G2OEPIC-1Wireless Foot Pedal

EPIC 10 User Manual P/N 5400525 Rev. B Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine and dentistry that feature proprietary and patented technologies for minimally invasive surgeries, reducing pain and improving clinical results. Only BIOLASE combines the leading laser technology – continuously improved through ongoing clinical R&D and engineering – with unmatched training, practice integration support and service. BIOLASE leads the global dental laser market with over 24,000 lasers in use today and the most complete family of dental lasers – from diode lasers to the most advanced all-tissue laser, the WaterLase iPlus. About BIOLASE BIOLASE, Inc. 4 Cromwell Irvine, CA 92618 USA 949.361.1200 888.424.6527 biolase.com © 2013 BIOLASE, Inc. All rights reser ved. EPIC, iLase, ezLase, ezTip, LaserWhite, Deep Tissue Handpiece, ComfortPulse, WaterLase, and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE, Incorporated in the United States and/or other countries. All other trademarks are property of their registered owners. Subject to change without notice. User Manual EPIC 10 User Manual P/N 5400525 Rev. B Made in the USA Conforms to: AAMI ES60601-1 IEC60601-1 IEC6060-2-22 IEC62366 IEC80601-2-60 IEC60825-1 Certified to: CSA C22-2 No. 60601-1 5400525 Rev A, User Manual Cover, EPIC 10 Canada.indd 112/20/2013 10:24:46 AM EPIC™10 User Manual pg. 1 5400525 Rev B TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................. 1 Introduction ................................................................................................................................ 4 1.Packaging ............................................................................................................................... 5 1.1 System Parts List .............................................................................................................. 5 1.2 Facility Requirements ....................................................................................................... 5 2. Equipment Description ........................................................................................................... 6 2.1 General ............................................................................................................................ 6 2.2 Base Console ................................................................................................................... 6 2.3 Control Panel .................................................................................................................... 6 2.4 Surgical Delivery System .................................................................................................. 7 2.6 Fiber Optic Connection ..................................................................................................... 7 2.7 Single-Use Tips ................................................................................................................ 8 2.8 Surgical Handpiece Assembly .......................................................................................... 8 2.9 Whitening/Contour Handpiece (Optional Accessory) .......................................................11 3. Safety....................................................................................................................................12 3.1 Precautions .....................................................................................................................12 3.2 Safety Instructions ...........................................................................................................12 3.3 Safety Features ...............................................................................................................13 Energy Monitor ..................................................................................................................13 System Monitor ..................................................................................................................13 Power Switch .....................................................................................................................14 Access Key Code ...............................................................................................................14 Control Button ....................................................................................................................14 Wireless Footswitch ...........................................................................................................14 Remote Interlock ................................................................................................................15 Emergency Stop ................................................................................................................15 Functional Display ..............................................................................................................16 3.4 Safety Classification ........................................................................................................16 4. Operation Instructions ...........................................................................................................17 4.1 System setup ...................................................................................................................17 4.2 Operation - Turn on the EPIC 10 Laser ..........................................................................18 EPIC™10 User Manual pg. 2 5400525 Rev B 4.3 Settings Screen ...............................................................................................................19 4.4 Pairing the Footswitch to the Laser console .....................................................................19 4.5 Control Button .................................................................................................................21 4.6 Entering READY o…

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Artwork of the 15.19 statement label:

FCC / IC Label placement on the Foot Switch:

MODEL: EPIC 10 FCC ID: G2OEPIC-1 IC: 10338A-EPIC 5400365 Rev. D

MODEL: EPIC S-SERIES FCC ID: G2OEPIC-1 IC: 10338A-EPIC 5400469 Rev. C

MODEL: EPIC V-SERIES FCC ID: G2OEPIC-1 IC: 10338A-EPIC 5400452 Rev. C

PCB top side: PCB bottom side: Internal assembly External assembly

INTERTEK TESTING SERVICES ==================================================== RF exposure analysis report FCC ID: G2OEPIC-1 Model: EPIC 10 Footswitch Unit The equipment under test (EUT) is a Wireless Footswitch of a surgical and therapeutic device. It incorporates a RF transceiver for ZigBee and IEEE 802.15.4. For more detail information pls. refer to the user manual. Operating Frequencies: 2425 MHz, 2450 MHz, 2475 MHz Modulation Type: OGFSK Antenna Type: Integral PCB antenna Antenna Gain: 5.5 dBi Maximum rated conducted output power: is 3.5dBm (2.24 mW) According to the KDB 447498: The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR = > (2.24mW/5mm) * SQRT(2.475GHz) = 0.71 ≤ 7.5 Since the above calculation is less than 7.5, the product fulfils the RF exposure requirement without SAR testing. Remark: 1. When the minimum test separation distance is < 5mm, a distance of 5mm is applied to determine SAR test exclusion.

This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. 25800 Commercentre Drive Lake Forest, CA 92630 Telephone: 949-448-4100 www.intertek-etlsemko.com TEST REPORT Report Number: 101344818LAX-001a Project Number: G101344818 Report Issue Date: 1/9/2014 Product Name: Footswitch for Epic Family Series Soft Tissue Laser Systems Model Number: EPIC T-SERIES / EPIC S-SERIES FCCID: G2OEPIC-1 ICID: IC: 10338A-EPIC Standards: Title 47 CFR Part 15 Subpart C and RSS-210 Issue 8 Tested by: Client: Intertek Testing Services NA, Inc. 25800 Commercentre Drive Lake Forest, CA 92630 USA Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 USA Report prepared by Report reviewed by David O’Reilly David Chernomordik EMC Staff Engineer Sr. Staff Engineer Intertek Issued: 1/9/2014 EMC Report for Biolase Technology, Inc. on the Footswitch for the EPIC 10 Series Soft Tissue Laser System FCCID: G2OEPIC-1; ICID: 10338A-EPIC Page 2 of 36 TABLE OF CONTENTS 1 Introduction and Conclusion .......................................................................................................... 3 2 Test Summary ................................................................................................................................. 3 3 Description of Equipment Under Test ........................................................................................... 4 4 Peak Conducted Power .................................................................................................................. 6 5 Occupied Bandwidth .................................................................................................................... 10 6 Conducted Spurious Emissions .................................................................................................. 17 7 Power Spectral Density ................................................................................................................ 18 8 Duty Cycle Correction Factor ....................................................................................................... 22 9 Radiated Spurious Emissions (Transmitter) ............................................................................... 23 10 Radiated Spurious Emissions (Receiver) .................................................................................... 27 11 AC Powerline Conducted Emissions ........................................................................................... 31 12 Antenna Requirement per FCC Part 15.203 ................................................................................. 36 13 Measurement Uncertainty ............................................................................................................ 36 14 Revision History ........................................................................................................................... 36 Intertek Issued: 1/9/2014 EMC Report for Biolase Technology, Inc. on the Footswitch for the EPIC 10 Series Soft Tissue Laser System FCCID: G2OEPIC-1; ICID: 10338A-EPIC Page 3 of 36 1 Introduction and Conclusion The tests indicated in section 2 were performed on the product constructed as described in section 3. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test method, a list of the actual test equipment used, documentation photos, results and raw data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complied with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. The INTERTEK Lake Forest - is located at 25800.Commercentre Drive, Lake Forest CA, 92630. The radiated emission test site is a 10-meter semi-anechoic chamber. The chamber meets the characteristics of CISPR 16-1 and ANSI C63.4. For measurements, a remotely controlled flush-mount metal-top turntable is used to rotate the EUT a full 360 degrees. A remote controlled non-conductive antenna mast is used to scan the antenna height from one to four meters. The test site is listed with the FCC under registration number 485103. The test site is listed with Industry Canada under site number IC 2042M-1. 2 Test Summary Test full name FCC Reference IC Reference Result Output Power § 15.247(b)(3) RSS-210 (A8.4) Pass Occupied Bandwidth § 15.247(a)(2) RSS-210 A8.2(a) Pass Power Spectral Density § 15.247(e) RSS-210 (A8.2b) Pass Conducted Spurious Emissions § 15.247(d) RSS-210 (A8.5) Pass The EUT has a permanently attached internal antenna. It does not contain an antenna port connector. Instead of Antenna Conducted measurements, Radiated measurements were performed. Out-of-Band Radiated Emission (except emissions in Restricted Bands) 15.247(d) A8.5 15.247(d) A8.5 Pass Radiated Spurious Emissions (Transmitter) § 15.247(d), § 15.209, and § 15.205 RSS-210 (2.2) (A8.5) Pass Radiated Spurious Emissions (Receiver) § 15.109 RSS-Gen (6.1) Pass AC Powerline Conducted Emissions § 15.107, § 15.207 R…

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Test setup photos: Front view Rear view Above 1GHz Below 1Ghz