Dandy Scan Bodies and Instructions for Use (IFU)

Overview: This article provides the Instructions for Use (IFU) for Dandy Scan Bodies, including sterilization protocols, intended use, and critical safety precautions.

Product Overview and Intended Use

Dandy Scan Bodies are non-sterile components intended to be fixed onto an implant to obtain exact implant position information. This data is transferred to a 3D model for dental restorations.

The scan body consists of:

• Scanflag: Manufactured from AL6061-T6.
• Base: Manufactured from SUS316L.
• Screw: Manufactured from TC4ELI.

General Instructions for Use

1. Select the appropriate Dandy Scan Body model for the specific implant.
2. Ensure the seating surface of the implant is clean and free of residue, liquids, or soft tissue.
3. Install the Dandy Scan Body onto the implant in the patient's mouth.
4. Tighten the integrated screw.
5. Ensure that the Scan Body is fully seated (dental X-ray, if not visible).
6. Use a dental three-way syringe or cotton balls to ensure the Dandy Scan Body surface is completely dry before starting the scan.
7. Complete the scan using an intraoral scanner. Do not rotate the scan body once it is installed.

Safety Contraindications and Cautions

• Swallowing Hazard: Handle the Dandy Scan Body and tools with caution to prevent the patient from swallowing or inhaling components. Bind tools when necessary.
• Hardware Integrity: Refrain from using a damaged Dandy Scan Body. Do not disassemble or modify the component.
• Software Compatibility: Use only with the compatible digital database in your design software.
• Life Cycle: The product has a total life cycle of 5 years.

Alteration of the Scan Body

• If seating is difficult, minimal alterations can be done to the Scan Body.
• Ensure not to remove identifying markings.
• Disposes of after use (single-use).

Sterilization and Cleaning Protocol

Dandy Scan Bodies are provided non-sterile and must be manually cleaned and sterilized before every use. Note: Auto-cleaning and ultrasonic cleaning are not supported as they may damage coded markers.

Step 1: Rinse and Soak

1. Rinse the Dandy Scan Body under flowing water (15°C–30°C) for at least 1 minute immediately after removal from the patient's mouth.
2. Submerge the component in a neutral enzymatic cleaning solution (ratio 1:100-200) for at least 10 minutes.
3. Agitate the liquid during soaking to ensure the screw channels are cleaned.

Step 2: Final Rinse and Dry

1. Rinse residual solution using purified water for at least 1 minute. Do not use tap water.
2. Gently wipe the surface with a clean, lint-free cloth until dry.

Step 3: Autoclave Parameters

Place the Dandy Scan Body in a sterilization box, seal it in an autoclave bag, and use one of the following settings:

Maintenance and Disposal

• Replacement: Replace the Dandy Scan Body after 300 autoclave cycles or if surface scratches are visible.
• Handling: Do not use metal tweezers on the black coded top of the Dandy Scan Body. Clamp only the metal bottom.
• Disposal: Dispose of the Dandy Scan Body as medical waste according to national requirements.

Related Information

• Dandy Scan Bodies Information for Use PDF
• How to Order a Scan Body
• Correcting an Improperly Seated Scan Body