sorin Perceval S Gebrauchsanweisung Seite 15

- After Perceval S implantation, manipulation of the heart should be avoided; if
this is not possible take care not to touch the aortic root, as this may drive to
unknown effects on the implanted valve, including displacement.
- Surgery training is mandatory for the correct prosthesis positioning and implant.
13. IMPLANT CARD
Every prosthesis is supplied with a patient's card that identifies the bearer and the
prosthesis. This enables the surgeon to give the patient a document containing
concise but comprehensive data about the operation and the implanted valve,
which can be used whenever this information needs to be provided.
14. MRI INFORMATION
Non-clinical testing demonstrated that the Perceval S is MR Conditional. A patient
with this device can be scanned safely immediately after placement under the fol-
lowing conditions:
- Static magnetic field of 3 Tesla or less
- Maximum spatial gradient magnetic field of 720 Gauss/cm or less
In non-clinical testing, the Perceval S produced a maximum temperature rise of
1.8°C during MRI performed in a 3 Tesla MR system for 15 min. The reported
whole body averaged SAR was 2.9 W/kg.
MR image quality may be compromised if the area of interest is in the exact same
area or relatively close to the position of the Perceval S.
15. WARRANTY
Sorin Biomedica Cardio guarantees that the Perceval S prosthesis is designed,
manufactured and packaged with all possible care, using the most suitable state
of the art processes and applying the principle of integrating safety into its design
and manufacture. This system is designed to guarantee the safe use of the
device when it is employed under the conditions and for the purposes for which it
is intended, in accordance with the precautions described in the previous para-
graphs, and to minimize the risks associated with the use of the device as far as
possible, although they cannot be totally eliminated. The device must only be
used under the responsibility of specialized medical personnel, taking into
account the unavoidable risks and the possible side effects and complications of
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