Ti-Max Z Z-SG45L and Z-SG45 Surgical Contra Angle Handpiece Operation Manual Oct 2015

User: Qualified Professionals Indications for Use: This medical device is intended for transmitting rotation of the power source at an increasing gear ratio, thereby running the instrument such as a bur or a reamer to cut and polish natural or artificial teeth during dental treatment and to cut teeth or maxillary/mandibular bones during oral surgery.

ENGLISH

1. User and Indications for Use

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. 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.

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WARNING

• Immediately after a surgery, the handpiece should be cleaned, lubricated and sterilized. Failure to properly maintain the handpiece can lead to contaminants remaining inside the handpiece. Unremoved blood may result in product failure due to the internal blood coagulation. Improper maintenance may also lead to overheating, causing burn injuries, product failure, or difficulty in attaching and detaching the bur. (Refer to "8. Post-use Maintenance") • Depressing 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. • Supply coolant water through the spray nozzle while using the handpiece. Other water supply methods than recommended may lead to overheating causing burn injuries, or product failure. • Do not use the handpiece for prophylaxis 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. • Keep 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.

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EN

WARNING

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• Ball bearings are wear items and may require replacement. Be sure to inspect the handpiece before use (Refer to "7. Checking the Handpiece Before Each Use"). 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.

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CAUTION

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• 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. • Users are responsible for the operational control, maintenance and continual inspection of this product. • 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") • Do not disassemble or alter the handpiece except as recommended by NSK in this Operation Manual. • Do not allow any impact on to the product. Do not drop the product.

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CAUTION

• Operators and all others in the area must wear eye protection and a mask when operating this handpiece. • Do 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. • Do not use burs other than specified in "10. Specifications" as such burs may be accidentally released or break during rotation. • Always keep the bur shank clean. Dirt or debris in the chuck could cause poor bur concentricity or low chuck retention force. • Always 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. • Do not exceed Max. Bur Length shown in "10. Specifications". • 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. • Always follow the instructions provided by the bur manufacturer. • Do not exceed the bur speed recommended by the bur manufacturer. • Should the handpiece function abnormally during use, stop using the handpiece immediately and contact your Authorized NSK Dealer. 4

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CAUTION

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Quantity 1 1

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Part Name E Type Spray Nozzle Purge Nozzle

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No. 1 2

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3. Accessory List

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• Do not use the following fluids to wipe, immerse or clean the product; strong/super acid water, strong acid/alkaline chemicals, chlorinecontaining solutions, solvents such as benzine or thinner. • The handpiece is delivered in a non-sterile condition and must be autoclaved prior to use. • Perform regular function and maintenance checks. (Refer to "9. Periodical Maintenance Checks") • If the handpiece has not been used for a long period, rotate the handpiece and check for noise, vibration and overheating before use. • To avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during treatment. • 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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4. Connecting and Disconnecting the Handpiece and the Motor 4-1 Connecting 1) Insert the handpiece direct into the motor (Fig. 1). When connecting an optic handpiece, turn the handpiece until it clicks and locks into position. 2) Confirm that the handpiece is firmly connected to the motor. 4-2 Disconnecting Hold the motor and the handpiece, then pull apart.

CAUTION

• Do not connect or disconnect the handpiece until the motor has completely stopped. • Connect ONLY to E type motors (ISO 3964 (EN ISO 3964)). • Do not exceed the Max. Rotation Speed (Motor) shown in "10. Specifications". 6

Handpiece

Motor

Fig. 1

Push Button

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5-1 Inserting the Bur 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 not removed by gently pulling and pushing the bur without depressing the Push Button.

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5. Inserting and Removing the Bur

Fig. 2 ES

NOTICE

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• Grip the handpiece while placing your thumb tip on the Push button which makes it easier to depress the button.

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

) and remove the bur (

).

Push Button

Fig. 3

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EN

CAUTION

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• Do 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. • Do not use burs other than specified in "10. Specifications" as such burs may be accidentally released or break during rotation. • Always keep the bur shank clean. Dirt or debris in the chuck could cause poor bur concentricity or low chuck retention force. • Always 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. • Do not exceed Max. Bur Length shown in "10. Specifications". • 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. • Always follow the instructions provided by the bur manufacturer. • Do not exceed the bur speed recommended by the bur manufacturer. • Do not mount or remove the bur until the motor has completely stopped. • Do not apply excess pressure to the bur as it may break or bend or become difficult to remove.

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CAUTION • When using a bur with a length of 20-25mm, the working diameter must be within the value specified in the table below. The use of a bur with a diameter that exceeds the specified values may result in a bur run out and cause the bur to bend or break. øa

Diamond Bur : ø2mm or less Carbide Bur : ø1mm or less

øa

ø1.59-1.60mm 20 - 25mm

ø1.59-1.60mm

øa 20 - 25mm

Water

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Be careful of overheating when using some types of carbide bur, as the coolant water (in “water jet” mode) cannot reach the bur tip because of the shape of the tip.

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6. Connection of the Irrigation Tube

Irrigation Tube

Connect the Irrigation Tube to the External Spray Nozzle firmly (Fig. 4). DE FR

Irrigation Tube

Fig. 4 ES IT PT

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7. Checking the Handpiece Before Each Use Follow the check 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 the coolant water is flowing properly. 3) Mount the bur. (Refer to "5. Mounting and Removing the Bur") 4) Rotate the handpiece for about one minute with coolant water at the Max. rotation speed of the attached motor. 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. 5).

CAUTION

• To avoid injury, keep your hands away from the bur during rotation. 12

Fig. 5

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

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WARNING

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CAUTION

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• Do not use the following fluids to wipe, immerse or clean the product; strong/super acid water, strong acid/alkaline chemicals, chlorinecontaining solutions, solvents such as benzine or thinner. • Do not rotate the handpiece in water as such operation may cause handpiece failure.

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• Immediately after a surgery, the handpiece should be cleaned, lubricated and sterilized. Failure to properly maintain the handpiece can lead to contaminants remaining inside the handpiece. Unremoved blood may result in product failure due to the internal blood coagulation. Improper maintenance may also lead to overheating, causing burn injuries, product failure, or difficulty in attaching and detaching the bur.

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8-1 Preparation 1) Wear a eye protection, a mask and gloves to avoid infection. 2) Remove the bur. 3) Disconnect the handpiece from the motor. 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

• When cleaning debris off the handpiece surface, make sure no water enters from the rear side of the handpiece as entry of water may cause handpiece malfunction. If water comes inside the handpiece, blow air into the rear of the handpiece using an air syringe and remove the remaining 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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• After washing with thermo-disinfector and prior to lubrication, dry the product until all internal moisture is thoroughly removed. Thermodisinfector moisture remaining inside the product could reduce the effect of lubrication and could cause corrosion inside of the product.

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8-3 Cleaning (Optic) Wipe clean the Glass Rod tip with an alcohol-immersed cotton swab. Remove all debris and oil. Glass Rod Cotton Swab

Fig. 6

CAUTION

• Do not use a sharp tool to clean the Glass Rod. It could damage the glass and reduce the light transmission. 8-4 Cleaning (Spray Port) Insert the Irrigation Tube into the nozzle and rinse the inside with clean water. 16

EN

8-5 Disinfection Manual Disinfection (External Surface) Wipe the surface with cloth soaked in disinfectant solution such as alcohol.

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Automatic Disinfection (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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8-6 Lubrication NSK PANA SPRAY Plus Apply NSK PANA SPRAY Plus 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. 7).

E-Type Spray Nozzle

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Handpiece

Fig. 7

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3) Insert the Purge Nozzle into the rear of the handpiece until it is locked in place with a clicking sound (Fig. 8 ). 4) Insert an air syringe/air blow gun into the Purge Nozzle. Then blow air for 30 seconds or more to purge excess oil inside the handpiece (Fig. 8 ).

WARNING

1

2

Air Syringe

Purge Nozzle

• Excess oil remaining inside the handpiece may cause overheating of the handpiece which could lead to a burn injury.

CAUTION

• Debris and blood could enter the product during surgical operations. To avoid accumulation of debris inside the product, NSK recommends lubrication with PANA SPRAY Plus immediately after use and before sterilization. • 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. 18

Fig. 8

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Bur Insertion Hole

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Tip Nozzle

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Chuck cleaning Clean the Push Button chuck once a week. 1) Mount the Tip Nozzle into the spray can port. 2) Lubricate the chuck directly through the bur insertion hole (Fig. 9). 3) Lubricate handpiece by using NSK PANA SPRAY Plus (Fig. 7) or NSK automatic handpiece cleaning and lubrication system.

Fig. 9 ES

CAUTION

• If the chuck is not regularly cleaned the chuck grip may be weakened and the bur may be accidentally released during use. IT PT

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