NSK FX204 M4 User manual

1
ENGLISH
Class
WARNING
CAUTION
NOTICE
Degree of Risk
Hazard that could result in serious injury or
damage to the device if the safety instructions are
not correctly followed.
Hazard that could result in light or moderate injury
or damage to the device if the safety instructions
are not correctly followed.
General product specification information
highlighted to avoid product malfunction and
performance reduction.
•ReadthisOperationManualbeforeusetofullyunderstandthe
productfunctionsandfileforfuturereference.
•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.
•Donotattempttodisassembletheproductnortamperwiththe
mechanismexceptasrecommendbyNSKinthisOperation
CAUTION
1. User and Indications for Use
User:QualifiedProfessionals
IntendedUse:Thismedicaldeviceisintendedforconverting
compressedairsuppliedfromadentalunit,etc.torotationalmotionas
wellastransmittingtherotationtotheinstrumentfordentaltreatment
suchasastraightorgearedanglehandpiecetocutandpolishnaturalor
artificialteeth.
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.

2
•Donotuseaircontaminatedbydust,moistureandoil.
CAUTION
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motor.
•Shouldtheproductfunctionabnormally,ceaseoperation
immediatelyandcontactyourAuthorizedNSKDealer.
•Donotusehighacidwaterorsterilizingsolutionstowipe,immerse
orcleantheproduct.
•Theproductsaredeliveredinanon-sterileconditionandmustbe
autoclavedpriortouse.
•Performregularfunctionandmaintenancechecks.
•Iftheproductisnotusedforalongperiodcheckitisfunctioning
correctlybeforeusingonapatient.
•Toavoidclinicaldowntimeitisrecommendedthatasparebekept
onhandincaseofabreakdownduringsurgery.
•U.S.Federallawrestrictsthisdevicetosalebyorontheorderofa
licensedphysician.
4. Setting of Air & Water Supply Pressure
Measurethesupplypressureatthehandpiece/hoseconnectionpoint
andsetthepressuretothevaluespecifiedonthespecificationtable.
(Fig.1)
ForMultiGaugeinformationrefertoOptionPartsList.
•Donotexceedtheoptimumpressurespecifiedonthespecification
table.
WARNING
PartName Quantity
TurbineOil 1
3. Accessory List

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•Disconnectthehandpieceonlyafterthemotorhascompletely
stoppedrotating.
CAUTION
8. Forward / Reverse Rotation
1)ForwardRotation:TurntheFWD/REVChangeRingto“F”.(Fig.4)
2)ReverseRotation:TurntheFWD/REVChangeRingto“R”.(Fig.5)
3)WhentheFWD/REVChangeRingispositionedatthemiddleof“F”
and“R”,thedriveairisinterruptedandthemotordoesnotrotate.
(Fig.6)
*F:ForwardRotation
R:ReverseRotation
9. Post-use Maintenance
Aftereachpatientmaintaintheproductasfollows.
5. Connection & Disconnection of the Handpiece
5-1 Connection
1)Connectthehandpiecedirecttothemotor.(Fig.2)
2)Makesurethehandpieceisfirmlyconnectedtothemotor.
5-2 Disconnection
Holdthemotorandthehandpieceseparatelyanddisconnectwith
care.
6. Check before treatment
Connectthehandpiecetothemotorandcheckformotorvibration,noise
andoverheating.Ifanyabnormalitiesarefounddonotusethemotor
andcontactyourAuthorizedNSKDealer.
7. Water and Chip Air Supply to the Handpiece
(FX205 M4/FX205m M4/FX205 B2/FX205m B2)
1)InserttheSprayTubeAttachmentintotheSprayTubeNozzle.
(Fig.3)
2)Trimthetubetothedesiredlength.
3)InserttheotherendoftheSprayTubeAttachmentintothenozzle
clampontheContraAngleorStraighthandpiece.

4
•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.
CAUTION
•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.
WARNING
9-1 Preparation
1)Wearaeyeprotection,amaskandglovestoavoidinfection.
2)Disconnectthehandpiecefromthemotor.
3)Removethemotorfromthehose.
9-2 Cleaning
ManualCleaning(ExternalSurface)
1)Removedirtanddebrisonthemotor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.
AutomaticCleaning(ExternalandInternalSurfaces)
(OnlyforFX204mM4/FX204mB2/FX205mM4/FX205mB2)
Useathermo-disinfectorinaccordancewithISO15883(ENISO15883).
Refertothethermo-disinfectormanual.
•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.
CAUTION
9-3 Disinfection
ManualDisinfection(ExternalSurface)

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•Holdthespraycanupright.
CAUTION
9-4 Lubrication
NSKPANASPRAYPlus
ApplyNSKPANASPRAYPluseverytimeaftereachuseand/orbefore
autoclaving.
1)Removethemotorfromthehose.
2)Mountthearrow-headspraynozzletipintothespraycanport.
(Fig.7)
3)InserttheSprayNozzleintotheDriveAirPortofthemotor.Holdthe
motorandsprayforapproximately2-3seconds.Applylubricant
untilitexpelsfromtheexhaustairpartforatleast2seconds.(Fig.8)
LubricationOil
1)Removethemotorfromthehose.
2)Apply1-2dropsoflubricationoilintotheDriveAirPortshownin
theFig.8.
3)Connectthemotortothehose.Operatethemotorforabout10
seconds.
9-5 Sterilization
Sterilizetheproductbyautoclavesterilization.Aftereachpatient
sterilizeasnotedbelow.
1)Insertintoanautoclavepouch.Sealthepouch.
2)Autoclavableundertheconditionsbelow.
Autoclaveformorethan20min.at121°C,or15min.at132°C,or
3min.at134°C.
Wipethesurfacewithclothsoakedindisinfectantsolutionsuchas
alcohol.
AutomaticDisinfection(ExternalandInternalSurfaces)
(OnlyforFX204mM4/FX204mB2/FX205mM4/FX205mB2)
Useathermo-disinfectorinaccordancewithISO15883(ENISO15883).
Refertothethermo-disinfectormanual.
•Besuretoholdthehandpiecefirmlytopreventslippingoutof
handbythespraypressurewhenlubricating.
•NSKrecommendstheuseof"SprayMistAbsorber"(Y900084)to
preventoilmistexpellingoutofthemotor.

6
Points to check
Rotation
Details
Rotate the motor and check for abnormalities
such as abnormal rotation, vibration, noise, and
overheating.
11. Symbol
ThisproductisAutoclavableuptoMax.135°C.
10. Periodical Maintenance Checks
Performperiodicalmaintenancecheckseverythreemonths,referring
tothechecksheetbelow.Ifanyabnormalitiesarefound,contactyour
AuthorizedNSKDealer.
3)Thehandpieceshouldremainintheautoclavepouchuntilrequired
foruse.
•Donotautoclavetheproductwithotherinstrumentsevenwhenit
isinapouch.Thisistopreventpossiblediscolorationanddamage
totheproductfromchemicalresidueonotherinstruments.
•Donotheatorcooltheproducttooquickly.Rapidchangein
temperaturecouldcausedamagetotheproduct.
•Toavoidproductfailure,donotuseasterilizerwhosetemperature
exceeds138°Cduringuseincludingthedrycycle.Thechamber
temperatureofsometypeofsterilizersmayexceed138°C.
Contactthesterilizermanufacturerfordetailedinformation.
•Keeptheproductinsuitableatmosphericpressure,temperature,
humidity,ventilation,andsunlight.Theairshouldbefreefrom
dust,saltandsulphur.
•Donottouchtheproductimmediatelyafterautoclavingasitwillbe
veryhotandmustremaininasterilecondition.
CAUTION
•NSKrecommendsClassBsterilizersasstatedinEN13060.
NOTICE
•Autoclavesterilizationisrecommendedfortheproduct.The
validityofothersterilizationmethodsisnotconfirmed.

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Model
MG-4H Multi Gauge
MG-2/3H Multi Gauge
Order Code
Z109400
Z109200
Compatible Product
FX204 M4/FX204m M4
FX205 M4/FX205m M4
FX204 B2/FX204m B2
FX205 B2/FX205m B2
ThisproductcanbewashedviaThermoDisinfector.
ConformstoCEEuropeanDirectiveof“Medicalequipment
directive93/42/EEC.”
Manufacturer.
AuthorizedrepresentativeintheEuropeancommunity.
Caution:U.S.Federallawrestrictsthisdevicetosalebyoronthe
orderofalicensedphysician. 14. Disposing product
Inordertoavoidthehealthrisksofoperatorshandlingthedisposalof
medicalequipment,aswellastherisksofenvironmentalcontamination
causedthereof,asurgeonoradentistisrequiredtoconfirmthe
equipmentissterile.Askspecialistfirmswhoarelicensedtodisposeof
speciallycontrolledindustrialwastes,todisposetheproductforyou.
12. Warranty
NSKproductsarewarrantedagainstmanufacturingerrorsanddefects
inmaterials.NSKreservestherighttoanalyzeanddeterminethecause
ofanyproblem.Warrantyisvoidedshouldtheproductbenotused
correctlyorfortheintendedpurposeorhasbeentamperedwithby
unqualifiedpersonnelorhashadnonNSKpartsinstalled.Replacement
partsareavailableforsevenyearsbeyonddiscontinuationofthemodel.
13. Option Parts List