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Manuals and User Guides for TransMedics OCS Lung System. We have
1
TransMedics OCS Lung System manual available for free PDF download: Clinical User Manual
TransMedics OCS Lung System Clinical User Manual (103 pages)
Organ Care System
Brand:
TransMedics
| Category:
Medical Equipment
| Size: 3 MB
Table of Contents
Table of Contents
3
List of Symbols in this Guide
5
Glossary of Terms
6
Chapter 1: Read this First
9
Directions to User
9
User Training Requirements
9
Patient Counseling
9
Indications for Use
9
Contraindications
9
Warnings and Precautions
10
Conventions
10
Supplies
11
Contacting Transmedics
11
Chapter 2: Overview of Ocs™ Lung System
12
System Components
12
Overview of OCS™ Lung System Preservation Process
12
Overview of Perfusion and Ventilation
12
Clinical Study of the OCS ™ Lung System
13
Chapter 3: Activities Performed before Departure to Donor Site
14
Procedure Overview Checklist
14
Checklists for OCS™ Lung Gas Cylinders
15
OCS™ Lung Solution & Additives Checklists
16
Leukocyte Reduced Packed Red Blood Cells (Prbcs) Checklist
18
OCS™ Lung Perfusion Set Checklists
18
Run Bag Checklist and Contents
19
Transport Considerations
19
Chapter 4: Activities Performed at Donor Site
21
Unpacking, Installation, and OCS™ Lung System Setup
21
Installing the LPM on the OCS ™ Lung System
22
Attaching the Probes
25
Running the OCS ™ Lung System Self Test
27
Preparing the OCS™ Lung System for Lung Instrumentation
28
Harvesting Donor Lungs
33
Draping the Work Area in Preparation for Instrumentation
37
Instrumenting Lungs on the OCS™ Lung System
38
Initial (Baseline) Monitoring Overview
44
Continuous Monitoring Mode
45
Preservation Mode
47
Chapter 5: Activities Performed During Preservation and Transport
49
Preparing for Transport
49
Managing the Lung and OCS™ Lung System During Preservation and Transport
50
Chapter 6: Activities Performed at Recipient Site
52
Final Recruitment in Preservation Mode
52
Final Monitoring/Overview
52
Implantation Decision
55
Lung Preservation Termination
55
Performing the Shut-Down Protocol
60
Preparing the OCS™ Lung System for Shutdown
60
Removing the Probes from Tubing
60
Disconnecting the Ventilator Lines
61
Turning off the Lung Preservation Gas
61
Removing and Disposing of the LPM
61
Preparing the OCS™ Lung System for Storage
62
Steps of Resetting the OCS ™ Lung System
62
Chapter 7: Critical Scenarios and Troubleshooting
63
If PEEP Can Not be Maintained During Preservation Mode
63
If Mean PAP, VR, And/Or PAWP Is Rising at same Ventilation and Perfusion Settings, Manage as Follows
64
Appendix A. Ocs Lung System Inspire Study
65
Appendix B. Body Weight Formula
101
Appendix C. Primary Graft Dysfunction Classification Used in Inspire Trial
102
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