TF3-73345D4MIDWEST RDH Freedom Cordless Prophy System Handpiece Inner Module

ENGLISH • 1ENGLISH • 1 DIRECTIONS FOR USE Mode d’emploi Instrucciones de uso Gebrauchsanweisung Istruzioni per l’uso Указания по применению Cordless Prophy System Please read carefully and completely before operating unit. Prière de lire attentivement et complètement avant la première utilisation de l’appareil. Por favor lea cuidadosamente y en su totalidad antes de operar la unidad. Bitte vor Inbetriebnahme der Einheit sorgfältig und vollständig durchlesen. Si prega di leggere attentamente e completamente prima di utilizzare l’apparecchio. Пожалуйста, внимательно и полностью прочтите перед использованием устройства. ENGLISH • 2ENGLISH • 2 TABLE OF CONTENTS OVERVIEW . . . . . . . . . . . . . . . . . . . .3 1. INDICATIONS FOR USE. . . . . . . .3 2. CONTRAINDICATIONS . . . . . . . .3 3. WARNINGS . . . . . . . . . . . . . . . .3 4. PRECAUTIONS . . . . . . . . . . . . . .4 5. ADVERSE REACTIONS . . . . . . . .4 6. MIDWEST ® RDH FREEDOM ™ CORDLESS PROPHY SYSTEM DESCRIPTION . . . . . . . . . . . . . .5 7. UNPACKING THE SYSTEM . . . . .6 8. INFECTION CONTROL PROCEDURES . . . . . . . . . . . . .6 9. SYSTEM SETUP . . . . . . . . . . . . .9 10. CHARGING THE HANDPIECE AND FOOTPEDAL. . . . . . . . . . . .9 11. SYNCHRONIZING THE HANDPIECE AND FOOT PEDAL . . . . . . . . . . . . . . . . . . . 10 12. PREPARATION FOR USE. . . . . . 11 13. OPERATION . . . . . . . . . . . . . . . 12 14. HANDPIECE INDICATOR LIGHTS (WHEN IN USE) . . . . . . 12 15. SPECIFICATIONS . . . . . . . . . . . 13 16. CLASSIFICATIONS . . . . . . . . . . 13 17. SYMBOL IDENTIFICATION. . . . . 14 18. DISPOSAL OF UNIT. . . . . . . . . . 15 19. TROUBLESHOOTING. . . . . . . . . 15 20. ACCESSORIES . . . . . . . . . . . . . 17 21. LIMITED WARRANTY . . . . . . . . 17 ENGLISH • 3 1. Indications for Use The Midwest RDH Freedom is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth. WARNING Use care to prevent personal and / or patient injury PRECAUTION Use care to prevent product damage and ensure safe and effective product use Safety Conventions in This Document 3. Warnings • Sterilizing the inner module will cause component damage to the handpiece and the sterilizing equip- ment, and may cause personal bodily injury. • The outer sheath must be steam sterilized before first use and between patients to prevent cross contamination. See Section 8 for the Infection Control Procedures. • The Disposable Prophy Angles are designed for single-patient use only and should never be used more than once. Disposable Prophy Angles are not autoclavable or designed to withstand disinfection solutions. The risk of reuse of a Disposable Prophy Angle are damage to equipment and cross-con- tamination. Install a new Prophy Angle before each use. • It is the responsibility of the Dental Healthcare Professional to determine the appropriate uses of this product and to understand: • the health of each patient • the dental procedures being undertaken • applicable industry and governmental agency recommendations for infection control in dental healthcare settings • requirements and regulations for safe practice of dentistry • these Directions for Use in their entirety • Per FCC Part 15.21, changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to oper- ate this equipment. • Failure to follow recommendations for environ- mental operating conditions (see Section 15 for Specifications) could result in injury to patients or users. • Inspect the handpiece system before each use for worn, loose or damaged parts. Do not attempt to operate unless the Disposable Prophy Angle (DPA) is properly installed. A loose DPA could eject from the handpiece causing bodily injury. Reinstall the DPA or replace any damaged parts as necessary. • Operating the Disposable Prophy Angle at an excessive speed or with excessive force may cause heating of the tooth and temporary discom- fort to the patient. • To prevent bodily injury and damage to the device, do not sterilize the disposable prophy angle, inner module, charging base, foot pedal or power supply. Disinfect the inner module, charging base, foot pedal and power supply using only the tested and approved disinfectants listed in Section 8, Infection Control Procedures. • The inner module, foot pedal, charging base and power supply are not waterproof. To prevent dam- age to the equipment, contamination or bodily injury, do not immerse any of these components in water or a chemical solution. • Use only components and accessories listed in Section 7 of this manual. Failure to do so will void the warranty, may decrease system performance and may lead to unsafe operation. • Never mount a Disposable Prophy Angle to the handpiece body while it is operating. Overview The MIDWEST ® RDH Freedom™ Cordless Prophy System offers a cordless design that eliminates cord drag and allows clinicians easy access and comfort during prophylaxis procedures. Quieter than traditional hygiene and low speed handpieces, the system offers all-day battery life while delivering the same performance you would expect from a corded handpiece. The system includes an autoclavable outer sheath for infection control. 2. Contraindications None Known. ENGLISH • 4 • There are no user-serviceable items in the inner module, power supply, outer sheath, foot pedal or charging base. Opening any of these units may result in unsafe operation and will void the war- ranty. • According to IEC 60601-1/UL60601-1, this device must not be used in the presence of a flammable anesthetic gas mixed with air, oxygen, or nitrous oxide. (Note: nitrous oxide by itself is not a flam- mable anesthetic gas.). 4. Precautions • Before using this product, carefully read and follow all instructions and save them for future reference. Observe all precautions and warnings. • The handpiece system can only…

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FCC ID: TF3-73345D4 D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 January 18, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for Dentsply Professional Division, the MIDWEST® RDH Freedom™ Cordless Prophy System Handpiece Inner Module, Model Numbers: 761161, 761160 and 761255, with an FCC ID: TF3-73345D4 for Certification. This unit has been tested and complies to Part 15, Subpart C. If there are any questions in regard to this application, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Section 15.249. Thank you for your assistance in this matter. Sincerely, William M. Stumpf DLS/js

166 South Carter Street, Genoa City, WI 53128 Letter of Agency Date: 1/18/2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To Whom It May Concern: Please be advised that Dentsply Professional Division authorizes D.L.S. Electronic Systems, Inc. to act on their behalf, until otherwise notified, for applications submitted to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you for your attention to this matter. Signatory, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 FCC Labeling Requirements and Information Date: 1/18/2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: FCC Labeling Requirements FCC ID: TF3-73345D4 The following label information is required by the FCC Rules and Regulations for certified devices. Also attached, please find marketing information required by the FCC Rules and Regulations. Thank you for your attention to these matters. Sincerely, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Modification Letter Date: 1/18/2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: TF3-73345D4 Please be advised that the following information is a list of modifications that will be included in the production process for the above-referenced equipment. Change 1: There were no modifications made during testing. Change 2: Change 3: Change 4: Change 5: Change 6: Change 7: Change 8: Change 9 Change 10: Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Manufacturer’s Letter Date: 1/18/2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: TF3-73345D4 To Whom It May Concern: Please be advised that the manufacturer will ensure that the above-referenced model will be manufactured in accordance with the FCC Rules and Regulations. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

166 South Carter Street, Genoa City, WI 53128 Request for Confidentiality Date: 1/18/11 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: TF3-73345D4 Pursuant to 47 CFR Section 0.459 Dentsply Professional Division understands that requests for non disclosure and confidential treatment is being made for the following information as stated under the Code of Federal Regulations Chapter 47, Part 0.459: • Block Diagram • Schematics • Description of Operation The above materials contain trade secrets, proprietary and technical information that would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. Dentsply Professional Division understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

FCC ID: TF3-7334761248 FCC ID: TF3-73345D4 D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 January 25, 2012 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for Dentsply Professional Division, a final Users’ Manual for FCC ID: TF3-7334761248 and FCC ID: TF3-73345D4. The manual was not finalized until the FDA trials were completed. No modifications have been made to the units themselves. The final manual differs from the draft version in style, with additional photos, and with additional languages. The French statements that are included for Industry Canada have been moved to a separate location in the manuals. If there are any questions in regard to this update, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of the final manual as required under Part 2, Section 2.1033 (b) (3). Thank you for your assistance in this matter. Sincerely, William M. Stumpf OATS Manager DLS/js

Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Exterior

SN Type B Equipment Consult Instructions for Use WEEE Made in the U.S.A 5 min 25 min FCC ID: TF3- 73345D4 IC: 4681B-73345D4 MODEL: 761255

LASER MARKING AREA ALL AROUND DIAMETER 1.00

Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Interior – board placement Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Board connection Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Board - TOP Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Board – BOTTOM

166 South Carter, Genoa City, WI 53128 Page 1 of 26 Company: Dentsply Professional Model Tested: 761255 Report Number: 16681 Project Number: 4349 i. Cover Page Code of Federal Regulations 47 Part 15 – Radio Frequency Devices Subpart C – Intentional Radiators Section 15.249 Operation within the bands 902 - 928 MHz, 2400 – 2483.5 MHz, 5725 – 5875 MHz, and 24.0 – 24.5 GHz THE FOLLOWING MEETS THE ABOVE TEST SPECIFICATION Formal Name: MIDWEST ® RDH Freedom TM Cordless Prophy System Handpiece Inner Module Kind of Equipment: Standalone battery operated handheld transceiver Frequency Range: 2405 - 2480 MHz Test Configuration: Battery operated handheld transceiver tested for intentional radiated emissions in three orthogonal planes. Model Number(s): 761255 (Purple), 761160 (Teal), 761161 (Lavender) Model(s) Tested: 761255 Serial Number(s): 7334-POD-1-OS-AA0054 Date of Tests: December 14 - 21, 2010 Test Conducted For: Dentsply Professional Division 1301 Smile Way York, PA 17404, USA NOTICE: “This test report relates only to the items tested and must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government”. Please see the "Description of Test Sample" page listed inside of this report. © Copyright 1983 - 2011 D.L.S. Electronic Systems, Inc. COPYRIGHT NOTICE This report must not be reproduced (except in full), without the approval of D.L.S. Electronic Systems, Inc. 166 South Carter, Genoa City, WI 53128 Page 2 of 26 Company: Dentsply Professional Model Tested: 761255 Report Number: 16681 Project Number: 4349 ii. Signature Page SIGNAT URE PAGE Report By: Adam Alger Test Engineer Reviewed By: William Stumpf OATS Manager Approved By: Brian Mattson General Manager 166 South Carter, Genoa City, WI 53128 Page 3 of 26 Company: Dentsply Professional Model Tested: 761255 Report Number: 16681 Project Number: 4349 iii. Table of Contents Table of Contents i. Cover Page .......................................................................................................................................1 ii. Signature Page .................................................................................................................................2 iii. Table of Contents .............................................................................................................................3 iv. NVLAP Certificate of Accreditation ...............................................................................................4 1.0 Summary of Test Report ..................................................................................................................5 2.0 Introduction ......................................................................................................................................5 3.0 Test Facilities ...................................................................................................................................5 4.0 Description of Test Sample ..............................................................................................................6 5.0 Test Equipment ................................................................................................................................7 6.0 Test Arrangements ...........................................................................................................................8 7.0 Test Conditions ................................................................................................................................8 8.0 Modifications Made To EUT For Compliance ................................................................................8 9.0 Additional Descriptions ...................................................................................................................9 10.0 Results ..............................................................................................................................................9 11.0 Conclusion .......................................................................................................................................9 Appendix A – Test Photos .........................................................................................................................10 Appendix B – Measurement Data ..............................................................................................................14 1.0 Emission Bandwidth – 20 dB ................................................................................................... 14 2.0 Band Edge Measurement .......................................................................................................... 16 3.0 Duty Cycle Correction .............................................................................................................. 18 4.0 Field Strength of Emissions – Fundamental and Spurious ....................................................... 22 166 South Carter, Genoa City, WI 53128 Page 4 of 26 Company: Dentsply Professional Model Tested: 761255 Report Number: 16681 Project Number: 4349 iv. NVLAP Certificate of Accreditation 166 South Carter, Genoa City, WI 53128 Page 5 of 26 Company: Dentsply Professional Model Tested: 761255 Report Number: 16681 Project Number: 4349 1.0 Summary of Test Report It was determ ined that the Dentsply Professional Division MIDWEST® RDH Freedom TM Cordless Prophy System Hand piece Inner Module, Model 761255, complies with the requirements of CFR 47 Part 15 Subpart C Section 15.249. Subpart C Section 15.249 Applicable Technical Requirements Tested: Section Description Procedure Note Compliant? 15.215(c) 20 dB Emission Bandwidth ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.205 Band Edge Measurement Near a Restricted Band ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.35(c) Duty Cycle Correction for Pulsed operation ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.249 & 15.205 / 15.209 Field Strength of Emissions Fundamental and Spurious ANSI C63.4-2009 & ANSI C63.1…

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Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Radiated – X Position Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Radiated – Y Position Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Radiated – Z Position Company: Dentsply Professional Division Handpiece, Model: 761255 Photo Description: Radiated – Above 1 GHz