Nakanishi NSK Ti-Max Z User manual

001
OM-C0597E

1
EN FR
1 User and Indications for Use
User: Qualified Professionals
Indications for Use:
The General Cutting Contra Handpiece is powered by either an
air-motor or electronic micromotor for use in general dentistry.
The device is intended for cutting and grinding teeth, cavity
preparations, tooth and crown preparations, finishing and
trimming teeth and filling materials and removal of crowns and
filling materials.
CAUTION
•Connect ONLY to E type motors (ISO 3964 (EN ISO 3964)).
nano15LS / nano25LS / nano95LS
•This handpiece can ONLY be connected to
E type motors in accordance with ISO 3964
(EN ISO 3964) with a motor insert length of
23mm or less.
23mm
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.
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2
NOTICE
General product specification information
highlighted to avoid product malfunction and
performance reduction.
WARNING
•Cleanandlubricatethehandpieceimmediately
(within1hour)aftereachtreatmenttoremove
residue.Failuretoproperlymaintainthe
handpiecemaycauseinfection,productfailure,
overheatingleadingtoburninjuries.(Referto“8
Post-useMaintenance”)
•Ifbloodinfiltratesinsideahandpiece,cleanand
lubricatethehandpieceimmediatelyusingthe
PANASPRAYPlusorcleanthehandpieceusing
athermo-disinfector.
WARNING
•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.
•Alwaysoperatewithcoolantwater.Without
coolantwater,thehandpiecemayresultin
overheatingwhichcouldcauseaburninjury.
•Usethemotorthatsuppliescoolantair.
•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.
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3
EN FR
WARNING
•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“6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.
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 “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. 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.
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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.
•Do not use burs other than specified in “11 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 “11 Specifications”.
CAUTION
•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, chlorinecontaining 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”)
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5
EN FR
CAUTION
•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.
Z85L / 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.
CAUTION
Z95L / X95L / X95 / M95L / M95 / nano95LS
•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.
NOTICE
•Repairs of this product are only to be performed by authorized
service technicians according to NSK requirements. Contact
your Authorized NSK Dealer if repairs are necessary.
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6
3 Accessory List
No. Part Name Quantity
1 E-Type Spray Nozzle 1
2 Wrench* 1
*Included in the package for Z95L
4 Connecting and Disconnecting the Handpiece from 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.
Fig. 1
Handpiece Motor
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7
EN FR
4-2 Disconnecting
Hold the motor and the Handpiece, then pull apart.
CAUTION
•Do not connect or disconnect the handpiece until the motor
has completely stopped.
•Do not exceed the Max. Rotation Speed (Motor) shown in
“11 Specifications”.
•Connect ONLY to E type motors (ISO 3964 (EN ISO 3964)).
nano15LS / nano25LS / nano95LS
•This handpiece can ONLY be connected
to E type motors in accordance with ISO
3964 (EN ISO 3964) with a motor insert
length of 23mm or less.
23mm
5 Mounting and Removing the Bur
5-1 Mounting the Bur
Z10L / Z15L / Z25L / X10L / X10 / X12L / X12 / X15L / X15 /
X25L / X25 / M15L / M15 / M25L / M25 / nano15LS /
nano25LS (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.
Push Button
D-shape
Fig. 2
3) Confirm that the bur is not removed by gently pulling and
pushing the bur without depressing the Push Button.
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8
Z85L / Z95L / X20L / X20 / X85L / X85 / X95L / X95 /
M95L/ M95 / nano95LS (Fig. 3)
1) Insert the bur into the
chuck.
2) Depress the Push Button
to open the chuck (1).
3) Insert the bur fully into the
chuck until it stops (2)
then release the Push
Button.
Push Button
Fig. 3
4) Confirm that the bur is not removed by gently pulling and
pushing the bur without depressing the Push Button.
NOTICE
•Grip the handpiece while placing your thumb tip on the
Push button which makes it easier to depress the button.
5-2 Removing the Bur
Depress the Push Button to
open the chuck (1) and
remove the bur (2).
Push Button
Fig. 4
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9
EN FR
WARNING
•Alwaysuseaclean,sterilebur.Besureto
wearsterileglovesbeforemountingthebur.
•Whenchangingbursduringtreatment,remove
theburandwipearoundtheburinsertionhole
andgloveswithadrylintfreeclothuntilthe
insertionholeisvisuallyclean,thenmounta
clean,sterilebur.Residualbloodordebrismay
enterthehandpiecewhilechangingburs,
whichcouldleadtohigherriskofcross-
contamination.
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.
•Do not use burs other than specified in “11 Specifications”
as such burs may be accidentally released or break during
rotation.
•Insert a sterilized bur and always keep the bur shank clean.
When changing burs, make sure that there is no dirt or
debris in and around the bur insertion hole of the
handpiece. Debris in the chuck could cause infection,
heating, poor bur concentricity or low chuck retention
force.
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10
CAUTION
•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 “11
Specifications”.
•Always follow the instructions provided by the bur
manufacturer.
•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.
6 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. Fig. 5
2) Check the coolant water is flowing properly.
3) Mount the bur. (Refer to “5 Mounting and Removing the Bur”)
4) 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.
5) After the handpiece rotation has completely stopped, touch
the handpiece head to confirm the head is NOT heating
abnormally (Fig. 5).
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11
EN FR
CAUTION
•To avoid injury, keep your hands away from the bur during
rotation.
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12
7 Switching coolant water type
(Z95L)
It is possible to switch the type of coolant water flow which cools
the drilling point.
Turn the switching valve with an attached wrench to switch the
coolant water type.
- Align the mark and to set the water spray shape.
- Align the mark and to set the water jet shape.
Fig. 6
Switching Valve
Water spray
shape
Water jet
shape
Wrench
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13
EN FR
CAUTION
•Makesuretoturntheswitchingvalveuntilit
stops.
•Beforeinitiatingtreatment,assurethewateris
sprayingcorrectly.
•Ifwaterisnotbeingsuppliedcorrectly,recheck
theswitchingvalve.
•Becarefulofoverheatingwhenusingsometypes
ofcarbidebur,asthecoolantwater(in“water
jet”mode)cannotreachtheburtipbecauseof
thelengthofthetip.Ifthewaterdoesnotreach
thetip,select“waterspray”mode.
•Forthewaterjetshape,setthewater
consumptionto50mL/minormoretoprovide
sufficientcooling.
8 Post-use Maintenance
After each patient maintain the product as follows.
WARNING
•Toensurecleaningandsterilizationefficacy,use
onlythefollowingproceduresforreprocessing.
•Followanyadditionallocaldirectives,standards,
andguidelinesforcleaningandsterilization.
•Cleanandlubricatethehandpieceimmediately
(within1hour)aftereachtreatmenttoremove
residue.Failuretoproperlymaintainthe
handpiecemaycauseinfection,productfailure,
overheatingleadingtoburninjuries.
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14
8-1 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.
1) Always wear protective
gloves, a mask, and
protective goggles for
safety purposes and to
minimize the risk of
infection. (Fig. 7) Fig. 7
2) Remove the bur. (Fig. 8)
Fig. 8
3) Wipe the exterior of the
handpiece clean using a
cloth moistened with
disinfectant or ethanol with
a concentration of
60-90%. (Fig. 9)
When using disinfectant, Fig. 9
follow the instructions given by the manufacturer of the
disinfectant.
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15
EN FR
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)
4) Operate the handpiece at
the chair-side for at least
20 seconds to purge fluids
in the handpiece (Fig. 10).
After the handpiece rotation
has completely stopped,
touch the handpiece head Fig. 10
to confirm the head is NO heating abnormally.
(In case of Z95L, purge after switching the coolant spray
type to the water spray. Cleaning in the water jet mode
may cause clogging of the chip air circuit.)
CAUTION
•If the head is heating abnormally, stop using the handpiece
immediately and contact your Authorized NSK Distributor.
5) Remove the handpiece
from the motor. (Fig. 11)
6) Carry the handpiece to the
decontamination area.
Fig. 11
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16
8-2 Cleaning and Drying
Perform cleaning and drying using either the manual or
automatic method.
Manual Method (Cleaning and Drying the Exterior)
Wash the handpiece under running water following the
procedures below.
(Water condition: ≤38°C, ≥3.5L/min; water should be of the
same quality as drinking water)
1) Clean the external surfaces
of the handpiece with a soft
bristled toothbrush for 15
seconds or more. (Fig. 12)
Fig. 12
2) Clean around the bur
insertion hole for 15
seconds or more, using an
interdental brush (wire
thickness 0.7mm) that
conforms to size 4 in ISO
16409. (Fig. 13) Fig. 13
Under appropriate lighting (natural office lighting, 500 lx or
higher), inspect the handpiece for blood or other debris. If
any visible debris remains, repeat the process until the
handpiece is visually clean.
3) After using the wrench,
clean the external surfaces
of the wrench with a soft
bristled toothbrush for each
15 seconds or more. (Only
for Z95L) (Fig. 14)
Fig. 14
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17
EN FR
4) Wipe the exterior of the
handpiece, wrench clean
using a cloth moistened
with disinfectant or ethanol
with a concentration of
60-90%. (Fig. 15)
Fig. 15
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, 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.(Only for
the wrench, wipe off with dry cloth.)
When blowing off with compressed air, cover the handpiece
with cloth to prevent scattering of water. Proceed to “8-3
Cleaning and Lubrication”.
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18
Automatic Method (Cleaning 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 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.
NOTICE
•All water is “building supply” (at least drinking water
quality) unless otherwise indicated.
•The Wrench can be washed via thermo-disinfector.
1) Prepare and pre-cleaning the device as described above in
step “8-1 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)
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