 All Investigators using the DLS in the registry must be trained on the registry device, the registry protocol requirements, national regulations and requirements of the ISO 14155 prior to becoming involved in the patient registry and include their curriculum vitae CV in the Investigator file with a copy for the Sponsor TMF. This training shall be documented by the CRA andor the Principal Investigator on the site personnel log along with the authorized tasks the Principal Investigator delegates to each team member and an identification of signature. 