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Related Manuals for OrthoAccel Technologies AcceleDent Aura
Summary of Contents for OrthoAccel Technologies AcceleDent Aura
- Page 1 Direction for Use ® AcceleDent Aura OrthoAccel Technologies, Inc. ®...
- Page 2 OrthoAccel® is a registered trademark of OrthoAccel Technologies, Inc. AcceleDent is a registered trademark of OrthoAccel Technologies, Inc. AcceleDent Aura is covered by one or more of the following US patents: 6648639, 6832912, 7029276, and others pending. For orthodontic applications Direction for Use AcceleDent®...
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Page 3: Table Of Contents
Table of Contents Click to view each section 1.0 Introduction Thank you for choosing AcceleDent Aura About the Manufacturer Intended Use/Indications for Use and Contra indications Aura Components 2.0 Use Set Up and Charging the Unit Steps for Use and Use Schedule Travel Case FastTrac –... -
Page 4: Introduction
1.0 Introduction Thank you for choosing AcceleDent Aura Thank you for choosing AcceleDent Aura which works with your current orthodontic treatment to deliver a better experience from start to finish. AcceleDent Aura uses SoftPulse Technology® to help your current orthodontic treatment work faster. It does this by generating small vibrations called micropulses to gently accelerate the movement of your teeth as they are guided by your orthodontics. -
Page 5: Aura Components
Features and Components Activator Power Button and LED Indicator USB cover Mouthpiece Power Adapter USB Extension Cable Travel Case Direction for Use AcceleDent® Aura Back to Contents... -
Page 6: Use
FastTrac Usage Report. DO NOT USE THE ACCELEDENT AURA WHEN THE ACTIVATOR IS CHARGING OR WHEN IT IS CONNECTED TO A COMPUTER. If you have any questions before using AcceleDent Aura, please consult your orthodontist. Direction for Use AcceleDent® Aura... - Page 7 3. Place AcceleDent Aura in mouth and bite down gently. Biting lightly, with just enough force to hold the AcceleDent Aura in place, is ideal. It is not necessary to bite with excessive pressure. The AcceleDent Aura does not need to be held by hand...
- Page 8 5. Cleaning the mouthpiece. Your mouthpiece is made of medical grade, biocompatible materials and when used as directed, requires no special cleaning process. However, if desired the mouthpiece can be rinsed in tap water. When removing the mouthpiece from the Activator make sure to pull straight away from the device without applying a rocking motion.
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Page 9: Steps For Use And Use Schedule
Try to find a time that you can use AcceleDent Aura uninterrupted – it is best not to stop use in the middle of a session. It is fine to adjust the external unit with your hand occasionally. -
Page 10: Fasttrac Usage Report
To view the FastTrac Usage Report, insert the AcceleDent Aura into a USB port on the host computer. The AcceleDent Aura will register as if it were a FLASH drive. The user will need to navigate to that drive as they would for any other FLASH drive. - Page 11 Trac report. The time and date will date will be updated. be updated. The AcceleDent Aura will read the date and time from the time stamp provided by the host PC operating system. No files will be saved on the device.
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Page 12: Care
Use a soft cloth to wipe the external and internal surfaces of the travel case. Note: Do not clean any of the AcceleDent Aura components or accessories in a dishwasher. Simple hand-cleaning is sufficient to remove accumulation of dirt or other build-up. -
Page 13: Disposal
The internet can be a helpful tool to locate the nearest recycling center for batteries and electrical devices or contact OrthoAccel Technologies, Inc. at +1.866.866-4919 (North America) or +44 (0) 203.318.1915 (outside North America) or customerservice@orthoaccel. -
Page 14: Safety
Discontinue use of this product and immediately contact your orthodontist if any discomfort or pain is experienced. AcceleDent Aura is a prescription device for a single patient. Sharing the appliance and/or Mouthpiece is prohibited. The appliance has been fitted for your use and based on your orthodontic case and treatment. As with many medical devices, use by an individual without the proper issuance from an orthodontist can result in unintended consequences. -
Page 15: Precautions
Do not use components, accessories, or attachments other than those recommended by the manufacturer. DO NOT clean any component or accessory of AcceleDent Aura in the dishwasher. Radiofrequency energy (RF) from cell phones and other sources of electromagnetic energy such as hand held radio transceivers can interfere with normal operation of the Activator. -
Page 16: Help
Customer Care Center in your country (visit www.acceledent.com for contact information). If you need immediate assistance please contact the OrthoAccel Technologies Customer Service Center: North America: +1 866.866.4919 Outside North America: +44 (0) 203.318.1915 Email: customerservice@orthoaccel.com... -
Page 17: Warranties
Why doesn’t the Activator work? You may need to charge AcceleDent Aura. Charge the Activator overnight by connecting it to the Power Adaptor. The Activator is properly charging when it is plugged into the Power Adapter and the LED Indicator is slowly flashing orange. - Page 18 Your exclusive remedy for breach of this limited warranty during the Warranty Period shall be, at the option of OrthoAccel the repair or replacement of the Product (with new or comparable rebuilt parts) or a new or refurbished Product, as determined by OrthoAccel. Warranty repair or replacement shall not extend the original Warranty Period.
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Page 19: Faqs
Q. How Does AcceleDent Aura Work? A. By inserting the Mouthpiece – fitted around your existing orthodontics – and turning on the Activator for 20 minutes every day, AcceleDent Aura can speed up tooth movement by using SoftPulse Technology®. Faster tooth movement may decrease the duration of your orthodontic treatment –... - Page 20 I turn my AcceleDent Aura back on, does it remember how long I used it? A. Yes. AcceleDent Aura will remember how long you used it as long as the interruption does not exceed 5 minutes. After 5 minutes of being turned off, AcceleDent Aura will work for a full session of 20 minutes at its next use.
- Page 21 Q. Can I sanitize my AcceleDent Aura and share it with a friend or family member who also has braces? A. No. AcceleDent Aura is an FDA cleared, single-use prescription device. Sharing the AcceleDent Aura and/or the Mouthpiece is prohibited.
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Page 22: Technical Description
Technical Description The following is a technical description for the AcceleDent Aura. This information is intended to provide environmental operating conditions, transport/storage conditions, as well as IEC 60601 equipment ratings, and electrical safety classification for the included equipment. Conditions should fall between the ranges detailed below. -
Page 23: Environmental Specifications
Environmental Specifications Electromagnetic Requirements. The Activator complies with all applicable and required standards for electromagnetic compatibility. • It can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity. •... - Page 24 Electromagnetic Immunity – Part 1 The Activator is intended for use in the electromagnetic environment specified below. The customer or the user of the Activator should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic Immunity Test environment-guidance Test Level Level...
- Page 25 Electromagnetic Immunity – Part 2 The Activator is intended for use in the electromagnetic environment specified below. The customer or the user of the Activator should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level environment-guidance...
- Page 26 Recommended Separation Distance The Activator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Activator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Activator as recommended below, according to the maximum output power of the communications equipment.
- Page 27 OrthoAccel Technologies, Inc., 6575 West Loop South, Suite 200, Bellaire, TX 77401. North America: +1 866.866.4919 / Outside North America: +44 (0) 203.318.1915 www.orthoaccel.com. Made in the USA EMERGO EUROPE Molenstraat 15, 2513 BH, The Hague, The Netherlands Phone: +31.70.345.8570 / Fax: +31.70.346.7299...
- Page 28 acceledent.com Back to Contents...
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