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mviceconti63
09-13-2001, 05:31 PM
Referring to message from Dr. Rassoulian, I agree this is an important
issue to be considered. In fact, our announcement Ton van den Bogert
forwarded to the list presents a disclaim which warns about this aspect:

** Disclaim **
Hip-Op(c) has not been certified for clinical use, yet. Currently it is
intended for educational and investigational purposes only. Please read
carefully the license agreement for more information.

Hip-Op is a research and teaching software. In the license agreement it is
made clear that:

SOFTWARE is intended for educational and investigational purposes only.
Thus, NO medical decision should be based on results provided by SOFTWARE.
Under no circumstances shall SOFTWARE be used as a clinical diagnostic
tool. To be sure the user is aware of this aspect we placed a warning in
this sense also in the splash screen which appears at program start-up.


Furthermore as for any free software we apply the following clause:

SINCE THE SOFTWARE IS PROVIDED FREE OF CHARGE, THE SOFTWARE IS PROVIDED ON
AN "AS IS" BASIS. ACCORDINGLY, IOR DOES NOT MAKE AND HEREBY EXPRESSLY
DISCLAIMS, ANY AND ALL REPRESENTATIONS OR WARRANTIES OF ANY KIND WITH
RESPECT TO THE SOFTWARE, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND
NON-INFRINGEMENT, AND ANY WARRANTY WITH RESPECT TO THE ACCURACY OR
APPLICABILITY OF THE SOFTWARE OR OF DATA OR ALGORITHMS CONTAINED IN THE
SOFTWARE.

To conclude, not every thing a surgeon use must be certified. I quite sure
that the planning template any surgeon use to plan a THR do not carry any
CE mark or other certification. This because no matter how he or she plans
it, the surgical procedure is controlled by the surgeon and not by the
software.

Thank you for your comment.

Regards


Marco


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MARCO VICECONTI, PhD (viceconti@tecno.ior.it)
Laboratorio di Tecnologia Medica tel. 39-051-6366865
Istituti Ortopedici Rizzoli fax. 39-051-6366863
via di barbiano 1/10, 40136 - Bologna, Italy

Tiger! Tiger! Burning bright in the forest of the night,
what immortal hand or eye could frame thy fearful symmetry?
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Opinions expressed here do not necessarly reflect those of my employer

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