Download Direction for Use

Direction for Use
AcceleDent® Aura
405-0415-001C, L87005
OrthoAccel® is a registered
405-0415-001
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
1.0 Introduction
Thank you for choosing AcceleDent Aura
AcceleDent Aura Features and Components
1 Activator
A Power Button and LED Indicator
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.
2 Mouthpiece
About the Manufacturer
5 Travel Case
Contact the manufacturer - OrthoAccel Technologies, Inc. about any questions or concerns that are specifically related to
AcceleDent Aura and its components.
B USB cover
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.
3 Power Adapter
1.Insert
Mouthpiece
into
Activator. Make sure these two
components
are
properly
attached. 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.
4 USB Extension Cable
Customer Service Information
For assistance, contact the OrthoAccel Customer Service Center:
1.0 Introduction
2.0 Use
3.0 Care
4.0 Safety
5.0 Help
Thank you for choosing AcceleDent Aura
About the Manufacturer
Intended Use/Indications for Use
and Contra indications
Aura Components
Set-Up and Charging the Unit
Steps for Use and Use Schedule
FastTrac – Usage Report
Travel Case
Cleaning
Storage
Replacement
Disposal
Voltage
Water
Warnings
Precautions
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
Contra indications for Use
2.0 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.
Set Up and Charging the Unit
Customer Service
Troubleshooting
Warranties
FAQs
Technical Description
Environmental Specifications
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, fire, 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 effects on any other specific
medical devices (such as pacemakers, cochlear implants, nerve
stimulators). Please contact the other device manufacturers
with any questions or concerns about effects 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.
5.0 Help
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
This section lists several of the more commonly observed
troubleshooting situations. If you cannot find 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:
2
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. Its affect on overall treatment time has
not been established. This is due to the many individual factors
that may impact orthodontic treatment. You are encouraged to
speak with your orthodontist to determine the impact this device
may have on your specific treatment plan.
North America: +1 866.866.4919
Outside North America: +44 (0) 203.318.1915
Email: [email protected]
Online: www.acceledent.com
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.
I charged my Activator according to the instructions and the
appliance is still not working.
Check to confirm 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 flashing orange.
My appliance would not charge while I was traveling
internationally, but it charges just fine 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 significant 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 modified 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
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 flashing
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 flashing orange. Do
not let the battery completely discharge as this may affect the data
reporting of the FastTrac Usage Report.
such as discoloration or fading, and normal wear that does not compromise use of
the appliance such as chips, scratches, and abrasions. 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 FITNESS FOR ANY PARTICULAR USE. IN NO EVENT SHALL
ORTHOACCEL OR ANY OF ITS AFFILIATED 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 PROFIT; 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 effect. You may have rights in addition to this limited
warranty under the laws of your jurisdiction, which may vary from jurisdiction to
jurisdiction.
4
2.Turn the Activator “ON.”
Press the Power Button 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
3
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
5
6
6
6
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 off or paused during
use, simply press the Power
Button on the Activator.
Use Schedule
FastTrac Usage Report
To Reset Device Clock:
inserting anything into the recess that receives the Mouthpiece.
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.
Follow directions in previous section (FastTrac Usage Report
for Windows or for MAC) to access ACCELEDENT drive and the
FastTrac.htm file is visible.
Use a soft cloth to wipe the external and internal surfaces of the
travel case.
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. ONLY
RINSE THE MOUTHPIECE WHEN
IT IS DETACHED FROM THE
ACTIVATOR. The activator is not
water resistant and should not
be exposed to running water or
submerged under water. See the
care section for details.
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.
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 configuration 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.
6.Charging the Activator. When
the LED indicator is quickly
flashing 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 flashing
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.
FAQs
Q. How Does AcceleDent Aura Work?
5
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 – 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. 6How is the orthodontic treatment accelerated?
A. Your braces work on their own by moving your teeth in specific
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 firm 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.
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 off, 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 benefit?
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 flashing orange.
Q: Why does the device vibrate for a few seconds when first 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 off, 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 first 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. 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. Your orthodontist prescribed AcceleDent Aura for
your use only based upon your unique orthodontic treatment plan.
Use of AcceleDent Aura without the supervision and direction of
an orthodontist may result in adverse unintended consequences.
Q. What type of battery does AcceleDent Aura contain?
A. The rechargeable battery in AcceleDent Aura is a medical grade
Lithium ion battery.
Q. What shall I do with my AcceleDent Aura once treatment
is finished?
A. You should dispose of your AcceleDent Aura as you would
with any other device with a rechargeable battery. Reference the
“Disposal” section of the Directions for Use manual for further
details.
Q. Is my AcceleDent Aura under warranty?
A. Yes, the details of the warranty can be found in this manual.
Q. What does it mean if my Activator stops working and the LED
Select a consistent time for use each day. This way, it becomes a
routine and you are less likely to forget. 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.
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 off, 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 water resistant and should not be exposed
to running water or submerged under water. The Mouthpiece is
waterproof and may be cleaned under running water after first
being disconnected from the Activator.
No component of AcceleDent Aura is dishwasher safe. Handclean 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.
When the files on the ACCELEDENT drive are displayed double
click on the FastTrac.html file. The file 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 specific treatment date.
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.
Warning: No modification of this equipment is allowed.
Environmental operating conditions:
Ambient temperature range 5° C - 40° C
Maximum temperature of any external component at
maximum ambient temperature: 46°C
Relative humidity range 15% - 93%
Atmospheric pressure range 700 hPa – 1060 hPa
Transport and Storage Conditions:
Minimum Ambient Temperature: - 20° C
Maximum Ambient Temperature: 60° C
Maximum Humidity: 93%
Type BF Applied Part
The power adapter technical information is detailed below.
Part Number: PSA05F-050Q
Output Voltage: 5V
Current Limit: 1 A
AC Input Voltage Range: 100-240 V
AC Input Frequency: 50 - 60 Hz
Protection Class: Class II Equipment
Verify the “Save as type”
(Windows) or “Format” (MAC) is
Text Files.
Next, Save the file by typing
the file name “SET CLOCK.txt”
Select “Save” button.
Close FastTrac Report and
safely eject Activator from host
computer.
Plug the activator back into the
host computer and open the
FastTrac report. The time and
date will be updated.
For Safari
Click on FastTrac.htm file to
open file in the Safari browser.
Select “File” menu.
Next, select “Save As”.
Verify in “Where” that
ACCELEDENT device is
selected.
Verify the “Format”selected is
“Page Source”.
Save the file in”Export As” as
the file name “SETCLOCK.htm”
Select “Save” button.
Close FastTrac Report and
safely eject Activator from host
computer.
Plug the activator back into the
host computer and open the
FastTrac report. The time and
date will be updated.
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.
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.
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.
Cleaning
Note: The AcceleDent Aura will not be damaged if it is removed
from the host PC properly.
Indicator is flashing alternating green and orange?
A. The Activator will deactivate after completing the equivalent
of 18 months of 20 minute daily sessions.
If you are in the middle of a treatment plan please contact your
orthodontist.
Q Why did the date change on my FastTrac Usage Report?
A. If your Activator battery is fully drained and the activator
shuts down (no flashing LED indicator or vibrations) the date on
the Usage report will reset to the factory default settings. The
battery has to be charged when the LED indicator is quickly
flashing orange. Refer to the FastTrac Usage Report section to
reset device clock. For Activators with completed sessions the
device clock will be reset to the date based on the last session
completed.
Technical Description
For Google Chrome, Firefox,
Internet Explorer, etc.
Click on FastTrac.htm to open file
in the browser.
Select “File” menu.
Next, select “Save Page As” for
Google Chrome and Firefox or
select “Save As” for Internet
Explorer.
Verify location to save file is
ACCELEDENT drive.
Activator “ON/OFF” button is a push-push buttonto turn
activator on and off.
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.
• Portable and mobile RF communications equipment can also
affect the Activator performance and care should be taken to
minimize such interference. However, there is no guarantee that
interference will not occur in a particular installation.
• It would be good practice to avoid using the activator in extremely
close proximity to other electronic equipment.
Electromagnetic Emissions
The Activator is intended for use in the electromagnetic environment
specified below. The customer or the user of the unit should assure
that it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
Compliance
Group 1
RF emissions
CISPR 11
Class B
Harmonic
emissions
IEC 61000-3-2
Not Applicable
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Not Applicable
Electromagnetic
environment-guidance
The Activator uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
The Activator is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
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.
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. Different Mouthpiece forms
exist for different and specific stages of your treatment. You may
be refitted and issued a new Mouthpiece even if your current one
does not appear to be damaged in any way.
Disposal
3.0 Care
The Mouthpiece and Travel Case can be disposed of with normal
household waste. The rechargeable battery inside of your
Activator cannot be replaced.
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 landfill.
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.
4.0 Safety
Voltage
Caution, to reduce the risk of electrocution or fire, DO NOT plug the
power adapter into an outlet with a voltage other than that specified
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 fit 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, fire, 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.
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
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 off while in use. Consult your orthodontist if the Mouthpiece
no longer fits comfortably for any reason. Inappropriate cleaning
Electromagnetic Immunity – Part 1
Electromagnetic Immunity – Part 2
Recommended Separation Distance
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.
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.
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.
Remove the Mouthpiece from the Activator by gently pulling the
two components apart from one another to disconnect. This should
not require significant force.
Use a soft cloth to wipe down all surfaces of the Activator. Avoid
Immunity Test
IEC 60601
Test Level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Compliance
Level
Electromagnetic
environment-guidance
± 6 kV contact Floors should be wood,
or ceramic tile. If
± 8 kV air concrete,
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Not Applicable
Not Applicable
Electrical fast
± 2 kV
transient/burst for power supply
lines
IEC 61000-4-4
± 1 kV
for input/output
lines
Not Applicable
Not Applicable
Surge
± 1 kV
IEC 61000-4-5 line(s) to line(s)
± 2 kV
line(s) to earth
<5 % UT
Not Applicable
Not Applicable
Voltage dips,
(>95 % dip in UT)
short
for
0,5
cycle
interruptions
40 % UT
and voltage
(60 % dip in UT)
variations on
for 5 cycles
power supply
70 % UT
input lines
(30 % dip in U )
IEC 61000-4-11 for 25 cyclesT
<5 % UT
(>95 % dip in UT)
for 5 s
Power frequency magnetic
Power frequency
3 Alm
3 Alm
fields should be at levels
(50/60 Hz)
characteristic of a typical
magnetic field
location in a typical
IEC 61000-4-8
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
IEC 60601 Compliance
Immunity Test Test
Level
Level
3 Vrms
150 kHz
to 80 MHz
Radiated RF IEC 3 V/m
61000-4-3
80 MHz
to 2.5 GHz
Conducted RF
IEC 61000-4-6
Electromagnetic
environment-guidance
Not
Applicable
Not Applicable
3 V/m
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,' should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Electromagnetic environment-guidance: Portable and mobile RF communications equipment
should be used no closer to any part of the Activator, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of the transmitter.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Activator is used exceeds the applicable RF compliance level
above, the Activator should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Activator.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Rated maximum
output power of
transmitter W
may also cause damage to the Mouthpiece (see “Care” section).
This product is designed to enhance your orthodontic treatment
only. 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 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. 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 effort 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-specific 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.
CAUTION: AcceleDent Aura is a prescription-only, medical device
and should be handled with care. Please note that repeatedly
pressing the Activator butting (on/off) very quickly may permanently damage the device and voice your warranty. Please refer to
the Direction for Use before using AcceleDent Aura.
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
Separation distance according to
frequency of transmitter m
Australia Representative
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P
d = 1.2 √P
d = 2.3 √P
EMERGO AUSTRALIA
201 Sussex Street, Darling Park, Tower II, Level 20, Sydney,
NSW, 2000, Australia
Phone: + 61 (0) 2.9006.1662 / Fax: +61 (0) 2.9006.1010
0.01
0.12
0.12
0.23
405-0415-001C, L87005
0.1
0.38
0.38
0.73
Batch code
1
12
1.2
2.3
Date of
manufacture
10
3.8
3.8
7.3
Manufacturer
23
Lower limit of
temperature
100
12
12
For transmitters rated a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Follow
Instructions
for Use
Refer to
Instruction
Manual
Caution: Federal law restricts
this device to sale by or on the
order of a physician.
Class II
Equipment
Use by
YYYY-MM-DD
Separated
collection for
electrical and
electronic
equipment
Reference
Catalog number
Keep dry
Upper limit of
temperature
Type BF
Applied Part
Temperature
limitation
Fragile
Negative
control
Authorized representative in
the European Community
“ON”/”OFF”
(Push-Push)
CE Mark