TransMedics® Organ Care System™
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TransMedics® Organ Care System™ Clinical User Guide: OCS™ Lung System Software Version 3.1.2 PN 100004071 Rev 5 REF 2102 © 2018 by TransMedics, Inc. All rights reserved. Printed in U.S.A.

Manufacturer’s Address: TransMedics, Inc. 200 Minuteman Rd., Suite 302 Andover, MA 01810, USA Tel: +1 978 552 0999 Fax: +1 978 552 0978 Website: www.transmedics.com 0086 This device complies with the Medical Device Directive 93/42 EEC. Authorized EU Representative: Healthlink Europe BV De Tweeling 20-22 5215 MC’s Hertogenbosch The Netherlands Tel: +31-(0) 13-5479316 Patents: U.S. Patents 6,046,046, 6,100,082; International Patents EU, UK, FR, ES, IT, BE, DK, FI, IE, LU, MC, NL, PT, CH, SE 1017274, DE 69819759.3-08, AU728233, ATE253819; Additional Patents Pending. Manual PN & Rev PN...

CHAPTER 5: ACTIVITIES PERFORMED DURING PRESERVATION AND TRANSPORT49 5.1. 5.2.

LIST OF SYMBOLS IN THIS GUIDE Symbol Meaning Run/Standby button on Wireless Monitor Wireless Bluetooth link between the Wireless Monitor and the OCS™ Lung Console ON position for OCS™ Lung Console Pause Preservation mode icon on the Wireless Monitor screen Preservation mode icon on the Wireless Monitor screen Continuous Monitoring mode icon on the Wireless Monitor screen Bronchoscope Monitoring mode icon on the Wireless Monitor screen Pump Adjust button on Wireless Monitor Main configuration button on Wireless Monitor

GLOSSARY OF TERMS Term Bronchoscope Mode Ventilation of the lungs with ambient air, to allow endoscopic examination of lung’s airways Bronchoscope Port Port on the Lung Perfusion Module through which a Bronchoscope probe may be inserted to inspect the interior of the lung Refers to the perfusate loop in the Lung Perfusion Module Continuous Monitoring Mode The Ventilator Mode in which the OCS™ Lung System continuously deoxygenates the perfusate by supplying Lung Monitoring Gas into the gas exchanger. At the same time, ambient air is used to ventilate the lung. Medical professionals may...

Glossary of Terms Term Pause Preservation Mode A Ventilator mode in which the bellows remain stationary and the OCS™ Lung System achieves a static level of lung inflation. Pause Preservation enables oxygenation of perfusate prior to lung instrumentation using the Lung Preservation Gas. Peak Air Way Pressure. The peak pressure in the lungs at the end of the inspiration. When the measured PAWP reaches the user-set PAWP limit, the Ventilator will stop. PAWP corresponds to Peak Inspiratory Pressure on mechanical Ventilators. Positive End Expiratory Pressure. The pressure maintained in the lungs...

Glossary of Terms Term Oxygen saturation of venous (deoxygenated) perfusate, expressed as a percentage and measured at the inflow to the lung on the PA line An OCS™ Lung System probe that you attach to the Lung Perfusion Module. It is used to measure the venous oxygen saturation and hematocrit of the perfusate entering the lung through the pulmonary artery cannula. Temperature of perfusate supplied to the lung, displayed on the Wireless Monitor in degrees Celsius Tidal Volume. The volume of air breathed in and out of the lungs during a respiration cycle. Vascular Resistance. This is a...

Chapter 1: Read this First CHAPTER 1: READ THIS FIRST This chapter contains important information about the documentation for your TransMedics® Organ Care System (OCS™) and about contacting TransMedics. This manual provides detailed instructions regarding clinical use of the OCS™ Lung System. For a system overview, how to set up the system, and understanding the Wireless Monitor controls and functions, see the TransMedics Technical User Guide: OCS™ Lung System. Both guides are to be reviewed prior to using the system, noting the Warnings and Cautions throughout the guides. The OCS™ Lung...

Chapter 1: Read this First WARNING— Only trained users are allowed to use the OCS™ Lung System. WARNING—Safety and effectiveness of the OCS™ Lung System for marginal/extended criteria lungs, including donor lungs subjected to extended preservation times, have not been studied in the INSPIRE trial. PRECAUTIONS— The safety and effectiveness of the OCS™ Lung System has not been studied in recipients with the following: • Single lung transplant Prior solid organ or bone marrow transplant Multi-organ transplants Chronic use of hemodialysis or diagnosis of chronic renal failure requiring...

Chapter 1: Read this First The components, accessories, and supplies required when using the OCS™ Lung System must be used in accordance with this user manual, associated documents, and accepted medical standards. CAUTION—Only accessories and supplies purchased from or recommended by TransMedics, Inc. are to be used with the TransMedics OCS™ Lung System. Use of accessories and supplies other than those supplied by or recommended by TransMedics may cause system malfunction and invalidate the TransMedics warranty. For details on what is included with your OCS™ Lung System, see the TransMedics...

Chapter 2: Overview of OCS™ Lung System CHAPTER 2: OVERVIEW OF OCS™ LUNG SYSTEM The TransMedics® Organ Care System (OCS™) Lung System is a portable organ perfusion, ventilation and monitoring medical device intended to preserve donated lungs in a near physiologic, ventilated, and perfused state for transplantation. The OCS™ Lung System enables medical professionals to continuously monitor key parameters that may be useful in assessing organ condition and function according to their clinical judgment. System Components The system consists of the following major components: 1. Lung Console:...

Chapter 2: Overview of OCS™ Lung System Figure 2.2: Circulation and Ventilation Overview Clinical Study of the OCS™ Lung System The safety and effectiveness of the OCS™ Lung System was studied in a large randomized, controlled, multi-center study. A summary of the study and the results are provided in Appendix A of this document. NOTE—It is essential that you carefully review the study results in Appendix A: OCS™ Lung System INSPIRE Study. If you have any questions about these results, please contact TransMedics.