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SureSmile
VPro
®
INSTRUCTIONS FOR USE
INDICATIONS FOR USE
SureSmile VPro is intended for use by the orthodontic patient during
treatment with aligners to facilitate minor anterior tooth movement.
The SureSmile VPro Mouthpiece is intended for use with the SureSmile VPro
Vibration Device.
HOW SUPPLIED
The SureSmile VPro is supplied with a Vibration Device, Mouthpiece, and
Charging Cable.
The Mouthpiece and Charging Cable are also sold individually.
CONTRAINDICATIONS
• Do not use the vibration device if you have Vertigo or Temporomandibular
Joint (TMJ) Syndrome to avoid symptoms such as headache, dizziness, and
aching facial pain related to these disorders.
• Do not use any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) during the
treatment to avoid inhibition of orthodontic tooth movement.
• Do not use the vibration device if you are pregnant.
WARNING
• Use the vibration device only as instructed by your clinician. Discontinue
use of the device and consult your clinician if you experience sensitivity to
vibrations or if you experience headache, dizziness, nausea, discomfort or
pain.
• Do not make any modification to the vibration device. Any modification may
impair functionality of the device.
• The vibration device may not be suitable to use in conjunction with certain
dental restorations. Consult with your clinician before use.
• The vibration device is not recommended for patients diagnosed with
periodontal disease.
• Discontinue use of the vibration device if your orthodontic appliance is
damaged.
PRECAUTIONS
• It is important to read the SureSmile VPro Instructions for Use prior to
operation for proper use, maintenance and care.
• The vibration device and mouthpiece are intended to be re-used.
• Before use, inspect the device, mouthpiece and packaging to verify that
no damage has occurred as a result of shipping and handling. Do not use
damaged products.
• Always recharge the vibration device in accordance with the Instructions for
Use prior to use. Never use device when plugged into power source. Refer to
CHARGING section.
• Never use any other alternative power sources or instruments in conjunction
with the vibration device. Only use a power source with output less than or
equal to 5V 1A.
• Do not use the vibration device to clean or brush teeth to avoid any
undesired tooth movement.
• Use the vibration device only as instructed by the clinician.
• The vibration device is not waterproof, don't use near running water or get
the device wet. The mouthpiece can be cleaned with water according to
the instructions in CLEANING section. Do not expose the mouthpiece to
extreme hot water to avoid damaging the mouthpiece.
• Do not put the mouthpiece in the dishwasher to avoid damaging the
mouthpiece.
STEP-BY-STEP INSTRUCTIONS
1. Inspect and clean prior to use. Rinse the mouthpiece under water prior
to first use. Refer to HOW TO DETACH MOUTHPIECE section on how to
separate the mouthpiece from the vibration device.
2. Charge the vibration device fully prior to first use. Refer to CHARGING
section.
3. Connect the mouthpiece to the vibration device. Confirm that the vibration
device feels secure and stable before inserting the mouthpiece into mouth.
4. The vibration device is meant to be used while the orthodontic appliances
are in your mouth.
5. Depress the button located on the vibration device to activate the vibration
session.
Vibration Device
MOUTHPIECE
VIBRATON DEVICE
CHARGING CABLE
6. The vibration device is intended to be used for a total of 5 minutes per day
in a single session. The vibration device will function for 5 minutes per use
and will automatically shut-off afterward.
7. Clean the mouthpiece after use and charge the unit if necessary. Refer to
CHARGING and CLEANING sections. Store the vibration device and the
mouthpiece at room temperature.
HOW TO DETACH MOUTHPIECE
1. Hold the vibration device in a way that the button is facing toward you.
2. Push the mouthpiece downward while holding the vibration device in place
to detach the mouthpiece.
YES
HOLD
CLEANING
The mouthpiece should be cleaned after each treatment use. Detach the
mouthpiece from the vibration device. Rinse the mouthpiece under water and
brush with a toothbrush as necessary. The USB charging cable and SureSmile
VPro Vibration Device should be kept DRY.
CHARGING
Charge the vibration device by connecting the charging cable to a USB power
source. Ensure that the output of the power source is less than or equal to
5V 1A. The device will blink blue intermittently when the device is charging.
The device will emit continuous green light when the charging is complete.
The vibration device will blink red intermittently when it is low in battery. The
vibration device will not vibrate while it is charging. Recommended charging
time is once a week. The vibration device is internally powered (3.7 VDC)
by a rechargeable lithium-ion polymer battery pack. The vibration device is
inoperable while it is charging. Never use device when plugged into power
source.
DEVICE NOTIFICATIONS
Blue (3 Blinks)
Blue (Slow Blinking)
Green (3 Blinks)
Green (Slow Blinking)
Green (Blinks & Vibrates)
Orange* (Slow Blinking)
Orange*, Green, Blue (1 Blink Each)
*Orange LED may appear Red for some devices.
STORAGE
Proper care should be taken to ensure that the vibration device and
mouthpiece are not damaged. The mouthpiece should be stored in the original
packaging. The vibration device and the mouthpiece should be stored at room
temperature.
Storage/Operating Temperature: 0°C to 30°C
Storage/Operating Humidity: 15% to 90%
Storage/Operating Atmospheric Conditions: 700 hPa to 1060 hPA
Transport Temperature: -20°C to 45°C.
DISPOSAL
After the completion of your orthodontic treatment, discard the mouthpiece in
the garbage. The vibration device and charging cable should be discarded in a
separate collection for electrical and electronic equipment in accordance with
your local regulations.
Used electrical and electronic equipment (WEEE) should not be mixed with
general household waste. For proper treatment, recovery and recycling, please
take this product to a designated collection point where it will be accepted
free of charge. Disposing of this product correctly will help save valuable
resources and prevent any potential negative effects on human health and
the environment, which could otherwise arise from inappropriate waste
handling. Please contact your local authority for further details of your nearest
designated collection point/household hazardous waste collection point.
Penalties may be applicable for incorrect disposal of this waste, in accordance
with your national legislation.
NO
PUSH
PUSH
HOLD
Session Start
Charging in Progress
Session End
Charging Complete
Device Locate
Low Battery
Device Reset/Reboot
EN
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Resumen de contenidos para DENTSPLY SureSmile VPro

  • Página 1 Charging in Progress PRECAUTIONS Green (3 Blinks) Session End • It is important to read the SureSmile VPro Instructions for Use prior to operation for proper use, maintenance and care. Green (Slow Blinking) Charging Complete • The vibration device and mouthpiece are intended to be re-used.
  • Página 2 • This equipment has been tested and found to comply with the limits for a If your SureSmile VPro Vibration Device, or any of its components, no Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are...
  • Página 3 Grøn (langsomme blink) Opladning fuldført FORHOLDSREGLER Grøn (blinker og vibrerer) Enhedslokalisering • Det er vigtigt at læse SureSmile VPro-brugsanvisningen før brug for korrekt Orange* (langsomme blink) Lavt batteri brug, vedligeholdelse og pleje. Orange*, Grøn, Blå (1 blink hver) Nulstilling af enhed/Genstart •...
  • Página 4 Drej eller flyt modtagerantennen. Øg afstanden Dentsply Sirona, Inc. garanterer over for den oprindelige køber, at SureSmile mellem udstyret og modtageren. Tilslut udstyret til en stikkontakt på et VPro-vibrationsenheden vil være fri for defekter i et (1) år fra datoen for det...
  • Página 5 Vibrationsgerät sicher und stabil anfühlt, bevor Sie das vorgesehen, um kleinere Frontzahnbewegungen zu erleichtern. Mundstück in den Mund einführen. Das SureSmile VPro Mundstück ist für die Verwendung mit dem SureSmile 4. Das Vibrationsgerät soll verwendet werden, während sich die VPro Vibrationsgerät vorgesehen.
  • Página 6 • Dieses Gerät wurde getestet und entspricht den Grenzwerten für ein digitales Gerät der Klasse B gemäß Teil 15 der FCC-Vorschriften. Diese Dentsply Sirona, Inc. garantiert dem Erstkäufer, dass das SureSmile VPro Grenzwerte sind so ausgelegt, dass sie einen angemessenen Schutz gegen Vibrationsgerät für ein (1) Jahr ab dem Datum des ursprünglichen Kaufs frei...
  • Página 7 φόρτισης. Ποτέ μη χρησιμοποιείτε τη συσκευή όταν είναι συνδεδεμένη σε πηγή υποστεί ζημιά. τροφοδοσίας. ΠΡΟΦΥΛΑΞΕΙΣ ΕΙΔΟΠΟΙΗΣΕΙΣ ΣΥΣΚΕΥΗΣ • Είναι σημαντικό να διαβάσετε τις Οδηγίες χρήσης του SureSmile VPro πριν από τη Μπλε (αναβοσβήνει 3 φορές) Έναρξη συνεδρίας λειτουργία για τη σωστή χρήση, συντήρηση και φροντίδα. Μπλε (αναβοσβήνει αργά) Φόρτιση...
  • Página 8 Η Dentsply Sirona, Inc. εγγυάται στον αρχικό αγοραστή ότι η συσκευή δόνησης και χρησιμοποιηθεί σύμφωνα με τις οδηγίες, μπορεί να προκαλέσει επιβλαβείς SureSmile VPro θα είναι απαλλαγμένη από ελαττώματα για ένα (1) έτος από την παρεμβολές στις ραδιοεπικοινωνίες. Ωστόσο, δεν υπάρχει καμία εγγύηση ότι δεν θα...
  • Página 9 NOTIFICACIONES DEL DISPOSITIVO dañado. PRECAUCIONES Azul (3 parpadeos) Inicio de sesión • Es importante leer las Instrucciones de uso de SureSmile VPro antes de la Azul (parpadeo lento) Carga en curso operación para un uso, mantenimiento y cuidado adecuados. Verde (3 parpadeos) Fin de la sesión...
  • Página 10 Dentsply Sirona, Inc. garantiza al comprador original que el dispositivo de genera, usa y puede irradiar energía de radiofrecuencia y, si no se instala y vibración SureSmile VPro no tendrá defectos durante un (1) año a partir de la usa de acuerdo con las instrucciones, puede causar interferencias dañinas fecha de compra original.
  • Página 11 à une source d’alimentation. PRÉCAUTIONS NOTIFICATIONS DU DISPOSITIF • Veuillez lire le mode d’emploi du SureSmile VPro avant de l’utiliser, afin de garantir une utilisation, une maintenance et un entretien appropriés. Bleu (3 Clignotements) Démarrage de la séance •...
  • Página 12 La société Dentsply Sirona, Inc. garantit à l’acheteur initial que le dispositif appareils numériques de classe B, conformément à la partie 15 des règles de vibration SureSmile VPro sera exempt de tout défaut pendant un (1) an à de la FCC. Ces limites sont destinées à fournir une protection raisonnable compter de la date de l’achat initial.
  • Página 13 Hreinsaðu munnstykkið með vatni og burstaðu Temporomandibular Joint (TMJ) Syndrome) til að koma í veg fyrir einkenni það með tannbursta ef þörf krefur. USB hleðslusnúran og SureSmile VPro eins og höfuðverk, svima og verki í andliti sem tengjast þessum kvillum.
  • Página 14 þína. Ekki reyna að þjónusta eða þessi búnaður veldur skaðlegum truflunum á móttöku á útvarps- eða sinna viðhaldi á búnaðinum. Engar breytingar eru leyfilegar á SureSmile VPro sjónvarpsbylgjum, sem kann að stýrast af því að kveikt eða slökkt sé á...
  • Página 15 è in carica. Non utilizzare mai il dispositivo quando è collegato alla fonte di PRECAUZIONI alimentazione. • È importante leggere le istruzioni per l’uso di SureSmile VPro prima del NOTIFICHE DEL DISPOSITIVO funzionamento per un uso, una manutenzione e una cura adeguati.
  • Página 16 Dentsply Sirona, Inc. garantisce all’acquirente originale che il dispositivo a sono progettati per fornire una protezione adeguata contro le interferenze vibrazione SureSmile VPro sarà esente da difetti per un (1) anno dalla data dannose in un’installazione residenziale. Il dispositivo genera, utilizza e può...
  • Página 17 PEMBUNGKUSAN PRODUK 6. Peranti getaran bertujuan untuk digunakan selama 5 minit sehari dalam satu SureSmile VPro dibekalkan dengan Peranti Getaran, Pelekap Mulut dan Kabel sesi. Peranti getaran akan berfungsi selama 5 minit setiap kali penggunaan Pengecasan. dan akan dimatikan secara automatik selepas itu.
  • Página 18 Dentsply Sirona, Inc. memberi jaminan kepada pembeli asal yang Peranti menggunakan dan boleh memancarkan tenaga frekuensi radio dan, jika Getaran SureSmile VPro bebas daripada kerosakan selama satu (1) tahun dari ia tidak dipasang dan digunakan mengikut arahan, ia boleh menyebabkan tarikh pembelian asal.
  • Página 19 VOORZORGSMAATREGELEN Blauw (3 x knipperen) Start sessie • Het is belangrijk om de gebruiksaanwijzing van de SureSmile VPro te lezen Blauw (langzaam knipperen) Bezig met opladen voor gebruik, voor correct gebruik, onderhoud en zorg. • Het vibratieapparaat en het mondstuk zijn bedoeld om opnieuw te worden...
  • Página 20 Er kunnen sancties van toepassing zijn op onjuiste verwijdering VERVANGING van dit afval, in overeenstemming met uw nationale wetgeving. Als uw SureSmile VPro-trilapparaat, of een van de onderdelen ervan, niet meer BLOOTSTELLING EN INTERFERENTIE goed werkt of gerepareerd moet worden, neem dan onmiddellijk contact •...
  • Página 21 Lading fullført FORHOLDSREGLER Grønn (blinker og vibrerer) Grønn (blinker og vibrerer) Enhetslokalisering • Det er viktig å lese SureSmile VPro-bruksanvisningen før bruk for riktig bruk, vedlikehold og stell. Oransje* (sakte blinking) Oransje* (sakte blinking) Lavt batterinivå • Vibrasjonsanordningen og munnstykket er ment for gjenbruk.
  • Página 22 Dentsply Sirona, Inc. garanterer overfor den opprinnelige kjøperen at utstyret forårsaker skadelig interferens på radio- eller TV-mottak, noe som SureSmile VPro vibrasjonsenhet vil være fri for defekter i ett (1) år fra den kan fastslås ved å slå utstyret av og på, oppfordres brukeren til å prøve å...
  • Página 23 6. Aparat wibracyjny należy używać przez 5 minut dziennie podczas jednej sesji. Aparat wibracyjny będzie działać przez 5 minut za każdym użyciem, Ustnik SureSmile VPro Mouthpiece jest przeznaczony do użytku z aparatem po czym wyłączy się automatycznie. wibracyjnym SureSmile VPro.
  • Página 24 Dentsply Sirona, Inc. gwarantuje pierwotnemu nabywcy, że aparat wibracyjny te służą zapewnieniu rozsądnej ochrony przed szkodliwymi zakłóceniami SureSmile VPro będzie wolny od wad przez jeden (1) rok od daty pierwotnego w instalacji mieszkaniowej. Urządzenie to generuje, wykorzystuje i może zakupu.
  • Página 25 Início de sessão PRECAUÇÕES Azul (a piscar lentamente) Carregamento em andamento • É importante ler as Instruções de utilização do SureSmile VPro antes da operação para uso, manutenção e cuidados adequados. Verde (3 piscadelas) Fim de sessão • O dispositivo de vibração e a boquilha devem ser reutilizados.
  • Página 26 A Dentsply Sirona, Inc. garante ao comprador original que o Dispositivo de gera, usa e pode irradiar energia de radiofrequência e, se não for instalado vibração SureSmile VPro estará livre de defeitos durante um (1) ano a partir da e usado de acordo com as instruções, pode causar interferência prejudicial data da compra original.
  • Página 27 7. Curățați piesa bucală după utilizare și încărcați aparatul dacă este necesar. MOD DE PREZENTARE Consultați secțiunile ÎNCĂRCARE și CURĂȚARE. Păstrați dispozitivul de SureSmile VPro este livrat cu un dispozitiv de vibrații, o piesă bucală și un vibrații și piesa bucală la temperatura camerei. cablu de încărcare.
  • Página 28 Dentsply Sirona, Inc. îi garantează cumpărătorului original că dispozitivul TV, care pot fi determinate de oprirea și pornirea echipamentului, utilizatorul de vibrații SureSmile VPro nu va avea defecte timp de un (1) an de la data este încurajat să încerce să corecteze interferențele folosind una dintre achiziției originale.
  • Página 29 • Lopeta värinälaitteen käyttö, jos oikomishoitolaitteesi on vahingoittunut. Vihreä (hidas välkkyminen) Laite on ladattu VAROTOIMET • Ennen laitteen käyttöä on tärkeää lukea SureSmile VPro -käyttöohjeista Vihreä (välkkyy ja värisee) Laitteen paikallistaminen asianmukaisen käytön, puhdistuksen ja huollon ohjeet. • Värinälaite ja suukappale on tarkoitettu uudelleenkäytettäviksi.
  • Página 30 OSIEN KORVAAMINEN suojaluokitus: IP22 normaaliasennostaan. Jos SureSmile VPro -värinälaite tai mikä tahansa sen osista ei enää toimi tai vaatii korjausta, ota välittömästi yhteyttä lääkäriin, joka on vastuussa oikomishoidostasi. Älä yritä huoltaa tai korjata laitetta. Minkäänlaisia muutoksia SureSmile VPro -laitteeseen ei sallita.
  • Página 31 Laddning pågår FÖRSIKTIGHETSÅTGÄRDER Grönt sken (tre blinkningar) Sessionsstopp • Det är viktigt att läsa användarinstruktionerna för SureSmile VPro för att se till att den används, underhålls och sköts korrekt. Grönt sken (blinkar sakta) Laddning klar • Ultraljudsapparaten och munstycket är återanvändbara.
  • Página 32 Försök inte serva eller Denna utrustning genererar, använder och kan skicka radiofrekvensenergi utföra underhåll på apparaten. Ingen ändring får göras på SureSmile VPro och om den inte är korrekt installerad och används enligt instruktionerna ultraljudsapparat.
  • Página 33 SureSmile VPro ม ี จ ุ ด ประสงค ์ ส ำ � หร ั บ ใช ้ โ ดยผ ู ้ ป ่ ว ยท ี ่ จ ั ด ฟ ั น ในระหว ่ � งก�รร ั ก ษ�...
  • Página 34 ภ�ระผ ู ก พ ั น แต ่ เ พ ี ย งฝ ่ � ยเด ี ย วของ Dentsply Sirona จะข ึ ้ น อย ู ่ ก ั บ ด ุ ล ยพ ิ น ิ จ ของ...
  • Página 35 SureSmile VPro Ağızlık, SureSmile VPro Titreşim Cihazı ile kullanılmak üzere doğru itin. tasarlanmıştır. EVET HAYIR NASIL TEMİN EDİLİR SureSmile VPro, Titreşim Cihazı, Ağızlık ve Şarj Kablosu ile birlikte temin edilir. AĞIZLIK TİTREŞİM CİHAZI ŞARJ KABLOSU BASILI TUT BASILI TUT TEMİZLİK Ağızlık her tedavi kullanımından sonra temizlenmelidir.
  • Página 36 Bu ekipman, açılıp kapatılarak tespit edilecek şekilde radyo veya televizyon sinyali alımında zararlı parazite neden oluyorsa, kullanıcının Dentsply Sirona, Inc., SureSmile VPro Titreşim Cihazının ilk satın alma aşağıdaki önlemlerden birini alarak bu paraziti gidermeye çalışması tavsiye tarihinden itibaren bir (1) yıl boyunca kusursuz çalışacağını ilk satın alan kişiye edilir: Alıcı...
  • Página 37 Màu cam* (Nhấp nháy chậm) Pin yếu PHÒNG NGỪA • Điều quan trọng là cần đọc Hướng dẫn sử dụng thiết bị rung SureSmile VPro trước Màu cam*, Xanh lá, Xanh dương Cài đặt lại/Khởi động lại thiết bị khi dùng để sử dụng, bảo trì và chăm sóc đúng cách.
  • Página 38 điều kiện sau: (1) Thiết bị này không được gây nhiễu có hại và (2) bảo hành. Chỉ bác sĩ chỉnh nha hoặc nha sĩ ban đầu mua hàng từ Dentsply Sirona thiết bị này phải chấp nhận mọi nhiễu nhận được, bao gồm cả nhiễu có thể gây ra mới được yêu cầu bảo hành.
  • Página 39 Medical Device Catalog Number Lot Number Prescription Medicinsk udstyr Katalognummer Partinummer Ordination Medizinprodukt Katalognummer Chargennummer Behandlungsplan Ιατροτεχνολογικό προϊόν Αριθμός καταλόγου Αριθμός παρτίδας Συνταγογράφηση Dispositivo médico Número de catálogo Número de lote Prescripción Dispositif médical Numéro de référence Numéro de lot Sur prescription Lækningatæki Vörunúmer...
  • Página 40 Date of Manufacture Type BF Applied Part Interference Fremstillingsdato Interferens Type BF anvendt del Herstellungsdatum Störung Anwendungsteil vom Typ BF Ημερομηνία κατασκευής Παρεμβολή Εφαρμοζόμενο μέρος τύπου BF Fecha de fabricación Dispositivo médico Pieza aplicada tipo BF Date de fabrication Interferencia Partie appliquée de type BF Framleiðsludagsetning Truflanir...
  • Página 41 Caution, Consult accompanying documents Follow Instructions for Use Keep Dry Vær forsigtig, se medfølgende dokumenter Følg brugsanvisningen Opbevares tørt Achtung, Begleitdokumente beachten Gebrauchsanweisung beachten Vor Nässe schützen Προσοχή, Συμβουλευτείτε τα συνοδευτικά έγγραφα Ακολουθήστε τις Οδηγίες χρήσης Διατηρείται στεγνό Precaución: consultar los documentos adjuntos Siga las instrucciones de uso Mantener seco Attention, consulter la documentation jointe...
  • Página 42 Australian Sponsor European Conformity Authorized Representative Australia Europæisk overensstemmelse Autoriseret repræsentant i Australien Europäische Konformität Bevollmächtigter Vertreter, Australien Ευρωπαϊκή συμμόρφωση Εξουσιοδοτημένος αντιπρόσωπος, Αυστραλία Conformidad europea Representante autorizado, Australia Conformité Européenne Représentant autorisé en Australie Evrópsk samræmisyfirlýsing Viðurkenndur umboðsaðili í Ástralíu Conformità...