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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EN FR
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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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