Summary of Contents for OrthoAccel Technologies AcceleDent
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Directions for Use ™ FAST TRACK TO STRAIGHT TEETH Introduction...
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OrthoAccel® is a registered trademark of Ortho- Accel Technologies, Inc. ® AcceleDent ™ is a trademark of OrthoAccel Technologies, Inc. ® AcceleDent is covered by one or more of the following US patents: 6648639, 6832912, 7029276, and others pending. Rx only...
Table of Contents 1.0 Introduction Thank You for Choosing AcceleDent Talk with Your Orthodontist About the Manufacturer Intended Use/Indications for Use and Contraindications AcceleDent Components 2.0 Use Set-up and Charging the Unit Steps for Use and Use Schedule Charging Port Travel Shell 3.0 Care...
1.0 Introduction Talk with Your Orthodontist About the Manufacturer Intended Use, Indications for Use and Contraindications 10 AcceleDent Components...
Talk with Your Orthodontist Your orthodontist is your best resource for information about your care and AcceleDent. If you need assistance with any aspect of your orthodontic care, ask your orthodontist. Or- thoAccel is not authorized to make any repre-...
About the Manufacturer Talk with the manufacturer – OrthoAccel Tech- nologies, Inc. - about any questions or concerns that are specifi cally related to AcceleDent and its components. Customer Service Information For assistance, contact the OrthoAccel Custom- er Service Center: North America: +1 832.631.1660...
Intended Use/Indications for Use AcceleDent is an orthodontic accessory in- tended for use during orthodontic treatment. It is used in conjunction with orthodontic appli- ances such as braces and helps facilitate minor anterior tooth movement. Contraindications for Use • Use of osteoporosis drugs •...
AcceleDent Components Activator Power Button Battery Gauge Mouthpiece Charging Port SmartDisplay (See Charging Port section for complete display information) Display Button Power Source Travel Shell...
Although it takes several hours to fully charge a discharged Activator, most of the charge occurs within the fi rst hour. The battery life is approxi- mately 2.5 years. If you have any questions about beginning your use of AcceleDent, ask your orthodontist.
Steps for Use 1. Insert Mouthpiece into Activator. Make sure these two components are properly at- tached. Two small recessed slots on the end of the Mouthpiece guide the connection with the correct side of the Mouthpiece facing up. A very light tug on the Mouthpiece should not cause disconnection from the Activator.
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3. Place appliance in mouth and bite down. Biting lightly, with just enough force to hold the appliance in place, is ideal. It is not necessary to bite with excessive pressure. The appliance does not need to be held by hand once placed inside the mouth and held by the bite, although the hands can be used to adjust the position throughout the session...
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Steps for Use (cont’d) 4. Complete 20-minute session. Simply keep the appliance in place while it is pulsing. The HalfTime indicator will “stutter” at the 10-min- ute mark. If the appliance needs to be shut off or paused during use, simply press the button on the Activator in the same manner used when turning the appliance on.
6. Dock Activator. When a session is com- plete, the Activator can be re-docked on the Charging Port. Please note that the Activator must be enclosed within the Travel Shell in order to dock on the Charging Port. To properly dock the Travel Shell for charging, engage the Mouthpiece end into the Charging Port and then gently push downward.
Note: OrthoAccel recommends bringing your AcceleDent to each orthodontist appointment so that your appliance and usage can be checked. Use Schedule Use AccceleDent for twenty minutes per day and experience gentle pulsing to the teeth that will help your teeth respond to orthodontic treatment more quickly.
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The appliance will maintain memory toward the twenty-minute total use duration as long as the interruption does not exceed fi ve minutes. After fi ve minutes, re-starting AcceleDent will result in a new twenty-minute session. AcceleDent features a HalfTime Indicator, dur-...
Charging Port Use the Charging Port for best results from AcceleDent. Each time you dock your Activator, usage information is loaded to the Charging Port. This may be recorded and provided to your orthodontist. Your orthodontist may ask you to provide information about duration of use or number of uses, and all is readily avail- able from your SmartDisplay.
releasing the power button. Once fully charged the appliance will continue to work without further recharging for approximately fi ve days. It is not necessary to attach the Mouthpiece in order to dock the Activator, but the Activator must be enclosed in the Travel Shell to properly dock the Activator.
Charging Port (cont’d) The Travel Shell and Mouthpiece are both waterproof. None of the system components are dishwasher-safe. See related details in the warranty. There are no self-service parts in the Charging Port. Removing the cover will void the warran- ty and presents an electrical shock hazard.
The fi rst information window, the Welcome Screen, is displayed when the Charging Port is turned on. You will see “Visit www.acceledent. com” The second window is the “Last Week” data area. This area indicates the number of days that Ac- celeDent was used during the last 7 days.
AcceleDent. Note: For all information windows related to use, a standard treatment session involves using AcceleDent for the full intended twenty minutes. Therefore, when counting daily use sessions, if the appliance is used for less than ten minutes, no treatment usage is registered. If the appliance...
Travel Shell The Travel Shell serves two purposes. First, it is a convenient carrying case for patients who use AcceleDent daily in locations away from home. Second, it serves as an enclosure for docking the Activator on the Charging Port.
Cleaning Remove the Mouthpiece from the Activator by gently pulling the two components away from one another to disconnect. This should not require signifi cant force. Use a damp cloth to wipe down all surfaces of the Activator. Avoid inserting anything into the recess that receives the Mouthpiece.
Cleaning (cont’d) suffi cient for regular, everyday cleaning. Periodically, the Mouthpiece can be further cleaned with a toothbrush and toothpaste. Always unplug the Charging Port before clean- ing. Use a damp cloth to wipe the external surfaces of the unit. Note: Do not clean any of the appliance com- ponents or accessories in a dishwasher.
Storage The Activator and attached Mouthpiece can be housed on the Charging Port at all times, but the Charging Port can also be stored when not in use. Unplug, clean and store it in a cool, dry place away from direct sunlight. The conve- nient cord wrap underneath the Charging Port is helpful.
Replacement The Mouthpiece is the only component of AcceleDent that is intended for replacement during the course of your treatment. Periodi- cally, the Mouthpiece may become worn or torn from routine daily use. If you have any questions about whether or not a replace- ment Mouthpiece needs to be issued, ask your orthodontist.
The internet can be a helpful tool to locate the nearest recycling center for batteries and electrical devices or contact OrthoAccel Technologies, Inc at +1 832.631.1660 (North America) or +44 (0) 203.318.1915 (outside North America) or customerservice@acceledent. com for assistance. Care...
Voltage Caution, to reduce the risk of electrocution or fi re, DO NOT plug the Charging Port into an outlet with a voltage other than that specifi ed on the AC adapter plug. This product is de- signed to operate within a range of 100 – 240 volts.
Use this product only for its intended use as described in this manual. Discontinue use of this product and immediately contact your orthodontist if any discomfort or pain is experienced. AcceleDent is a prescription appliance for a...
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Do not play with the appliance or use it for any purpose aside from its intended use as de- scribed in this manual. AcceleDent is a treatment-specifi c appliance and none of its components or accessories, alone or in combination, is intended for use by...
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Do not use components, accessories, or attach- ments other than those recommended by the manufacturer. Never incinerate the Activator, as its battery may explode. DO NOT clean any component or accessory of AcceleDent in the dishwasher.
Please contact the other device manufacturers with any questions or concerns about eff ects on their devices. AcceleDent has been tested and is in compli- ance with safety standards for electromechani- cal devices. Call your physician or orthodontist if you have any medical concerns about AcceleDent.
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If you have any questions or comments after reading the enclosed materials (this Directions for Use manual and the Quick-Start Reference Guide), please contact the OrthoAccel Tech- nologies Customer Service Center: North America: +1 832.631.1660 Outside North America: +44 (0) 203.318.1915 Email: customerservice@acceledent.com Online: www.acceledent.com Help...
203.318.1915 (outside North America) or customerservice@acceledent.com. Why doesn’t the Activator work? You may need to charge AcceleDent. Charge the Activator overnight by docking it on the Charging Port. Also confi rm that the Mouth- piece is inserted correctly into the Activator.
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docked to the Charging Port if the LED lights on the Activator cycle from dark to light and the SmartDisplay LCD viewing screen on the Charging Port can be advanced to the various information windows. Why does my appliance seem less powerful when I use it? You may get used to the pulsation and there- fore notice the vibration less over time.
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EXPRESS LIMITED WARRANTY OrthoAccel Technologies Inc. (“OrthoAccel”) warrants that the product packaged with this warranty (the “Product”) will be free from signifi cant defects in materials and work- manship under normal use and service for a period of two years from the date of purchase (the “Warranty Period”).
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insure, pack and ship the Product to an authorized service center in accordance with OrthoAccel’s instructions within 7 days after your receipt of an RMA. The packing must include your RMA. RMA’s will not be extended or reissued. NO IMPLIED WARRANTIES; LIMITATIONS ON DAMAGES THE EXPRESS LIMITED WARRANTY PROVIDED ABOVE IS THE ONLY EXPRESS WARRANTY MADE TO YOU AND IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IM-...
A safety review of panagraphic x-rays showed no indication of increased root resorption due to AcceleDent use and the number of patients with loose mini implants was equally distributed between the treatment and control groups.
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The AcceleDent System is designed to increase the rate of tooth movement in patients under- going treatment with a conventional fi xed orth- odontic appliance, which may reduce treatment time. The use of AcceleDent with other types of orthodontic appliances has not been studied. Help...
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AcceleDent. 5. Is AcceleDent safe? AcceleDent has a good safety profi le, as indicat- ed by a university study in humans and several animal studies. AcceleDent is considered safe under normal conditions of use with a conven- tional fi xed orthodontic appliance.
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9. What if the appliance is just turned “on” and then set down on the countertop for the required twenty minutes? The compliance information will be transferred to the Charging Port and it will appear that the appliance was used for a full session. However, there will be no clinical benefi t and so it is likely that an orthodontist will be able to determine non-compliance clinically.
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Additional daily use greater than the prescribed twenty-minute duration has not been evaluated and thus is not recommended. 13. What is the best way to clean AcceleDent? The Mouthpiece should be rinsed well with lukewarm water after each use. You may occa-...
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16. Can I try to wear AcceleDent while I am sleeping? It is not recommended that the appliance be used while sleeping.
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FAQ (cont’d) 19. It feels powerful - is there a lower-intensi- ty setting? The intensity cannot be reduced. The settings for the appliance have been preset and cannot be adjusted. 20. How often does the appliance need to be recharged? It is recommended that the appliance be placed on the Charging Port only when it needs to be recharged as indicated by the Battery Gauge on...
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You may experience a tingling sensation, similar to a vibrating toothbrush, when using Accele- Dent for the fi rst several times. This sensation will diminish as you become more accustomed to using the appliance . 25. Is the product under warranty? Yes, the details of the warranty can be found in this manual.
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Symbols Do not reuse Batch code Date of manufacture Caution, consult accompanying documents Manufacturer Lower limit of temperature Consult instructions for use Caution: Federal law restricts this Rx only device to sale by or on the order of a physician or dentist...
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Use by YYYY-MM-DD or YYYY-MM Serial number Authorized representative in the EC REP European Community Upper limit of temperature Temperature limitation Negative control CONTROL Separated collection for L00002 electrical and November 2011 electronic 405-0401-001A equipment Help...
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OrthoAccel Technologies, Inc. 8275 El Rio Street - Suite 100 Houston, TX 77054 USA North America: +1 832.631.1660 Outside North America: +44 (0) 203.318.1915 www.orthoaccel.com Made in the USA EMERGO EUROPE EC REP Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570...
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