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  • Re: Surgical Planning Software

    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


    --------------------------------------------------
    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?
    --------------------------------------------------
    Opinions expressed here do not necessarly reflect those of my employer

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