SORIN GROUP 200-100 Mode D'emploi page 3

Removal should always be done under visualization.
Handle with care after use as the product may be contaminated with blood and/or body fluids. Dispose of
in accordance with applicable regulations in the country of use.
DO NOT REUSE. DO NOT RESTERILIZE.
PRECAUTIONS
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Verify all connections are secure prior to use.
Prior to use, insert obturator firmly into cannula so that it is fully seated.
INSTRUCTIONS FOR USE
Sterile Contents/Non-Pyrogenic Fluid Pathway unless package is opened or damaged. Sterilized with Ethylene
Oxide.
1 Using aseptic technique, remove the RAP FV Cannula from sterile packaging and place in the sterile field.
2 Femoral bypass cannulation is accomplished either by direct vision via cut-down or by standard Seldinger
technique.
WARNING: Ensure that the vessel used is of adequate diameter to allow sufficient insertion of the
cannula.
3 Insert obturator into cannula prior to use. Obturator should fit snuggly into and adjacent to the barbed
connector of the cannula.
4 Advance the obturator/cannula over the guidewire. Do not advance against significant resistance.
5 Remove the obturator and guidewire.
6 Following removal of the obturator, the cannula may be clamped in the area between the wire reinforcement
and the barbed connector, prior to connection to the extracorporeal circuit.
DISPOSAL
Handle with care after use as the product may be contaminated with blood and/or body fluids. Dispose of in
accordance with applicable regulations in the country of use.
RETURN OF USED PRODUCTS
If for any reason this product must be returned to Sorin Group USA, Inc., a returned goods authorization (RGA)
number is required from Sorin Group USA, Inc., prior to shipping.
If the product has been in contact with blood or body fluids, it must be thoroughly cleaned and disinfected before
packing. It should be shipped in either the original carton, or an equivalent carton, to prevent damage during
shipment; and it should be properly labeled with an RGA number and an indication of the biohazardous nature of
the contents of the shipment.
Instructions for cleaning and materials, including appropriate shipping containers, proper labeling, and an RGA
number may be obtained from the Sorin Group USA, Inc. Returned Goods Coordinator, Quality Assurance
Department (800-650-2623).
Sorin Group USA, Inc.
966100702, Rev. C
For Customers within the United States
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