FX65 and FX65m Straight Handpiece Operation Manual

User : Qualified Professionals Intended Use : Dental Treatment / Dental Prosthetics (Cutting, Polishing)

2. Precautions for handling and operation • Please read these precautions carefully and use only as intended or instructed. • Safety instructions are intended to avoid potential hazards that could result in personal injury or damage to the device. Safety instructions are classified as follows in accordance with the seriousness of the risk.  

  


 

 

 



 






 
 


 
    
  
  
 

        


  
  

  
  

CAUTION • Read this Operation Manual before use to fully understand the product functions and file for future reference. • When operating the product always consider the safety of the patient. • This product does not consider patient’s age (except infants), gender, weight or nationality. • This product does not consider operator’s age (mature person), height, weight, gender, or nationality. • Users are responsible for the operational control, maintenance and continual inspection of this product. • Do not attempt to disassemble the product nor tamper with the mechanism except as recommend by NSK in this Operation Manual. • Do not allow any impact on to the product. Do not drop the product. • Operators and all others in the area must wear eye protection and a mask when operating this handpiece.

ENGLISH

1. User and Intended Use

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• Should the product function abnormally, cease operation immediately and contact your Authorized NSK Dealer. • Do not use high acid water or sterilizing solutions to wipe, immerse or clean the handpiece. • The products are delivered in a non-sterile condition and must be autoclaved prior to use. • Perform regular function and maintenance checks. • If the product is not used for a long period check it is functioning correctly before using on a patient. • To avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during surgery. • U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

3. Connection & Disconnection of the Handpiece and Motor 3-1 Connection 1) Connect the handpiece direct to the motor. (Fig.1) 2) Make sure the handpiece is firmly connected to the motor. 2

3-2 Disconnection Hold the motor and the handpiece separately and disconnect with care.

CAUTION • Disconnect the handpiece only after the motor has completely stopped rotating. • Connect ONLY to E type motors (ISO 3964).

4. Insertion & Removal of the Bur 4-1 To Insert the Bur 1) Turn the Bur Lock Ring in the direction of the " " mark until it clicks. (Fig.2) 2) Insert the bur fully into the chuck then turn the Bur Lock Ring in the direction of the mark " " until it clicks. 3) Test that the bur is secure by gently pulling and pushing the bur.

" mark until it clicks

CAUTION • Make sure to align the mark with " " mark. If those marks are not completely aligned, it may cause handpiece overheating or patient burn injuries. • Always insert the bur fully into the chuck. Insufficient insertion of the bur could cause premature failure of the bearing. • Remove the bur only after the handpiece has completely stopped rotating. • Do not rotate the handpiece when the Bur Lock Ring is turned to " " (OPEN) position or a bur is not inserted. • Always keep the bur shank clean. • Entry of debris into the chuck, via the bur shank, could cause bur rotation slip and also prevent the bur from being securely located in the chuck. • Do not exceed the bur speed recommended by the bur

manufacturer. • Do not exceed maximum bur length recommended by the handpiece manufacturer. • Do not apply excess pressure to the bur as it may break or bend or become difficult to remove. • DO NOT use burs with problems listed below as the bur may break or disengage from the chuck. - Bent, deformed, anisomerous (worn), rusted, broken, deficient bur. - Bur which is cracked on the edge or axis. - Non-ISO standard, or tampered bur.

5. Check before treatment Check for handpiece vibration, noise and overheating. If any abnormalities are found do not use the handpiece and contact your Authorized NSK Dealer.

ENGLISH GERMAN FRENCH SPANISH ITALIAN

4-2 To Remove the Bur Turn the Bur Lock Ring in the direction of the " then remove the bur.

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6. Maintenance After each patient maintain the product as follows. 6-1 Cleaning (Handpiece) 1) Remove dirt and debris from the product. Do not use a wire brush. 2) Wipe clean with alcohol-immersed cotton swab or cloth. This icon denotes that the product can be washed via Thermo Disinfector. (FX65m) Refer to the Thermo-Disinfector manual.

CAUTION

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• After washing with Thermo-Disinfector and prior to lubrication, dry the product until all internal moisture is thoroughly removed. Thermo-Disinfector moisture remaining inside the product could reduce the effect of lubrication and could cause corrosion inside of the product. • To clean the product never use any solvent such as benzine or thinner.

6-2 Lubrication NSK PANA SPRAY Plus Apply NSK PANA SPRAY Plus every time after each use and/or before autoclaving. 1) Remove the bur from the handpiece. 2) Insert the Spray Nozzle into the Spray Port nozzle on the can. 3) Insert the Spray Nozzle in rear of the handpiece. Hold the handpiece and spray for approximately 2-3 seconds. Apply lubricant until it expels from the handpiece head for at least 2 seconds. (Fig.3)

CAUTION • When applying spray be sure to hold the handpiece firmly to prevent the handpiece from slipping out of the hand due to the spray pressure. • Hold the spray can upright.

6-3 Sterilization Sterilize the product by autoclave sterilization. Remove the bur after each patient and sterilize as noted below. 1) Insert into an autoclave pouch. Seal the pouch. 2) Autoclavable under the conditions below. Autoclave for more than 20 min. at 121°C, or 15 min. at 132°C, or 3 min. at 134°C. 3) The handpiece should remain in the autoclave pouch until required for use.

CAUTION • Do not autoclave the product with other instruments even when it is in a pouch. This is to prevent possible discoloration and damage to the product from chemical residue on other instruments. • Keep the product in suitable atmospheric pressure, temperature, humidity, ventilation, and sunlight. The air should be free from dust, salt and sulphur. • Immediately after use, the product should be cleaned, lubricated and sterilized. If blood remains on the external or internal surfaces it can become clotted and cause rust. • Do not heat or cool the product too quickly. Rapid change in temperature could cause damage to the product. • If the sterilizer chamber temperature may exceed 135°C during the dry cycle then delete the dry cycle. • Autoclave sterilization is recommended for the product. The validity of other sterilization methods is not confirmed. • Do not touch the product immediately after autoclaving as it will be very hot and must remain in a sterile condition.

ENGLISH GERMAN FRENCH SPANISH ITALIAN

NSK Care3 Plus When using NSK Care3 Plus automatic handpiece cleaning and lubrication system, refer to the Care3 System instructions.

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NOTICE • NSK recommends Class B sterilizers as stated in EN13060.

7. Periodical Maintenance Checks Perform periodical maintenance checks every three months, referring to the check sheet below. If any abnormalities are found, contact your Authorized NSK Dealer. 

     

 

 

 
 




 

   

8. Symbol This product is Autoclavable up to Max.135°C. This product can be washed via Thermo Disinfector. 6

Conforms to CE European Directive of “Medical equipment directive 93/42/EEC.”

Manufacturer. Authorized representative in the European community. Caution: U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

9. Warranty NSK products are warranted against manufacturing errors and defects in materials. NSK reserves the right to analyze and determine the cause of any problem. Warranty is voided should the product be not used correctly or for the intended purpose or has been tampered with by unqualified personnel or has had non NSK parts installed. Replacement parts are available for seven years beyond discontinuation of the model.

10. Option Parts List    


 
  

In order to avoid the health risks of operators handling the disposal of medical equipment, as well as the risks of environmental contamination caused thereof, a surgeon or a dentist is required to confirm the equipment is sterile. Ask specialist firms who are licensed to dispose of specially controlled industrial wastes, to dispose the product for you.

ENGLISH GERMAN FRENCH SPANISH ITALIAN

11. Disposing product

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