SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 28
Appendix B
Outline of Training Program
Operation of this device should only be undertaken by personnel trained in accordance with
the SynCardia Training Program. The training will include the following topics:
1)
Indications and Contraindications
2)
System Overview
3)
Implant Procedures
4)
Operation of the console
5)
Explant Procedures
6)
Patient Management
7)
Summary of Clinical Studies
8)
Animal Procedure – a minimum of one implant needs to be performed.
9)
Practical Experience - Physicians will be required to minimally view
one live implant procedure or have their first procedure proctored.
SynCardia will maintain centers of excellence where surgeons may
view implantations. Further, proctors will be made available by
SynCardia for surgical teams during their first case.
