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Den-Mat Portable Diode Laser, Инструкция по эксплуатации

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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. 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 local safety 
and health organization requirements.  

Conformance to Medical Device Regulations

The Den-Mat Holdings, LLC Sapphire Portable Diode Laser is in conformity with the Essential Requirements 
spelled out in the Medical Device Directive (MDD), 93/42/EEC, dated 14 June 1993 as amended by 
Directive 2007/47/EC.

The device follows the conformity assessment procedure for CE marking described in Annex II, point 3 (Full 
Quality Assurance) of the MDD.

Den-Mat Holdings, LLC’s Notified Body is LNE/G-MED, number 0459.

The Company’s Authorized Representative to the European Community is:
 

 

 

 

 

GLS GLOBAL LEGAL

 

 

16, boulevard Saint-Germain

 

 

75005 PARIS, FRANCE

Содержание Portable Diode Laser

Страница 1: ...Sapphire Portable Diode Laser Instructions for Use PORTABLE DIODE LA SER ...

Страница 2: ... 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 Doo...

Страница 3: ...ser 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...

Страница 4: ...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...

Страница 5: ...r 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 fi...

Страница 6: ...e 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 fib...

Страница 7: ...re 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 ...

Страница 8: ...LC 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 local safety and health organization requirements Conformance to Medical Device Regulations The Den Mat Holdings LLC Sapphire Portable Diode Laser is in conformit...

Страница 9: ...low 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...

Страница 10: ...turned on the Sapphire Portable Diode Laser unit will default to STANDBY status indicated by 0 8 showing in the LASER POWER display and the CW icon glowing green Operating Key Switch In order to operate the Sapphire Portable Diode Laser unit the Laser Operating Key must be inserted into the key switch in the Sapphire Portable Diode Laser Control Module and turned clockwise to the ON position to pl...

Страница 11: ...t switch optional 5 The display on the Sapphire Portable Diode Laser unit will show the default output 0 8 W in the CW Mode The CW icon will glow green 6 If the battery power level for the Sapphire Portable Diode Laser unit is low identified by a blank LASER POWER display and a red Battery Indicator the unit will need to charge its batteries before use Wait until the Battery Indicator has turned t...

Страница 12: ...es the components and functions as shown below 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 Avoid Exposure Laser Radiation is emitted from this aperture 1 2 3 4 ...

Страница 13: ...tor 6 CW CONTINUOUS WAvE mode indicator glowing RED indicating working beam firing 7 CW P CONTINUOUS WAvE PULSE Mode Toggle Button 8 Laser Power Level Indicator 9 STOP LASER EMERGENCY STOP Button 10 Battery power level indicator 5 PULSE mode indicator 5 PULSE mode indicator 5 PULSE mode indicator 6 CW CONTINUOUS WAvE mode indicator glowing RED indicating working beam firing 6 CW CONTINUOUS WAvE mo...

Страница 14: ... glows green offering a visual indication that the unit is READY to fire the working beam Target Indicating Device The disposable Fiberoptic Tips point to where the Laser working beam will perform its surgical or theraputic purpose and therefore functions as the Sapphire Portable Diode Laser s target indicating device Laser Activation and Laser ON Indication The Sapphire Portable Diode Laser worki...

Страница 15: ...er footswitch jack doubles as a remote interlock jack when the Y shaped bifurcated door interlock cord not provided is installed This feature enables a clinician to establish a separate laser treatment room with an entrance door that is electronically wired to the Sapphire Portable Diode Laser When the remote interlock is installed the laser will turn off anytime the door to the room is opened hyp...

Страница 16: ...cating that there is not enough power to initiate lasing The unit will need to be plugged into the wall outlet and allowed to recharge before it can be used Error Codes E 1 Output power Not in Calibration Exceeds 20 of indicated output E 2 Over temp Diode base temperature 50 C E 3 Low battery Recharge or replace battery Battery indicator RED E 4 No power No output or drive current READY LED blinks...

Страница 17: ...er or of the tip moving too slowly Always use the least amount of power that is required to complete your procedure The ideal tissue response will show little or no discoloration after treatment and will result in less residual damage and faster healing Avoid penetrating or damaging the periosteum and do not attempt to use the laser on alveolar bone Because the 808 nm laser energy is attracted to ...

Страница 18: ...if damaged do not use the Tips Special care should be taken not to break or snap the fiber when removing Tips from packaging Do not touch the ends of the fiber Re using Fiber Optic Tips will greatly increase the chance of patient to patient infection Dispose used Fiber Optic Tips in a Sharps Container Confirm that the unit s Operating Key is turned to OFF when changing Fiber Optic Tips To install ...

Страница 19: ...when working in and around the cervical areas of the tooth Due to the thin layer of enamel in this area energy may be absorbed by the hemoglobin in the pulp and pulpal hyperemia may occur Extended exposure to such energy could cause patient discomfort and even lead to possible pulpal necrosis Cleaning Instructions The Sapphire Portable Diode Laser Handpiece and power communication cord should be c...

Страница 20: ...output The laser should be set at 1 2 and 3W in CW with output checked at each level Similarly the output should be set 1 3 and 5W in P with output checked at each level The output display on the hand held meter should be within 20 of each setting If not replace the Fiber Optic Tip and recheck power outputs If output displays are still outside the 20 tolerance return the unit to Den Mat Holdings L...

Страница 21: ...ed with water Do not use alcohol or any other combustible material to wet the 2 x 2 sponge as it may ignite Tip Initiation when indicated Not all soft tissue procedures require contacting tissue with the Fiber Optic Tip Those procedures that do not require contact will use a Fiber Optic Tip that has NOT been initiated because to be effective in non contact mode laser energy must flow unimpeded fro...

Страница 22: ...iva 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 5 mm or more of gingival tissue above the crest of the bone when performing a soft tissue contouring procedure so as to not infringe upon the biological width of the tooth 4 Angle the tip slightly toward the incisal and make a series of 2 3...

Страница 23: ...va to create a reference for the incision path 4 With the Fiber Optic Tip angled slightly toward the occlusal or incisal remove the diseased tissue down to the previously marked incision line 5 If necessary to achieve desired results increase power level but always use the lowest amount of power necessary to reach the treatment objectives and avoid charring tissue 6 Taper and festoon the crestal g...

Страница 24: ...sing very light pressure begin lasing as you make small paint brush like strokes tracing the area of the tooth that needs to be exposed or where the restoration margins are not completely visible 5 If necessary to achieve desired results increase power level but always use the lowest amount of power necessary to reach the treatment objectives and avoid charring tissue 6 Create a small trough betwe...

Страница 25: ... to the root surface or tilted slightly toward the gingival tissue during treatment in order to maximize ablation of the inflamed tissue 6 While keeping the Fiber Optic Tip in contact with the epithelium move the Fiber Optic Tip in both horizontal and vertical directions covering the epithelium and adjacent inflammatory connective tissue Move the Tip smoothly and at a moderate speed Debride all gr...

Страница 26: ... cut into or damage the periosteum 5 The incision may need to extend laterally when there is a wide attachment 6 Wipe the debris from the hard and soft tissues using hydrogen peroxide or warm saline solution Note Sutures are usually not required Lingual frenum Lingual frenum relief must be approached with caution to ensure that you do not inadvertently rupture or incise the rich vascular beds in t...

Страница 27: ...ea inside the parulis as you advance the tip apically 5 Once you have established the base of the parulis back the Fiber Optic Tip out approximately 2 mm and activate the Sapphire Portable Laser as you slowly withdraw the tip 6 Remove the Tip briefly and allow any exudate to drain 7 After draining has slowed re enter the parulis and insert the Fiber Optic Tip just short of the base and then withdr...

Страница 28: ... tooth This should take about 30 40 seconds NOTE Do not stop the movement of the Fiber Optic Tip until you have reached the starting point again and do not contact the tissue Examine the sulcus and see if you have hemostasis or if the oozing has slowed Repeat in 30 second intervals if hemorrhage persists If bleeding continues after the second attempt clean any excessive hemorrhage and lase for a t...

Страница 29: ...s with IEC 60601 1 IEC 60601 1 2 IEC 60601 2 22 IEC 60825 1 Handpiece Length 5 20 in Diameter 0 65 in Tip removal Manual friction fit Activation method Electrical contact on Handpiece Footswitch control optional Power cable 60 in x 0 26 in Sanitizing Wipe with appropriate disinfecting solution Fiber Optic Tips Type Removable Single Use Disposable Material Fused Silica coated Size 400 μm x 2 inch S...

Страница 30: ... manufacturer s discretion Returned units that are outside the Warranty period will be evaluated for the cause and extent of failure or damage by Den Mat Holdings LLC Service Representatives Subject to the results of this evaluation Den Mat Holdings LLC will contact the customer through the Authorized Den Mat Holdings LLC Distributor with a price quotation for the cost of repairs This is a limited...

Страница 31: ...31 ...

Страница 32: ... 2011 Den Mat Holdings LLC World Rights Reserved 823057399 01 11DO ...

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