Root Canal Files
Instructions for use

Before using this product, please read the following instructions

Intended use

Root canal files are used with active instruments designed to cut, flatten, clean and shape teeth and root canals in dental root canal treatment. it contacts dentin or tissue for less than 24 hours. This product is a reusable device, provided in a non-sterile state and needs to be steaming sterilized before use.

Indication

Root canal therapy

MODEL:Refer to the label

Contraindications

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

Warnings

This product is non-sterile packaging and needs to be sterilized before use. Pre-check before use, if the package is broken or the surface of the device is not smooth and clean, please do not use it.

Potential complications: □ Pain □ Infection □ Dentin fracture

Precautions

1) Before using this product, please be sure to read the instructions for use carefully, or contact us to receive relevant skills training, so as to better understand the operation process of this product.
2) This product is for professional dentists only.
3) To prevent infection, please sterilize this product with autoclave before use, and use it after confirming sterilization. The user shall bear the responsibility for the failure to operate in accordance with the instructions for use or sterilize using unverified methods.
4) Determine the working length by X-ray or root apex locator, select the appropriate model, and apply it correctly.
5) Perform rotation test outside the mouth before use to make sure there is no loosening.
6) Before using this product on patients, please confirm whether there is any crimping, defect, crack, etc. on it. Once found, it should be discarded immediately and treated as medical device waste.
7) The Root Canal Files manufactured by our company should be used with the legally listed root canal motor with controllable torque.
8) It is suggested to operate according to the recommended rotation speed and torque (refer to the label).Exceeding the maximum rotation speed and torque may cause breakage and injury.And the interfaces need to comply with the requirements of EN ISO 14457:2017 Dentistry-Handpieces and motors.
9) As this product is mechanically driven, it is not suggested to be used under severe bending or abrupt bending of the root apex.
10) During the use of this product, it is necessary to confirm whether the rod connected with the root canal motor is inserted to the end, and avoid using this product in the half-inserted state. Breakage
and injury may occur if the number of rotations is exceeded. Please be sure to follow the allowable number of rotations.
11) This product may cause tissue damage or needle breakage due to heat effect when it is rotated in certain parts for a long time, so it should be carefully operated.
12) Select hand file up to #15 for preliminary preparation according to general usage.
13) For models with thin, long and large heads, please avoid using them with excessive force or at an unreasonable angle, which may cause breakage or bending to them.
14) When enlarging the canals, the tip of file should not exceed the apical foramen.
15) If the enlargement of the root canal is incorrect, the rotation angle exceeds 180°, the preparation of the root canal is not carried out in accordance with the number sequence, thus forming steps, the root canal is not smooth, and there is resistance or excessive force, it is difficult to achieve the best application effect of this product.
16) Do not apply excessive force in the direction of the root apex.
17) It is suggested to use the Root Canal Files in a short pulling way, and apply it along the root canal in a passive mode, until the required length is reached.
18) It is suggested that the user takes personal protective measures during operation, such as wearing protective glasses and dust masks.
19) It is suggested to use rubber dam in pulp operation to effectively prevent instrument drop, accidental swallowing and transmission of pathogenic factors.
20) To prevent the surface corrosion of this product, it should not be immersed in irrgation solutions for a long time.
21) During root canal plasty, the root canal should be thoroughly and frequently irrigated, and debris attached to the file needle should be removed on a regular basis.
22) Clean immediately with a medical lotion and brush after use to completely remove the attached fluids, biological tissues and other foreign bodies.
23) To avoid damage to the edge when cleaning with ultrasonic instrument, please put it into a fixed box for cleaning.
24) This product has a sharp tip, so the user should be careful not to stab his/her fingers.
25) This product can be reused for no more than 5 times. Do not overuse it, as it may lead to broken needles. After the operation, this product should be immediately put into the disinfection box to clean. Before reuse, sterilize it effectively according to the recommended sterilization method.

Cleaning, disinfection and sterilization processing

The Root Canal Files 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.
Pre-Cleaning Usually, no manual pre-cleaning is required. In case of heavy contamination, submerge the instruments in distilled water and clean the surfaces with a soft bristle brush.
Cleaning Regarding cleaning/disinfection, rinsing and drying, it is 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 mins 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 mins 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 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.
Packaging Pack the instruments in an appropriate packaging material for sterilization. The packaging material and 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

The crown down technique is the technique of choice for rotary instruments.
1. According to the desired length and taper of the root canal, select the corresponding model of root canal file and open the package.
2. Cleaning, Disinfection and sterilization according to the method described in this manual.
3. Connect the root canal files to a low-speed handpiece.
4. Start the root canal preparation.

Performance characteristics

The surface of root canal files should be polished and passivated. The surface should be smooth, no notch, roll, crack, burr. The working part of the root canal files should be free from aging, and the shanks should not be distorted or changed in color.

Shelf life:5 years

Storage

The Root Canal Files should not be stored together with toxic substances, chemicals and harmful substances. It should be stored in a room with no more than 80% relative humidity, no corrosive gases and good ventilation.

Notice to the user/patient

If there is any serious incident that has occurred in relation to the device, please reported to the manufacturer and the competent authority in your country immediately.

Symbols Used on Labels

图标1 Unique device identifier
图标2 Caution
图标3 Nickel titanium
图标2 Non-sterile
图标3 Medical device
图标1 Consult instructions for use
图标2 Humidity limitation no more than 80%
图标3 Batch number
图标1 CE mark and Identification number of Notified Body
图标2 Date of Manufacture
图标3 Manufacturer
图标3 Catalogue number
图标3 Use-by date
图标3 Authorised representative in the european community
图标3 Sterilizable in a steam sterilizer (autoclave) at 134°C
图标3 Model number
图标3 Keep away from sunlight
图标3 Keep dry

Clinical benefit

It can effectively remove and clean the dental decay and pathogens, reduce pain and complications.
NITI can withstand greater stress than other materials, so the risk of device fracture and deformation is reduced.

SHANGHAI FANTA DENTAL MATERIALS CO.,LTD

Room 1305, Building 14, No. 655 Road Fengzhou,
District Jiading, 201801 Shanghai, China
+86 2164033133

Riomavix S.L. (ES-AR-000001202)

Add.: Calle de Almansa 55, 1D, Madrid 28039 Spain
Tel.: +34 658 396 230
E-mail: leis@riomavix.com