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User: Qualified Professionals Indications for Use: FX15 / FX15m / FX22 / FX23 / FX23m / FX25 / FX25m This medical device is intended for transmitting rotation of the power source at the direct drive ratio or at a different gear ratio, thereby running the instrument such as a bur or a reamer to cut and polish natural or artificial teeth during dental treatment. FX75 / FX75m This medical device is intended for transmitting rotation of the power source at a reduction gear ratio, thereby running the rotary endodontic instrument, etc. to perform endodontic treatments such as root canal enlargement.
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.
ENGLISH
1. User and Indications for Use
1
Class
Degree of Risk Hazard that could result in serious injury WARNING or damage to the device if the safety instructions are not correctly followed. Hazard that could result in light or moderate CAUTION injury or damage to the device if the safety instructions are not correctly followed. General product specification information NOTICE highlighted to avoid product malfunction and performance reduction.
WARNING
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DE FR ES
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EN IT PT
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CAUTION Ř When operating the product always consider the safety of the patient. Ř Users are responsible for the operational control, maintenance and continual inspection of this product. Ř Prior to clinical use, inspect the handpiece. Check for vibration, noise and overheating. If any abnormalities are found, stop using the handpiece immediately and contact your Authorized NSK Dealer. (Refer to "7. Checking the Handpiece Before Each Use") Ř Do not disassemble or alter the handpiece except as recommended by NSK in this Operation Manual. Ř Do not allow any impact on to the product. Do not drop the product. Ř Operators and all others in the area must wear eye protection and a mask when operating this handpiece. Ř Do not use burs/files with problems listed below as the bur/ file may break, seize up or disengage from the chuck. 4
- Bent, deformed, worn, rusted, broken, deficient bur/file. - Bur/File which is cracked on the edge or axis. - Non-ISO(EN ISO) standard, or tampered bur/file. Ř Do not use burs/files other than specified in "11. Specifications" as such burs/files may be accidentally released or break during rotation. Ř Always keep the bur/file shank clean. Dirt or debris in the chuck could cause poor bur/file concentricity or low chuck retention force. Ř Always insert the bur/file all the way into the chuck. If insertion is insufficient, premature failure of the bearings or accidental release of the bur/file may occur. Ř Do not exceed Max. Bur Length shown in "11. Specifications". Ř Always follow the instructions provided by the bur/file manufacturer. Ř Do not exceed the bur/file speed recommended by the bur/file manufacturer.
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Ř The operation of the handpiece is permitted only on dental units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). Ř U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
EN FR ES IT PT
Ř Should the handpiece function abnormally during use, stop using the handpiece immediately and contact your Authorized NSK Dealer. Ř Do not use the following fluids to wipe, immerse or clean the product; strong/super acid water, strong acid/alkaline chemicals, chlorine-containing solutions, solvents such as benzine or thinner. Ř The handpiece is delivered in a non-sterile condition and must be autoclaved prior to use. Ř Perform regular function and maintenance checks. (Refer to "10. Periodical Maintenance Checks") Ř If the handpiece has not been used for a long period, rotate the handpiece and check for noise, vibration and overheating before use. Ř To avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during treatment.
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3. Accessory List No. Part Name 1 FX Wrench
6
2
Cap Wrench
3
E-Type Spray Nozzle
4. Connecting and Disconnecting the Handpiece from the Motor Quantity Remarks 1 Included in the package for FX22 / FX23 / FX23m / FX25 / FX25m 1 Included in the package for FX22 1 -
4-1 Connecting 1) Insert the handpiece direct into the motor (Fig. 1). 2) Confirm that the handpiece is securely connected to the motor. 4-2 Disconnecting Hold the motor and the handpiece, then pull apart.
5. Inserting and Removing the Bur/File
FR ES IT
CAUTION
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5-1 Inserting the Bur/File FX15 / FX15m / FX23 / FX23m / FX25 / FX25m / FX75 / FX75m (Fig. 2) 1) Insert the bur/file until it is correctly secured in place. 2) Depress the Push Button and insert the bur/file into the chuck until the bur/file "notch" mechanism engages. Release the button. 3) Confirm that the bur/file is secure by gently pulling and pushing the bur/file without depressing the Push Button.
EN
CAUTION Ř Do not connect or disconnect the handpiece until the motor has completely stopped. Ř Connect ONLY to E type motors (ISO 3964 (EN ISO 3964)). Ř Do not exceed the Max. Rotation Speed (Motor) shown in "11. Specifications".
Ř Only FX75 / FX75m can use file. PT
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5-2 Removing the Bur/File FX22 (Fig. 3, 4) 1) Turn the Latch Plate to open the chuck. FX15 / FX15m / FX23 / FX23m / FX25 / FX25m / FX75 / FX75m (Fig. 5) 2) Insert the bur into the chuck until the bur securely Depress the Push Button to open the chuck ( ) and remove engages. Swing the Latch Plate back to closed position. the bur/file ( ). 3) Ensure that the bur is secure by gently pulling and pushing the bur. FX22 (Fig. 3) Turn the Latch Plate to open position and pull the bur out.
CAUTION Ř Do not use burs/files with problems listed below as the bur/file may break, seize up or disengage from the chuck. - Bent, deformed, worn, rusted, broken, deficient bur/file. - Bur/File which is cracked on the edge or axis. - Non-ISO(EN ISO) standard, or tampered bur/file. Ř Do not use burs/files other than specified in "11. Specifications" as such burs/files may be accidentally released or break during rotation. 8
6. Connection of the Spray Nozzle (FX22 / FX23 / FX23m / FX25 / FX25m)
DE FR
1) Attach the Spray Nozzle (Optional) to the handpiece head (Fig. 6). 2) Cut the Irrigation Tube to the desired length then connect to the Spray Tube Nozzle on the motor (Fig. 6). *Refer to "14. Option Parts List" to identify the correct cartridge.
EN ES IT PT
Ř Always keep the bur/file shank clean. Dirt or debris in the chuck could cause poor bur/file concentricity or low chuck retention force. Ř Always insert the bur/file all the way into the chuck. If insertion is insufficient, premature failure of the bearings or accidental release of the bur/file may occur. Ř Do not exceed Max. Bur Length shown in "11. Specifications". Ř Always follow the instructions provided by the bur/file manufacturer. Ř Do not exceed the bur/file speed recommended by the bur/file manufacturer. Ř Do not insert or remove the bur/file until the rotation has completely stopped. Ř Do not apply excess pressure to the bur/file as it may break or bend or become difficult to remove.
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7. Checking the Handpiece Before Each Use Follow the check procedure below before use. If any abnormalities are found, stop using the handpiece immediately and contact your Authorized NSK Dealer. 1) Check the Head Cap or Cap (FX22) is firmly tightened. 2) Insert the bur/file. (Refer to "5. Inserting and Removing the Bur/File") 3) Rotate the handpiece for about one minute at the Max. rotation speed of the attached motor. During rotation, check for abnormalities such as abnormal rotation, vibration, noise. 4) After the handpiece rotation has completely stopped, touch the handpiece head to confirm the head is NOT heating abnormally (Fig. 7).
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CAUTION Ř To avoid injury, keep your hands away from the bur during rotation.
After each patient maintain the product as follows.
FR ES IT
CAUTION
PT
Ř Do not use the following fluids to wipe, immerse or clean the product; strong/super acid water, strong acid/alkaline chemicals, chlorine-containing solutions, solvents such as benzine or thinner.
DE
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8-1 Preparation 1) Wear a eye protection, a mask and gloves to avoid infection. 2) Remove the bur/file. 3) Disconnect the handpiece from the motor.
EN
8. Post-use Maintenance
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8-2 Cleaning Manual Cleaning (External Surface) 1) Remove dirt and debris on the handpiece surface using a brush under running water (at 38°C or less). Do not use a wire brush. 2) Wipe off the moisture on the surface using absorbent cloth.
CAUTION Ř If water comes inside the handpiece, blow air into the rear of the handpiece using an air syringe and remove the remaining water.
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Automatic Cleaning (External and Internal Surfaces) (Only for FX15m / FX23m / FX25m / FX75m) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual.
CAUTION Ř 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.
EN DE FR ES
8-3 Disinfection 8-4 Lubrication Manual Disinfection (External Surface) NSK PANA SPRAY Plus / PANA SPRAY Wipe the surface with cloth soaked in disinfectant solution Apply NSK PANA SPRAY Plus / PANA SPRAY every time after such as alcohol. each use and/or before autoclaving. Automatic Disinfection (External and Internal Surfaces) 1) Attach the Spray Nozzle into the Spray Port nozzle on the (Only for FX15m / FX23m / FX25m / FX75m) can. Use a thermo-disinfector in accordance with ISO 15883 2) Insert the Spray Nozzle into the rear of the handpiece. Hold (EN ISO 15883). the handpiece and spray for approximately 2-3 seconds. Refer to the thermo-disinfector manual. Apply lubricant until it expels from the handpiece head for at least 2 seconds (Fig. 8).
IT PT
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CAUTION Ř Hold the spray can upright. Ř Be sure to hold the handpiece firmly to prevent slipping out of hand by the spray pressure when lubricating. Ř Supply lubricant until it comes out of the handpiece head. Ř If you wish to expel excessive oil from inside of the handpiece, rotate the handpiece for approx.15 seconds without a bur/ file. During the rotation, do not depress the push button inadvertently, especially when using absorbent cloth to prevent oil from scattering. Depressing the push button during rotation may cause a failure to attach a bur/file. (Except for FX22)
Fig. 9 14
Fig. 10
FR ES
NSK automatic handpiece cleaning and lubrication system When using NSK automatic handpiece cleaning and lubrication system, refer to the system instructions.
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DE
Ř NSK recommends the use of "Spray Mist Absorber" (Y900084) to prevent oil mist expelling out of the handpiece head.
EN
NOTICE
IT PT
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8-5 Sterilization Sterilize the product by autoclave sterilization. After each patient sterilize as noted below. 1) Insert into an autoclave pouch. Seal the pouch. 2) Autoclavable under the conditions below. Autoclave for more than 20min. at 121°C, or 15min. at 132°C, or 3min. at 134°C. 3) The handpiece should remain in the autoclave pouch until required for use.
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CAUTION Ř Be sure to clean and lubricate the handpiece prior to autoclaving. If blood remains on the internal surface it can become clotted and cause product failure. Ř 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. Ř Do not heat or cool the product too quickly. Rapid change in temperature could cause damage to the product. Ř To avoid product failure, do not use a sterilizer whose temperature exceeds 138°C during use including the dry cycle. The chamber temperature of some type of sterilizers may exceed 138°C. Contact the sterilizer manufacturer for detailed information.
1) Detach the shank by turning it counter clockwise and remove the head from the shank (Fig.11).
FR
CAUTION Ř After removing, do not hold the shank upside down as it could cause the internal parts to drop.
DE ES IT
NOTICE
9. Replacing the Cartridge (FX22 / FX23 / FX23m / FX25 / FX25m)
EN
Ř Keep the product in suitable atmospheric pressure, temperature, humidity, ventilation, and sunlight. The air should be free from dust, salt and sulphur. Ř Do not touch the product immediately after autoclaving as it will be very hot and must remain in a sterile condition. Ř Autoclave sterilization is recommended for the product. The validity of other sterilization methods is not confirmed.
Ř NSK recommends Class B sterilizers as stated in EN 13060. PT
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2) Insert the wrench firmly into the rear of the handpiece head until it stops, as shown in Fig. A-1. 3) Tightly hold the FX wrench as illustrated in Fig. B then pull the drive shaft straight out in the direction of the arrow (Fig. B).
Fig. A-1
Fig. A-2
Fig. B
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CAUTION Ř Be sure to insert the FX wrench straight into the handpiece head. Do not insert the FX wrench at an angle as shown in Fig. A-2. Ř When removing the drive shaft, tightly hold the FX wrench as directed in Fig. B.
DE FR ES IT PT
FX22 4) Locate the correct Cap Wrench tool for the cap then turn the cap wrench counter clockwise to loosen the cap. Remove the cap (Fig. 15). 5) Use the bur to gently push the entire cartridge out from the head (Fig. 16). 6) Clean the head interior with NSK PANA SPRAY Plus / PANA SPRAY. 7) Wipe the NSK PANA SPRAY Plus / PANA SPRAY oil over the head interior. 8) Insert the new cartridge into the head by aligning the pin on the cartridge with the slot on the head (Fig. 17). 9) Tighten the cap with the correct cap wrench. 10) Insert the drive shaft firmly into the handpiece head until it clicks. If the click is not heard, insert it again. 11) Reattach the shank. *Refer to "15. Spare Parts List" to identify the correct cartridge.
EN
FX23 / FX23m / FX25 / FX25m 4) Locate the correct wrench tool for the head cap then turn the wrench counter clockwise to loosen the cap. Remove the cap (Fig.12). 5) Use the bur to gently push the entire cartridge out from the head (Fig. 13). 6) Clean the head interior with NSK PANA SPRAY Plus / PANA SPRAY. 7) Wipe the NSK PANA SPRAY Plus / PANA SPRAY oil over the head interior. 8) Insert the new cartridge into the head by aligning the pin on the cartridge with the slot on the head (Fig. 14). 9) Tighten the head cap with the correct wrench. 10) Insert the drive shaft firmly into the handpiece head until it clicks. If the click is not heard, insert it again. 11) Reattach the shank. *Refer to "15. Spare Parts List" to identify the correct cartridge.
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CAUTION
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Ř Before turning the head cap, make sure the wrench is correctly aligned with the cap. Do not turn the wrench at an angle as abrasion of the wrench may occur. Ř Secure the shank firmly to the handpiece head so that there is no gap between them. A loose connection could make the head unstable, resulting in an accident during use. Ř Use only a genuine NSK cartridge. If a non genuine cartridge is used NSK cannot guarantee performance and the handpiece warranty would become invalid. Ř Always first finger tighten the head cap then secure firmly with the wrench. Ř NSK never recommends the disassembly and repair of any NSK cartridge. There is NO EXCEPTION. In such a case a handpiece may perform abnormally (abnormal noise or abnormal vibration). Damage, failure or accidents are outside of our guarantee.
10. Periodical Maintenance Checks Every 3 months perform periodical maintenance checks, referring to the check sheet below. If any abnormalities are found, contact your Authorized NSK Dealer. Points to check Details Head Cap or Cap Tighten firmly using the correct head cap (FX22) is loose wrench or cap wrench. Rotate the handpiece and check for Rotation abnormalities such as abnormal rotation, vibration, noise, and overheating.