NSK FX15 User manual

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ENGLISH
1. User and Indications for Use
User: Qualified Professionals
Indications for Use:
FX15 / FX15m / FX22 / FX23 / FX23m / FX25 / FX25m
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.
FX75 / FX75m
This medical device is intended for transmitting rotation of
the power source at a reduction gear ratio, thereby running
the rotary endodontic instrument, etc. to perform endodontic
treatments such as root canal enlargement.
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.

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•Ifbloodinltratesinsideahandpiece,an
automatichandpiececleaningandlubrication
systemmaynottotallycleantheinternal
handpiececomponents,whichmayleadto
internalbloodcoagulation.Coagulatedblood
insidethehandpiece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.(ExceptforFX22)
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"8.Post-
useMaintenance")
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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EN DE FR ES IT PT
•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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.
•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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- Bent, deformed, worn, rusted, broken, deficient bur/file.
- Bur/File which is cracked on the edge or axis.
- Non-ISO(EN ISO) standard, or tampered bur/file.
•Do not use burs/files other than specified in
"11. Specifications" as such burs/files may be
accidentally released or break during rotation.
•Always keep the bur/file shank clean. Dirt or debris in
the chuck could cause poor bur/file concentricity or low
chuck retention force.
•Always insert the bur/file all the way into the chuck. If
insertion is insufficient, premature failure of the bearings
or accidental release of the bur/file may occur.
•Do not exceed Max. Bur Length shown in
"11. Specifications".
•Always follow the instructions provided by the bur/file
manufacturer.
•Do not exceed the bur/file speed recommended by the
bur/file manufacturer.
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/files with problems listed below as the bur/
file may break,seize up or disengage from the chuck.

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EN DE FR ES IT PT
•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 "10. 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.

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3. Accessory List
No. Part Name Quantity Remarks
1FX Wrench 1 Included in the package
for FX22 / FX23 / FX23m /
FX25 / FX25m
2Cap Wrench 1 Included in the package for
FX22
3 E-Type Spray Nozzle 1 -
4. Connecting and Disconnecting the Handpiece from the Motor
4-1 Connecting
1) Insert the handpiece direct into the motor (Fig. 1).
2) Confirm that the handpiece is securely connected to the
motor.
4-2 Disconnecting
Hold the motor and the handpiece, then pull apart.

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EN DE FR ES IT PT
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
"11. Specifications".
5. Inserting and Removing the Bur/File
5-1 Inserting the Bur/File
FX15 / FX15m / FX23 / FX23m / FX25 / FX25m / FX75 / FX75m (Fig. 2)
1) Insert the bur/file until it is correctly secured in place.
2) Depress the Push Button and insert the bur/file into the
chuck until the bur/file "notch" mechanism engages.
Release the button.
3) Confirm that the bur/file is secure by gently pulling and
pushing the bur/file without depressing the Push Button.
CAUTION
•Only FX75 / FX75m can use file.

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FX22 (Fig. 3, 4)
1) Turn the Latch Plate to open the chuck.
2) Insert the bur into the chuck until the bur securely
engages. Swing the Latch Plate back to closed position.
3) Ensure that the bur is secure by gently pulling and pushing
the bur.
5-2 Removing the Bur/File
FX15 / FX15m / FX23 / FX23m / FX25 / FX25m / FX75 / FX75m (Fig. 5)
Depress the Push Button to open the chuck ( ) and remove
the bur/file ( ).
FX22 (Fig. 3)
Turn the Latch Plate to open position and pull the bur out.
CAUTION
•Do not use burs/files with problems listed below as the
bur/file may break, seize up or disengage from the chuck.
- Bent, deformed, worn, rusted, broken, deficient bur/file.
- Bur/File which is cracked on the edge or axis.
- Non-ISO(EN ISO) standard, or tampered bur/file.
•Do not use burs/files other than specified in
"11. Specifications" as such burs/files may be
accidentally released or break during rotation.

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EN DE FR ES IT PT
•Always keep the bur/file shank clean. Dirt or debris in
the chuck could cause poor bur/file concentricity or low
chuck retention force.
•Always insert the bur/file all the way into the chuck. If
insertion is insufficient, premature failure of the bearings
or accidental release of the bur/file may occur.
•Do not exceed Max. Bur Length shown in
"11. Specifications".
•Always follow the instructions provided by the bur/file
manufacturer.
•Do not exceed the bur/file speed recommended by the
bur/file manufacturer.
•Do not insert or remove the bur/file until the rotation has
completely stopped.
•Do not apply excess pressure to the bur/file as it may
break or bend or become difficult to remove.
6. Connection of the Spray Nozzle (FX22 / FX23 / FX23m / FX25 / FX25m)
1) Attach the Spray Nozzle (Optional) to the handpiece head
(Fig. 6).
2) Cut the Irrigation Tube to the desired length then connect
to the Spray Tube Nozzle on the motor (Fig. 6).
*Refer to "14. Option Parts List" to identify the correct cartridge.

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7. 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 or Cap (FX22) is firmly tightened.
2) Insert the bur/file. (Refer to "5. Inserting and Removing the
Bur/File")
3) Rotate the handpiece for about one minute 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. 7).
CAUTION
•To avoid injury, keep your hands away from the bur
during rotation.

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EN DE FR ES IT PT
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.
8. Post-use Maintenance
After each patient maintain the product as follows.
8-1 Preparation
1) Wear a eye protection, a mask and gloves to avoid
infection.
2) Remove the bur/file.
3) Disconnect the handpiece from the motor.

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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.
Automatic Cleaning (External and Internal Surfaces)
(Only for FX15m / FX23m / FX25m / FX75m)
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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EN DE FR ES IT PT
8-3 Disinfection
Manual Disinfection (External Surface)
Wipe the surface with cloth soaked in disinfectant solution
such as alcohol.
Automatic Disinfection (External and Internal Surfaces)
(Only for FX15m / FX23m / FX25m / FX75m)
Use a thermo-disinfector in accordance with ISO 15883
(EN ISO 15883).
Refer to the thermo-disinfector manual.
8-4 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 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. 8).

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CAUTION
•Hold the spray can upright.
•Be sure to hold the handpiece firmly to prevent slipping out of hand by the spray pressure when lubricating.
•Supply lubricant until it comes out of the handpiece head.
•If you wish to expel excessive oil from inside of the handpiece, rotate the handpiece for approx.15 seconds without a bur/
file. During the rotation, do not depress the push button inadvertently, especially when using absorbent cloth to prevent oil
from scattering. Depressing the push button during rotation may cause a failure to attach a bur/file. (Except for FX22)
Fig. 9 Fig. 10

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EN DE FR ES IT PT
NOTICE
•NSK recommends the use of "Spray Mist Absorber"
(Y900084) to prevent oil mist expelling out of the
handpiece head.
WARNING
•Ifbloodinltratesinsideahandpiece,an
automatichandpiececleaningandlubrication
systemmaynottotallycleantheinternal
handpiececomponents,whichmayleadto
internalbloodcoagulation.Coagulatedblood
insidethehandpiece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.
NSK automatic handpiece cleaning and lubrication
system
When using NSK automatic handpiece cleaning and
lubrication system, refer to the system instructions.