Emergence Profile
Handpiece
Tip Types
Power
Hz
PREF
PREF
NOM
NOM
Gold
Gold
Mode
H
S
Spray, %
Water
Air
MZ5*
2.75
75
H
40
20
MT4
2.50
75
H
40
20
MZ6*
6.00
25
H
50
80
MZ8
8.50
25
H
70
90
MGG6
6.00
25
H
50
80
MZ5*
2.00
100
H
10
10
MC3
2.00
100
H
10
10
Handpiece
Tip Types
Power
Hz
PREF
PREF
NOM
NOM
H
Gold
Peri-implantitis
Expanded
Procedure
Procedure Step
Rapid Cut
Gold
Troughing
Hemostasis
Wet
Gold
Gold
Laser Bandage
Dry
60
Gold
Mode
S
Spray, %
Water
Air
MZ6*
2.75
75
H
40
20
MGG6
2.75
75
H
40
20
MZ6*
0.50
30
S
OFF
20
MGG6
0.50
30
S
OFF
20
MZ6*
0.50
30
H
5
20
MGG6
0.50
30
H
5
20
MZ5
0.50
30
H
5
20
MZ6*
0.50
30
H
OFF
20
MGG6
0.50
30
H
OFF
20
MZ5
0.50
30
H
OFF
20
10 Cleaning and Sterilization
CAUTION: Handpieces and laser tips must be sterilized prior to initial use and cleaned and sterilized between patients.
Disposable single use tips, i.e. quarts (glass) must be disposed of in a biohazard medical waste Sharps container.
CAUTION: Cleaning must be performed within a maximum of 1 hour after the procedure prior to sterilization.
CAUTION: Use only MANUAL CLEANING described below. Other cleaning methods should be avoided since water entering the portals
of the exhaust ring may damage the fiber optics inside the handpiece.
STEP 1—CLEANING PROCESS
The cleaning process is intended to remove blood, protein and other potential contaminants and to reduce the quantity of particles,
microorganisms and pathogens present from the handpieces, laser tip surfaces and crevices. Cleaning should be performed prior
to sterilization and must be conducted only by qualified office personnel trained to perform the procedure and handle the laser
handpiece and tips while wearing goggles, masks, gloves and shields.
1. Upon completion of the procedure, ensure that laser tips remains installed in the handpiece. Do not remove the tip.
2. Install the Rear Plug in the handpiece. During the cleaning procedure care must be taken to prevent the cleaning solution and
rinse water from entering the portals of the exhaust ring.
3. Rinse the handpiece with the tip under lukewarm water (22 – 43°C) for 10 seconds to remove gross soil.
4. Prepare a cleaning solution per the manufacturer’s instructions. Use a commercially-available surgical instrument detergent/
enzymatic cleaning solution with a pH of 7.0, such as Enzol® or similar enzymatic presoak and cleaner. Follow instructions for
disposal of used solution.
5. Soak a piece of gauze sufficient to wrap the handpiece in the cleaning solution. Squeeze out the excess liquid and wrap the
handpiece with the installed tip. Leave it wrapped for a minimum of 10 minutes.
6. Unwrap the handpice and the tip. Using a soft-bristled brush dipped in the cleaning solution, gently brush around the tip ferrule,
crevices and other hard-to-clean areas for 15 seconds. The brush should be wet but not dripping. Avoid contact with the exhaust
ring and portals.
7. Rinse the handpiece under lukewarm running, tap water (22-43°C) for 10 seconds.
8. Dry the handpiece with a lint-free cloth.
9. Visually inspect the handpiece for any residual soil. If present, repeat steps 5 through 8, until any residual soil is removed.
10. Using the Tip Remover or Revolving Tip Holder, remove the tip from the handpiece per steps described below.
11. Gently wipe the orifice of the handpiece head with a dry lint-free cloth making sure to remove any soil/debris that may have
accumulated in the crevice between the laser tip and the handpiece.
Tip removal using the Tip Remover or Revolving Tip Holder
• Slide the handpiece laterally toward the Tip Remover or Revolving Tip Holder [Fig. 10.1]
• Place your thumb against the selected tip slot to prevent laser tip from falling out of the Tip Holder when
disconnecting from the handpiece
FIG 10.1
61
10 Cleaning and Sterilization
(continued)
• Carefully lift the handpiece to disengage the tip ferrule from the handpiece head
• Use tweezers to slide the tip out from the Tip Holder or Tip Remover [Fig. 10.2]
12. If the tip is a single use accessory, dispose of in a biohazard medical waste Sharps container. If the tip is reusable, rinse it with distilled water for 10 seconds. Dry with lint-free cloth.
13. Visually inspect the tip for any residual soil. If present, repeat step 12, above, until residual soil is removed.
FIG 10.2
STEP 2—HANDPIECE STEAM STERILIZATION
The Steam sterilization process is intended to destroy infectious microorganisms and pathogens.
NOTE: Always perform the procedure immediately after cleaning and prior to use and only use FDA-cleared
(USA) or CE-marked ( Europe) sterilization accessories, i.e., sterilization pouch and autoclave tray.
1.
Prior to sterilization, remove the Rear and Tip Plugs, if installed.
2. Place the handpiece inside a single-wrap, self-sealed sterilization pouch.
3. The tips may be sterilized in the Tip Holder. Place the individual tips or the Tip Holder loaded with tips inside a separate single-wrap self-sealed pouch.
4. Place the pouches on an autoclave tray. Take care when handling the handpiece and tips.
5.
Do not stack other instruments on top of the pouches.
6. Place the tray into the autoclave chamber and set appropriate cycle as recommended below.
7.
Type of sterilizer
Temperature
Min Time
Drying Time
Gravity Displacement
132°C (270°F)
15 minutes
15 - 30 minutes
Dynamic-Air-Removal
132°C (270°F)
4 minutes
20 - 30 minutes
(Pre-Vacuum)
134°C EU only
4 minutes
20 - 30 minutes
Upon completion of the cycle, the handpiece and tips must remain in the sterilization pouches prior to use to ensure sterility.
8. To reassemble the tip, remove the tip from the sterilization pouch with tweezers and insert it into the Tip Remover or Tip Holder (if not in the Tip Holder).
Follow the INSTALLING AND CHANGING THE TIP IN THE HANDPIECE procedure detailed in Section 4.
WARNING: Warning: Repeated processing of the handpiece and reusable tips may reduce the useful life
of these devices. Check the handpiece for damage or wear prior to each use. The handpiece should be free
of nicks, distortion, corrosion or other signals of mechanical degradation. If damage or wear is observed,
discard the handpiece.
Use of damaged or worn tips may cause damage to the delivery system and will compromise the clinical
performance of the iPlus Laser System. The tips must be inspected prior to each use for damage or wear as
described under TIP INSPECTION in Section 9.
62
11 Maintenance
BASIC MAINTENANCE
MIRROR CHECK AND CLEANING
NOTE: If performance of the delivery system is questioned and the Tip is in good condition, check the Mirror
for damage or contamination.
WARNING: Use of contaminated or damaged Mirror will cause damage of the Fiber Delivery System.
Set system in the “Standby” mode, navigate to the illumination screen (Fig 5.10), and remove the Tip;
MIRROR INSPECTION AND CLEANING
1. Point the Handpiece towards a white surface. The visible spot of the aiming beam should be clear,
uniform and well confined. If dark areas and irregularities are present, inspect the mirror; (Applies to
both Turbo and Gold handpieces).
FIG 11.1
NOTE: If the plastic tip ferrule is continuously getting damaged at the input end, mirror should be checked
and cleaned. Mirror alignment should be checked.
2. To inspect the mirror, remove it following proper procedure (see: Changing the Waterlase iPlus
Handpiece Mirror);
3. Mirror can be contaminated or damaged;
4. Contaminated mirror can be cleaned and with cotton swab, moistened with optical grade acetone or
alcohol:
• Place wet swab over the mirror surface and wait for ~5sec for solvent to soften the contaminating
material;
• Wipe off the contamination by quick turn and removal of the swab;
• Repeat several times until all contamination is removed.
63
11 Maintenance
(continued)
FIG 11.2
FIG 11.3
5. If mirror has remaining burn marks or scratches, it should be replaced;
6. While mirror is removed and it has contamination or burn marks, clean the internal reflector inside handpiece head with long
cotton swab, moistened with acetone or alcohol;
7. Install the new or cleaned mirror and check proper alignment.
MIRROR ALIGNMENT CHECK
1. Point the Handpiece towards a white surface. The visible spot of the aiming beam should be clear, uniform and well confined;
2. If spot is confined on one side and has satellite-type reflection (smile) on the opposite side, mirror alignment is questioned;
FIG 11.4
FIG 11.5
3. To improve alignment, remove the mirror and turn it 180 degrees (see Second. Changing the Waterlase iPlus Handpiece Mirror ).
If this does not help, replace the handpiece. If that does not help, replace the trunk fiber;
NOTE: If the plastic tip ferrule is continuously getting damaged at the input end, mirror alignment should be
questioned.
64
11 Maintenance
(continued)
CHANGING THE HANDPIECE MIRROR
CHANGING THE WATERLASE MD HANDPIECE MIRROR
to open and examine mirror
[01]
[02]
[03]
[01]Insertthe3-pinsideofthetoolonto3holesofthecap [02] Inserttheothersideofthetoolperpendiculartotheplane [03]Pullmirrorstraightoutfromtheheadopening.Grabthe
inahandpiecehead.Makesureallpinsfitsnugly.Turn
counterclockwiseapproximately3turnstounscrewthe
cap. Remove the cap from the tool and place in a
safe place.
Do not turn handpiece with the opening down,
otherwise the mirror may fall out and be lost.
to close and secure mirror
[04]
of the backside of the mirror inside the opening. Screw
thethreadedsideofthetoolintothemirrorbyturningtool
clockwise2-2.5fullturns.Donotthreadallthewayintothe
mirror for easier release of the mirror later.
[05]
mirror with fingers or tweezers and unscrew from the
tool (wear gloves or finger tips – do not handle mirror
withbarehands).Ifyoutouchthemirrorsurface,gently
cleanitwithalcohol.Threadnewmirrorontothemirror
replacement tool.
Ifmirrorhasburnmarks,cleantheinternal
Note surfacesofthehandpieceheadwithalong
cotton swab, moistened with alcohol.
99.9% pure isopropyl alcohol is required for the use of this
product.Pleaseorderfromyourauthorizeddistributor(Biolase
P/N 3000251).
To insert and secure the NEW mirror into the handpiece,
repeat whole procedure in reverse order.
Attention ! Mirror is oval symmetrical, make sure of
properorientationwheninsertingthemirror
into the handpiece head.
part no. 5200126 Rev. E
To reorder this kit (part no. 7200105S) or additional mirrors (part no. 6200280S), call BIOLASE Customer Service at 1.888.424.6527
BiolaseTechnology,Inc.-4Cromwell-Irvine,CA92618-949.361.1200-biolase.com EC REP MTPromedtConsultingGmbH-Altenhofstrasse80-D-66386St.Ingbert/Germany-+496894581020-www.mt-procons.com
65
11 Maintenance
(continued)
TROUBLESHOOTING THE DELIVERY SYSTEM
Warning: Early discovery
sing the Flowchart:
U
Find the Symptom – on the left.
Inspect the Areas to Check – in the middle.
Perform the recommended Repair Action – to the right.
Use the Repair Actions to direct you to the appropriate
corrections in this reference guide.
3
and repair of problems will
improve the dependability
of the laser system and
prevent further problems.
2
1
4
6
5
SYMPTOMS
- Slow cutting
- Weak or no
“popping” sound
- Weak or no red beam
- Tip Flashing
- Slow cutting
- Weak or no
“popping” sound
- Weak or no red beam
- Smell burnt plastic
AREAS TO CHECK
1. Tip, Distal End
bad
- Evaluate tip
- Clean tip
- Replace tip
2. Tip, Proximal End
bad
- Evaluate tip
- Clean tip
- Replace tip
3. Handpiece Mirror
bad
- Evaluate mirror
- Clean mirror
- Replace mirror
4. Trunk Fiber, Window
bad
- Evaluate window
- Clean window
- Replace trunk fiber
5. Trunk Fiber, Input End
bad
- Evaluate input end
- Clean input end
- Replace trunk fiber
6. Laser Aperture
bad
- Evaluate aperture
- Clean aperture
Call service
1.800.321.6717
66
REPAIR ACTIONS
11 Maintenance
(continued)
FIBER CHECK
NOTE: Regularly inspect the end of the Fiber Shaft. Always inspect and clean the Protective Window at the
end of the Fiber Shaft after input end of the Tip or Handpiece mirror were damaged.
WARNING: Use of dirty or contaminated Protective Window will cause damage of the Fiber Delivery
System.
1. Disconnect the Handpiece following proper procedure;
2. Verify laser is in the “Standby” mode;
3. Check polished reflective surface of the window in the middle of the Fiber Shaft;
4. Clean with cotton swab and isopropyl alcohol if surface is contaminated;
GOOD
“STANDBY”
MODE
GOOD
FIG 11.7
WHEN
ILLUMINATION
SCREEN IS
DISPLAYED
FIG 11.6
• If damage found (crater in the middle of the window), replace Fiber Delivery System;
5. Wear protective eyewear. Navigate to the illumination screen (Fig 5.10).
6. Visible aiming beam and illumination fibers should be lit (adjust brightness, if necessary). If aiming
beam is not visible, replace Fiber Delivery System.
DANGER: Invisible and/or visible laser radiation­– Avoid eye or skin exposure to direct or scattered radiation.
ANNUAL MAINTENANCE
The Waterlase iPlus should be serviced annually by a qualified, trained and certified technician. During
the annual visit the system flash lamp will be inspected and the system will be calibrated. The entire
laser cavity and optical train will be cleaned. All relevant electronic circuits will be calibrated. Filters
and cooling fluid will be changed as well. Please contact your local representative to discuss extended
service contracts and annual maintenance options.
67
11 Maintenance
DELIVERY SYSTEM
The fiber delivery system and handpiece represent high technology laser transmitting components. Depending on use, and due to
the precision involved in the manufacture and alignment of the laser beam and internal optics, the components may need to be
periodically replaced to maintain tissue cutting efficiency. Properly following the operating and maintenance instructions of this
Manual will increase the delivery system’s lifetime.
LASER CONSOLE
The laser console contains electronic and mechanical components that are thoroughly checked when the unit is first shipped, as
well as when a trained engineer services the unit. Depending on the use of the unit, some of these components may require
periodic servicing and/or replacement between annual maintenances. The unit will usually deliver lower power than normal if this
is the case. Please contact your service representative for assistance.
DAILY MAINTENANCE
Use standard dental disinfectant to wipe down the handpiece after each procedure. Do not use bleach or abrasive cleansers. Be
careful to prevent water from entering the unit, especially around the fiber optic handpiece connectors.
Clean the tips before and after every use to maximize their useful life. (See Tip Cleaning Instructions for details)
TRANSPORTATION
The Waterlase iPlus is susceptible to misalignment if not handled properly. The unit should ALWAYS be packed inside of its shipping crate when transported from one location to another. While the unit is semiportable, and may be rolled from one operatory to
another inside of the same office, care should be taken when pushing the unit over doorway thresholds and other bumps or objects
on the ground.
Do not roll the unit outside of the office building, across a road or over any other rough surface. Do not place the unit into a pick-up
truck, van or other moving machine for transportation unless it is completely packaged inside of its shipping crate.
Once crated, the unit should be transported by fork lift or pallet jack, and should never be laid on its side, dropped or banged.
If you have any questions regarding transportation please call your local representative.
STORAGE
The Waterlase iPlus should be stored in a cool dry place when not in use. Storage temperature should be 15° to 30°(59°F to 86°F),
relative humidity 20 to 80%. Cover the unit when not in use for extended periods of time. Store the system in a place where it will
not be accidentally bumped or banged.
The Waterlase iPlus was shipped inside of a custom shipping crate. Please save and store the crate in a cool dry place. The unit
must not be transported unless packaged inside of the crate.
68
12 Calibration
Calibration requires specialized equipment, and is to be performed only by a trained service engineer.
The service engineer will follow this procedure:
• Connect an output power meter to the laser, using a test fiber. The power meter head should be 1 to
2 inches from the fiber tip.
• Using the software provided by Biolase, verify the test setup is complete.
• Begin the calibration routine. The software will vary the unit’s output power settings and use the
power readings from the meter to calibrate the power output monitoring settings.
• If required, the software will revise the unit’s internal calibration settings to ensure power remains
within ± 20%.
CALIBRATION SCHEDULE:
Power calibration is to be performed annually. The Service Engineer shall write the date of installation
and subsequent power calibration dates in the table provided below:
Table 6: Installation and Calibration Dates
Installation Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
Calibration Date:
Technician
69
Appendix A Labels
Laser Hazard Symbol
Location: Top cover of Laser head, directly above the
Fiber Optic Connector. (Only visible during service)
High Voltage Hazard Symbol
(Only visible during service)
Locations:
• Top cover or Laser head, directly above the High
Voltage input.
• PFN Board Capacitor
• Front Capacitor Bracket
Certification
Location: Back Panel
Non-Interlocked Protection Housing Warning
Location: Laser head, access plate. Accessible only
during service proceedings.
Laser Aperture
Location: On the top cover, adjacent to Fiber Optic
Connector
70
Appendix A Labels
(continued)
Laser Explanatory Label
Location: On top cover, adjacent to fiber
optic connector
Ground
Location: Next to E1 ground terminal,
inside unit.
Identification
Location: Back Panel, above ventilation
channels
Electrical Ratings
Location: Next to Power cord connection
Air Label
Location: Base, rear of unit
Key Switch
Location: Back panel
71
Appendix A Labels
(continued)
Remote Interlock Label
Location: Back Panel
ETL Listed
Location: Back Panel
Footswitch Label
Location: Back Panel
Emergency Stop Label
Location: Front Covert
Protective Earth Ground
Location: Back Panel
Attention (Small)
Location: Back Panel
WEEE Label
Location: Back Panel
72
Appendix A Labels
(continued)
Remote Label
Keyswitch Label
Identification
Certification
ETL Listing
Electrical
Rating Label
Footswitch Label
Air Intake
73
Appendix A Labels
(continued)
Laser Explanatory Label
Laser Aperture + Label
74
Appendix B Accessories
KEYS
REMOTE INTERLOCK
FOOTSWITCH
POWER CORD (USA)
POWER CORD (EUROPE)
AIR HOSE
75
Appendix C Clinical Procedure Guidelines
PERIODONTAL THERAPY CLINICAL PROTOCOL
WARNINGS & PRECAUTIONS:
Eyewear: Doctor, patient, assistant and all others inside the operatory must wear appropriate laser
protective eyewear for the 2.78 μm wavelength (OD 4). Use caution when using the tip inside the
periodontal pocket. Excessive force could break the tip and inconvenience your patient. Laser protective
magnification loupes are recommended for this procedure.
Do not direct air or spray toward tissue that may entrap air or water. Exercise caution when working
inside the pocket without continuous water flow. Hard tissue structures that come in immediate contact
with the laser energy in the absence of water could be damaged. Make sure to maintain a consistent
water flow during the entire treatment, especially in the deeper areas of the pocket.
PROCEDURE
After routine periodontal evaluation through radiographic and clinical examination and assessment of
probing depth, gingival recession, clinical attachment level, hyperplasia, bleeding on probing, plaque,
suppuration, bone loss, furcation and mobility, proceed with the following steps:
STEP 1: ANESTHESIA
Apply anesthetic to the treatment site as needed. Topical anesthetic is usually adequate.
STEP 2: TROUGHING AND INNER EPITHELIUM LINING
Step 2
Tip
Power
Pulse Rate
Air
Water
Mode
Troughing & Inner
Epithelium Removal
RFPT5-14
1.5W
30Hz
11%
20%
H
SELECT SETTINGS AS PROVIDED IN THE TABLE ABOVE, USING A GOLD HANDPIECE
Place tip in contact with the gingival crest, parallel to the long axis of the tooth. Activate laser and start
moving along the gingival margin to prepare a trough all the way to the crest of the bone. This trough
will allow for increased visibility and access and to initiate removal of diseased epithelium lining. The
radial and forward cutting action of this tip allows for effective separation and removal at the same
time of the inflamed and diseased epithelium lining. The narrow tip glides easily to allow minimally
invasive treatment of the entire epithelium lining all the way to the bottom of the pocket.
Alternatively, a bottom-up technique can be used in which the laser is fired only when moving the tip
coronally. The protocol is optimized for safety and efficacy using either one of the techniques.
STEP 3: CALCULUS REMOVAL
76
Step 3
Tip
Power
Pulse Rate
Air
Water
Mode
Calculus Removal
RFPT5-14
1.5W
30Hz
11%
20%
H
Root Surface
Smoothening
RFPT5-14
1.5W
50Hz
11%
20%
H
Appendix C Clinical Procedure Guidelines
(continued)
Proceed with the mechanical removal of calculus using preferred hand and/or ultrasonic scalers. After
gross calculus removal, remove calculus using the laser using the same settings provided in the
previous step. To remove calculus from the root surface, aim the laser tip 5 to 15 degrees from the root
surface. Move the tip in the same pattern as used to remove epithelium lining. Make enough passes to
cover the entire root surface. Use a curette to insert into the pocket and push the gingiva away and
with loupes, visualize the root surface. The surface has to look clean and free of any calculus deposits.
Use the Root Surface Smoothening setting to refine the root surface to promote new attachment. Use
the same pattern as used for calclus removal. Make enough passes to cover the entire root surface
STEP 4: OUTER EPITHELIUM LINING REMOVAL
Step 4
Tip
Power
Pulse Rate
Air
Water
Mode
Outer Epithelium
Removal
RFPT5-14
1.5W
30Hz
11%
20%
H
Remove the outer epithelium using the same tip and laser settings provided in the Step 3. Position the
tip parallel to and approximately 1 mm away from the outer gingiva. Angle the end of the tip slightly
toward the surface. Activate the laser and move the tip over a 5 mm area from the gingival margin
apically. The tissue surface is altered only enough to disrupt the epithelium layer, without significant
tissue removal.
After removing the soft tissue, proceed with root surface preparation. Use your preferred conventional
instrumentation and technique to perform this next step.
STEP 5: PRESSURE CLOT
Insert a curette into the pocket to push the gingiva away and visualize the root surface. The surface
should be clean and free of any calculus deposits. Applying external pressure should produce a thin
layer blood clot inside the pocket. Hold and press a wet gauze in place over the outer area of the pocket
for approximately 3 minutes to achieve this effect. Seal the clot within the sulcus by applying a barrier
such as surgical glue (cyanoacrylate) along the gingival margin using a pipette. This seal is necessary to
provide a barrier from external debris that might interfere with proper initiation of healing of the treated
pocket. The first probing should be performed 3 months after the treatment.
POST-OPERATIVE PATIENT INSTRUCTIONS
Do not to use a toothbrush for the first 24 hours after the procedure. Rinse with Peridex™ or other
chlorhexidine solution two times per day for 2 weeks post-treatment. After 24 hours, start brushing
again using a soft-bristle toothbrush and toothpaste, floss daily, and use an over-the-counter
mouthwash rinse after the 2-week Peridex regimen. Schedule follow-up visits, including the first
probing at 3 months. Some offices bring the patient back on a routine basis for coronal polishing and
post-operative evaluation prior to the 3-month follow-up.
77
Appendix C Clinical Procedure Guidelines
(continued)
SINGLE USE NON-STERILE TIPS INCLUDED
1. Use only as specified in this guide.
2. Tip may break if excessive force is applied.
3. Dispose of tip in sharps container after single use.
Specifications
RFPT5-14
Tip Diameter
580µm
Tip Length
14mm
Max Power of
Operation
4.0W
Calibration Factor
0.80
* Always start treatment at the lowest power setting for the specific tissue and increase as required.
Closely observe the clinical effects and use your judgment to determine the aspects of the treatment
(technique, proper power, air and water settings, tip type and duration of operation) and to make
appropriate power, air and water adjustments to compensate for varying tissue composition, density
and thickness.
ENDODONTIC THERAPY CLINICAL PROTOCOL
WARNINGS & PRECAUTIONS:
Eyewear: Doctor, patient, assistant and all others inside the operatory must wear appropriate laser
protective eyewear for the 2.78 µm wavelength (OD 4). Clinical Use: The Endolase RFT™ system is
suited for straight and slightly curved canals. Before proceeding with any endodontic treatment, a
careful review of Contraindications, Precautions and Warnings, proper clinical training and practice on
extracted teeth is recommended. Use caution when using tips through narrow and curved passages at
all times. Forcing a tip through a narrow curved or obstructed canal could results in tip breakage and/or
perforation. Activate the laser only when moving the tip upward coronally.
STEP 1: ACCESS PREPARATION
All settings provided are for use with the Gold Handpiece.
1. Access is prepared using the MZ5 ZipTip™ (6mm).
2. Select settings listed in the table below. Angle the tip 30-45° to the long axis of the tooth to cut
enamel effectively.
3. Lower power setting or defocus the beam to cut through dentin.
4. Use the MZ5 for removal of pulp. Select “pulp removal” settings (see table below) to remove vital/
non-vital pulpal tissue.
78
Appendix C Clinical Procedure Guidelines
(continued)
Step 1
Tip
Power
Pulse Rate
Access
MZ5
Step 1
Tip
Power
Pulse Rate
Pulp Removal
MZ5
.75-1.0 W
20 Hz
4.5-5.5 W 15/20 Hz
Air
Water
Mode
60%
30%
H
Air
Water
Mode
2-11% 7-11%
H
STEP 2: CONVENTIONAL INSTRUMENTATION
1. Estimate the working length following standard protocol.
2. Start instrumentation using K-files or a combination of K-files and rotary files to enlarge and shape
the canal.
3. Apical instrumentation is performed to at least a size 30 K-file to allow the RFT2 tip to reach the
apex.
* Always start treatment at the lowest power setting for the specific tissue and increase as required.
Closely observe the clinical effects and use your judgment to determine the aspects of the treatment
(technique, proper power, air and water settings, tip type and duration of operation) and to make
appropriate power, air and water adjustments to compensate for varying tissue composition, density
and thickness.
STEP 3: CLEANING & ENLARGEMENT
RFT2
1. Use the RFT2 to perform apical and partial coronal 2/3 cleaning.
2. Place tip into handpiece and select settings from the table below.
3. Fill canal with sterile solution.
4. Insert RFT2 (1) mm short of the apex. (Use the rubber slider on the tip as a depth indicator.)
5. Activate laser and start moving the tip coronally at approximately 1 mm/s. Maintain tip in contact
with the side surface of the canal wall during the entire apical to coronal pass.
6. Repeat steps 4 and 5 one or two more times to ensure that the entire inner-canal has been cleaned.
RFT3
7. Use the RFT3 to perform final cleaning of the coronal 2/3.
8. Place tip into the handpiece and select settings from the table below.
9. Fill canal with sterile solution.
10. Insert RFT3 at the junction between apical and middle third.
11. Activate laser and start moving the tip coronally at approximately 1 mm/s.
Use the same technique as step 5.
12. Re-insert tip and perform an additional pass over the same area.
13. Repeat Steps 10 through 12 three more times to ensure cleaning of the remaining coronal 2/3.
79
Appendix C Clinical Procedure Guidelines
(continued)
Step 3
Tip
Power
Pulse Rate
Air
Water
Mode
Cleaning & Enlargement
RFT2
1.25 W
50 Hz
34%
24%
H
Step 3
Tip
Power
Pulse Rate
Air
Water
Mode
Cleaning & Enlargement
RFT3
1.25 W
50 Hz
34%
24%
H
Tip position during
different passes
Hydrophotonic effect
STEP 4: DISINFECTION
RFT2
1. Use the RFT2 to perform disinfection of the apical and partial coronal 2/3.
2. Place tip into handpiece and select settings from the table below. This procedure is performed with
10% air flow and no water.
3. Insert RFT2 (1) mm short of the apex.
4. Activate laser and start moving the tip coronally, at approximately 1 mm/s. Maintain tip in contact
with the side surface of the canal wall during the entire pass. Use a brushing technique to deliver YSGG laser energy to the surface.
5. Re-insert tip immediately and perform an additional pass over the same area.
6. Repeat steps 3 through 5, two to three more times to ensure disinfection of apical and partial coronal
2/3.
RFT3
7. Use the RFT3 to perform final disinfection of the coronal 2/3.
8. Place tip into handpiece and select settings from the table below. Use 10% air flow as before (see
step 2).
9. Insert RFT3 at the junction between apical and middle third.
10. Activate laser and start moving the tip coronally, at approximately 1mm/s. Use the same techniques
as step 4 (disinfection).
11. Re-insert tip immediately and perform an additional pass over the same area.
12. Repeat steps 9 through 11, three to four more times to ensure disinfection of the remaining coronal
2/3.
OBTURATION & RESTORATION PLACEMENT
Use any of your preferred techniques and materials to fill the canal and restore the tooth. Single Use
Non-Sterile Tips Included
1. Use only as specified in this guide.
2. Tip may break when excessive force is applied.
3. Dispose in sharps container after single use.
80
Step 4
Tip
Power
Pulse Rate
Air
Water
Mode
Disinfection
RFT2
.75 W
20 Hz
10%
Off
H
Step 4
Tip
Power
Pulse Rate
Air
Water
Mode
Disinfection
RFT3
.75 W
20 Hz
10%
Off
H
Appendix C Clinical Procedure Guidelines
(continued)
CALIBRATION FACTOR
RFT2
RFT3
Tip Diameter, μm
275
415
Tip Length, mm
25, 21
21, 17
Max Power
of Operation [Watt]
4.0
4.0
Calibration Factor *
0.55
0.85
RFT2
RFT3
* Laser Power recommended with procedural steps are values on the display. The actual power output
can be calculated by multiplying that value by the Calibration Factor for each tip.
NOTE: Clinicians who are conservative of tooth structure and wish to keep the tapered shape of the canal to
a minimum may find this laser procedure sufficient for such goals. However, if the goal is to achieve a more
tapered shape to accommodate the wide Gutta-Percha points, additional instrumentation may be necessary.
81
Appendix D Tips: Suggested Clinical Specifications
SAPPHIRE TIPS GUIDE
“Z” TIPS GUIDE
82
Appendix D Tips: Suggested Clinical Specifications
(continued)
TIP SETTINGS: WATERLASE IPLUS / MD GOLD HANDPIECES
Tip Type
Gold Handpieces
Ferrule Color/
Diameter
(µm)
Lengths
(µm )
Calibration
Factor*
Maximum
Power (W)
Tissue Types
200
21, 25
0.55
4.0
Root Canal
0.85
4.0
.90
4.0
All Types
4.0
All Types
6.0
Bone, Soft Tissue
Z - Glass Tips
RFT2
MZ3
RFT3
MZ4
MZ5
RFPT5
MZ6
320
400
500
9, 14, 18, 20, 22, 25, 28
17, 21
3, 6, 9, 14, 18, 20, 22,
25, 28
3, 6, 9, 14
10, 14
.95
Root Canal, Soft Tissue
Root Canal
600
3, 6, 9, 14
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MZ8
800
3, 6, 9
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MZ10
1000
3, 6, 9
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MT4
400
6
1.00
2.5
Enamel, Dentin, Soft Tissue
MGG6
600
4, 6, 9
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MS75
750
6
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MC3
300 x 1200
9
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MC6
600
4, 6, 9
1.00
No Limit
Enamel, Bone, Dentin, Soft Tissue
MC12
1200
9
1.00
No Limit
Bone, Dentin, Soft Tissue
Sapphire Tips
83
Appendix D Tips: Suggested Clinical Specifications
(continued)
INDICATIONS FOR USE
Tip Type
Soft Tissue
Hard Tissue
Z – Glass Tips
RFT2
N/A
Root canal debridement, cleaning and disinfection
MZ3
Sulcular debridement; Laser soft tissue currettage
Removal of granulation tissue
RFT3
N/A
Root canal debridement, cleaning and disinfection
MZ4
Same as MT4. Sulcular debridement; Laser soft tissue
currettage
Same as MT4
MZ5
Combines applications of MZ4 and MZ6 tips
Combines applications of MZ4 and MZ6 tips
RFPT5
Decontamination and ablation of soft tissue in periodontal
pockets
Cleaning the root surface, similar to MZ5
M Z6
Same as MGG6
Same as MGG6
Same as MGG6
Same as MGG6
Same as MGG6
M Z8
M Z10
Same as MGG6
Sapphire Tips
MT4
MC3
MGG6
MS75
MC6
MC12
Frenectomy and frenetomy; Gingival troughing;
Gingivectomy; Gingivoplasty; Gingival incision and
excision; Removal of pathological tissues; Incision and
drainage of periapical abscessess; Full, partial and split
thickness flap preparation
Most applications are the same as for MT4 and MGG6
tips, taking into consideration “flat” shape of the tip
Same as MT4; Excisional and incisional biopsies;
Exposure of unerupted teeth; Fibroma removal;
Hemostasis; Implant recovery; Incision and drainage
of abscesses; Leukoplakia; Operculectomy; Oral
papillectomy; Reduction of gingival hypertrophy; Soft
tissue crown lengthening; Treatment of canker sores;
Vestibuloplasty
Excavation of pits and fissures for placement of
sealants; Pits and fissures/caries removal
Cutting, contouring, shaving and resection of oral
osseous tissue (bone)
Cavity preparation I-V; Caries removal; Hard tissue
roughening or etching; enameloplasty; Tooth
preparation to access to a root canal; Cutting,
contouring, shaving and resection of oral osseous
tissue (bone); Osteotomy, ostectomy, osteoplasty
and osseous recontouring; Cutting bone to prepare a
window access to the apex of the root; Apicoectomy;
Root end preparation for retrofill
Same as MGG6
Same as MGG6
Same as MGG6, considering more “shallow” cutting
profile of tip
Same as MGG6 and MG6, considering bigger surface
area and significantly “shallower” cutting profile of tip
Same as MGG6, considering more “shallow” cutting
profile of tip
Same as MGG6, considering bigger surface area and
significantly “shallower” cutting profile of tip
**Calibration Factor: Actual power emitted from the tip = displayed power multiplied by the Calibration Factor.
Cautions:
IMPORTANT:
i
84
Applicable to entire range of power settings for the tip type.
If a reduction in cutting efficiency is observed, replace the tip. Failure to replace the tip correctly could result in damage of the tip or the
handpiece mirror. The tips have limited lifetime therefore damage of the delivery system attributed to overuse of the disposable tip may
not be covered by warranty.
Federal law restricts this device to sale by or on the order of a dentist or a physician. Only licensed professionals who have successfully
completed training should use the laser and accessories. Always start treatment at the lowest power setting and increase as required.
Closely observe the clinical effects and use your professional judgment to determine the aspects of the treatment (technique, proper
power settings, air and water settings, tip type and duration of the operation) and to make appropriate adjustments to compensate for
varying tissue composition, density and thickness.
Appendix E Electromagnetic Compatibility
CAUTION: Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility
(EMC) and needs to be installed and put into service according to the EMC information provided in the
following tables.
Portable and mobile Radio Frequency (RF) communications equipment can affect Medical Electrical
Equipment.
Accessories: Medical grade power cord, maximum length 10ft (2.44 meters) (Biolase part number
2000204).
Footswitch: includes shielded, coiled footswitch cable, footswitch, 5 conducting wires. (Biolase part
number 6200150)r sold by Biolase Technology as replacement parts for internal or external
components, may result in increased EMISSIONS or decreased IMMUNITY of the
WARNING:
The useMD.
of accessories, other than those specified, except those supplied or sold by Biolase
model
Waterlase
Technology as replacement parts for internal or external components, may result in increased EMISSIONS or
decreased IMMUNITY of the model Waterlase iPlus.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The Waterlase iPlus is intended for use in the electromagnetic environment specified below. The customer or the
user of the Waterlase iPlus should assure it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Compliance
Group 1
Class A
Class A
Electromagnetic environment-guidance
The model Waterlase MD uses RF energy only for its
internal function. Therefore,
its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The model Waterlase iPlus is suitable for use in
all establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Class A
85
Appendix E Electromagnetic Compatibility
(continued)
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The model Waterlase iPlus is intended for use in the electromagnetic environment specified below. The
customer or the user of the model Waterlase iPlus should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electrostatic
discharge (ESD)
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, relative
humidity should be at least 30%.
Electrical fast
transient/burst
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be that of a typical
commercial or hospital environment.
IEC 61000-4-4
±1 kV for input/
output lines
N/A
Input/output that does not apply because the
footswitch cable length is less than 3 meters
Surge
±1 kV differential
mode
±1 kV differential
mode
Mains power quality should be that of a typical
commercial or hospital environment.
±2 kV common
mode
±2 kV common
mode
IEC 61000-4-2
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
<5% Ur
<5% Ur
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycle
for 0.5 cycle
40% Ur
(60% dip in UT)
for 5 cycles
40% Ur
(60% dip in Ur)
for 5 cycles
70% Ur
(30% dip in Ur)
for 25 cycles
70% Ur
(30% dip in Ur)
for 25 cycles
<5% Ur
(>95% dip in Ur)
for 5 seconds
<5% Ur
3 A/m
3 A/m
Electromagnetic environment – guidance
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the model Waterlase iPlus requires continued operation during power mains interruptions, it is recommended that the model Waterlase iPlus be powered
from an uninterrupted power supply.
(>95% dip in Ur)
for 5 seconds
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital environment.
NOTE Ur is the A.C. mains voltage prior to application of the test level.
86
Appendix E Electromagnetic Compatibility
(continued)
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The model Waterlase iPlus is intended for use in the electromagnetic environment specified below. The customer or the user
of the model Waterlase iPlus should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80
GHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5
GHz
Compliance
level
3V
3 V/m
Electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the model Waterlase iPlus, including cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80MHz to 800 MHz
d = 2.3√P 800MHz to 2.5GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Waterlase iPlus is
used exceeds the applicable RF compliance level above, the Waterlase iPlus should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Waterlase iPlus.
B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
87
Appendix E Electromagnetic Compatibility
(continued)
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS
EQUIPMENT AND THE WATERLASE iPLUS
The Waterlase iPlus is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Waterlase iPlus can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Waterlase iPlus as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of
transmitter
Separation distance according to frequency of transmitter
M
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
W
d = 1.2√P
d = 1.2√P
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
88
BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA
949.361.1200
888.424.6527
biolase.com
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
+49 6894 581020
mt-procons.com
About BIOLASE
Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine and
dentistry that feature proprietary and patented technologies for minimally
invasive surgeries, reducing pain and improving clinical results.
Only BIOLASE combines the leading laser technology – continuously
improved through ongoing clinical R&D and engineering – with unmatched
training, practice integration support and service.
BIOLASE leads the global dental laser market with over 25,000 lasers in
use today and the most complete family of dental lasers – from diode
lasers to the most advanced all-tissue laser, the WaterLase iPlus™.
Made in the USA. Rx Only.
Copyright © BIOLASE, Inc. All rights reserved. EPIC, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece,
ComfortPulse, WaterLase, and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE,
Incorporated in the United States and/or other countries. All other trademarks are property of their registered
owners. Subject to change without notice.
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