VIK-OH003Footpedal transmitter to operate dental laser surgical devices.

SL3 User’s Manual This manual must be read thoroughly and understood prior to using the laser system. CAUTION: Using the controls and adjustments or performing laser procedures, other than as specified herein, may result in hazardous radiation exposure. 20-2954 081710 Discus Dental, LLC 8550 Higuera Street Culver City, CA 90232 USA Tel: (310) 845-8200 Fax: (310) 876-9917 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands EC REP 0470 © 2010 Discus Dental, LLC. All rights reserved. CaviWipes is a registered trademark of Metrey Research, LLC. 1 Section 1: Introduction ...............................................1 Introduction ...................................................................................1 Indications for Use .......................................................................1 What’s in the box? ........................................................................1 Section 2: Specifications .............................................2 Laser System Specifications ......................................................2 Laser System Description ..........................................................2 LCD Screen ......................................................................................3 Unifiber ™ System ...........................................................................3 Section 3: Safety Indications ......................................4 Testing Standards .........................................................................4 Labels ................................................................................................4 Precautions .....................................................................................4 Warnings ..........................................................................................5 Protective Eyewear.......................................................................7 Laser System Safety Features ...................................................7 Section 4: System Set Up .............................................8 Unpacking .......................................................................................8 What’s in the box? ........................................................................8 Installation ......................................................................................8 Cleaning and Sterilization .........................................................10 Transportation ...............................................................................10 Preparing the Unifiber Hand Piece Assembly ....................11 Section 5: Operation ....................................................12 Procedure Guide ...........................................................................12 Laser Operation Procedure .......................................................13 Section 6: Labels & Symbols ......................................15 FCC Compliance Label ................................................................15 Section 7: Warranty and Service ................................16 Service and Maintenance ..........................................................16 SL3 Unit Warranty .........................................................................16 Compliance .....................................................................................18 Table of ContentsSection 1: Introduction INTROdUCTION The SL3 ™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAlAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. For a list of approved procedures please refer to page 12. All of the safety features, warnings and precautions should be observed for the SL3 ™ . All of the Safety Warning Labels are described in detail on page 15 of this guide. The SL3 ™ is especially designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures. Indications for Use The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions. What’s in the box? • Laser • Unifiber ™ with Hand Piece • Foot Pedal • Disposable Tips (10) • Power Adapter • Safety Glasses (3) • Introductory DVD • Caution Sign • Initiating Film • User’s Manual • Basic User’s Guide What’s in the box photo 23 Section 2: Specifications The SL3 ™ uses an internal battery that is recharged when it is plugged in. When fully charged, the battery will last for 30 minutes in continuous use at maximum power. The SL3 ™ internal battery is not intended to be changed by the operator. The laser energy is activated by a wireless foot pedal. Depressing the foot-switch activates the lasing process, while releasing it stops the process. The SL3 ™ system is highly portable and self-contained with built-in safety features. It is capable of producing the rated output power in a continuous wave mode for more than half an hour without interruption, allowing completion of most surgical procedures. In the pulsed mode, the system delivers pulsed (interrupted) radiation at a repetition rate of 10 Hertz, and a pulse width of 50 ms. The SL3 ™ uses disposab…

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SL3 User’s Manual This manual must be read thoroughly and understood prior to using the laser system. CAUTION: Using the controls and adjustments or performing laser procedures, other than as specified herein, may result in hazardous radiation exposure. 20-2954 081710 Discus Dental, LLC 8550 Higuera Street Culver City, CA 90232 USA Tel: (310) 845-8200 Fax: (310) 876-9917 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands EC REP 0470 © 2010 Discus Dental, LLC. All rights reserved. CaviWipes is a registered trademark of Metrey Research, LLC. 1 Section 1: Introduction ...............................................1 Introduction ...................................................................................1 Indications for Use .......................................................................1 What’s in the box? ........................................................................1 Section 2: Specifications .............................................2 Laser System Specifications ......................................................2 Laser System Description ..........................................................2 LCD Screen ......................................................................................3 Unifiber ™ System ...........................................................................3 Section 3: Safety Indications ......................................4 Testing Standards .........................................................................4 Labels ................................................................................................4 Precautions .....................................................................................4 Warnings ..........................................................................................5 Protective Eyewear.......................................................................7 Laser System Safety Features ...................................................7 Section 4: System Set Up .............................................8 Unpacking .......................................................................................8 What’s in the box? ........................................................................8 Installation ......................................................................................8 Cleaning and Sterilization .........................................................10 Transportation ...............................................................................10 Preparing the Unifiber Hand Piece Assembly ....................11 Section 5: Operation ....................................................12 Procedure Guide ...........................................................................12 Laser Operation Procedure .......................................................13 Section 6: Labels & Symbols ......................................15 FCC Compliance Label ................................................................15 Section 7: Warranty and Service ................................16 Service and Maintenance ..........................................................16 SL3 Unit Warranty .........................................................................16 Compliance .....................................................................................18 Table of ContentsSection 1: Introduction INTROdUCTION The SL3 ™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAlAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. For a list of approved procedures please refer to page 12. All of the safety features, warnings and precautions should be observed for the SL3 ™ . All of the Safety Warning Labels are described in detail on page 15 of this guide. The SL3 ™ is especially designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures. Indications for Use The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions. What’s in the box? • Laser • Unifiber ™ with Hand Piece • Foot Pedal • Disposable Tips (10) • Power Adapter • Safety Glasses (3) • Introductory DVD • Caution Sign • Initiating Film • User’s Manual • Basic User’s Guide What’s in the box photo 23 Section 2: Specifications The SL3 ™ uses an internal battery that is recharged when it is plugged in. When fully charged, the battery will last for 30 minutes in continuous use at maximum power. The SL3 ™ internal battery is not intended to be changed by the operator. The laser energy is activated by a wireless foot pedal. Depressing the foot-switch activates the lasing process, while releasing it stops the process. The SL3 ™ system is highly portable and self-contained with built-in safety features. It is capable of producing the rated output power in a continuous wave mode for more than half an hour without interruption, allowing completion of most surgical procedures. In the pulsed mode, the system delivers pulsed (interrupted) radiation at a repetition rate of 10 Hertz, and a pulse width of 50 ms. The SL3 ™ uses disposab…

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8550 Higuera Street Culver City, CA 90232 (310) 845-8200 phone (310) 845 1500 fax discusdental.com 5 May 2010 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification FCC ID: VIK-OH001 Authority to Act as Agent On our behalf, I appoint Alan Laudani of Nemko USA Inc., 11696 Sorrento Valley Rd, San Diego, CA, USA to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in Federal Communication Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Discus Dental, LLC., 8550 Higuera Street, Culver City, CA 90232, expiring 15 Sept 2010. Sincerely,

FCC ID: VIK‐OH003 IC: 7260A‐ OH003

PROJECTION THIRD ANGLE 2.40 1.43 R.10 LABEL SIZE FCC/IC LABEL SIZE 3.94 1.18 R.125 LABEL LOCATION BOTTOM VIEW LABEL LOCATION END VIEW ENGINEERING RELEASE KB 11/16/10 A -B ECN/EDR# DATEREV. BYDESCRIPTION OF CHANGE SHEET 1 OF 1 8550 Higuera Street Culver City, CA 90232 USA THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF DISCUS DENTAL, LLC. ANY REPRODUCTION IN PART OR A WHOLE WITHOUT WRITTEN PERMISSION IS PROHIBITED. NA DWG SIZE A PROPRIETARY AND CONFIDENTIAL APPROVED CHECKED DRAWN BY Ken Blanchard DATE 11/16/10 DATE DATE NA MATERIAL SURFACE TREATMENT DESCRIPTION PART NUMBER SL3 FOOT PEDAL LABEL LOCATION E101116 REV. SCALE 1:2 GENERAL NOTES: UNLESS OTHERWISE SPECIFIED; 1. PART TO BE FREE OF BURRS AND SURFACE DEFECTS 2. BREAK CORNERS .015. 3. FILLETS AND RADII .O15 MAX. 4. SURFACE FINISH 63 MICROINCH . TOLERANCES: UNLESS OTHERWISE SPECIFIED; UNITS ARE IN INCHES FRACTIONAL = 1/32" .XXX = .005 .XX = .015 .X = .030 ANGLES/BENDS = 1 ADD FCC LABEL INFO. B 1/14/11 KB

Model: SL3 13-3835 011111 IC: 7260A-OH003 FCCID: VIK-OH003 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. Part No: 13-3835 Revision Info: Ink/Plate Setup: Black only Discus Dental 8550 Higuera St. Culver City, CA 90232 Contact: Nick Freeman 310.845.8292 IMPORTANT PRINTER NOTES: .125 radius corners File Desc: SL3 Foot Pedal Label Program: Illustrator Flat Size: 10cm x 3cm Finish Size: 10cm x 3cm Folds/Perf: na Imported Files: na Fonts: na R# Date Ini Notes: 1. 1/11/11 MH File created

FCC ID: VIK‐OH003 IC: 7260A‐ OH003

Nemko USA, Inc. 11696 Sorrento Valley Rd., Suite F San Diego, CA 92121-1024 Phone (858) 755-5525 Fax (858) 452-1810 FCC Part 15 Subpart C, 15.249 : 03 February 2011 CERTIFICATION TEST REPORT Report Number: 2010 10157984 FCC Project Number: 61466-1 Nex Number: 157984 Applicant: D ISCUS DENTAL INC. 8550 H IGUERA ST. Culver City, CA 90232 Equipment Under Test (EUT): WIRELESS FOOT PEDAL Model: SL3 FCC ID: VIK-OH003 IC: 7260A-OH003 In Accordance With: FCC Part 15 Subpart C, 15.249 IC RSS-210 Issue 8 December 2010 IC RSS-Gen Issue 3 December 2010 Tested By: Nemko USA Inc. 11696 Sorrento Valley Road, Suite F San Diego, CA 92121 Authorized By: Alan Laudani, EMC/RF Test Engineer Date: December 14, 2010 Total Number of Pages: 25 Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: VIK-OH003 Report Number: 2010 10157984 FCC IC: 7260A-OH003 Specification: FCC Part 15 Subpart C, 15.249 Page 2 of 25 Section1: Summary of Test Results General All measurements are traceable to national standards These tests were conducted on a sample of the equipment for the purpose of demonstrating compliance with FCC Part 15; Subpart C and IC RSS-210. Radiated tests were conducted is accordance with ANSI C63.4-2003. Radiated emissions are made on an open area test site. A description of the test facility is on file with the FCC and IC. The assessment summary is as follows: Apparatus Assessed: Wireless Foot Pedal Model: SL3 Specification: FCC Part 15 Subpart C, 15.249 IC RSS-210 Issue 8 December 2010 Date Received in Laboratory: October 13, 2010 Compliance Status: Complies Exclusions: None Non-compliances: None Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: VIK-OH003 Report Number: 2010 10157984 FCC IC: 7260A-OH003 Specification: FCC Part 15 Subpart C, 15.249 Page 3 of 25 1.1 Report Release History REVISION DATE COMMENTS - December 14, 2010 Prepared By: Ferdinand Custodio - December 14, 2010 Initial Release: Alan Laudani Note that the results contained in this report relate only to the items tested and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This test report has been completed in accordance with the requirements of ISO/IEC 17025. Nemko USA Inc. authorizes the applicant to reproduce this report provided it is reproduced in its entirety and for use by the company’s employees only. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko USA Inc. accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. TESTED BY: ___________________________________ Date: December 14, 2010 Ferdinand Custodio, EMC Test Engineer Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: VIK-OH003 Report Number: 2010 10157984 FCC IC: 7260A-OH003 Specification: FCC Part 15 Subpart C, 15.249 Page 4 of 25 TABLE OF CONTENTS Section1: Summary of Test Results ............................................................................ 2 1.1 Report Release History ..................................................................................... 3 Section 2: Equipment Under Test ................................................................................ 5 2.1 Product Identification ........................................................................................ 5 2.2 Samples Submitted for Assessment ................................................................. 5 2.3 Theory of Operation .......................................................................................... 6 2.4 Technical Specifications of the EUT ................................................................. 6 Section 3: Test Conditions ........................................................................................... 7 3.1 Specifications.................................................................................................... 7 3.2 Deviations From Laboratory Test Procedures................................................... 7 3.3 Test Environment .............................................................................................. 7 3.4 Test Equipment................................................................................................. 8 Section 4: Observations ............................................................................................... 9 4.1 Modifications Performed During Assessment................................................... 9 4.2 Record Of Technical Judgements..................................................................... 9 4.3 EUT Parameters Affecting Compliance ............................................................ 9 4.4 Test Deleted...................................................................................................... 9 4.5 Additional Observations .................................................................................... 9 Section 5: Results Summary ...................................................................................... 10 5.1 Test Results .................................................................................................... 10 Appendix A: Test Results........................................................................................... 11 Section 15.215(c) – Occupied Bandwidth ..................................................................... 11 RSS-Gen Section 4.6.1 – Occupied Bandwidth ............................................................ 11 Section 15.249(a) – Field Strength of Emissions .......................................................... 19 RSS-210 A2.9 – Field Strength of Emissions................................................................ 1…

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FCC ID: VIK‐OH003 IC: 7260A‐ OH003