Organ Chamber™ Leaflet
Single-use, sterile disposable container
The Organ Chamber™* is a single-use, sterile disposable container intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
The chamber is made of PETg and the slot enclosures are made of TPE, which is a USP Class VI biocompatible material free from phthalate plasticizers DEHP and latex.
The transparent lid allows for visual inspection during the EVLP process. Designed to aseptically hold the lungs and to prevent moisture loss, the Organ Chamber™ allows the transplant team to inspect the lung without interfering in the procedure. If needed the lid can easily be opened and the lung inspected.
With pre-cut openings for tubing and drainage ports, the Organ Chamber™ works together with the Lung Cannula Set™ to support enough traction on cannulas. The cannula positions should be checked and especially a gentle traction on the LA cannula is applied to assure good patency of pulmonary veins.
The Organ Chamber™ is opened in a sterile fashion and isolated lungs are placed onto the round base section. Some centers use a cotton lap sponge placed beneath the lung to prevent excessive sliding or displacement in the chamber once ventilation starts3.
Tubing connected to the lungs are attached through the lid slots. The loose (front) lid portion is attached to aseptically sealopening and prevent moisture loss.
Endotracheal tube is passed through opening cutout near base. Tubing for drainage or other container to drain port is attached to catch any residual fluid.
Once appropriate tubing connections have been established, the lungs are connected to the extracorporeal circulation system and evaluation of lung function according to established clinical routines can commence1,2.
After the procedure the chamber is disposed according to hospital standard routines.
To order: REF 19020; 1 box
Content: 1 Organ Chamber™ – base and lid
Packaging: Sterile poly bag, 2 layers of sterile blue surgical wrap.
Storage: Store at room temperature. Use only unopened and undamaged packages.
Shelf life: At least three months from date of shipment.
Intended Use: The Organ Chamber™ is a single-use container intended to be used as a temporary receptacle for isolated lungs in preparation for eventual transplantation into a recipient.
Properties: Sterility assurance level 10-6
Bacterial Endotoxins (LAL assay) EU/device <20
*Humanitarian Device. Authorized by Federal law in the USA for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation. The effectiveness of this device for this use has not been demonstrated.