Dandy Vision Instruction Manual

Colors on a Vision 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 familiarize 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 familiarize 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 anesthetics or agents.
  • Avoid pulling or twisting the cable.
  • Do not drop the scanner or its accessories.
  • Do not attempt to sterilize 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 organization should identify, analyze, 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 minimized 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.

Sterilization 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 minimize 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 Sterilization (See ‘Clean the Scanner Tip’ and ‘Sterilize the Scanner Tip’).

There are 2 product models of Scanner Tip:

Clean and Disinfect the Scanner

General Warnings

WARNING

• When handling the scanner, read and follow all warnings and personal protection guidelines in the sanitizer's Safety Data Sheet (SDS).
• Gloves must be worn when cleaning and disinfecting the scanner.
• After each patient, disinfect the scanner using a recommended medium-level disinfectant wipe with tuberculocidal properties.
• Do not use disinfectants containing phenol or iodine-based substances, as they may damage the scanner's surface coating.
• Do not place the scanner in a pressure steam sterilizer or immerse it in water or disinfectant solutions.
• Excessive liquid can harm the scanner.
• Avoid using cotton balls, cloth pieces, or paper towels soaked in disinfectant to sanitize the scanner.

Clean the Scanner

If visible blood or body fluid is on the scanner, clean it before proceeding with disinfection.

To clean the scanner, follow the steps below:

• Dampen a lint-free cloth with warm water (do not soak).
• Use the dampened lint-free cloth to wipe away blood or body fluids.

Disinfect the Scanner

The scanner must be thoroughly sanitized after use for each patient.

To properly disinfect the scanner, make sure to follow the disinfectant manufacturer's guidelines regarding the required contact time.

CAUTION: The scanner must be cleaned before disinfection if it is visibly soiled. Refer to "Cleaning the Scanner."

To disinfect the scanner, proceed with the following steps:

• Detach the Scanner Tip.
• Clear any visible debris (refer to "Cleaning the scanner").
• Use a commercially available intermediate-level disinfectant wipe. Follow the manufacturer's instructions for the necessary contact time.

Recommended disinfectant wipes: CaviWipes

WARNING: Using an unapproved disinfectant may damage the scanner.

• Thoroughly wipe down all scanner surfaces, ensuring no liquid enters any gaps, air outlets, or pinholes.

WARNING: Do not rinse the scanner.

• Let it air dry thoroughly.
• Once dry, use a clean, lint-free cloth dampened with water to remove any remaining disinfectant from the scanner's surface.

Clean and Sterilize the Scanner Tip

WARNING

• Always wear gloves when handling a contaminated Scanner Tip.
• Review and follow the safety and personal protection instructions in the detergent manufacturer's Safety Data Sheet (SDS).
• Avoid soaking the Scanner Tip in disinfectant for extended periods.
• Ensure the scanner tip is completely dry before mounting it to the scanner.
• Do not use an ultrasonic cleaner to clean the Scanner Tip.
• Do not soak the Scanner Tip with alcohol-based disinfectants.

Clean the Scanner Tip

To manually Clean the scanner Tip, follow these steps:

• Rinse the scanner tip under running water to remove excess debris (approximately 2 minutes).
• Brush all surfaces with an enzymatic detergent solution, like Metrex EmPower.
• Rinse thoroughly under fresh, running water for a full 2 minutes.
• Inspect the scanner tip. If it remains dirty, go through the steps above again.
• Clean the mirror inside the Scanner Tip using a lint-free cloth or lens tissue to remove dust.
• Dry the scanner tip’s mirror carefully with a lens tissue or lint-free cloth.

Sterilize the Scanner Tip

Scanner Tips are shipped non-sterile. You must sterilize them before use.

CAUTION: For TPDI1L and TPDI1S, if you limit the exposure time at 134°C to not more than 6 minutes, you can autoclave the Scanner Tip up to 180 cycles.

To sterilize the Scanner Tip, follow these steps:

• Put the Scanner Tip into a sealed steam sterilization pouch.
• Place the Scanner Tip in a steam autoclave for sterilization.

• Exposure temperature should be set as 134°C.
• Exposure time should exceed 3 minutes.
• Exposure time should not exceed 6 minutes.

Precautions before Use

Perform the following activities on your product and accessories before use.

Visually Inspecting the Scanner for Damage

Visually inspect the scanner for damage or signs of deterioration by doing the following:

• Inspect the scanner's Lens Window.
• Inspect around the scanner buttons and contact points.

If damage is noted, do not use the scanner, and contact Dandy.

Visually Inspecting the Scanner Tips

Visually inspect the Scanner Tips for signs of deterioration by doing the following:

• Verify that the Scanner Tip is not damaged, and its components are not detached.
• Verify that the Scanner Tip mirror does not have any smudges or scratches on it.
• If deterioration is noted, replace the Scanner Tip.

WARNING

The scanner's Lens Window is a delicate optical component. When the scanner is not in use, mount the lens window protective cover to protect it from damage and dirt.

The mirror in the Scanner Tip is a delicate optical component. Its clean and undamaged surface is critical to scan quality.

If you see poor scan quality or an unclear video preview in the software, clean the mirror of the Scanner Tip and the Lens Window using a microfiber cleaning swab, applying ethanol that is free of impurities.

Use

Accessing the Software User Interface

To access Chairside, the software user interface, refer to the quick start guide.

Review the Help Center articles for individual workflows and ordering steps.

Preparing the Teeth

• If there is a preparation area, retract the gingiva by gingival restriction cords. And extract the cords just before scanning the preparation.
• Before starting the scan, dry the teeth thoroughly.
• During the scan, re-dry the teeth moderately.

Preparing the Scanner

The Scanner Tip attached to the scanner provides a sanitary shield for patients. Always disinfect the body of the scanner and perform sterilization on the Scanner Tip after each use.

CAUTION: Scanner Tips received from the manufacturer are NOT sterilized. You must sterilize them before the first use.

CAUTION: Avoid any liquid from leaking into the air outlet near the Lens Window or the air inlet at the rear of the scanner (see the figure below); otherwise, the scanner may be damaged.

To prepare the scanner, follow these steps:

• Make sure the Lens Window at the tip of the scanner is clean by wiping it with a moist, lint-free cloth or lens tissue.
• Slide the Scanner Tip onto the scanner as shown below.
• The 2 rectangles (indicated by a red circle) are the tip detection sensor. See the troubleshooting section for more information if malfunctioning.

• Scanning
  • To start scanning, place the Scanner Tip on the surface of the tooth to stabilize the scanner and press the Scan button. Wait until a 3D model appears on the 3D model display screen, and then slowly move it along the arch at 0-5mm from the teeth
  • The recommended scanning protocol consists of 3 sweeps: occlusal, lingual, and buccal to ensure good data coverage of all surfaces.
    • It is recommended that you start the first sweep from the occlusal surface, with the first molar.
  • The second sweep can scan both the lingual and buccal sides
  • The third scan covers the opposite side of the second sweep.

Troubleshooting

Regulatory Information

The DI-1 complies with the following regulations:

• FDA Center for Devices & Radiological Health CDRH - Title 21 CFR 872.3661 (USA).
• Medical Devices Regulations (Canada).

Compliance with European and International Standards

IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance

ANSI / AAMI ES 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance

CAN / CSA-C22.2 No. 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

IEC 80601-2-60: Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

IEC 62471: Photobiological safety of lamps and lamp systems: Equipment classification, requirements, and User’s Guide

ISO 17664: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices

ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

IEC 62366-1: Medical devices - Application of usability engineering to medical devices 

IEC 62304: Medical device software - Software life cycle Processes

ISO 10993: Biological evaluation of medical devices

ISO 14971: Medical devices - Application of risk management to medical devices

ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements

ISO 20417: Medical devices — Information to be supplied by the manufacturer

ISO 9687: Dentistry - Graphical symbols for dental equipment

AAMI TIR 12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

AAMI TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

ANSI/AAMI ST98: 2022; Cleaning Validation of Health Care Products—Requirements for Development and Validation of a Cleaning Process for Medical Devices

ISO 17664-1: 2021 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices —Part 1: Critical and semi-critical medical devices

Classification in Accordance with IEC 60601-1

Type of protection against electric shock: N/A

Degree of protection against electric shock: Type BF Applied Part

Mode of operation: Continuous operation

Flammable anesthetics: Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide.

Conformity with IEC 60601-1-2

Classification in Accordance with EN / IEC 60601-1

Type of protection against electric shock: N/A

Degree of protection against electric shock: Type BF Applied Part

Mode of operation: Continuous operation

Flammable anesthetics: Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide.

Conformity with EN/ IEC 60601-1-2

IEC 60601-1-2 EMC requirements and tests, Medical Electrical Equipment including CISPR 11 Group 1, Class B.

Electromagnetic Compatibility Precautions

Medical electrical devices need specific measures to ensure electromagnetic compatibility (EMC).

Medical devices should be set up and used following the EMC guidelines detailed in this document.

Even equipment that meets CISPR emission standards may disrupt communication with the DI-1.

WARNING: To maintain the DI-1's optimal performance, ensure that all portable and mobile RF communication devices—including peripherals like antenna cables and external antennas—are used at a distance of no less than 30 cm (12 inches) from any part of the system, including the cables specified by the manufacturer. Using such equipment closer than this recommended distance may result in decreased performance of the DI-1.

Guidance and Manufacturer’s Declarations

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The DI-1 is intended for use in the electromagnetic environment specified below. The customer or user of the DI-1 should assure that it is used in such an environment.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for Equipment and Systems

The DI-1 should be operated only within the electromagnetic environments described below for optimal performance. Customers or users must ensure that the device is used under these specified conditions.

The DI-1 meets the immunity requirements for proximity fields from RF wireless communication devices, in line with the test levels outlined below according to the IEC 60601-1-2 standard. It is the customer or user's responsibility to ensure that the DI-1 is operated in a suitable environment.

Accessories

Using cables or accessories other than those specified—unless they are manufacturer-approved replacements for internal components—could lead to increased emissions or reduced immunity of the medical device.

Other Equipment

WARNING: Avoid placing this equipment next to or stacking it with other devices, as this may cause improper functioning. If such placement is necessary, monitor this equipment and the other devices to ensure they operate correctly.

Technical Specification

Product Model

DI-1

DI-1 Technical Specifications

Environmental Requirements