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______________________________________________________________________
INSTRUCTIONS FOR USE
System Description
®
The MicroCutter XCHANGE
30 Stapler is a single patient device that, when
loaded with a MicroCutter XCHANGE
316L stainless steel staples while simultaneously transecting tissue between the
two, double staple rows. The MicroCutter XCHANGE
®
XCHANGE
30 Cartridge are designed for introduction and use through a 5 mm
trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be
loaded, fired, and reloaded with the MicroCutter XCHANGE
the number deployments indicated on package label in a single surgical
procedure. The Stapler can fire different sized staples, with the size of the
staple indicated by the color of the MicroCutter XCHANGE
Shaft
Anvil
Jaws
Channel
Tissue Stop
Cartridge (Standard)
Cartridge (Curved Tip)
Note: Other accessories may be provided to assist with device usage
BEFORE USING MICROCUTTER PRODUCTS, PLEASE READ THE
FOLLOWING INFORMATION COMPLETELY AND THOROUGHLY.
Control Number: 103685
Revision: A
®
30 Cartridge, delivers two double rows of
®
30 Stapler and MicroCutter
®
Cartridge for up to
®
Cartridges.
Rotation Knob
Articulation
Return Slide
Buttons
Mode
Selector
Button
Handle
Trigger
Staple Slots
®
MicroCutter XCHANGE
30 White Cartridge only
Page 1 of 38
______________________________________________________________________
Important
This booklet is designed to assist in using this product, providing detailed
instructions on the use of the MicroCutter XCHANGE
reference on surgical techniques.
Indications
®
The MicroCutter XCHANGE
30 is intended for the transection, resection, and/or
creation of anastomoses. The instrument has applications in multiple general,
gynecologic, urologic, thoracic, and pediatric surgical procedures.
®
MicroCutter XCHANGE
system can be used to blunt dissect or separate target
tissue from other tissue.
Contraindications
®
1.
The MicroCutter XCHANGE
30 White Cartridge is designed for tissue
that is easily compressible to 1.0 mm.
®
2.
The MicroCutter XCHANGE
30 Blue Cartridge is designed for tissue that
is easily compressible to 1.5 mm. Not applicable for white cartridge
only stapler.
3.
Do not use the Stapler on ischemic or necrotic tissue.
4.
Do not use the Stapler on the aorta.
5.
The Stapler is not intended for use when surgical stapling is contraindicated.
Precautions
1.
Do not load or fire the MicroCutter XCHANGE
on the package label.
2.
The Staplers are shipped without a Cartridge and must be loaded prior to
use. Use only the indicated MicroCutter XCHANGE
®
MicroCutter XCHANGE
30 Stapler. Do not use MicroCutter XCHANGE
Cartridges in an instrument other than the designated MicroCutter
®
XCHANGE
30 Stapler.
3.
Do not use a Cartridge if there is any portion of the staples exposed above
the surface. If the Cartridge is not replaced then the Stapler will not fire.
4.
Always inspect tissue thickness and select the MicroCutter XCHANGE
Cartridge with the appropriate size Staples prior to firing. Consideration
should be given to existing pathological conditions, such as preoperative
radiotherapy, which may cause changes in tissue thickness that would fall
outside the indicated range of tissue for the standard choice of staple size.
5.
When positioning the Stapler Jaws at the target site, ensure that no
obstructions are present such as Staples, clips, stents, guide wires, etc.
Firing over an obstruction may result in incomplete transection, improperly
formed Staples, and impact the release from tissue.
6.
The Stapler will cut and staple any tissue clamped between the Jaws.
Use caution to ensure that only structures intended to be cut and
stapled are within the Stapler Jaws.
7.
Attempting to grasp too much tissue between the Jaws will prevent the
Stapler from fully clamping and also prevent firing. Firing in excessively thick
or thin tissue may result in an incomplete deployment and / or poor staple
formation.
8.
After the orange Mode Selector button is activated, pulling the Trigger
will fire the Stapler.
9.
Failure to completely fire, or to fully reset the MicroCutter XCHANGE
30 System will result in an incomplete cut and/or incomplete staple
formation, which may result in poor hemostasis and/or leakage.
Control Number: 103685
MicroCutter XCHANGE
Revision: A
®
30 System. It is not a
The
®
30 Stapler more than indicated
®
30 Cartridges in the
®
30
®
®
®
30 White Cartridge only
Page 2 of 38
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Inhaltsverzeichnis
Verwandte Anleitungen für Cardica MicroCutter XCHANGE 30
Inhaltszusammenfassung für Cardica MicroCutter XCHANGE 30
- Seite 1 ______________________________________________________________________ ______________________________________________________________________ Important INSTRUCTIONS FOR USE This booklet is designed to assist in using this product, providing detailed ® instructions on the use of the MicroCutter XCHANGE 30 System. It is not a reference on surgical techniques. Indications ® The MicroCutter XCHANGE 30 is intended for the transection, resection, and/or creation of anastomoses.
- Seite 2 30 System components that come into contact with bodily fluids may require special disposal handling to prevent These are general directions on system operation. Please refer to our website biological contamination. http://www.cardica.com for the latest videos and directions or consult our Sales ® The MicroCutter XCHANGE 30 System was developed, tested, packaged Team.
- Seite 3 ______________________________________________________________________ ______________________________________________________________________ CAUTION: Do not attempt to rotate or articulate the Shaft after the Stapler Jaws have been clamped or damage could occur. 3.2. Instructions for Stapler Use: 3.2.1. The Shaft can be rotated in either direction. To rotate the Shaft, turn the Rotation Knob.
-
Seite 4: How Supplied
Carefully push upward (toward the Anvil) to unsnap the used Cartridge from the Channel. A fine tip forcep, Cartridge Retainer, or Cardica Unloader if supplied, can be used to push the Cartridge tip out of the Channel. Discard the used Cartridge. See below for instruction:... - Seite 5 0086 directives Sterilization Barrier or its Packaging is Drehknopf Abwinkeltasten Rückführschieber Compromised Schaft Moduswähler European MDSS GmbH Authorized Manufacturer Cardica, Inc. Schiffgraben 41 Amboss Representatives 900 Saginaw Dr. D-30175 Griff Redwood City, Hannover, Gewebeanschlag CA 94063, USA Klemmbacken Germany Auslöser Made In USA 82º...
- Seite 6 ______________________________________________________________________ ______________________________________________________________________ Wichtig des Klammerinstruments ausschließlich Strukturen befinden, deren Durchtrennung und Verklammerung gewünscht wird. Das vorliegende Heft ist als Hilfsmittel für den Gebrauch dieses Produkts gedacht Der Versuch, zu viel Gewebe in den Klemmbacken zu erfassen, verhindert und enthält ausführliche Anweisungen für den Gebrauch des MicroCutter das vollständige Arretieren der Klemmbacken des Klammerinstruments sowie ®...
-
Seite 7: Phthalat-Hinweis
3.2.1. Der Schaft kann in beide Richtungen gedreht werden. Zum Drehen des Schafts den Drehknopf drehen. Hierbei handelt es sich um allgemeine Anweisungen zur Systembedienung. Auf unserer Website finden Sie die www.cardica.com neuesten Videos und Anleitungen. Sie können sich auch an unser Vertriebsteam wenden. 3.1. Laden des Klammerinstruments: ®... - Seite 8 ______________________________________________________________________ ______________________________________________________________________ 3.3.2. Auslösen: 0º 3.3.2.1. Nach dem Festklemmen und vor dem 20º 0º 20º 40º Auslösen des Klammerinstruments den orangefarbenen 40º Moduswähler betätigen. 60º 60º WARNHINWEIS: Nach der Aktivierung des orangefarbenen 80º 80º Moduswählers leitet jede Betätigung Auslösers Klammerinstrumentauslösung ein. 3.2.3.
-
Seite 9: Klemmbacken Arretiert Jaw Clamped
3.3.4.1. Vorsichtig nach oben (zum Amboss) drücken, um die Kartusche aus dem Kanal ausrasten zu lassen. Um die Kartuschenspitze aus dem Kanal zu drücken, eine Zange mit feiner Spitze, die Kartuschenhalterung oder eine Cardica- Entladevorrichtung (falls Lieferumfang enthalten) ®... - Seite 10 Tige Verpackung des Sélecteur de Produkts nicht mode verwenden. Branche Poignée Mâchoires Butée Détente Autorisierte EU- Cardica, Inc. MDSS GmbH Hersteller Rail de Vertretung 900 Saginaw Dr. Schiffgraben 41 guidage Redwood City, 30175 Hannover CA 94063, USA Deutschland Hergestellt in...
- Seite 11 ______________________________________________________________________ ______________________________________________________________________ Important 10. La compatibilité entre le matériau de renforcement des lignes d’agrafes et le ® système MicroCutter XCHANGE 30 n’a pas été démontrée. Cette brochure est destinée à faciliter l'utilisation de ce produit et fournit un mode ® 11.
- Seite 12 Fonctionnement du système Nous présentons ici des instructions générales d’utilisation du système. Veuillez vous référer à notre site Web www.cardica.com pour découvrir les vidéos et instructions les plus récentes ou consulter notre équipe commerciale. 3.1. Chargement de l'agrafeuse : ®...
- Seite 13 ______________________________________________________________________ ______________________________________________________________________ 3.3.1.2. Pour repositionner, ramener le curseur de retour vers le bouton de rotation. 3.3.3. Réinitialisation et ouverture : 3.3.3.1. Pour ouvrir les mâchoires de l’agrafeuse, déplacer le curseur de retour vers le bouton de rotation. 3.3.2. Activation : 3.3.2.1.
- Seite 14 Une pointe fine, la Date de péremption dispositif n’est retenue de cartouche ou un déchargeur Cardica, le cas échéant, peut autorisée que par un ONLY servir à pousser la pointe de la cartouche afin de la sortir du canal.
-
Seite 15: Istruzioni Per L'uso
______________________________________________________________________ ______________________________________________________________________ Importante ISTRUZIONI PER L’USO Questo opuscolo ha lo scopo di semplificare l’impiego del prodotto, fornendo ® istruzioni dettagliate per l’uso del dispositivo MicroCutter XCHANGE 30. Non deve essere utilizzato come materiale di riferimento per procedure chirurgiche. Indicazioni ® Il MicroCutter XCHANGE 30 è... - Seite 16 Prima di eseguire qualunque dispositivo. Per le istruzioni e i video aggiornati si consiglia di visitare il nostro sito procedura, consultare la letteratura medica relativa a tecniche, www.cardica.com o di consultare il nostro personale addetto alle vendite. complicanze e rischi.
- Seite 17 ______________________________________________________________________ 3.1.3. Inserire la punta delle ganasce nel trocar, quindi rilasciare il grilletto e continuare a spingere la suturatrice attraverso il 3.3. Azionamento, declampaggio, reimpostazione e ricarica trocar. 3.3.1. Clampaggio: 3.3.1.1. Per clampare le ganasce della suturatrice, premere completamente il grilletto verso l’impugnatura. Per poter procedere con l’applicazione, la suturatrice deve essere clampata.
- Seite 18 Per spingere la punta della cartuccia fuori dal canale, è possibile utilizzare delle pinze a punte sottili, il fermo della cartuccia oppure lo scaricatore Cardica, se fornito in dotazione. Gettare la cartuccia usata. Si vedano le istruzioni sotto riportate.
- Seite 19 Non risterilizzare la risonanza magnetica). ASTM International, 100 Barr Harbor Drive, all’asciutto P.O. Box C700, West Conshohocken, PA, USA. Contattare Cardica, Inc. per ulteriori informazioni. Non utilizzare se la Informazioni sul brevetto confezione è...