Medtronic 735AC25 Instructions for Use

Simulus™

Adjustable Annuloplasty Ring/Band
Anneau/Bande pour annuloplastie ajustables
Anpassbarer Annuloplastie-Ring/anpassbares

Annuloplastie-Band
Anillo/banda ajustable para anuloplastia
Anello/emianello regolabile per anuloplastica
Verstelbare annuloplastiekring/-band
justerbar anuloplastikring/-band
Justérbar(t) annuloplastikring/-bånd
Justerbar annuloplastikkring/-bånd
Anel/banda de anuloplastia ajustáveis
Ρυθμιζόμενος δακτύλιος

δακτυλιοπλαστικής/Ρυθμιζόμενος δακτύλιος
δακτυλιοπλαστικής με λαβή

Nastavitelný anuloplastický prstenec/proužek
Regulowany pierścień zamknięty/pierścień otwarty do

annuloplastyki
Állítható anuloplasztikai gyűrű/pánt
Ayarlanabilir Anüloplasti Halkası/Bandı
Nastaviteľný anuloplastický prstenec/pásik

735AF, 735AC
Instructions for Use • Mode d’emploi

Gebrauchsanweisung • Instrucciones de uso
Istruzioni per l’uso • Gebruiksaanwijzing
Bruksanvisning • Brugsanvisning • Bruksanvisning
Instruções de utilização • Οδηγίες χρήσης
Návod k použití • Instrukcja użytkowania
Használati útmutató • Kullanım Talimatları
Pokyny na používanie

Caution: Federal law (USA) restricts

this device to sale by or on the order of a
physician.

Trademarks may be registered and are the property of their respective owners.
Les marques commerciales mentionnées peuvent être déposées et appartiennent à leurs propriétaires
respectifs.
Marken sind eventuell eingetragen und sind das Eigentum ihrer jeweiligen Inhaber.
Las marcas comerciales pueden estar registradas y pertenecen a sus respectivos propietarios.
I marchi di fabbrica possono essere registrati e sono di proprietà dei rispettivi titolari.
Handelsmerken kunnen zijn geregistreerd en zijn het eigendom van de desbetreffende eigenaars.
Varumärken kan vara registrerade och tillhör respektive ägare.
Varemærker kan være registrerede og tilhører de respektive ejere.
Varemerkene kan være registrert og tilhører de respektive eierne.
As marcas comerciais podem ser registadas e são propriedade dos respectivos detentores.
Τα εμπορικά σήματα μπορεί να είναι καταχωρημένα και είναι ιδιοκτησία των αντίστοιχων κατόχων
τους.
Ochranné známky (mohou být registrované) jsou majetkem příslušných vlastníků.
Znaki towarowe mogą być zastrzeżone i są własnością odpowiednich podmiotów.
A védjegyek a megfelelő védjegytulajdonosok tulajdonát képezhetik.
Ticari markalar tescilli olabilir ve ilgili sahiplerinin mülkiyetindedir.
Ochranné známky môžu byť registrované a sú majetkom ich príslušných vlastníkov.

Explanation of symbols on package labeling / Explication
des symboles des étiquettes sur l’emballage / Erläuterung
der Symbole auf dem Verpackungsetikett / Explicación de
los símbolos que aparecen en la documentación del
envase / Spiegazione dei simboli sulle etichette della
confezione / Verklaring van de symbolen op de
verpakkingslabels / Förklaring av symboler på
förpackningsetiketten / Forklaring af symbolerne på
emballagens mærkater / Forklaring av symboler på
pakningen / Explicação dos símbolos na documentação da
embalagem / Επεξήγηση των συμβόλων στη σήμανση της
συσκευασίας / Vysvětlení symbolů uvedených na štítcích
balení / Objaśnienie symboli znajdujących się na etykietach
opakowania / A csomagoláson látható szimbólumok
jelentése / Ambalaj etiketlerindeki sembollerin açıklaması /
Vysvetlivky k symbolom na označení balenia

Refer to the outer package label to see which symbols apply to this
product / Se référer à l'étiquette sur l'emballage extérieur pour savoir
quels symboles s'appliquent à ce produit / Welche Symbole für dieses
Produkt gelten, entnehmen Sie bitte dem Etikett auf der Verpackung /
Consulte la etiqueta del envase exterior para comprobar qué símbolos
son aplicables a este producto / Fare riferimento all'etichetta sulla
confezione esterna per sapere quali simboli si applicano a questo
prodotto. / Controleer het label op de buitenverpakking om te zien welke
symbolen op dit product van toepassing zijn / Se etiketten på
ytterförpackningen för vilka symboler som gäller denna produkt / Se
mærkaten på den ydre emballage for de symboler, der gælder for dette
produkt / Se på etiketten utenpå pakningen for å fastslå hvilke symboler
som gjelder for dette produktet / Consultar as etiquetas exteriores da
embalagem para ver que símbolos se aplicam a este produto / Ανατρέξτε
στην ετικέτα της εξωτερικής συσκευασίας για να δείτε ποια σύμβολα
αφορούν αυτό το προϊόν / Symboly, které se vztahují k tomuto výrobku,
naleznete na štítku na vnější straně obalu / Należy zapoznać się z
etykietą na zewnętrznym opakowaniu, aby określić, które symbole
dotyczą niniejszego produktu / A termékre vonatkozó szimbólumok a
külső csomagoláson találhatóak. / Bu üründe hangi sembollerin geçerli
olduğunu görmek için dış ambalaj etiketine başvurun / Prezrite si
označenie na vonkajšom obale a zistite, ktoré symboly sa vzťahujú na
tento produkt

1

Conformité Européenne (European Conformity).
This symbol means that the device fully complies
with European Council Directive 93/42/EEC. /
Conformité Européenne. Ce symbole signifie que
l’appareil est entièrement conforme à la Directive
européenne 93/42/CEE. / Conformité
Européenne (Europäische Konformität). Dieses
Symbol besagt, dass das Gerät allen Vorschriften
der europäischen Richtlinie 93/42/EWG
entspricht. / Conformité Européenne
(Conformidad Europea). Este símbolo indica que
el dispositivo cumple totalmente la Directiva del
Consejo Europeo 93/42/CEE. / Conformité
Européenne (Conformità Europea). Questo
simbolo indica che il dispositivo è conforme alla
Direttiva del Consiglio Europeo 93/42/CEE. /
Conformité Européenne (Europese
Conformiteit). Dit symbool betekent dat het
product volledig voldoet aan de Europese
Richtlijn 93/42/EEG. / Conformité Européenne
(Europeisk standard). Denna symbol betyder att
enheten helt följer rådets direktiv 93/42/EEG. /
Conformité Européenne (Europæisk Standard).
Dette symbol betyder, at enheden fuldt ud
overholder Det Europæiske Råds direktiv
93/42/EØF. / Conformité Européenne (samsvar
med europeisk standard). Dette symbolet betyr at
enheten er fullstendig i samsvar med EU-direktiv
93/42/EØF. / Conformité Européenne
(Conformidade Europeia). Este símbolo significa
que o dispositivo está em total conformidade com
a Directiva do Conselho Europeu 93/42/CEE. /
Conformité Européenne (Ευρωπαϊκή
Συμμόρφωση). Το σύμβολο αυτό σημαίνει ότι το
προϊόν συμμορφώνεται πλήρως με την Οδηγία
93/42/ΕΟΚ του Ευρωπαϊκού Συμβουλίου. /
Conformité Européenne (Evropská shoda).
Tento symbol znamená, že prostředek zcela
splňuje požadavky směrnice Evropské rady
93/42/EHS. / Conformité Européenne (Zgodność
z normami Unii Europejskiej). Symbol ten

2

oznacza, że produkt spełnia wszystkie
wymagania dyrektywy Rady Unii Europejskiej
93/42/EWG. / Conformité Européenne (Európai
megfelelőség). Ez a szimbólum azt jelenti, hogy
az eszköz teljes mértékben megfelel az Európai
Tanács 93/42/EGK irányelvének. / Conformité
Européenne (Avrupa Normlarına Uygunluk).
Bu sembol, cihazın 93/42/EEC sayılı
Avrupa Konseyi Direktifi ile tamamen uyumlu
olduğu anlamına gelir. / Conformité Européenne
(Zhoda s požiadavkami EÚ). Tento symbol
znamená, že zariadenie úplne vyhovuje
požiadavkám uvedeným v smernici Európskej
rady 93/42/EHS.

Nonpyrogenic / Apyrogène / Pyrogenfrei /
Apirógeno / Non pirogeno / Niet-pyrogeen / Icke­pyrogen / Ikke-pyrogen / Pyrogenfri /
Apirogénico / Μη πυρετογόνο / Apyrogenní /
Produkt niepirogenny / Nem pirogén / Pirojenik
Değildir / Apyrogénne

Sterilized Using Irradiation / Stérilisation par
irradiation / Sterilisiert mittels Strahlung /
Esterilizado mediante irradiación / Sterilizzato
mediante radiazione / Gesteriliseerd met
straling / Steriliserad med strålning / Steriliseret
med stråling / Sterilisert med stråling /
Esterilizado por irradiação / Αποστειρωμένο με
ακτινοβολία / Sterilizováno zářením / Produkt
sterylizowany przy użyciu promieniowania /
Sugárzással sterilizálva / İrradyasyonla Sterilize
Edilmiştir / Sterilizované žiarením

Inner Diameter / Diamètre interne /
Innendurchmesser / Diámetro interno / Diametro
interno / Binnendiameter / Innerdiameter /
Indvendig diameter / Indre diameter / Diâmetro
interno / Εσωτερική διάμετρος / Vnitřní průměr /
Średnica wewnętrzna / Belső átmérő / İç Çap /
Vnútorný priemer

3

Do Not Reuse / Ne pas réutiliser / Nicht
wiederverwenden / No reutilizar / Non
riutilizzare / Niet opnieuw gebruiken / Får inte
återanvändas / Må kun bruges én gang / Bare
for engangsbruk / Não reutilizável / Μην
επαναχρησιμοποιείτε / Nepoužívejte
opakovaně / Produkt do jednorazowego
zastosowania / Kizárólag egyszeri használatra /
Yeniden Kullanmayın / Nepoužívajte opakovane

Do Not Resterilize / Ne pas restériliser / Nicht
resterilisieren / No reesterilizar / Non
risterilizzare / Niet hersteriliseren / Får inte
omsteriliseras / Må ikke resteriliseres / Skal ikke
resteriliseres / Não reesterilizar / Μην το
επαναποστειρώνετε / Neprovádějte resterilizaci /
Nie należy resterylizować / Nem
újrasterilizálható / Yeniden Sterilize Etmeyin /
Opakovane nesterilizujte

Use By / À utiliser jusqu'au / Zu verwenden bis
einschließlich / No utilizar después de / Data di
scadenza / Te gebruiken tot en met / Används
före / Sidste anvendelsesdato / Siste
forbruksdato / Não utilizar depois de / Χρήση
έως / Použijte do / Data ważności / Lejárat /
Son Kullanma Tarihi / Dátum najneskoršej
spotreby

Lot Number / Numéro de lot / Losnummer /
Número de lote / Numero di lotto / Partijnummer /
Lotnummer / Partinummer / Lotnummer /
Número de lote / Αριθμός παρτίδας / Číslo
šarže / Numer partii produkcyjnej / Tételszám /
Lot Numarası / Číslo šarže

Quantity / Quantité / Menge / Cantidad /
Quantità / Aantal / Antal / Antal / Antall /
Quantidade / Ποσότητα / Množství / Ilość /
Mennyiség / Miktar / Množstvo

4

Consult Instructions for Use / Consulter le mode
d'emploi / Gebrauchsanweisung beachten /
Consultar las instrucciones de uso / Vedere le
istruzioni per l'uso / Raadpleeg
gebruiksaanwijzing / Läs bruksanvisningen / Se
brugsanvisningen / Se i bruksanvisningen /
Consultar instruções de utilização /
Συμβουλευτείτε τις Οδηγίες χρήσης / Viz návod
k použití / Należy zapoznać się z instrukcją
użytkowania / Lásd a használati útmutatót /
Kullanım Talimatlarına Bakın / Pozrite pokyny na
používanie

For US Audiences Only / Ne s'applique qu'aux
États-Unis / Gilt nur für Leser in den USA / Sólo
aplicable en Estados Unidos / Esclusivamente
per il mercato statunitense / Alleen van
toepassing voor de VS / Gäller endast i USA /
Gælder kun i USA / Gjelder bare USA / Apenas
aplicável aos E.U.A. / Μόνο για πελάτες εντός
των ΗΠΑ / Pouze pro uživatele z USA / Dotyczy
tylko odbiorców w USA / Csak egyesült
államokbeli felhasználóknak / Yalnızca ABD'deki
Kullanıcılar İçin / Len pre používateľov v USA

Keep Dry / À conserver dans un endroit sec /
Trocken aufbewahren / Mantener seco /
Conservare in un luogo asciutto / Droog houden /
Förvaras torrt / Skal opbevares tørt / Skal holdes
tørr / Manter seco / Διατηρήστε στεγνό / Udržujte
v suchu / Chronić przed wilgocią / Szárazon
tartandó / Kuru Olarak Saklayın / Uschovajte v
suchu

Date of Manufacture / Date de fabrication /
Herstellungsdatum / Fecha de fabricación / Data
di fabbricazione / Productiedatum /
Tillverkningsdatum / Fabrikationsdato /
Produksjonsdato / Data de fabrico / Ημερομηνία
κατασκευής / Datum výroby / Data produkcji / A
gyártás ideje / Üretim Tarihi / Dátum výroby

5

Serial Number / Numéro de série /
Seriennummer / Número de serie / Numero
seriale / Serienummer / Serienummer /
Serienummer / Serienummer / Número de série /
Σειριακός αριθμός / Sériové číslo / Numer
seryjny / Sorozatszám / Seri Numarası / Sériové
číslo

Catalog Number / Numéro de référence /
Katalognummer / Número de catálogo / Numero
di catalogo / Catalogusnummer /
Katalognummer / Katalognummer /
Artikkelnummer / Número de catálogo / Αριθμός
καταλόγου / Katalogové číslo / Numer
katalogowy / Katalógusszám / Katalog
Numarası / Katalógové číslo

Manufacturer / Fabricant / Hersteller /
Fabricante / Produttore / Fabrikant / Tillverkare /
Fabrikant / Produsent / Fabricante /
Κατασκευαστής / Výrobce / Producent / Gyártó /
İmalatçı / Výrobca

Authorized Representative in the European
Community / Représentant agréé dans la
Communauté européenne / Autorisierter
Repräsentant für die Europäische
Gemeinschaft / Representante autorizado en la
Comunidad Europea / Rappresentante
autorizzato nella Comunità Europea /
Geautoriseerde vertegenwoordiger in de
Europese Gemeenschap / Auktoriserad
representant inom EG / Autoriseret repræsentant
i EF / Autorisert representant i Det europeiske
fellesskap / Representante Autorizado na
Comunidade Europeia / Εξουσιοδοτημένος
αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα /
Oprávněný zástupce pro Evropské společenství /
Autoryzowany przedstawiciel we Wspólnocie
Europejskiej / Meghatalmazott képviselő az
Európai Közösségben / Avrupa Topluluğu'ndaki
Yetkili Temsilci / Autorizovaný zástupca
v Európskom spoločenstve

6

Do Not Use if Package is Damaged / Ne pas
utiliser si l'emballage est endommagé / Nicht
verwenden, wenn die Verpackung beschädigt
ist / No utilizar si el envase está dañado / Non
utilizzare se la confezione appare danneggiata /
Niet gebruiken als de verpakking beschadigd is /
Får inte användas om förpackningen är skadad /
Må ikke anvendes, hvis emballagen er
beskadiget / Skal ikke brukes hvis pakningen er
skadet / Não utilizar se a embalagem estiver
danificada / Μην τo χρησιμοποιείτε εάν η
συσκευασία έχει υποστεί ζημιά / Nepoužívejte,
je-li balení poškozeno / Nie stosować, jeśli
opakowanie jest uszkodzone / Sérült
csomagolás esetén nem használható / Ambalaj
Hasarlıysa Kullanmayın / Nepoužívajte, ak je
obal poškodený

Manufactured In / Fabriqué à / Hergestellt in /
Fabricado en / Prodotto in / Vervaardigd in /
Tillverkad i / Fremstillet i / Produsert i / Fabricado
em / Κατασκευάστηκε σε / Vyrobeno v /
Wyprodukowano w / A gyártás helye / İmalat
Yeri / Vyrobené v

MR Safe / RM sans risque / MR-sicher / Seguro
para RM / Dispositivo sicuro per la risonanza
magnetica (RM) / MR Safe (MR-veilig) / MR­säker / MR-scanningssikker / MR-sikker / RM
seguro / Ασφαλές για μαγνητική τομογραφία
(MR) / Bezpečné z hlediska magnetické
rezonance / Bezpieczny w zastosowaniu z
rezonansem magnetycznym / MR
szempontjából biztonságos / MR Güvenli /
Bezpečné v prostredí MR

7

Ring / Anneau / Ring / Anillo / Anello / Ring / Ring / Ring /

1

2

1

Ring / Anel / Δακτύλιος / Prstenec / Pierścień zamknięty /
Gyűrű / Halka / Prstenec

Figure 1 / Figure 1 / Abbildung 1 / Figura 1 / Figura 1 / Afbeelding 1 /

Figur 1 / Figur 1 / Figur 1 / Figura 1 / Εικόνα 1 / Obrázek 1 / Rycina 1 /

1. ábra / Şekil 1 / Obrázok 1

1. Mitral trigone/tricuspid commissure markers /
Marqueurs des commissures de la valve
tricuspide/des trigones de la valve mitrale /
Markierungen für die Mitralklappentrigona/
Trikuspidalklappenkommissuren / Marcas de los
trígonos (válvula mitral)/de las comisuras (válvula
tricúspide) / Marcatori dei trigoni (valvola
mitrale)/delle commissure (valvola tricuspide) /
Mitrale trigonummarkering/tricuspidale
commissuurmarkering / Markörer för
mitraltrigoner/trikuspidalkommissurer / Markører
for mitral trigonum/trikuspidal kommissur /
Markører for mitralt trigon/tricuspidal kommissur /
Marcadores dos trígonos mitrais/comissuras
tricúspides / Δείκτες μιτροειδούς
τριγώνου/συνδέσμων τριγλώχινος / Značky pro
mitrální trigonum/trikuspidální komisuru / Znaczniki
trójkątów włóknistych zastawki mitralnej/spoideł
zastawki trójdzielnej / Mitrális
trigonum-/tricuspidális commissurajelölések /

8

Mitral trigon/triküspid komisür belirteçleri / Značky

1

2

1

mitrálneho trigona/trikuspidálnej komisúry

2. Drawstring sutures / Sutures en cordon de bourse /
Zugfäden / Suturas de cordón / Cordoncini di
chiusura / Trekkoordjes / Dragsuturer /
Snøresuturer / Trekksnorsuturer / Suturas com
cordão / Ράμματα έλξης / Zdrhovací stehy / Szwy
regulacyjne do pociągania / Húzózsinór-öltések /
Büzme sütürleri / Stehy sťahovadla

Band / Bande / Band / Banda / Emianello / Band / Band /
Bånd / Bånd / Banda / Δακτύλιος με λαβή / Proužek /
Pierścień otwarty / Pánt / Bant / Pásik

Figure 2 / Figure 2 / Abbildung 2 / Figura 2 / Figura 2 / Afbeelding 2 /

Figur 2 / Figur 2 / Figur 2 / Figura 2 / Εικόνα 2 / Obrázek 2 / Rycina 2 /

2. ábra / Şekil 2 / Obrázok 2

1. Mitral trigone/tricuspid commissure markers /
Marqueurs des commissures de la valve
tricuspide/des trigones de la valve mitrale /
Markierungen für die Mitralklappentrigona/
Trikuspidalklappenkommissuren / Marcas de los
trígonos (válvula mitral)/de las comisuras (válvula
tricúspide) / Marcatori dei trigoni (valvola
mitrale)/delle commissure (valvola tricuspide) /
Mitrale trigonummarkering/tricuspidale
commissuurmarkering / Markörer för
mitraltrigoner/trikuspidalkommissurer / Markører

9

for mitral trigonum/trikuspidal kommissur /
Markører for mitralt trigon/tricuspidal kommissur /
Marcadores dos trígonos mitrais/comissuras
tricúspides / Δείκτες μιτροειδούς
τριγώνου/συνδέσμων τριγλώχινος / Značky pro
mitrální trigonum/trikuspidální komisuru / Znaczniki
trójkątów włóknistych zastawki mitralnej/spoideł
zastawki trójdzielnej / Mitralis
trigonum-/tricuspidalis commissurajelölések /
Mitral trigon/triküspid komisür belirteçleri / Značky
mitrálneho trigona/trikuspidálnej komisúry

2. Drawstring sutures / Sutures en cordon de bourse /
Zugfäden / Suturas de cordón / Cordoncini di
chiusura / Trekkoordjes / Dragsuturer /
Snøresuturer / Trekksnorsuturer / Suturas com
cordão / Ράμματα έλξης / Zdrhovací stehy / Szwy
regulacyjne do pociągania / Húzózsinór-öltések /
Büzme sütürleri / Stehy sťahovadla

10

Sizing Mitral Annulus / Calibrage de l'anneau mitral /
Größenbestimmung des Mitralklappen-Annulus / Medición
del anillo mitral / Determinazione della dimensione
dell'annulus mitralico / Meten van de annulus van de
mitralisklep / Mätning av mitralklaffens anulus / Opmåling
af den mitrale annulus / Måle mitralannulus /
Dimensionamento do anel mitral / Προσδιορισμός
μεγέθους δακτυλίου μιτροειδούς / Určení velikosti
mitrálního anulu / Pomiar pierścienia mitralnego / Mitrális
anulus méretvétele / Mitral Anülus Boyutunun
Belirlenmesi / Určenie veľkosti mitrálneho anulu

Figure 3 / Figure 3 / Abbildung 3 / Figura 3 / Figura 3 / Afbeelding 3 /

Figur 3 / Figur 3 / Figur 3 / Figura 3 / Εικόνα 3 / Obrázek 3 / Rycina 3 /

3. ábra / Şekil 3 / Obrázok 3

11

Sizing Tricuspid Annulus / Calibrage de l'anneau
tricuspide / Größenbestimmung des Trikuspidalklappen­Annulus / Medición del anillo tricuspídeo / Determinazione
della dimensione dell'annulus tricuspidale / Meten van de
annulus van de tricuspidalisklep / Mätning av
trikuspidalklaffens anulus / Opmåling af den trikuspidale
annulus / Måle tricuspidalannulus / Dimensionamento do
anel tricúspide / Προσδιορισμός μεγέθους δακτυλίου
τριγλώχινας / Určení velikosti trikuspidálního anulu /
Pomiar pierścienia trójdzielnego / Tricuspidális anulus
méretvétele / Triküspid Anülus Boyutunun Belirlenmesi /
Určenie veľkosti trikuspidálneho anulu

Figure 4 / Figure 4 / Abbildung 4 / Figura 4 / Figura 4 / Afbeelding 4 /

Figur 4 / Figur 4 / Figur 4 / Figura 4 / Εικόνα 4 / Obrázek 4 / Rycina 4 /

4. ábra / Şekil 4 / Obrázok 4

12

/ / / / / / / / / / / / / / /

Figure 5 / Figure 5 / Abbildung 5 / Figura 5 / Figura 5 / Afbeelding 5 /

Figur 5 / Figur 5 / Figur 5 / Figura 5 / Εικόνα 5 / Obrázek 5 / Rycina 5 /

5. ábra / Şekil 5 / Obrázok 5

/ / / / / / / / / / / / / / /

Figure 6 / Figure 6 / Abbildung 6 / Figura 6 / Figura 6 / Afbeelding 6 /

Figur 6 / Figur 6 / Figur 6 / Figura 6 / Εικόνα 6 / Obrázek 6 / Rycina 6 /

6. ábra / Şekil 6 / Obrázok 6

13

/ / / / / / / / / / / / / / /

Figure 7 / Figure 7 / Abbildung 7 / Figura 7 / Figura 7 / Afbeelding 7 /

Figur 7 / Figur 7 / Figur 7 / Figura 7 / Εικόνα 7 / Obrázek 7 / Rycina 7 /

7. ábra / Şekil 7 / Obrázok 7

/ / / / / / / / / / / / / / /

Figure 8 / Figure 8 / Abbildung 8 / Figura 8 / Figura 8 / Afbeelding 8 /

Figur 8 / Figur 8 / Figur 8 / Figura 8 / Εικόνα 8 / Obrázek 8 / Rycina 8 /

8. ábra / Şekil 8 / Obrázok 8

14

/ / / / / / / / / / / / / / /

Figure 9 / Figure 9 / Abbildung 9 / Figura 9 / Figura 9 / Afbeelding 9 /

Figur 9 / Figur 9 / Figur 9 / Figura 9 / Εικόνα 9 / Obrázek 9 / Rycina 9 /

9. ábra / Şekil 9 / Obrázok 9

/ / / / / / / / / / / / / / /

Figure 10 / Figure 10 / Abbildung 10 / Figura 10 / Figura 10 /

Afbeelding 10 / Figur 10 / Figur 10 / Figur 10 / Figura 10 / Εικόνα 10 /

Obrázek 10 / Rycina 10 / 10. ábra / Şekil 10 / Obrázok 10

15

/ / / / / / / / / / / / / / /

Figure 11 / Figure 11 / Abbildung 11 / Figura 11 / Figura 11 /

Afbeelding 11 / Figur 11 / Figur 11 / Figur 11 / Figura 11 / Εικόνα 11 /

Obrázek 11 / Rycina 11 / 11. ábra / Şekil 11 / Obrázok 11

/ / / / / / / / / / / / / / /

Figure 12 / Figure 12 / Abbildung 12 / Figura 12 / Figura 12 /

Afbeelding 12 / Figur 12 / Figur 12 / Figur 12 / Figura 12 / Εικόνα 12 /

Obrázek 12 / Rycina 12 / 12. ábra / Şekil 12 / Obrázok 12

/ / / / / / / / / / / / / / /

Figure 13 / Figure 13 / Abbildung 13 / Figura 13 / Figura 13 /

Afbeelding 13 / Figur 13 / Figur 13 / Figur 13 / Figura 13 / Εικόνα 13 /

Obrázek 13 / Rycina 13 / 13. ábra / Şekil 13 / Obrázok 13

16

/ / / / / / / / / / / / / / /

Figure 14 / Figure 14 / Abbildung 14 / Figura 14 / Figura 14 /

Afbeelding 14 / Figur 14 / Figur 14 / Figur 14 / Figura 14 / Εικόνα 14 /

Obrázek 14 / Rycina 14 / 14. ábra / Şekil 14 / Obrázok 14

/ / / / / / / / / / / / / / /

Figure 15 / Figure 15 / Abbildung 15 / Figura 15 / Figura 15 /

Afbeelding 15 / Figur 15 / Figur 15 / Figur 15 / Figura 15 / Εικόνα 15 /

Obrázek 15 / Rycina 15 / 15. ábra / Şekil 15 / Obrázok 15

17

/ / / / / / / / / / / / / / /

Figure 16 / Figure 16 / Abbildung 16 / Figura 16 / Figura 16 /

Afbeelding 16 / Figur 16 / Figur 16 / Figur 16 / Figura 16 / Εικόνα 16 /

Obrázek 16 / Rycina 16 / 16. ábra / Şekil 16 / Obrázok 16

/ / / / / / / / / / / / / / /

Figure 17 / Figure 17 / Abbildung 17 / Figura 17 / Figura 17 /

Afbeelding 17 / Figur 17 / Figur 17 / Figur 17 / Figura 17 / Εικόνα 17 /

Obrázek 17 / Rycina 17 / 17. ábra / Şekil 17 / Obrázok 17

18

/ / / / / / / / / / / / / / /

Figure 18 / Figure 18 / Abbildung 18 / Figura 18 / Figura 18 /

Afbeelding 18 / Figur 18 / Figur 18 / Figur 18 / Figura 18 / Εικόνα 18 /

Obrázek 18 / Rycina 18 / 18. ábra / Şekil 18 / Obrázok 18

19

Simulus™
Adjustable Annuloplasty Ring/Band

1. Device Description

The Simulus™ adjustable annuloplasty ring model 735AF (Figure 1) and
Simulus™ adjustable annuloplasty band model 735AC (Figure 2) consist
of a flexible braided polyester fabric. Both the ring and band may be
implanted in the mitral or tricuspid annulus to stabilize the annulus
following valve repair. The individual ring and band size (25 to 39 mm in
2-mm increments) refers to the distance between the mitral valve trigone
markers or tricuspid valve septal commissure markers on the ring or
band. The devices contain circumferential flexible radiopaque markers.
The entire circumference of each ring and band is radiopaque. The device
has two drawstrings used to make any final size adjustments during valve
repair surgery.

2. Indication

The Simulus™ adjustable annuloplasty rings and bands are for use in
those patients undergoing surgery of diseased or damaged mitral or
tricuspid valves in whom the surgeon determines that the valve can be
preserved by employing the appropriate surgical repair. The Simulus™
adjustable annuloplasty ring or band provides support for the mitral or
tricuspid annulus and restricts expansion of the annulus.

3. Contraindications

■

severe, generalized or localized bacterial endocarditis

■

heavily calcified valves

■

greatly dilated annulus (not reducible by standard techniques)

■

severe valvular dysfunction (not correctable by standard techniques)

■

valvular retraction with severely reduced mobility

■

congenital malformations with lack of valvular tissue

4. Warnings

■

For single use only. Do not resterilize the ring or band.

■

Only surgeons who have received adequate training to determine
whether incompetent, stenotic, or diseased heart valves are capable
of being repaired or replaced should use this device.

■

Only surgeons who have received appropriate training in valve repair,
including ring and band implant and sizing techniques, should use
this device.

20 Instructions for Use English

■

Correct annuloplasty ring and band sizing is an important element of
a successful valve repair. Undersizing the ring or band can result in
valve stenosis. Oversizing the ring or band can result in valve
regurgitation.

■

Care should be taken that sutures are not placed in atrial tissue, as
this may result in impairment of the cardiac conduction system.

■

It is necessary to secure the ends of the ring and band into fibrous
mitral trigone tissue to maintain permanent attachment of the ring or
band.

■

Suture knots must be securely tied. Loose knots and long suture tails
may be a source for hemolysis, thrombosis, or thromboembolism.

■

Do not cut the ring/band, as resultant loose threads can be a source
of hemolysis, thrombosis, and/or thromboembolism.

■

Intraoperative and/or postoperative echocardiography should be
used to evaluate the effectiveness of the valve repair. Minimizing
regurgitation and preventing systolic anterior motion (SAM) are
important elements of an effective repair.

■

Surgeons who use annuloplasty rings and/or bands should be current
on all anticoagulation regimens.

■

When postoperative anticoagulant therapy is used, the patient’s
anticoagulation status should be carefully monitored.

■

Patients with intra-atrial thrombi or a giant left atrium may benefit from
long-term anticoagulation therapy.

■

The surgeon may desire that patients in atrial fibrillation remain on
anticoagulation therapy until sinus rhythm is established.

■

Use continuous running sutures around the posterior portion of the
ring or band. Placement of sutures through the posterior portion of
the ring or band will result in disabling the adjustable drawstrings.

■

Do not pass a needle or suture through the posterior portions of the
ring or band, as this may prevent the drawstring adjustment of the
ring or band.

5. Precautions

■

Do not use cutting edge needles, as they may damage the
annuloplasty device potentially leading to ring/band dehiscence, and
possible mitral regurgitation.

■

Take care not to damage the annuloplasty ring or band during
handling.

■

This device was designed for single patient use only. Do not reuse,
reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device

Instructions for Use English 21

and/or create a risk of contamination of the device, which could result
in patient injury, illness, or death.

6. Potential Adverse Events

While infrequent, certain complications have been reported when using
annuloplasty ring/bands. These include the following:

■

uncorrected or recurrent regurgitation

■

stenosis

■

ring/band dehiscence

■

hemolysis (even with mild regurgitation)

■

low cardiac output

■

heart block

■

systolic anterior motion (SAM) and left ventricular outflow tract
obstruction (LVOTO)

■

damage to coronary arteries

■

endocarditis

■

thrombosis

■

thromboembolism

■

anticoagulant-related hemorrhage

■

leaflet perforation

■

bleeding diathesis

The potential for these complications should be considered when
selecting the most beneficial surgical procedure for each patient. To avoid
or minimize occurrence of these adverse events, the annuloplasty repair,
including sizing and implantation, should be conducted in accordance
with the methods described in these Instructions for Use by surgeons with
appropriate training and experience in valve repair.

7. Individualization of Treatment

To allow for healing and incorporation of the annuloplasty ring or band by
host tissue, regardless of cardiac rhythm, postoperative anticoagulation
therapy should be considered for at least six weeks following surgery.

8. Patient Counseling Information

8.1. Patient Dental Care

Patients with annuloplasty rings or bands who undergo dental or other
potentially bacteremic procedures must be considered for prophylactic
antibiotic therapy.

22 Instructions for Use English

8.2. MRI Conditions

The Simulus™ adjustable annuloplasty ring/band is MR safe. This device
contains no metal and therefore poses no known hazards in any Magnetic
Resonance (MR) environment.

The device will not cause any harm to the patient when exposed to MR
scanning immediately after implantation. MRI at 1.5 and 3.0 Tesla and
other field strengths may be performed immediately following the
implantation of the device.

The presence of other implants or medical circumstances of the patient
may require lower limits on some or all of the above parameters.

9. How Supplied

9.1. Packaging

The Simulus™ adjustable annuloplasty ring and band models 735AF and
735AC are available in the following sizes: 25, 27, 29, 31, 33, 35, 37, and
39 mm. The products are nonpyrogenic. They are sterilized using
irradiation, and supplied in double-aseptic transfer pouches contained in
an outer carton. The packaging system is designed to ease placement of
the device into the sterile field. The ring and band assemblies are sterile
if the pouches are undamaged and unopened. The outer surfaces of the
outer pouch are NONSTERILE and must not be placed in the sterile field.

9.2. Storage

Store the product in its original packaging, including the outer shelf
carton, in a clean, cool, and dry area to protect the product and minimize
the potential for contamination.

The sterility and nonpyrogenicity of the Simulus™ adjustable
annuloplasty ring/band are validated to remain unaffected until the Use
By date identified on the shelf carton, provided the pouches are not
opened or damaged.

10. Instructions for Use

10.1. Sizing

The Simulus™ adjustable annuloplasty ring/band sizers are used to
select the proper Simulus™ adjustable annuloplasty ring/band size for
repair of the mitral and tricuspid valves. Sizers are reusable; however,
they must be cleaned and sterilized by autoclave (steam) prior to each
use.

Proper ring/band size selection is an important part of valvular
annuloplasty to help restore proper function. Use a Simulus™ adjustable

Instructions for Use English 23

annuloplasty ring/band sizer set (available in models 760 and 765) and
annuloplasty handle (model 752 or 752XL) for size selection (Figure 3).

Handles and sizers are provided NONSTERILE; they must be cleaned
and sterilized prior to use. To attach the handle, gently squeeze the two
square protrusions on either side of the central slot on the handle and
insert it into the sizer.

Warning: Do not use other manufacturers’ annuloplasty sizers or sizers
from other Medtronic annuloplasty products to size Simulus™ adjustable
annuloplasty ring/band. Other ring/band sizers may not indicate the
appropriate Simulus™ adjustable annuloplasty ring/band size.

10.2. Mitral Annulus Sizing

Place 3-0 or 2-0 PROLENE™ (Ethicon, Inc.) sutures in the trigones,
approximately 4 mm apart. Lower the sizer onto the valve annulus and
align the sizer notches with the trigones (Figure 3).

Measure the distance between the trigones (intertrigonal distance). The
sizer that has a notch spacing most nearly matching the intertrigonal
distance corresponds to the proper Simulus™ adjustable ring or band
size to use.

10.3. Tricuspid Annulus Sizing

Place 3-0 or 2-0 PROLENE™ sutures in the septal commissures,
approximately 4 mm apart. Lower the sizer onto the valve annulus and
align the sizer notches with the commissures of the septal leaflet
(Figure 4).

Measure the distance between the septal commissures. The sizer that
has a notch spacing most nearly matching the intercommissural distance
of the septal leaflet corresponds to the proper Simulus™ adjustable ring
or band size to use.

10.4. Handling and Preparation Instructions

1. Open the box and remove the product literature, Patient Registration
Form, and envelopes.

2. Remove the double-aseptic transfer pouch containing the device.

3. Inspect the pouches ensuring they have not been opened or
damaged. The ring and band assemblies are sterile as long as the
inner pouch has not been compromised. If the inner pouch is
damaged, do not implant the device.

4. If the outer pouch is damaged, the exterior surface of the inner pouch
may not be sterile.

24 Instructions for Use English

5. Open the outer transfer pouch and, while still holding the bottom of
the outer pouch, pass the inner pouch into the sterile field.

6. The inner pouch should be opened only in the sterile field.

10.5. Device Implantation

Caution: The Simulus™ adjustable annuloplasty ring/band is designed

for implantation only with continuous suture techniques.
Warning: The handle must be cleaned and sterilized prior to use.

1. Remove the appropriately sized Simulus™ adjustable annuloplasty
ring or band from the sterile package using aseptic technique.

2. Remove the serial number identification tag by cutting the retaining
suture and record the serial number in the patient’s record. Verify that
the serial number matches the serial number on the Patient
Registration Form.

Warning: The serial tag must be removed from the ring/band for
proper function. Do not cut or tear the ring/band fabric during removal
of the serial tag.

3. Unwind the drawstrings from the white backing card. Discard the
white backing card.

10.6. Mitral Annulus Implantation

1. Implantation should be performed using the two trigone sutures. Pass
the trigone sutures through the ring or band with a leg on each side
of the green trigone marker (Figure 5).

2. Ring: One leg of the left trigone suture should be run continuously
around the anterior segment of the ring to the right trigone and tied
to one leg of the right trigone suture (Figure 6). Trim excess suture.

3. Band: Tie the trigone sutures and trim one suture from each trigone
(Figure 7).

4. The remaining legs of the trigone sutures should be run continuously
around the left and right posterior segments of the ring or band
(Figure 8) and tied together near the midpoint of the posterior
segment of the ring or band (Figure 9).

5. The sutures must not be placed through the posterior segments of
the ring because drawstring function will be compromised and
prevent final adjustments of the ring or band.

6. Securely tie the Prolene suture legs together near the midpoint of the
posterior segment of the ring or band and trim excess suture
(Figure 10).

Instructions for Use English 25

10.7. Tricuspid Annulus Implantation

1. Implantation should be performed using the two septal commissure
sutures. Pass the septal commissure sutures through the ring or band
with a leg on each side of the green commissure marker (Figure 11).

2. Ring:
a. One leg of the antero-septal commissure suture should be run

continuously around the septal leaflet segment of the ring to the
postero-septal commissure and tied to one leg of the postero­septal commissure suture (Figure 12).

b. The remaining legs of the septal commissure sutures should be

run continuously around the left and right segments of the ring
(Figure 13).

3. Band:
a. Tie the septal commissure sutures and trim one suture from each

commissure (Figure 14).

b. The remaining legs of the septal commissure sutures should be

run continuously around the left and right segments of the band
(Figure 15).

4. The sutures must not be placed through the tricuspid
anterior/posterior segments of the ring or band because drawstring
function will be compromised and prevent final adjustments to the
ring or band.

Warning: Avoid placing sutures in the coronary sinus, right coronary
artery, AV node, bundle of His, or other conduction tissue.

5. Securely tie the Prolene suture legs together near the midpoint of the
ring or band and trim excess suture (Figure 16).

10.8. Final Adjustments

1. After suturing the ring or band into place, test the valve for
competence by filling the left or right ventricle with saline and
observing leaflet coaptation.

2. If the valve is regurgitant, note the area of reflux and shorten that area
of the ring or band by pulling one or both drawstring sutures to
contract the ring or band asymmetrically or symmetrically
(Figure 17).

3. Once proper valve function is obtained, the drawstring sutures are
firmly tied together and the excess sutures cut off (Figure 18).

4. Test for mitral or tricuspid valve competency.

26 Instructions for Use English

10.9. Accessories

Use one of the Simulus™ adjustable annuloplasty ring/band sizer sets to
determine the appropriate device size.

Model 760: sterilization tray, rigid polysulfone sizer set, and 2 standard
handles

Model 765: sterilization tray and polysulfone robotic sizer set
Use only handle models 752 or 752XL to interface with the sizers.
Refer to the Simulus™ annuloplasty ring/band accessories Instructions

for Use for detailed information on accessory use and sterilization.
Warning: Do not use annuloplasty sizers or handles from other

manufacturers or other Medtronic annuloplasty products to size the
Simulus™ adjustable annuloplasty ring/band.

10.10. Sterilization

The ring and band are provided sterile (irradiation) on the holder and must
not be resterilized. Rings and bands that have been damaged or
contaminated from patient contact should not be used.

11. Registration Information

Note: Patient registration does not apply in countries where patient

privacy laws conflict with providing patient information, including
countries from the EU.

A patient registration form is included in each device package. After
implantation, please complete all requested information. The serial
number may be found on the package and on the identification tag
attached to the device. Return the original form to the Medtronic address
indicated on the form and provide the temporary identification card to the
patient prior to discharge.

12. Disclaimer of Warranty

The following disclaimer of warranty applies to United States
customers only:

ALTHOUGH THE SIMULUS™ ADJUSTABLE ANNULOPLASTY RING
AND BAND, HEREAFTER REFERRED TO AS “PRODUCT” HAVE
BEEN MANUFACTURED UNDER CAREFULLY CONTROLLED
CONDITIONS, MEDTRONIC HAS NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED.
MEDTRONIC, THEREFORE DISCLAIMS ALL WARRANTIES, BOTH
EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF

Instructions for Use English 27

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
MEDTRONIC SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY
FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT,
FAILURE OR MALFUNCTION OF THE PRODUCT, WHETHER A
CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY,
CONTRACT, TORT OR OTHERWISE. NO PERSON HAS ANY
AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR
WARRANTY WITH RESPECT TO THE PRODUCT.

The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held
to be illegal, unenforceable or in conflict with applicable law, by a court
of competent jurisdiction, the validity of the remaining portions of this
Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

13. Disclaimer of Warranty

The following disclaimer of warranty applies to customers outside
the United States:

ALTHOUGH THE SIMULUS™ ADJUSTABLE ANNULOPLASTY RING
AND BAND, HEREAFTER REFERRED TO AS “PRODUCT” HAVE
BEEN CAREFULLY DESIGNED, MANUFACTURED AND TESTED
PRIOR TO SALE, THE PRODUCT MAY FAIL TO PERFORM ITS
INTENDED FUNCTION SATISFACTORILY FOR A VARIETY OF
REASONS. THE WARNINGS CONTAINED IN THE PRODUCT
LABELING PROVIDE MORE DETAILED INFORMATION AND ARE
CONSIDERED AN INTEGRAL PART OF THIS DISCLAIMER OF
WARRANTY. MEDTRONIC, THEREFORE, DISCLAIMS ALL
WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO
THE PRODUCT. MEDTRONIC SHALL NOT BE LIABLE FOR ANY
INCIDENTAL OR CONSEQUENTIAL DAMAGES CAUSED BY ANY
USE, DEFECT, OR FAILURE OF THE PRODUCT, WHETHER THE
CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR
OTHERWISE.

The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held
by any court of competent jurisdiction to be illegal, unenforceable or in

28 Instructions for Use English