Overview
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operators should receive in-service training from an authorized EKOS™ trainer before
operating this equipment.
Intended Use
The Control Unit is intended exclusively for use with EKOS™
Devices.
Contraindications
See the EkoSonic™ Device Instructions for Use to get detailed information on
contraindications for EKOS Devices.
Principles of Operation
The EkoSonic™ 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 EkoSonic™ 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 EkoSonic™ Devices. These devices
can deliver ultrasound therapy simultaneously, yet are controlled independently.
Component Glossary
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.
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