Medtronic Custom Pack Instructions D'utilisation page 9

Medtronic Custom Pack
Instructions for Use
Description
The design and components of this product are specified by the user. For more information
and instructions regarding the components in this pack, please read the instructions for use
of the involved devices.
Indications
The Medtronic Custom Pack is indicated for use in the extracorporeal circuit during
cardiopulmonary or other bypass procedures.
Contraindications
This device is not designed or intended for use except as indicated.
Warranty disclaimer
This product may, at the customers' request, contain products manufactured by other
suppliers than Medtronic. Medtronic does not verify the safety or efficiency of such
components, or intend the use of any component for a purpose not included in the labeling
of the original manufacturer.
Warnings and precautions
1. Contents are sterile and non pyrogenic. Do not use devices if packaging is opened or
damaged.
2. If a roller pump is used: Make sure the tubing is properly positioned and occluded in
the roller pump head and that there is no excess tubing in the pump head.
3. Do not lubricate silicone tubing with silicone fluid or grease since these may swell and
weaken the tubing.
4. Leaks in the extracorporeal circuit can cause blood loss or air embolism. Check for
leaks during priming and during the bypass procedure. Band potentially high-pressure
connection sites.
5. Due to the presence of phthalates in the product, the clinician must weigh the medical
benefits of product use against the drawbacks of phthalate exposure for male children
and pregnant or nursing women.
6. This device was designed for single patient use only. Do not reuse, reprocess, or
resterilize this product. Reuse, reprocessing, or resterilization may compromise the
structural integrity of the device and/or create a risk of contamination of the device,
which could result in patient injury, illness, or death.
Instructions for use
1. Remove the product from the packaging using aseptic technique.
2. Inspect the set for any obvious defects in materials or assembly.
3. Connect all components to form an extracorporeal system using aseptic technique.
Check all luer locks and fittings. Do not overtighten them.
4. Prime the circuit. To prime the components of the circuit, refer to their respective
instructions.
English 9