Overview: This guide explains scan colour indicators for the Dandy Vision Intraoral Scanner (DI-1) and provides essential safety, setup, and sterilisation protocols for dental professionals.

Dandy Vision Instruction Manual

Understand scan colour indicators and Dandy Vision safety

Use the following table to interpret data quality during a live scan:

Dandy Vision User Manual

The Dandy Vision Intraoral Scanner, model DI-1 (hereinafter referred to as "the scanner"), is a digital optical scanning device used to obtain digital impressions of hard and soft tissues, such as teeth, gingiva, and mucous membranes, using oral scanning, for oral restoration and orthodontic treatment of malocclusion.

Indications for Use

• The Dandy Vision Intraoral Scanner benefits dental practices by enabling them to acquire digital impressions with the quality and accuracy required for digital CAD/CAM dental applications.
• The device's actual performance is dependent on the user's training and operating execution.
• The user is solely responsible for the acquired data's accuracy, completeness, and adequacy.
• The scanner is designed to acquire 3D models of:
  • Upper jaw
  • Lower jaw
  • Buccal bite registration
• The Dandy Vision is intended for professional use only.
• We recommend that you thoroughly familiarise yourself with the user manual to get the most out of your system.
• Dandy Vision supports the following indications:
  • Single crowns
  • Bridges
  • Inlays
  • Onlays
  • Veneers
  • Implants (Single crowns and Bridges)
  • Dentures (Full and Partial)
  • Orthodontic Aligners and Retainers
  • Guards
  • TMJ/TMD appliances
  • Sleep Apnea appliances
  • Removables (bleaching trays and retainers)
  • Diagnostically imaging patients

Notice

We recommend that you thoroughly familiarise yourself with this guide to make the most effective use of your system.

The content of this document may change over time. The manufacturer and its affiliates are not responsible for any errors in this document or any incidental damages related to its provision, performance, or use. Reproduction of any part of this publication is prohibited without the prior written permission of the manufacturer.

This document is originally written in English.

All trademarks and registered trademarks belong to their respective owners.

The Dandy Vision is intended for professional use only.

Under U.S. federal law, this device can only be sold by a dentist or on a dentist's order.

Conventions

The following special notices highlight important information or potential risks to personnel or equipment.

Product Warnings

• DANGER OF ELECTRIC SHOCK
  • WARNING! Electric Shock Hazard. This is an electrical unit. Never use this device in or near water. Contact with water can result in severe electric shock, potentially causing serious injury or death. Such action can also cause malfunction of the unit.
• Dandy Vision
  • Before using the scanner, you must read and understand all safety information.
  • Use the scanner only within hospitals and professional healthcare facilities. Do not operate it near high-frequency surgical equipment or inside the RF-shielded room of an ME system for magnetic resonance imaging, where electromagnetic disturbances are intense.
  • Before operating the scanner, inspect the scanner and its accessories for any rough surfaces, sharp edges, or protrusions that could pose a safety hazard.
  • You are responsible for the scanner's operation and maintenance. Training is required to use the scanner safely.
  • Do not place objects within the scanner's operational field.
  • Ensure the scanner is turned off when not in use.
  • Do not use the scanner in oxygen-rich environments. It is not intended for use with flammable anaesthetics or agents.
  • Avoid pulling or twisting the cable.
  • Do not drop the scanner or its accessories.
  • Do not attempt to sterilise the scanner via autoclave.
  • Keep the scanner away from water, and do not immerse it in water or disinfectants.
  • Avoid subjecting the scanner to heavy vibrations.
  • Avoid exposing the scanner to ultraviolet radiation directly. The scanner is not designed for ultraviolet disinfection.
  • Avoid staring directly at the LED emission window.
  • Avoid removing the cover from any part of the scanner. The device contains no user-serviceable components. If repairs are needed, please contact Dandy.
  • Do not use any cables other than those provided with the scanner. Using different cables may damage the scanner and compromise its safety features and EMC performance.
  • If the equipment malfunctions, switch it off, post an "Out of Service" notice, and contact Dandy. To ensure the safety and optimal functionality of your device, do not attempt to self-repair it.
  • The use of components, accessories, cables, or spare parts not specified or supplied by the manufacturer of this equipment can compromise the scanner's safety features. This may lead to higher electromagnetic emissions, reduced electromagnetic immunity, and improper equipment functioning.
  • Do not modify this equipment in any way.
  • Do not connect additional power strips or extension cords to the system.
  • The scanner and scanner tip may reach temperatures up to 43 °C (109.4 °F). To prevent overheating, avoid prolonged use.
  • To completely disconnect the device from the main power supply, unplug the USB connector from the USB port.
  • DO NOT maintain or service this equipment while it is in use with the patient.
  • Connection of the PEMS (Programmable Electrical Medical System) to an IT NETWORK that includes other equipment could result in risks to patients, operators, or third parties. The responsible organisation should identify, analyse, evaluate, and control these risks.
  • Patients with oral mucosal diseases, mental illnesses, severe respiratory diseases, asthma, Parkinson's disease, attention deficit hyperactivity disorder (ADHD), and epilepsy are prohibited from using this product.
  • Patients with moderate or severe opening limitations should use the scanner with caution.
• Computer
  • The scanner is only intended to be connected to a computer that is at least IEC 60950 / IEC 62368, or equivalent standards certified. Connecting the scanner to other equipment may be hazardous.
  • Refer to your computer's installation guide for details on the data processing system, computer, and monitor. Ensure there is enough space around the computer to allow for proper ventilation.
  • Place the screen so that light reflections from both internal and external sources are minimised to achieve the best image quality and ensure comfortable viewing.
• Disposal
  • This device contains materials and chemicals commonly used in electrical and electronic products. Improper disposal at the end of its life can lead to environmental pollution. Therefore, do not discard it with regular household waste. Please take it to a designated electronic waste disposal or recycling facility. For more information on how to dispose of electronic waste, please contact your local authorities. Dispose of the Scanner Tips according to standard operating procedures or local regulations for the disposal of contaminated medical waste. For additional Scanner Tips, contact your dealer.

Scanner Parts

1. Handpiece
2. Scanner Tip
3. Capture Button
4. Mode Switch Buttons
5. Status Indicator
   1. Off - Scanner powered off or get into shipping mode
   2. Blinking slowly - Starting up
   3. Blinking rapidly - Preparing network
   4. Breathing - Ready to be connected to the scanning software
   5. Solid on - Connected to the scanning software
6. Lens Window
7. Connection Cable
8. USB Type-C Connector
9. USB Type-A Connector
10. Scanner Stand

Setting Up the Scanner

To set up the scanner, follow these steps:

• Insert the USB Type-C Connector. Then push up to secure the USB Type-C Connector.

• To disconnect the USB Type-C Connector, use thumb and index finger to pinch the area with a red circle and pull the cable thumb push sleeve off. Then detach the USB Type-C Connector from its socket.

• Remove the lens window protective cover on the Lens Window.
• Firmly mount the Scanner Tip onto the Lens Window.

• Insert the Type-A Connector to a USB 3.0 Type-A port on the computer.

CAUTION: Make sure the scanner is connected to the USB 3.0 port. If connected to a USB 2.0 port, the scanner may not work properly.

• The scanner will automatically turn on, the status indicator will flash rapidly, then the Status Indicator will stay on once it's connected to the computer and ready to scan.

NOTE: When the scanner is connected to the software, the indicator stays in solid on.

Installing the Desktop Holder

To use the holder as a Desktop Holder, follow these steps:

• Select a clean surface area.
• Place the scanner in the Scanner Stand.
• The Scanner Stand contains a magnet that helps to secure the scanner in the stand.

Sterilisation of the scanner and tips

Regularly perform the maintenance tasks outlined below for your scanner and accessories.

Carefully follow the instructions when preparing the scanner to ensure the highest level of hygienic safety for patients.

To ensure maximum patient hygiene safety and minimise cross-contamination risk, carefully perform the following maintenance activities on your scanner and accessories.

After each patient:

• Clean and disinfect the scanner. (See 'Clean and Disinfect the Scanner')
• Clean the Scanner Tip, and then perform Autoclave Sterilisation (See 'Clean the Scanner Tip' and 'Sterilise the Scanner Tip').

There are 2 product models of Scanner Tip: