Nakanishi NSK Ti-Max X-SG25L User manual

000OM-C0596E

ENGLISH
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1. User and Indications for Use
User: Qualified Professionals
Indications for Use: Surgical 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 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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whileusingthehandpiece.Nosupplyingthecoolantwatermayleadtooverheating,
causingburninjuriesorproductfailure.
•Do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.
•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 FR
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WARNING
•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
•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.
•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.
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EN FR
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CAUTION
•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".
•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 "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.
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3. Accessory List
No. Part Name Quantity Remarks
1Cleaning Wire 1 Included in the package for X-SG25L
2 E Type Spray Nozzle 1 -
CAUTION
X-SG93L / X-SG93
•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.
•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.
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CAUTION
4. Connecting and Disconnecting the Handpiece and the Motor
4-1 Connecting
1) Insert the handpiece direct to the motor (Fig. 1). When connecting an optic handpiece,
screw 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.
•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".
Fig. 1
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5. Mounting and Removing the Bur
5-1 Mounting the Bur
X-SG25L (Fig. 2)
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.
3) Confirm that the bur is not removed by gently pulling and pushing the bur without
depressing the Push Button.
Fig. 2
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EN FR
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NOTICE
•Grip the handpiece while placing your thumb tip on the Push button which makes it easier to depress the 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 not removed by gently pulling and pushing the bur without
depressing the Push Button.
Fig. 3
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5-2 Removing the Bur
Depress the Push Button to open the chuck ( ) and remove the bur ( ).
Fig. 4
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.
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EN FR
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CAUTION
•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 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.
•After the bur is locked in place, pull and push the bur to make sure the bur is locked.
•Depress the push button until it is almost parallel to the head cap.
•If removing the bur is difficult, grip the bur with fine pliers while depressing the Push-button, and gently remove the bur. This
situation can be avoided by frequently mounting and removing the bur.
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6. Spray Nozzle
Connect the Irrigation Tube to the Spray Nozzle firmly. (Fig. 5)
Irrigation Tube
Fig. 5
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EN FR
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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) Insert the bur into the handpiece. Then 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.
4) After the handpiece rotation has completely stopped, touch the handpiece head to
confirm the head is NOT heating abnormally (Fig. 6).
CAUTION
•To avoid injury, keep your hands away from the bur during rotation.
Fig. 6
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8. Post-use Maintenance
After each patient maintain the product as follows.
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.
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.
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EN FR
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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
•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)
Use a thermo-disinfector in accordance with ISO 15883 (EN ISO 15883).
Refer to the thermo-disinfector manual.
CAUTION
•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.
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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.
CAUTION
•Do not use a sharp tool to clean the Glass Rod. It could damage the glass and reduce the light transmission.
Fig. 7
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8-4 Cleaning (Spray Port) (X-SG25L)
1) Internally clean the Spray Nozzle by using Cleaning Wire. (Fig. 8)
2) Connect the Irrigation Tube to Spray Nozzle, and wash the inside with clean water.
(Refer to "6. Spray Nozzle")
CAUTION
•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, and cause reduction of cooling efficiency.
Fig. 8
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