SynCardia TAH-t, Инструкция по эксплуатации

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SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc. Page 2
Table of Contents
Page
1.0 Device Description .…………………………………………...…... 3
1.1 Implantable TAH-t…………………………...………...…… 3
1.2 External Console………………………………….….......... 4
2.0 Indications for Use ………………………………………....…..… 4
3.0 Contraindications ………………………………………………... 4
4.0 Warnings ...........................………………………………………. 5
5.0 Precautions ……………………………………………........…..... 6
6.0 Summary of Clinical Study ……………………………………… 7
6.1 Trial Success……………………………………………….. . 7
6.2 Hemodynamics……………………………………………….. 7
6.3 Adverse Events……………………………………………….. 8
6.4 TAH-t Reliability……………………………………………….. 9
7.0 Implant Procedures .......................................................................... 10
7.1 Materials Needed but not Provided………………………… 10
7.2 Preparation.............................................................................. 11
7.3 Removal of Native Ventricles................................................. 11
7.4 Preparing the Atria................................................................... 13
7.5 Outflow Connectors.................................................................. 15
7.6 Connect Artificial Ventricles.................................................... 16
8.0 Operator’s Manual for Console ………………………………… 20
8.1 Warnings for Console Operation…………............................. 20
8.2 Readying Console for Clinical Use............................................ 21
8.3 TAH-t Startup Procedure...................................................……… 21
9.0 Explant Procedures …………………………………...……...…… 23
10.0 System Components ............................................................................. 24
Appendix A: Patient Selection and Management ……………………………….. 25
Patient Selection...……………………………....…...…….……………… 25
Anticoagulation………………………………..…......…………….....…... 25
Exit Site…………………………………………………………………… 26
Appendix B: Outline of Training Program …………………………………….. 27
Appendix C: Materials Matrix
…………………………………………………… 28