OrthoAccel Technologies AcceleDent Aura Manual

Direction for Use
AcceleDent®Aura
OrthoAccel®Technologies, Inc.

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Direction for Use AcceleDent® Aura Back to Contents
405-0409-001D, L67000
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

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1.0 Introduction Thank you for choosing AcceleDent Aura
About the Manufacturer
Intended Use/Indications for Use
and Contra indications
Aura Components
4
4
4
5
2.0 Use Set Up and Charging the Unit
Steps for Use and Use Schedule
Travel Case
FastTrac – Usage Report
6
9
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10
3.0 Care Cleaning
Storage
Replacement
Disposal
12
12
12
13
4.0 Safety Voltage
Water
Warnings
Precautions
14
14
14
15
5.0 Help Customer Service
Troubleshooting
Warranties
FAQs
Technical Description
Environmental Specications
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16
17
19
22
23
Table of Contents Click to view each section

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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 nish.
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.
About the Manufacturer
Contact the manufacturer - OrthoAccel Technologies, Inc. - about any
questions or concerns that are specically related to AcceleDent Aura and
its components.
Customer Service Information
For assistance, contact the OrthoAccel Customer Service Center:
North America: +1 866.866.4919
Outside North America: +44 (0) 203.318.1915
Email: [email protected]
Online: www.acceledent.com
Intended Use/Indications for Use
AcceleDent Aura is an orthodontic accessory intended for use during
orthodontic treatment. It is used in conjunction with orthodontic appliances
such as braces and helps facilitate minor anterior tooth movement.
Contra indications for Use
• Use of osteoporosis drugs
• Poor oral hygiene
• Periodontal disease that is not under full control for at least 3-4
months prior to the start of treatment.
1.0 Introduction

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Features and Components
1Activator
APower Button and LED Indicator
BUSB cover
2Mouthpiece
3Power Adapter
4USB Extension Cable
5Travel Case

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Set Up and Charging the Unit
Fully charge the Activator prior to initial use by charging it overnight.
The Activator is properly charging when it is plugged into the Power
Adapter and the LED indicator is slowly ashing orange. Based on the
recommended 20 minute daily usage, the activator should be recharged
approximately 3 days for a minimum of 2 hours or when the LED indicator
is quickly ashing orange. Do not let the battery completely discharge as
this may aect the data reporting of the 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.
2.0 Use

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1.Insert Mouthpiece into Activator.
Ensure the Mouthpiece and Activator
are pressed rmly together with no
space in between. 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.
2. Turn the Activator “ON”
Press the Power Button one time and
the Activator will begin to gently pulse.
The LED indicator will be solid green
when device is on.
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
once placed inside the mouth and held
by the bite, although the hands can be
used to adjust the position throughout
the session as needed. You will be
more comfortable if you relax the jaw
and facial muscles, while maintaining
enough force to stabilize the Mouthpiece.
4. Complete 20-minute session.
Simply keep the AcceleDent Aura in
place while it is powered on. The Half-
Time indicator will pulse 3 times at the
10-minute mark. If the appliance needs to
be shut o or paused during use, simply
press the Power Button on the Activator.
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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. ONLY RINSE THE MOUTHPIECE
WHEN IT IS DETACHED FROM THE
ACTIVATOR. The activator is not moisture
resistant and should not be exposed
to water or high humidity. See the care
section for details.
6. Charging the Activator.
When the LED indicator is quickly
ashing orange, indicating a low battery,
the Activator should be charged for a
minimum of 2 hours. The Activator is
properly charging when it is plugged into
the Power Adapter and the LED Indicator is
slowly ashing orange and then changes
to solid green. The Activator may also be
charged by plugging the USB Extension
Cable into a computer’s USB port.
Note: OrthoAccel recommends bringing your AcceleDent
Aura to each orthodontist appointment so that your usage
can be checked.

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Use Schedule
Use AcceleDent Aura for twenty minutes per day hands-free and
the small vibrations, or micropulses will help your teeth respond to
orthodontic treatment more quickly.
Select a consistent time for use each day. This way, it becomes a
routine and you are less likely to forget. Try to nd a time that you can
use AcceleDent Aura uninterrupted – it is best not to stop use in the
middle of a session. It is ne to adjust the external unit with your hand
occasionally.
Some patients prefer using AcceleDent Aura just after they wake up
and brush their teeth in the morning. Others use the appliance while
engaged in a consistent daily activity, such as reading or watching
TV. Try several approaches and decide on the approach that works
best for you. Plug the USB into the computer to upload and view the
FastTrac.htm usage report. Refer to the “FastTrac” section for further
details.
You may easily pause and resume use if you are interrupted during a
session. To pause, press the Power Button on the Activator. When you
are ready to resume, press it again to unpause. 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 o, AcceleDent Aura
will operate for a full session of 20 minutes at its next use.
AcceleDent Aura features a Half-Time Indicator, which will pulse 3 times
at the 10-minute mark to signal that ten minutes has elapsed.
The Activator is not moisture resistant and should not be exposed
to water or high humidity. The Mouthpiece is waterproof and may be
cleaned under running water after rst being disconnected from the
Activator.
No component of AcceleDent Aura is dishwasher safe. Hand-clean only.
Travel Case
The Travel Case serves two purposes:
1) As a convenient carrying case for patients who use
AcceleDent Aura daily in locations away from home.
2) To securely store the Activator, Mouthpiece, Power Adapter and
USB Extension Cord.

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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.
For Windows
The default Windows conguration will ask how the drive is to be
opened. Open it as a folder. If the folder does not open, go to My
Computer and select ACCELEDENT drive.
For Mac
“MAC OS will display a drive icon on the screen.
When the les on the ACCELEDENT drive are displayed double click on
the FastTrac.html le. The le will open in the default browser. This is
the FastTrac usage report for Internet Explorer only. Accept “Enable
Active X controls”. The data table is always displayed.
(1) The AcceleDent Usage Summary
(2) The AcceleDent Daily Usage Graph
(3) The AcceleDent Daily Usage Table
The AcceleDent Usage Summary summarizes the Total Number of
Days in Treatment, Total Minutes Used, Average Use (Minutes/Day),
Overall Usage, Device Time, and Battery Depletion Count. When the
battery had been fully drained the overall usage percentage may be
inaccurate. If this occurs, please reset the device and date.
The AcceleDent Daily Usage Graph shows the usage percentage by
date. Drag the cursor over the graph to view Daily %, Prior 30 Day %,
Total Number of Sessions, and Total Number of Minutes for any specic
treatment date.
The AcceleDent Daily Usage Table details Daily %, Prior 30 Day %, Total
Number of Sessions and Total Number of Minutes of use per session.
This area of the report indicates the summary of each session by date.
You must use the “Safely Remove Hardware” feature in Windows or the
“Eject Drive” feature in MAC OS before removing the device from the
Host PC; otherwise error messages may appear on the host PC. This is
standard operation for any FLASH drive.
Note: The AcceleDent Aura will not be damaged if it is removed from
the host PC properly.

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To Reset Device Clock:
Follow directions in previous section (FastTrac Usage Report for
Windows or for MAC) to access ACCELEDENT drive and the FastTrac.
htm le is visible.
For Google Chrome, Firefox,
Internet Explorer.
For Safari
Click on FastTrac.htm to open le
in the browser.
Click on FastTrac.htm le to open
le in the Safari browser.
On the keyboard press “Ctrl+S”
to save the le.
Select “File” menu.
Verify location to save le is
ACCELEDENT drive.
Verify in “Where” that ACCELEDENT
device is selected.
Verify the "Save as type" is
Text les (.txt, .text). For Google
Chrome choose "Webpage,
Complete".
Verify the “Format”selected is
“Page Source”.
Next, Save the le by typing the
le name “SETCLOCK.txt”
Save the le in”Export As” as the
le name “SETCLOCK.htm”
Select “Save” button. Select “Save” button.
Close FastTrac Report and
safely eject Activator from host
computer.
Close FastTrac Report and safely
eject Activator from host com-
puter.
Plug the activator back into the
host computer and open the
FastTrac report. The time and
date will be updated.
Plug the activator back into the
host computer and open the Fast-
Trac report. The time and date will
be updated.
The AcceleDent Aura will read the date and time from the time stamp
provided by the host PC operating system. No les will be saved on the
device.

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Cleaning
Remove the Mouthpiece from the Activator by gently pulling the two
components apart from one another to disconnect. This should not require
signicant force and no rocking motion should be used.
Use a soft cloth to wipe down all surfaces of the Activator. Avoid inserting
anything into the recess that receives the Mouthpiece.
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 sucient to remove accumulation
of dirt or other build-up.
Storage
Unplug the Activator from the USB extension cable or wall mount power
supply, clean and store it in a cool, dry place away from direct sunlight.
The Activator and attached Mouthpiece can also be stored in the Travel
Case designed to allow for safe storage. The Travel Case contains storage
cavities for the Activator and Mouthpiece, USB Extension Cord, and Power
Adapter. Avoid storing the Activator and Mouthpiece in areas where they
may be exposed to extreme temperatures.
Replacement
The Mouthpiece is the only component of AcceleDent Aura that may require
replacement during the course of your treatment. Periodically, the Mouthpiece
may become worn or torn from routine daily use. Throughout the course
of your treatment, your bite pattern may change and an alternate sized
mouthpiece may be required. If you have any questions about whether or not a
replacement Mouthpiece needs to be issued, ask your orthodontist. Generally,
evidence of bite marks does not indicate that the Mouthpiece needs to be
replaced, although it may indicate that too much bite force is being exerted
during use. If any surface of the hard inner core of the Mouthpiece is exposed
it should not be used and should be replaced immediately. As your orthodontic
treatment progresses, your orthodontist may issue you a new Mouthpiece
based on the progress of your tooth realignment. Dierent Mouthpiece forms
exist for dierent and specic stages of your treatment. You may be retted
and issued a new Mouthpiece even if your current one does not appear to be
damaged in any way.
3.0 Care

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Disposal
The Mouthpiece and Travel Case can be disposed of with normal household
waste. The rechargeable battery inside of your Activator cannot be replaced.
In order to protect and preserve our environment, the Activator should
be disposed of at a designated collection facility for batteries and other
electrical devices like cell phones, computers, video games and electronic
tools. The crossed out wheeled trash can symbol, which appears on the
product packaging and labeling, indicates that separated collection is
required for the recycling of electrical and electronic equipment.
These designated collection facilities are free of charge to the consumer
because OrthoAccel and its distributors have acquired the appropriate
registrations. The separated collection of electronic equipment waste allows
for proper recycling, saves energy and resources and prevents hazardous
material from going to a landll. 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.
com for assistance.

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Voltage
Caution, to reduce the risk of electrocution or re, DO NOT plug the power
adapter into an outlet with a voltage other than that specied on the AC
adapter plug. This product is designed to operate within a range of 100
- 240 volts. Voltage converters DO NOT guarantee voltage compatibility.
Never force the plug into an outlet; if it does not easily t into the outlet,
discontinue attempts to force the plug.
Water
Caution, do not place or store the Power Adapter or Activator where it can
fall or be pulled into a bathtub, sink, or toilet. DO NOT reach for an Activator
that has fallen into water. Unplug immediately.
Warnings
To reduce the risk of burns, electrocution, re, or injury:
Discontinue use if this product appears damaged in any way (Activator, Mouthpiece,
Power Adapter, USB Extension Cord). This product contains no serviceable parts.
Refer to the section in this manual titled “Customer Service” if your AcceleDent
Aura or any of its components no longer works properly or needs repair.
NEVER charge your device using an unauthorized AC adapter plug as it
may cause permanent damage to your device.
Never use the USB Extension Cord if it has a damaged cord or plug. Keep
away from heated surfaces. Avoid using a Mouthpiece that is damaged,
particularly if it is crushed or bent. Torn edges may break o while in use.
Consult your orthodontist if the Mouthpiece no longer ts comfortably
for any reason. Inappropriate cleaning may also cause damage to the
Mouthpiece (see “Care” section).
This product is designed to enhance your orthodontic treatmentonly.
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 Aura is a prescription device for a single patient. Sharing the
appliance and/or Mouthpiece is prohibited. The appliance has been tted
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.
4.0 Safety

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In addition, use of the appliance by more than one person may result in
the transmission of viral and bacterial infective agents, even if an eort
has been made to sanitize it.
This appliance is not intended for use by persons (including children) with
reduced physical, sensory, or mental capabilities unless they have been
given supervision or instruction concerning use by a person responsible
for their safety, or unless otherwise indicated by an orthodontist. Do not
use the appliance while performing tasks that require full attention, such
as driving or operating heavy machinery.
Do not play with the appliance or use it for any purpose aside from its
intended use as described in this manual.
AcceleDent Aura is a treatment-specic appliance, and none of its components
or accessories, alone or in combination, is intended for use by more than
a single patient in any setting. 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. If the Activator exhibits erratic
operation make sure it is not in close proximity to a cell phone or any other
device suspected of emitting radiofrequency energy.
Never incinerate the Activator, as its battery may explode.
CAUTION: Never put batteries in mouth. If swallowed, contact your
physician or local poison control center.
CAUTION: DO NOT Open, crush, disassemble, heat above 150 ºC, incinerate,
short circuit, or any similar action to the battery. Mishandling the battery
may cause burns, re, or explosion.
Precautions
Consult your orthodontist prior to use of this product if you have had any
recent craniofacial surgery (above the neck). Contact your orthodontist
if any bleeding, discomfort, or pain occurs after the initial use of
AcceleDent Aura. AcceleDent Aura meets the required electrical safety
and emissions standards; however the appliance has not been tested
for eects on any other specic medical devices (such as pacemakers,
cochlear implants, nerve stimulators). Please contact the other device
manufacturers with any questions or concerns about eects on their
devices. AcceleDent Aura has been tested and is in compliance with
safety standards for electromechanical devices.
Call your physician or orthodontist if you have any medical concerns
about AcceleDent Aura.

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Customer Service
If you have any questions or comments after reading the enclosed
materials (this Directions for Use manual), please contact the
OrthoAccel Technologies Customer Service Center:
North America: +1 866.866.4919
Outside North America: +44 (0) 203.318.1915
Email: [email protected]
Online: www.acceledent.com
Troubleshooting
Thissectionlistsseveralofthemorecommonlyobservedtroubleshooting
situations. If you cannot nd the answer to your question here, or if the
situation you are experiencing is not addressed here, please contact the
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: [email protected]
Online: www.acceledent.com
5.0 Help

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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 ashing orange.
I charged my Activator according to the instructions and the appliance
is still not working.
Check to conrm that the power adapter and USB cord are plugged
in appropriately. The electrical outlet must be live. The Activator must
be connected to the USB extension cord or directly to the wall mount
power supply. The Activator is properly charging when it is plugged into
the Power Adapter and the LED Indicator is slowly ashing orange.
My appliance would not charge while I was traveling internationally,
but it charges just ne when I am at home.
The Power Adapter and USB cable can be used with common worldwide
voltages between 100 - 240V AC, at either 50 or 60 Hz.
A simple plug adapter, appropriate for that country, is all that is required.
EXPRESS LIMITED WARRANTY
OrthoAccel Technologies Inc. (“OrthoAccel”) warrants that the product
packaged with this warranty (the “Product”) will be free from signicant
defects in materials and workmanship under normal use and service for
a period of one year from the date of purchase (the “Warranty Period”).
This limited warranty is non-transferrable and applies only to the original
purchaser and his or her initial dental patient using the Product. This limited
warranty also applies only when the Product is used in accordance with the
Product manual and directions for use packaged with this Product.
This limited warranty covers all defects encountered in normal use and
service but does not apply if: (1) the Product is modied or tampered with or
disassembled, (2) the Product is damaged by an Act of God, misuse, abuse,
neglect, accident or mishandling, (3) the Product is not used or maintained
in accordance with the accompanying user documents, (4) the Product is
repaired by someone other than an authorized service center, or (5) the
serial number on the Product is defaced, altered or removed. In addition,
this limited warranty does not cover normal wear such as discoloration or
fading, and normal wear that does not compromise use of the appliance
such as chips, scratches, and abrasions.

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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.
All returns for warranty service will require an RMA (Return Merchandise
Authorization). To receive an RMA for obtaining warranty services, you must
call +1 866.866.4919 if in North America or +44 (0) 203.318.1915 if outside
of North America. In addition, if your product has not been registered you
must submit proof of the date of original purchase such as a copy of your
dated invoice and must 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 implied.
Without limiting the generality of the foregoing, orthoaccel disclaims any
and all other warranties, express or implied, with respect to the product
including its condition, the existence of any latent or patent defects, its
non-infringement of third party rights and its merchantability or tness for
any particular use. In no event shall orthoaccel or any of its aliated or
subsidiary companies be liable for any special, incidental, or consequential
damages based upon breach of warranty, breach of contract, negligence,
tort, or any other legal theory. Such damages include, without limitation,
loss of savings or revenue; loss of prot; loss of use; the claims of third
parties including, without limitation, dental professionals; and cost of any
substitute equipment or services.
LEGAL LIMITATIONS
Some jurisdictions do not permit or allow limitations on how long implied
warranties last or the exclusion or limitation of incidental or consequential
damages. If any terms of this limited warranty, including, without limitation,
the exclusion of damages, are limited or prohibited by your jurisdiction,
the prohibited provision shall not apply but the remainder of this limited
warranty shall remain in full force and eect. You may have rights in
addition to this limited warranty under the laws of your jurisdiction, which
may vary from jurisdiction to jurisdiction.

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FAQs
Q. How Does AcceleDent Aura Work?
A. By inserting the Mouthpiece – tted 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 – and
can even help to make your orthodontics more comfortable.
Q. Is AcceleDent Aura safe?
A. Yes. AcceleDent with SoftPulse Technology® has been proven safe in
several clinical trials.
Q. How is the orthodontic treatment accelerated?
A. Your braces work on their own by moving your teeth in specic
directions. AcceleDent Aura uses SoftPulse Technology® to generate small
vibrations – micropulses – enhancing the movements directed by your
braces allowing for faster overall treatment.
Q. How do I know if I am biting into the Mouthpiece correctly and with
the right amount of force?
A. Bite pressure on the Mouthpiece should be just rm enough to hold your
AcceleDent Aura in place without using your hands. Avoid biting forcibly
into the Mouthpiece as that may cause excessive wear.
Q. Can I try to wear AcceleDent Aura while I am sleeping?
A. No. It is not recommended that AcceleDent Aura be used while sleeping.
Q. Can I wear my AcceleDent Aura when it is charging or connected
to a computer?
A. No, do not wear your AcceleDent Aura when it is charging or
connected to a computer.
Q. Do I have to do the full 20 minute treatment at one time?
A. Yes. It is recommended that you use your AcceleDent Aura for a
continuous 20 minute period each day.

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Q. If I absolutely have to interrupt the 20 minute session for a few
minutes, when 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 o, AcceleDent Aura will work for a full session of 20 minutes
at its next use.
Q. If I use AcceleDent Aura for more than the recommended 20 minute
treatment time, does it add incremental benet?
A. No. Additional daily use greater than the prescribed 20 minutes
duration is not recommended.
Q. How often does AcceleDent Aura need to be recharged?
A. Based on the recommended 20 minute daily usage the Activator
should be recharged approximately every 3 days for a minimum of 2
hours or when the LED indicator is quickly ashing orange.
Q: Why does the device vibrate for a few seconds when rst turned on
and then stop, even though the LED indicator is solid green?
A: If the device turns on for a few seconds and then turns o, it is time
to charge the device. There is not enough battery power to run a full 20
minute session.
Q. What is the best way to clean AcceleDent Aura?
A. The Mouthpiece should rst be disconnected from the Activator and then
rinsed well with lukewarm water after each use. You may occasionally use
a soft liquid dishwashing detergent, a mild soap, or toothpaste to gently
brush the Mouthpiece. The Activator can be wiped with a soft cloth as
necessary. It is recommended that you allow your AcceleDent to air dry
before being stored in the Travel Case. Do not place the Mouthpiece or the
Activator in a dishwasher as this will void the warranty and could cause
damage to the product.
Q. Can I use my AcceleDent Aura in the shower?
A. No. AcceleDent Aura is not water-resistant and should not be used
in the shower
Q. Is my AcceleDent Aura under warranty?
A. Yes, the details of the warranty can be found in this manual.