General Information
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EkoSonic™ Device
The EkoSonic™ Device (device) is a single-use sterile device, consisting of a multi-
lumen Infusion Catheter and an Ultrasonic Core that contains multiple transducers. The
Infusion Catheter delivers the specified solutions to the target area while the
transducers simultaneously deliver ultrasound therapy to the same location.
See the
EkoSonic™ Device Instructions for Use
to get detailed information on
preparation and placement of the EkoSonic™ Device. The instructions for use
packaged with the EkoSonic™ Device may still reference both Control System 4.0 and
the previous EkoSonic™ Control System (PT-3B) or may reference only the PT-3B
Control System. All EkoSonic™ Devices will function as intended whether connected to
a PT-3B Control System or Control System 4.0.
EKOS™ Control System 4.0
The Control System 4.0 includes a portable Control Unit and reusable Connector
Interface Cables. The Control Unit has two ports or channels for Connector Interface
Cable connections. The channels are labeled A and B and can provide energy for up to
two devices at the same time.
The Control Unit should be connected to AC power during operation, but has an internal
lithium-ion battery to power the Control Unit temporarily during patient transport.
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.
Caution
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.
The Control Unit is designed to be operated by trained medical personnel who have
knowledge of endovascular therapy and who are responsible for direct patient care in
the setting of the Cardiac Cath Lab, Interventional Radiology Lab, Critical Care Unit,
Cardiac Care Unit, or other areas of the hospital where the unit is used. All Control Unit
Summary of Contents for EKOS
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