Table Des Matières - St.Jude Medical PRT-23 Mode D'emploi

TabLE OF CONTENTS
DESCRIPTION .......................................................................................................................................................................2
Portico™ Valve ...............................................................................................................................................................2
Portico™ Transfemoral Delivery System ("Delivery System") .................................................................................2
Portico™ Transfemoral/alternative access Loading System ("Loading System") ................................................3
INDICaTIONS ........................................................................................................................................................................3
CONTRaINDICaTIONS .........................................................................................................................................................3
waRNINGS ............................................................................................................................................................................4
PRECaUTIONS .....................................................................................................................................................................4
Pre-Implantation Precautions .......................................................................................................................................4
Implantation Precautions ..............................................................................................................................................4
Post-Implantation Precautions .....................................................................................................................................4
MaGNETIC RESONaNCE (MR) SaFETy ............................................................................................................................4
1.5T Radio Frequency (RF) heating .............................................................................................................................4
3.0T RF heating ..............................................................................................................................................................4
MR artifacts ....................................................................................................................................................................4
POTENTIaL aDVERSE EVENTS .........................................................................................................................................4
REqUIRED MaTERIaLS/EqUIPMENT ................................................................................................................................5
PaCKaGING aND STORaGE ..............................................................................................................................................5
Valve ................................................................................................................................................................................5
Delivery System/Loading System ................................................................................................................................5
DIRECTIONS FOR USE ........................................................................................................................................................6
Pre-Implant handling .....................................................................................................................................................6
Removing the Valve from the Outer Packaging .........................................................................................................6
Removing the Valve from the Storage Container .......................................................................................................6
Rinsing the Valve ...........................................................................................................................................................6
Compressing the Valve in the Loading System .........................................................................................................6
Loading the Valve on the Delivery System ................................................................................................................6
Implanting the Valve ......................................................................................................................................................7
PaTIENT REGISTRaTION .....................................................................................................................................................8
INDIVIDUaLIZaTION OF TREaTMENT ................................................................................................................................8
Patient Counseling Information ..................................................................................................................................8
DISPOSaL .............................................................................................................................................................................8
LIMITED waRRaNTy ...........................................................................................................................................................8
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