Simulus™
Semi-Rigid Annuloplasty Ring/Band • Anneau/bande pour annuloplastie semirigides • Halbstarrer Annuloplastie-Ring/halbstarres Annuloplastie-Band •
Anillo/banda semirrígido para anuloplastia • Anello/emianello semirigido per
anuloplastica • Semirigide annuloplastiekring/-band • Halvstyv anuloplastikring/band • Halvstiv/halvstift annuloplastikring/-bånd • Halvstiv annuloplastikkring/bånd • Anel/banda de anuloplastia semirrígidos • Ημιάκαμπτος δακτύλιος
δακτυλιοπλαστικής/Ημιάκαμπτος ανοικτός δακτύλιος δακτυλιοπλαστικής •
Poloohebný anuloplastický prstenec/proužek • Półsztywny pierścień
zamknięty/pierścień otwarty do annuloplastyki • Félmerev anuloplasztikai
gyűrű/pánt • Yarı Sert Anüloplasti Halkası/Bandı • Polotuhý anuloplastický
prstenec/pásik
800SR, 800SC
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 eigenaren.
Varumärken kan vara registrerade och tillhör respektive ägare.
Varemærker kan være registrerede og tilhører deres respektive ejere.
Varemerkene kan være registrert og tilhører de respektive eierne.
As marcas comerciais podem ser registadas e são propriedade dos respetivos 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 bejegyzettek lehetnek, és a megfelelő védjegytulajdonosok tulajdonát képezik.
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 der Verpackung / 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 och i
övrig förpackningsdokumentation / 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 ve belgelerindeki 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 zutreffen, 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 a etiqueta exterior da embalagem para ver que símbolos se
aplicam a este produto / Ανατρέξτε στην ετικέτα της εξωτερικής
συσκευασίας για να δείτε ποια σύμβολα ισχύουν για το παρόν 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
találhatók. / Bu üründe hangi sembollerin geçerli olduğunu görmek için
1
dış ambalaj etiketine başvurun / Prezrite si označenie na vonkajšom
obale a zistite, ktoré symboly sa vzťahujú na tento výrobok
2
Conformité Européenne (European Conformity).
This symbol means that the device fully
complies with applicable European Union Acts. /
Conformité Européenne. Ce symbole signifie
que l'appareil est entièrement conforme aux lois
en vigueur de l'Union européenne. / Conformité
Européenne (Europäische Konformität). Dieses
Symbol besagt, dass das Gerät alle
Vorschriften der einschlägigen EUGesetzgebung erfüllt. / Conformité Européenne
(Conformidad Europea). Este símbolo indica
que el dispositivo cumple totalmente las
Directivas europeas pertinentes. / Conformité
Européenne (Conformità europea). Questo
simbolo indica che il dispositivo è pienamente
conforme alle direttive europee in vigore. /
Conformité Européenne (Europese
conformiteit). Dit symbool betekent dat het
product volledig voldoet aan de geldende
Europese wetgeving. / Conformité Européenne
(Europeisk standard). Denna symbol anger att
enheten uppfyller alla gällande lagar i den
Europeiska unionen. / Conformité Européenne
(Europæisk Standard). Dette symbol betyder, at
enheden fuldt ud overholder gældende EUlovgivning. / Conformité Européenne (samsvar
med europeisk standard). Dette symbolet betyr
at enheten er fullstendig i samsvar med
gjeldende EU-rettsakter. / Conformité
Européenne (Conformidade Europeia). Este
símbolo significa que o dispositivo está em total
conformidade com os Atos da União Europeia
aplicáveis. / Conformité Européenne
(Ευρωπαϊκή Συμμόρφωση). Το σύμβολο αυτό
σημαίνει ότι το προϊόν συμμορφώνεται πλήρως
με τους ισχύοντες νόμους της Ευρωπαϊκής
Ένωσης. / Conformité Européenne (Evropská
shoda). Tento symbol znamená, že zařízení
zcela splňuje požadavky příslušných zákonů
Evropské unie. / Conformité Européenne
(zgodność z normami Unii Europejskiej). Ten
3
symbol oznacza, że urządzenie spełnia
wszystkie wymogi wynikające z właściwych
aktów prawnych Unii Europejskiej. / Conformité
Européenne (Európai Megfelelőség). Ez a
szimbólum azt jelenti, hogy az eszköz teljes
mértékben megfelel az Európai Unió vonatkozó
jogszabályainak. / Conformité Européenne
(Avrupa Normlarına Uygunluk). Bu sembol,
cihazın yürürlükteki Avrupa Birliği Yasalarına
tam olarak uygun olduğunu ifade eder. /
Conformité Européenne (Zhoda s požiadavkami
EÚ). Tento symbol znamená, že zariadenie je
v úplnom súlade s platnými právnymi predpismi
Európskej únie.
Nonpyrogenic / Apyrogène / Pyrogenfrei /
Apirógeno / Apirogeno / Niet-pyrogeen / Ickepyrogen / Ikke-pyrogen / Pyrogenfri /
Apirogénico / Μη πυρετογόνο / Nepyrogenní /
Produkt niepirogenny / Nem pirogén / Pirojenik
Değildir / Apyrogénne
Sterilized Using Irradiation / Stérilisation par
irradiation / Mit Strahlung sterilisiert /
Esterilizado mediante irradiación / Sterilizzato
con radiazioni ionizzanti / Gesteriliseerd met
straling / Steriliserad med strålning / Steriliseret
med stråling / Sterilisert med stråling /
Esterilizado por irradiação / Αποστειρωμένο με
ακτινοβολία / Sterilizováno zářením / Produkt
sterylizowany metodą radiacyjną / 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
4
Do Not Reuse / Ne pas réutiliser / Nicht
wiederverwenden / No reutilizar / Non
riutilizzare / Niet opnieuw gebruiken / Får inte
återanvändas / Må ikke genbruges / Skal ikke
brukes flere ganger / Não reutilizar / 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
επαναποστειρώνετε / Neprovádějte
resterilizaci / Nie sterylizować ponownie / Nem
újrasterilizálható / Yeniden Sterilize Etmeyin /
Opakovane nesterilizujte
Use By / À utiliser jusqu'au / Zu verwenden bis
einschließlich / No utilizar después de /
Utilizzare entro / Uiterste gebruiksdatum / Får
användas till och med / Kan anvendes til og
med / Siste forbruksdag / Não utilizar depois
de / Χρήση έως / Datum použitelnosti / Termin
ważności / Lejárat / Son Kullanma Tarihi /
Dátum najneskoršej spotreby
Lot Number / Numéro de lot / Chargennummer /
Número de lote / Numero di lotto /
Partijnummer / Lotnummer / Partinummer /
Lotnummer / Número de lote / Αριθμός
παρτίδας / Číslo šarže / Numer partii / Gyártási
szám / Lot Numarası / Číslo šarže
Quantity / Quantité / Menge / Cantidad /
Quantità / Aantal / Antal / Antal / Antall /
Quantidade / Ποσότητα / Množství / Ilość /
Mennyiség / Miktar / Množstvo
5
Consult Instructions for Use / Consulter le mode
d'emploi / Gebrauchsanweisung beachten /
Consultar las instrucciones de uso / Consultare
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 návod na
použitie
For US Audiences Only / Uniquement pour les
États-Unis / Gilt nur für Leser in den USA / Sólo
aplicable en EE. UU. / 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
EUA / Μόνο για πελάτες εντός των ΗΠΑ /
Pouze pro uživatele z USA / Dotyczy tylko
klientów w USA / Csak egyesült államokbeli
felhasználóknak / Sadece ABD'deki Kullanıcılar
İçin / Len pre používateľov v USA
Keep Dry / À conserver dans un endroit sec /
Trocken aufbewahren / Mantener seco /
Mantenere asciutto / Droog bewaren / Förvaras
torrt / Skal opbevares tørt / Skal holdes tørr /
Manter seco / Διατηρήστε στεγνό / Udržujte v
suchu / Chronić przed wilgocią / Szárazon
tartandó / Kuru Olarak Saklayın / Uchovávajte v
suchu
Date of Manufacture / Date de fabrication /
Herstellungsdatum / Fecha de fabricación /
Data di fabbricazione / Productiedatum /
Tillverkningsdatum / Fremstillingsdato /
Produksjonsdato / Data de fabrico / Ημερομηνία
κατασκευής / Datum výroby / Data produkcji / A
gyártás ideje / İmalat Tarihi / Dátum výroby
6
Serial Number / Numéro de série /
Seriennummer / Número de serie / Numero di
serie / Serienummer / Serienummer /
Serienummer / Serienummer / Número de
série / Αριθμός σειράς / 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 / Fabbricante / 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 in der Europäischen
Gemeinschaft / Representante autorizado en la
Comunidad Europea / Rappresentante
autorizzato nella Comunità europea /
Geautoriseerd vertegenwoordiger in de
Europese Gemeenschap / Auktoriserad
representant inom EG / Autoriseret
repræsentant i EU / Autorisert representant i
Det europeiske fellesskap / Representante
autorizado na Comunidade Europeia /
Εξουσιοδοτημένος αντιπρόσωπος στην
Ευρωπαϊκή Κοινότητα / Autorizovaný zástupce
pro Evropské společenství / Autoryzowany
przedstawiciel w Unii Europejskiej / Hivatalos
képviselet az Európai Közösségben / Avrupa
Topluluğu'ndaki Yetkili Temsilci / Splnomocnený
zástupca v Európskom spoločenstve
7
MR Conditional / RM sous conditions / Bedingt
MR-sicher / Condicionalmente compatible con
la RM / Compatibilità RM condizionata / MR
Conditional (MR-veilig onder voorwaarden) /
MR-villkorlig / Betinget kompatibel med MRscanning / MR-betinget / RM condicional /
Μαγνητική τομογραφία (MR) υπό όρους /
Podmíněná magnetická rezonance / Badanie
MR dopuszczalne w określonych warunkach /
MR-kondicionális / MR Koşullu / Podmienečne
bezpečné v MR
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 l'imballaggio non è integro / 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
το χρησιμοποιείτε εάν η συσκευασία έχει
υποστεί ζημία / Nepoužívejte, je-li balení
poškozeno / Nie stosować, jeśli opakowanie jest
uszkodzone / Ne használja fel, ha a
csomagolás sérült / Ambalaj Hasarlıysa
Kullanmayın / Nepoužívajte, ak je obal
poškodený
Manufactured In / Lieu de fabrication /
Hergestellt in / Fabricado en / Fabbricato in /
Vervaardigd in / Tillverkad i / Fremstillet i /
Produsert i / Fabricado em / Κατασκευάστηκε
σε / Vyrobeno v / Miejsce produkcji / A gyártás
helye / İmalat Yeri / Vyrobené v
8
1
2
1
Figure 1. Ring / Figure 1. Anneau / Abbildung 1. Ring / Figura 1. Anillo /
Figura 1. Anello / Afbeelding 1. Ring / Figur 1. Ring / Figur 1. Ring /
Figur 1. Ring / Figura 1. Anel / Εικόνα 1. Δακτύλιος /
Obrázek 1. Prstenec / Rycina 1. Pierścień zamknięty / 1. ábra. Gyűrű /
Şekil 1. Halka / Obrázok 1. Prstenec
1. Trigone markers / Marqueurs des trigones /
Trigonamarkierungen / Marcas de los trígonos /
Marcatori dei trigoni / Trigonummarkeringen /
Trigonmarkörer / Trigonummarkører /
Trigonmarkører / Marcadores dos trígonos /
Δείκτες τριγώνων / Značky trigonu / Znaczniki
trójkątów włóknistych / Trigonumjelölések / Trigon
belirteçleri / Značky trigona
2. Demarcation suture / Suture de démarcation /
Abgrenzungsnaht / Sutura de demarcación /
Sutura di demarcazione / Markeringshechtdraad /
Avgränsningssutur / Demarkationssutur /
Demarkasjonssutur / Sutura de demarcação /
Ράμμα οριοθέτησης / Demarkační steh / Szew
rozdzielający / Elválasztó öltés / Demarkasyon
sütürü / Vymedzovací steh
9
1
2
1
Figure 2. Band / Figure 2. Bande / Abbildung 2. Band /
Figura 2. Banda / Figura 2. Emianello / Afbeelding 2. Band /
Figur 2. Band / Figur 2. Bånd / Figur 2. Bånd / Figura 2. Banda /
Εικόνα 2. Ανοικτός δακτύλιος / Obrázek 2. Proužek /
Rycina 2. Pierścień otwarty / 2. ábra. Pánt / Şekil 2. Bant /
10
Obrázok 2. Pásik
1. Trigone markers / Marqueurs des trigones /
Trigonamarkierungen / Marcas de los trígonos /
Marcatori dei trigoni / Trigonummarkeringen /
Trigonmarkörer / Trigonummarkører /
Trigonmarkører / Marcadores dos trígonos /
Δείκτες τριγώνων / Značky trigonu / Znaczniki
trójkątów włóknistych / Trigonumjelölések / Trigon
belirteçleri / Značky trigona
2. Demarcation suture / Suture de démarcation /
Abgrenzungsnaht / Sutura de demarcación /
Sutura di demarcazione / Markeringshechtdraad /
Avgränsningssutur / Demarkationssutur /
Demarkasjonssutur / Sutura de demarcação /
Ράμμα οριοθέτησης / Demarkační steh / Szew
rozdzielający / Elválasztó öltés / Demarkasyon
sütürü / Vymedzovací steh
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
1. Handle / Poignée / Handgriff / Asa / Impugnatura /
Handgreep / Handtag / Håndtag / Håndtak /
Manípulo / Λαβή / Rukojeť / Uchwyt / Fogantyú /
Kol / Rukoväť
2. Ring holder / Support de l'anneau / Ringhalter /
Soporte del anillo / Supporto dell'anello /
11
Ringhouder / Ringhållare / Ringholder /
Ringholder / Suporte do anel / Υποδοχή
δακτυλίου / Držák prstence / Uchwyt pierścienia
zamkniętego / Gyűrűtartó / Halka tutucusu /
Držiak prstenca
3. Band holder / Support de la bande / Bandhalter /
Soporte de la banda / Supporto dell'emianello /
Bandhouder / Bandhållare / Båndholder /
Båndholder / Suporte da banda / Υποδοχή
ανοικτού δακτυλίου / Držák proužku / Uchwyt
pierścienia otwartego / Pánttartó / Bant tutucusu /
Držiak pásika
4. Ring / Anneau / Ring / Anillo / Anello / Ring /
Ring / Ring / Ring / Anel / Δακτύλιος / Prstenec /
Pierścień zamknięty / Gyűrű / Halka / Prstenec
5. Band / Bande / Band / Banda / Emianello / Band /
Band / Bånd / Bånd / Banda / Ανοικτός
δακτύλιος / Proužek / Pierścień otwarty / Pánt /
Bant / Pásik
12
Figure 4. Sizing the mitral annulus / Figure 4. Calibrage de l'anneau
mitral / Abbildung 4. Größenbestimmung des Mitralklappen-Anulus /
Figura 4. Medición del anillo mitral / Figura 4. Determinazione della
dimensione dell'annulus mitrale / Afbeelding 4. Meten van de annulus
van de mitralisklep / Figur 4. Mätning av mitralklaffens anulus /
Figur 4. Måling af den mitrale annulus / Figur 4. Måle mitralannulus /
Figura 4. Dimensionamento do anel mitral / Εικόνα 4. Προσδιορισμός
μεγέθους του δακτυλίου μιτροειδούς / Obrázek 4. Určení velikosti
mitrálního anulu / Rycina 4. Pomiar pierścienia mitralnego /
4. ábra. Mitrális anulus méretvétele / Şekil 4. Mitral anülus boyutunun
belirlenmesi / Obrázok 4. Určenie veľkosti mitrálneho anulu
13
Figure 5. Suture placement / Figure 5. Pose des sutures /
Abbildung 5. Anlegen der Nähte / Figura 5. Realización de las suturas /
Figura 5. Applicazione delle suture / Afbeelding 5. Plaatsing van de
hechtingen / Figur 5. Suturplacering / Figur 5. Placering af suturerne /
Figur 5. Suturplassering / Figura 5. Colocação das suturas /
Εικόνα 5. Τοποθέτηση ραμμάτων / Obrázek 5. Umístění stehů /
Rycina 5. Zakładanie szwów / 5. ábra. Öltések elhelyezése /
Şekil 5. Sütürün yerleştirilmesi / Obrázok 5. Umiestnenie stehov
14
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
15
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 /
16
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 /
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 /
8. ábra / Şekil 8 / Obrázok 8
9. ábra / Şekil 9 / Obrázok 9
17
Semi-Rigid Annuloplasty Ring/Band
1. Device Description
The Simulus™ semi-rigid annuloplasty ring model 800SR (Figure 1)
and Simulus™ semi-rigid annuloplasty band model 800SC (Figure 2)
consist of a MP35N wire stiffener in the posterior segment, running
from trigone to trigone. The ring stiffener is enclosed within a closecoiled MP35N spring that passes around the circumference of the
annuloplasty ring. The band stiffener is enclosed within a coiled MP35N
spring from trigone to trigone. The spring is covered by a thin silicone
sheath. Braided polyester fabric is used to cover and form the body of
the ring and band. The ring and band have two green markers to
indicate the anterior and posterior trigones. A green demarcation suture
runs around the upper face of the ring and band. The individual ring or
band size (24 to 40 mm in 2-mm increments) refers to the inner
circumference between the green trigone markers on the ring or band.
The internal spring and stiffener provide radiographic visualization
around the circumference of the ring and band.
2. Indications
The Simulus™ semi-rigid annuloplasty rings and band are for use in
patients undergoing surgery for diseased or damaged mitral valves.
The Simulus™ semi-rigid annuloplasty ring and band provide support
for and restrict 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.
18 Instructions for Use English
■
Only surgeons who have received appropriate training in valve
repair, including ring and band implant and sizing techniques,
should use this device.
■
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
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.
■
Do not alter or deform the ring or band to conform to annular
anatomy as this could lead to ring/band fracture and possible mitral
regurgitation.
■
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.
■
Do not squeeze the ring or band with sharp instruments as this may
damage the surface of the stiffener, which may result in ring/band
fracture and possible mitral regurgitation.
■
The ring and band are indicated for use in the mitral position only.
Use in the tricuspid position may result in ring/band fracture,
conduction system damage, tricuspid regurgitation, and/or
ring/band dehiscence.
Instructions for Use English 19
■
When placing the implantation sutures, be careful to avoid snaring
the spokes of the holder.
5. Precautions
■
Do not use cutting edge needles, as they may damage the
annuloplasty device potentially leading to ring/band dehiscence,
ring/band fracture, 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
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
■
ring/band fracture
■
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
20 Instructions for Use English
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.
8.2. MRI Information
Nonclinical testing has demonstrated that the Simulus™ semi-rigid
annuloplasty ring and band is Magnetic Resonance (MR) Conditional.
The device can be scanned safely under the following conditions:
■
static magnetic field of 3.0 Tesla or less
■
spatial gradient field of 2500 gauss/cm or less
■
normal or first level controlled mode with a maximum whole body
SAR of 4.0 W/kg for 15 minutes as read from the equipment
monitor
8.2.1. RF Heating
In nonclinical testing, the device produced a temperature rise of less
than 1.6°C at a maximum whole body averaged SAR of 2.7 W/kg as
assessed by calorimetry for 15 minutes of MR scanning in a 3.0 Tesla
(128 MHz) MR System using a transmit/receive body coil (Excite, HDx,
Software 14X.M5, General Electric Healthcare).
8.2.2. Deflection and Torsion
The device should not move or migrate when exposed to MR scanning
immediately after implantation. MRI at 3.0 Tesla or less may be
performed immediately following the implantation of the device.
8.2.3. Image Artifact
MR image quality may be compromised if the area of interest is in the
same area or relatively close to the position of the device. It may be
necessary to optimize MR imaging parameters for the presence of this
implant. When tested at 3.0 Tesla, the image artifact extended less
Instructions for Use English 21
than 15 mm beyond the device for the spin echo sequence with
repetition time (TR) = 500 ms and echo time (TE) = 20 ms and less
than 20 mm beyond the device for the gradient echo sequence with
TR = 100 ms, TE = 15 ms and flip angle = 30°.
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™ semi-rigid annuloplasty ring and band models 800SR
and 800SC are available in the following sizes: 24, 26, 28, 30, 32, 34,
36, 38, and 40 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™ semi-rigid
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™ semi-rigid annuloplasty ring/band sizers are used to
select the proper Simulus™ semi-rigid annuloplasty ring/band size for
repair of the mitral valve. 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™ semirigid annuloplasty ring/band sizer set (available in models 850, 851,
and 856) and annuloplasty handle (model 752 or 752XL) for size
selection (Figure 3).
22 Instructions for Use English
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 or holder.
Warning: Do not use other manufacturers’ annuloplasty sizers or
sizers from other Medtronic annuloplasty products to size Simulus™
semi-rigid annuloplasty ring/band. Other ring/band sizers may not
indicate the appropriate Simulus™ semi-rigid annuloplasty ring/band
size.
10.2. Mitral Annulus Sizing
To determine the proper Simulus™ semi-rigid annuloplasty ring or
band size to be used, measure the distance between the trigones
(intertrigonal distance) and the outer periphery of the sizer on the valve
annulus. Lower the sizer onto the valve annulus and align the sizer
notches with the trigones (Figure 4). The sizer with a notch spacing that
most nearly matches the intertrigonal distance and the outer periphery
of the sizer on the valve annulus corresponds to the ring/band size that
should be selected. The outer periphery of the sizer corresponds to the
midline of the ring/band and indicates where the implantation sutures
will be placed.
10.3. 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.
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.
10.4. Device Implantation
The Simulus™ semi-rigid annuloplasty ring/band assembly may be
used with or without the handle (annuloplasty handle, model 752
or 752XL, provided separately).
Instructions for Use English 23
Caution: The Simulus™ semi-rigid annuloplasty ring/band is designed
for implantation only with interrupted-suture techniques.
Warning: The handle must be cleaned and sterilized prior to use.
1. Remove the appropriate sized Simulus™ semi-rigid 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. Align and engage a sterile handle into the snap-fit cavity of the
holder. The handle must be inserted into the side of the holder with
the snap-fit cavity and printed text. The thin section of the handle is
malleable to permit alignment of the ring holder with the annulus.
10.5. Mitral Annulus Suture Placement
The implantation sutures should be placed outside the green
demarcation marker to avoid the internal spring.
Ring: Place sutures in each trigone, approximately 4 mm apart. Place
additional interrupted sutures, approximately 4 mm apart, in the
anterior and posterior portions of the mitral annulus (Figure 5).
Band: Place sutures in each trigone, approximately 4 mm apart. Place
additional interrupted sutures, approximately 4 mm apart, in the
posterior portion of the mitral annulus (Figure 5). To simplify the
maneuver, always use a forceps to hold the free edges of the
corresponding leaflet while sutures are passed.
Warning: Avoid placing sutures in the circumflex coronary artery.
Note: To reduce the possibility of ring/band dehiscence, pledgets may
be used for the trigone sutures and mid-posterior annulus sutures.
10.6. Ring and Band Suture Placement
1. Orient the ring or band holder/handle assembly on the mitral
annulus.
2. Pass the sutures through the ring or band, approximately 2 to
4 mm apart, entering at the bottom of the ring/band and exiting at
the periphery of the ring/band (Figure 6).
3. Place the sutures completely around the ring or band, including the
anterior mitral annulus region (ring only).
24 Instructions for Use English
10.7. Holder/Handle Removal
1. Use the handle to push the ring or band down onto the valve
annulus while pulling back on the sutures.
2. Remove the ring/band from the disposable holder by cutting the
retention suture on the holder, identified by the word “CUT” and an
arrow pointing to the cutting guide slot (Figure 7). Dispose of the
holder.
Warning: Do not cut the ring/band fabric while cutting the holder
retention suture.
Warning: The holder must be removed from the annuloplasty
ring/band at the end of the procedure for proper function. Under no
circumstances is the holder to be left attached to the annuloplasty
ring/band.
3. Tie all knots around the ring/band securely and trim all excess
sutures (Figure 8 and Figure 9).
4. Test valvular competency.
10.8. Accessories
Use one of the Simulus™ semi-rigid annuloplasty ring/band sizer sets
to determine the appropriate device size.
Model 850: Sterilization tray, rigid polysulfone sizer set, and 2 standard
handles
Model 851: Rigid polysulfone sizer set
Model 856: Flexible silicone sizer set
Use only handle models 752 or 752XL to interface with the holder and
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™ semi-rigid annuloplasty ring/band.
10.9. 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.
Instructions for Use English 25
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™ SEMI-RIGID 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
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.
26 Instructions for Use English
13. Disclaimer of Warranty
The following disclaimer of warranty applies to customers outside
the United States:
ALTHOUGH THE SIMULUS™ SEMI-RIGID 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
conflict with applicable law, the validity of the remaining portion of the
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.
Instructions for Use English 27
Anneau/bande pour annuloplastie semi-rigides
1. Description du dispositif
L'anneau pour annuloplastie semi-rigide Simulus™ Modèle 800SR
(figure 1) et la bande pour annuloplastie semi-rigide Simulus™
Modèle 800SC (figure 2) se composent d'un raidisseur en alliage
MP35N dans le segment postérieur, allant d'un trigone à l'autre. Le
raidisseur de l'anneau est enfermé dans un ressort en MP35N à spires
serrées qui suit toute la circonférence de l'anneau pour annuloplastie.
Le raidisseur de la bande est enfermé dans un ressort enroulé en
MP35N allant d'un trigone à l'autre. Le ressort est recouvert d'une
mince gaine en silicone. Un tissu tressé en polyester est utilisé pour
recouvrir et former le corps de l'anneau et de la bande. L'anneau et la
bande comportent deux marqueurs verts qui indiquent les trigones
antérieur et postérieur. Une suture de démarcation verte est présente
tout autour de la face supérieure de l'anneau et de la bande. La taille
d'un anneau ou d'une bande (24 à 40 mm par incréments de 2 mm) se
rapporte à la circonférence intérieure entre les marqueurs verts de
trigones sur l'anneau ou la bande. Le ressort et le raidisseur internes
permettent la visualisation radiographique autour de la circonférence
de l'anneau et de la bande.
2. Indications
Les anneaux et la bande pour annuloplastie semi-rigides Simulus™
sont destinés à être utilisés chez les patients subissant une
intervention chirurgicale en raison de valves mitrales malades ou
endommagées. L'anneau et la bande pour annuloplastie semi-rigides
Simulus™ offrent le support nécessaire à l'anneau tout en limitant son
expansion.
3. Contre-indications
■
Endocardite bactérienne grave, généralisée ou localisée
■
Valves fortement calcifiées
■
Anneau fortement dilaté (non réductible par les techniques
standard)
■
Dysfonctionnement valvulaire grave (non corrigible par les
techniques standard)
■
Rétraction valvulaire avec mobilité fortement réduite
■
Malformations congénitales avec perte de tissu valvulaire
28 Mode d’emploi Français
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