Den-Mat Sapphire Manual de usuario

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. SAPPHIRE®PORTABLE DIODE LASER INDICATIONS FOR USE................................................................6

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

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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.: 800-433-6628 or 805-922-8491

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.

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.

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. SAPPHIRE PORTABLE DIODE LASER INDICATIONS FOR USE

The Sapphire Portable Diode Laser is indicated for use in dental intraoral soft tissue general, oral maxilla-facial

and cosmetic surgery including ablating, incising, excising, vaporizing and coagulation of soft tissues using a ﬁber

optic delivery system. Indications include:

Excision and incision biopsies

Hemostatic assistance

Treatment of apthous ulcers

Gingival incision and excision

Gingivectomy

Gingivoplasty

Gingival troughing

Gingival recontouring

Tissue retraction for impressions

Oral papillectomy

Sulcular debridement

Sulcular tissue removal

Removal of granulation tissue

Frenectomy

Frenotomy

Abcess incision and draining and excision

Operculectomy

Removal of ﬁbromas

Soft tissue crown lengthening

Vestibuloplasty

General guidelines for some of these procedures may be found in section 9 of this user instruction manual. In

addition to receiving proper training in the use of dental Lasers, users should be familiar and experienced with

these procedures using electrosurgical devices or traditional instruments before performing them on patients with

the Sapphire Portable Diode Laser. Non-experienced users should seek appropriate training or guidance before

attempting clinical treatments with the Sapphire Portable Diode Laser system.

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:

External AC/DC Power Supply:

Input Power - 110 – 120 V AC @ 60 Hz, 3A; 220-240 V AC @ 50 Hz, 1.5A (switchable)

Output Power - 12W, +5 V DC at 2.4A maximum

Heating and Ventilation:

The room where the Sapphire Portable Diode Laser is used should have an appropriate cooling and heating

system so that the lasers can be operated within the optimal temperature range of 20º - 30ºC (68º - 86º F).

Avoid storing or transporting the lasers in temperatures below 0º Celsius (32º F).

Lighting:

Overhead lighting and/or dental unit light should provide enough illumination to allow proper operator visibility of

the surgical site when activating the Sapphire Portable Diode Laser intra-orally.

Combustible Chemicals and Gases:

All gases that are combustible or support combustion and are used in the operatory area where the Sapphire

Portable Diode Laser is being operated must be turned off during the procedure. Cleaning supplies or other

ﬂammable chemical compounds should be stored in an area away from the surgical site in order to avoid possible

combustion. Do not use in the presence of supplemental therapeutic oxygen supplies for patients with respiratory

or related diseases.

Plume evacuation:

Plume evacuation should be addressed when vaporizing tissues. A high volume vacuum system should be used

and 0.1 micron or less high ﬁltration masks that are suitable for virus and bacterial control should be worn by

Clinicians, operators and auxiliary staff in the vicinity of procedures being performed with the Sapphire Portable

Diode Laser system.

Operatory Access during Sapphire Portable Diode Laser Use:

Access to the treatment area should be restricted while the lasers are in use. A sign indicating “LASER IN USE”

should be placed in a designated area adjacent to the treatment area entry location.

DANGER

LASER RADIATION. A V OID EYE OR SKIN

EXPOSURE TO DIRECT OR SCA T TERED

RADIATION.

Wavelength: 808nm

Max Output Power: 3W

Pulse Duration: 125ms

LASER PROTECTIVE EYEWEAR REQUIRED

CLASS IV LASER PRODUCT

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. Dental professionals have also developed

protocols and guidelines for Laser use on oral soft tissues which should be employed when using the Sapphire

Portable Diode Laser system.

Marketing Requirements Regarding Medical Device Safety (USA):

The United States Food and Drug Administration has control over the sale and use of the all medical devices

including the Sapphire Portable Diode Laser. Manufacturers of products subject to performance standards under

the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control

are required to certify compliance with the regulations and furnish various reports to the Center for Devices and

Radiological Health (CDRH). For manufacturers of medical lasers (such as the Sapphire Portable Diode Laser

system), additional review by the FDA of the safety and effectiveness of the device is required. Companies who

intend to market a medical laser or equivalent device must receive authorization from the FDA before the device

is permitted into commercial distribution. The premarket notiﬁcation (510(k)) process used for the Sapphire

Portable Diode Laser system is applicable for devices that are documented to be substantially equivalent to

existing legally marketed Class II devices.

Statutory Licensure for Dental Laser use:

Usually, states or provinces do not have a speciﬁc licensure requirement for use of surgical Laser devices by

dentists. Many states do, however, require hygienists who will be using Lasers to attend licensure training that

includes both a lecture and hands-on experience. The license applicants are then required to pass a proﬁciency

test for certiﬁcation prior to using Lasers. These courses are usually taught by members of the Academy of

Laser Dentistry who possess instructor credentials. Such training would be appropriate for use of the Sapphire

Portable Diode Laser system.

OSHA Provisions:

Worker safety is the responsibility of the employer and is regulated by OSHA (Occupational Safety and Health

Administration), a division of the U.S. Department of Labor. OSHA recognizes ANSI standard Z136.1 as a

source for analyzing safety with respect to medical lasers. For more information see OSHA Technical Manual

(TED 1-0.15A) Section III, Chapter 6, 1999. Den-Mat®Holdings, LLC recommends implementation of a safety

program for the safety of your patients and ofﬁce staff in connection with the use of the Sapphire Portable Diode

Laser. Den-Mat Holdings, LLC also recommends checking and complying with applicable state and provincial

safety and health organization requirements.

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.

Nominal Ocular Hazard Distance (NOHD) is the distance from the source of laser emission to the point

where it no longer exceeds its Maximum Permissible Exposure (MPE – highest level of laser radiation to

which a person may be exposed without hazardous effects or adverse biological changes in the eyes or

skin). The Nominal Hazard Zone (NHZ) is the space within which the level of direct, reﬂected, or scattered

radiation during normal operation exceeds the appropriate MPEs. The outer limit of the NHZ is equal to the

NOHD. The NOHD for persons wearing recommended safety glasses is shown in Table 1 below.

Never point the Sapphire Portable Diode Laser tip directly at the face, eyes or skin of anyone while emitting energy.

Emergency Shutdown Options:

Perform any of these actions to terminate laser emissions in the event of a real or perceived emergency:

1. Release the handpiece activation button.

2. Depress the emergency “STOP” button.

3. Remove your foot from the foot switch.

4. Turn the key counterclockwise to the “OFF” position.

5. Switch the power switch to the “OFF” (O) position.

6. Press the READY button to go to Standby mode.

NOHD (inches/cm)

MPE

mW/cm2

Without eye With Recommended

protection Eye Protection

Fiber Optic Tip (direct) 1.66 9° (± 1°) 155/393.7 1.55/3.94

Reﬂected from tissue 1.66 n/a 0.25/0.63 0.0025/0.0063

Radiation Source Divergence Angle

Table 1 NOHD

Electromagnetic Environment Guidance

(Class B (CISPR 11:2009), Group 1 per IEC 60601-1-2, sub-clause 6.8.3.201)

The Sapphire Portable Diode Laser 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.

Floors should be wood, concrete, or ceramic tile. If ﬂoors are covered in synthetic material, the relative

humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment. The Sapphire

Portable Diode Laser does not require continued operation during power mains interruptions, merely

it is recommended that the Sapphire Portable Diode Laser should be powered from an uninterruptible

power supply (UPS) or its battery.

Power Frequency Magnetic Fields should be at levels characteristic of a typical location in a typical

commercial or hospital environment.

6. SAPPHIRE PORTABLE DIODE LASER INSTALLATION AND SETUP

Instructions on Unpacking & Customer Service Assistance:

A Den-Mat Holdings, LLC customer service representative can provide assistance when you are ready to remove

the Sapphire Portable Diode Laser from its shipping container. Please do not attempt to unpack the Sapphire

Portable Diode Laser and install or setup the unit without reading this section ﬁrst. If you are unsure about any

aspect of the assembly, call your Den-Mat Holdings, LLC customer service representative for assistance.

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.

Contents of Sapphire Portable Diode Laser Shipping Container:

The contents of the shipping container should include the following:

• Sapphire Portable Diode Laser Control Module with Laser Handpiece

• AC/DC Power Converter

• Laser Operating Key

• Fiber Optic Tips, 400 µm/5 pc

• Single-use Barrier Sleeves for Handpiece 25 pc

• Protective Glasses 3 pc

• Safety Sign

• Sapphire Portable Diode Laser Instructions

• Sapphire Portable Quick Start Guide

• Warranty Information

• Extended Warranty Offer

• Online Training Offer

• Battery Charging Notice

Please check to insure that all items are accounted for.

Installing the Sapphire Portable Diode Laser:

Each of the items listed below should be inspected and the instructions followed. Use of any cables or

accessories other than those provided by Den-Mat Holdings, LLC may damage the device and may result in

increased RF emissions or decreased immunity of the equipment.

Sapphire Portable Diode Laser control module – Plug the AC/DC Power Converter into the wall outlet and

attach the small, low-voltage plug to the jack on the rear of the Control Module.

Power Switch – The power switch for the Sapphire Portable Diode Laser is located on the rear panel of the

Control Module. This switch must be in the “ON” position when the Sapphire Portable Diode Laser unit is to

be used. To conserve battery power always turn the rear Power Switch to the “OFF” position when the

laser is not in use.

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