NSK Ti-Max X10L User manual

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ENGLISH
1. User and Indications for Use
User: Qualified Professionals
Indications for Use: 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.
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 Degree of Risk
WARNING Hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed.
CAUTION Hazard that could result in light or moderate injury or damage to the device if the safety instructions are not correctly
followed.
NOTICE General product specification information highlighted to avoid product malfunction and performance reduction.

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WARNING
•Immediately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"7.Post-useMaintenance")
•Ifbloodinfiltratesinsideahandpiece,anautomatichandpiececleaningandlubricationsystemmaynottotallycleanthe
internalhandpiececomponentsandmayleadtobloodcoagulationinsidethehandpiece.Coagulatedblood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.
•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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.
•Donotusethehandpieceforprophylaxispurposes.Polishingpastecouldenterthehandpiece,causingthefailureofthe
PushButtonorcause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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WARNING
• Ballbearings,intime,willbecomewornandwillrequirereplacement.Besuretoinspectthehandpiecebeforeuse(Referto"6.CheckingtheHandpiece
BeforeEachUse").Ifabnormalvibrationornoisearefound,thebearingsorotherinternalpartsmayrequirereplacement.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.
CAUTION
•When operating the product always consider patient safety.
•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 "6. 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.
•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 "9. Specifications" as such burs may be accidentally released or break during rotation.
•Always keep the bur shank clean. 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 handpiece head bearings, or accidental release of the bur, may occur.

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CAUTION
•Do not exceed Max. Bur Length shown in "9. Specifications".
•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.
•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.
•The handpiece is delivered in a non-sterile condition and must be autoclaved prior to use.
•Perform regular function and maintenance checks. (Refer to "8. 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).
•U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
X85L / X85
•Use a short shank FG bur for the product because the handpiece has the miniature head. Using a long bur with this handpiece may lead to
premature abrasion of the bearings. In addition, sudden release, bend or breakage of the bur may occur.
X95L / X95
•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.

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3. Accessory List
No. Part Name Quantity
1 E-Type Spray Nozzle 1
CAUTION
4. Connecting and Disconnecting the Handpiece from 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 securely connected to the motor.
4-2 Disconnecting
Hold the motor and the handpiece, then pull apart.
•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 "9. Specifications".
Handpiece Motor
Fig. 1

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5. Inserting and Removing the Bur
5-1 Inserting the Bur
X10L / X10 / X12L / X12 / X15L / X15 / X25L / X25 (Fig. 2)
1) Insert the bur 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 is secure by gently pulling and pushing the bur without depressing the Push
Button.
X20L / X20 / X85L / X85 / X95L / X95 (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.
D-shape
Push Button
Fig. 2
Push Button
Fig. 3

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NOTICE
•For easy operation of the Chuck Release Button simply grip the handpiece and use your thumb tip to press the Chuck Release Button.
5-2 Removing the Bur
Depress the Chuck Release Button to open the chuck ( ) and, while the chuck is open, remove the bur
( ).
CAUTION
•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.
Push Button
Fig. 4

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CAUTION
•Do not use burs other than specified in "9. Specifications" as such burs may be accidentally released or break during rotation.
•Always keep the bur shank clean. 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 handpiece head bearings, or accidental release of the bur, may occur.
•Do not exceed Max. Bur Length shown in "9. Specifications".
•Always follow the instructions provided by the bur manufacturer.
•Do not exceed the bur speed recommended by the bur manufacturer.
•Do not insert or remove the bur until rotation has completely stopped.
•Do not apply excess pressure to the bur as it may break or bend and become difficult to remove.
6. 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")
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. 5). Fig. 5

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7. Post-use Maintenance
After each patient maintain the product as follows.
WARNING
•Immediately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
•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.
7-1 Preparation
1) Wear eye protection, a mask and gloves to avoid infection.
2) Remove the bur.
3) Disconnect the handpiece from the motor.
CAUTION
•To avoid injury, keep your hands away from the bur during rotation.

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Automatic Cleaning (External and Internal Surfaces)
Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883).
Refer to the thermo-disinfector manual.
CAUTION
•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.
7-2 Cleaning
Manual Cleaning (External Surface)
1) Remove 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 moisture on the surface using an absorbent cloth.
CAUTION
•If water enters the handpiece, using an air syringe, blow air into the rear of the handpiece to remove the internal water.

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7-3 Cleaning of Optic Illumination Points
Wipe clean all Optic Illumination Points (Glass Rod) using an alcohol-immersed cotton swab.
Remove all debris and oil.
CAUTION
•Do not use a sharp tool to clean the Glass Rod. It could damage the glass and reduce the light transmission.
Glass Rod
Cotton Swab
Fig. 6
7-4 Disinfection
Manual Disinfection (External Surface)
Wipe the surface with cloth soaked in disinfectant solution such as alcohol.
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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7-5 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 for approximately
2-3 seconds. Apply lubricant until it expels from the handpiece head for at least 2 seconds (Fig. 7).
CAUTION
•Hold the spray can upright.
•Firmly hold the handpiece to prevent it slipping when spray pressure is applied.
•Spray lubricant until it expels from the handpiece head.
E-Type Spray
Nozzle
Handpiece
Fig. 7

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CAUTION
•If you wish to purge excessive oil from inside the handpiece, rotate the handpiece for approx 15 seconds without a bur. 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.
Fig. 8 Fig. 9
NOTICE
•NSK recommends the use of "Spray Mist Absorber" (Y900084) to prevent oil mist expelling out of the handpiece head.

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CAUTION
•If the chuck is not regularly cleaned the chuck grip may be weakened and the bur may be accidentally released during use.
Chuck cleaning (X20L / X20 / X85L / X85 / X95L / X95)
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. 10).
3) Lubricate handpiece by using NSK PANA SPRAY Plus / PANA SPRAY (Fig. 7) or NSK automatic handpiece
cleaning and lubrication system.
Bur Insertion Hole
Tip Nozzle
Fig. 10

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WARNING
•Ifbloodinfiltratesinsideahandpiece,anautomatichandpiececleaningandlubricationsystemmaynottotally
cleantheinternalhandpiececomponentsandmayleadtobloodcoagulationinsidethehandpiece.Coagulated
blood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.
7-6 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.
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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CAUTION
•Clean and lubricate the handpiece prior to autoclaving. If blood remains on the internal surface it can become clotted and cause product
failure.
•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.
•Do not heat or cool the product too quickly. Rapid change in temperature could cause damage to the product.
•To avoid product failure, do not use a sterilizer that exceeds a cycle temperature of 138°C, including the dry cycle. In some sterilizers, the
chamber temperature may exceed 138°C. Contact the sterilizer manufacturer for detailed information about cycle temperatures.
•Keep the product in suitable atmospheric pressure, temperature, humidity, ventilation, and sunlight. The air should be free from dust, salt and
sulphur.
•Do not touch the product immediately after autoclaving as it will be very hot and must remain in a sterile condition.
•Autoclave sterilization is recommended for the product. The validity of other sterilization methods is not confirmed.
NOTICE
•NSK recommends Class B sterilizers as stated in EN 13060.

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8. 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 is loose Check that the Head Cap is firmly tightened.
Rotation Rotate the handpiece and check for abnormalities such as abnormal rotation, vibration, noise, and overheating.
Coolant Water Operate the handpiece and check that the coolant water is flowing through all spray ports.

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9. Specifications
Model X10L X10 X12L X12 X15L X15 X20L X20 X25L X25 X85L X85 X95L X95
Max. Rotation Speed (Motor) 40,000min-1
Max. Rotation Speed (Handpiece) 2,500min-1 4,000min-1 10,000min-1 40,000min-1 200,000min-1
Gear Ratio 16:1 Reduction 10:1 Reduction 4:1 Reduction 1:1 Direct Drive 1:5 Increasing
Bur Type ISO 1797-1 (EN ISO 1797-1) Type1
Ø2.35mm CA Bur
ISO 1797-1 (EN
ISO 1797-1) Type3
Ø1.59-1.60mm
Standard FG Bur
ISO 1797-1 (EN
ISO 1797-1) Type1
Ø2.35mm CA Bur
ISO 1797-1 (EN
ISO 1797-1) Type3
Ø1.59-1.60mm
Short Shank FG Bur
ISO 1797-1 (EN
ISO 1797-1) Type3
Ø1.59-1.60mm
Standard FG Bur
Chuck Length 11.6mm 11.9mm 11.6mm 10.2mm 11.6mm
Max. Bur Length 22.5mm
25mm
(Recommended 19mm)
22.5mm 21mm
25mm
(Recommended 19mm)
Max. Working Part Diameter Ø4.0mm Ø2.0mm Ø4.0mm Ø2.0mm
Optic
Glass Rod - Glass Rod - Glass Rod - Glass Rod - Glass Rod - Glass Rod - Glass Rod -
Water Spray Type Single Quattro
Water Pressure 0.08 - 0.20MPa (0.8 - 2.0kgf/cm2)
Chip Air Pressure 0.10 - 0.20MPa (1.0 - 2.0kgf/cm2)