ProDigiDent (the Manufacturer) provides the ImplaStation software product (hereinafter – the Software) for dental implantation and surgical guides planning.
Users can not make changes to the policies, design, program components of the Software.
The Software is intended for use by qualified users.
Before using, users should be familiar with the User Manual.
Before starting, the user must ensure that the Software is installed and functioning correctly.
The manufacturer is not responsible for the quality of the user-planned treatment in the Implastation planning program.
The Manufacturer is not responsible for the results of the patient’s treatment.
The Manufacturer assumes no responsibility for damage or injury that may arise as a result of user’s planning and treatment.
The user assumes all responsibility for the use and results of using the Software;
The user assumes all responsibility for monitoring the implementation of various phases associated with the Software use and subsequent phases associated with the results of the Software use.
Before surgical guide creation, the user must be satisfied in correctness of his planning in stages.
The user understands that ignoring certain steps and criteria can lead to incorrect planning and unusable surgical guides.
In particular, the following should be done:
– The user must ensure that the DICOM and STL files downloaded into the Software are up-to-date, with sufficient visualization quality for implant treatment planning;
– The user must ensure that the alignment of surfaces, if carried out, is performed accurately and correctly;
– The user must ensure that the marking of the mandibular canal and critical zones has been carried out correctly;
– The user must ensure that during the implant position planning, there is no collision of the implant and its elements with the mandibular canal, other implants, teeth and other anatomical structures;
– The user must ensure that the planning was carried out carefully, the most appropriate implant and related elements were selected, the safety zone was taken into account towards the existing teeth, dental restorations, main anatomical structures and the proposed final restoration solution;
– The user must be satisfied with the medical and clinical aspects of his planning;
– The user should know and understand the peculiarities of use of surgical and related instruments intended for use during operation;
– The user should be familiar with the technical limitations that govern the manufacture of the surgical guide;
– The user confirms that he will check the quality, functions of the surgical guide before performing the operation;
– The user confirms that the surgical guide is designed correctly, ensures a stable and firm fit throughout the operation, fulfills the intended functions;
– The user should familiarize himself with the surgical protocol before the operation and check the compliance of the information in the protocol to the planned operation and the tools intended for use.
The requirements of these conditions, the protocols created by the Software and other information arising and taken into account when working with the Software, should be considered as an addition to the requirements of legislation and other documentation related to implantation, does not replace or abolish other documents.