BIOLUX RESEARCH OrthoPulse User Manual

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OrthoPulse

User Guide

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Summary of Contents for BIOLUX RESEARCH OrthoPulse

Page 1 Smile. OrthoPulse ® User Guide...
Page 3: Table Of Contents
Contents 1. Introduction 1.1 About OrthoPulse ® 1.2 Intended Use / Indications for Use 1.3 Contraindications for Use 2. How to Use 2.1 Steps and Schedule for Use 2.2 Charging 2.3 OrthoPulse ® 3. Care and Maintenance 3.1 Cleaning 3.2 Storage 3.3 Service Life...
Page 4 Inside Your OrthoPulse ®...
Page 5 Charging Case Quick Start Power Adaptor Micro USB Cord Ensure that all package contents are enclosed and that there is no visible damage. Power adaptor may be slightly different than that shown.
Page 7: Introduction
® OrthoPulse is an established device that uses ® prescription device. Do not use the OrthoPulse ® low levels of light energy to stimulate the bone appliance on multiple patients. Use by an individual surrounding the roots of your teeth which may without the proper issuance from an orthodontist reduce treatment time for braces or clear aligners.
Page 8 Subjects who were pregnant, enrolled in another change in Little’s Irregularity Index measurements study, had periodontally involved teeth, used in both groups to evaluate OrthoPulse® use with bisphosphonates during the study or had spaces fixed orthodontic appliances. Root resorption was between anterior teeth were excluded.
Page 9: Contraindications For Use
Several additional clinical studies were also to do your treatment. conducted with prototype and final OrthoPulse ® devices to supplement the clinical findings The status light guide is available on the bottom of...
Page 10: Charging
Apple App Store or Google Play Store and type complete two treatment sessions. When the “orthopulse” in the search field. Use the login device is fully charged, the status light will turn off credentials provided to you in the welcome email.
Page 11: Care And Maintenance
The device should last for 3. Care and Maintenance up to two years of continuous use if used with 3.1 Cleaning care. It is not necessary to clean OrthoPulse after ® The OrthoPulse device contains a lithium ®...
Page 12: Environmental Protection Disposal
Patented orthopulse.com/patents cable and power supply by delivering them to a designated collection point for the recycling of 4.3 Troubleshooting waste electrical and electronic equipment. Visit the FAQ section on the OrthoPulse website, ® available here: WARNING: Never incinerate OrthoPulse , expose ®...
Page 13 THEN BIOLUX’S AGGREGATE LIABILITY WILL ® Non-warranty work is charged at the minimum BE LIMITED TO AN AMOUNT EQUAL TO THE repair rate effective at the time the OrthoPulse PURCHASE PRICE PAID FOR THE ORTHOPULSE ® ® returned to Biolux. All repairs include a complete functional test using factory test fixtures.
Page 14: Safety
• OrthoPulse® is considered to be an applied part harmful interference to radio communications. according to the IEC 60601-1 3rd Ed. OrthoPulse®...
Page 15 To maintain electromagnetic compatibility (EMC) Canada - User Information within limits, the device must be used with the OrthoPulse® contains transmitter module IC ID: cables and accessories specified by Biolux. The use 11306A-ISP091201. of accessories or cables other than those specified...
Page 16: Electromagnetic Compatibility
This device includes a micro-USB cable with a maximum length of 4’ 4” or 132 centimeters. WARNING: Use of other accessories including power supplies and cables other than the ones provided by Biolux Research for this device may result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
Page 17 Test or Standards Test Method Description Results Measurement *Highest frequency generated by the device is 2.4GHz Emission Test Compliance Comments RF Emissions Group 1 This device uses RF energy CISPR 11 only for its internal functions. RF Emissions Class B This device is predominantly intended CISPR 11 for use in a HOME HEALTHCARE...
Page 18 Electromagnetic Immunity Immunity Test Standard/Test Method Test Levels Compliance Electrostatic Discharge IEC 61000-4-2 Air Discharge: ± 2, 4, Complies 8, 15 kV Contact Discharge: ± 8 kV Radiated RF IEC 61000-4-3 10V/m, 80% AM @ Complies 1kHz, 30MHz to 2.5GHz, Vertical and Horizontal Polarizations Immunity to Proximity...
Page 19: Power Adaptor Specification
United States Federal law and other national regulations restrict this device to sale by or on the order of a doctor. Biolux Research Ltd. cannot be held responsible for any damage or injury resulting from a failure to follow the directions in this user guide. Ensure that you are entirely familiar with the correct procedures...
Page 20 ATTENTION: Biolux Research (“we, ” “our, ” or “us”), collects, uses, and discloses information about you through • Use only as directed. OrthoPulse must be the OrthoPulse and the associated OrthoPulse ® ® ® used under the direction or supervision of an mobile application (the “OrthoPulse...
Page 21 App, and when providing you and your dental provider with ® an OrthoPulse syncs with the OrthoPulse App. information about your use of the OrthoPulse ® ® ® The information provided to us may include, but is operating the OrthoPulse System, including ®...
Page 22 Moreover, we are not responsible Privacy Policy. for the security of information you transmit to and from the OrthoPulse® System over networks In Connection with a Transaction: we may disclose that we do not control, including the Internet and...
Page 23 App. If you would like to do so, please authority in Austria. ® contact us at support@orthopulse.com. Biolux appointed Biolux Research GmbH, located in Vienna, Austria as their EU representative. Your California Privacy Rights You can reach Biolux Research GmbH:...
Page 24 Catalog Number Manufacturer Authorized representative in Date of manufacture the European Community Direct current General Caution Sign Class II Equipment Follow the instructions Refer to instruction manual Shipping and storage temperature range Keep Dry Type BF Applied Part Fragile, handle with care Humidity Limitation Federal law restricts this Separated collection for...
Page 25 Conforms to 93/42/EEC Medical Device Directive Certified by TUV 2797 for Europe © 2019 Biolux Research. All rights reserved. OrthoPulse and all other Biolux product names and slogans ® are trademarks and registered trademarks of Biolux Research. 382-003 Rev B...
Page 28 Questions? orthopulse.com...