ProductDesignSpecificationFinal-UniversityofPittsburgh.docVIP

Number: PDS-004 Revision: 4 Title: Product Design Specification UNCONTROLLED DOCUMENT UNLESS ISSUED WITH A RED STAMP This document is the confidential property of ECMOre and may not be reproduced without prior written consent. Revision Approvals: Date Originator Desiree Bonadonna 04/18/2004 [Originating dept. approval] Bioengineering 04/18/2004 [Other dept. approval] Electrical Engineering 04/18/2004 Quality Assurance Laura Gilmour 04/18/2004 General Management Apryle Craig 04/18/2004 Purpose To state the problem being addressed by our product. To describe the need for the product. To provide background information that is not common knowledge. Scope Affects all other controlled documents as the originator for those ideas and specifications. References PDS-003 Product Design Specification Problem Background Current Technology Proposal Revision History PDS-001; Revision 1; 11/14/2003 PDS-002; Revision 2; 11/15/2003 PDS-003; Revision 3; 12/04/2003 PDS-004; Revision 4; 04/18/2004 FINAL PROBLEM In order to improve the quality of perfusion device performance, a cost efficient, universal pressure monitor and alarm system is needed. Currently, many different pressure-monitoring systems are in use from analog to digital, and most are not compatible with both roller and centrifugal pumps. BACKGROUND Extracorporeal membrane oxygenation (ECMO) uses an artificial heart-lung machine to take over the work of the lungs. ECMO is used most frequently in newborns and young children for such pathologies as meconium aspiration syndrome, persistent pulmonary hypertension, respiratory distress syndrome, congenital diaphragmatic hernia, pneumonia, heart failure, and respiratory failure caused by trauma, birth defect, or severe infection. This procedure requires cannulas to be placed into the carotid artery and jugular vein to receive and return the blood from the perfusion device. The patient’s blood leaves the body from the jugular vein and flows into the c