Den-Mat Sapphire User manual

Sapphire®Portable Diode Laser
Instructions for Use

2
Table of Contents
1. INTRODUCTION.............................................................................................................................................................4
2. WARNINGS AND CAUTIONS....................................................................................................................................5
Emergency Termination of Laser Emissions...............................................................................................................6
3. SAPPHIRE®PORTABLE DIODE LASER INDICATIONS FOR USE................................................................6
4. SAPPHIRE PORTABLE DIODE LASER FACILITY AND ENVIRONMENTAL CONSIDERATIONS ............7
Heating and Ventilation...................................................................................................................................................7
Lighting:..............................................................................................................................................................................7
Combustible Chemicals and Gases............................................................................................................................7
Plume evacuation .............................................................................................................................................................7
Operatory Access during Sapphire Portable Diode Laser Use ............................................................................7
5. GENERAL SAFETY WITH THE SAPPHIRE PORTABLE DIODE LASER......................................................8
General Safety Considerations.....................................................................................................................................8
Marketing Requirements Regarding Medical Device Safety (USA).....................................................................8
Statutory Licensure for Dental Laser use...................................................................................................................8
OSHA Provisions.............................................................................................................................................................8
Electromagnetic Environment Guidance ....................................................................................................................9
Eye and Skin Protection .................................................................................................................................................9
Emergency Shutdown Options.....................................................................................................................................9
6. SAPPHIRE PORTABLE DIODE LASER INSTALLATION AND SETUP........................................................ 10
Instructions on Unpacking & Customer Service Assistance............................................................................... 10
Shipping Container Information................................................................................................................................. 10
Contents of Sapphire Portable Diode Laser Shipping Container ..................................................................... 10
Installing the Sapphire Portable Diode Laser......................................................................................................... 10
7. SAPPHIRE PORTABLE DIODE LASER CONTROLS AND DISPLAYS.................................................... 12
Sapphire Portable Diode Laser Handpiece............................................................................................................ 12
Sapphire Portable Diode Laser Control Panel....................................................................................................... 13
Sapphire Portable Diode Laser Power Level Adjustment ................................................................................... 14
Continuous Wave and Pulse Mode ................................................................................................ 14
READY Activation of Sapphire Portable Diode Laser Unit ................................................................................. 14
Laser Activation and Laser “ON” Indication ........................................................................................................... 14
EMERGENCY DEACTIVATION of LASER............................................................................................................ 15
Remote Door Interlock................................................................................................................................................. 15
Portablility of the Sapphire Portable Diode Laser ................................................................................................. 16
Battery Power Level Indicator .................................................................................................................................... 16
Error Codes.................................................................................................................................................................... 16
Sleep Mode and Conserving Battery Power.......................................................................................................... 16



3
8. SAPPHIRE PORTABLE DIODE LASER OPERATION AND USE.................................................................. 16
Operating Modes .......................................................................................................................................................... 16
Continuous Wave (CW) Mode .................................................................................................................................. 16
Pulsed Energy Mode .....................................................................................................................................................17
Tissue Responses to Laser Energy............................................................................................................................17
Installing and Replacing Single-Use Fiber Optic Tips...........................................................................................17
Initiating the Fiber.......................................................................................................................................................... 19
Setting Parameters ....................................................................................................................................................... 19
Hard Tissue Procedures.............................................................................................................................................. 19
Cleaning Instructions.................................................................................................................................................... 19
Calibration....................................................................................................................................................................... 19
9. PROCEDURAL RECOMMENDATIONS FOR USING THE SAPPHIRE PORTABLE DIODE LASER...... 21
Contraindications .......................................................................................................................................................... 21
Test Firing the Sapphire Portable Diode Laser ...................................................................................................... 21
Tip Initiation (when indicated) .................................................................................................................................... 21
Sapphire Portable Diode Laser Use......................................................................................................................... 21
Gingival Contouring with the Sapphire Portable Diode Laser System ............................................................ 22
Gingivectomy, Gingivoplasty and Papillectomy with the Sapphire Portable Diode Laser........................... 23
Gingival Troughing & Tissue Retraction for Impressions with Sapphire Portable Diode Laser.................. 24
Sulcular Debridement with the Sapphire Portable Diode Laser System ......................................................... 25
Labial Frenectomy with the Sapphire Portable Diode Laser System................................................................ 26
Abcess Excision with the Sapphire Portable Diode Laser .................................................................................. 27
Hemostasis with the Sapphire Portable Diode Laser........................................................................................... 28
10. SAPPHIRE PORTABLE DIODE LASER SPECIFICATIONS........................................................................... 29
11. SERVICING THE SAPPHIRE PORTABLE DIODE LASER.............................................................................. 30
12. SYSTEM WARRANTY................................................................................................................................................. 31
MANUFACTURER INFORMATION
Den-Mat®Holdings, LLC
2727 Skyway Drive
Santa Maria, CA 93455 USA
Tel.: [phone] or 805-922-8491

4
1. INTRODUCTION
The Sapphire®Portable Diode Laser unit is a dental soft-tissue laser surgical/debridement device. The Sapphire
Portable Diode Laser may be used for a variety of soft-tissue, gingival modification, and sulcular
therapy procedures.
Dental professionals and staff who will use the Sapphire Portable Diode Laser should receive proper laser use
training prior to patient treatment with these devices. Applicable training programs for dental Laser use are
available through the Academy of Laser Dentistry, dental schools, and many dental continuums. Your authorized
Den-Mat Holdings, LLC Representative can also provide the names of local dentists who have a Sapphire
Portable Diode Laser and may be able to provide additional guidance for new Sapphire Portable Diode
Laser users.
Safety is paramount when using any energy-based surgical instrument and your office should implement a safety
program for the Sapphire Portable Diode Laser. If your office does not already have a safety officer, one should
be appointed to be responsible for understanding proper use, safe operation, and maintenance of the Sapphire
Portable Diode Laser system. Their duties should include training office personnel in all aspects of system safety
and management of the Sapphire Portable Diode Laser and all accessories.
Manufacturer’s Laser Identification, output and standards label
The Sapphire Portable Diode Laser carries the Manufacturer’s identification label affixed to the bottom panel of
the Control Module.
MODEL: Sapphire®Portable Diode Laser
MODEL NO.: 033981000-0
MANUFACTURED BY: DEN-MAT HOLDINGS, LLC. SANTA MARIA, CA 93455 USA
LASER CLASSIFICATION: (PER IEC 60825-1): Class 4
MAXIMUM LASER OUTPUT: 3W Continuous Wave, 5W Pulsed
FREQUENCY IN PLUSED MODE: Fixed, 10 Hz
PULSE DURATION: 0.05 seconds
WORKING BEAM WAVELENGTH: 808nm (±5nm)
AIMING BEAM WAVELENGTH: 640nm (±10nm)
POWER INPUT: 12W, 5 VDC supplied from 110 - 120 VAC
@ 60 Hz, or 220 - 240 VAC @ 50 Hz
COMPLIES WITH IEC 60601-1, 60601-2-22; IEC 60825-1; IEC 60601-1-2,
CLASS B PER IEC 60601-1-2 AS WELL AS TO US FEDERAL REGULATIONS FOR LASER
PERFORMANCE STANDARDS SET OUT IN 21 CFR1040.10 AND 1040.11 EXCEPT
FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATED JULY 26, 2001.

5
2. WARNINGS AND CAUTIONS
Warning: Visible and Invisible Laser Radiation – Avoid eye or skin
exposure to direct or scattered radiation
CLASS 4 Laser Product
Warning: Do not use in the presence of combustible or combustion
supporting gases
Warning: Do not use in the presence of supplemental therapeutic
oxygen supplies
Warning: Always test activate the device outside the mouth before
using on a patient.
Caution: US Federal Law restricts the use of this device to use by or on the order of a dentist
Caution: Use of controls or adjustments, or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
Warning: Laser Safety Eye Protection MUST BE WORN by the
Operator, Patient, Assistant, and anyone present when the laser is
activated. Eye Protection must conform to Specification DIN EN207
Annex II of the Directive 89/686/EEC with optical density in 800nm-
818nm of OD 4+ such as NoIR Laser Company filter model DII
Above Warning is affixed to the front panel of the Sapphire Portable Diode Laser Control Module.
LASER APERTURE
at the end of handpiece
Above Warning is affixed to the cover overhanging the power/communications cord receptacle.