I - Description Of The Device - B.Braun CELISTE Instrucciones De Uso

en : Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
es : Este producto sólo debe venderse a médicos o bajo presciptión facultativa
en: The Celsite® Access Port Systems are implantable port and catheter systems that allow safe, repeated access
to the patient's bloodstream. The port chamber and catheter design (See Figure A) can be used for the
administration of medications and fluids. The Celsite® port systems consist of an access port with a silicone
septum, which is connected to a catheter using a connection ring, and implantation accessories. The triangular
shaped port has a low-profile nose, finger stops on the side of the housing, and a round base. Celsite® Access
Ports have suture holes or suture zones to secure placement during implantation. The system is provided sterile
and intended for single use only. Celsite® ports are offered in "standard" or "small" sizes. (A "standard" size has
0.50 or 0.25 mL dead volume of port; a "small" size has 0.15 mL dead volume of port.) The Celsite® access port
family includes the below product lines. Refer to page 13 of this IFU for a complete list of Celsite® reference
numbers and information regarding port/catheter materials, volume, implantation route, and implantation
techniques.
• Celsite® Access Ports (Venous) are standard sized ports manufactured with a low-profile design with
titanium/polysulphone/silicone or titanium/epoxy/silicone materials. Catheters are available in either
polyurethane or silicone materials (REF: 05430425, 05432460, 05433823, 05433750, 05433556, 05436946,
05430095). Some Celsite® ports are available with pre-connected catheters (REF: 05436709, 05436717,
05436725). The Celsite® Dual Venous, Celsite® Brachial, and pediatric Celsite® Babyport® and Celsite®
Babyport® S are included in the product line.
• Celsite® Access Ports (Dual Venous) are standard sized double access ports manufactured with
titanium/epoxy/silicone materials that allow direct connection to a two-lumen silicone catheter. One catheter
connection attaches both lumens of the catheter to the port (REF: 05430100, 05430101).
• Celsite® Access Ports (Brachial Venous) are small sized ports manufactured with titanium/epoxy/silicone
materials and a polyurethane catheter. Celsite® brachial ports are for peripheral implantation in the arm of the
patient (REF: 05433734).
• Celsite® Discreet
TM Access Ports (Venous) are standard sized ports manufactured with a low-profile design with
a left or right off-set exit cannula that permits a vertical incision and a 90 degree port/exit cannula. Celsite®
Discreet
TM ports are manufactured with titanium/epoxy/silicone materials. Catheters are available in either
polyurethane or silicone materials (REF: 05430144, 05430145, 05430146).
• Celsite® Concept
TM
weight design and have three silicone suture areas, which provide the physician with flexibility in suturing.
Celsite® Concept
TM
ports are manufactured with titanium/polysulphone/silicone materials. Catheters are
available in either polyurethane or silicone materials (REF: 05437025, 05437026, 05437028).
• Celsite® Babyport® and Babyport® S (Pediatric Venous) are small sized ports manufactured with
titanium/epoxy/silicone materials. The Babyport® has a 4.5Fr polyurethane catheter; the Babyport® S has a 6Fr
silicone catheter (REF: 05433742, 05433842).
es : Los Sistemas de Acceso Implantables Celsite®, son sistemas de acceso implantables y catéteres que permiten el
repetido acceso, sin riesgo, al torrente sanguíneo de los pacientes (vea figura A). El diseño de la cámara de acceso y el
catéter permite utilizarlos en la administración de medicamentos y líquidos. Las vías de acceso implantadas Celsite®
consiste en una vía de acceso implantada con un tabique de silicona, que esta conectada al catéter usando un anillo de
conexión y accesorios de implante. La vía de acceso implantada de forma triangular tiene una nariz disimulada, soportes
en la parte dorsal de la cubierta, y alrededor de la base. Las vías de acceso implantadas Celsite® tiene orificios suturados
o zonas suturadas para asegurar la colocación durante el implante. El sistema se provee estéril y con la intensión de uso
único. Las vías de acceso implantadas Celsite® se ofrecen el tamaño "regular" o "pequeño" (El "regular" tienen una vía de
acceso implantada de un volumen residual de 0.50 o 0.25mL de vía de acceso el "pequeño" tiene tienen una vía de acceso
implantada con un volumen residual de 0.15 ml de vía de acceso). La familia de los Sistemas de Acceso Implantables
Celsite® incluye las líneas de productos mostradas más abajo. Refiérase a la página 13 de este folleto de información para
una lista completa de los números de referencia Celsite® e información relacionada con los materiales de la vía de acceso
implantada/catéter, volumen, ruta de implante y técnicas de implante.
en (English) : I - DESCRIPTION OF THE DEVICE
es (Spanish) : I - DESCRIPCION DEL DISPOSITIVO
Access Ports (Venous) are standard sized ports manufactured with a low-profile, light
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