Ivoclar Vivadent Bluephase Style User manual

Bluephase® Style
The curing light
EN Instructions for Use
Page 2
DE Gebrauchsinformation
Seite 16
FR Mode d’emploi
Page 30
IT Istruzioni d’uso
Pagina 44
ES Instrucciones de uso
Pagina 58
PT Instruções de uso
Página 72
Appendix
Page / Seite 86
For dental use only!
Caution: U.S. Federal law restricts this device to sale by or on the order of a licensed dentist
Made in Austria
Ivoclar Vivadent AG, FL-9494 Schaan / Liechtenstein
NEW
The smallest LED
for every use

2
Dear Customer
Optimum polymerization is an important
requirement for all light-cured materials in order to
consistently produce high-quality restorations. The
polymerization light selected also plays a decisive
role in this respect. Therefore, we would like to
thank you for having purchased Bluephase®Style.
Bluephase Style is a high-quality medical device
which has been designed according to the latest
standard of science and technology in compliance
with the relevant industry standards.
These Instructions for Use will help you safely start
up the device, make full use of its capabilities and
ensure a long service life.
Should you have any further questions, please do
not hesitate to contact us (see addresses on the
reverse page).
Your Ivoclar Vivadent Team

3
Product Overview 4
– List of parts
– Indicators on the charging base
– Indicators on the handpiece
– Operating the light
Safety 6
– Intended use
– Indication
– Sings & symbols
– Safety notes
– Contraindication
Start-Up 8
Operation 11
Maintenance and Cleaning 12
What If ... 14
Warranty /Procedure in Case of Repair 15
Product Specifications 15
Table of Contents
English

4
Product Overview
• Indicatorisblack=Batteryischarged
• Indicatorlightsupinbluewithdifferentlight
intensity=batteryisbeingcharged
Anti-glarecone
10mmshortened,parallel-
walllightprobe,black
Startbutton
Timeselectionbutton
Chargingbase
Powercord
Powerpack
Powerindicator
List of parts
Indicators on the charging base Indicators on the handpiece
30s
20s
15s
10s
Curingtime
Battery

5
Withthehandpieceswitchedon,thecurrentcharging
statusisshownonthehandpieceasfollows:
• Green:
Battery fully charged
 (curingcapacityofapprox.
20minutes)
• Orange:
Battery weak
 Timecanstillbesetanda
polymerizationtimeof
approximately3minutesis
left.Placethelightinto
thechargingbaseassoon
aspossible.
• Red:
Battery completely discharged
 Thelightcannolongerbecalledupandthecuring
timecannolongerbeset.However,thehandpiececan
beusedintheClick&Curecordedoperation.
Operating the light
Intuitive two-button operation
Startbutton
Timeselection
button
Acoustic signal –
Setting the signal volume
Withthelightswitchedoff,
pressthetimeselection
buttonfor5secondsuntila
bluelightappears.The
volumecanbeadjusted
usingthetimeselection
button.Thereisaselection
offourvolumelevels.The
volumeissavedbypressing
theStartbutton.

6
Safety
Intended use
BluephaseStyleisanLEDpolymerizationlightthat
producesenergy-richbluelight.Itisusedforthepoly-
merizationoflight-curingdentalmaterialsimmediately
atthedentalunit.Theintendedusealsoincludesthe
observationofthenotesandregulationsinthese
InstructionsforUse.
Indication
Withits“Polywave®”broadbandspectrum,Bluephase
Styleissuitableforthepolymerizationofalllight-curing
dentalmaterialscuringinthewavelengthrangeof
385–515nm.Thesematerialsincluderestoratives,
bondingagents/adhesives,bases,liners,fissuresealants,
temporaries,aswellaslutingmaterialsforbracketsand
indirectrestorations,suchasceramicinlays.
Signs and symbols
 Contraindication
Symbols on the curing light
 Doubleinsulation
(devicecomplieswithsafetyclassII)
 Protectionagainstelectricalshock
(BFtypeapparatus)
 ObserveInstructionsforUse
 ObserveInstructionsforUse
 Caution
 Thecuringlightmustnotbedisposedofin
thenormaldomesticwaste.Information
regardingdisposalofthelightcanbefound
ontherespectivenationalIvoclarVivadent
homepage.
 Recyclable

Safety notes
BluephaseStyleisanelectronicdeviceandamedical
productwhichissubjecttoIEC60601-1(EN60601-1)
andEMCdirectives,aswellasthe93/42/EECMedical
DeviceDirective.Theappliancecomplieswiththe
relevantEUregulationsandisclassifiedasanLED
Class2product.
NRTL (Nationally Recognized
Testing Laboratory)
Thecuringlighthasbeenshippedfromthemanufacturer
inasafeandtechnicallysoundcondition.Inorderto
maintainthisconditionandtoensurerisk-freeoperation,
thenotesandregulationsintheseInstructionsforUse
havetobeobserved.Topreventdamagetoequipment
andrisksforpatients,usersandthirdparties,the
followingsafetyinstructionshavetobeobserved.
Contraindications
 Materials,thepolymerizationofwhichis
activatedoutsidethewavelengthrangeof
385–515nm(nomaterialsknowntodate).
Ifyouarenotsureaboutcertainproducts,
pleaseaskthemanufacturerofthe
correspondingmaterial.
 Usewithoutlightprobe
 Donotchargeorusetheappliancenear
flammableorcombustiblesubstances.
 Portableandmobilehigh-frequencycommuni-
cationdevicesmayinterferewithmedical
equipment.Theuseofmobilephonesduring
operationisnotallowed.


7
Usage and liability
– BluephaseStylemustonlybeemployedforthe
intendeduse.Anyotherusesarecontraindicated.Do
nottouchdefective,opendevices.Liabilitycannotbe
acceptedfordamageresultingfrommisuseorfailureto
observetheOperatingInstructions.
– TheuserisresponsiblefortestingBluephaseStylefor
itsuseandsuitabilityfortheintendedpurposes.Thisis
particularlyimportantifotherequipmentisusedinthe
immediatevicinityofthecuringlightatthesametime.
– Useonlyoriginalsparepartsandaccessoriesfrom
IvoclarVivadent(seeAccessories).Themanufacturer
doesnotacceptanyliabilityfordamageresultingfrom
theuseofothersparepartsoraccessories.
– Thelightprobeisanappliedpartandmaywarmupto
amaximumof45°C(113°F)attheinterfacetothe
handpieceduringoperation.
Operating voltage
Beforeswitchingon,makesurethat
a)thevoltageindicatedontheratingplatecomplieswith
thelocalpowersupplyand
b)theunithasacquiredtheambienttemperature.
Ifthebatteryorpowerpackareusedseparately,e.g.
duringstart-uporClick&Curecordedoperation,contact
withpatientsorthirdpartiesmustbeprevented.Donot
touchtheexposedcontactsoftheconnectionplug
(powerpack).
Rating plate on the charging base
Assumption of impaired safety
Ifithastobeassumedthatsafeoperationisnolonger
possible,thepowermustbedisconnectedandthe
batteryremovedtoavoidaccidentaloperation.Thismay
bethecase,forexample,ifthedeviceisvisiblydamaged
ornolongerworkscorrectly.Acompletedisconnection
fromthepowersupplyisonlyensuredwhenthepower
cordisdisconnectedfromthepowersource.
Eye protection
Directorindirectexposureoftheeyesmustbeprevented.
Prolongedexposuretothelightisunpleasanttotheeyes
andmayresultininjury.Therefore,usingthesupplied
anti-glareconesisrecommended.Individualswhoare
generallysensitivetolight,whotakephotosensitizing
drugsordrugstotreatphotosensitivity,haveundergone
eyesurgery,orpeoplewhoworkwiththeapparatusor
initsvicinityforlongperiodsoftimeshouldnotbe
exposedtothelightofthisdeviceandwearprotective
goggles(orange)thatabsorblightbelow515nm.
Battery
Caution:Useonlyoriginalspareparts,particularlyIvoclar
Vivadentbatteriesandchargingbases.Donotshort
circuitbattery.Donotstoreattemperaturesabove40°C/
104°F(or60°C/140°Fforashortperiod).Always
storebatteriescharged.Thestorageperiodmustnot
exceed6months.Mayexplodeifdisposedofinfire.
Pleasenotethatlithium-polymerbatteriesmayreactwith
explosion,fireandsmokedevelopmentifhandled
improperlyormechanicallydamaged.Damagedlithium-
polymerbatteriesmustnolongerbeused.
Theelectrolytesandelectrolytefumesreleasedduring
explosion,fireandsmokedevelopmentaretoxicand
corrosive.Incaseofaccidentalcontactwiththeeyesor
skin,immediatelywashwithcopiousamountsofwater.
Avoidinhalationoffumes.
Incaseofindisposition,seeaphysicianimmediately.

8
Start-Up
Checkthedeliveryforcompletenessandanypossible
transportationdamage(seedeliveryform).Ifpartsare
damagedormissing,contactyourIvoclarVivadent
representative.
Charging base
Beforeyouswitchonthedevice,makesurethatthe
voltagementionedontheratingplatecomplieswith
yourlocalpowersupply.
Slidetheconnectionplugofthepowerpackintothe
socketontheundersideofthechargingbase.Tiltit
slightlyandapplyslightpressureuntilyouhearandfeel
itsnapintoplace.Placethechargingbaseonasuitable,
flattabletop.
Heat development
Asitisthecasewithallhigh-performancelights,the
highlightintensityresultsinacertainheatdevelopment.
Prolongedexposureofareasnearthepulpandsofttis-
suesmayresultinirreversibledamage.Therefore,the
stipulatedpolymerizationtime,particularlyinareasnear
thepulp(adhesives:10seconds)mustbeobserved.
Uninterruptedcuringtimesofmorethan20secondson
thesametoothsurface,aswellasdirectcontactwiththe
gingiva,oralmucousmembraneorskinhavetobepre-
vented.Polymerizeindirectrestorationsatintermittent
intervalsof20secondseachoruseexternalcoolingwith
anairstream.

9
Connectthepowercordwiththepowersupplyandthe
powerpack.ThePowerOnindicatoronthepowerpack
lightsupingreenandtheilluminatedringonthe
chargingbasebrieflylightsup.
Handpiece
Removethehandpiecefromitspackagingandcleanthe
lightprobeandthehandpiece(seechapterMaintenance
andCleaning).Thelightprobecanberemovedand
reattachedbyslightlyrotatingit.
Afterthat,mounttheanti-glareconeonthelightprobe.
Battery
Werecommendfullychargingthebatterybeforethefirst
use.Ifthebatteryisfullycharged,itfeaturesacuring
capacityofapprox.20minutes.
Slidethebatterystraightintothehandpieceuntilyou
hearandfeelitclickintoplace.

Gentlyplacethehandpieceinthe
correspondingrestinthecharging
basewithoutusinganyforce.Ifa
hygienesleeveisused,please
removeitbeforeyouchargethe
battery.Ifpossible,usethelight
alwayswithafullychargedbattery.
Thiswillprolongtheservicelife.It
isthereforerecommendedtoplace
thehandpieceintothecharging
baseaftereachpatient.Ifthe
batteryisfullydischarged,the
chargingtimeis2hours.

10
Click & Cure corded operation
BluephaseStylecanbeusedincordedoperationatany
time,butparticularlywhenthebatteryiscompletely
empty.
Forthispurpose,removethebatteryfromthehandpiece
bypressingthebatteryreleasebutton.
Sincethebatteryisanexpendablepart,ithastobe
replacedafteritstypicallifecyclehasexpiredafter
approximately2.5years.Seebatterylabelfortheageof
thebattery.
Battery charging status
Therespectivechargingstatusisindicatedonthe
chargingbaseasdescribedonPage5.
Thenremovethepowerpackfromtheundersideofthe
chargingbase.Donotpullonthepowercord.
Inserttheconnectionplugstraightintothehandpiece
untilyouhearandfeelitclickintoplace.
Duringcordedoperation,thechargingbasecannot
chargethebattery,sinceitisnotconnectedtoapower
source.