CooperSurgical Advincula Arch 53469 Directions For Use Manual
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CooperSurgical Advincula Arch 53469 Directions For Use Manual

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Table of Contents
  • Directions for Use
  • Explanation of Symbols
  • Instrucciones de Uso
  • Explicación de Símbolos
  • Explication des Symboles
  • INDICAZIONI PER L'uso
  • Spiegazione Dei Simboli
  • Contra-Indicações
  • Instruções de Utilização
  • Explicação Dos Símbolos

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  • ENGLISH, page 1

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Advincula Arch
for use with the Advincula Arch
Directions for Use (English)
DEVICE DESCRIPTION
The Advincula Arch
attach the Advincula Arch Uterine Manipulator Handle to the Uterine
Positioning System
PRECAuTIONS AND WARNINGS
•
Failure to properly follow instructions for the Advincula Arch Adapter
(Adapter), including instructions supplied with the Uterine Positioning
System (UPS, 371550-03) and the Advincula Arch Uterine
Manipulator Handle (Manipulator Handle, UMH750), may lead to
injury and result in improper functioning of the system.
• The Adapter is only intended for use with the Advincula Arch
Manipulator Handle and the UPS. Use of this device with any other
Manipulator is not recommended, and could lead to injury and
improper functioning of the device.
• Surgical procedures requiring vaginal instrumentation are not sterile.
Conventional operating room procedures for maintaining sterility
must be observed when the UPS is in use.
• The Adapter is supplied non-sterile and must be cleaned and
sterilized prior to use.
• Verify that the correct Adapter is being used with the Manipulator
Handle.
• Refer to the UPS Directions for Use for further instructions.
• ALWAYS position the patient and the OR table prior to attaching the
UPS to the Manipulator Handle.
• ALWAYS have the patient under general endotracheal anesthesia
when the UPS is attached to the Manipulator Handle.
CONTRAINDICATIONS
Refer to the Manipulator Handle (UMH750) Directions for Use for
applicable contraindications of the device.
CAuTION
U.S. Federal law restricts this device to sale by or on the order of a
physician.
53469
Adapter is a reusable device that is used to
™
exclusively.
™
Adapter
™
NON-STERILE
STERILIZE bEfORE uSE
CAuTION: U.S. Federal law restricts
this device to sale by or on the order
of a physician.
37340 • Rev. B • 9/11

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Summary of Contents for CooperSurgical Advincula Arch 53469

  • Page 1 Advincula Arch Adapter ™ for use with the Advincula Arch 53469 Directions for Use (English) NON-STERILE STERILIZE bEfORE uSE CAuTION: U.S. Federal law restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION The Advincula Arch Adapter is a reusable device that is used to ™...

  • Page 2: Directions For Use

    DIRECTIONS fOR uSE front View back View Mating Pin Latch Alignment Pin Engagement Pin figure 1. Advincula Arch™ Adapter before Attaching the Adapter The following steps must be completed prior to attaching the Adapter to the UPS arm: ™ 1. Patient is positioned, prepped and the Manipulator Handle is inserted.
  • Page 3 4. Close and lock the Latch, and ensure that the Manipulator Handle is securely attached to the Adapter with no free movement. Removing the manipulator Handle from the Adapter CAuTION: When securing the Latch, use care to avoid contacting the patient or other accessories in the surgical field. To detach the Manipulator Handle, unlock and open the Latch on the Adapter while holding the Manipulator Handle and separate it from the Adapter.

  • Page 4: Explanation Of Symbols

    Authorized Representative in the European Community. Neutrad ® is a registered trademark of Decon Labs, Inc. CooperSurgical is a registered trademark of CooperSurgical, Inc. All other marks bearing the symbols “TM” and “®” are trademarks and registered trademarks of CooperSurgical, Inc.
  • Page 5 Advincula Arch Adapter ™ zur Verwendung mit Advincula Arch 53469 Gebrauchsanleitung (Deutsch / German) uNSTERIL VOR GEbRAuCH STERILISIEREN VORSICHT: Laut US-Bundesgesetz ist der Verkauf dieses Produkts nur an Ärzte oder im Auftrag von Ärzten erlaubt. bESCHREIbuNG DES PRODuKTS Der Advincula Arch Adapter ist eine wiederverwendbare ™...
  • Page 6 GEbRAuCHSANLEITuNG Vorderansicht Rückansicht Paarungsstift Riegel Ausrichtungsstift Eingriffsstift Abb. 1. Advincula Arch™ Adapter Vor Anschluss des Adapters Die folgenden Schritte müssen vor Anschluss des Adapters am UPS ™ Arm durchgeführt werden: 1. Patientin ist positioniert und vorbereitet und der Manipulatorgriff ist eingeführt. 2.
  • Page 7 4. Schließen und arretieren Sie den Riegel und stellen Sie sicher, dass der Manipulatorgriff sicher am Adapter angebracht ist und keine freie Bewegung möglich ist. Entfernung des manipulatorgriffs vom Adapter VORSICHT: Bei der Sicherung des Riegels ist darauf zu achten, dass kein Kontakt mit der Patientin oder anderem Zubehör im Operationsfeld erfolgt.
  • Page 8 EC REP Europäischen Gemeinschaft. Neutrad ® ist eine eingetragene Marke von Decon Labs, Inc. CooperSurgical ist eine eingetragene Marke von CooperSurgical, Inc. Alle anderen Marken mit dem Symbol „TM“ oder „®“ sind Marken und eingetragene Marken von CooperSurgical, Inc. © 2011 CooperSurgical, Inc. Alle Rechte vorbehalten.
  • Page 9 Adaptador Advincula Arch ™ para su uso con el Advincula Arch 53469 Instrucciones de uso (Español / Spanish) NO ESTÉRIL ESTERILÍCESE ANTES DE Su uSO PRECAuCIÓN: las leyes federales de EE UU limitan la venta de este dispositivo a médicos o por prescripción médica.

  • Page 10: Instrucciones De Uso

    INSTRuCCIONES DE uSO Vista delantera Vista trasera Orificio de acoplamiento Pestillo Patilla de alineación Patilla de acoplamiento figura 1. Adaptador Advincula Arch™ Antes de conectar el adaptador Deben realizarse los pasos siguientes antes de conectar el adaptador al brazo del UPS ™...
  • Page 11 4. Cierre y bloquee el pestillo; asegúrese de que el asa de manipulación esté firmemente unida al adaptador y no pueda moverse libremente. Extracción del asa de manipulación del adaptador PRECAuCIÓN: al bloquear el pestillo, tenga especial cuidado de evitar cualquier contacto con la paciente o con otros accesorios del campo quirúrgico.

  • Page 12: Explicación De Símbolos

    Comunidad Europea. Neutrad ® es una marca comercial registrada de Decon Labs, Inc. CooperSurgical es una marca comercial registrada de CooperSurgical, Inc. El resto de marcas con los símbolos TM y ® son marcas comerciales y marcas comerciales registradas de CooperSurgical, Inc.
  • Page 13 Adaptateur Advincula Arch ™ à utiliser avec Advincula Arch 53469 Mode d’emploi (Français / French) NON STÉRILE STÉRILISER AVANT L’uTILISATION ATTENTION : Selon la loi fédérale américaine, ce produit ne peut être vendu que par un médecin ou sur son ordonnance. DESCRIPTION Du DISPOSITIf L’adaptateur Advincula Arch est un dispositif réutilisable qui...
  • Page 14 mODE D’EmPLOI Vue avant Vue arrière Trou correspondant Loquet Broche d’alignement Broche d’engagement figure 1. Adaptateur Advincula Arch™ Avant de fixer l’adaptateur Les étapes suivantes doivent être accomplies avant de fixer l’adaptateur au bras de l’UPS ™ 1. Positionner et préparer la patiente puis introduire la poignée pour manipulateur.
  • Page 15 4. Fermer et verrouiller le loquet, puis vérifier que la poignée pour manipulateur est bien fixée sur l’adaptateur, sans jeu. Retrait de la poignée pour manipulateur de l’adaptateur ATTENTION : En verrouillant le loquet, veiller à éviter tout contact avec la patiente ou d’autres accessoires dans le champ stérile.

  • Page 16: Explication Des Symboles

    CooperSurgical est une marque déposée de CooperSurgical, Inc. Toutes les autres marques avec les symboles TM et ® sont des marques de commerce et des marques déposées de CooperSurgical, Inc. © 2011 CooperSurgical, Inc. Tous droits réservés. Fabriqué pour : Fabriqué...
  • Page 17 Adattatore Advincula Arch ™ da usare con Advincula Arch 53469 Istruzioni per l’uso (Italiano / Italian) NON STERILE STERILIZZARE PRImA DELL’uSO ATTENZIONE: la legge federale statunitense limita la vendita di questo dispositivo ai medici o su presentazione di prescrizione medica. DESCRIZIONE DEL DISPOSITIVO L’adattatore Advincula Arch è...

  • Page 18: Indicazioni Per L'uso

    INDICAZIONI PER L’uSO Vista frontale Vista posteriore Foro di accoppiamento Spinotto di allineamento Spinotto di bloccaggio figura 1. Adattatore Advincula Arch™ Prima di attaccare l’adattatore Prima di attaccare l’adattatore al braccio del sistema UPS si devono ™ completare i seguenti passaggi: 1.
  • Page 19 4. Chiudere e bloccare la serratura a scatto e assicurarsi che l’impugnatura per manipolatore sia saldamente attaccata all’adattatore e che non possa muoversi liberamente. Rimozione dell’impugnatura per manipolatore dall’adattatore ATTENZIONE: nel bloccare la serratura a scatto, fare attenzione a evitare il contatto con la paziente o con altri accessori nel campo chirurgico.

  • Page 20: Spiegazione Dei Simboli

    Comunità Europea. Neutrad ® è un marchio depositato di Decon Labs, Inc. CooperSurgical è un marchio depositato di CooperSurgical, Inc. Tutti gli altri marchi recanti i simboli “TM” e “®” sono marchi commerciali e marchi commerciali depositati di CooperSurgical, Inc.

  • Page 21: Contra-Indicações

    Adaptador Advincula Arch ™ para utilização com Advincula Arch 53469 Instruções de Utilização (Português / Portuguese) NÃO ESTERILIZADO ESTERILIZE ANTES DE uTILIZAR CuIDADO: A lei federal dos EUA só permite a venda deste dispositivo sob receita médica. DESCRIÇÃO DO DISPOSITIVO O Adaptador Advincula Arch é...

  • Page 22: Instruções De Utilização

    INSTRuÇÕES DE uTILIZAÇÃO Vista frontal Vista Traseira Pino de Correspondência Fecho Pino de Alinhamento Pino de Encaixe figura 1. Adaptador Advincula Arch™ Antes de fixar o Adaptador Os passos que se seguem têm de ser concluídos antes de fixar o Adaptador ao braço do UPS ™...
  • Page 23 4. Feche e bloqueie o Fecho e certifique-se de que a Pega para Manipulador está firmemente fixa no Adaptador sem possibilidade de movimento livre. Remoção da Pega para manipulador do Adaptador CuIDADO: Ao bloquear o Fecho, tenha cuidado para evitar o contacto com a paciente ou outros acessórios no campo cirúrgico.

  • Page 24: Explicação Dos Símbolos

    95 Corporate Drive Telefone: +1 (203) 601-9818 Trumbull, CT 06611 USA Fax: +1 (203) 601-4747 Telefone: +1 (800) 243-2974 Fax: +1 (800) 262-0105 EC REP www.coopersurgical.com Leisegang Feinmechanik GmbH Leibnizstraße 32 37340 • Rev. B • 9/11 D-10625, Berlin GERMANY...

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