AZDENT FG Diamond Burs User Manual

1. Introduction

This manual provides essential information for the safe and effective use, maintenance, and sterilization of AZDENT FG Diamond Burs. These burs are designed for professional dental use only.

Intended Use: AZDENT FG Diamond Burs are designed to fit into a dental handpiece and are intended to cut hard structures in the mouth, such as teeth or bone. They can also be used to shape teeth for the application of artificial teeth in dentistry.

2. Safety Information

2.1. General Warnings

• Professional Use Only: This item is intended for use by professional health care providers only. Users may be required to provide evidence of qualification to purchase and use these items in their country.
• Non-Sterile Upon Receipt: Burs are not sterile upon receipt and MUST be sterilized before use in accordance with the instructions provided in this manual.
• Chemical Compatibility: Burs can be damaged by alkaline and acidic detergents. Always use a pH neutral detergent or solution.
• Temperature Limit: Do not exceed 140°C during cleaning and sterilization processes.
• Handling Contaminated Burs: Contaminated burs should be handled with gloves and eye protection.
• Nickel Allergy: Patients who are allergic to nickel cannot use these burs.

3. Product Overview

AZDENT FG Diamond Burs are high-quality dental instruments featuring diamond abrasive coatings for efficient cutting and shaping of dental structures. They are supplied in black storage boxes, typically containing 10 burs per box.

4. Setup and Sterilization

Proper sterilization is critical before initial use and between patients. Follow these steps carefully:

4.1. Preparation for Cleaning

• Remove burs from packaging.
• Remove all excess soil from the burs using a disposable cloth or paper wipe.
• Protect delicate or fine burs from damage during handling. Burs left standing wet may stain or corrode.
• Burs should be reprocessed as soon as is reasonably practical following use.

4.2. Cleaning

Disassembly of burs is not required for cleaning.

1. Brush the dental burs in 75% ethanol liquid and then clean in pure water.
2. Soak the burs in a multi-enzyme cleaning fluid for at least 30 minutes.
3. For automated cleaning, use only validated washing machines and validated cleaning agents suitable for both devices and washing machines. Follow instructions issued by both the equipment and cleaning agent manufacturers.
4. After automated cleaning, inspect for complete removal of visible soil. If necessary, repeat the cycle or use manual cleaning before repeating the cycle.

4.3. Sterilization

The UK Department of Health recommends using validated pre-vacuum autoclaves for sterilizing wrapped burs. Autoclaves that only draw a post-sterilization vacuum for drying are not suitable for processing wrapped burs.

1. If using a vacuum autoclave, pack the burs into a dedicated instrument tray or pouch validated for sterilization.
2. If using a non-vacuum autoclave, the burs must be contained in a dedicated bur stand with a perforated lid.
3. Autoclave the burs for a holding time of not less than 3 minutes at a temperature between 134°C and 137°C, with a Nominal Pressure (MPa) of 2.2. This holding time is the minimum for which the minimum temperature is sustained.
4. Always follow the instructions from the autoclave manufacturer. Ensure not to exceed the maximum recommended load for the autoclave.
5. After sterilization, dry the burs using paper or dry heat not exceeding 140°C.
6. For single-use or re-use on a single patient, after cleaning with water, disinfect the dental bur with 75% alcohol for 20 minutes at least and then dry it naturally.

5. Operating Instructions

5.1. Bur Insertion and Removal

To insert a bur into a high-speed dental handpiece, gently push the bur into the chuck until it clicks into place. To remove, press the chuck release button (if applicable) and pull the bur out. Always ensure the bur is securely seated before operation.

5.2. General Usage

Use the FG Diamond Burs with appropriate dental handpieces for cutting hard structures like enamel, dentin, or bone. They are also suitable for shaping teeth in preparation for restorative procedures or prosthetic applications. Always use proper technique and follow established dental protocols.

6. Maintenance and Storage

6.1. Inspection and Function Testing

Before each use, visually inspect all burs to ensure all contamination has been removed. Check for any signs of damage or wear. Cutting edges should be free of defects. Discard any damaged or corroded burs immediately. For burs with long, slender features, check for distortion. If burs are part of a larger assembly, check the assembly with mating components. Discoloration or dulling after sterilization is normal and does not affect performance.

6.2. Storage

Store dental burs in their sterilization container (bur stand or pouch) until required. Ensure containers or pouches are dry before opening to prevent recontamination. Store in dry, clean conditions at ambient temperature.

6.3. Discarding

Discard damaged or worn-out burs according to local regulations for medical waste.

7. Troubleshooting

No specific troubleshooting steps are provided for these burs. If issues arise during use, ensure that:

• The bur is correctly inserted and secured in the handpiece.
• The bur is not damaged or excessively worn (refer to Inspection guidelines).
• Sterilization and cleaning protocols have been strictly followed.

If problems persist, discontinue use and replace the bur.

8. Specifications

9. User Tips

• Users have reported excellent hardness and durability, making these burs reliable for various dental procedures.
• The measurements and granulometry are noted to be accurate, contributing to precise work.
• Consider purchasing in multi-box quantities (e.g., 10 boxes) for better value.
• Always ensure proper sterilization and handling to maintain the quality and longevity of the burs.

10. Frequently Asked Questions (FAQ)

Q: Does "10 box × 10pcs" mean 100 pieces in total?

A: Yes, typically "10 Boxes" refers to 10 individual boxes, each containing 10 pieces, resulting in a total of 100 pieces.

11. Warranty and Support

For any inquiries or support regarding AZDENT FG Diamond Burs, please contact the manufacturer or their authorized representative:

Manufacturer:

Shenzhen Dian Fong Abrasives Company Limited

Contact: Tel: +86-755-2885 6248

European Authorized Representative (EC REP):

MedPath GmbH

Contact:

• Tel: +49(0)89 8130 6837
• Fax: +49(0)89 5485 884
• E-mail: info@medpath.pro

These instructions have been validated by the manufacturer as being capable of preparing a device for re-use. It remains the responsibility of the reprocessor to ensure that the reprocessing has actually achieved the desired result. This normally requires validation and routine monitoring of the process. Any deviation by the reprocessor from these instructions should be properly evaluated for effectiveness and potential adverse effects.