Dentsply Sirona TF3-91077 SureSmile VPro Vibration Device Instruction Manual

Dentsply Sirona TF3-91077 SureSmile VPro Vibration Device

Product Information

• Specifications:
  • Trim Size: 8 x 5
  • Finished Size (Label, Packaging, IFU folded): 4 x 5
  • Varnish: Specialty, TT Polyester Laminate Spot
  • Ink/Colors: Black
  • Stock: 40# White Text
  • # of Pages: 84 pages
  • IFU Finished Size (Folded): 4 x 5
  • FORM NO: 8000-FM-007-01
  • REVISION LEVEL: 3

Product Usage Instructions

• INDICATIONS FOR USE:
  • SureSmile VPro is intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement. The SureSmile VPro Mouthpiece is intended for use with the SureSmile VPro Vibration Device.
• HOW SUPPLIED:
  • The SureSmile VPro is supplied with a Vibration Device, Mouthpiece, and Charging Cable. The Mouthpiece and Charging Cable are also sold individually.
• Instructions for Use:
  • Before operation, refer to the following step-by-step instructions for proper use, maintenance, and care of the SureSmile VPro Vibration Device and Mouthpiece.
• STEP-BY-STEP INSTRUCTIONS:
  • Inspect and clean: Rinse the mouthpiece under water before first use. Refer to the “HOW TO DETACH MOUTHPIECE” section on how to separate the mouthpiece from the vibration device.
  • Charge the vibration device: Fully charge the vibration device before first use. Refer to the “CHARGING” section.
  • Connect mouthpiece: Connect the mouthpiece to the vibration device. Confirm that the vibration device feels secure and stable before inserting the mouthpiece into the mouth.
  • Usage: The vibration device is meant to be used while the orthodontic appliances are in your mouth.
  • Activate vibration session: Depress the button located on the vibration device to activate the vibration session.

FAQs

• Q: What is the purpose of the SureSmile VPro Vibration Device?
  • A: The SureSmile VPro Vibration Device is intended to facilitate minor anterior tooth movement during orthodontic treatment with aligners.
• Q: Can the Mouthpiece and Charging Cable be purchased separately?
  • A: Yes, both the Mouthpiece and Charging Cable are also available for individual purchase.
• Q: How should I clean the Mouthpiece?
  • A: Rinse the mouthpiece under water before first use. For detailed cleaning instructions, refer to the user manual.

INDICATIONS FOR USE

• SureSmile VPro is intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement.
• The SureSmile VPro Mouthpiece is intended for use with the SureSmile VPro Vibration Device.

HOW SUPPLIED

The SureSmile VPro is supplied with a Vibration Device, Mouthpiece, and Charging Cable.

1. MOUTHPIECE
2. VIBRATION DEVICE
3. CHARGING CABLE

The Mouthpiece and Charging Cable are also sold individually.

CONTRAINDICATIONS

• Do not use the vibration device if you have Vertigo or Temporomandibular Joint (TMJ) Syndrome to avoid symptoms such as headache, dizziness, and aching facial pain related to these disorders.
• Do not use any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) during the treatment to avoid inhibition of orthodontic tooth movement.
• Do not use the vibration device if you are pregnant.

WARNING

• Use the vibration device only as instructed by your clinician. Discontinue use of the device and consult your clinician if you experience sensitivity to vibrations or if you experience headache, dizziness, nausea, discomfort or pain.
• Do not make any modifications to the vibration device. Any modification may impair the functionality of the device.
• The vibration device may not be suitable for use in conjunction with certain dental restorations. Consult with your clinician before use.
• The vibration device is not recommended for patients diagnosed with periodontal disease.
• Discontinue the use of the vibration device if your orthodontic appliance is damaged.

PRECAUTIONS

• It is important to read the SureSmile VPro Instructions for Use before the operation for proper use, maintenance and care.
• The vibration device and mouthpiece are intended to be re-used.
• Before use, inspect the device, mouthpiece and packaging to verify that no damage has occurred as a result of shipping and handling. Do not use damaged products.
• Always recharge the vibration device following the Instructions for Use before use. Never use the device when plugged into a power source. Refer to the CHARGING section.
• Never use any other alternative power sources or instruments in conjunction with the vibration device. Only use a power source with output less than or equal to 5V 1A.
• Do not use the vibration device to clean or brush your teeth to avoid any undesired tooth movement.
• Use the vibration device only as instructed by the clinician.
• The vibration device is not waterproof, don’t use it near running water or get the device wet. The mouthpiece can be cleaned with water according to the instructions in the CLEANING section. Do not expose the mouthpiece to extremely hot water to avoid damaging the mouthpiece.
• Do not put the mouthpiece in the dishwasher to avoid damaging the mouthpiece.

STEP-BY-STEP INSTRUCTIONS

1. Inspect and clean before use. Rinse the mouthpiece under water before first use. Refer to the HOW TO DETACH MOUTHPIECE section on how to separate the mouthpiece from the vibration device.
2. Charge the vibration device fully before first use. Refer to the CHARGING section.
3. Connect the mouthpiece to the vibration device. Confirm that the vibration device feels secure and stable before inserting the mouthpiece into the mouth.
4. The vibration device is meant to be used while the orthodontic appliances are in your mouth.
5. Depress the button located on the vibration device to activate the vibration session.
6. The vibration device is intended to be used for a total of 5 minutes per day in a single session. The vibration device will function for 5 minutes per use and will automatically shut off afterwards.
7. Clean the mouthpiece after use and charge the unit if necessary. Refer to the CHARGING and CLEANING sections. Store the vibration device and the mouthpiece at room temperature.

HOW TO DETACH MOUTHPIECE

1. Hold the vibration device in a way that the button is facing toward you.
2. Push the mouthpiece downward while holding the vibration device in place to detach the mouthpiece.

CLEANING

• The mouthpiece should be cleaned after each treatment use. Detach the mouthpiece from the vibration device. Rinse the mouthpiece under water and brush with a toothbrush as necessary.
• The USB charging cable and SureSmile VPro Vibration Device should be kept DRY.

CHARGING

• Charge the vibration device by connecting the charging cable to a USB power source. Ensure that the output of the power source is less than or equal to 5V 1A.
• The device will blink blue intermittently when the device is charging.
• The device will emit a continuous green light when the charging is complete.
• The vibration device will blink red intermittently when it is low in battery.
• The vibration device will not vibrate while it is charging. The recommended charging time is once a week.
• The vibration device is internally powered (3.7 VDC) by a rechargeable lithium-ion polymer battery pack.
• The vibration device is inoperable while it is charging. Never use the device when plugged into a power source.

DEVICE NOTIFICATIONS

Orange LED may appear Red for some devices.

STORAGE

Proper care should be taken to ensure that the vibration device and mouthpiece are not damaged. The mouthpiece should be stored in the original packaging. The vibration device and the mouthpiece should be stored at room temperature.

• Storage/Operating Temperature: 0°C to 30°C
• Storage/Operating Humidity: 15% to 90%
• Storage/Operating Atmospheric Conditions: 700 hPa to 1060 hPA
• Transport Temperature: -20°C to 45°C.

DISPOSAL

• After the completion of your orthodontic treatment, discard the mouthpiece in the garbage.
• The vibration device and charging cable should be discarded in a separate collection for electrical and electronic equipment following your local regulations.
• Used electrical and electronic equipment (WEEE) should not be mixed with general household waste.
• For proper treatment, recovery and recycling, please take this product to a designated collection point where it will be accepted free of charge.
• Disposing of this product correctly will help save valuable resources and prevent any potential negative effects on human health and the environment, which could otherwise arise from inappropriate waste handling.
• Please contact your local authority for further details of your nearest designated collection point/household hazardous waste collection point.
• Penalties may be applicable for incorrect disposal of this waste, per your national legislation.

EXPOSURE AND INTERFERENCE

• This equipment has been tested and found to comply with the limits for a Class B digital device, under Part 15 of the FCC Rules. 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 per the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in an installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.
• Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
• 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.
• To comply with FCC/RF Exposure requirements, this device must be installed to provide at least 20 cm separation from the human body during charging.
• CANADA WARNING: This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:
• This device may not cause interference.
• This device must accept any interference, including interference that may cause undesired operation of the device.

NOTICE OF SERIOUS INCIDENT REPORTING

• If a serious incident occurs with this medical device, report it to the manufacturer and to the competent medical authority for the user/patient’s country.

REPLACEMENT

• If your SureSmile VPro Vibration Device, or any of its components, no longer works properly or needs repair, immediately contact the physician in charge of your orthodontic treatment.
• Do not attempt to service or perform maintenance on the device. No modification of the SureSmile VPro Vibration Device is allowed.

WARRANTY

LIMITED WARRANTY

• Dentsply Sirona, Inc. warrants to the original purchaser that the SureSmile VPro Vibration Device will be free from defects for one (1) year from the date of the original purchase.
• Dentsply Sirona’s sole obligation will be, at Dentsply Sirona’s discretion, to replace the device with a comparable product or to refund the purchaser the original price paid for the device upon verification of eligible defect.
• Warranty can only be claimed by the original orthodontist or dentist who purchased Dentsply Sirona.
• This warranty does not apply to normal wear and tear that does not affect the device’s functionality, nor any defect or malfunction in the device caused by misuse, neglect, or any cause other than the intended normal use.

TECHNICAL SPECIFICATIONS AND SYMBOLS

• Warning: No modification of this equipment is allowed This device has a minimum service/useful life of one year.

effect when the device is tilted at an angle of 15° from its normal position.
Guidance and Manufacturer’s Declaration (Electromagnetic Emissions)

Emissions Test| Compliance| Electromagnetic Environment (Guidance)
RF emissions| Group 1| 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.
CISPR 11| Class B| Is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| N/A| N/A
Voltage fluctuations/flicker emissions

IEC 61000-3-3

| N/A| N/A
Guidance and Manufacturer’s Declaration (Electromagnetic Immunity)

Immunity Test

| IEC 60601

Test level

|

Compliance Level

| Electromagnetic Environment (Guidance)

Electrostatic Discharge (ESD)

IEC 61000-4-2

| ± 2 kV, ± 4 kV,

± 8 kV, contact

± 8 kV, ± 15 kV, air

| ± 2 kV, ± 4 kV,

± 8 kV, contact

± 8 kV, ± 15 kV, air

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

N/A

|

N/A

|

N/A

ICONS

• Medical Device
• Catalog Number
• Lot Number
• Prescription
• Non-sterilized
• Single Patient – Multiple Use
• Manufacturer
• Date of Manufacture
• Type BF Applied Part
• FCC Declaration of Conformity
• Waste Electrical and Electronic Equipment Directive (WEEE)
• Caution, Consult accompanying documents
• Follow Instructions for Use
• Upper and Lower Temperature Limits
• Humidity Limits
• Atmospheric Pressure Limits
• Interference
• Keep Dry
• European Conformity
• Authorized Representative Australia
• Authorized Representative, EU
• Swiss Authorized Representative

CONTACT

• Dentsply LLC
• 1301 Smile Way
• York PA 17404 USA
• www.dentsplysirona.com.
• Australian Sponsor
• Dentsply Sirona Pty Ltd
• 11-21 Gilby Road
• Mount Waverley, VIC 3149
• Australia
• European Authorized Representative
• DeguDent GmbH
• Rodenbacher Chaussee 4
• 63457 Hanau-Wolfgang
• Germany
• Tel. +49/6181/5950
• Switzerland Representative
• Maillefer Instruments
• Holding Sàrl
• Chemin du Verger 3
• CH-1338 Ballaigues
• PRT-10238 Rev. 15
• Issued 07-2024
• Covered by one or more Patents,
• Pat.: US10,449,015; US10,806,545; US10,500,019

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