PHYSICIAN TRAINING

Urologists require appropriate training for the safe and effective use of Ablatherm. A physician who has not completed Phase III of the Ablatherm Physician Training Program is not permitted to use the Ablatherm clinically without the Assistance of a Trainer. A user license is issued when the program is completed. The user license is valid for a physician not for a site. Ablatherm procedures at a site must be performed by a licensed user or under the supervision of a Trainer.

HIFU solution will provide all the necessary training as part of its on going commitment to Urologists who sign up for use of HIFU Solution services. HIFU Solution has a technical team that is the envy of the industry with a technicians who have performed over 500 cases, and are the most experienced technicians in the US. They have also worked with all different types of cases including: focal therapy, hemi therapy, whole gland therapy, radiation failures, and the rare cases of repeat HIFU. During the course of these cases they have seen all the potential problems and the required machine adjustments to ensure an uneventful experience with patient therapy and physician training. HIFU Solution will also provide experienced proctors as required by FDA and EDAP. HIFU Solution currently conducts monthly training at its Ocala and Washington DC centers and many urologists have attended these training courses. Training is provided free of cost for HIFU Solution members.

Ablatherm training will be conducted in three phases:

PHASE I: Ablatherm® Introduction

The purpose of this training phase is to:

  • Provide the Trainee with a general view of the treatment process from patient selection to clinical follow-up.

  • Prepare the Trainee for the integration of the Ablatherm® Robotic HIFU into the hospital/clinic (i.e. management of the operation room).

  • Provide the Trainee with basic knowledge of the System and the treatment procedure.

  • The Trainee will obtain the basic knowledge of the System and treatment procedure through didactic training and observation of a training video or a live procedure.

Phase I components:

  • User Manual: Trainee has been given the User Manual either physically or electronically.

  • Didactic Training: Trainee underwent didactic training from a Proctor in person, via webinar or online. This training covered important sections of the User Manual including patient selection, procedure description and follow-up.

  • Case Observation: Trainee will either observe a video highlighting the fundamental procedure steps or observe a live procedure.

PHASE II: Physician Proctoring

The purpose of this training phase:

To familiarize the Trainee with treatment strategy and safety features of the system. The completion of this treatment phase, in addition to completion of phase I, will allow the Trainee to perform treatments with the Ablatherm® Robotic HIFU under the supervision of a Trainer.

Proctoring: The Trainee will perform at least two HIFU procedures under the guidance of a Proctor. During this phase, a Proctor must be physically present for the duration of the procedures.

 

PHASE III: HIFU Procedure with a Trainer

The purpose of this training phase:

To further familiarize the Trainee with treatment strategy and safety features of the Ablatherm® Robotic HIFU in order to ensure that the Trainee is ready to treat patients independently in his own Clinical Site.

Trainer Assistance: The Trainee will perform at least four HIFU procedures under the guidance of a Trainer. During this phase, a Trainer must be physically present during the procedures.

DEFINITIONS

Proctor: A physician who has previously been trained on Ablatherm® Robotic HIFU, is a current user of Ablatherm® Robotic HIFU for the ablation of prostatic tissue and is certified by EDAP as a Proctor.

Ablatherm® Reference Site: Proctor’s Clinical SiteTrainer: A Proctor and/or a Level III Application Specialist who is certified by EDAP for the set-up, operation, maintenance and physician training of Ablatherm® Robotic HIFU.

Trainee: A licensed physician being trained on the use of the Ablatherm® Robotic HIFU for the ablation of prostatic tissue.

Trained Physician: A physician who has completed Phase III Ablatherm® Robotic HIFU training and possesses a certificate memorializing the completion of their training.

Operator: A qualified medical professional by training and experience to conduct prostate ablation procedures, to conduct patient care, or to operate software-driven, electrical medical equipment for procedures requiring patient sedation or anesthesia. Operators of the Ablatherm® Robotic HIFU will include users, operating room nurses and medical device technicians.

For further information on Training contact Gerry Schuster Vice President of Sales HIFU Solution.

DR NARAYAN AT    NFLUA.HIFU@GMAIL.COM

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