Sorin Remote Access Perfusion (Rap); Femoral Venous Cannula; English - SORIN GROUP 200-100 Mode D'emploi

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Federal (USA) law restricts this device to sale by or on the order of a physician.

PRODUCT DESCRIPTION

The Sorin Remote Access Perfusion Femoral Venous Cannula (RAP FV) is a single use sterile device. See

package labeling for French size. The RAP FV Cannula is a wire reinforced polymer tube used to deliver venous

blood from the body to the cardiopulmonary bypass circuit. The distal sections of the cannula are perforated with

multiple holes to allow entry of the blood to the cannula. The clear proximal section is not reinforced to allow

clamping. The proximal end terminates in a 1/2 inch (12.7 mm) barbed connector for connection to standard

cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a central

lumen to accommodate a 0.035 inch (0.89 mm) guidewire. Each component is packaged inside a protective

sheath in a single sterile, sealed pouch. The following cannula sizes are available:

Remote Access Perfusion (RAP) Femoral Venous Cannula

Catalog No.

200-100

22 French:

0.29 inch (7.3 mm)

200-150

23 French Distal / 25 French Proximal:

0.30 inch (7.7 mm) Distal / 0.33 inch (8.3 mm) Proximal

INDICATION FOR USE

The Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during

cardiopulmonary bypass for up to 6 hours.

WARNINGS

This device is only intended to be used by professionally trained personnel. Proper surgical procedures

and techniques are necessarily the responsibility of the medical professional. These instructions are

furnished for informational purposes only. Each surgeon must evaluate the appropriate use of this

device, case by case, based on medical training, experience, and the type of surgical procedure

employed.

For single use and for single patient use only. During use, the device is in contact with human blood,

body fluids, liquids or gases for the purpose of eventual infusion, administration or introduction into the

body and due to its specific design, it cannot be fully cleaned and disinfected at the end of use.

Therefore, reuse on other patients might cause cross-contamination, infection and sepsis. In addition,

reuse increases the probability of product failure (integrity, functionality and clinical effectiveness).

If used on children, pregnant or nursing women, be aware that this device contains di(2-ethylhexyl)

phthalate (DEHP) that is presently classified in the European Union as toxic to reproduction. The amount

of phthalate which might be released from the device does not raise specific concerns about residual

risks. Further information is available on request.

Do not use this device if package is damaged or opened.

Never use a device if it is beyond its expiration date.

Do not use this device if it shows signs of damage, e.g., crimps, kinks, or crushed areas.

This cannula is for short term use only (<6 hours).

Do not cut or alter the cannula in any way. Cutting the cannula could release particulate matter which

may be thrombogenic or embolic and may render the device unusable.

Ensure that the vessel used is of adequate diameter to allow sufficient insertion of the cannula.

Sorin Group USA, Inc.

966100702, Rev. C

Instructions for Use