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General| Device Type | Organ Care System |
|---|---|
| Organ Type | Lung |
| Preservation Method | Normothermic Perfusion |
| Transport Method | Portable System |
| Category | Medical Equipment |
| Device Name | TransMedics OCS Lung System |
| Regulatory Approvals | FDA Approved, CE Marked |
| Power Source | Battery and AC power |
| Intended Use | Preservation and assessment of donor lungs for transplantation |
| Perfusion Type | Continuous Perfusion |
| Temperature Control | Maintains normothermic conditions |
| Monitoring | Real-time monitoring of lung function |
| Purpose | To preserve and assess donor lungs |
| Technology | Normothermic ex-vivo lung perfusion |
| Portability | Yes |
| Perfusion Medium | Oxygenated perfusate solution |
Lists critical safety warnings and precautions for system operation and patient safety.
Instructions for unpacking and setting up the OCS™ Lung System.
Instructions for the process of instrumenting donor lungs onto the system.
Monitoring lung parameters and system status during transport.
Guidance for resolving issues with PEEP maintenance during preservation.
Management steps for rising PAP, VR, and PAWP at constant settings.
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