FX205 Series Air Motor and FX Series Handpieces Operation Manual March 2022

Accessory List No. Part Name 1 FX Wrench

Air Motor (FX205 M4/FX205m M4/FX205 B2/FX205m B2) Quantity 1

2 3

Cap Wrench FX Spray Nozzle

1 1

4 5 6

Spray Nozzle E-Type Spray Nozzle Turbine Oil

1 1 1

Remarks FX205 M4 Set FX205 B2 Set FX205 M4/FX22 Set FX205 B2/FX22 Set FX205 M4/FX25 Set FX205 B2/FX25 Set FX205m M4 Set FX205m B2 Set FX205 M4/FX22 Set FX205 B2/FX22 Set FX205 M4 Set FX205 B2 Set FX205 M4/FX25 Set FX205 B2/FX25 Set FX205m M4 Set FX205m B2 Set FX205 M4/FX22 Set FX205 B2/FX22 Set -

Precautions for handling and operation ŘPlease read these precautions carefully and use only as intended or instructed. ŘS afety 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. Class Degree of Risk Hazard that could result in serious injury or damage to the device if the safety

WARNING instructions are not correctly followed.

Hazard that could result in light or moderate injury or damage to the device if the

C A U T I O N safety instructions are not correctly followed.

General product specification information highlighted to avoid product malfunction

N O T I C E and performance reduction. 2

CAUTION ŘRead this Operation Manual before use to fully understand the product functions and file for future reference. ŘWhen operating the product always consider the safety of the patient. ŘU sers are responsible for the operational control, maintenance and continual inspection of this product. ŘDo not disassemble or alter the motor except as recommended by NSK in this Operation Manual. ŘDo not allow any impact on to the product. Do not drop the product. ŘOperators and all others in the area must wear eye protection and a mask when operating this motor. ŘShould the motor function abnormally during use, stop using the motor immediately and contact your Authorized NSK Dealer. ŘD o 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. ŘThe motor is delivered in a non-sterile condition and must be autoclaved prior to use. ŘPerform regular function and maintenance checks. (Refer to "7. Periodical Maintenance Checks") ŘIf the motor has not been used for a long period, rotate the motor and check for noise, vibration and overheating before use. ŘTo avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during treatment. ŘU.S. Federal law restricts this device to sale by or on the order of a licensed physician.

1) Attach the attached FX Spray nozzle to the neck of the Contra Angle handpiece. 2) Trim the tube to the desired length then insert the tube end into the nozzle clamp on the motor. (Fig. 3)

WARNING ŘDo not exceed the optimum pressure specified on the specification table.

CAUTION ŘDo not use air contaminated by dust, moisture and oil.

2. Connection & Disconnection of the Handpiece 2-1 Connection 1) Connect the handpiece direct to the motor. (Fig. 2) 2) Make sure the handpiece is firmly connected to the motor. 2-2 Disconnection Hold the motor and the handpiece separately and disconnect with care.

CAUTION ŘDisconnect the handpiece only after the motor has completely stopped rotating.

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

Air Motor

4. Water and Chip Air Supply to the Handpiece

Measure the supply pressure at the handpiece / hose connection point and set the pressure to the value specified on the specification table. (Fig. 1) For Multi Gauge information refer to Option Parts List.

5. Forward / Reverse Rotation 1) Forward Rotation : Turn the FWD/REV Change Ring to “F”. (Fig. 4) 2) Reverse Rotation : Turn the FWD/REV Change Ring to “R”. (Fig. 5) 3) When the FWD/REV Change Ring is positioned at the middle of “F” and “R” , the drive air is interrupted and the motor does not rotate. (Fig. 6) F : Forward Rotation R : Reverse Rotation

6. Post-use Maintenance After each patient maintain the product as follows.

WARNING ŘImmediately after a treatment, the motor should be cleaned, lubricated and sterilized. Failure to properly maintain the motor may lead to overheating, causing burn injuries or product failure.

CAUTION ŘD o 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. 6-1 Preparation 1) Wear a eye protection, a mask and gloves to avoid infection. 2) Disconnect the handpiece from the motor. 3) Remove the motor from the hose. 3

ENGLISH

1. Setting of Air & Water Supply Pressure

6-2 Cleaning Manual Cleaning (External Surface) 1) Remove dirt and debris on the motor 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. Automatic Cleaning (External and Internal Surfaces) (Only for FX205m M4/FX205m B2) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual.

CAUTION ŘA fter 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. 6-3 Disinfection Manual Disinfection (External Surface) Wipe the surface with cloth soaked in disinfectant solution such as alcohol. Automatic Disinfection (External and Internal Surfaces) (Only for FX205m M4/FX205m B2) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual. 6-4 Lubrication NSK PANA SPRAY Plus / PANA SPRAY Apply NSK PANA SPRAY Plus / PANA SPRAY every time after each use and/or before autoclaving. 1) Remove the motor from the hose. 2) Mount the arrow-head spray nozzle tip into the spray can port. (Fig. 7) 4

3) Insert the Spray Nozzle into the Drive Air Port of the motor. Hold the motor and spray for approximately 2-3 seconds. Apply lubricant until it expels from the exhaust air part for at least 2 seconds. (Fig. 8)

CAUTION ŘHold the spray can upright. ŘB e sure to hold the motor firmly to prevent slipping out of hand by the spray pressure when lubricating.

NOTICE ŘN SK recommends the use of "Spray Mist Absorber" (Y900084) to prevent oil mist expelling out of the motor. Lubrication Oil 1) Remove the motor from the hose. 2) Apply 1-2 drops of lubrication oil into the Drive Air Port shown in the Fig. 8. 3) Connect the motor to the hose. Operate the motor for about 10 seconds. 6-5 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 motor should remain in the autoclave pouch until required for use.

Model Hose Connection Type Handpiece Connection Type Max. Rotation Speed Breakdown Torque Drive Air Pressure Air Consumption Water Pressure Chip Air Pressure Coolant Water Supply Coolant Air Supply Water Spray Type Use Environment Transportation and Store Environment Thermo Disinfector

FX205 M4 FX205m M4 FX205 B2 FX205m B2 ISO 9168 Type 3 (Midwest 4 hole) ISO 9168 Type 1 (Borden 2 hole) E Type ISO 3964 22,500-27,500min-1(0.25MPa) 19,800-24,200min-1(0.25MPa) 1.5N·cm and more(0.25MPa) 0.20 - 0.25MPa (2.0 - 2.5kgf/cm2) <66NL/min(0.25MPa) 0.10 - 0.25MPa (1.0 - 2.5kgf/cm2) 0.15 - 0.25MPa (1.5 - 2.5kgf/cm2) 50mL/min and more (0.20MPa) 1.5NL/min and more (0.20MPa) External Spray Temperature: 10 - 40°C, Humidity: 30 - 75% (No Condensation) Temperature: -10 - 50°C, Humidity: 10 - 85%, Atmospheric Pressure: 500 - 1,060hPa -

Air Motor

NOTICE Ř1 6.UHFRPPHQGV&ODVV%VWHULOL]HUVDVVWDWHGLQ(1

8. Specifications

7. Periodical Maintenance Checks 3HUIRUPSHULRGLFDOPDLQWHQDQFHFKHFNVHYHUWKUHHPRQWKVUHIHUULQJWRWKHFKHFNVKHHWEHORZ,IDQ DEQRUPDOLWLHVDUHIRXQGFRQWDFWRXU$XWKRUL]HG16.'HDOHU Points to check Details Rotation Rotate the motor and check for abnormalities such as abnormal rotation, vibration, noise, and overheating.

5

ENGLISH

CAUTION Ř'RQRWDXWRFODYHWKHSURGXFWZLWKRWKHULQVWUXPHQWVHYHQZKHQLWLVLQDSRXFK7KLVLVWRSUHYHQW SRVVLEOHGLVFRORUDWLRQDQGGDPDJHWRWKHSURGXFWIURPFKHPLFDOUHVLGXHRQRWKHULQVWUXPHQWV Ř'RQRWKHDWRUFRROWKHSURGXFWWRRTXLFNO5DSLGFKDQJHLQWHPSHUDWXUHFRXOGFDXVHGDPDJHWRWKH SURGXFW Ř7RDYRLGSURGXFWIDLOXUHGRQRWXVHDVWHULOL]HUZKRVHWHPSHUDWXUHH[FHHGVr&GXULQJXVH LQFOXGLQJWKHGUFFOH7KHFKDPEHUWHPSHUDWXUHRIVRPHWSHRIVWHULOL]HUVPDH[FHHGr& &RQWDFWWKHVWHULOL]HUPDQXIDFWXUHUIRUGHWDLOHGLQIRUPDWLRQ Ř.HHSWKHSURGXFWLQVXLWDEOHDWPRVSKHULFSUHVVXUHWHPSHUDWXUHKXPLGLWYHQWLODWLRQDQGVXQOLJKW 7KHDLUVKRXOGEHIUHHIURPGXVWVDOWDQGVXOSKXU Ř'RQRWWRXFKWKHSURGXFWLPPHGLDWHODIWHUDXWRFODYLQJDVLWZLOOEHYHUKRWDQGPXVWUHPDLQLQD VWHULOHFRQGLWLRQ Ř$XWRFODYHVWHULOL]DWLRQLVUHFRPPHQGHGIRUWKHSURGXFW7KHYDOLGLWRIRWKHUVWHULOL]DWLRQPHWKRGVLV QRWFRQILUPHG

Contra Angle Handpiece (FX22/FX23/FX25/FX25m) WARNING ŘImmediately after a treatment, the handpiece should be cleaned, lubricated and sterilized. Failure to properly maintain the handpiece may lead to overheating, causing burn injuries or product failure. (Refer to "13. Post-use Maintenance") ŘIf blood infiltrates inside a handpiece, an automatic handpiece cleaning and lubrication system may not totally clean the internal handpiece components, which may lead to internal blood coagulation. Coagulated blood inside the handpiece may cause handpiece failure and overheating, causing burn injuries. To avoid the risk, NSK recommends to immediately lubricate those handpieces with PANA SPRAY Plus / PANA SPRAY. ŘDepressing the Push Button while the handpiece is in rotation may lead to overheating, causing burn injuries or product failure. Avoid the push button to contact with any oral tissue. (Except for FX22) ŘSupply coolant water and coolant air while using the handpiece. No supplying the coolant water and coolant air may lead to overheating, causing burn injuries or product failure. ŘDo not use the handpiece for polishing purposes. Polishing paste could enter the handpiece, causing the failure of the Push Button or burn injuries due to the overheating of the handpiece head. ŘKeep any debris or other foreign materials away from inside the gear or the handpiece. Foreign materials remaining inside may lead to overheating, causing burn injuries or other accidents. ŘBall bearings are wear items and may require replacement. Be sure to inspect the handpiece before use (Refer to "11. Check before treatment"). If abnormal vibration or noise are found, the bearings or other internal parts may be worn out or damaged. Damaged parts may lead to handpiece overheating causing burn injuries. If overheating is suspected, stop using the handpiece immediately and contact your Authorized NSK Dealer.

6

CAUTION ŘWhen operating the product always consider the safety of the patient. ŘU sers are responsible for the operational control, maintenance and continual inspection of this product. ŘP rior 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 "11. Check before treatment") ŘDo not disassemble or alter the handpiece except as recommended by NSK in this Operation Manual. ŘDo not allow any impact on to the product. Do not drop the product. ŘO perators and all others in the area must wear eye protection and a mask when operating this handpiece. ŘDo not use burs with problems listed below as the bur may break, seize up or disengage from the chuck. - Bent, deformed, worn, rusted, broken, deficient bur. - Bur which is cracked on the edge or axis. - Non-ISO(EN ISO) standard, or tampered bur. ŘD o not use burs other than specified in "16. Specifications" as such burs may be accidentally released or break during rotation. ŘA lways keep the bur shank clean. Dirt or debris in the chuck could cause poor bur concentricity or low chuck retention force. ŘA lways insert the bur all the way into the chuck. If insertion is insufficient, premature failure of the bearings or accidental release of the bur may occur. ŘDo not exceed Max. Bur Length shown in "16. Specifications". ŘA lways follow the instructions provided by the bur manufacturer. ŘDo not exceed the bur speed recommended by the bur manufacturer. ŘShould the handpiece function abnormally during use, stop using the handpiece immediately and contact your Authorized NSK Dealer. ŘD o not use the following fluids to wipe, immerse or clean the product; strong/super acid water,

9-1 Connection 1) Connect the handpiece direct to the motor. (Fig. 2) 2) Make sure the handpiece is firmly connected to the motor. 9-2 Disconnection Hold the motor and the handpiece separately and disconnect with care.

CAUTION ŘDo not connect or disconnect the handpiece until the motor has completely stopped. ŘC onnect ONLY to E type motors (ISO 3964 (EN ISO 3964)). ŘDo not exceed the Max. Rotation Speed (Motor) shown in "16. Specifications".

10-1 To Insert the Bur FX23/FX25/FX25m 1) Insert the bur until it is correctly seated in place. 2) Depress the Push Button and insert the bur into the chuck until the bur "notch" mechanism engages. Release the button. (Fig. 9) 3) Ensure that the bur is secure by gently pulling and pushing the bur WITHOUT depressing the Push Button. FX22 1) Turn the Latch Plate to open the chuck. (Fig. 10) 2) Insert the bur into the chuck until the bur securely engages. Swing the Latch Plate back to closed position. (Fig. 11) 3) Ensure that the bur is secure by gently pulling and pushing the bur. 10-2 To Remove the Bur FX23/FX25/FX25m Depress the Push Button to open the chuck (

) and remove the bur (

). (Fig. 12)

FX22 Turn the Latch Plate to open position and pull the bur out.

CAUTION ŘDo not use burs with problems listed below as the bur may break, seize up or disengage from the chuck. - Bent, deformed, worn, rusted, broken, deficient bur. - Bur which is cracked on the edge or axis. - Non-ISO(EN ISO) standard, or tampered bur. 7

ENGLISH

9. Connection & Disconnection of the Handpiece and Motor

10. Insertion & Removal of the Bur

Contra Angle Handpiece

strong acid/alkaline chemicals, chlorine-containing solutions, solvents such as benzine or thinner. ŘThe handpiece is delivered in a non-sterile condition and must be autoclaved prior to use. ŘPerform regular function and maintenance checks. (Refer to "15. Periodical Maintenance Checks") ŘI f the handpiece has not been used for a long period, rotate the handpiece and check for noise, vibration and overheating before use. ŘTo avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during treatment. ŘThe 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). ŘU.S. Federal law restricts this device to sale by or on the order of a licensed physician.

ŘD o not use burs other than specified in "16. Specifications" as such burs may be accidentally released or break during rotation. ŘA lways keep the bur shank clean. Dirt or debris in the chuck could cause poor bur concentricity or low chuck retention force. ŘA lways insert the bur all the way into the chuck. If insertion is insufficient, premature failure of the bearings or accidental release of the bur may occur. ŘDo not exceed Max. Bur Length shown in "16. Specifications". ŘA lways follow the instructions provided by the bur manufacturer. ŘDo not exceed the bur speed recommended by the bur manufacturer. ŘDo not insert or remove the bur until the rotation has completely stopped. ŘDo not apply excess pressure to the bur as it may break or bend or become difficult to remove.

11. Check before treatment 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. (Refer to "10. Insertion & Removal of the Bur") 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. 13).

CAUTION ŘTo avoid injury, keep your hands away from the bur during rotation.

8

12. Connection of the Spray Nozzle 1) Attach the Spray Nozzle to the handpiece head (Fig. 14). 2) Cut the Irrigation Tube to the desired length then connect to the Spray Tube Nozzle on the motor (Fig. 14).

13. Post-use Maintenance After each patient maintain the product as follows.

WARNING ŘImmediately after a treatment, the handpiece should be cleaned, lubricated and sterilized. Failure to properly maintain the handpiece may lead to overheating, causing burn injuries or product failure.

CAUTION ŘD o 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. 13-1 Preparation 1) Wear a eye protection, a mask and gloves to avoid infection. 2) Remove the bur. 3) Disconnect the handpiece from the motor. 13-2 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 ŘA fter 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. 13-3 Disinfection Manual Disinfection (External Surface) Wipe the surface with cloth soaked in disinfectant solution such as alcohol. Automatic Disinfection (External and Internal Surfaces) (Only for FX25m) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual. 13-4 Lubrication NSK PANA SPRAY Plus / PANA SPRAY Apply NSK PANA SPRAY Plus / PANA SPRAY every time after each use and/or before autoclaving. 1) Attach the Spray Nozzle into the Spray Port nozzle on the can. 2) Insert the Spray Nozzle into the 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. 15).

NOTICE ŘN SK recommends the use of "Spray Mist Absorber" (Y900084) to prevent oil mist expelling out of the handpiece head.

9

ENGLISH

Automatic Cleaning (External and Internal Surfaces) (Only for FX25m) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual.

CAUTION ŘHold the spray can upright. ŘB e sure to hold the handpiece firmly to prevent slipping out of hand by the spray pressure when lubricating. ŘSupply lubricant until it comes out of the handpiece head. ŘIf you wish to expel excessive oil from inside of the handpiece, rotate the handpiece for approx.15 seconds without a bur. 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. (Except for FX22)

Contra Angle Handpiece

CAUTION ŘIf water comes inside the handpiece, blow air into the rear of the handpiece using an air syringe and remove the remaining water.

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

WARNING ŘIf blood infiltrates inside a handpiece, an automatic handpiece cleaning and lubrication system may not totally clean the internal handpiece components, which may lead to internal blood coagulation. Coagulated blood inside the handpiece may cause handpiece failure and overheating, causing burn injuries. To avoid the risk, NSK recommends to immediately lubricate those handpieces with PANA SPRAY Plus / PANA SPRAY. 13-5 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.

CAUTION ŘBe 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. ŘDo 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. ŘDo not heat or cool the product too quickly. Rapid change in temperature could cause damage to the product. ŘTo 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. ŘKeep the product in suitable atmospheric pressure, temperature, humidity, ventilation, and sunlight. The air should be free from dust, salt and sulphur. 10

ŘDo not touch the product immediately after autoclaving as it will be very hot and must remain in a sterile condition. ŘAutoclave sterilization is recommended for the product. The validity of other sterilization methods is not confirmed.

NOTICE ŘN SK recommends Class B sterilizers as stated in EN 13060.

14. Replacing the Cartridge 1) Detach the shank by turning it counter clockwise and remove the head from the shank (Fig.16).

CAUTION ŘAfter removing, do not hold the shank upside down as it could cause the internal parts to drop. 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).

A-2

Hold tight!

B

CAUTION ŘBe 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. ŘWhen removing the drive shaft, tightly hold the FX wrench as directed in Fig. B. FX23/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. 17). 5) Use the bur to gently push the entire cartridge out from the head (Fig. 18). 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. 19). 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

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. 20). 5) Use the bur to gently push the entire cartridge out from the head (Fig. 21). 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. 22). 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 "25. Spare Parts List" to identify the correct cartridge.

ENGLISH

A-1

Contra Angle Handpiece

again. 11) Reattach the shank. *Refer to "25. Spare Parts List" to identify the correct cartridge.

CAUTION ŘBefore 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. ŘS ecure 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. ŘU se only a genuine NSK cartridge. If a non genuine cartridge is used NSK cannot guarantee performance and the handpiece warranty would become invalid. ŘA lways first finger tighten the head cap then secure firmly with the wrench. ŘN SK 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. 11

15. 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 (FX22) is loose Tighten firmly using the correct head cap wrench or cap wrench. Rotation Rotate the handpiece and check for abnormalities such as abnormal rotation, vibration, noise, and overheating.

16. Specifications Model Max. Rotation Speed (Motor) Max. Rotation Speed (Handpiece) Gear Ratio Bur Type Chuck Type Chucking Length Max. Bur Length Max. Working Part Diameter Use Environment Transportation and Store Environment Thermo Disinfector

12

FX22 FX23 FX25 FX25m 30,000 min-1 40,000 min-1 30,000 min-1 40,000 min-1 1:1 Direct Drive ISO 1797-1 Type1 ø2.35mm CA Bur Latch Type Push Button Type 13.2mm 12.7mm 22.5mm ø4.0mm Temperature: 10 - 40°C, Humidity: 30 - 75% (No Condensation) Temperature: -10 - 50°C, Humidity: 10 - 85%, Atmospheric Pressure: 500 - 1,060hPa -

Straight Handpiece (FX65/FX65m) CAUTION ŘRead this Operation Manual before use to fully understand the product functions and file for future reference. ŘWhen operating the product always consider the safety of the patient. ŘU sers are responsible for the operational control, maintenance and continual inspection of this product. ŘDo not disassemble or alter the handpiece except as recommended by NSK in this Operation Manual. ŘDo not allow any impact on to the product. Do not drop the product. ŘO perators and all others in the area must wear eye protection and a mask when operating this handpiece. ŘShould the handpiece function abnormally during use, stop using the handpiece immediately and contact your Authorized NSK Dealer. ŘD o 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. ŘThe handpiece is delivered in a non-sterile condition and must be autoclaved prior to use. ŘPerform regular function and maintenance checks. (Refer to "21. Periodical Maintenance Checks") ŘI f the handpiece has not been used for a long period, rotate the handpiece and check for noise, vibration and overheating before use. ŘTo avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during treatment. ŘU.S. Federal law restricts this device to sale by or on the order of a licensed physician.

17-2 Disconnection Hold the motor and the handpiece separately and disconnect with care.

CAUTION ŘDisconnect the handpiece only after the motor has completely stopped rotating.

18. Insertion & Removal of the Bur 18-1 To Insert the Bur 1) Turn the Bur Lock Ring in the direction of the " " mark until it clicks. (Fig. 23) 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 th e bur. 18-2 To Remove the Bur Turn the Bur Lock Ring in the direction of the "

" mark until it clicks then remove the bur.

WARNING

CAUTION ŘA lways insert the bur fully into the chuck. Insufficient insertion of the bur could cause premature failure of the bearing. ŘRemove the bur only after the handpiece has completely stopped rotating. ŘDo not rotate the handpiece when the Bur Lock Ring is turned to " " (OPEN) position or a bur is not inserted. ŘA lways 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. ŘDo not exceed the bur speed recommended by the bur manufacturer. ŘDo not exceed maximum bur length recommended by the handpiece manufacturer. ŘDo not apply excess pressure to the bur as it may break or bend or become difficult to remove. ŘDO 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.

ENGLISH

17-1 Connection 1) Connect the handpiece direct to the motor. (Fig. 2) 2) Make sure the handpiece is firmly connected to the motor.

Straight Handpiece

17. Connection & Disconnection of the Handpiece and Motor

19. 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.

CAUTION ŘTo avoid injury, keep your hands away from the bur during rotation.

ŘMake sure to align the mark with " " mark. If those marks are not completely aligned, it may cause handpiece overheating or patient burn injuries.

13

20. Post-use Maintenance After each patient maintain the product as follows.

WARNING ŘImmediately after a treatment, the handpiece should be cleaned, lubricated and sterilized. Failure to properly maintain the handpiece may lead to overheating, causing burn injuries or product failure.

CAUTION ŘD o 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. 20-1 Preparation 1) Wear a eye protection, a mask and gloves to avoid infection. 2) Remove the bur. 3) Disconnect the handpiece from the motor. 20-2 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 ŘIf water comes inside the handpiece, blow air into the rear of the handpiece using an air syringe and remove the remaining water.

14

Automatic Cleaning (External and Internal Surfaces) (Only for FX65m) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual.

CAUTION ŘA fter 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. 20-3 Disinfection Manual Disinfection (External Surface) Wipe the surface with cloth soaked in disinfectant solution such as alcohol. Automatic Disinfection (External and Internal Surfaces) (Only for FX65m) Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883). Refer to the thermo-disinfector manual. 20-4 Lubrication NSK PANA SPRAY Plus / PANA SPRAY Apply NSK PANA SPRAY Plus / PANA SPRAY every time after each use and/or before autoclaving. 1) Attach the Spray Nozzle into the Spray Port nozzle on the can. 2) Insert the Spray Nozzle into the 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. 15).

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

WARNING ŘIf blood infiltrates inside a handpiece, an automatic handpiece cleaning and lubrication system may not totally clean the internal handpiece components, which may lead to internal blood coagulation. Coagulated blood inside the handpiece may cause handpiece failure and overheating, causing burn injuries. To avoid the risk, NSK recommends to immediately lubricate those handpieces with PANA SPRAY Plus / PANA SPRAY. 20-5 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.

ENGLISH

NOTICE ŘN SK recommends the use of "Spray Mist Absorber" (Y900084) to prevent oil mist expelling out of the handpiece head.

CAUTION ŘBe 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. ŘDo 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. ŘDo not heat or cool the product too quickly. Rapid change in temperature could cause damage to the product. ŘTo 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. ŘKeep the product in suitable atmospheric pressure, temperature, humidity, ventilation, and sunlight. The air should be free from dust, salt and sulphur. ŘDo not touch the product immediately after autoclaving as it will be very hot and must remain in a sterile condition. ŘAutoclave sterilization is recommended for the product. The validity of other sterilization methods is not confirmed.

Straight Handpiece

CAUTION ŘHold the spray can upright. ŘB e sure to hold the handpiece firmly to prevent slipping out of hand by the spray pressure when lubricating. ŘSupply lubricant until it comes out of the handpiece head.

NOTICE ŘN SK recommends Class B sterilizers as stated in EN 13060.

21. 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. Points to check Details Rotation Rotate the handpiece and check for abnormalities such as abnormal rotation, vibration, noise, and overheating. 15

22. Specifications Model Max. Rotation Speed (Motor) Max. Rotation Speed (Handpiece) Gear Ratio Bur Type Chucking Length Max. Bur Length Max. Working Part Diameter Use Environment Transportation and Store Environment Thermo Disinfector

Air Motor/Contra Angle Handpiece/Straight Handpiece FX65

FX65m

40,000 min-1 40,000 min-1 1:1 Direct Drive ISO 1797-1 Type2 ø2.35mm HP Bur / ISO 14457 2012 Prophy Handpiece 30mm 44.5mm ø4mm Temperature: 10 - 40°C, Humidity: 30 - 75% (No Condensation) Temperature: -10 - 50°C, Humidity: 10 - 85%, Atmospheric Pressure: 500 - 1,060hPa -

23. Symbol This product is Autoclavable up to Max.135°C. This product can be washed via Thermo Disinfector. Conforms to CE European Directive of “Medical device 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.

24. 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.

25. Option Parts List Model MG-4H Multi Gauge MG-2/3H Multi Gauge Spray Nozzle

16

Order Code Z109400 Z109200 H019711

Compatible Product FX205 M4/FX205m M4 FX205 B2/FX205m B2 FX65/FX65m

Order Code C032701 C1052702 C030011 C1056700 C1052700 C1052500 10000996 10000946 C1052701 C071751 Z019090

Compatible Product FX22 FX23/FX25/FX25m FX22 FX23 FX25/FX25m FX23/FX25/FX25m FX22 FX23/FX25/FX25m FX22/FX23/FX25/FX25m FX22 FX22/FX23/FX25/FX25m/FX65/FX65m

Remarks Cartridge Cartridge Cartridge Head Cap Drive Shaft Drive Shaft -

ENGLISH

Model Spray Nozzle FX Spray Nozzle NAC-03 FX23-03 FX25-03 FX25-04 FX22-02 FX25-02 FX Wrench Cap Wrench E-Type Spray Nozzle

Straight Handpiece

26. Spare Parts List

27. Disposing product 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.

17

2022-03-22 CACC0427 05E