Endodontic Hand Instruments
Instructions for use

Before using this product, please read the following instructions

Structural composition

Endodontic Hand Instruments are composed of an operating part, a handle and a limiting block.The operation part is made of nickel-titanium alloy or stainless steel wire, and the handle material is TPX.

Intended use

Used for cutting, leveling, cleaning, shaping teeth bone and root canal in dental treatment.

MODEL

Stainless Steel C FILE, Stainless Steel K FILE, Stainless Steel H FILE, Stainless Steel Reamer FILE, Micro File(MC- Opener), Micro File(MC- Shaper), V- Taper Hand FILE, NITI K FILE, NITI H FILE, NITI Reamer FILE

Contraindications

Those who are allergic to stainless steel, nickel-titanium materials should not be used.

Warnings

This product is non-sterile packaging and needs to be sterilized before use.

Precautions

1) When extending the root canal, the file tip should not go beyond the apical hole.
2) If the technique of refiling the root canal is not correct, the rotation Angle exceeds 180, the preparation of the root canal is not carried out in accordance with the number of steps, the root canal is not smooth, there is resistance or too hard, it is difficult to achieve the best application effect of this product.
3) It can be used for 5-10 teeth under normal use. It should be cleaned and disinfected after each use. It is found that the instrument is deformed and the tip of the file becomes dull, stop using it immediately.
4) Store in dry environment under normal temperature.

Cleaning, disinfection and sterilization processing

The Endodontic Hand Instruments must be cleaned, disinfected and sterilized before use.

Device	The device is supplied non-sterile but is intended to be used in a clean, disinfected and sterile state and therefore will require processing prior to use. The devices are reusable. The devices must be reprocessed after clinical use. Re-use what is not reprocessed after clinical use may result in infection, patient injury or death.
Advice	The devices have to be cleaned, disinfected and sterilized prior to the use. Processing procedures have only limited implications to these dental devices.
	Processing Instructions
Preparation at prior to processing	The product is supplied in clean, but non-sterile state. Remove the packaging material of the products and put the products onto a cleaning tray for cleaning and disinfection.
Cleaning	Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated processing methods. Preference is to be given to automated processing methods, especially due to the better standardizing potential and industrial safety. Automated Cleaning: Use a washer-disinfector meeting the requirements of the ISO 15883 series. Put the instrument into the washer/disinfector on a tray and start the program: • 4 mins pre-washing with cold water (<40°C); • emptying • 5 mins washing with a mild alkaline cleaner at 55°C • emptying • 3 mins neutralizing with warm water (>40°C); • emptying • 5 mins intermediate rinsing with warm water (>40°C) • Emptying The automated cleaning processes have been validated by using 0.5% neodisher Medi Clean forte (Dr. Weigert). Note Acc. to EN ISO 17664 no manual processing methods are required for these devices. If a manual processing method has to be used, please validate it prior to use
Disinfection	Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0 value (see EN 15883). A disinfection cycle of 5 min disinfection at 90°C has been validated for the device to achieve an A0 value of > 3000. Here we suggest a disinfection cycle of 5 min disinfection time at 93°C.
Drying	Automated Drying: Drying the instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air.
Functional Testing,Maintenance	Automated Drying: Visual inspection for cleanliness of the instruments. After cleaning and disinfection, a thorough inspection and maintenance ensures that the products are fit for use. -Check that the product has no dents, cracks, deformations, scratches or corrosion; -Check all markings on the product for clear visibility. Defective device should be immediately discarded. The defects include: material deformation and corrosion for Endodontic Hand Instrumentss.
Packaging	Pack the instruments in an appropriate packaging material for sterilization. The packaging materialand system refer to EN ISO 11607.
Sterilization	Sterilization of instruments by applying a fractionated pre-vacuum steam sterilization process (according to EN 285/EN 13060/EN ISO 17665) under consideration of the respective country requirements. Minimum requirements: 5 mins at 134 °C Maximum sterilization temperature: 137°C Drying time: For steam sterilization, we recommend a drying time of 15 to 40 minutes. Choose a suitable drying time, depending on the autoclave and load. Refer to the autoclave’s instructions for use. After sterilization: a. Remove the product from the autoclave. b. Let the product cool down at room temperature for at least 30 minutes. Do not use additional cooling. c. Check that the sterilization wraps or pouches are not damaged. Flash sterilization is not allowed on lumen instruments!
Storage	Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures, refer to label and instructions for use.
Processing validation study information	The above-mentioned processing (cleaning, disinfection, sterilization) has been successfully validated. Refer to test reports: -United Dental Evaluation Report of Processing acc.to EN ISO 17664 incl. Cleaning, Disinfection, Sterilization for Medical Devices Processed Prior to Use, Report No.: RDS-REV-210730-0087, Revision No.: 00
	Additional Instructions: None
	It is the duty of the user to ensure that the processing including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly.

Instructions for Use

It is necessary to open the pulp cavity, sterilize the root canal and pull out the pulp before use.The product should be sterilized before use.
1. To measure the length of the root canal, it is recommended to use finger-sensing method and X-ray root canal measurement method.
2. From fine to thick, this product should be used in serial order. No file number should be crossed. No file number should be replaced until each file number reaches the root tip.
3. During the operation, the file should be rotated clockwise against the wall of the root canal, and the rotation Angle should not exceed 180 degrees. In case of resistance, do not rotate again, and then pull up with the pulling force.
4. The main function of H file is pulling file, the main function of expanding file is rotating cutting, and the main function of K&C file is rotating cutting and pulling cutting.
5. The instrument should be filed and rinsed at the same time, and the instrument should enter the canal slowly and gently during operation.

Shelf life:5 years

Storage

The device should be stored in a a clean environment with a relative humidity of no more than 80%, no corrosive gas and good ventilation.

Symbols Used on Labels

	Unique device identifier
	Caution
	Nickel titanium
	Steinless Steel
	Non-sterile
	Medical device
	Consult instructions for use
	Humidity limitation no more than 80%
	Batch number
	CE mark and Identification number of Notified Body
	Date of Manufacture
	Manufacturer
	Catalogue number
	Use-by date
	Authorised representative in the european community
	Sterilizable in a steam sterilizer (autoclave) at 134°C
	Model number
	Keep away from sunlight
	Keep dry