TI-Max X S-Max Series Surgical Handpiece Operation Manual Oct 2015

Class WARNING CAUTION NOTICE

Degree of Risk Hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed. Hazard that could result in light or moderate injury or damage to the device if the safety instructions are not correctly followed. General product specification information highlighted to avoid product malfunction and performance reduction.

WARNING

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CAUTION

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Ř When operating the product always consider patient safety. 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")

EN

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CAUTION

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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 Only X-SG20L / SG20 can use drill. Ř Do not use bur/drills with problems listed below as the bur/drill may break, seize up or disengage from the chuck. - Bent, deformed, worn, rusted, broken, deficient bur/drill. - Bur/drill which is cracked on the edge or axis. - Non-ISO(EN ISO) standard, or tampered bur/drill. Ř Do not use bur/drills other than specified in "10. Specifications" as such bur/drills may be accidentally released or break during rotation. Ř Always keep the bur/drill shank clean. Dirt or debris in the chuck could cause poor bur/drill concentricity or low chuck retention force. Ř Always insert the bur/drill all the way into the chuck. If insertion is insufficient, premature failure of the bearings or accidental release of the bur may occur. Ř Do not exceed Max. Bur/Drill Length shown in "10. Specifications". Ř Always follow the instructions provided by the bur/Drill manufacturer.

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X-SG93L / X-SG93 Ř Do not use a surgical bur with its maximum length of 25mm or longer. Using such bur with this handpiece may lead to premature abrasion of the bearings. In addition, sudden release, bend or breakage of the bur may occur.

EN

CAUTION Ř Do not exceed the bur/drill speed recommended by the bur/drill manufacturer. 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 "9. 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. 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).

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3. Accessory List No. 1 2 3 4 5

Part Name Internal Spray Nozzle Nozzle Holder Y-Connector Cleaning Wire E-Type Spray Nozzle

Quantity 1 1 1 1 1

Remarks Included in the package for X-SG20L / SG20 Included in the package for X-SG20L / SG20 Included in the package for X-SG20L / SG20 Included in the package for X-SG20L / X-SG25L / SG20 -

4. Connecting and Disconnecting the Handpiece from the Motor 4-1 Connecting 1) Insert the handpiece direct into the motor (Fig. 1). Turn the handpiece until it clicks and locks into position. 2) Confirm that the handpiece is securely connected to the motor. Handpiece

4-2 Disconnecting 6 Hold the motor and the handpiece, then pull apart.

Motor

Fig. 1

IT PT

5-1 Inserting the Bur/Drill

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5. Inserting and Removing the Bur/Drill

FR

SG20 Ř The handpiece is designed for connection to a NSK Non-optic motor or to a motor with a stopper pin. Connection to any other type of motor cannot lock the handpiece.

DE

X-SG20L / SG20 Ř This handpiece is intended for use only with Surgical Units with Torque Calibration System such as NSK Surgic Pro. Using this product with other surgical units may damage the handpiece or bone.

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 "10. Specifications".

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X-SG20L / X-SG25L / SG20 (Fig. 2) 1) Insert the bur/drill until it is correctly secured in place. 2) Depress the Push Button and insert the bur into the chuck until the bur "notch" mechanism engages. Release the button. 3) Confirm that the bur/drill is secure by gently pulling and pushing the bur/drill without depressing the Push Button.

Push Button

D-shape

CAUTION

Fig. 2

Ř Only X-SG20L / SG20 can use drill. Push Button

X-SG93L / X-SG93 (Fig. 3) 1) Insert the bur into the chuck. 2) Depress the Push Button to open the chuck ( ). 3) Insert the bur fully into the chuck until it stops ( ) then release the Push Button. 4) Confirm that the bur is secure by gently pulling and pushing the bur without depressing the Push Button. 8

Fig. 3

EN

NOTICE

) and, while the chuck is open, remove the bur/drill (

Push Button

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Ř Do not use bur/drills with problems listed below as the bur/drill may break, seize up or disengage from the chuck. - Bent, deformed, worn, rusted, broken, deficient bur/drill. - Bur/drill which is cracked on the edge or axis. - Non-ISO(EN ISO) standard, or tampered bur/drill. Ř Do not use bur/drills other than specified in "10. Specifications" as such bur/drills may be accidentally released or break during rotation.

).

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CAUTION

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5-2 Removing the Bur Depress the Push Button to open the chuck (

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Ř For easy operation of the Chuck Release Button, simply grip the handpiece and use your thumb tip to press the Chuck Release Button.

Fig. 4

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CAUTION Ř Always keep the bur/drill shank clean. Debris in the chuck could cause poor bur/drill concentricity or low chuck retention force. Ř Always insert the bur/drill all the way into the chuck. If insertion is insufficient, premature failure of the handpiece head bearings, or accidental release of the bur/drill, may occur. Ř Do not exceed Max. Bur/Drill Length shown in "10. Specifications". Ř Do not exceed the bur/drill speed recommended by the bur/drill manufacturer. Ř Do not insert or remove the bur/drill until rotation has completely stopped. Ř Do not apply excess pressure to the bur/drill as it may break or bend and become difficult to remove. Ř After the bur/drill is locked in place, pull and push the bur/drill to make sure the bur/drill is locked. Ř Depress the push button until it is almost parallel to the head cap. Ř If removing the bur/drill is difficult, grip the bur with fine pliers while depressing the Push-button, and gently remove the bur/ drill. This situation can be avoided by frequently mounting and removing the bur/drill.

6. Spray Nozzle Three irrigation methods are available for X-SG20L / SG20; External, Internal or both simultaneously, depending on the instrument 10 and operation procedure.

Nozzle Holder

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Fig. 5

Fig. 6 ES

Internal Spray Nozzle

Irrigation Tube IT

6-2 Internal Spray Nozzle Only for a drill with internal irrigation system. 1) Attach the Nozzle Holder. (Fig.6) 2) Connect the Irrigation Tube to the Internal Spray Nozzle firmly. (Fig.7) 3) Insert the end of the Internal Spray Nozzle into the hole at the top of the handpiece head, then attach the Internal Spray Nozzle into the slot on the Nozzle Holder. (Fig.8)

Irrigation Tube External Spray Nozzle

EN

6-1 External Spray Nozzle Connect the Irrigation Tube to the External Spray Nozzle firmly. (Fig. 5)

PT

Fig. 7

Fig. 8

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6-3 Simultaneous External and Internal Irrigation 1) Connect one end of the Y-Connector to the External Spray Nozzle and the other end into the Internal Spray Nozzle. (Refer to "6-1, 6-2") 2) Connect the Irrigation Tube to the Y-Connector firmly. (Fig.9)

Y-Connector

Irrigation Tube

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 is firmly tightened. 2) Check coolant water is flowing properly. 3) Insert the bur. (Refer to "5. Inserting and Removing the Bur/Drill") 4) Rotate the handpiece for about one minute, using coolant water, and with the motor operating at full speed. During rotation, check for abnormalities such as abnormal rotation, vibration, noise. 5) After the handpiece rotation has completely stopped, touch the handpiece head to confirm the head is NOT heating abnormally (Fig. 10). 12

Fig. 9

Fig. 10

EN

CAUTION Ř To avoid injury, keep your hands away from the bur/drill during rotation.

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8. Post-use Maintenance FR

After each patient maintain the product as follows.

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CAUTION PT

Ř Do not use the following fluids to wipe, immerse or clean the product; storng / super acid water, strong acid / alkaline chemicals, chlorine-containing solutions, solvents such as benzine or thinner.

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8-1 Preparation 1) Wear eye protection, a mask and gloves to avoid infection. 2) Remove the bur/drill. 3) (Only for X-SG20L / SG20) Immerse about 20mm of the handpiece head in water, and rotate the handpiece for about 15 seconds while switching the Forward/Reverse rotation direction (Fig. 11) 4) Disconnect the handpiece from the motor. Fig. 11 8-2 Cleaning Manual Cleaning (External Surface) 1) Remove debris on the handpiece surface using a brush under running water (at 38r C or less). Do NOT use a wire brush. 2) Wipe off moisture on the surface using an absorbent cloth.

CAUTION Ř If water enters the handpiece, using an air syringe, blow air into the rear of the handpiece to remove the internal water. 14

EN

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

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CAUTION

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Cotton Swab

IT

8-3 Cleaning of Optic Illumination Points Wipe clean all Optic Illumination Points (Glass Rod) using an alcohol-immersed cotton swab. Remove all debris and oil.

Glass Rod

Fig. 12

PT

CAUTION Ř Do not use a sharp tool to clean the Glass Rod. It could damage the glass and reduce the light transmission.

FR

Ř After washing with thermo-disinfector, prior to lubrication, dry the product until all internal moisture is completely removed. Thermo-disinfector moisture remaining inside the product could reduce the effect of lubrication and could cause corrosion inside of the product.

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8-4 Cleaning (Spray Port) 1) Internally clean the Internal Spray Nozzle and/ or the External Spray Nozzle by using Cleaning Wire. (Fig. 13,14) (X-SG20L / X-SG25L / SG20) 2) Connect the Irrigation Tube to each Spray Nozzle, and wash the inside with clean water. (Refer to "6. Spray Nozzle") (X-SG20L / X-SG25L / X-SG93L / X-SG93 / SG20)

Cleaning Wire

Internal Spray Nozzle

Fig. 13

External Spray Nozzle

Fig. 14

CAUTION Ř Do not forcibly insert the cleaning wire into the Spray Nozzle. Resultant port damage could cause the spray to be directed away from the bur/drill, and cause reduction of cooling efficiency. 8-5 Disinfection Manual Disinfection (External Surface) Wipe the surface with cloth soaked in disinfectant solution such as alcohol. 16

EN

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

DE FR

8-6 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 CORRECT Spray Nozzle onto the spray port nozzle on the can. 2) Insert the Spray Nozzle into the rear of the handpiece. Hold the handpiece and spray E-Type Spray Nozzle 2-3 times for approximately 2-3 seconds each time. Apply lubricant until it expels from the handpiece head for at least 2 seconds (Fig. 15).

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Handpiece PT

Fig. 15 17

CAUTION Ř Hold the spray can upright. Ř Firmly hold the handpiece to prevent it slipping when spray pressure is applied. Ř Spray lubricant until it expels from the handpiece head. Ř If you wish to purge excessive oil from inside the handpiece, rotate the handpiece for approx 15 seconds without a bur/ file. During the rotation, do not depress the chuck release button, especially when using absorbent cloth to prevent oil from scattering. Depressing the push button during rotation may damage the chuck mechanism.

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Fig. 16

Fig. 17

EN

NOTICE Ř NSK recommends the use of͆Spray Mist Absorber͇(Y900084) to prevent oil mist expelling out of the handpiece head.

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Tip Nozzle

Fig. 18

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8-7 Sterilization Sterilize the product by autoclave sterilization. After each patient sterilize as noted below. The following items can be autoclaved: Handpiece, Internal Spray Nozzle, Nozzle Holder

Bur Insertion Hole FR

CAUTION Ř If the chuck is not regularly cleaned the chuck grip may be weakened and the bur may be accidentally released during use.

DE

Chuck cleaning (X-SG93L / X-SG93) Clean the Push Button chuck once a week. 1) Mount the Tip Nozzle onto the spray can port. 2) Lubricate the chuck directly where the bur is inserted (Fig. 18). 3) Lubricate handpiece by using NSK PANA SPRAY Plus / PANA SPRAY (Fig. 15) or NSK automatic handpiece cleaning and lubrication system.

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1) Insert into an autoclave pouch. Seal the pouch. 2) Autoclavable under the conditions below. Autoclave for more than 20min. at 121r C, or 15min. at 132r C, or 3min. at 134r C. 3) The handpiece should remain in the autoclave pouch until required for use.

CAUTION

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Ř 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 that exceeds a cycle temperature of 138r C, including the dry cycle. In some sterilizers, the chamber temperature may exceed 138r C. Contact the sterilizer manufacturer for detailed information about cycle temperatures. 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.