PORTABLE DIODE LA SER Sapphire® Portable Diode Laser Instructions for Use
Table of Contents 1. INTRODUCTION .............................................................................................................................................................4 2. WARNINGS AND CAUTIONS ....................................................................................................................................5 Emergency Termination of Laser Emissions...............................................................................................................6 3.
8. SAPPHIRE PORTABLE DIODE LASER OPERATION AND USE................................................................... 16 Operating Modes........................................................................................................................................................... 16 Continuous Wave (CW) Mode................................................................................................................................... 16 Pulsed Energy Mode.......................................
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.
2. WARNINGS AND CAUTIONS Warning: Visible and Invisible Laser Radiation – Avoid eye or skin exposure to direct or scattered radiation CLASS 4 Laser Product 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.
Emergency Termination of Laser Emissions: The Sapphire® Portable Diode Laser has been designed with several methods to terminate emission of Laser energy if the operator wishes to deactivate the system in an emergency situation. These include an emergency shutoff switch, a key switch, a power switch, and pressing the READY button on the control pad. Any of these may be used to terminate laser emissions from the Sapphire Portable Diode Laser System. 3.
4. SAPPHIRE PORTABLE DIODE LASER FACILITY AND ENVIRONMENTAL CONSIDERATIONS In order to insure the safe use of the Sapphire Portable Diode Laser in your facility, please check to make sure that the proposed location is compatible with the specifications listed below. Power requirements for the Sapphire Portable Diode Laser follows: Input Power - 110 – 120 V AC @ 60 Hz, 3A; 220-240 V AC @ 50 Hz, 1.
5. GENERAL SAFETY WITH THE SAPPHIRE® PORTABLE DIODE LASER General Safety Considerations: Safe use of the Sapphire Portable Diode Laser is the responsibility of the entire dental team including the doctor, any system operators and the dental office safety officer. Protocols for the safe use of Lasers have been developed by medical and dental professionals, scientists and laser manufacturers. These protocols should be followed when using the Sapphire Portable Diode Laser system.
Eye and Skin Protection: While the Sapphire Portable Diode Laser is in use, doctors, system operators, auxiliary staff, patients, and anyone attending them in the operatory must wear the appropriate safety eyewear that has been designed for use with the 700-plus nm wavelengths associated with Lasers. 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 DI1.
Shipping Container Information: The shipping container you received with your Sapphire® Portable Diode Laser was specially designed to safely transport the Laser. In the unlikely event that you need to return the Laser for service or repair, please retain the original shipping container.
Sapphire Portable Diode Laser Assembly Instructions Summary: 1. Plug the Power Converter into the wall outlet and the low voltage plug into the jack on the rear of the Control Module. 2. Switch the Power Switch on the Control Module to “ON.” 3. Insert the Operating Key into the key switch on the Control Module and turn the switch to the “ON” position. 4. Attach the foot switch (optional) 5. The display on the Sapphire Portable Diode Laser unit will show the default output 0.8W in the CW Mode.
7. SAPPHIRE® PORTABLE DIODE LASER CONTROLS AND DISPLAYS Sapphire Portable Diode Laser Handpiece: The Sapphire Portable Diode Laser Handpiece includes the components and functions as shown below: 3 1 2 4 Avoid Exposure-Laser Radiation is emitted from this aperture Sapphire Portable Diode Laser Handpiece Components 1. Removable, Disposable single-use Tip 2. ON/OFF Actuator Switch 3. Main Handle Barrel of Handpiece 4. Collar for Removable Tip 5. Sanitary, disposable single-use Barrier Sleeve (not shown).
Sapphire Portable Laser Control Panel: The Sapphire Portable Laser Control Panel has the following features and control functions: 6 7 8 3 4 10 1 5 9 Figure 1 2 1. “READY” Button 2. “READY” Indicator Light • Green in “READY” status • Unlit in “STANDBY” status 3. “UP” adjustment for Laser Power 4. “DOWN” adjustment for Laser Power 5. “PULSE” mode indicator 6. “CW” (CONTINUOUS WAVE) mode indicator (glowing RED, indicating working beam firing) 7. “CW/P” (CONTINUOUS WAVE/ PULSE) Mode Toggle Button 8.
Sapphire® Portable Diode Laser Power Level Adjustment: Power can be adjusted by using the UP and DOWN arrow keys to increase (UP) or decrease (DOWN) the power setting. The power level setting will be displayed by the Laser Power Level Indicator. Upon initial powerup, the unit defaults to the CW mode and the CW icon on the control panel glows green. The power setting will default to 0.8 Watts and will be displayed in the LASER POWER window.
When the Sapphire Portable Diode Laser is in READY and the ON/OFF button on the Handpiece is held down, or the footswitch is depressed and held down, the active mode icon will turn from GREEN to RED and an audible “chirp” will be heard, indicating that the laser working beam has been activated. After a 100 microsecond delay, the Handpiece will begin delivering laser working beam emissions to the target tissue by means of the disposable 400 micrometer fiberoptic delivery tip.
Portability of the Sapphire® Portable Diode Laser: The Sapphire Portable Diode Laser does not need to be attached to the wall outlet to function. A rechargeable lithium-ion battery powers the Sapphire Portable Diode Laser. When fully charged, the Sapphire Portable Diode Laser can be operated for up to 40 minutes, for most procedures, before needing to be recharged. So, the Sapphire Portable Diode Laser can be taken from operatory to operatory as needed.
Pulsed Energy Mode : Pulsing the Sapphire Portable Diode Laser energy will allow some cooling of the tissue between emissions of energy. The “duty cycle” is the percentage of the time that the system is emitting energy. The pulses per second, the duty cycle and the energy intensity per pulse determine the average power. In the pulsed mode, the Sapphire Portable Diode Laser is programmed to deliver 10 pulses per second with a duty cycle of 50%.
The Fiber is relatively flexible, but can be broken if bent at an angle that is too sharp or a radius that is too small. Protein debris from gingival tissue accumulates on the fiber during surgery and the extreme heat that develops will deteriorate the Tip. Fibers can fracture if a blackened area greater than 3 - 4 mm develops. This is especially important when using the Sapphire® Portable Diode Laser for periodontal pocket debridement.
Initiating the Fiber Some procedures call for the fiber tip to be ‘initiated.’ ‘Initiation’ prepares the tip of the fiber to retain heat by fusing a thin layer of pigment on the end. The easiest way to initiate a tip is by lightly moving the end of the fiber across a piece of articulating paper with the unit set to 1W CW (see below). The tip will retain pigment from the paper and will glow. Do not exceed contact time of 1 second.
We suggest that your practice establish an internal calibration program for your laser. Recalibration is recommended at least once per year based on typical usage. Recalibration may be performed by Den-Mat® Holdings, LLC by returning the unit. As an alternative, you may purchase a calibrated hand-held power meter approved for use with 808 nm devices to check power output. The laser should be set at 1, 2, and 3W in CW with output checked at each level.
9. PROCEDURAL RECOMMENDATIONS FOR USING THE SAPPHIRE® PORTABLE DIODE LASER Following procedure guidelines are provided as a guide only and have been developed based on information provided by experienced laser users and educators. Always review the patient’s history to evaluate possible contra-indication for use of local anesthesia or other complications.
Gingival Contouring with the Sapphire® Portable Diode Laser: Tip: Initiated Mode: Continuous Wave Power: 0.8 W Anesthesia: Local, as required Technique: Contact 1. After anesthesia is profound, insert a periodontal probe into the sulcus down to the crest of the bone. 2. Measure that depth from the crest of the gingiva to the bone. Note the reading and reduce it by 2.5 mm. 3. Make a stick mark in the facial gingiva at a point 2.5 mm above the crest of the bone. Always leave 2.
Gingivectomy, Gingivoplasty and Papillectomy with the Sapphire Portable Diode Laser: Tip: Initiated Mode: Continuous Wave Power: 1.0 W Anesthesia: Local, as required Technique: Contact 1. Using a periodontal probe, record the depth of the pocket to be treated and evaluate its condition, either acute or chronically inflamed. 2. If there is no apparent exudate present, use the periodontal probe to define the height of contour that is to be establish. 3.
Gingival Troughing & Tissue Retraction for Impressions with Sapphire® Diode Portable Laser: Tip: Initiated Mode: Continuous Wave Power: 0.8 W Anesthesia: Topical or Local, as required Technique: Contact 1. Following preparation of the tooth, cleanse the area (optional) with H2O2 and then rinse with a light spray of water. 2. Air dry with low volume flow of air. 3. Lightly contact the sulcus lining just inside the crest of the gingiva, angling the Tip away from the tooth. 4.
Sulcular Debridement with the Sapphire Portable Diode Laser: (Including removal of sulcular tissue and granulation tissue) Tip: Initiated Mode: Pulsed Power: 0.8 W Anesthesia: Topical or Local, as required Technique: Contact Time: 30 seconds Technique: Contact 1. After conventional instrumentation has been completed, insert the fiber tip to the full pocket depth. 2. Gently probe the pocket to get a sense of its geometry. 3. Begin lasing onto the diseased epithelial lining. 4.
Labial Frenectomy with the Sapphire® Portable Diode Laser: (and Frenotomy procedures) Tip: Initiated Mode: Continuous Wave Power: 1.0 W Anesthesia: Local, as required Technique: Contact The procedures to relieve the frenum will differ for three basic areas: 1) Mandibular frenum – labial or buccal; 2) Mandibular frenum – lingual (tongue-tied relief); 3) Maxillary frenum – labial and buccal. Mandibular labial frenum attachments: 1. Place tension on the frenum by retracting the lip or cheek. 2.
Abcess Excision with the Sapphire Portable Diode Laser Tip: Initiated Mode: Continuous Wave Power: 1.0 W Anesthesia: Topical or Local, as required Technique: Contact 1. Determine the status of the lesion, chronic or acute, and select a site to enter the parulis of the infection. 2. Based on the lesion status, enter the lesion by placing the fiber tip at the most coronal spot on the parulis and with short strokes, make an incision to establish a drainage path. 3.
Hemostasis with the Sapphire® Portable Diode Laser Tip: Uninitiated Mode: Continuous Wave Power: 1.0 W Anesthesia: Topical or as required Technique: Non-Contact Place the Fiber Optic Tip 2 mm above the gingival sulcus, in noncontact with tissue. Direct energy into sulcus and away from the dentin and cementum. • Active the laser as you make a series of 2 – 3 mm strikes while circling the tooth. This should take about 30 – 40 seconds.
10. SAPPHIRE PORTABLE DIODE LASER SPECIFICATIONS Laser Classification: Wavelength working beam: Beam Divergence: Power Range: Frequency (Pulsed): Pulse Duration: Duty Cycle: Wavelength aiming beam Output Audible signal: Visual signal: Power Supply: Laser diode Class 4 laser device (per IEC 60825) 808 nm ±5 nm 9° ± 1° 100 mW to 3 W, CW; 100mW to 5W, P fixed, 10 Hz fixed 0.
11. SERVICING THE SAPPHIRE® PORTABLE DIODE LASER In the event that the laser fails to operate correctly and your 1Call Representative is unable to help, the unit will need to be returned to Den-Mat® Holdings, LLC for repair, there are no user-repairable parts found with the device. It is recommended that lasers be returned in their original shipping box. If not available, one can be requested at the time you discuss your return with your sales representative.
12. SYSTEM WARRANTY When used under normal operating conditions as described in this Manual, the Sapphire Portable Diode Laser system is warranted to be free of defects in materials and workmanship for one (1) year from the date of original shipment. Within the warranty period, all parts and service charges for repairs to the Sapphire Portable Diode Laser system are covered by Den-Mat Holdings, LLC. If service is required, the system must be returned to Den-Mat Holdings, LLC for diagnosis and repair.
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