Operating Principle; Overview - Boston Scientific EKOS Control System 4.0 User Manual

The Control Unit provides electrical energy to the transducers of the Ultrasonic Core and monitors the device temperature during ultrasound
therapy� The temperature data is used to automatically optimize ultrasound therapy to the treatment area� The Control Unit also allows the
operator to monitor, control and troubleshoot operation of the device�
The ultrasound therapy delivered during operation disperses the solutions delivered into the treatment area via the Infusion Catheter� The
solutions are controlled by user supplied infusion pumps or syringes�
Precaution: This document provides instructions for operating the Control Unit, as well as configuration, maintenance and troubleshooting
information� It is important that all persons using the Control Unit read and understand all the information contained in these instructions
prior to use�

Operating Principle

The EKOS Endovascular System generates ultrasonic waves at the Infusion Catheter treatment zone through the piezoelectric transduction
of radio-frequency (RF) energy generated by the Control Unit� The ultrasound emanates radially from the treatment zone into and through
blood, thrombus, or tissue surrounding the treatment zone, within the patient's vasculature� The ultrasound acts locally to increase the
dispersion of the delivered solutions into the treatment region�
In addition to generating the prescribed ultrasound therapy profile, the Control Unit continually monitors output power and temperature of
the EKOS Device� The system has safeguards to prevent deviation of these parameters from preset ranges�

Overview

This section provides a basic orientation to the Control Unit controls, components, connectors and screens� The Control Unit is comprised of
a single display with an integrated touch screen and a set of hard controls� The display/touch screen and the hard controls are configured to
operate up to two EKOS Devices� These devices can deliver ultrasound therapy simultaneously, yet are controlled independently�
Table 1.
Component
Connector Interface Cable:
Used to connect the Infusion Catheter and Ultrasonic Core to the Control Unit
Note: This is sometimes referred to as the CIC�
Infusion Catheter:
Connects to the Connector Interface Cable� The Infusion Catheter is a multi-lumen catheter that
delivers physician specified fluids into the vasculature�
Ultrasonic Core:
Connects to the Connector Interface Cable� The Ultrasonic Core incorporates up to thirty fully
encapsulated, radiopaque piezoelectric ceramic ultrasound transducers along the distal length of the
shaft� The transducers emit ultrasound therapy radially along the axis of the treatment zone�
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Description
Black (K) ∆E ≤5.0