1. Manuals
  2. Brands
  3. OrthoAccel Technologies Manuals
  4. Dental equipment
  5. AcceleDent OPTIMA
  6. Directions for use manual

OrthoAccel Technologies AcceleDent OPTIMA Directions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
DIRECTIONS FOR USE
O P T I M A ™
OrthoAccel®, AcceleDent®, SoftPulse Technology® are registered trademarks and
Optima™ is a trademark of OrthoAccel Technologies, Inc.
For U.S. patent coverage, see: www.acceledent.com/patents
1060 hPa
93% RH
50
405-1307-001 Rev D
30% RH
700 hPa

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the AcceleDent OPTIMA and is the answer not in the manual?

Questions and answers

Related Manuals for OrthoAccel Technologies AcceleDent OPTIMA

Summary of Contents for OrthoAccel Technologies AcceleDent OPTIMA

  • Page 1 DIRECTIONS FOR USE O P T I M A ™ OrthoAccel®, AcceleDent®, SoftPulse Technology® are registered trademarks and Optima™ is a trademark of OrthoAccel Technologies, Inc. For U.S. patent coverage, see: www.acceledent.com/patents 1060 hPa 93% RH 405-1307-001 Rev D 30% RH...

  • Page 2: Table Of Contents

    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.

  • Page 3: Introduction

    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.

  • Page 4: Intended Use/Indications For Use And Contraindication

    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 •...

  • Page 5: Use

    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).
  • Page 6 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.

  • Page 7: Indicators For The Acceledent Optima Device

    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.

  • Page 8: 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.
  • Page 9 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.

  • Page 10: Care

    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.

  • Page 11: Storage

    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.
  • Page 12 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.

  • Page 13: Legal Limitations

    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.

  • Page 14: Warnings

    (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.

  • Page 15: Precautions

    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.

  • Page 16: Help

    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...
  • Page 17 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.
  • Page 18 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.
  • Page 19 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.
  • Page 20 288 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.
  • Page 21 should assure that it is used in such an environment. IMMUNITY Test EC60601 Test Compliance Level Electromagnetic Level Environment - Guidance Electrostatic discharge ±8 kV contact ±8 kV contact Floors should be wood, (ESD) IEC 61000-4-2 ±2, 4, 8, 15 kV air ±...
  • Page 22 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.

  • Page 23: Symbols And Definitions

    11.0 Symbols and Definitions Symbol Description 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.
  • Page 24 Temperature limitation 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 Not waterproof...

  • Page 25: Spain

    OrthoAccel Technologies, Inc. 6575 West Loop South Suite 200 Bellaire, TX 77401, USA North America: 1 866-866-4919 Spain: +34900839096 United Kingdom: +448000988430 France: + 33805080086 Italy: +39800596833 Germany: +498007244532 Outside North America: +44 (0) 203-318-1915 www.acceledent.com Emergo Europe Prinsessegracht 20, 2514 AP, The Hague, The Netherlands...

Table of Contents