Dental U File Made By Stainless Steel Also Named Ultrasonic File Used With Ultrasonic Handpiece

S&D U File

1. This product is used by connecting to active device (dental scalers etc.) and produces vertical reciprocating movement or lifting movement to enlarge root canal. It is the engine driven file with stainless steel shank. It is non-sterile instrument.

2. Main materials

1) Working part: Stainless steel (including nickel and chromium)

2) Shank : Stainless steel (including nickel and chromium)

Purpose of use and effect-efficacy

This product is for enlarging root canal and making smooth and flat root canal wall through grinding and polishing. It is produced by the movements of vertical reciprocation and ultrasonic oscillation or lifting. This is a dental instrument which is used by connecting to an active medical device.

Specifications

Under the provisions of ISO 13485 performance test, products’ durability for

twisting and bending must exceed specified value of our standard.

Method of manipulating or method of use

According to its intended use, choose the most appropriate FOREVER U- FILES and use it for enlarging root canal. Possible Combinations with active device

1. Use the active device which can hold the shank of this product precisely. (Diameter of shank :#10~#40:φ0.8mm, #45,#50:φ1.0mm)

2. Use the output controllable active devices (dental scalers etc.).

Precautions for use

1. To prevent infection, sterilize the product by autoclave and make sure sterilization is completed before using.

2. Do not apply excessive output in case of using with active devices

(dental scalers etc.).

3. Follow the instructions of active device manufacturer strictly and insert the shank all the way to avoid its half-way chucking.

4. The active device should be used in accordance with its instructions.

5. Choose the most appropriate type for each case and follow the general method.

6. Before using, run the instruments outside of oral cavity to make sure there is no distortion.

7. Before using, make sure the instruments outside of oral cavity that there are no deformations, scratches and cracks.

8. If the head of product is thin, long or large, there are possibilities for breaking or twisting. Because of this, be sure to avoid using

unreasonable angle and excessive pressure.

9. Wear safety glasses to protect your eyes from damage. Also, wear a dust protective mask to prevent inhaling dust.

10. Wear rubber dam etc. to avoid accidental ingestion and falling.

11. Do not use this instrument for any purposes except for listed applications above.

12. Only for use by dentists.

13. This product should be treated as medical waste when disposed.

14. Dispose the product if damaged or contaminated.

15. After using, wash it with medical cleaning agent and brush, then wash away foreign substances like adherent body fluids and body

tissues.

16. Set the product to a stand when cleaned by ultrasonic cleaner to avoid working part deterioration.

17. Use this product with great care to avoid puncturing fingers because of its possession of sharp-edged part.

18. This product has possibility that be corrosive if sunk into NAOCL, EDTA and etc. for a long time.

Storages and duration of use

1. Avoid storing at high temperature, humidity and direct sunlight. Keep liquids away. Store it at room temperature.

2. Do not damage or make a pinhole to packaging materials.

3. The product is subject to be improved without previous notice. Enforce the first-in first-out method for stock management.

4. Do not store the product under a germicidal lamp to avoid deterioration.

Maintenances and inspections

1. Sterilize this product by autoclave under established method and term for each use. Method of sterilization:

Put this product in a sterilization pack(or foil) and place it on a

sterilization tray for autoclave sterilization with reference to the following terms .

Terms for sterilization:

term(1) temperature: 121degrees Celsius time: 20 minutes or more

term(2) temperature: 126degrees Celsius time: 15 minutes or more

2. Do not use high pressure steam sterilizer which heats more than 200

degrees Celsius including drying process.

3. Dispose the product if damaged or decreased in performance.

4. Regarding use of medical cleaning agent, follow the instruction

manual by its manufacturer strictly.

5. Dispose the products if damaged or decreased performance.