sorin Perceval S Gebrauchsanweisung Seite 6

6. STERILITY
The Perceval S prosthesis is sterile if its packaging is sealed and undamaged.
The external surface of the container is not sterile and therefore must not come
into contact with sterile instruments.
WARNING: valves removed from their container but not implanted are no
longer sterile and must not be used. THE PROSTHESIS CANNOT BE REST-
ERILISED. DO NOT USE THE VALVE IF ITS CONTAINER HAS BEEN
OPENED OR DAMAGED.
7. ACCESSORIES AND MATERIALS FOR DEVICE PREPARATION AND
IMPLANTATION
The accessories for implanting the Perceval S prosthesis are:
- Sizers, designed to assist the physician in choosing the correct size of prosthe-
sis.
- Holder, indicated for the in situ positioning and deployment of the prosthesis.
- Collapsing tool, designed to evenly reduce the diameter of the prosthesis thus
allowing its mounting on the holder prior to implantation.
- Collapsing tool base, designed to allow proper positioning of the collapsing
tool and holder thus simplifying the prosthesis preparation procedure.
- Postdilation catheter, a balloon catheter indicated for in situ dilation of the
prosthesis after implantation.
WARNING: read the instructions for use enclosed in the packaging of the
accessories.
Sizers
Collapsing tool
Base for collapsing tool
Holder
Postdilation catheter
4
PVS21
ICV1151
ICV1140
ICV1148
Table 2: Perceval S accessories
PVS23
ICV1219
ICV1152
ICV1150
ICV1141
ICV1149
PVS25
ICV1178
ICV1142
ICV1170