OrthoAccel Technologies AcceleDent OPTIMA Directions For Use Manual

O P TIMA ™

DIRECTIONS FOR USE

OrthoAccel®, AcceleDent®, SoftPulse Technology® are registered trademarks and

405-1307-001 Rev D

Optima™ is a trademark of OrthoAccel Technologies, Inc.

For U.S. patent coverage, see: www.acceledent.com/patents

50

30% RH

93% RH

1060 hPa

700 hPa

Contents

1.0 Introduction

2.0 About the manufacturer

3.0 Intended Use/Indications for Use and Contraindication

4.0 Component summary

5.0 Use

5.1. Set up and charging

5.2. Indicators for the AcceleDent Optima Device

5.3. Use schedule

5.4. AcceleDent App Use

6.0 Care

6.1. Cleaning

6.2. Storage

6.3. Disposal

7.0 Warranty

3

3

4

4

5

5

7

7

8

10

10

10

11

11

7.1. Express Limited Warranty

7.2. Legal Limitations

7.3. Customer Service and Replacement,

including troubleshooting and FAQs location.

8.0 Safety

8.5. Warnings

8.6. Precautions

9.0 Help

10.0 Technical Description

11.0 Symbols and Definitions

11

13

13

13

14

15

16

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1.0 Introduction

Thank you for choosing AcceleDent® Optima™ which works with your
current orthodontic treatment to deliver a better experience from start to
finish. AcceleDent Optima 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.

2.0 About the Manufacturer

Contact the manufacturer, OrthoAccel®, about any questions or concerns that
are specifically related to AcceleDent Optima and its components.

Customer Service Center:

North America: 1-866-866-4919
Spain: [phone]
United Kingdom: [phone]
France: + 33805080086
Italy: [phone]
Germany: [phone]
Outside North America: [phone]

EMERGO EUROPE: [phone]
Email: [e-mail]
Online: www.acceledent.com

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3.0 Intended Use/Indications for
Use and Contraindication

AcceleDent Optima is an orthodontic accessory intended for use during
orthodontic treatment. It is used in conjunction with orthodontic appliances
such as braces and aligners to help facilitate minor anterior tooth movement.

Contraindications 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.

4.0 AcceleDent Optima

Component Summary with Images

5

3

3

4

4

1

1

2

2

7

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8

8

5

6

6

9

9

1

MOUTHPIECE

2

ACTIVATOR

3

ON/OFF BUTTON (STAND-BY)

4

STATUS INDICATOR

5

CHARGING CASE

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USB CHARGING PORT

7

USB CHARGING CABLE

8

POWER ADAPTER

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5.0 Use

5.1. Set-Up and Charging

5.1.1. Power the Charging Case by connecting the USB Charging Cable to an

electrical source.

5.1.2. Open Charging Case by pushing down on the top of the latch (Unlock symbol).

Check to make sure the AcceleDent Optima Activator is secure in the Charging Case
for proper charging. To close the lid securely, push down on the front of the latch
(Lock symbol).
Note: The lid does not need to be closed for proper charging.

5.1.3. The Status Indicator on the AcceleDent Optima Activator will be solid

orange while charging and turn o when fully charged.

5.1.4. Prior to first use, charge for at least 8 hours.

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5.1.5. To begin your treatment session, press the on/o button. The Activator will

vibrate, and the Status Indicator will be solid blue. The device will automatically
turn o after 20 minutes of treatment.

2 0

min

5.1.6. Place the Mouthpiece in your mouth and bite down gently. AcceleDent

Optima features a half-time indicator, which will pulse 2 times at the 10-minute

mark. After 20 minutes of treatment, the Activator and Status Indicator light
will automatically turn o.

5.1.7. To pause your treatment session for up to 5 minutes, press the on/o

button once. During the pause, the Status Indicator will pulse blue slowly.
When you are ready to resume, press the on/o button again to resume
treatment. AcceleDent Optima will remember how long you used it as long
as the interruption does not exceed 5 minutes. After 5 minutes of being
paused, AcceleDent Optima will operate for a full session of 20 minutes at
its next use.

5.1.8. Recharge the Activator after each treatment by returning it to the

powered Charging Case. Place the AcceleDent Optima Activator securely in
the Charging Case to ensure proper charging.

5.1.9. The Status Indicator will blink orange when the battery is low.

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5.2. Indicators for the AcceleDent Optima Device

Solid orange Charging battery
Blinking orange Low battery
Solid blue Active treatment
Solid blue and pulsing vibration Mid-point treatment
Slow pulsing blue Paused treatment
Fading blue to none End of treatment
Alternating orange and blue blinking End of device life

5.3. Use Schedule

5.3.1. By using AcceleDent Optima for 20 minutes per day, the small vibrations, or
micropulses will help your teeth respond to orthodontic treatment more quickly.

5.3.2. Select a consistent time for use each day. This way using AcceleDent Optima
becomes a routine, and you may be less likely to forget a daily session.

5.3.2.1. Some patients prefer using AcceleDent Optima 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, watching TV, or
using a computer/mobile device. Try several approaches and decide on the
approach that works best for you.

5.3.2.2. You may find that occasionally using AcceleDent Optima right
after you receive a wire change

or switch to a new aligner tray is a good

time to help reduce pain.

5.3.3. Try to find a time that you can use AcceleDent Optima without
interruption as it is best not to stop use in the middle of a session.

5.3.4. You may easily pause and resume use if you are interrupted during a
session. To pause, press the power button on the Activator. Refer to 5.1.7 for
further information.

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5.4. AcceleDent App Use

5.4.1. The AcceleDent App was developed to provide doctors and patients an easy

way to track usage and provide motivation during your orthodontic treatment.
It is not mandatory for AcceleDent Optima treatment, but your Orthodontist may
recommend its use so that they can easily see if you will be experiencing the intended
faster tooth movement, by using your AcceleDent for the recommended 20 minutes
every day. The app is also a great motivational tool, an easy way to register your
warranty, and connect with your practice through the app’s messaging feature.

5.4.2. AcceleDent App is compatible with mobile devices with Android 6.0 or iOS

9.0 or later versions.

5.4.3. Install the Free AcceleDent App:

5.4.3.1. Android™ Device: Search in Android Market or Google Play™ Store

for the AcceleDent App. Apple® Device: Search in Apple App Store® for the
AcceleDent App.

5.4.3.2. Follow specific steps recommended by your device manufacturer

for downloading the app.

5.4.4. Complete Registration:

5.4.4.1. Open the app and begin registration by tapping on Register.

5.4.4.2. Enter your name and email address, read and accept the Terms of

Use.

5.4.4.3. Enter profile information including email address.

5.4.4.4. When you receive your confirmation email, confirm your registration

and then log back in.

5.4.5. Pair Your Activator with Your Mobile Device:

5.4.5.1. Follow prompts given in the app during registration as a patient

to complete pairing, including allowing the app to use your device’s camera to
scan the larger 2D barcode on the AcceleDent packaging. If you do not have
your packaging, use the barcode located on the bottom of your Charging Case.

5.4.5.2. If you did not pair your Activator during registration of the app, you

may pair later by accessing the Support tab located at the bottom of the main
Menu (the three horizontal bars in the top left corner) and then tap on My
Activator. You will then receive prompts given in the app to complete pairing.

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5.4.6. Use Your Timer:

5.4.6.1. Go to Main Menu and tap My AcceleDent. The Timer starts automatically

once you have paired your activator and press the on/o button on your Activator
to start treatment.

5.4.6.2. If you pause your treatment session, a unique Pause Timer will be

automatically visible on your app screen. When you resume treatment by pressing
the button on the activator, the Timer will pick up where you left o.

5.4.7. View Your Dashboard:

5.4.7.1. From Usage History on the Main Menu, you will be able to see your

overall usage percentage, which is your own achievement progress towards
the goal of daily 20 minute sessions, your global ranking compared to all the other
AcceleDent patients and more.

5.4.8. See Your Achievements:

5.4.8.1. On the Achievements Screen, you will see awards you have earned and

awards that are still waiting for you to unlock.

5.4.9. Set Your Reminder:

5.4.9.1. To set up a daily reminder in your AcceleDent App, navigate to the

Support tab and tap on Notifications. Make sure your notifications are on and
select your preferred treatment time. You will then receive a push notification
every day at this time, even if your app is closed.

5.4.10. Connect to Your Community:

5.4.10.1. Within Community, you can receive messages and keep track of friends.

Positive reinforcement from your support network can be motivating to achieve
excellent usage goals.

5.4.10.2. Family and friends can also use the AcceleDent App and register to

become Observers, you may then grant them permission to view your dashboard
reports, achievements, and send words of encouragement from within the
messaging feature.

5.4.11. The information that is wirelessly transmitted via the Bluetooth communication

link between the AcceleDent Optima Activator and the paired mobile device is the
Activators motor performance information, battery status, and use data such as
length of use and time of use. No patient identifying information is communicated
through the wireless connection between your Activator and the app. Firmware
updates, if needed, may also be wirelessly communicated from the AcceleDent App
through the Bluetooth connection back into the Activator. Before any firmware
updates are made, you will receive a notification so that you can choose a convenient
time for the update to occur. For any questions about the firmware update, please

contact customer service.

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6.0 Care

6.1. Cleaning

6.1.1. Simple hand cleaning is sucient to remove accumulation of dirt or
other build-up on the Activator and Charging Case.

6.1.2. For the Charging Case:

6.1.2.1. DO NOT rinse or submerge the Charging Case in water.

6.1.2.2. As needed, unplug from power source and wipe external and

internal surfaces using a soft moist cloth. Dry with a soft cloth before
reconnecting to power source.

6.1.3. For the Mouthpiece:

6.1.3.1. After each use, rinse the Mouthpiece with warm running water and

wipe with a dry cloth prior to storage or charging.

6.1.3.2. Activator is waterproof, but it is recommended that the Activator is
not submerged in water or cleaning solutions for an extended period of time.

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6.1.3.3. Occasional cleaning with dish soap, dental cleaning solutions,
and/ or brushing with toothpaste is acceptable.

6.2. Storage

6.2.1. Store AcceleDent Optima and Accessories away from pets, pests, and
children to avoid inadvertent damage.

6.2.2. Activator should be stored in the Charging Case when not in use.

6.2.3. When not charging, unplug the Charging Case from the USB Cable and

wall mount power supply.

6.2.4. Clean and store all components in a cool, dry place.

6.3. Disposal

6.3.1. The rechargeable battery inside of your Activator cannot be
replaced.

6.3.2. In order to protect and preserve our environment, the Activator Assembly,
Charging Case, USB Cable and Power Adapter should be disposed of at a
designated collection facility for batteries and other electrical devices like
cell phones, computers, video games and electronic tools.

6.3.3. These designated collection facilities are free of charge to the consumer
because OrthoAccel and its distributors h
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 of North America) or customerservice@orthoaccel.
com for assistance.

ave acquired the appropriate

7.0 Warranty

7.1. Express Limited Warranty

7.1.1. OrthoAccel Technologies, Inc. (“OrthoAccel”) warrants that the product
packaged with this warranty (the “Product”) will be free from significant defects

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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-transferable and applies only to the original purchaser and
the initial orthodontic 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 found on the Product website.

7.1.2. 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, or (4) 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. Your exclusive remedy for breach of this limited warranty during
the Warranty Period shall be, at the option of OrthoAccel, the replacement of
the Product with a new Product, as determined by the OrthoAccel Warranty.
Replacement shall not extend the original Warranty Period.

7.1.3. 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 in North America or [phone]­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 package must include your RMA.
RMA’s will not be extended or reissued.

7.1.4. No Implied Warranties: Limitations on Damages

7.1.5. The Express Limited Warranty provided above is the only expressed

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 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 profit; loss of use; the claims of third
parties including, without limitation, dental professionals; and cost of
any substitute equipment or services.

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7.2. Legal Limitations

7.2.1. 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.

7.3. Customer Service and Replacement

7.3.1. For additional support during use, please reference the Frequently

Asked Questions (FAQ) and Troubleshooting Guide located at acceledent.
com/FAQ.

7.3.2. If you have any questions or comments after reading the provided

materials, please contact the OrthoAccel Customer Service:

North America: 1-866-866-4919
Outside North America: [phone]
Email: [e-mail]
Online: www.acceledent.com
EMERGO EUROPE: [phone]

8.0 Safety

8.1. Patients undergoing orthodontic treatment under the supervision of an

orthodontist or dental professional are the intended operators of this product.
While not exclusive, the intended user profile primarily comes from the following
demographics: male and female teens (13 - 17 years old with adult consent or
supervision, as required), and male and female adults (18 - 65 years old). No
age or eduction level restrictions.

8.2. This product is designed to enhance your orthodontic treatment only. Use

this product only for its intended use as described in this manual.

8.3. (For healthcare professionals): Please instruct patients to read these

Directions For Use for precautions to be taken in the event of changes in the
performance of the device and precautions to be taken regarding the exposure
of the device to reasonably foreseeable environmental conditions.

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8.4. Contact your physician, orthodontist or dentist if you have any medical

concerns about AcceleDent Optima. Discontinue use of this product and
immediately contact your orthodontist if any discomfort or pain is
experienced.

8.5. AcceleDent Optima has been tested and is in compliance with safety

standards for electromechanical devices. AcceleDent Optima meets the required
electrical safety and emissions standards; however, the appliance has not been
tested for eects on any other specific medical devices (such as pacemakers,
cochlear implants, and/or nerve stimulators). Please contact the other device
manufacturers with any questions or concerns about eects on their devices.

8.6. 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 or dentist.

8.5. Warnings

8.5.1. WARNING: DO NOT plug the Power Adapter into an outlet with a voltage
other than that specified on the Power Adapter as it may cause electric shock
and permanent damage to your device. This product is designed to operate
within a range of 100 – 240 volts. Voltage converters DO NOT guarantee
voltage compatibility.

8.5.2. WARNING: NEVER force the Power Adapter into an outlet; if it does not

easily fit into the outlet, discontinue attempts as it may cause electric shock
and permanent damage to your device.

8.5.3. WARNING: NEVER charge your device using a Power Adapter that does

not meet specifications as listed in the Technical Description of this manual
as it may cause electric shock and permanent damage to your device.

8.5.4. WARNING: AcceleDent Optima should not be stacked or located on or

around other equipment that may create electromagnetic interferences.

8.5.5. WARNING: Portable RF communications equipment (including

peripherals such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of AcceleDent Optima, including cables
specified by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.

8.5.6. WARNING: NEVER use a damaged Activator, Charging Case, USB

Charging Cable, or Power Adapter as it may cause electric shock and/or
further damage to your device. Refer to the section in this manual titled
“Customer Service and Replacement” if your AcceleDent Optima or any of its
components no longer work properly.

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8.5.7. WARNING: DO NOT place or store the device or accessories near any

heated surfaces, as it could cause fire or permanent damage to your device.

8.5.8. WARNING: DO NOT place or store the Power Adapter or Charging Case

where it will sit in a pool of water or where it can fall or be pulled into a
bathtub, sink, or toilet. DO NOT reach for a Charging Case that has fallen into
water. Unplug immediately.

8.5.9. WARNING: DO NOT use accessories and cables other than those

specified or provided by the manufacturer of this equipment. This could
result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.

8.5.10. WARNING: DO NOT interconnect the Charging Case USB connector to

equipment not specified in this manual.

8.5.11. WARNING: The Federal Communications Commission does not allow

any modifications or changes to the unit EXCEPT those specified in this
manual. Failure to comply with this government regulation could void your
right to operate this equipment.

8.5.11.1. No modification of the equipment is allowed.

8.5.11.2. DO NOT attempt to replace the battery.

8.6. Precautions

8.6.1. DO NOT use AcceleDent Optima without it being prescribed by an

orthodontist or dentist. This is a prescription device which must be prescribed
by an orthodontist or dentist. As with many medical devices, use by an individual
without the proper issuance from an orthodontist or dentist can result in
unintended consequences.

8.6.2. CONSULT your orthodontist or dentist prior to use of this product if you

have had any recent craniofacial surgery (above the neck).

8.6.3. DO NOT share your AcceleDent Optima device. AcceleDent Optima is a

single patient device (one patient to one device). Use of the device 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.

8.6.4. DO NOT use a Mouthpiece that is damaged. Consult your orthodontist or

dentist if the Mouthpiece no longer fits comfortably for any reason. Inappropriate
cleaning may also cause damage to the Mouthpiece (see “Care” section).

8.6.5. DO NOT use AcceleDent Optima outside of the environmental conditions

specified in the Technical Description of this manual.

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8.6.6. DO NOT use AcceleDent Optima outside of the electromagnetic

environment specified in the Technical Description of this manual.

8.6.7. DO NOT clean any components or accessories in the dishwasher or

microwave.

8.6.8. DO NOT boil, steam or dry heat sterilize any components or accessories.

8.6.9. DO NOT rinse or submerge the Charging Case or accessories in water.

8.6.10. DO NOT attempt to service or perform maintenance on the device. This

product contains no serviceable parts.

8.6.11. DO NOT attempt to charge the Activator with a Qi charger or any other

wireless charger than the one supplied by OATI.

8.6.12. DO NOT expose Activator or Charging Case to UV light for an extended

period of time as it may discolor.

9.0 Help

9.1. If you have any questions, concerns, or to report an unexpected operation

or events regarding your AcceleDent Optima product, please contact the
Customer Care Center for your country (visit www.acceledent.com for contact
information). If you need immediate assistance, please contact the OrthoAccel
Customer Service.

10.0 Technical Description

10.1. AcceleDent Optima complies with IEC 60601-1 and 3rd Edition

Amendment 1; IEC 60601-1-11; IEC 60601-1-2 and 4th Edition; IEC 60601­1-6/62366; IEC 60601-1 2nd Edition Amendment 1 and 2. This information
is intended to provide environmental operating conditions, transport/
storage conditions, as well as IEC 60601 equipment ratings, electrical safety
classification for the included equipment. Conditions should fall between the
ranges detailed below.

10.2. The expected service life of AcceleDent Optima is two years.

10.3. Environmental Operating Conditions

Ambient Temperature Range: 5-35°C
Maximum temperature of any external component at maximum ambient

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temperature: 50°C
Relative Humidity Range: 15-90%
Atmospheric Pressure Range: 700-1060 hPa

10.4. Transport and Storage Conditions

Ambient Temperature Range: -20 to 50°C
Relative Humidity Range: 30 - 93% RH

10.4.1. If AcceleDent Optima has been transported or stored at its maximum

or minimum transport or storage conditions, the product shall be allowed
to cool or warm for at least two hours within the environmental operating
conditions before use.

10.5. The Activator is a Type BF Applied Part, meaning this medical device

has direct contact with the patient. Such devices shall be marked with
symbol.

10.6. A Power Adapter intended for connection to the USB port of the Charging

Case shall comply with the relevant product standard e.g. IEC 60950-1 or
IEC 62368-1 for IT-equipment and the IEC 60601-series for Medical Electrical
Equipment. In addition, all such combinations – Medical Electrical Systems
– shall comply with the safety requirements stated in the general standard
IEC 60601-1, edition 3, clause 16. Any equipment not complying with the
leakage current requirements in IEC 60601-1 shall be kept outside the patient
environment i.e. at least 1.5 m from the patient support or shall be supplied
via a separation transformer to reduce the leakage currents.

10.7. Use the provided Power Adapter or one that is certified as Class II

adapter with double or reinforced insulation. Such Power Adapter shall be
marked with

symbol or labeled Class II. The specifications of an appropriate

Power Adapter are detailed below:

10.7.1. Certification: Class II, IEC 60950

Output Voltage: 5 V
Output Current Limit: 1 A
AC Input Voltage Range: 100-240 V
AC Input Current: 0.2 A
AC Input Frequency: 50/60 Hz

10.8. Any person who connects external equipment to the USB connector

has formed a Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact a qualified medical
technician or your local representative.

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10.9. The USB port located on the back of the Charging Case is for battery

charging purposes only. The Charging Case has no data communication
ability. The Charging Case shall have two means of protection, as Class II
equipment, in order to prevent the parts from exceeding voltage, current,
or energy limits defined by IEC 60601-1. As a precaution, the USB connector
should not be touched or manipulated when connected to the Power Adapter
and when the Power Adapter is connected to the supply mains. The Power
Adapter can be isolated from the supply mains by unplugging the device. Do
not position the charging case to make it dicult to operate the disconnection
device (USB cable).

10.10. Ingress Protection Class

10.10.1. The Charging Case is rated IP32; it is protected from intrusion of

solid foreign objects greater than 2.5 millimeters, except dust or lint, and
against vertically falling water drops when enclosure is tilted up to 15°.

10.10.2. The Activator is rated IP67; it is protected from total dust ingress and

from immersion between 15 centimeters and 1 meter in depth.

10.11. FCC Compliance Statement

10.11.1. This device complies with part 15 of the FCC Rules. Operation is

subject to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.

10.11.1.1. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can
be recognized by turning the equipment o and on, the user is encouraged
to troubleshoot to correct and reduce the interference by one or more of
the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on a circuit dierent from that

to which the receiver is connected.

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- Please contact the OrthoAccel Customer Service.

10.11.2. Recommended separation distances:

10.11.2.1. AcceleDent Optima is intended for use in an electromagnetic

environment in which radiated RF disturbances are controlled. The
customer or the user of AcceleDent Optima can help prevent, reduce or
correct electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters)
and the AcceleDent Optima device as recommended below, according to the
maximum output power of the communications equipment.

Rated maximum
output power of
transmitter
W

0.01 0.12 0.12 .23

For transmitters rated at 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 aected by
absorption and reflection from structures, objects and people.

Separation distance according to frequency of transmitted
m

1150 kHz to 80 MHz

d=1.2√P

80 MHz to 800 MHz

d=1.2√P

800 MHz to 2.5 GHz

d=2.3√P

10.12. CAN ICES -3 (B)/NMB-3(B)

10.12.1. This device complies with Industry Canada’s licence -exempt RSSs.

Operation is subject to the following two conditions:
(1) This device may not cause interference; and
(2) This device must accept any interference, including interference that may
cause undesired operation of the device.

10.13. Environmental Specifications

10.13.1. Electromagnetic Requirements:

10.13.1.1. AcceleDent Optima complies with all applicable and

required standards for electromagnetic compatibility.
AcceleDent Optima is suitable for the home healthcare environment meaning
all environments except for near active HF SURGICAL EQUIPMENT and
areas of high intensity of EM DISTURBANCE.

10.13.1.2. AcceleDent Optima transmits and receives electromagnetic

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energy at 288 kHz +/- 10 kHz for the purposes of wireless charging.

AcceleDent Optima complies with the Bluetooth Low Energy (BLE) standard; it
transmits and receives electromagnetic energy through at 2.4 to 2.4835 GHz.
The band is split into 40 2 MHz channels. The maximum transmit power is
less than 1 mW.

10.13.1.3. See IEC 60601-1-11 clause 4.2.3.1 for applicable conditions. This
device has been tested and found to comply with requirements for CISPR 11
Class B digital devices, which is designed to provide reasonable protection
against interference in a residential setting. However, there is no guarantee that
interference will not occur in a particular installation.

10.14. Electromagnetic Emissions

10.14.1. 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.

10.14.2. In accordance with Clause 4.3 of IEC 60601-1, AcceleDent Optima

does not have Essential Performance.

Emissions Test Compliance The AcceleDent Optima uses RF energy for internal

function and low power communication; therefore, its

RF Emissions
CISPR 11

RF Emissions
CISPR 11

Harmonic emissions
IEC61000-3-2

Voltage fluctuations
/ Flicker emissions
IEC61000-3-3

Group 1

Class B The system is suitable for use in all establishments,

N/A

N/A

RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.

including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.

10.14.3. Bluetooth Low Energy:

10.14.3.1. Bluetooth, Bluetooth Low Energy, Bluetooth Smart and the

Bluetooth logo are registered trademarks of Bluetooth SIG.

10.15. Electromagnetic Immunity

10.15.1. Electromagnetic Immunity Part 1

10.15.1.1. The Activator is intended for use in the electromagnetic

environment specific below. The customer or the user of the Activator

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should assure that it is used in such an environment.

IMMUNITY Test IEC60601 Test

Level

Electrostatic discharge
(ESD) IEC 61000-4-2

Electrical fast transient/
burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11

±8 kV contact
±2, 4, 8, 15 kV air

± 2 kV for power supply
lines ± 1 kV

for input/output lines

± 1 kV line(s) to line(s)
± 2 kV line(s) to earth

100% drop,

0.5 periods, 0º, 45º, 90º,
135º, 180º, 225º, 270º,
315º
100% dip,
1 period
30% dip,
25/30 periods

Compliance Level Electromagnetic

Environment ­Guidance

±8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15
kV air

± 2 kV for power supply
lines ± 1 kV for input/
output lines

± 1 kV dierential mode
± 2 kV common mode

100% drop,

0.5 periods, 0º, 45º, 90º,
135º, 180º, 225º, 270º,
315º
100% dip,
1 period
30% dip,
25/30 periods

Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.

Mains power quality
should be that of a typical
domestic environment.

Mains power quality
should be that of a typical
domestic environment.

Mains power quality
should be that of a
typical domestic
environment

Voltage
Interruptions
(all input current)

Power frequency (50/60
Hz) magnetic field IEC
61000-4-8

NOTE: UT is the A.C. mains voltage prior to application of the test level.

30 A/m 30 A/m Power frequency

100% drop, 5 seconds

magnetic fields should
be at levels characteristic
of a typical domestic
environment.
Tested in X, Y, and Z
axes.
Can be waived due
to a justification that
there are no magnetic
components. Assumes a
minimum distance of 15
cm to magnetic source
in actual usage

10.15.2. Electromagnetic Immunity Part 2

10.15.2.1. The Activator is intended for use in the electromagnetic

environment specific below. The customer or the user of the Activator
should assure that it is used in such an environment.

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IMMUNITY Test IEC60601 Test

Level

Conducted RF IEC
61000-4-6

Radiated RF IEC
61000-4-3

6V Amateur
0,15 MHz – 80 MHz

Enclosure

10V/m
80% AM at 1 kHz
or risk frequency
80 MHz – 2700 MHz

Compliance
Level

6 V

Enclosure
10V/m

Electromagnetic
Environment - Guidance

Portable and mobile RF communications
equipment should be used no
closer to any part of AcceleDent
Optima, including cables, than the
recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
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,
a) 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:

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 aected 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 AcceleDent Optima is
used exceeds the applicable RF compliance level above, the AcceleDent Optima should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating AcceleDent Optima.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

10.16 Material:

10.16.1. AcceleDent Optima is made of biocompatible materials. The

AcceleDent Optima Activator has been tested and verified to have less than

0.01% by mass of Latex proteins. The AcceleDent Optima Activator has been

tested and verified to have less than 0.01% by mass of DEHP.

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11.0 Symbols and Definitions

Symbol Description

S/N

P/N

Lot number or batch code

Reference or Catalog number

Serial Number

Part Number, Model Number or Reference

Date of manufacture

Manufacturer

Use by date

Follow Instructions for use

Refer to instruction manual

Rx Only

Caution: Federal law restricts this device to sale by or on the order of a physician.

Certification that the electromagnetic interference from the device is under limits
approved by the Federal Communications Commission.

Class II Equipment

Type BF Applied Part: Devices that have direct contact with the patient, or parts that
have long term contact with the patient.

Interference may occur in the vicinity of equipment marked with the following symbol.

Bluetooth enabled

Authorized representative in the European Community

European Conformity (CE) Mark, with notified body number

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Temperature limitation

2 0

min

Separate collection for electric and electrical equipment

Keep Dry

Fragile

Stand-by

20 minutes for treatment

Open Charging Case by pushing down on this part of the latch

Close Charging Case by pushing down on this part of the latch

Humidity limitation

Atmospheric pressure limitation

IP32

IP67

Not waterproof

Is protected from intrusion of solid foreign objects greater than 2.5 millimeters, except
dust or lint, and against vertically falling water drops when enclosure is tilted up to 15°.

Is protected from total dust ingress and from immersion between 15 centimeters and
1 meter in depth.

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OrthoAccel Technologies, Inc.

6575 West Loop South Suite 200

Bellaire, TX 77401, USA

North America: 1 866-866-4919

Spain: [phone]

United Kingdom: [phone]

France: + 33805080086

Italy: [phone]

Germany: [phone]

Outside North America: [phone]

www.acceledent.com

Emergo Europe

Prinsessegracht 20, 2514 AP, The Hague, The Netherlands

Phone: [phone] / Fax: [phone]

Australia Representative

Emergo Australia

201 Sussex Street, Darling Park, Tower II, Level 20

Sydney, NSW 2000, Australia

Phone: + 61 (0) 2-9006-1662 / Fax: [phone]

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