NSK SGS Series User manual
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ENGLISH
1. User and Indications for Use
User: Licensed dentists / oral surgeons
Indications for Use:
The Surgical Straight / Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use.
Typical uses include sectioning and removal of wisdom teeth, cutting teeth, oral surgery (such as root tip resection, bone removal, bone shaping) and implant treatment
(such as drilling the maxilla and mandible).
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
•Clean,disinfect,lubricateandsterilizethehandpieceimmediately(within1hour)aftereachtreatmenttoremoveresidue.Failuretoproperlymaintain
thehandpiecemaycauseinfection,productfailure,overheatingleadingtoburninjuries.(Referto"9.Post-useMaintenance")
•Donotchangeorotherwisereinsertaburintothehandpieceduringaprocedure.Doingsocanintroducebloodorotherdebrisintothechuck,
increasingtheriskofcross-contamination.
•DonotrotatethemotorwhentheBurLockRingisattheOPENposition,orwhenaburisnotmountedinthechuck.EithersituationItmaycauseburn
injuriesduetosuddenheatgeneration.Inaddition,themotorinsertcouldbedamagedwhichmayleadtodifficultyinconnectinganddisconnectingthe
handpiece.
•Alwayskeeptheburshankclean.Dirtordebrisinthechuckcouldcauseheating,poorburconcentricity,orlowchuckretentionforce.
•Supplycoolantwaterthroughtheirrigationnozzlewhileusingthehandpiece.Otherirrigationmethodsthanrecommendedmayleadtooverheating
causingburninjuries.
•Donotapplyexcesspressuretotheburasitmaybreak,bendorbecomedifficulttoremove.Doingsomayalsocauseburninjuryduetoabnormal
heating.
•Ballbearingsarewearitemsandmayrequirereplacement.Besuretoinspectthehandpiecebeforeuse(Referto"8.CheckingtheHandpieceBefore
EachUse").Ifabnormalvibrationornoisearefound,thebearingsorotherinternalpartsmaybewornoutordamaged.Damagedpartsmayleadto
handpieceoverheatingcausingburninjuries.Ifoverheatingissuspected,stopusingthehandpieceimmediatelyandcontactyourAuthorizedNSK
Dealer.
•Thetemperatureatthetipofthehandpiecemayreachupto51˚Cdependingontheenvironment.
Contactwiththebodysurfaceofthepatientortheoperatormustbewithin1min..
Contactforlongerthanthespecifiedtimecouldcausehigherriskoflowtemperatureburninjury.
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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 "8. 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 to the handpiece. Do not drop the handpiece. Deformation may cause the handpiece to fail during use.
•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.
–Tampered bur.
•Do not use burs other than specified in "11. Specifications" as such burs may be accidentally released or break during rotation.
•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.
•Always follow the instructions provided by the bur manufacturer.
•Always confirm before use that the bur is attached securely. Improper attachment may lead to sudden release of the bur during rotation.
•Never turn the Bur Lock Ring while the handpiece is rotating.
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CAUTION
•For patients safety, be sure to use a sterile handpiece and sterile bur for each surgical operation and / or dental procedure.
•Should it be necessary to change or replace a bur during treatment, make sure that clean and sterile handpiece and bur are used.
•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, chlorinecontaining solutions,
solvents such as benzine or thinner.
•The handpiece is delivered in a non-sterile condition and perform steam sterilization prior to use.
•Perform regular function and maintenance checks. (Refer to "10. Periodical Maintenance Checks")
•To avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during treatment.
•U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
NOTICE
•Contact your Authorized NSK Dealer if repairs are necessary.
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3. Accessory List
No. Part Name Quantity
1Irrigation Nozzle 1
2 E-Type Spray Nozzle 1
3Test bur 1
4. Connecting and Disconnecting the Handpiece from the Motor
4-1 Connecting
1) Insert the handpiece until it reaches the end of the Motor Insert. (Fig. 1)
2) For motors that feature a locking mechanism, insert the handpiece until it reaches the
end of the motor insert and then screw the handpiece until is locked into place.
3) After connection, confirm that the handpiece is firmly connected to the motor by pulling
and pushing the handpiece.
Motor
Motor Insert
Handpiece
Fig. 1
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4-2 Disconnecting
Hold the Motor and the Handpiece, then pull apart.
5. Mounting and Removing the Bur
5-1 Mounting the Bur
1) Turn the Bur Lock Ring in the direction of the " " mark until it clicks. (Fig. 2)
2) Insert the bur fully into the chuck then turn the Bur Lock Ring in the direction of the " " mark
until the " " mark and the " " mark align with a click.
3) Confirm that the bur is secure by gently pulling and pushing the bur.
Fig. 2
Bur Lock Ring
Open
Close
Chuck Closed
Chuck Open
CAUTION
•Do not connect or disconnect the handpiece until the motor has completely stopped.
•Connect ONLY to E type motors (ISO 3964) with the Max. Speed of 40,000 min-1 or less.
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5-2 Removing the Bur
Turn the Bur Lock Ring in the direction of the " " mark until it clicks then remove the bur.
WARNING
•Alwaysuseaclean,sterilebur.Besuretowearsterileglovesbeforemountingthebur.
•DonotrotatethemotorwhentheBurLockRingisattheOPENposition(the" "markandthe" "markaremisaligned),orwhenaburisnot
mountedinthechuck.EithersituationItmaycauseburninjuriesduetosuddenheatgeneration.Inaddition,themotorinsertcouldbedamagedwhich
mayleadtodifficultyinconnectinganddisconnectingthehandpiece.
•Aftermountingtheburinthechuck,besuretoconfirmthatthe" "markandthe" "markalign.Ifthesemarksarenotcompletelyaligned,burn
injuriesmayoccurduetohandpieceoverheatingduringrotation.
•Donotreplace,remove/mounttheburduringtreatment.Thiscausesbloodordebristoenterthehandpiece,leadingtosecondaryinfection.Ifyou
needtouseadifferentburduringtreatment,mountitonanewhandpiece.
•Donotchangeorotherwisereinsertaburintothehandpieceduringaprocedure.Doingsocanintroducebloodorotherdebrisintothechuck,
increasingtheriskofcross-contamination.
Shoulditbenecessarytochangeorreplaceaburduringtreatment,makesurethatcleanandsterilehandpieceandburareused.
CAUTION
•Do not mount or remove the bur until the motor has completely stopped.
•Insert a sterilized bur and always keep the bur shank clean. Should it be necessary to change or replace a bur during treatment, make sure that clean and
sterile handpiece and bur are used.
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6. The Bur
The SGS / SGA series handpieces are designed for use with surgical burs (Ø2.35mm, 70mm in shank length).
■To Mount the Stopper (ONLY for SGS-ES / SGA-ES)
When using a bur designed for dental straight handpieces in implant surgery, etc., attach the Stopper (Optional) to the handpiece. The Stopper is designed for burs
with the following specifications:
Ø2.35mm, 44.5mm in total bur length, 30mm or more in chuck length. (Fig. 3)
1) Remove the bur from the handpiece. (Refer to "5. Mounting and Removing the Bur")
2) Turn the Bur Lock Ring to the OPEN position. (Fig. 2)
3) Insert the threaded portion of the Stopper into the chuck then screw it in with the provided screwdriver.
*Refer to Option Parts List to identify the correct parts.
CAUTION
•Use only with surgical burs designed for the following dental straight handpieces.
SGS-E2S, SGA-E2S
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Fig. 3
Tighten Screwdriver Stopper (Option)
Threaded Portion
Fig. 4
Irrigation Nozzle Irrigation Tube
7. Irrigation Nozzle
Insert the Irrigation Nozzle (Accessory) into the handpiece. Then push the Irrigation Tube into the nozzle securely. (Fig. 4)
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CAUTION
•To avoid injury, keep your hands away from the bur during rotation.
8. Checking the Handpiece Before Each Use
Wear sterile gloves then follow the check below before use. If any abnormalities are found, stop using the handpiece immediately and contact your Authorized NSK
Dealer.
1) Mount the Bur. (Refer to "5. Mounting and Removing the Bur")
2) Adjust the handpiece rotation speed in accordance with the allowable maximum speed for the attached bur.
At that time, do not exceed the Max. rotation speed for the handpiece. (Refer to "11. Specifications")
3) Rotate the handpiece and check for abnormal rotation, vibration, noise and overheating.
Also make sure that the water spray is hitting the tip of the bur.
If any of these conditions are found, stop using the handpiece and contact your Authorized NSK Dealer.
4) Check that water is supplied to the cutting portion of the bur. If any abnormalities are found with the Irrigation function, stop using the Irrigation Nozzle and replace
it with a sterilized new Irrigation Nozzle. (Refer to "15. Spare Parts List")
5) If there are no immediate apparent abnormalities, continue to rotate the handpiece for about 1 minute. Then stop rotation and check for abnormal heating at the tip
of the handpiece. If abnormal heating is detected, stop using the handpiece and contact your Authorized NSK Dealer.
6) Operate the handpiece if no abnormalities are observed.
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9-1 Cleaning at point-of use
CAUTION
•Do not use the following liquids to wipe, immerse, or clean the product:
strong / super acid water, strong acid / alkaline chemicals, chlorine-containing solutions, solvents such as benzine or thinner.
•Do not immerse NSK instruments in disinfectant solution or clean in ultrasonic devices.
WARNING
•Toensurecleaningandsterilizationefficacy,useonlythefollowingproceduresforreprocessing.
•Followanyadditionallocaldirectives,standards,andguidelinesforcleaning,disinfection,andsterilization.
•Clean,disinfect,lubricateandsterilizethehandpieceimmediately(within1hour)aftereachtreatmenttoremoveresidue.Failuretoproperlymaintain
thehandpiecemaycauseinfection,productfailure,overheatingleadingtoburninjuries.
9. Post-use Maintenance
Post-use maintenance includes cleaning, lubricating, and sterilization after each patient use.
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1) Always wear protective gloves, a mask, and protective goggles for safety purposes and to minimize the risk of
infection. (Fig. 5)
2) Operate the handpiece while running clean water into the irrigation tube with the irrigation nozzle, at the chair-
side for at least 20 seconds to purge fluids out of the handpiece. (Fig. 6)
After the handpiece rotation has completely stopped, confirm the handpiece head is NOT heating abnormally.
(Water temperature 38˚C or less, drinking water level of water quality recommended)
Fig. 5
Fig. 6
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CAUTION
•If the head is heating abnormally, stop using the handpiece immediately and contact your Authorized NSK Dealer.
•Be sure to take the step "9-1 2)" before removing the bur. If the handpiece operates without the bur, it may cause burn injuries due to sudden heat generation.
In addition, the motor insert could be damaged which may lead to difficulty in connecting and disconnecting the handpiece.
3) Remove the bur from the handpiece using tweezers to firmly hold the bur. (Fig. 7)
Fig. 7
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4) Wipe the exterior of the handpiece clean using a cloth moistened with disinfectant or ethanol with a
concentration of 60 - 90%. (Fig. 8)
When using disinfectant, follow the instructions given by the manufacturer of the disinfectant.
Use a state-sanctioned disinfectant with proven bactericidal, fungicidal, and virucidal properties.
The following disinfectants can be used in the United States and Canada.
CaviCide®, CaviWipes®(manufactured by Metrex)
5) Remove the irrigation tube from the irrigation nozzle and remove moisture with a dry cloth. Then remove the
irrigation nozzle from the handpiece. (Fig. 9)
Fig. 8
Fig. 9
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6) Remove the handpiece from the motor. (Fig. 10)
(Refer to "4-2 Disconnecting")
7) Carry the handpiece and the irrigation nozzle to the decontamination area.
9-2 Cleaning, Disinfecting, and Drying
Perform cleaning, disinfecting, and drying using either the manual or automatic method.
Manual Method (Cleaning, Disinfecting, and Drying the Exterior)
Wash the handpiece and irrigation nozzle under running water following the procedures below.
(Water condition: ≤ 38˚C, ≥ 3.5L / min; water should be of the same quality as drinking water)
Fig. 10
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1) Clean the external surface of the handpiece with a soft bristled toothbrush for 15 seconds or more.
(Fig. 11)
2) Clean the interior cavity of the handpiece for 15 seconds or more, using an interdental brush (wire thickness
0.7mm) that conforms to size 4 in ISO 16409. (Fig. 12)
Fig. 11
Fig. 12
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3) Clean the external surfaces of the irrigation nozzle with a soft bristled toothbrush for 15 seconds or more.
(Fig. 13)
4) Clean the attachment part of the irrigation nozzle for 15 seconds or more, using an interdental brush (wire
thickness 0.7mm) that conforms to size 4 in ISO 16409. (Fig. 14)
Under appropriate lighting (natural office lighting, 500lux or higher), inspect the handpiece and irrigation
nozzle for blood or other debris. If any visible debris remains, repeat the process until the handpiece is
visually clean.
Fig. 13
Fig. 14
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5) Wipe the exterior of the handpiece and the irrigation nozzle clean using a cloth moistened with disinfectant
or ethanol with a concentration of 60 - 90%. (Fig. 15, 16)
When using disinfectant, follow the instructions given by the manufacturer of the disinfectant.
Use a state-sanctioned disinfectant with proven bactericidal, fungicidal, and virucidal properties.
The following disinfectants can be used in the United States and Canada.
CaviCide®, CaviWipes®(manufactured by Metrex)
After cleaning and disinfection, if the residual moisture is present, wipe off with dry cloth or blow it off with
compressed air( ≤ 0.35MPa) until there is no moisture in the interior and exterior.
When blowing off with compressed air, cover the handpiece with cloth to prevent scattering of water.
Proceed to "9-3 Cleaning and Lubrication".
Fig. 15
Fig. 16
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Automatic Method (Cleaning, Disinfecting, and Drying the Exterior and Interior)
NSK handpieces with this symbol are compatible with medical thermo-disinfectors.
Due to the variation in cleaning / disinfection cycles and cleaning agents available from the various manufacturers, NSK has validated the Getinge 46 Series Washer
Disinfector Cycle P7-Anesthesia for automatic processing / reprocessing of the product.
Only validated procedures must be used for cleaning, disinfection and sterilization. When using reprocessing procedures that are different from those described in this
manual, those procedures must be validated by the respective practice or hospital using a thermo-disinfector that conforms to ISO 15883-1.
1) Prepare and pre-disinfect the device as described above in step "9-1 Cleaning at point-of use".
2) Wipe off a dirt on a part held by a handpiece holder using the cloth moistened with 60 - 90% ethanol or disinfectant.
When using disinfectant, follow the instructions given by the manufacturer of the disinfectant.
Use a state-sanctioned disinfectant with proven bactericidal, fungicidal, and virucidal properties.
The following disinfectants can be used in the United States and Canada.
CaviCide®, CaviWipes®(manufactured by Metrex)
NOTICE
•All water is "building supply" (at least drinking water quality) unless otherwise indicated.
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